Sunday 29 April 2012

Vaseretic


Generic Name: enalapril and hydrochlorothiazide (Oral route)


en-AL-a-pril MAL-ee-ate, hye-droe-klor-oh-THYE-a-zide


Oral route(Tablet)

ACE inhibitors can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .



Commonly used brand name(s)

In the U.S.


  • Vaseretic

Available Dosage Forms:


  • Tablet

Therapeutic Class: ACE Inhibitor/Thiazide Combination


Pharmacologic Class: Enalapril


Chemical Class: Thiazide


Uses For Vaseretic


Enalapril and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


Enalapril is an angiotensin converting enzyme (ACE) inhibitor. It works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, enalapril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.


Hydrochlorothiazide is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine which helps lower the blood pressure. a


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


Before Using Vaseretic


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 have not been performed on the relationship of age to the effects of enalapril and hydrochlorothiazide combination 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 enalapril and hydrochlorothiazide combination 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 enalapril and hydrochlorothiazide combination.


Pregnancy














Pregnancy CategoryExplanation
1st TrimesterCAnimal 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.
2nd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.


  • Dofetilide

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.


  • Acetyldigoxin

  • Allopurinol

  • Alteplase, Recombinant

  • Amiloride

  • Arsenic Trioxide

  • Azathioprine

  • Azilsartan Medoxomil

  • Candesartan Cilexetil

  • Canrenoate

  • Deslanoside

  • Digitalis

  • Digitoxin

  • Digoxin

  • Droperidol

  • Eplerenone

  • Eprosartan

  • Flecainide

  • Interferon Alfa-2a

  • Ketanserin

  • Levomethadyl

  • Lithium

  • Losartan

  • Metildigoxin

  • Olmesartan Medoxomil

  • Ouabain

  • Potassium

  • Proscillaridin

  • Sotalol

  • Spironolactone

  • Telmisartan

  • Triamterene

  • Valsartan

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.


  • Aceclofenac

  • Acemetacin

  • Alacepril

  • Alclofenac

  • Aliskiren

  • Apazone

  • Aspirin

  • Azosemide

  • Bemetizide

  • Benazepril

  • Bendroflumethiazide

  • Benoxaprofen

  • Benzthiazide

  • Bepridil

  • Bromfenac

  • Bufexamac

  • Bumetanide

  • Bupivacaine

  • Buthiazide

  • Capsaicin

  • Captopril

  • Carbamazepine

  • Carprofen

  • Celecoxib

  • Chlorothiazide

  • Chlorpropamide

  • Chlorthalidone

  • Cholestyramine

  • Cilazapril

  • Clometacin

  • Clomipramine

  • Clonixin

  • Clopamide

  • Cyclopenthiazide

  • Cyclophosphamide

  • Cyclothiazide

  • Delapril

  • Dexketoprofen

  • Diclofenac

  • Diflunisal

  • Dipyrone

  • Droxicam

  • Enalaprilat

  • Enalapril Maleate

  • Ethacrynic Acid

  • Etodolac

  • Etofenamate

  • Felbinac

  • Fenbufen

  • Fenoprofen

  • Fentiazac

  • Floctafenine

  • Flufenamic Acid

  • Flurbiprofen

  • Fosinopril

  • Furosemide

  • Ginkgo

  • Glipizide

  • Gold Sodium Thiomalate

  • Gossypol

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Ibuprofen

  • Ibuprofen Lysine

  • Imidapril

  • Indapamide

  • Indomethacin

  • Indoprofen

  • Isoxicam

  • Ketoprofen

  • Ketorolac

  • Licorice

  • Lisinopril

  • Lornoxicam

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Metformin

  • Methyclothiazide

  • Metolazone

  • Moexipril

  • Nabumetone

  • Naproxen

  • Nepafenac

  • Nesiritide

  • Niflumic Acid

  • Nimesulide

  • Oxaprozin

  • Oxyphenbutazone

  • Pentopril

  • Perindopril

  • Phenylbutazone

  • Pirazolac

  • Piretanide

  • Piroxicam

  • Pirprofen

  • Polythiazide

  • Propyphenazone

  • Proquazone

  • Quinapril

  • Quinethazone

  • Ramipril

  • Rifampin

  • Salicylic Acid

  • Salsalate

  • Spirapril

  • Sulindac

  • Suprofen

  • Temocapril

  • Tenidap

  • Tenoxicam

  • Tiaprofenic Acid

  • Tolmetin

  • Topiramate

  • Torsemide

  • Trandolapril

  • Trichlormethiazide

  • Trimethoprim

  • Xipamide

  • Zofenopril

  • Zomepirac

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:


  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase the risk of this condition occurring again.

  • Anuria (not able to pass urine) or

  • Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

  • Asthma, history of—May increase likelihood of having an allergic reaction.

  • Collagen vascular disease (an autoimmune disease) together with kidney disease—Increased risk of blood problems.

  • Congestive heart failure, severe or

  • Dehydration or

  • Dialysis, patients receiving or

  • Diarrhea or

  • Kidney problems—These conditions may cause the blood pressure to fall too low with this medicine.

  • Kidney problems or

  • Diabetes—Increased risk of potassium levels in the body becoming too high.

  • Electrolyte imbalance (e.g., hypercalcemia, hypokalemia, hyponatremia, hypomagnesemia) or

  • Gout or

  • Heart or blood vessel disease (e.g., aortic stenosis, hypertrophic cardiomyopathy) or

  • Hypercholesterolemia (high cholesterol in the blood) or

  • Hyperglycemia or

  • Hyperuricemia (high uric acid in the blood) or

  • Liver disease or

  • Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

Proper Use of Vaseretic


This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.


In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.


Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.


Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.


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 high blood pressure:
      • Adults—1 or 2 tablets taken as a single dose or two times a day.

      • Children—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.


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


Precautions While Using Vaseretic


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


Using this medicine while you are pregnant (especially in your second or third trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.


This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.


Stop using this medicine and call your doctor right away if you have severe stomach pain. This could be a symptom of a condition called intestinal angioedema.


Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.


Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.


Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium in the body).


This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.


Check with your doctor if you have any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cells.


Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).


Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.


This medicine may increase the amount of potassium in your blood. Do not use salt substitutes or supplements containing potassium or without first checking with your doctor.


Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.


If your symptoms do not improve within a few days or if they become worse, check with your doctor.


Black patients may be less sensitive to the blood pressure-lowering effects of this medicine. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.


Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.


Vaseretic 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
  • Blurred vision

  • chest pain or discomfort

  • chills

  • cold sweats

  • coma

  • confusion

  • decreased urine output

  • diarrhea

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • drowsiness

  • dry mouth

  • fainting

  • fast, slow, or irregular heartbeat

  • headache

  • increased thirst

  • irritability

  • loss of appetite

  • mood changes

  • muscle pain or cramps

  • nausea or vomiting

  • numbness or tingling in the hands, feet, or lips

  • rapid breathing

  • seizures

  • shortness of breath

  • sunken eyes

  • sweating

  • swelling of the face, ankles, or hands

  • thirst

  • unusual tiredness or weakness

  • weak pulse

  • wrinkled skin

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:


Less common
  • Cough

  • decreased interest in sexual intercourse

  • inability to have or keep an erection

  • lack or loss of strength

  • loss in sexual ability, desire, drive, or performance

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: Vaseretic 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.


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More Vaseretic resources


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


  • Vaseretic 10-25 Concise Consumer Information (Cerner Multum)



Compare Vaseretic with other medications


  • Heart Failure
  • High Blood Pressure

Friday 27 April 2012

Veripred 20


Generic Name: prednisolone (pred NIS oh lone)

Brand Names: Bubbli-Pred, Flo-Pred, Hydeltrasol, Key-Pred SP, Millipred, Orapred, Orapred ODT, Pediapred, Pred-Ject-50, Predacort 50, Predalone 50, Predate-50, Veripred 20


What is Veripred 20 (prednisolone)?

Prednisolone is in a class of drugs called steroids. Prednisolone prevents the release of substances in the body that cause inflammation.


Prednisolone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.


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


What is the most important information I should know about Veripred 20 (prednisolone)?


You should not use this medication if you are allergic to prednisolone, or if you have a fungal infection anywhere in your body.

Before taking prednisolone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.


Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.


Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.


Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.


Do not receive a "live" vaccine while you are taking prednisolone. Vaccines may not work as well while you are taking a steroid.


Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

What should I discuss with my healthcare provider before taking Veripred 20 (prednisolone)?


You should not use this medication if you are allergic to prednisolone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.


If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:



  • liver disease (such as cirrhosis);




  • kidney disease;




  • a thyroid disorder;




  • diabetes;




  • a history of malaria;




  • tuberculosis;




  • osteoporosis;




  • a muscle disorder such as myasthenia gravis;




  • glaucoma or cataracts;




  • herpes infection of the eyes;




  • stomach ulcers, ulcerative colitis, or diverticulitis;




  • depression or mental illness;




  • congestive heart failure; or




  • high blood pressure




FDA pregnancy category C. It is not known whether prednisolone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Prednisolone 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. Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take Veripred 20 (prednisolone)?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.


Your doctor may occasionally change your dose to make sure you get the best results from this medication.


Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.


Measure the liquid form of prednisolone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Keep the disintegrating tablet (Orapred ODT) in its blister pack until you are ready to take the medicine. Open the package using dry hands, and peel back the foil from the tablet blister (do not push the tablet through the foil). Remove the tablet and place it in your mouth.


Allow the disintegrating tablet to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.


Steroids can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using prednisolone.


Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication. Store prednisolone at room temperature away from moisture and heat.

What happens if I miss a dose?


If you miss a dose or forget to take your medicine, contact your doctor or pharmacist for instructions.


What happens if I overdose?


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

A single large dose of prednisolone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.


What should I avoid while taking Veripred 20 (prednisolone)?


Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.


Do not receive a "live" vaccine while you are being treated with prednisolone. Vaccines may not work as well while you are taking a steroid.


Avoid drinking alcohol while you are taking prednisolone.

Veripred 20 (prednisolone) 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. Call your doctor at once if you have any of these serious side effects:

  • problems with your vision;




  • swelling, rapid weight gain, feeling short of breath;




  • severe depression, unusual thoughts or behavior, seizure (convulsions);




  • bloody or tarry stools, coughing up blood;




  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);




  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).



Less serious side effects may include:



  • sleep problems (insomnia), mood changes;




  • acne, dry skin, thinning skin, bruising or discoloration;




  • slow wound healing;




  • increased sweating;




  • headache, dizziness, spinning sensation;




  • nausea, stomach pain, bloating; or




  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).



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.


What other drugs will affect Veripred 20 (prednisolone)?


There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:



  • aspirin (taken on a daily basis or at high doses);




  • a diuretic (water pill);




  • a blood thinner such as warfarin (Coumadin);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • insulin or diabetes medications you take by mouth;




  • ketoconazole (Nizoral);




  • rifampin (Rifadin, Rifater, Rifamate, Rimactane); or




  • seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).



This list is not complete and there may be other drugs that can interact with prednisolone. 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 Veripred 20 resources


  • Veripred 20 Side Effects (in more detail)
  • Veripred 20 Use in Pregnancy & Breastfeeding
  • Veripred 20 Drug Interactions
  • 0 Reviews for Veripred 20 - Add your own review/rating


  • Veripred 20 Prescribing Information (FDA)

  • Veripred 20 Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Veripred 20 Advanced Consumer (Micromedex) - Includes Dosage Information

  • Flo-Pred Prescribing Information (FDA)

  • Flo-Pred Consumer Overview

  • Flo-Pred Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Millipred Prescribing Information (FDA)

  • Millipred DP MedFacts Consumer Leaflet (Wolters Kluwer)

  • Orapred Consumer Overview

  • Orapred Prescribing Information (FDA)

  • Orapred ODT Prescribing Information (FDA)

  • Orapred ODT MedFacts Consumer Leaflet (Wolters Kluwer)

  • PediaPred Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prednisolone tablets Prescribing Information (FDA)

  • Prednisolone Monograph (AHFS DI)

  • Prednisolone Professional Patient Advice (Wolters Kluwer)

  • Prednisolone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prednisolone Acetate eent Monograph (AHFS DI)

  • Prelone Syrup MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Veripred 20 with other medications


  • Asthma, acute
  • Bronchopulmonary Dysplasia
  • Bullous Pemphigoid
  • Dermatitis
  • Immunosuppression
  • Inflammatory Conditions
  • Multiple Sclerosis
  • Nephrotic Syndrome
  • Pemphigoid
  • Pemphigus


Where can I get more information?


  • Your pharmacist can provide more information about prednisolone.

See also: Veripred 20 side effects (in more detail)


Vumon


Generic Name: Teniposide
Class: Antineoplastic Agents
VA Class: AN900
Molecular Formula: C32H32O13S
CAS Number: 29767-20-2



  • Administer only under supervision of qualified clinicians experienced in the use of cytotoxic therapy.1




  • Possible severe myelosuppression with resulting infection and bleeding.1 6 (See Myelosuppression under Cautions.)




  • Possible serious and potentially fatal hypersensitivity reactions.1 14 15 16 Epinephrine, with or without corticosteroids and antihistamines, has been used to alleviate signs and symptoms.1 14 15 16 (See Sensitivity Reactions under Cautions.)




Introduction

Antineoplastic agent; a semisynthetic podophyllotoxin-derivative that is structurally and pharmacologically related to etoposide.1 2 3 4 5 6


Uses for Vumon


Acute Lymphocytic Leukemia


Induction therapy (as a component of multiple-drug antineoplastic regimens) in childhood acute lymphocytic (lymphoblastic) leukemia (ALL) that is refractory to induction with other therapy or has relapsed despite such therapy1 6 26 (designated an orphan drug by FDA for this use).25


May prolong remission;1 23 however, experience is limited, and only a minority of patients achieve long-term survival.1 2 5 21


Vumon Dosage and Administration


General



  • Consult specialized references for procedures for proper handling and disposal of antineoplastics.1 (See IV Administration under Dosage and Administration.)



Administration


IV Administration


For solution and drug compatibility information, see Compatibility under Stability.


Administer diluted solution by slow IV infusion.1 Do not administer by rapid IV injection.1 (See Cardiovascular Effects under Cautions.)


To prevent leaching of diethylhexyl phthalate (DEHP) plasticizer, use IV administration sets that do not contain DEHP (e.g., lipid sets, low DEHP-containing nitroglycerin sets).1


Ensure that IV catheter or needle is in proper position and functional prior to infusion to avoid extravasation.1 (See Local Effects under Cautions.)


Flush IV access site thoroughly with 5% dextrose or 0.9% sodium chloride injection prior to and following administration.1 Heparin should not be used due to potential for drug precipitation.1


Observe carefully for possible occlusion of the IV access site, including central venous catheters, particularly during prolonged (e.g., 24-hour) infusions.1 (See Compatibility under Stability.)


Observe closely for possible hypotensive or hypersensitivity reactions during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.1 (See Cardiovascular Effects and also see Sensitivity Reactions under Cautions.)


Handle cautiously.1 Skin reactions may occur following accidental exposure; use protective equipment (e.g., gloves).1 If accidental contact occurs, wash skin thoroughly with soap and water or flush mucosa thoroughly with water.1


Dilution

Must be diluted before IV infusion.1


Plastic equipment or devices may soften or crack and possibly leak when used with undiluted teniposide injection.1


To prevent leaching of DEHP plasticizer, prepare diluted solutions in containers that do not contain DEHP (e.g., glass or polyolefin plastic bags or containers).1 Use of PVC containers not recommended.1


For IV infusion, dilute concentrate in 5% dextrose or 0.9% sodium chloride injection to a final concentration of 0.1, 0.2, 0.4, or 1 mg/mL.1


Rate of Administration

Administer over at least 30–60 minutes to minimize risk of hypotension.1 6 (See Cardiovascular Effects under Cautions.) If hypotensive reaction occurs, use slower rate of infusion and monitor carefully if restarting after discontinuance and appropriate treatment.1


Dosage


Pediatric Patients


Acute Lymphocytic Leukemia

Patients Who Failed Induction Therapy with a Cytarabine-containing Regimen

IV

165 mg/m2 (in combination with cytarabine 300 mg/m2) twice weekly for 8 or 9 doses.1


Patients Who Failed Induction Therapy with Vincristine/Prednisone-containing Regimens

IV

250 mg/m2 (in combination with vincristine 1.5 mg/m2) weekly for 4–8 weeks with oral prednisone 40 mg/m2 daily for 28 days.1


Special Populations


Hepatic Impairment


Use with caution; dosage adjustments may be necessary.1


Renal Impairment


Dosage adjustments may be necessary.1


Patients with Down’s Syndrome


Initially, give half the usual dose; subsequent doses may be increased depending on degree of myelosuppression and mucositis encountered with previous doses.1


Cautions for Vumon


Contraindications



  • Known hypersensitivity to teniposide or polyoxyl 35 castor oil (Cremophor EL, polyoxyethylated castor oil).1 (See Sensitivity Reactions under Cautions.)



Warnings/Precautions


Warnings


Adequate Patient Evaluation and Monitoring

Administer only under supervision of qualified clinicians experienced in the use of cytotoxic therapy.1


Perform CBCs and renal and hepatic function tests prior to, during, and after completion of therapy.1 (See Myelosuppression under Cautions.)


Myelosuppression

Risk of dose-limiting myelosuppression (e.g., neutropenia, leukopenia, thrombocytopenia, anemia).1 2 5 6 8 9 Severe myelosuppression with resulting infection or bleeding may occur.1 6


Monitor for myelosuppression frequently during and after treatment.1 Perform CBCs (leukocyte count with differential, platelet count, hemoglobin) prior to initiation of therapy and before each subsequent dose.1 If severe myelosuppression occurs, consider supportive therapy, antibiotics for complicating infections, and blood product transfusions; repeat bone marrow examination before continuing therapy.1


Cardiovascular Effects

Transient hypotension reported following rapid IV administration, possibly resulting from direct effect of polyoxyl 35 castor oil contained in preparation.1


Administer over at least 30–60 minutes; observe patient closely during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.1


If clinically important hypotension occurs, discontinue infusion.1 BP usually normalizes within hours in response to infusion discontinuance and administration of IV fluids and other supportive therapy as necessary.1 Use slower rate of infusion and monitor carefully if restarting after discontinuance and appropriate treatment.1


Sudden death secondary to intractable hypotension and probable arrhythmia reported in at least 1 geriatric patient receiving teniposide in combination therapy for a nonleukemic malignancy.1 Hypertensive reactions, sometimes severe and accompanied by cardiac failure, reported rarely.12 13


Nervous System Effects

Acute CNS depression (manifested as somnolence and lethargy) and hypotension, accompanied by metabolic acidosis,11 reported in patients pretreated with antiemetics and receiving high-dose regimens of teniposide.1 11 CNS depression possibly resulting from depressant effects of antiemetic agents and high alcohol content of teniposide formulation.1


Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.1 19 Teratogenicity and embryotoxicity demonstrated in animals.1 Avoid pregnancy during therapy.1 If used during pregnancy or if pregnancy occurs during therapy, apprise of potential fetal hazard.1


Sensitivity Reactions


Hypersensitivity Reactions

Risk of hypersensitivity reactions,1 14 15 16 including anaphylaxis-like manifestations (e.g., chills, fever, urticaria, tachycardia, flushing, bronchospasm, dyspnea, hypotension or hypertension).1 Reaction may occur with initial dose or with repeated exposure and may be life-threatening if not treated promptly with antihistamines, corticosteroids, epinephrine, IV fluids, and other supportive measures as necessary.1 Etiology unknown, but reactions may result from polyoxyl 35 castor oil component or from teniposide itself.1 14 15 16 Frequency possibly increased in patients with neuroblastomas or brain tumors.1 14 15 Observe patients closely during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.1 If manifestations of anaphylaxis occur, discontinue infusion immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, antihistamines, pressor agents, IV fluids).1


Generally contraindicated in patients with known hypersensitivity to teniposide or polyoxyl 35 castor oil; however, may consider cautious administration when the antileukemic benefit already demonstrated clearly outweighs the possible risk.1 When reinitiating therapy in a patient who previously developed a hypersensitivity reaction, pretreat with a corticosteroid and antihistamine and observe patient carefully during and after infusion.1


Appropriate equipment and agents (e.g., epinephrine, antihistamines, corticosteroids, IV fluids, oxygen) should be readily available.1


No evidence of cross-sensitization between teniposide and etoposide.1


General Precautions


Toxicity

Administer only under constant supervision by clinicians experienced in therapy with cytotoxic agents and only when the potential benefits outweigh the possible risks.1


Most adverse effects are reversible if detected early.1


Discontinue or reduce dosage and institute appropriate measures as necessary when severe adverse effects occur.1


Reinstitute therapy with caution, considering further need for the drug and possible toxicity recurrence.1


Local Effects

Extravasation may result in local tissue necrosis and/or thrombophlebitis.1


Dermatologic Effects

Alopecia reported; usually reversible but sometimes may progress to total baldness.1


Carcinogenicity

Secondary acute myeloid (myelogenous, nonlymphocytic) leukemia (AML, ANLL), with or without a preleukemic phase, reported in patients receiving maintenance therapy with teniposide in combination with other antineoplastic agents.1 10 Assess potential benefit versus risks of therapy.1 10


Animal studies to determine the carcinogenic potential of teniposide have not been performed to date; however, the drug should be considered a potential carcinogen.1


Specific Populations


Pregnancy

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


Lactation

Not known whether teniposide is distributed into milk.1 Discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy established only for combination therapy of refractory childhood ALL.1 6 In an analysis of data from 7 studies involving 303 patients ranging in age from 0.5 months to 20 years who received teniposide as a single agent for a variety of hematologic malignancies and solid tumors, no age-related difference in tolerance was reported.27 f


Each mL of teniposide concentrate for injection contains 30 mg of benzyl alcohol.1 Although a causal relationship has not been established, injections preserved with benzyl alcohol have been associated with toxicity in neonates.a b c d e


Hepatic Impairment

Use with caution.1 (See Elimination: Special Populations, under Pharmacokinetics.)


Patients with Down’s Syndrome

Possible increased sensitivity to myelosuppressive chemotherapy.1 Dosage adjustments necessary.1 (See Down's Syndrome under Dosage and Administration.)


Patients with Hypoalbuminemia

Careful monitoring recommended.1 (See Distribution: Special Populations, under Pharmacokinetics.)


Common Adverse Effects


Neutropenia, leukopenia, anemia, thrombocytopenia, myelosuppression (nonspecified), mucositis, diarrhea, nausea, vomiting, infection, alopecia, bleeding, hypersensitivity reactions, rash, fever, hypotension.1


Interactions for Vumon


Specific Drugs





















Drug



Interaction



Comments



Antiemetic agents



Possible CNS depression when used concomitantly with higher than recommended dosages of teniposide1



Methotrexate



Possible increased methotrexate clearance1



Sodium salicylate



Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1



Use concomitantly with caution1



Sulfamethizole



Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1



Use concomitantly with caution1



Tolbutamide



Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1



Use concomitantly with caution1


Vumon Pharmacokinetics


Distribution


Extent


Limited distribution throughout the body because of extensive protein binding.1 Limited distribution into the brain; however, CSF concentrations are higher in patients with brain tumors.1


Concentrations in saliva, CSF, and malignant ascites fluid are low relative to those in plasma.1


Plasma Protein Binding


>99%.1


Special Populations


Volume of distribution increases with decreasing albumin concentrations.1 (See Patients with Hypoalbuminemia under Cautions.)


Elimination


Elimination Route


44% of dose is excreted in urine within 120 hours after dosing (with only 4–12% excreted as unchanged drug); 0–10% of dose is excreted in feces within 72 hours.1


Half-life


5 hours.1


Special Populations


Possible association between increased concentrations of serum alkaline phosphatase or γ-glutamyltransferase (γ-glutamyltranspeptidase, GT, GGTP) and a decrease in plasma teniposide clearance.1 (See Hepatic Impairment under Cautions.)


Stability


Storage


Parenteral


Injection

2–8°C; protect from light.1


Store diluted solutions at room temperature; do not refrigerate.1 Diluted solutions at concentrations of 0.1, 0.2, or 0.4 mg/mL are stable for up to 24 hours at room temperature.1 Diluted solutions at concentration of 1 mg/mL should be administered within 4 hours to reduce potential for precipitation.1 Stability and use times are identical for solutions prepared in glass or plastic containers.1


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Possible precipitation of diluted solutions.1 Precipitation reported during 24-hour infusions of teniposide diluted to concentrations of 0.1–0.2 mg/mL, resulting in occlusion of central venous access catheters.1 17 (See IV Administration under Dosage and Administration.) To minimize precipitation, avoid agitation, decrease storage time prior to administration, and avoid contact with other drugs or fluids.1


Solution CompatibilityHID






Compatible



Dextrose 5% in water



Ringer’s injection, lactated



Sodium chloride 0.9%


Drug Compatibility





































































































Y-Site CompatibilityHID

Compatible



Acyclovir sodium



Allopurinol



Amifostine



Amikacin sulfate



Aminophylline



Amphotericin B



Ampicillin sodium



Ampicillin sodium–sulbactam sodium



Aztreonam



Bleomycin sulfate



Bumetanide



Buprenorphine HCl



Butorphanol tartrate



Calcium gluconate



Carboplatin



Carmustine



Cefazolin sodium



Cefotaxime sodium



Cefoxitin sodium



Ceftazidime



Ceftizoxime sodium



Ceftriaxone sodium



Cefuroxime sodium



Chlorpromazine HCl



Cimetidine HCl



Ciprofloxacin



Cisplatin



Cladribine



Clindamycin phosphate



Co-trimoxazole



Cyclophosphamide



Cytarabine



Dacarbazine



Dactinomycin



Daunorubicin HCl



Dexamethasone sodium phosphate



Diphenhydramine HCl



Doxorubicin HCl



Doxycycline hyclate



Droperidol



Enalaprilat



Etoposide



Etoposide phosphate



Famotidine



Floxuridine



Fluconazole



Fludarabine phosphate



Fluorouracil



Furosemide



Gallium nitrate



Ganciclovir sodium



Gemcitabine HCl



Gentamicin sulfate



Granisetron HCl



Haloperidol lactate



Hydrocortisone sodium phosphate



Hydrocortisone sodium succinate



Hydromorphone HCl



Hydroxyzine HCl



Ifosfamide



Imipenem–cilastatin sodium



Leucovorin calcium



Lorazepam



Mannitol



Mechlorethamine HCl



Melphalan HCl



Meperidine HCl



Mesna



Methotrexate sodium



Methylprednisolone sodium succinate



Metoclopramide HCl



Metronidazole



Minocycline HCl



Mitomycin



Mitoxantrone HCl



Morphine sulfate



Nalbuphine HCl



Netilmicin sulfate



Ondansetron HCl



Potassium chloride



Prochlorperazine edisylate



Promethazine HCl



Ranitidine HCl



Sargramostim



Sodium bicarbonate



Streptozocin



Thiotepa



Ticarcillin disodium



Ticarcillin disodium–clavulanate potassium



Tobramycin sulfate



Vancomycin HCl



Vinblastine sulfate



Vincristine sulfate



Vinorelbine tartrate



Zidovudine



Incompatible



Heparin1



Idarubicin HCl


ActionsActions



  • Exact mechanism(s) of action not known; apparently produces cytotoxic effects by damaging DNA and thereby inhibiting or altering DNA synthesis.1 6 7




  • Induces single- and double-stranded DNA breaks and also induces DNA-protein cross-links,1 2 5 possibly through inhibition of type II topoisomerase.1 6




  • Cell-cycle specific, inducing G2-phase arrest and preferentially killing cells in the G2 and late S phases.1 2 5



Advice to Patients



  • Importance of advising patients and/or their parents or guardians of adverse effects and associated manifestations.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and to advise pregnant women of risk to the fetus.1




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.













Teniposide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



For injection concentrate, for IV infusion only



10 mg/mL



Vumon (with dehydrated alcohol 42.7% and benzyl alcohol 30 mg and polyoxyl 35 castor oil 500 mg per mL)



Bristol-Myers Squibb



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



1. Bristol-Myers Squibb Oncology Division. Vumon (teniposide injection) prescribing information. Princeton, NJ: 1998 Oct.



2. National Cancer Institute Cancer Therapy Evaluation Program. Group C treatment protocol: VM-26 in combination with Ara-C for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. NCI protocol No. 188-16. Bethesda, MD: National Cancer Institute; 1988 Aug 15.



3. Strife J, Jardine I. Analysis of the anticancer drugs VP 16-213 and VM 26 and their metabolites by high-performance liquid chromatography. J Chromatogr. 1980; 182:211-20. [IDIS 178818] [PubMed 7380913]



4. Grem JL, Hoth DF, Leyland-Jones B et al. Teniposide in the treatment of leukemia: a case study of conflicting priorities in the development of drugs for fatal diseases. J Clin Oncol. 1988; 6:351-79. [PubMed 3276827]



5. National Cancer Institute Therapy Evaluation Program. Group C treatment protocol: VM-26 in combination with Ara-C for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. NCI protocol No. 188-0016. Bethesda, MD: National Cancer Institute; 1989 Jan 25.



6. Anon. Teniposide for acute lymphoblastic leukemia. Med Lett Drugs Ther. 1992; 34:105-6. [PubMed 1435505]



7. Krishan A, Paika K, Frei E III. Cytofluorometric studies on the action of podophyllotoxin and epipodophyllotoxins (VM-26, VP-16-213) on the cell cycle traverse on human lymphoblasts. J Cell Biol. 1975; 66:521-30. [PubMed 1057547]



8. O’Dwyer PJ, Alonso MT, Leyland-Jones B et al. Teniposide: a review of 12 years of experience. Cancer Treat Rep. 1984; 68:1455-66. [IDIS 195977] [PubMed 6391663]



9. Bristol-Myers Squibb Oncology Division. Vumon (teniposide) concentrate for injection formulary guide. Princeton, NJ; 1992.



10. Pui CH, Ribeiro RC, Hancock ML et al. Acute myeloid leukemia in children treated with epipodophyllotoxins for acute lymphoblastic leukemia. N Engl J Med. 1991; 325:1682-7. [IDIS 288970] [PubMed 1944468]



11. McLeod HL, Baker DK Jr, Pui CH et al. Somnolence, hypotension, and metabolic acidosis following high-dose teniposide treatment in children with leukemia. Cancer Chemother Pharmacol. 1991; 29:150-4. [PubMed 1760858]



12. Razon-Veronesi S. Cardiovascular toxic effects of VM26 in the treatment of acute lymphatic leukemia: presentation of two cases. Tumori. 1982; 68:253-5. [PubMed 6958114]



13. Shimizu H, Frankel LS, Culbert SJ. Severe hypertensive reactions to teniposide (VM-26) in infants with congenital leukemia. Am J Pediatr Hematol/Oncol. 1987; 9:239-41.



14. O’Dwyer PJ, King SA, Fortner CL et al. Hypersensitivity reactions to teniposide (VM-26): an analysis. J Clin Oncol. 1986; 4:1262-9. [PubMed 3525769]



15. Hayes FA, Abromowitch M, Green AA. Allergic reactions to teniposide in patients with neuroblastoma and lymphoid malignancies. Cancer Treat Rep. 1985; 69:439-41. [IDIS 201327] [PubMed 3857970]



16. Kellie SJ, Crist WM, Pui CH et al. Hypersensitivity reactions to epipodophyllotoxins in children with acute lymphoblastic leukemia. Cancer. 1991; 67:1070-5. [IDIS 277532] [PubMed 1991254]



17. Strong DK, Morris LA. Precipitation of teniposide during infusion. Am J Hosp Pharm. 1990; 47:512,518. [PubMed 2316530]



18. DeMarini DM, Brock KH, Doerr CL et al. Mutagenicity and clastogenicity of teniposide (VM-26) in L5178Y/JK±-3.7.2C mouse lymphoma cells. Mutat Res. 1987; 187:141-9. [PubMed 3821767]



19. Food and Drug Administration. Prescription drug advertising; content and format for labeling of human prescription drugs. Fed Regist. 1979; 44:37434-67.



20. Bleyer WA, Sather H, Hammond GD. Prognosis and treatment after relapse of acute lymphoblastic leukemia and non-Hodgkins lymphoma: 1985. Cancer. 1986; 58:590-4. [PubMed 3459571]



21. Rivera GK, Buchanan G, Boyett JM et al. Intensive retreatment of childhood acute lymphoblastic leukemia in first bone marrow relapse: a Pediatric Oncology Group study. N Engl J Med. 1986; 315:273-8. [IDIS 218989] [PubMed 3523250]



22. Childhood acute lymphoblastic leukemia. From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Oct.



23. Sadowitz PD, Smith SD, Shuster J et al. Treatment of late bone marrow relapse in children with acute lymphocytic leukemia: a Pediatric Oncology Group study. Blood. 1993; 81: 602-9.



24. Rivera GK, Raimondi SC, Hancock ML et al. Improved outcome in childhood acute lymphoblastic leukemia with reinforced early treatment and rotational combination chemotherapy. Lancet. 1991; 337:61-6. [IDIS 276376] [PubMed 1670723]



25. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 1998 Aug 13. From FDA web site ().



26. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]



27. Food and Drug Administration. MedWatch—Safety-related drug labeling changes: Vumon (teniposide) [October 1, 2002]. From FDA web site .



a. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10-11. [PubMed 7188569]



b. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR Morb Mortal Wkly Rep. 1982; 31:290-1. [IDIS 150868] [PubMed 6810084]



c. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]



d. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]



e. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]



f. Bristol-Myers Squibb Company. Vumon (teniposide injection) prescribing information. Princeton, NJ: 2004 Aug.



HID. Trissel LA. Handbook on injectable drugs. 12th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1272-1280.



More Vumon resources


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


  • Vumon Prescribing Information (FDA)

  • Vumon MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vumon Concise Consumer Information (Cerner Multum)

  • Vumon Advanced Consumer (Micromedex) - Includes Dosage Information

  • Teniposide Professional Patient Advice (Wolters Kluwer)



Compare Vumon with other medications


  • Acute Lymphoblastic Leukemia
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Thursday 26 April 2012

Vancoled



Generic Name: vancomycin (Intravenous route)

van-koe-MYE-sin

Commonly used brand name(s)

In the U.S.


  • Vancocin HCl

  • Vancoled

Available Dosage Forms:


  • Solution

  • Powder for Solution

Therapeutic Class: Antibiotic


Chemical Class: Glycopeptide


Uses For Vancoled


Vancomycin is used to treat infections caused by bacteria. It belongs to the family of medicines called antibiotics. Vancomycin works by killing bacteria or preventing their growth. Vancomycin will not work for colds, flu, or other virus infections.


Vancomycin is used to treat infections in many different parts of the body. It is sometimes given with other antibiotics. Vancomycin is also used in patients with heart valve disease (e.g., rheumatic fever) or prosthetic (artificial) heart valves who are allergic to penicillin. Under certain circumstances, this medicine also may be used to prevent endocarditis (inflammation of the lining of the heart) in these patients who are having dental work done or surgery on the upper respiratory tract (for example, nose or throat). Vancomycin also may be used for other conditions as determined by your doctor.


Vancomycin given by injection is used mainly for serious infections for which other medicines may not work. However, this medicine may cause some serious side effects, including damage to your hearing and kidneys. These side effects may be more likely to occur in elderly patients. You and your doctor should talk about the good this medicine will do as well as the risks associated with receiving it.


Vancomycin is available only with your doctor's prescription.


Before Using Vancoled


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


Vancomycin can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine will do as well as the risks of using it.


Geriatric


Elderly patients may be especially sensitive to the unwanted effects of vancomycin. This may increase the chance for hearing problems or kidney damage.


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. When you are receiving 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.


  • Amikacin

  • Gentamicin

  • Tobramycin

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.


  • Succinylcholine

  • 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:


  • Kidney disease or

  • Loss of hearing or deafness, history of—Use with caution. May cause side effects to become worse.

Proper Use of vancomycin

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


Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital for the full time of treatment. If you are receiving this medicine at home, make sure you clearly understand and carefully follow your doctor's instructions.


To help clear up your infection completely, vancomycin must be given for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, vancomycin must be given on a regular schedule.


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 injection dosage form:
    • For treatment of bacterial infections:
      • Adults and teenagers—7.5 milligrams (mg) per kilogram (kg) of body weight, or 500 mg, injected into a vein every six hours; or 15 mg per kg of body weight, or 1 gram, injected into a vein every twelve hours.

      • Children 1 month to 12 years of age—10 milligrams (mg) per kilogram (kg) of body weight injected into a vein every six hours; or 20 mg per kg of body weight injected into a vein every twelve hours.

      • Infants 1 week to 1 month of age—15 milligrams (mg) per kilogram (kg) of body weight injected into a vein at first, then 10 mg per kg of body weight injected into a vein every eight hours.

      • Newborns younger than 1 week of age—15 milligrams (mg) per kilogram (kg) of body weight injected into a vein at first, then 10 mg per kg of body weight injected into a vein every twelve hours.



Vancoled 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
  • Change in the frequency of urination or amount of urine

  • chills

  • coughing

  • difficulty with breathing

  • drowsiness

  • fever

  • increased thirst

  • loss of appetite

  • nausea or vomiting

  • sore throat

  • weakness

Rare
  • Abnormal bleeding or bruising

  • large blisters on the arms, legs, hands, feet, or upper body

  • loss of hearing

  • ringing, buzzing, or a feeling of fullness in the ears

  • severe stomach cramps and pain

  • stomach tenderness

  • watery and severe diarrhea, which may also be bloody

Symptoms of “red man syndrome” - Less common

Note: Some of these side effects may occur several weeks after you stop receiving this medicine.


  • Chills or fever

  • fainting

  • fast heartbeat

  • hives

  • itching

  • low blood pressure

  • nausea or vomiting

  • rash or redness of the face, base of the neck, upper body, back, and arms

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: Vancoled 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.


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More Vancoled resources


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


  • Vancomycin Professional Patient Advice (Wolters Kluwer)

  • Lyphocin Concise Consumer Information (Cerner Multum)

  • Vancocin Monograph (AHFS DI)

  • Vancocin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vancocin Prescribing Information (FDA)

  • Vancocin HCl Concise Consumer Information (Cerner Multum)



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Wednesday 25 April 2012

Adult Meltus Dry Coughs with Congestion





1. Name Of The Medicinal Product



Adult Meltus Dry Coughs with Congestion.


2. Qualitative And Quantitative Composition



Dextromethorphan Hydrobromide BP 10mg/5ml



Pseudoephedrine Hydrochloride BP 10mg/5ml



For excipients, see 6.1



3. Pharmaceutical Form



Oral liquid.



4. Clinical Particulars



4.1 Therapeutic Indications



Symptomatic relief of dry painful tickly coughs and catarrh.



4.2 Posology And Method Of Administration



Oral Use.



Adults, the elderly and children over 12 years of age: One or two 5ml spoonfuls to be taken four times a day.



Not to be given to children under 12 years of age.



4.3 Contraindications



Patients with cardiovascular disease, hypertension, hyperthyroidism, hyperexcitability, phaechromocytoma, closed angle glaucoma. Use with caution in patients with liver disease and asthma. May increase the difficulty of micturition in patients with prostatic enlargements. Hypersensitivity to any of the ingredients or if also taking monoamine oxidase inhibitors.



4.4 Special Warnings And Precautions For Use



Do not exceed the stated dose.



If symptoms persist of worsen, seek medical advice.



Keep out of reach of children.



If pregnant or taking regular medication, consult your doctor before taking this product.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Mono-amine oxidase inhibitors. The activity of the pseudoephedrine content is diminished by guanethidine, reserpine and methyldopa and may be diminished or enhanced by tricyclic antidepressants; it may diminish the effects of guanethidine and may increase the possibility of arrhythmias in digitalised patients.



Use with caution in patients with diabetes.



4.6 Pregnancy And Lactation



Not to be used by pregnant or lactating women.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Large doses may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness, tremors, anxiety, restlessness and insomnia.



4.9 Overdose



Management of overdose generally involves supportive and symptomatic therapy, and in cases of severe overdose, aspiration followed by gastric lavage may be used to empty the stomach. Treatment of dextromethorphan hydrobromide overdose is by the specific antidote, naloxone.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: Dextromethorphan, ATC code: R05DA09



Adult Meltus Dry Coughs with Congestion contains dextromethorphan hydrobromide and pseudoephedrine hydrochloride to provide cough suppression and bronchodilation in cases of dry irritating coughs.



5.2 Pharmacokinetic Properties



Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract following oral administration with no presystemic metabolism, achieving peak plasma concentrations between one and three hours after oral dosing. It has a plasma half-life of 5 to 8 hours following oral dosing but its urinary elimination and hence its half-life is pH dependent such that elimination will be increased in patients with acidic urine and decreased in subjects with alkaline urine.



Dextromethorphan is well absorbed following oral administration but is subject to extensive presystemic metabolism in the liver. The main metabolite is dextrorphan. Dextromethorphan is extensively biotransformed in the liver with about 50% of the dose excreted in the urine over 24 hours. Less than 1% of a dose being excreted in the faeces. About 8% of the dose is excreted as unchanged drug in the urine within 6 hours.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Menthol BP



Alcohol 96% BP



Glycerin BP



Sorbitol Solution BP



Chloroform BP



Sodium Cyclamate BP



Loganberry Flavour 500 195E



Sodium Saccharin BP



Sodium Carboxymethylcellulose BP



Methyl Hydroxybenzoate BP



Propyl Hydroxybenzoate BP



Water.



6.2 Incompatibilities



Mono-amine oxidase inhibitors (MAOIs). Antihypertensive therapy. Chloroform, cyclopropane, halothane and other halogenated anaesthetics.



6.3 Shelf Life



36 months unopened.



6.4 Special Precautions For Storage



Store below 25oC.



6.5 Nature And Contents Of Container



100ml: Amber glass bottles with tamper evident cap with fitted polycone liner packed into a carton enclosing a 5ml spoon with a 2.5ml graduation.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Cupal Limited



Tubiton House



Oldham



OL1 3HS



8. Marketing Authorisation Number(S)



PL 0338/5029R.



9. Date Of First Authorisation/Renewal Of The Authorisation



31/01/90 / 26/04/01



10. Date Of Revision Of The Text



29/01/2007