SEO PLR Article Directory Tonga: May 2012

Thursday 31 May 2012

Vibramycin Hyclate

Generic Name: doxycycline (Oral route)

dox-i-SYE-kleen

Commonly used brand name(s)

In the U.S.

Adoxa

Adoxa CK

Adoxa Pak

Adoxa TT

Alodox

Doryx

Monodox

Oracea

Periostat

Vibramycin Calcium

Vibramycin Hyclate

Vibramycin Monohydrate

Vibra-Tabs

Available Dosage Forms:

Tablet

Powder for Suspension

Capsule

Capsule, Extended Release

Tablet, Delayed Release

Capsule, Delayed Release

Syrup

Therapeutic Class: Antibiotic

Chemical Class: Tetracycline (class)

Uses For Vibramycin Hyclate

Doxycycline is used to treat bacterial infections in many different parts of the body. It is also used to treat pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne.

Doxycycline delayed-release tablets are also used to prevent malaria and treat anthrax infection after possible exposure and other problems as determined by your doctor.

Doxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Vibramycin Hyclate

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

Doxycycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger (except for treatment of exposure to inhalational anthrax), unless directed by the child's doctor.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies 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.

Acitretin

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.

Digoxin

Isotretinoin

Methotrexate

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

Bismuth Subsalicylate

Calcium

Desogestrel

Dienogest

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Fosphenytoin

Iron

Levonorgestrel

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Medroxyprogesterone Acetate

Mestranol

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Penicillin G

Penicillin G Procaine

Penicillin V

Rifampin

Rifapentine

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.

Proper Use of doxycycline

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

Take this medicine 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. To do so may increase the chance of side effects.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

If you are using Doryx® delayed-release tablets:

It may be taken with food or milk, if it upsets your stomach.

You may take this medicine by breaking the tablets. Hold the tablet between your thumb and index fingers close to the appropriate score (separation) line. Then, apply enough pressure to snap the tablet segments apart. Do not use the tablet if it does not break on the scored lines.

You may also take this medicine by sprinkling the equally broken tablets onto cold, soft food such as an applesauce. This mixture must be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. Do not store the mixture for later use.

Drink plenty of fluids to avoid throat irritation and ulceration.

If you are using this medicine to prevent malaria while traveling, start taking the medicine 1 or 2 days before you travel. Take the medicine every day during your trip and continue taking it for 4 weeks after you return. However, do not use the medicine for longer than 4 months.

If you are using For Oracea™ delayed-release capsules:

You should take this medicine on an empty stomach, preferably at least 1 hour before or 2 hours after meals.

You should take this medicine with a full glass of water while sitting or standing.

To prevent throat irritation, do not lay down right after taking this medicine.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 (delayed-release tablets):
- For infections:
  - Adults—100 milligrams (mg) every 12 hours on the first day, then 100 mg once a day or 50 to 100 mg every 12 hours.
  - Children older than 8 years of age who weigh 45 kg or less—Dose is based on body weight and must be determined by your doctor. The dose is usually 4.4 milligrams (mg) per kilogram (kg) of body weight per day and divided into two doses on the first day of treatment. This is followed by 2.2 mg per kg of body weight per day, taken as a single dose or divided into two doses on the following days.
  - Children up to 8 years of age—Use is not recommended.
- For the prevention of malaria:
  - Adults—100 milligrams (mg) once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
  - Children older than 8 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 milligrams (mg) per kilogram (kg) of body weight per day, taken as a single dose. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
  - Children up to 8 years of age—Use is not recommended.

For oral dosage form (delayed-release capsules):
- For the treatment of pimples from rosacea:
  - Adults—40 milligrams (mg) or one capsule once a day, in the morning.
  - 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 Vibramycin Hyclate

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

Using this medicine while you are pregnant 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 darken the color of your skin, nails, eyes, teeth, gums, or scars. Talk with your doctor if you have any concerns.

Doxycycline may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Birth control pills (containing estrogen) may not work properly while you are using doxycycline. To keep from getting pregnant, use other forms of birth control. These include condoms, diaphragms, or contraceptive foams or jellies.

Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat. Also, wear sunglasses.

Apply a sunblock product that has a skin protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.

Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Contact your doctor immediately if fever, rash, joint pain, or tiredness occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.

You should not take antacids that contain aluminum, calcium or magnesium, or any product that contains iron such as vitamin or mineral supplements.

If you are using this medicine to prevent malaria, take extra care not to get bitten by mosquitoes. Use protective clothing, mosquito netting or screens, and an insect repellent.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

Vibramycin Hyclate 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

Abdominal or stomach tenderness

bloating

clay-colored stools

cough

dark urine

decreased appetite

diarrhea

diarrhea, watery and severe, which may also be bloody

difficulty with swallowing

dizziness

fast heartbeat

feeling of discomfort

fever

headache

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

hives or welts

increased thirst

inflammation of the joints

itching

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

nausea and vomiting

numbness or tingling of the face, hands, or feet

pain

rash

redness and soreness of the eyes

redness of the skin

shortness of breath

sore throat

sores in the mouth

stomach cramps

stomach pain or tenderness

swelling of the feet or lower legs

swollen lymph glands

tightness in the chest

unusual tiredness or weakness

unusual weight loss

wheezing

yellow eyes or 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:

Incidence not known

Back, leg, or stomach pains

black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

chest pain, discomfort, or burning

chills

cracks in the skin

decrease in vision

difficulty breathing

discoloration of the thyroid glands

double vision

general body swelling

heartburn

increased sensitivity of the skin to sunlight

loss of heat from the body

lower back or side pain

nosebleeds

pain or burning in the throat

pain with swallowing

painful or difficult urination

pale skin

pinpoint red spots on the skin

rash with flat lesions or small raised lesions on the skin

red, swollen skin

redness or other discoloration of the skin

redness, swelling, or soreness of the tongue

scaly skin

severe nausea

severe stomach pain

severe sunburn

sores, ulcers, or white spots on the lips or tongue or inside the mouth

unusual bleeding or bruising

vomiting blood

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.

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More Vibramycin Hyclate resources

Vibramycin Hyclate Use in Pregnancy & Breastfeeding
Drug Images
Vibramycin Hyclate Drug Interactions
Vibramycin Hyclate Support Group
153 Reviews for Vibramycin Hyclate - Add your own review/rating

Doxycycline Prescribing Information (FDA)

Doxycycline Monograph (AHFS DI)

Doxycycline Professional Patient Advice (Wolters Kluwer)

Doxycycline MedFacts Consumer Leaflet (Wolters Kluwer)

Adoxa MedFacts Consumer Leaflet (Wolters Kluwer)

Alodox Prescribing Information (FDA)

Doryx Prescribing Information (FDA)

Doryx Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Doxycycline Calcium Monograph (AHFS DI)

Monodox Prescribing Information (FDA)

Ocudox Convenience Kit MedFacts Consumer Leaflet (Wolters Kluwer)

Oracea Prescribing Information (FDA)

Oracea Consumer Overview

Periostat Prescribing Information (FDA)

Periostat MedFacts Consumer Leaflet (Wolters Kluwer)

Vibra-Tabs MedFacts Consumer Leaflet (Wolters Kluwer)

Vibramycin Prescribing Information (FDA)

Compare Vibramycin Hyclate with other medications

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Monday 28 May 2012

varicella virus vaccine Subcutaneous

var-i-SEL-a VYE-rus VAX-een

Commonly used brand name(s)

In the U.S.

Varivax

Zostavax

In Canada

Varilrix

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Vaccine

Uses For varicella virus vaccine

Varicella virus vaccine is an active immunizing agent that is given to protect against infection caused by the varicella-zoster virus (VZV). The vaccine works by causing the body to produce its own protection (antibodies) against the virus.

Varicella (commonly known as chickenpox) is an infection that is easily spread from one person to another. Chickenpox is usually a mild infection but sometimes it can cause serious problems, such as pneumonia, inflammation of the brain, and a rare disease called Reye's syndrome.

Immunization against chickenpox is recommended for anyone 12 months of age and older who has not had chickenpox. Immunization against chickenpox is not recommended for infants younger than 12 months of age.

You can be considered to be immune to chickenpox only if you have received the right number of varicella vaccine doses (1 dose if you are between 12 months and 12 years of age; or 2 doses if you are 13 years of age or older). You also are considered to be immune if you have a doctor's diagnosis of a previous chickenpox infection or if you have had a blood test showing that you are immune to varicella.

Varicella virus vaccine (Zostavax®) is also used for the prevention of herpes zoster (commonly known as shingles) in people 50 years of age and older.

This vaccine is to be administered only by or under the supervision of your doctor or other authorized health care professional.

Before Using varicella virus vaccine

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to varicella virus vaccine 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

Varivax® (for preventing chickenpox)—Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of varicella virus vaccine in children 1 year of age and older. However, varicella virus vaccine is not recommended for infants younger than 12 months of age.

Zostavax® (for preventing shingles)—This vaccine should not be used in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varicella virus vaccine in the elderly.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 vaccine, 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.

Receiving this vaccine 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.

Aclarubicin

Acyclovir

Adalimumab

Aldesleukin

Alemtuzumab

Altretamine

Amonafide

Amsacrine

Asparaginase

Aspirin

Azacitidine

Azathioprine

Benorilate

Bleomycin

Broxuridine

Busulfan

Capecitabine

Carboplatin

Carmustine

Certolizumab Pegol

Chlorambucil

Choline Magnesium Trisalicylate

Cisplatin

Cladribine

Cyclophosphamide

Cytarabine

Cytarabine Liposome

Dacarbazine

Dactinomycin

Daunorubicin

Daunorubicin Citrate Liposome

Decitabine

Docetaxel

Doxifluridine

Doxorubicin Hydrochloride

Doxorubicin Hydrochloride Liposome

Edatrexate

Eflornithine

Epirubicin

Estramustine

Etanercept

Etoposide

Everolimus

Fingolimod

Floxuridine

Fludarabine

Fluorouracil

Fotemustine

Gallium Nitrate

Gemcitabine

Golimumab

Hydroxyurea

Idarubicin

Ifosfamide

Irinotecan

Lomustine

Mechlorethamine

Melphalan

Mercaptopurine

Mesalamine

Methotrexate

Mitolactol

Mitomycin

Mitotane

Mitoxantrone

Mycophenolic Acid

Olsalazine

Oxaliplatin

Paclitaxel

Pegaspargase

Pentostatin

Pipobroman

Pirarubicin

Plicamycin

Pneumococcal Vaccine Polyvalent

Procarbazine

Raltitrexed

Rilonacept

Rituximab

Salicylamide

Salicylic Acid

Salsalate

Sirolimus

Sodium Salicylate

Sodium Thiosalicylate

Streptozocin

Tacrolimus

Teceleukin

Tegafur

Temsirolimus

Teniposide

Thioguanine

Thiotepa

Topotecan

Treosulfan

Trimetrexate

Trofosfamide

Trolamine Salicylate

Uracil Mustard

Ustekinumab

Vinblastine

Vincristine

Vincristine Liposome

Vindesine

Vinorelbine

Receiving this vaccine 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.

Abatacept

Leflunomide

Interactions with Food/Tobacco/Alcohol

Proper Use of varicella virus vaccine

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot under your skin (usually in the upper arms).

Children 12 months to 12 years of age may need a second shot within 3 months after receiving the first dose of Varivax®. Teenagers and adults should have a "booster" shot 4 to 8 weeks after the first dose of this vaccine.

Adults receiving Zostavax® should receive only one dose of the vaccine unless your doctor tells you otherwise.

This vaccine comes with a patient information insert. Make sure you understand all of the information in the insert. Ask your doctor if you have any questions.

Tell your doctor before receiving this vaccine if you are severely ill or if you have a fever greater than 101.3 °F.

This vaccine needs to be given on a fixed schedule. If you or your child missed the scheduled dose, call your doctor or your child’s doctor for another appointment as soon as possible.

Precautions While Using varicella virus vaccine

It is very important that you or your child return to your doctor’s office at the right time if you or your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after your child receive this vaccine.

Do not become pregnant for 3 months after receiving varicella virus vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.

Zostavax® should not be used in place of Varivax®.

Zostavax® should not be used in children.

Tell your doctor that you or your child have received this vaccine:

If you are to receive blood transfusions or other blood products within 5 months of receiving this vaccine.

If you are to receive varicella-zoster immune globulin (VZIG) or other immune globulins within 2 months after receiving this vaccine.

If you are to receive any other live virus vaccines within 1 month of receiving this vaccine.

This vaccine 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 after you receive the vaccine.

Do not take aspirin or medicines that contain aspirin (such as certain cold medicines) for 6 weeks after receiving this vaccine. Carefully check the label of any pain, headache, or cold medicine you or your child use to be sure it does not contain aspirin or salicylic acid.

You or your child may be able to pass the virus to other people after getting this vaccine. You or your child should avoid close contact with people at high risk for getting chickenpox for 6 weeks after receiving this vaccine. People who are most at risk of catching the virus from you are pregnant women, newborn babies, and people whose bodies cannot fight infection (such as with bone marrow disease, cancer drug treatment, or AIDS). Talk to your doctor about this risk.

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.

varicella virus vaccine 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 or nurse immediately if any of the following side effects occur:

More common

Fever over 39 °C (102 °F)

Less common

Blue lips and fingernails

chest pain

chickenpox-like skin rash

coughing that sometimes produces a pink frothy sputum

decreased urine output

difficult, fast, or noisy breathing, sometimes with wheezing

dilated neck veins

extreme fatigue

general feeling of discomfort or illness

increased sweating

irregular breathing

irregular heartbeat

irritability

pale skin

shortness of breath

swelling of the ankles, face, fingers, feet, or lower legs

tightness in the chest

troubled breathing

weight gain

wheezing

Rare

Black, tarry stools

blood in the urine or stools

chills

confusion

convulsions (seizures) with high fever

cough

difficulty with breathing or swallowing

fever

hives

itching, especially of the feet or hands

muscle or joint pain

pinpoint red spots on the skin

reddening of the skin, especially around the ears

severe or continuing headache

stiff neck

swelling of the glands in the neck

thickening of bronchial secretions

unusual bleeding or bruising

unusual tiredness or weakness, sudden and severe

vomiting

Incidence not known

Back pain, sudden and severe

bleeding gums

blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody nose

blurred vision

bruising more easily

convulsions (seizures)

dizziness

fast heartbeat

headache

heavier menstrual periods

inability to move the arms and legs

inability to speak

itching

large, flat, blue, or purplish patches in the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of bladder control

muscle spasm or jerking of all extremities

painful blisters on the trunk of the body

painful knees and ankles

pale skin

pinpoint red spots on the skin

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

raised red swellings on the skin, buttocks, legs, or ankles

rapid weight gain

red irritated eyes

red skin lesions, often with a purple center

shakiness and unsteady walk

skin rash

slurred speech

sores, ulcers, or white spots in the mouth or on the lips

stomach pain

sudden loss of consciousness

sudden numbness and weakness in the arms and legs

swelling or puffiness of the face

swollen or painful glands

temporary blindness

tingling of the hands or feet

unsteadiness, trembling, or other problems with muscle control or coordination

unusual weight gain or loss

weakness in the arm or leg on one side of the body, sudden and severe

weakness of the muscles in your face

More common

Fever of 37.7 °C (100 °F) or higher, but not above 39 °C (102 °F)

hives, itching, pain, redness, soreness, tenderness, or warmth at the injection site

Less common

Common cold

congestion

constipation

cracked, dry, or scaly skin

diaper rash

diarrhea

disturbed sleep

dry skin

earache

heat rash or prickly heat

lack or loss of strength

loss of appetite

muscle aching or cramping

muscle stiffness

nausea

nervousness

runny nose

skin rash, encrusted, scaly, and oozing

sneezing

sore throat

stuffy nose

swelling

swollen joints

teething

Incidence not known

Bacterial skin infections

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty with moving

dryness or soreness of the throat

hoarseness

pain, redness, swelling, tenderness, or warmth on the skin

red rash with watery, yellow-colored, or pus filled blisters

tender, swollen glands in the neck

thick yellow to honey-colored crusts

voice changes

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: varicella virus vaccine Subcutaneous side effects (in more detail)

More varicella virus vaccine Subcutaneous resources

Varicella virus vaccine Subcutaneous Side Effects (in more detail)
Varicella virus vaccine Subcutaneous Use in Pregnancy & Breastfeeding
Varicella virus vaccine Subcutaneous Drug Interactions
Varicella virus vaccine Subcutaneous Support Group
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Varicella-Zoster, Prophylaxis

Sunday 27 May 2012

Sildenafil Citrate

Class: Phosphodiesterase Inhibitors
VA Class: GU900
Chemical Name: 2 - Hydroxy - 1,2,3 - propanetricarboxylate - 1 - [[3 - (6,7 - dihydro - 1 - methyl - 7 - oxo - 3 - propyl - 1H - pyrazolo[4,3 - d - pyrimidin - 5 - yl) - 4 - ethoxyphenyl]sulfonyl] - 4 - methyl - piperazine
Molecular Formula: C₂₂H₃₀N₆O₄S•C₆H₈O₇
CAS Number: 171599-83-0
Brands: Revatio, Viagra

Special Alerts:

[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (Revatio) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: , , , , , and .

Introduction

Vasodilating agent; a selective phosphodiesterase (PDE) type 5 inhibitor.¹ ² ⁴ ⁵ ⁷ ⁸ ¹⁰ ²⁴ ²⁷ ³³ ⁴¹ ⁵⁶ ⁵⁷ ⁶⁷ ⁹¹ ¹³¹ ¹⁸⁴ ²⁰³

Uses for Sildenafil Citrate

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Erectile Dysfunction

To facilitate attainment of a sexually functional erection in males with erectile dysfunction (ED, impotence).¹ ⁴ ⁶ ⁷ ⁸ ⁹ ¹⁰ ²⁵ ³³ ³⁴ ⁶⁷ ⁸¹ ¹⁰² ¹⁰⁴ ¹⁰⁵ ¹⁰⁷ ¹⁰⁸ ¹¹² ¹¹⁸ ¹¹⁹ ¹²⁶ ¹²⁷ ¹²⁸ ¹²⁹ ¹³⁰ ¹³¹ ¹³² ¹³³ ¹³⁴ ¹³⁵ ¹⁴⁰ ¹⁴² ¹⁴³ ¹⁴⁴ ¹⁸⁹

Most experts currently recommend that selective PDE type 5 inhibitors be offered as first-line therapy for erectile dysfunction unless contraindicated.¹⁸⁹ Insufficient evidence to support the superiority of one selective PDE type 5 inhibitor over another.¹⁸⁹

Pulmonary Arterial Hypertension

Symptomatic treatment (e.g., to improve exercise capacity) of pulmonary arterial hypertension (PAH; WHO group I pulmonary hypertension).²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹¹ ²¹³

Precise role (alone and combined with other therapies) remains to be fully elucidated.²⁰⁴ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹¹ ²¹³ Whether long-term sildenafil therapy has a beneficial effect on mortality remains to be established;²⁰⁵ ²⁰⁸ ²¹³ some preliminary data suggest a survival benefit.²⁰⁹

Sildenafil Citrate Dosage and Administration

General

Erectile Dysfunction

Carefully individualize dosage according to the patient’s tolerance and erectile response.¹ ³³ ⁶⁷ ⁷⁷ ⁸¹

Sexual stimulation is required for response to therapy.¹

Administration

Oral Administration

Erectile Dysfunction

Administer orally ¹ ³³ ²⁰⁸ no more than once daily.¹ ⁶⁷ ⁸¹ ⁹³ ⁹⁴ ¹⁰² ¹⁰⁷ ¹¹⁴ ¹³⁰ ¹³¹

Administer about 1 hour (range: 4 hours to 30 minutes) before sexual activity.¹ ⁶⁰ ⁹¹ ¹²⁷ ¹³²

Administration with a high-fat meal may delay the onset of action.¹ ¹¹⁴ ¹¹⁵ ¹¹⁷ ¹³¹

PAH

Administer orally 3 times daily (approximately 4–6 hours apart) without regard to meals.²⁰³ ²⁰⁸

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as sildenafil citrate; dosage expressed in terms of sildenafil.¹ ²⁰³

Adults

Erectile Dysfunction

Oral

Initially, 50 mg.¹ ²⁸ ³³ ⁸¹ ⁹¹ ⁹³ ⁹⁴ ¹⁰² ¹⁰⁵ ¹¹⁸ ¹³⁰ ¹³² ¹⁴⁹ ¹⁶¹ Depending on effectiveness and tolerance, increase dosage to a maximum of 100 mg or decrease to 25 mg.¹ ²⁸ ³³ ⁹¹ ⁹³ ⁹⁴ ¹⁰⁵ ¹⁴⁹ ¹⁶¹

PAH

Oral

20 mg 3 times daily.²⁰³ Efficacy of lower dosages not established.²⁰³

Prescribing Limits

Adults

Erectile Dysfunction

Oral

Maximum 100 mg daily.¹ ⁶⁰ ⁹¹ ¹¹⁴ ¹³¹

PAH

Oral

Dosages up to 80 mg 3 times daily have been studied but have not been more effective than recommended dosage of 20 mg 3 times daily.²⁰³ ²⁰⁷ ²⁰⁸ ²⁰⁹

Special Populations

Hepatic Impairment

Erectile Dysfunction

Oral

Reduce initial dose to 25 mg.¹ ²⁸ ³¹ ⁶⁷

PAH

Oral

No dosage adjustments necessary for mild to moderate hepatic impairment (Child-Pugh class A and B).²⁰³ Not studied in severe hepatic impairment (Child-Pugh class C).²⁰³

Renal Impairment

Erectile Dysfunction

Oral

If Cl_cr is <30 mL/minute, reduce initial dose to 25 mg.¹ ²⁸ ⁶⁷ ⁸⁰ ¹³¹

PAH

Oral

No dosage adjustment needed, even in severe impairment (Cl_cr <30 mL/minute).²⁰³

Geriatric Patients

Erectile Dysfunction

Oral

Reduce initial dose to 25 mg in men ≥65 years of age.¹ ³¹ ⁶⁷

PAH

Oral

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.²⁰³

Cautions for Sildenafil Citrate

Contraindications

Known hypersensitivity to sildenafil or any ingredient in the formulation.¹ ²⁰³

Concomitant use of organic nitrates or nitrites.¹ ²⁹ ⁵⁷ ⁶⁷ ¹⁴⁸ ¹⁵⁴ ²⁰³ (See Specific Drugs under Interactions.)

Should not be used for treatment of erectile dysfunction in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.¹ ⁶⁷ ¹⁵⁴ ¹⁸⁹

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Cardiovascular Effects

Serious, potentially fatal cardiovascular effects reported rarely.¹ ² ⁴ ⁶ ⁷ ⁹ ¹⁰ ³³ ⁵⁶ ⁶¹ ⁶⁷ ⁹¹ ⁹³ ⁹⁴ ¹⁰² ¹⁰⁷ ¹¹⁴ ¹²⁷ ¹³⁰ ¹³² ²⁰⁸

Use with caution in the treatment of erectile dysfunction in patients with a recent (within 6 months) MI, stroke, or life-threatening arrhythmia;¹ ³¹ ¹⁰¹ ¹²⁷ ¹⁴⁴ ¹⁵⁴ ¹⁵⁵ ¹⁵⁹ in patients with resting hypotension (BP <90/50 mm Hg) or hypertension (BP >170/110 mm Hg);¹ ³¹ ¹⁰¹ ¹²⁷ ¹⁴⁴ ¹⁵⁴ ¹⁵⁵ ¹⁵⁹ or in patients with cardiac failure or CAD causing unstable angina.¹ ³¹ ¹⁰¹ ¹²⁷ ¹⁴⁴ ¹⁵⁴ ¹⁵⁵ ¹⁵⁹ Assess cardiovascular and cerebrovascular status (including use of organic nitrates and nitrites) prior to initiating therapy.¹ ²⁸ ³⁰ ³¹ ⁵³ ⁶⁴ ⁶⁵ ⁶⁷ ⁹¹ ⁹³ ¹²¹ ¹⁵⁴ ¹⁸⁹

Safety and efficacy for the treatment of PAH not established in patients with a recent (within 6 months) MI, stroke, or life-threatening arrhythmia; in patients with hypertension (BP >170/110 mm Hg) or with CAD causing unstable angina; or in those currently receiving bosentan (see Specific Drugs under Interactions).²⁰³ Caution advised.²⁰³

Possible symptomatic hypotension may occur in patients receiving concomitant¹ ³¹ ⁶⁷ α-adrenergic blocking agents; hypotension may be severe or fatal in patients receiving an organic nitrate or nitrite concomitantly.¹ ²⁸ ²⁹ ³¹ ⁵³ ⁵⁷ ⁶¹ ⁶⁷ ⁶⁹ ¹⁴⁸ (See Specific Drugs under Interactions.)

Consider whether patients with underlying cardiovascular disease (e.g., severe left ventricular outflow obstruction, autonomic dysfunction, resting hypotension [BP <90/50 mm Hg], fluid depletion) could be adversely affected by sildenafil’s vasodilatory activity,²⁰³ especially in combination with sexual activity.¹ ⁶⁷ ¹⁵⁴

Use not recommended in patients with pulmonary veno-occlusive disease.²⁰³ Clinical data on use in this population are not available, and pulmonary vasodilators may worsen cardiovascular status of such patients.²⁰³ If pulmonary edema occurs during sildenafil therapy, consider the possibility of pulmonary veno-occlusive disease.²⁰³

Ocular Effects

Possible visual disturbances (e.g., blue/green vision, changes in light sensitivity), particularly at high doses.¹ ³³ ⁵⁶ ⁵⁷ ⁶⁷ ⁷⁷ ⁸⁶ ⁸⁷ ⁸⁸ ⁹¹ ⁹⁵ ²⁰³ ²⁰⁸ Possible persistent and/or serious retinal changes in older patients or with long-term use.³² ⁸⁷ ⁸⁸ ⁹⁵ ¹⁰⁶

Nonarteritic anterior ischemic optic neuropathy (NAION) reported rarely in patients receiving PDE type 5 inhibitors for the treatment of erectile dysfunction.¹ ¹⁸² ¹⁸³ ¹⁹⁰ ¹⁹¹ ¹⁹² ¹⁹⁴ ¹⁹⁵ ¹⁹⁶ ¹⁹⁷ ¹⁹⁸ ¹⁹⁹ ²⁰² ²⁰³ Potential increased risk of NAION in the second eye in patients who already have had NAION in one eye.¹ ¹⁸² ¹⁸³ ¹⁹⁶ ²⁰² ²⁰³

Use with caution in patients with retinitis pigmentosa.¹ ³¹ ³² ⁶⁰ ¹⁵⁵ ²⁰³ Periodically monitor retinal function in patients with ocular manifestations suggestive of retinal effects and in those at risk.⁸⁸ ¹¹⁵

Priapism

Possible prolonged erections (>4 hours in duration) and priapism (painful erection >6 hours).¹ ³¹ ¹³⁹ ¹⁴⁶ ¹⁴⁷

May result in penile tissue damage and permanent loss of potency if priapism is not treated immediately.¹ ³¹ Use with caution in patients with conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).¹ ³³ ¹¹⁴ ¹¹⁵ ¹⁵⁹ ²⁰³

Interactions with Potent CYP3A4 Inhibitors

Concomitant use with potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir) substantially increases serum sildenafil concentrations.¹ ²⁰³ Depending on the particular use of sildenafil (e.g., erectile dysfunction, PAH) and the specific CYP3A4 inhibitor, concomitant use may not be recommended or precautions (e.g., dosage adjustments) may be required.¹ ²⁰³ (See Specific Drugs under Interactions.)

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Assessment of Patients with Erectile Dysfunction

Thorough medical history and physical examination recommended to diagnose erectile dysfunction, determine potential underlying causes, exclude potentially reversible or treatable causes, and identify appropriate treatment.¹ ¹² ²⁸ ³⁰ ³¹ ³⁶ ⁵⁷ ⁵⁸ ⁶⁵ ⁶⁶ ⁷⁰ ⁷⁸ ⁸² ⁸³ ⁹⁴ ¹¹⁴ ¹¹⁵ ¹¹⁹ ¹⁴⁴ ¹⁴⁵ ¹⁶⁰ ¹⁶¹

Review of patient’s current drug regimens recommended to detect possible drug-induced erectile dysfunction.¹² ²⁸ ⁷⁰ ⁸¹ ¹¹⁸ ¹¹⁹ ¹⁴⁴ ¹⁵² ¹⁶¹

Hypotensive Effects

Possible hypotensive reaction in patients receiving concomitant antihypertensive therapy, in patients with CHF and a borderline low blood volume and low BP status, and in patients with left-ventricular outflow obstruction.²⁸ ³¹ ⁶⁷ (See Specific Drugs under Interactions.) Monitor BP during initiation of therapy in these patients.²⁸ ⁶⁷ ¹⁵⁹

Bleeding Disorders

Use with caution in patients with bleeding disorders or active peptic ulcers.¹ ²⁷ ³³ ⁶⁷ ¹³¹

Incidence of epistaxis in sildenafil-treated patients is higher in those with PAH secondary to connective tissue disease (13%) than in those with primary pulmonary hypertension (3%).²⁰³

GU Precautions

Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease).¹ ³³ ¹¹⁴ ¹¹⁵ ¹⁵⁹ ²⁰³

Concomitant Therapies for Erectile Dysfunction

Safety and efficacy not established for use in combination with other treatments for erectile dysfunction; combined therapy is not recommended.¹ ¹⁵⁵

Specific Populations

Pregnancy

Category B.¹ ²⁰³

Lactation

Not known whether sildenafil is distributed into milk.²⁰³ Use with caution in nursing women.²⁰³

Pediatric Use

Safety and efficacy not established in patients <18 years of age;¹¹⁵ ²⁰³ however, has been used effectively in a limited number of children† for symptomatic treatment of PAH.¹⁵⁸ ²⁰⁵ ²⁰⁶

Geriatric Use

Pooled clinical trial data indicate that efficacy in men ≥65 years of age with erectile dysfunction is similar to that in younger men.¹³¹ ¹⁵⁷ Decreased clearance and increased plasma concentrations may increase incidence of adverse effects in geriatric patients with erectile dysfunction.¹ ⁶⁰ ¹³⁹ (See Geriatric Patients under Dosage and Administration.)

Insufficient data from clinical trials to determine whether geriatric patients with PAH respond differently than younger adults, but other clinical experience has not identified overall differences in response relative to younger patients.²⁰³

Select dosage carefully due to greater frequency of decreased renal, hepatic, and/or cardiac function and of concomitant disease or drug therapy observed in geriatric patients.²⁰³

Hepatic Impairment

Decreased clearance.¹ ³¹ ⁶⁰ ⁶⁷ ⁶⁹ ²⁰³ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Decreased clearance in patients with severe renal impairment.¹ ⁶⁰ ⁶⁷ ⁸⁰ ²⁰³ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Erectile dysfunction: Headache,¹ ⁴ ⁶ ⁷ ⁹ ¹⁰ ³¹ ³³ ⁵⁶ ⁹¹ ⁹³ ¹⁰⁴ ¹⁰⁵ ¹⁰⁷ ¹³⁰ ¹³² ²⁰⁸ flushing,¹ ⁴ ⁷ ⁹ ³³ ⁵⁶ ⁶⁷ ⁹³ ¹⁰⁵ ¹⁰⁷ ¹³⁰ ¹³² dyspepsia/heartburn.¹ ⁷ ¹⁰ ³¹ ³³ ⁶⁷ ⁹¹ ⁹³ ¹⁰² ¹⁰⁷ ¹³²

PAH: Headache,²⁰³ ²⁰⁸ ²¹¹ dyspepsia,²⁰³ ²⁰⁸ flushing,²⁰³ ²⁰⁸ epistaxis,²⁰³ insomnia,²⁰³ ²⁰⁸ exacerbated dyspnea,²⁰³ diarrhea,²⁰³ ²⁰⁸ myalgia,²⁰³ erythema,²⁰³ ²⁰⁸ pyrexia.²⁰³

Interactions for Sildenafil Citrate

Metabolized principally by CYP3A4 and to some extent by CYP2C9; weakly inhibits CYP1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 in vitro.¹ ²⁶ ⁵⁹ ⁶⁷ ⁹¹ ²⁰³

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4 and CYP2C9: Potential pharmacokinetic interaction (increased plasma sildenafil concentrations).¹ ²⁶ ⁵⁹ ⁶⁷ ⁹¹ ²⁰³ ²¹²

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma sildenafil concentrations).¹ ²⁶ ⁵⁹ ⁶⁷ ⁹¹ ²⁰³ ²¹²

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP1A2, 2C9, 2C19, 2D6, 2E1, and 3A4:¹ ²⁶ ⁶⁷ Potential pharmacokinetic interaction (increased substrate concentrations).²⁰³

Specific Drugs

Drug	Interaction	Comments
α-Adrenergic blockers	Possible potentiation of systemic vasodilation¹⁸⁹ ²⁰³ and occurrence of symptomatic hypotension¹ ²⁰³	Do not administer doses >25 mg within 4 hours before or after α-adrenergic blocker¹ Use with caution in PAH²⁰³
Alcohol	No additive hypotensive effects reported¹ ²⁰³	Consider possibility that heavy alcohol ingestion could add to stress of sexual activity and risk of cardiac ischemia during coitus⁶⁷ ¹¹⁵ and that alcohol consumption also may contribute to erectile dysfunction¹² ²⁸ ⁵⁸ ⁷⁰ ⁸² ¹¹⁴ ¹¹⁵ ¹¹⁹
Amlodipine	Possible additive hypotensive effects¹ ²⁹ ¹¹⁴ ¹⁵⁴ ²⁰³
Antacids	Oral bioavailability of sildenafil unaffected by single doses of aluminum and magnesium hydroxides-containing antacid¹ ¹¹⁴ ²⁰³
Antidepressants (e.g., SSRIs, tricyclic antidepressants)	Pharmacokinetic interaction unlikely¹
Antifungal agents (itraconazole, ketoconazole)	Possible increased AUC of sildenafil¹ ¹¹⁴ ²⁰³	Consider lower initial sildenafil dose (25 mg) for treatment of erectile dysfunction¹ ⁶⁷ Concomitant use not recommended in PAH²⁰³
Antihypertensive and hypotensive agents	Potential additive hypotensive effects¹ ²⁹ ⁶⁷ ²⁰³	Monitor during initial therapy, especially in patients receiving multiple agents and those with CHF²⁸ ⁶⁷ ¹⁵⁹ or renal impairment²⁸ ⁶⁷ ⁸⁰
Antiretroviral agents (HIV protease inhibitors)	Decreased clearance, increased plasma concentrations of sildenafil, and increased risk of sildenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)²⁶ ⁵⁹ ⁶⁷ ⁸⁴ ¹¹⁴ ¹³⁶ ¹³⁷ ¹³⁹ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁷¹ ¹⁷² ¹⁷³ ¹⁷⁴ ¹⁷⁵ ²⁰⁰ ²⁰¹ ²⁰³	Caution advised;⁸⁴ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁷¹ ¹⁷² ¹⁷³ ¹⁷⁴ ¹⁷⁵ closely monitor for adverse effects⁵⁹ ⁸⁴ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁷¹ ¹⁷⁰ ¹⁷⁴ ¹⁷⁵ ²⁰⁰ Amprenavir, atazanavir, fosamprenavir, indinavir, lopinavir in fixed combination with ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir in combination with low-dose ritonavir: reduce initial sildenafil dose for treatment of erectile dysfunction to 25 mg and do not exceed a single 25-mg dose every 48 hours⁵⁹ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁷¹ ¹⁷² ¹⁷³ ¹⁷⁴ ¹⁷⁵ ²⁰⁰ Concomitant ritonavir and sildenafil not recommended in PAH²⁰³ Concomitant saquinavir and sildenafil in PAH: No dosage adjustments necessary²⁰³
Antiretroviral agents (nonnucleoside reverse transcriptase inhibitors [NNRTIs])	Delavirdine: Possible increased sildenafil concentrations and risk of sildenafil-associated adverse effects (e.g., hypotension, visual changes, prolonged erection)²⁹ ¹⁶⁹ Efavirenz, nevirapine: Possible decreased plasma sildenafil concentrations and/or altered plasma NNRTI concentrations²⁰³	Delavirdine: Reduce initial sildenafil dose for treatment of erectile dysfunction to 25 mg and do not exceed a single 25-mg dose every 48 hours; monitor for adverse effects²⁹ ¹⁶⁹ Efavirenz, nevirapine: Possible dosage adjustments of either sildenafil or the NNRTI²⁰³
Antipsychotics	Pharmacokinetic interaction unlikely¹ ⁶⁰ ¹¹⁸
Aspirin	No increase in bleeding time reported¹ ⁶⁰ ⁶⁵ ⁶⁷ ¹¹⁴ ²⁰³
Atorvastatin	Pharmacokinetic interaction unlikely²⁰³
Barbiturates	Possible decreased plasma sildenafil concentrations and/or altered plasma barbiturate concentrations²⁰³	Possible dosage adjustment of either sildenafil or the barbiturate²⁰³
Bosentan	Decreased plasma sildenafil concentrations²⁰³ ²¹² Increased plasma bosentan concentrations²⁰³	Possible dosage adjustment of either agent²⁰³
Carbamazepine	Possible decreased plasma sildenafil concentrations and/or altered plasma carbamazepine concentrations ²⁰³	Possible dosage adjustment of either agent ²⁰³
Cimetidine	Increased plasma sildenafil concentrations¹ ⁶⁷ ²⁰³	Consider lower initial sildenafil dose (25 mg) for treatment of erectile dysfunction⁶⁷
Contraceptives, oral	Pharmacokinetic interaction unlikely²⁰³
Erythromycin	Increased AUC of sildenafil¹ ⁶⁹ ¹¹⁴ ²⁰³	Consider lower initial sildenafil dose (25 mg) for treatment of erectile dysfunction¹ ⁶⁷ Dosage adjustment not necessary in PAH²⁰³
Heparin	Increased bleeding time reported in animals¹ ²⁰³	Current evidence does not preclude concomitant heparin⁶⁷ ¹¹⁴ ¹¹⁵
Inhaled nitrites (e.g., amyl or butyl nitrite)	Possible sudden and marked BP reduction; potentially serious or even fatal²⁶ ⁶⁷ ⁹² Possible beneficial augmented cardiovascular effects in PAH²⁰⁴ ²¹⁰ ²¹¹	Concomitant use contraindicated¹ ²⁹ ⁵⁷ ⁶⁷ ¹⁴⁸ ¹⁵⁴ (see Cautions)
Nitrates and nitrites (e.g., nitroglycerin, isosorbide dinitrate)	Potentiation of vasodilatory effects (e.g., decrease in SBP of >25 mm Hg) of organic nitrates and nitrites; potentially life-threatening hypotension and/or hemodynamic compromise can result¹ ²⁸ ²⁹ ³¹ ³³ ⁵³ ⁵⁷ ⁶¹ ⁶⁷ ⁶⁹ ⁹¹ ¹²⁷ ¹³¹ ¹⁴⁸	Concomitant use contraindicated¹ ²⁹ ⁵⁷ ⁶⁷ ¹⁴⁸ ¹⁵⁴ ²⁰³ (see Cautions) Some clinicians suggest that nitrates and nitrites may be given >24 hours after sildenafil, but the point at which these drugs can be given safely after sildenafil is unclear;¹ ²⁹ ³¹ ⁶⁷ ¹⁵⁴ avoid concomitant use unless benefits outweigh risks⁶⁷ ¹¹⁴
Phenytoin	Possible decreased plasma sildenafil concentrations and/or altered plasma phenytoin concentrations²⁰³	Possible dosage adjustment of either agent²⁰³
Phosphodiesterase (PDE) inhibitors (e.g., dipyridamole, theophylline)	Potential pharmacodynamic interaction (increased inotropic effects in cardiac muscle, vascular smooth muscle relaxation, and platelet-aggregation inhibition)⁶⁷	Risk of cardiotoxic, hypotensive, or hemorrhagic event after concomitant use of specific or nonspecific PDE inhibitor (e.g., dipyridamole, theophylline) not known but appears unlikely⁶⁷
Rifamycins (rifabutin, rifampin)	Possible decreased plasma sildenafil concentrations¹ ⁶⁹ ²⁰³ (theoretically less likely with rifabutin than rifampin¹⁰³ ) and/or altered plasma rifabutin or rifampin concentrations²⁰³	Possible dosage adjustment of either sildenafil or the rifamycin²⁰³
Sodium nitroprusside	Potentiation of vasodilatory effects (e.g., decrease in SBP of >25 mm Hg) of organic nitrates and nitrites; potentially life-threatening hypotension and/or hemodynamic compromise can result¹ ²⁸ ²⁹ ³¹ ³³ ⁵³ ⁵⁷ ⁶¹ ⁶⁷ ⁶⁹ ⁹¹ ¹²⁷ ¹³¹ ¹⁴⁸ Also may potentiate the inhibitory effect of nitric oxide and sodium nitroprusside (a nitric oxide donor) on platelet aggregation¹ ⁵⁷ ⁶⁷ ²⁰³	Concomitant use contraindicated¹ ²⁹ ⁵⁷ ⁶⁷ ¹⁴⁸ ¹⁵⁴ (see Cautions) Some clinicians suggest that nitrates and nitrites may be given >24 hours after sildenafil, but the point at which these drugs can be given safely after sildenafil is unclear;¹ ²⁹ ³¹ ⁶⁷ ¹⁵⁴ avoid concomitant use unless benefits outweigh risks⁶⁷ ¹¹⁴
Tolbutamide	Pharmacokinetic interaction unlikely⁶⁷ ¹¹⁴ ²⁰³
Warfarin	Pharmacokinetic interaction unlikely⁶⁷ ¹¹⁴ Increased bleeding (epistaxis) observed with concomitant use in patients with PAH²⁰³

Sildenafil Citrate Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration;¹ ⁴ ⁵⁶ ⁶⁷ ⁹¹ ¹¹⁶ ¹¹⁷ ²⁰³ however, only about 40% of a dose reaches systemic circulation unchanged.¹ ⁴ ⁵⁶ ⁶⁷ ⁹¹ ¹¹⁴ ¹¹⁶ ¹³¹ ²⁰³

Peak plasma concentration usually attained within 30–120 minutes.¹ ⁴ ⁹¹ ¹¹⁷ ¹²⁷ ¹

Vemavite PRX 2

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Vemavite PRX 2 (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

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?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. 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.

More Vemavite PRX 2 resources

Vemavite PRX 2 Use in Pregnancy & Breastfeeding
Vemavite PRX 2 Drug Interactions
0 Reviews for Vemavite PRX 2 - Add your own review/rating

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

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Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

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MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

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Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

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Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

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Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

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