Friday 31 August 2012

Umecta Nail Film



urea

Dosage Form: topical film
Umecta Nail Film

Description





Rx only

For topical use only

Not for ophthalmic use


Umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin.  Each gram of Umecta 40% Nail Film suspension with applicator and pen applicator contains urea (40%), disodium EDTA, glycerin, hydroxyethylcellulose, PEG-6 caprylic/capric glycerides, purified water and xanthan gum.






Clinical Pharmacology




Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate which can result in the softening and eventual debridement of the nail plate.

Pharmacokinetics


The mechanism of action of topically applied urea is not yet known.



Indications and Uses


For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful

for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.



Contraindications


Known hypersensitivity to any of the listed ingredients.

Warnings


For external use only. Avoid contact with eyes, lips or mucous membranes.





Precautions


This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

Pregnancy Category C


Animal reproduction studies have not been conducted with Umecta. It is also not known whether Umecta can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Umecta should be given to a pregnant woman only if clearly needed.

Nursing Mothers


It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Umecta is administered to a nursing woman.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.



Adverse Reactions


Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing the medication.



Dosage and Administration


Apply Umecta 40% Nail Film suspension to diseased or damaged nail tissue or skin twice per day, or as directed by a physician. Cover with adhesive bandage or gauze, secure with adhesive tape. An additional option is to remove a “finger” from a plastic or vinyl glove and slip it over the bandage-covered site. Secure glove finger with additional adhesive tape.

How Supplied


Umecta® 40% Nail Film (urea, 40%) suspension is available in a:


18 ml bottle - with applicator NDC 68712-010-01


Box of 6 - 3 ml - pen applicators NDC 68712-010-03


Store at controlled room temperature 15-30°C (59-86°F).

Protect from freezing.

Manufactured for:


Innocutis Holdings LLC

Charleston, SC 29401

Toll Free: 1-800-499-4468

www.innocutis.com

www.umecta.com






















UMECTA   UREA
urea   film










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68712-010
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UREA)UREA400 mg  in 1 g
















Inactive Ingredients
Ingredient NameStrength
Edetate Disodium 
Glycerin 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES 
Water 
Xanthan Gum 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


























Packaging
#NDCPackage DescriptionMultilevel Packaging
168712-010-0118 g In 1 BOTTLENone
268712-010-036 DOSE PACK In 1 CARTONcontains a DOSE PACK
23 g In 1 DOSE PACKThis package is contained within the CARTON (68712-010-03)
368712-010-0418 DOSE PACK In 1 CARTONcontains a DOSE PACK
33 g In 1 DOSE PACKThis package is contained within the CARTON (68712-010-04)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2006


Labeler - Innocutis Holdings LLC (071501252)









Establishment
NameAddressID/FEIOperations
Ei Inc105803274manufacture
Revised: 11/2011Innocutis Holdings LLC

More Umecta Nail Film resources


  • Umecta Nail Film Side Effects (in more detail)
  • Umecta Nail Film Use in Pregnancy & Breastfeeding
  • Umecta Nail Film Support Group
  • 0 Reviews for Umecta Nail Film - Add your own review/rating


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  • Ultra Mide Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Umecta Nail Film MedFacts Consumer Leaflet (Wolters Kluwer)

  • Umecta PD Topical Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Uramaxin Foam MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Umecta Nail Film with other medications


  • Dermatological Disorders
  • Dry Skin
  • Pityriasis rubra pilaris

Thursday 30 August 2012

varenicline


var-EN-i-kleen


Oral route(Tablet)

Serious neuropsychiatric events (eg, depression, suicidal ideation, suicide attempt and completed suicide) have been reported in patients taking varenicline. All patients being treated with varenicline should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. Drug discontinuation, ongoing monitoring, and supportive care is advised if symptoms develop. These symptoms, as well as worsening of preexisting psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking varenicline in the postmarketing experience. The risks of varenicline should be weighed against the benefits of its use .



Commonly used brand name(s)

In the U.S.


  • Chantix

  • Chantix Start Month Pak

Available Dosage Forms:


  • Tablet

Therapeutic Class: Smoking Cessation Agent


Uses For varenicline


Varenicline is used together with a support program to help you stop smoking. The program will include counseling and educational materials.


varenicline is available only with your doctor's prescription.


Before Using varenicline


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For varenicline, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to varenicline or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of varenicline in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varenicline in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving varenicline.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of varenicline. Make sure you tell your doctor if you have any other medical problems, especially:


  • Angina (severe chest pain), history of or

  • Heart attack, history of or

  • Heart or blood vessel problems or

  • Stroke, history of—May increase risk to have more serious side effects.

  • Depression, history of or

  • Mental problems (e.g., psychosis), history of—Use with caution. May make these conditions worse.

  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of varenicline


Take varenicline exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. It is also important to participate in a stop-smoking program while you use varenicline. This will make it easier for you to quit smoking.


varenicline should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


You should set a date to stop smoking. Start taking varenicline one week before this date.


Your doctor may also tell you to start taking varenicline anytime and then to stop smoking between days 8 and 35 of treatment.


You may be told to take varenicline for 12 weeks. Even if you have already stopped smoking by this time, your doctor may tell you to take varenicline for 12 more weeks to help you keep off smoking.


Take varenicline after eating, and with a full glass of water.


Dosing


The dose of varenicline will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of varenicline. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • To stop smoking:
      • Adults—
        • Days 1 to 3: 0.5 milligram (mg) once a day.

        • Days 4 to 7: 0.5 mg two times per day.

        • Days 8 to end of treatment: 1 mg two times per day.


      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of varenicline, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using varenicline


It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take varenicline. This will allow for changes in your dose and to help reduce any side effects.


varenicline may increase your risk of having a heart attack in certain patients with heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; pain in your legs when walking; shortness of breath; sweating; or troubled breathing.


varenicline may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, stop taking varenicline and tell your doctor right away.


varenicline may cause serious types of allergic reactions, including angioedema. Stop taking varenicline and tell your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using varenicline.


Serious skin reactions can occur with varenicline. Stop using varenicline and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using varenicline.


varenicline may cause some people to become drowsy or dizzy, or to have problems with concentration. Make sure you know how you react to varenicline before you drive, use machines, or do anything else that could be dangerous if you are not alert or thinking clearly.


Tell your doctor if you have nausea or sleep problems (trouble sleeping or unusual dreams) while you are using varenicline. The dose of varenicline may need to be adjusted.


varenicline Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Difficult or labored breathing

  • hyperventilation

  • shortness of breath

  • tightness in the chest

  • wheezing

Incidence not known
  • Anger

  • anxiety

  • behavior changes

  • depression

  • discouragement

  • feeling sad or empty

  • feelings of panic

  • hallucinations

  • irregular heartbeats

  • irritability

  • loss of interest or pleasure

  • mood swings

  • nervousness

  • restlessness

  • thoughts of killing oneself

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abnormal dreams

  • bloated or full feeling

  • change in taste

  • difficulty having a bowel movement (stool)

  • dry mouth

  • excess air or gas in the stomach or intestines

  • general feeling of discomfort or illness

  • headache

  • lack or loss of strength

  • loss of taste

  • nausea

  • passing gas

  • sleeplessness

  • stomach pain

  • trouble sleeping

  • unable to sleep

  • unusual tiredness or weakness

Less common
  • Acid or sour stomach

  • belching

  • body aches or pain

  • chills

  • cough

  • decreased appetite

  • dizziness

  • ear congestion

  • fever

  • heartburn

  • increased appetite

  • indigestion

  • itching skin

  • loss of appetite

  • loss of voice

  • nightmares

  • rash

  • runny nose

  • sleepiness or unusual drowsiness

  • sneezing or sore throat

  • stomach discomfort or upset

  • stuffy nose

  • trouble concentrating

  • unusual drowsiness, dullness, or feeling of sluggishness

  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: varenicline side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More varenicline resources


  • Varenicline Side Effects (in more detail)
  • Varenicline Dosage
  • Varenicline Use in Pregnancy & Breastfeeding
  • Varenicline Drug Interactions
  • Varenicline Support Group
  • 384 Reviews for Varenicline - Add your own review/rating


  • Varenicline Professional Patient Advice (Wolters Kluwer)

  • Varenicline MedFacts Consumer Leaflet (Wolters Kluwer)

  • Chantix Prescribing Information (FDA)

  • Chantix Monograph (AHFS DI)

  • Chantix Consumer Overview



Compare varenicline with other medications


  • Smoking Cessation

Wednesday 29 August 2012

hyoscyamine, methenamine, methylene blue, and sodium biphosphate


Generic Name: hyoscyamine, methenamine, methylene blue, and sodium biphosphate (HYE oh SYE a meen, meth EN a meen, METH il een BLUE, FEEN il sa LIS il ate)

Brand names: Urogesic-Blue


What is hyoscyamine, methenamine, methylene blue, and sodium biphosphate?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.


Methenamine and methylene blue work as mild antiseptics that fight bacteria in the urine and bladder.


Sodium biphosphate is a form of phosphorus, which is a naturally occurring substance that is important in every cell in the body.


The combination of hyoscyamine, methenamine, methylene blue, and sodium biphosphate is used to treat bladder irritation (pain, burning, inflammation) caused by urinary tract infection. This medication is also used to prevent bladder discomfort during a medical procedure.


Hyoscyamine, methenamine, methylene blue, and sodium biphosphate may also be used for purposes not listed in this medication guide.


What is the most important information I should know about hyoscyamine, methenamine, methylene blue, and sodium biphosphate?


You should not use hyoscyamine, methenamine, methylene blue, and sodium biphosphate if you are allergic to it.

Before taking this medication, tell your doctor if you have any type of heart problem (congestive heart failure, coronary heart disease, a heart valve or heart rhythm disorder), glaucoma, an enlarged prostate, bladder obstruction, myasthenia gravis, a stomach ulcer or obstruction, or if you are allergic to belladonna (Donnatal and others).


Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and sodium biphosphate.

Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use.


What should I discuss with my healthcare provider before taking hyoscyamine, methenamine, methylene blue, and sodium biphosphate?


You should not use hyoscyamine, methenamine, methylene blue, and sodium biphosphate if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:



  • heart disease;




  • a heart rhythm disorder;




  • congestive heart failure;




  • coronary heart disease;




  • a heart valve disorder;




  • glaucoma;




  • an enlarged prostate or bladder obstruction;




  • myasthenia gravis;




  • an ulcer or obstruction in your stomach; or




  • if you are allergic to belladonna (Donnatal and others).




FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine, methenamine, methylene blue, and sodium biphosphate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hyoscyamine, methenamine, methylene blue, and sodium biphosphate should not be given to a child younger than 7 years old. Older adults may be more likely to have side effects from this medication.

How should I take hyoscyamine, methenamine, methylene blue, and sodium biphosphate?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Hyoscyamine, methenamine, methylene blue, and sodium biphosphate is usually taken 4 times daily. Follow your doctor's instructions.


Do not crush, chew, or break an enteric coated pill. Swallow it whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating. Drink plenty of liquids while you are taking this medication. If you have an eye exam and your pupils are dilated with eye drops, tell the eye doctor ahead of time that you are using hyoscyamine, methenamine, methylene blue, and sodium biphosphate. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include excitement or seizure (convulsions).


What should I avoid while taking hyoscyamine, methenamine, methylene blue, and sodium biphosphate?


Avoid taking an antacid or anti-diarrhea medicine within 1 hour before or after you take hyoscyamine, methenamine, methylene blue, and sodium biphosphate. Antacids or anti-diarrhea medicine can make it harder for your body to absorb hyoscyamine.


If you also take ketoconazole (Nizoral), wait at least 2 hours after taking it before you take hyoscyamine, methenamine, methylene blue, and sodium biphosphate.


Hyoscyamine, methenamine, methylene blue, and sodium biphosphate side effects


Methylene blue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, blurred vision, fast heart rate;




  • agitation, confusion, feeling restless or excited;




  • painful or difficult urination; or




  • feeling short of breath.



Less serious side effects may include:



  • mild dizziness;




  • dry mouth; or




  • nausea, vomiting.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Hyoscyamine, methenamine, methylene blue, and sodium biphosphate Dosing Information


Usual Adult Dose for Urinary Tract Infection:

Hyoscyamine/methenamine/m-blue/sodium biphosphate 0.12 mg-81.6 mg-10.8 mg-40.8 mg oral tablet:
1 tablet orally four times daily.


What other drugs will affect hyoscyamine, methenamine, methylene blue, and sodium biphosphate?


Many drugs can interact with this medicine. Also, hyoscyamine can make it harder for your body to absorb other medications you take by mouth. Tell your doctor about all other medicines you use, especially:



  • atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);




  • a diuretic (water pill);




  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);




  • glycopyrrolate (Robinul);




  • homatropine (Hycodan, Tussigon);




  • methantheline;




  • neostigmine (Prostigmin) or pyridostigmine (Mestinon);




  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or




  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);




  • medicines to treat symptoms of Alzheimer's disease such as donepezil (Aricept), galantamine (Razadyne), memantine (Namenda), rivastigmine (Exelon), or tacrine (Cognex);




  • narcotic pain medication such as codeine (Tylenol #3, Cheratuss, Guaiatuss), fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid), methadone (Dolophine, Methadose), morphine (Avinza, Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Endocet, Percocet), propoxyphene (Darvocet, Propacet), and others;




  • sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra);




  • sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or




  • ulcer or irritable bowel medications such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Hyomax), mepenzolate (Cantil), or propantheline (Pro Banthine).



This list is not complete and there are many other drugs that can interact with hyoscyamine, methenamine, methylene blue, and sodium biphosphate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.



More hyoscyamine, methenamine, methylene blue, and sodium biphosphate resources


  • Hyoscyamine, methenamine, methylene blue, and sodium biphosphate Drug Interactions
  • Hyoscyamine, methenamine, methylene blue, and sodium biphosphate Support Group
  • 0 Reviews for Hyoscyamine, methenamine, methylene blue, and sodium biphosphate - Add your own review/rating


Compare hyoscyamine, methenamine, methylene blue, and sodium biphosphate with other medications


  • Urinary Tract Infection


Where can I get more information?


  • Your pharmacist can provide more information about hyoscyamine, methenamine, methylene blue, and sodium biphosphate.


Tuesday 28 August 2012

Vandazole


Generic Name: metronidazole vaginal (MET roe NYE da zole)

Brand Names: MetroGel-Vaginal, Vandazole


What is Vandazole (metronidazole vaginal)?

Metronidazole is an antibiotic that fights bacteria in the body.


Metronidazole vaginal is used to treat vaginal infections caused by bacteria.


Metronidazole vaginal may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Vandazole (metronidazole vaginal)?


Do not use metronidazole vaginal if you have ever had an allergic reaction to it.


Before using metronidazole vaginal, tell your doctor if you have liver disease, a seizure disorder, problems with circulation (such as Raynaud's syndrome), or if you have taken disulfiram (Antabuse) within the past 14 days.


Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.


Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.


Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated. If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat.

What should I discuss with my doctor before using Vandazole (metronidazole vaginal)?


Do not use metronidazole vaginal if you have ever had an allergic reaction to it.


Before using metronidazole vaginal, tell your doctor if you are allergic to any drugs, or if you have:



  • liver disease;




  • a seizure disorder; or




  • problems with circulation (such as Raynaud's syndrome).



If you have any of these conditions, you may need a dose adjustment or special tests to safely use metronidazole vaginal.


FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Metronidazole vaginal may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Vandazole (metronidazole vaginal)?


Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.


Wash your hands before and after using this medication.

Insert the cream into your vagina using the applicator as directed.


Your medication may come with disposable applicators. Use each applicator for only 1 day and then throw it away. If you use the medication twice daily, wash and rinse the applicator after your morning dose and use it again for your evening dose. Then throw it away and use a new applicator the next day.


Use metronidazole vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.


If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that metronidazole will not treat.

You may need to use a sanitary napkin during treatment, but do not use a tampon.


Metronidazole vaginal can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using this medication.


Store metronidazole vaginal at room temperature away from moisture or heat. Do not allow it to freeze.

What happens if I miss a dose?


Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of metronidazole applied in the vagina is not expected to produce life-threatening symptoms.


What should I avoid while using Vandazole (metronidazole vaginal)?


Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with plenty of cool water.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.


Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.


Avoid using other vaginal creams or douches at the same time as metronidazole vaginal unless your doctor approves.


Avoid drinking alcohol while you are using metronidazole vaginal.

Vandazole (metronidazole vaginal) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Rare but serious side effects may include:



  • seizure (convulsions); or




  • numbness, burning, pain, or tingly feeling in your hands or feet.



Less serious side effects may include:



  • mild burning or stinging when the medication is applied;




  • pelvic pain or cramps;




  • loss of appetite, constipation, upset stomach, vomiting;




  • dizziness, sleep problems (insomnia);




  • runny nose;




  • urinating more than usual;




  • acne, increased sweating; or




  • breast discharge or enlargement.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Vandazole (metronidazole vaginal)?


Tell your doctor if you have taken disulfiram (Antabuse) within the past 14 days. Also tell your doctor if you are using:



  • cimetidine (Tagamet);




  • lithium (Eskalith, Lithobid, Lithonate); or




  • a blood thinner such as warfarin (Coumadin).



There may be other drugs that can interact with metronidazole vaginal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Vandazole resources


  • Vandazole Side Effects (in more detail)
  • Vandazole Use in Pregnancy & Breastfeeding
  • Vandazole Drug Interactions
  • Vandazole Support Group
  • 2 Reviews for Vandazole - Add your own review/rating


  • Vandazole Prescribing Information (FDA)

  • Vandazole Advanced Consumer (Micromedex) - Includes Dosage Information

  • MetroCream Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • MetroCream Prescribing Information (FDA)

  • MetroGel Prescribing Information (FDA)

  • Metrocream

  • Metrocream Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Metrolotion

  • Noritate Prescribing Information (FDA)

  • Rozex Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vitazol Prescribing Information (FDA)



Compare Vandazole with other medications


  • Bacterial Vaginitis


Where can I get more information?


  • Your pharmacist can provide more information about metronidazole vaginal.

See also: Vandazole side effects (in more detail)


Lescol XL


Generic Name: fluvastatin (Oral route)

floo-va-STAT-in

Commonly used brand name(s)

In the U.S.


  • Lescol

  • Lescol XL

Available Dosage Forms:


  • Capsule

  • Tablet, Extended Release

Therapeutic Class: Antihyperlipidemic


Pharmacologic Class: HMG-COA Reductase Inhibitor


Uses For Lescol XL


Fluvastatin is used together with proper diet to treat high cholesterol levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels. This medicine may also be used to prevent certain types of heart problems in patients with risk factors for heart problems .


Fluvastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood .


Fluvastatin is available only with your doctor's prescription .


Importance of Diet


Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed .


Before Using Lescol XL


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Fluvastatin is safe to use in children and adolescents (9 to 16 years of age) for treating certain types of high cholesterol .


Adolescent girls taking fluvastatin should be counseled on appropriate contraceptive methods .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fluvastatin in the elderly .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Bezafibrate

  • Ciprofibrate

  • Clofibrate

  • Dalfopristin

  • Danazol

  • Daptomycin

  • Fenofibrate

  • Gemfibrozil

  • Quinupristin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Colchicine

  • Eltrombopag

  • Oat Bran

  • Pectin

  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse (or history of) or

  • Liver disease, history—Use with caution. These conditions may increase the amount of fluvastatin in your blood .

  • Kidney disease, severe—Use with caution. This medicine may make the condition worse .

  • Liver disease, active or

  • Liver enzymes, persistently high levels—This medicine should NOT be used in these conditions. Use of this medicine may make liver problems worse .

  • Convulsions (seizures), uncontrolled or

  • Electrolyte disorder, severe or

  • Endocrine disorder (such as diabetes mellitus), severe or

  • Infection, severe or

  • Low blood pressure or

  • Major surgery or trauma or

  • Metabolic disorder, severe—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure .

Proper Use of fluvastatin

This section provides information on the proper use of a number of products that contain fluvastatin. It may not be specific to Lescol XL. Please read with care.


Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take more or less often than your doctor ordered .


Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly .


Do not open the capsule before taking it. Swallow the extended-release tablet whole. Do not crush, break, or chew it .


Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down .


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For high cholesterol:
    • For oral dosage form (capsules):
      • Adults—At first, 20 milligrams (mg) or 40 mg once a day in the evening, as instructed by your doctor. Your doctor may increase your dose if needed. The recommended dosage range is 20 to 80 mg per day.

      • Children (9 to 16 years of age)—At first, 20 mg once a day in the evening. Your doctor may increase your dose up to a maximum of 80 mg per day.

      • Children (less than 9 years of age)—Use and dose must be determined by your doctor .


    • For oral dosage form (extended-release tablets):
      • Adults and children (9 to 16 years of age)—80 mg once daily.

      • Children (less than 9 years of age)—Use and dose must be determined by your doctor .



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Lescol XL


It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects.


Your doctor will need to check your liver before you start using this medicine .


Do not take this medicine if you are pregnant. Check with your doctor immediately if you think that you may be pregnant. This medicine may cause birth defects or other problems in the baby if taken during pregnancy. Do not breastfeed while you are using this medicine .


Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine .


Do not use excessive amounts of alcohol while taking fluvastatin because it can worsen the adverse effects of this medicine on the liver .


Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever. These may be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney problems .


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .


Lescol XL Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Accidental injury

  • chills

  • cough

  • diarrhea

  • fever

  • general feeling of discomfort or illness

  • headache

  • joint pain

  • loss of appetite

  • muscle aches and pain

  • nausea

  • runny nose

  • shivering

  • sore throat

  • sweating

  • trouble sleeping

  • unusual tiredness or weakness

  • vomiting

Less common
  • Bladder pain

  • bloody or cloudy urine

  • cough producing mucus

  • dark-colored urine

  • difficult, burning, or painful urination

  • difficulty breathing

  • difficulty in moving

  • difficulty swallowing

  • dizziness

  • fast heartbeat

  • frequent urge to urinate

  • hives

  • itching

  • lower back or side pain

  • muscle cramps, spasms, or stiffness

  • muscular pain, tenderness, wasting or weakness

  • pain, swelling, or redness in joints

  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

  • shortness of breath

  • skin rash

  • tightness in chest

  • wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Acid or sour stomach

  • belching

  • heartburn

  • indigestion

  • stomach discomfort, upset or pain

Less common
  • Bloated full feeling

  • excess air or gas in stomach or intestines

  • pain or tenderness around eyes and cheekbones

  • passing gas

  • sleeplessness

  • stuffy nose

  • unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lescol XL side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Lescol XL resources


  • Lescol XL Side Effects (in more detail)
  • Lescol XL Use in Pregnancy & Breastfeeding
  • Drug Images
  • Lescol XL Drug Interactions
  • Lescol XL Support Group
  • 0 Reviews for Lescol XL - Add your own review/rating


  • Lescol XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluvastatin Professional Patient Advice (Wolters Kluwer)

  • Fluvastatin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluvastatin Sodium Monograph (AHFS DI)

  • Lescol Prescribing Information (FDA)

  • Lescol Consumer Overview



Compare Lescol XL with other medications


  • High Cholesterol
  • High Cholesterol, Familial Heterozygous
  • Hyperlipoproteinemia
  • Hyperlipoproteinemia Type IIa, Elevated LDL
  • Hyperlipoproteinemia Type IIb, Elevated LDL VLDL

Friday 17 August 2012

Uticap


Generic Name: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate (Oral route)


hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, SOE-dee-um FOS-fate, mono-BAY-sik


Commonly used brand name(s)

In the U.S.


  • Phosphasal

  • Urelle

  • Uretron D/S

  • Uribel

  • Urimar-T

  • UR N-C

  • Ustell

  • Uticap

  • Utira-C

  • Utrona-C

Available Dosage Forms:


  • Tablet

  • Capsule

  • Tablet, Enteric Coated

  • Tablet, Extended Release

Therapeutic Class: Urinary Antispasmodic


Pharmacologic Class: Hyoscyamine


Chemical Class: Salicylate, Non-Aspirin


Uses For Uticap


Urelle® is a combination of five medicines: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It is used to relieve discomfort, swelling, pain, frequent urge to urinate, and cramps or spasms of the urinary tract caused by an infection or a diagnostic procedure.


Hyoscyamine is an antispasmodic drug, which relieves muscle cramps or spasms. Methenamine and methylene blue are antiseptic drugs, which help clear a urinary tract infection. Phenyl salicylate is a pain reliever. Sodium phosphate makes the urine more acidic, which helps methenamine work better.


This medicine is available only with your doctor's prescription.


Before Using Uticap


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Urelle® in children. However, use is not recommended in children 6 years of age and younger.


Geriatric


No information is available on the relationship of age to the effects of Urelle® in geriatric patients.


Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Amitriptyline

  • Amoxapine

  • Bupropion

  • Cisapride

  • Citalopram

  • Clomipramine

  • Desipramine

  • Desvenlafaxine

  • Doxepin

  • Duloxetine

  • Escitalopram

  • Fluoxetine

  • Fluvoxamine

  • Imipramine

  • Isocarboxazid

  • Linezolid

  • Maprotiline

  • Mesoridazine

  • Mirtazapine

  • Nortriptyline

  • Paroxetine

  • Phenelzine

  • Pimozide

  • Potassium

  • Protriptyline

  • Selegiline

  • Sertraline

  • Sparfloxacin

  • Thioridazine

  • Tranylcypromine

  • Trimipramine

  • Venlafaxine

  • Vilazodone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alfuzosin

  • Amiodarone

  • Amitriptyline

  • Amoxapine

  • Apomorphine

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Azithromycin

  • Buspirone

  • Chloroquine

  • Chlorpromazine

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clomipramine

  • Clozapine

  • Crizotinib

  • Dasatinib

  • Desipramine

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Erythromycin

  • Flecainide

  • Fluconazole

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Ibutilide

  • Iloperidone

  • Imipramine

  • Lapatinib

  • Levofloxacin

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Methadone

  • Moxifloxacin

  • Nefazodone

  • Nilotinib

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Ondansetron

  • Paliperidone

  • Pazopanib

  • Perflutren Lipid Microsphere

  • Posaconazole

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quetiapine

  • Quinidine

  • Quinine

  • Ranolazine

  • Salmeterol

  • Saquinavir

  • Solifenacin

  • Sorafenib

  • Sotalol

  • Sunitinib

  • Telavancin

  • Telithromycin

  • Terfenadine

  • Tetrabenazine

  • Trazodone

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Aluminum Carbonate, Basic

  • Aluminum Hydroxide

  • Aluminum Phosphate

  • Calcium Acetate

  • Calcium Carbonate

  • Calcium Citrate

  • Dihydroxyaluminum Aminoacetate

  • Dihydroxyaluminum Sodium Carbonate

  • Magaldrate

  • Magnesium Carbonate

  • Magnesium Hydroxide

  • Magnesium Oxide

  • Magnesium Trisilicate

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Congestive heart failure or

  • Coronary heart disease or

  • Glaucoma or

  • Heart disease (e.g., mitral stenosis) or

  • Heart rhythm problems (e.g., arrhythmia) or

  • Myasthenia gravis (severe muscle weakness) or

  • Stomach or intestinal (bowel) blockage or

  • Stomach ulcers or

  • Urinary problems (e.g., bladder blockage due to an enlarged prostate)—Use with caution. May make these conditions worse.

  • Allergy or intolerance to belladonna or salicylates—Use with caution. May be sensitive to this medicine also.

Proper Use of hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate

This section provides information on the proper use of a number of products that contain hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It may not be specific to Uticap. Please read with care.


Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.


Drink extra fluids after you take this medicine so you will pass more urine.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For treatment of symptoms of urinary tract infection or diagnostic procedure:
      • Adults—One tablet four times a day

      • Children 7 years of age and older—Use and dose must be determined by your doctor.

      • Children 6 years of age and younger—Use is not recommended.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Uticap


It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.


If your or your child's symptoms do not improve or if they get worse, call your doctor.


Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.


This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.


This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Uticap Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Incidence not known
  • Blurred vision

  • dizziness

  • rapid pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Incidence not known
  • Blue-colored urine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Thursday 16 August 2012

Hyaluronate Sodium Cream


Pronunciation: HYE-al-ure-ON-ate SOE-dee-um
Generic Name: Hyaluronate Sodium
Brand Name: Bionect


Hyaluronate Sodium Cream is used for:

Protecting skin ulcers, wounds, incisions, irritations, and burns. It may also be used to treat other conditions as determined by your doctor.


Hyaluronate Sodium Cream is a polysaccharide. It works by replacing a substance found in the skin.


Do NOT use Hyaluronate Sodium Cream if:


  • you are allergic to any ingredient in Hyaluronate Sodium Cream

Contact your doctor or health care provider immediately if any of these apply to you.



Before using Hyaluronate Sodium Cream:


Some medical conditions may interact with Hyaluronate Sodium Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Hyaluronate Sodium Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Certain disinfectants (eg, that contain ammonium salts) because they may decrease Hyaluronate Sodium Cream's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyaluronate Sodium Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Hyaluronate Sodium Cream:


Use Hyaluronate Sodium Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Wash your hands before and after using Hyaluronate Sodium Cream, unless your hands are part of the treated area.

  • Clean the affected area as directed by your doctor.

  • Apply a thin layer of the medicine to the affected area. Avoid excessive rubbing. Cover the area with a sterile gauze pad as directed by your doctor.

  • If you miss a dose of Hyaluronate Sodium Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyaluronate Sodium Cream.



Important safety information:


  • Hyaluronate Sodium Cream is for external use only. Do not get Hyaluronate Sodium Cream in your eyes, nose, or mouth. If you get it in any of these areas, rinse with cool water right away.

  • Do not use Hyaluronate Sodium Cream for other skin conditions at a later time.

  • Do NOT use for longer than prescribed without checking with your doctor.

  • Talk with your doctor before you use any other medicines or cleansers on your skin.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyaluronate Sodium Cream while you are pregnant. It is not known if Hyaluronate Sodium Cream is found in breast milk. If you are or will be breast-feeding while you use Hyaluronate Sodium Cream, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Hyaluronate Sodium Cream:


Every medicine can cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Hyaluronate Sodium Cream. Seek medical attention right away if any of these SEVERE side effects occur:



Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); skin irritation.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Hyaluronate Sodium Cream:

Store Hyaluronate Sodium Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not use Hyaluronate Sodium Cream if it is expired. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyaluronate Sodium Cream out of the reach of children and away from pets.


General information:


  • If you have any questions about Hyaluronate Sodium Cream, please talk with your doctor, pharmacist, or other health care provider.

  • Hyaluronate Sodium Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hyaluronate Sodium Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Thursday 9 August 2012

Varivax


Generic Name: Varicella Virus Vaccine Live
Class: Vaccines
ATC Class: J07BK01
VA Class: IM100

Introduction

Live, attenuated virus vaccine.1 27 137 Varicella virus vaccine live contains varicella zoster virus (VZV) of the Oka/Merck strain1 27 and is used to stimulate active immunity to varicella (chickenpox).1 27 Commercially available in the US as a monovalent vaccine (Varivax) and a fixed-combination vaccine containing measles, mumps, rubella, and varicella antigens (MMRV; ProQuad).1 125 Other varicella vaccines may be available in other countries (e.g., Oka/Biken vaccine).8 11 15 27 45


Uses for Varivax


Prevention of Varicella (Chickenpox) Infection


Prevention of varicella (chickenpox) in adults, adolescents, and children ≥12 months of age.1 27 71 82 89 92 100 114 129 137


Varicella is caused by primary infection with varicella zoster virus (VZV).1 6 9 11 14 27 41 64 75 137 138 In otherwise healthy children, varicella usually is an acute, self-limited disease characterized by fever, malaise, and a generalized vesicular rash consisting of 200–500 lesions.1 6 9 11 14 27 41 64 75 137 138 In neonates, adolescents, adults, and immunocompromised individuals, it may be a more serious illness associated with a greater number of lesions and an increased risk of complications (e.g., pneumonia, encephalitis, glomerulonephritis, bacterial superinfection including necrotizing fasciitis).6 9 11 15 27 34 41 64 75 80 89 91 94 137 138 In the past, there were an average of 4 million cases of varicella and 100–150 varicella-associated deaths each year in the US.6 27 64 137 Since 1995, when varicella vaccine became commercially available, there have been substantial decreases in the incidence of varicella and varicella-associated hospitalizations in the US in all age groups, especially in children 1–9 years of age.112 138 The number of hospitalizations and deaths from varicella decreased >90% in the US since 1996.138


USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all susceptible children 12 months through 12 years of age be vaccinated against varicella, unless the vaccine is contraindicated.27 71 100 137 (See Contraindications under Cautions.)


ACIP, AAP, AAFP, American College of Obstetricians and Gynecologists (ACOG), and American College of Physicians (ACP) recommend that all susceptible adults and adolescents ≥13 years of age be vaccinated against varicella, unless contraindicated.27 71 89 100 114 129 (See Contraindications under Cautions.)


For internationally adopted children whose immune status is uncertain, vaccinations can be repeated or serologic tests performed to confirm immunity.26 Because varicella vaccine is not available in the majority of countries, especially developing countries, all internationally adopted children without reliable evidence of varicella immunity should be vaccinated according to the US recommended immunization schedule.26 112 (See Dosage and Administration.) Although serologic testing to verify immunization status in children >12 months of age is available, such testing prior to vaccination is not recommended in children <12 years of age coming from tropical countries, unless there is a history of the disease.112


The fixed-combination vaccine containing measles, mumps, and rubella virus vaccine live (MMR) and varicella virus vaccine live (MMRV; ProQuad) may be used instead of the monovalent varicella vaccine in children 12 months through 12 years of age when a dose of MMR and a dose of varicella vaccine is indicated in this age group.27 125 136 137 145 ACIP, AAP, and AAFP state that use of a combination vaccine generally is preferred over separate injections of the equivalent component vaccines.71 However, although use of MMRV (ProQuad) reduces the number of required injections when both vaccines are indicated during a single health-care visit,27 128 there is some evidence that the relative risk for febrile seizures in infants 12 through 23 months of age may be higher with MMRV (ProQuad) than when a dose of Varivax and a dose of MMR are given concomitantly.125 136 145 (See Use of Fixed Combinations under Cautions.)


ACIP states that evidence of varicella immunity includes documentation of age-appropriate vaccination against varicella, laboratory evidence of immunity or laboratory confirmation of prior varicella, birth in the US before 1980 (except pregnant women, immunocompromised individuals, health-care personnel), diagnosis or verification of history of varicella by health-care provider, or diagnosis or verification of history of herpes zoster (shingles, zoster) by health-care provider.27 Individuals without such evidence should be considered susceptible to varicella.27


Preexposure Vaccination Against Varicella Infection in High-risk Groups


Health-care personnel should ensure that they are immune to varicella, especially those who have close contact with individuals at high risk for serious complications from varicella.27 113 ACIP and the Hospital Infection Control Practices Advisory Committee of the US Public Health Service (HICPAC) recommend vaccination against varicella in all susceptible health-care personnel.27 113 This protects the worker following varicella exposure in the workplace and also may help reduce nosocomial transmission of VZV.11 27


Travelers should be vaccinated against varicella.27 112 Varicella occurs worldwide.112 138 Although vaccination against varicella is not a requirement for entry into any country (including the US), CDC states that individuals traveling or living abroad should ensure that they are immune.112


Certain immunocompromised individuals at risk of severe complications from varicella may benefit from vaccination against the disease.27 52 100 137 143 144 However, varicella vaccine generally is contraindicated in adults, adolescents, and children who are immunocompromised.1 54 70 100 137 (See Individuals with Altered Immunocompetence under Cautions.)


ACIP, AAP, CDC, National Institutes of Health (NIH), HIV Medicine Association of the Infectious Diseases Society of America (IDSA), Pediatric Infectious Diseases Society, and others recommend that vaccination against varicella be considered for certain HIV-infected individuals, especially those who are asymptomatic or only mildly symptomatic.27 100 137 143 144 These experts state that, after weighing risks and benefits, use of monovalent varicella vaccine should be considered in HIV-infected children 1–8 years of age with age-specific CD4+ T-cell percentages ≥15%27 137 144 and may be considered in HIV-infected adults, adolescents, and children >8 years of age with CD4+ T-cell counts ≥200/mm3.27 143 144 Other HIV-infected adults, adolescents, or children who are more severely immunocompromised should not receive varicella vaccine.1 27 143 144 (See Individuals with Altered Immunocompetence under Cautions.)


Although monovalent varicella vaccine was previously used under an investigational protocol in certain children and adolescents with acute lymphocytic (lymphoblastic) leukemia (ALL) in remission,27 52 100 this protocol has been terminated.100 The ACIP and AAP state that varicella vaccine should not be used routinely in susceptible children with leukemia and use of the vaccine in leukemic children in remission who do not have evidence of immunity to varicella should only be undertaken with expert guidance and only if antiviral therapy is available in case complications occur.27 100 137 (See Individuals with Altered Immunocompetence under Cautions.)


Postexposure Vaccination Against Varicella Infection and Outbreak Control


Postexposure vaccination in susceptible adults, adolescents, or children with recent exposure to varicella, unless contraindicated.27 100 138


Prevention and control of varicella outbreaks (e.g., in child-care facilities, schools, institutions).27 138 Varicella outbreaks can persist for up to 4–6 months.27 138


May prevent varicella or modify severity of the disease if given within 3 days, and possibly up to 5 days, after exposure.27 100 112 115 116 138


If the exposure does not cause infection, postexposure vaccination should provide protection against subsequent exposure.27 100 138 If the exposure results in infection, vaccination during the presymptomatic or prodromal stage of varicella does not appear to increase risk for vaccine-associated adverse effects or cause more severe natural disease.27 100 138


During varicella outbreaks, ACIP recommends a second dose of varicella vaccine for those who previously received only a single dose, provided the age-appropriate time interval has elapsed since the first dose (i.e., 3 months for children 12 months through 12 years of age, at least 4 weeks for adults and adolescents ≥13 years of age).27 138


In hospital settings, consider postexposure vaccination for unvaccinated health-care personnel who have no evidence of immunity at the time of varicella exposure.27 113 138 Preexposure vaccination is the preferred method for preventing varicella in health-care settings.27 138


When varicella vaccine cannot be used (e.g., pregnant women, neonates, immunocompromised individuals) and postexposure prophylaxis is considered necessary, passive immunization with varicella zoster immune globulin (VZIG) is recommended to prevent or reduce severity of varicella.15 27 100 138 143 144 The only VZIG preparation currently available for use in the US (VariZIG; Cangene) must be obtained through an investigational new drug (IND) expanded access protocol from the distributor (FFF Enterprises at 800-843-7477).134 135 If VZIG is not available for postexposure prophylaxis, immune globulin IV (IGIV) can be used.100


Varivax Dosage and Administration


Administration


Sub-Q Administration


Administer monovalent varicella vaccine (Varivax) by sub-Q injection.1


Administer fixed-combination vaccine containing MMR and varicella vaccine (MMRV; ProQuad) by sub-Q injection.125


Do not administer monovalent or fixed-combination vaccine IM.1 125 Inadvertent IM administration does not necessitate revaccination.26 30


Depending on patient age, administer sub-Q into the upper-outer triceps area or anterolateral thigh.1 26 125 For children ≥1 year of age, adolescents, and adults, the upper-outer triceps area usually is preferred.26


To ensure appropriate delivery, sub-Q injections should be made at a 45° angle using a 5/8-inch, 23- to 25-gauge needle.26


Prior to injection, ensure that needle is not in a blood vessel.1


Since syncope may occur following vaccination, observe vaccinees for approximately 15 minutes after the vaccine dose.26 If syncope occurs, observe patient until symptoms resolve.26 Syncope after vaccination occurs most frequently in adolescents and young adults.26


Do not administer concomitantly with VZIG.1 (See Specific Drugs and Laboratory Tests under Interactions.)


May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites).26 71 100 129 137 (See Interactions.)


When multiple vaccines are administered during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites.26 Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.26 If multiple vaccines must be given into a single limb, the deltoid may be used in older children and adults, but the anterolateral thigh is preferred in infants and younger children.26


Reconstitution

Varicella vaccine (Varivax): Reconstitute lyophilized vaccine by adding 0.7 mL of diluent provided by the manufacturer and gently agitating vial.1 Use only the diluent supplied by the manufacturer.1


MMRV (ProQuad): Reconstitute lyophilized vaccine according to manufacturer’s directions using diluent provided by the manufacturer.125 Gently agitate vial.125 Use only the diluent supplied by the manufacturer.125


Use sterile syringes and needles free of preservatives, antiseptics, and detergents to avoid inactivating the live virus vaccine.1 125


To minimize loss of potency and ensure an adequate immunizing dose, administer immediately following reconstitution; discard reconstituted vaccine not used within 30 minutes.1 125


Dosage


Pediatric Patients


Prevention of Varicella (Chickenpox)

Children 12 Months Through 12 Years of Age (Varivax)

Sub-Q

Each dose is 0.5 mL.1


Primary immunization consists of 2 doses given at least 3 months apart.1 27 71 100 137


ACIP, AAP, and AAFP recommend that the initial dose be given at 12 through 15 months of age and the second dose at 4 through 6 years of age (i.e., before child begins kindergarten or first grade).27 71 100 137 Second dose may be administered prior to 4 years of age, provided at least 3 months have elapsed since initial dose and both doses are administered at ≥12 months of age.1 27 71 100 137 If second dose was inadvertently administered early (but at least 28 days after initial dose), it does not need to be repeated.27 71 100 137


For catch-up vaccination in those not previously vaccinated, give 2 doses at least 3 months apart.1 27 71 100 137 In those who previously received a single dose of vaccine containing varicella vaccine, give a second dose preferably at least 3 months after initial dose.1 27 71 100 137


Children 12 Months Through 12 Years of Age (MMRV; ProQuad)

Sub-Q

Each dose is 0.5 mL.125


May be used when simultaneous administration of the first or second dose of varicella vaccine and first or second dose of MMR is indicated or whenever any components of the fixed-combination vaccine are indicated and the other components are not contraindicated.27 71 125


When considering use in infants and children 12 through 47 months of age, ACIP states that providers should advise the parent or caregiver about the benefits and risks associated with MMRV (ProQuad) compared with the individual component vaccines.145 (See Use of Fixed Combinations under Cautions.)


At least 1 month should elapse between a dose of a measles-containing vaccine (e.g., MMR) and a dose of MMRV (ProQuad) and preferably at least 3 months should elapse between a dose of Varivax and a dose of MMRV (ProQuad); however, if a second dose of a varicella-containing vaccine was administered at least 28 days following the first dose, the second dose does not need to be repeated.71 125


Adolescents 13–16 Years of Age (Varivax)

Sub-Q

Each dose is 0.5 mL.1


Primary immunization consists of 2 doses given at least 4–8 weeks apart.1 27 71 89 100 137 The minimum interval between the first and second dose is 28 days.71 100 A longer interval between first and second doses does not necessitate a third dose, but may leave individual susceptible during the intervening months.27 100


For catch-up vaccination in those who previously received only a single dose, give second dose at least 4 weeks (28 days) after first dose.1 27 71 137


HIV-infected Children 12 Months Through 8 Years of Age with Age-specific CD4+ T-cell Percentages ≥15% (Varivax)

Sub-Q

2 doses given at least 3 months apart recommended by ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and Pediatric Infectious Diseases Society.27 144 Give first dose as soon as possible after the first birthday.144


HIV-infected Adolescents and Children >8 Years of Age with CD4+ T-cell Counts ≥200/mm3 (Varivax)

Sub-Q

2 doses given at least 3 months apart recommended by ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and Pediatric Infectious Diseases Society.27 137 143 144


Postexposure Vaccination Against Varicella Infection and Outbreak Control (Varivax)

Sub-Q

Children ≥12 months of age who are unvaccinated or incompletely vaccinated: Give a vaccine dose within 3–5 days after exposure and complete primary immunization.27


For outbreak control, give a second dose to those who previously received only a single dose, provided the appropriate interval has elapsed since first dose (i.e., at least 3 months in children 12 months through 12 years of age and at least 4 weeks in adolescents ≥13 years of age).27 138


Adults


Prevention of Varicella (Chickenpox) Infection

Adults (Varivax)

Sub-Q

Each dose is 0.5 mL.125


Primary immunization consists of 2 doses given 4–8 weeks apart.1 27 82 129 A longer interval between first and second doses does not necessitate a third dose, but may leave individual susceptible for the intervening months.27


For catch-up vaccination in those who previously received only a single dose, give second dose at least 4 weeks after first dose.1 27 129


HIV-infected Adults with CD4+ T-cell Counts ≥200/mm3 (Varivax)

Sub-Q

2 doses given at least 3 months apart recommended by ACIP, NIH, CDC, and HIV Medicine Association of IDSA.27 129 143 144


Postexposure Vaccination Against Varicella (Chickenpox) Infection and Outbreak Control (Varivax)

Sub-Q

Unvaccinated or incompletely vaccinated: Give a vaccine dose within 3–5 days after exposure and complete primary immunization.27


For outbreak control, give a second dose to those who previously received only a single dose, provided the appropriate interval has elapsed since first dose (i.e., at least 4 weeks in adults).27 138


Special Populations


Hepatic Impairment


No specific dosage recommendations.1


Renal Impairment


No specific dosage recommendations.1


Geriatric Patients


No specific dosage recommendations.1


Cautions for Varivax


Contraindications


  • Monovalent Varicella Vaccine (Varivax) or Fixed Combination of Varicella Vaccine and MMR (MMRV; ProQuad)


  • Hypersensitivity to the vaccine or any component in the formulation, including gelatin.1 27 100 125 (See Gelatin Allergy under Cautions.)




  • History of anaphylactic reaction to neomycin.1 26 100 125 (See Neomycin Allergy under Cautions.)




  • Blood dyscrasias, leukemia, lymphomas of any type, or any other malignant neoplasms affecting the bone marrow or lymphatic system.1 26 70 92 100 125 (See Individuals with Altered Immunocompetence under Cautions.)




  • Primary and acquired immunodeficiencies, including acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of HIV infection, cellular immune deficiency, hypogammaglobulinemia, and dysgammaglobulinemia.1 26 54 70 92 100 125 (See Individuals with Altered Immunocompetence under Cautions.)




  • Immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation).1 26 54 70 92 100 125 (See Specific Drugs and Laboratory Tests under Interactions.)




  • Family history of congenital or hereditary immunodeficiency, unless immune competence has been demonstrated in the potential vaccine recipient.1 125 (See Individuals with Altered Immunocompetence under Cautions.)




  • Active untreated tuberculosis.1 125 (See Tuberculosis under Cautions.)




  • Febrile respiratory illness or other active febrile infection.1 125 (See Concomitant Illness under Cautions.)




  • Pregnancy.1 125 (See Pregnancy under Cautions.)



Warnings/Precautions


Warnings


Individuals with Altered Immunocompetence

Because monovalent varicella vaccine (Varivax ) and MMRV (ProQuad) contain live, attenuated viruses, they generally are contraindicated in individuals with altered immunocompetence, including those with primary or acquired immunodeficiencies or those receiving immunosuppressive therapy.1 27 70 100 125 137 143 144


These vaccines usually contraindicated in those with primary immunodeficiencies (e.g., cellular immune deficiency, hypogammaglobulinemia, dysgammaglobulinemia) and in individuals with suppressed immune responses resulting from AIDS or other clinical manifestations of HIV infection, blood dyscrasias, leukemia, lymphomas of any type, or any other malignant neoplasms affecting the bone marrow or lymphatic systems.1 27 70 100 125 137 143 144 Also generally contraindicated in individuals with a family history of congenital or hereditary immunodeficiency in a first-degree relative (e.g., parents and siblings), unless the immune competence of the potential vaccine recipient has been clinically substantiated or verified by a laboratory.1 20 27 100 125 137


Safety and efficacy not established in HIV-infected children, adolescents, or adults.1 27 125 However, because HIV-infected adults, adolescents, and children are at increased risk for morbidity from varicella and herpes zoster, ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, Pediatric Infectious Diseases Society, and others state that use of Varivax can be considered in selected HIV-infected individuals after weighing potential benefits and risks.27 100 137 143 144 (See Preexposure Vaccination Against Varicella Infection in High-risk Groups under Uses.) If Varivax is used in an HIV-infected individual, consider possibility that such individuals may be at increased risk for complications after vaccination with a live virus since they have impaired cellular immunity; encourage patient to consult clinicians if a postvaccination varicella-like rash develops.27 100 Do not use MMRV (ProQuad) in HIV-infected individuals.27 125 137 144


Safety and efficacy not established in children with leukemia.1 27 125 137 ACIP states that use of live virus vaccines can be considered in patients with leukemia or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.26 However, use of Varivax in susceptible leukemic children in remission should be undertaken only with expert guidance and only when antiviral agents are available to treat complications if they occur.27 100 137


The presence of an immunocompromised or HIV-infected individual in a household does not preclude administration of Varivax or MMRV (ProQuad) to other household members.27 100 137 Vaccination of household contacts decreases the likelihood that wild-type varicella will be introduced into the household.27 143 144 However, if vaccinee develops a varicelliform rash, they should avoid contact with immunocompromised household members.27 100 137 (See Transmission of Vaccine Virus under Cautions.)


Cerebral Injury or Seizures

MMRV (ProQuad): Use caution in individuals with a history of cerebral injury, individual or family history of seizures, or any other condition in which fever-induced stress should be avoided.125 (See Use of Fixed Combinations under Cautions.)


Interim results from an ongoing study indicate that the relative risk for febrile seizures 5–12 days after a dose of MMRV (ProQuad) in children 12–60 months of age (995 were 12–23 months of age) is 2.3 times higher than that reported with concurrent administration of a dose of Varivax and a dose of MMR given during a single health-care visit.136 (See Use of Fixed Combinations under Cautions.)


Thrombocytopenia

Thrombocytopenia has been reported after administration of varicella vaccine or MMR; thrombocytopenia has worsened in those with preexisting thrombocytopenia and may worsen with subsequent doses.27 125


Manufacturer of MMRV (ProQuad) states that potential benefits and risks should be evaluated before considering use of the vaccine in patients who develop thrombocytopenia or had worsening of thrombocytopenia with a previous dose.125 Serologic testing for antibody to MMR should be considered to determine whether additional doses should be given.125


Risk of Transmissible Agents in Preparations Containing Albumin

MMRV (ProQuad) contains albumin human.125


Since albumin is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).125 141


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylaxis,1 27 rash,1 urticaria,1 hypersensitivity vasculitis,105 erythema multiforme,1 27 and Stevens-Johnson syndrome1 reported rarely.


Prior to vaccine administration, question recipient and/or parent or guardian concerning reactions to previous doses of the vaccine or similar preparations.1 125


Epinephrine and other appropriate agents should be readily available in case anaphylaxis or similar reaction occurs.1 125


Gelatin Allergy

Varivax and MMRV (ProQuad) contain hydrolyzed gelatin as a stabilizer.1 125


Immediate reactions (i.e., wheezing and dyspnea with or without urticaria) and other reactions (i.e., erythema and swelling at injection site) have occurred and may be related to gelatin hypersensitivity.106 Consider possibility of such reactions.26 100 106 125


Although skin testing for gelatin sensitivity before administering a gelatin-containing vaccine can be considered, there are no specific protocols for this purpose.26 100 Because gelatin used in vaccines manufactured in the US usually is derived from porcine sources, and food gelatin may be derived solely from bovine sources, a negative food history does not exclude the possibility of a reaction to the gelatin contained in the vaccine.100


Neomycin Allergy

Varivax and MMRV (ProQuad) contain trace amounts of neomycin and are contraindicated in those with a history of anaphylactic reactions to neomycin.1 125


Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.26 27 100 125 ACIP and AAP state that vaccines containing trace amounts of neomycin should not be used in individuals with a history of anaphylactic reaction to neomycin, but use of such vaccines may be considered in those with a history of delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks.26 27 100


Manufacturer of MMRV (ProQuad) states that if use of this vaccine is considered medically necessary in an individual with a history of anaphylactic reactions to neomycin, an allergist or immunologist should be consulted and the vaccine should be given only in settings where anaphylactic reactions can be managed appropriately.125


Allergy to Egg-related Antigens

MMRV (ProQuad): MMR component of this fixed-combination vaccine is produced in chick embryo cell culture.125


Individuals with a history of anaphylactic or other immediate hypersensitivity reactions (e.g., hives, swelling of the mouth or throat, difficulty breathing, hypotension, shock) after egg ingestion may be at increased risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen.125


Consider potential benefits versus possible risks before administering MMRV (ProQuad) to an individual with a history of anaphylactic or other immediate hypersensitivity reaction to egg ingestion.125 Use extreme caution and have adequate treatment readily available in case a reaction occurs.125


Children with egg allergy, even those with severe hypersensitivity, are at low risk for anaphylactic reactions to MMRV (Proquad) and skin testing with dilute vaccine in such children is not predictive of reactions to the vaccine.100 125


Individuals who have egg allergies that are not anaphylactic in nature generally are not at increased risk of hypersensitivity reactions to vaccines produced in chick embryo cell cultures.26 125 There is no evidence that individuals with allergies to chickens or feathers are at increased risk of allergic reactions to such vaccines.26 125


General Precautions


Breakthrough Varicella Infections

Despite seroconversion following vaccination with varicella vaccine, breakthrough varicella infections may occur in some children or adults exposed to wild-type virus.1 13 16 17 18 20 24 27 42 44 47 48 52 53 55 75 77 122 123 137 These infections (i.e., wild-type VZV infection occurring >42 days after vaccination) generally are milder than those reported in unvaccinated individuals and are associated with a low rate of fever and rapid recovery.1 13 16 17 24 27 42 47 48 52 75 77 137


In vaccinated healthy children and adolescents 12 months to 17 years of age, breakthrough infections occur in about 19% within 10 years and generally involve <100 vesicles.1 13 16 17 27 47 48 75 77


In vaccinated healthy adults, breakthrough infections have occurred following household exposure in 4–27%.1 These infections generally involve <50 vesicles,1 11 27 137 but may be associated with ≥50–300 vesicles.1 11


Latent Infections and Herpes Zoster

Primary immunization with varicella vaccine does not necessarily ensure protection against subsequent latent infection with natural wild-type VZV or reactivation of latent infections.8 9 27 42 49 50 74 137


Herpes zoster has been reported rarely in immunocompromised children and healthy children, adolescents, and adults who received primary immunization with varicella vaccine.1 8 9 42 47 49 50 51 52 55 74 Most cases occurred 3–5 years after vaccination and were mild without sequelae.1 9 50 74


Herpes zoster in vaccinated individuals may be caused by vaccine virus or by wild-type virus.1 8 9 27 49 74 137 No evidence to date that latent vaccine virus infections are any more likely to reactivate than latent infections caused by wild-type virus.8 55


Waning cell-mediated immunity to VZV may predispose to reactivation of the virus.6 9 74 137 The long-term effect of primary immunization with varicella vaccine on the incidence of subsequent herpes zoster, particularly in vaccinees exposed to natural varicella, is unknown.1 9 21 24