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Saturday, March 17, 2012

Norvir

Generic Name: ritonavir (Oral route)

rit-OH-na-vir

Oral route(Capsule, Liquid Filled;Solution;Tablet)

Coadministration of ritonavir with sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs .

Commonly used brand name(s)

In the U.S.

Norvir

Available Dosage Forms:

Capsule, Liquid Filled

Tablet

Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For Norvir

Ritonavir is used alone or in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Ritonavir will not cure HIV infection or prevent AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Ritonavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems related to AIDS or HIV disease.

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

Before Using Norvir

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 ritonavir in infants younger than 1 month old. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of ritonavir have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of ritonavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving ritonavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Alfuzosin

Amiodarone

Astemizole

Bepridil

Cisapride

Colchicine

Conivaptan

Dihydroergotamine

Dronedarone

Encainide

Eplerenone

Ergoloid Mesylates

Ergonovine

Ergotamine

Flecainide

Lovastatin

Methylergonovine

Methysergide

Midazolam

Pimozide

Propafenone

Quinidine

Ranolazine

Sildenafil

Silodosin

Simvastatin

St John's Wort

Terfenadine

Tolvaptan

Triazolam

Voriconazole

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.

Abiraterone

Aprepitant

Bosentan

Brentuximab Vedotin

Cabazitaxel

Crizotinib

Dasatinib

Digoxin

Docetaxel

Etravirine

Everolimus

Fentanyl

Fluticasone

Fusidic Acid

Garlic

Iloperidone

Ixabepilone

Lapatinib

Methylenedioxymethamphetamine

Nilotinib

Oxycodone

Pazopanib

Pitavastatin

Quinine

Rifabutin

Rifampin

Rivaroxaban

Romidepsin

Ruxolitinib

Salmeterol

Sunitinib

Tamoxifen

Tamsulosin

Temsirolimus

Ticagrelor

Topotecan

Toremifene

Vemurafenib

Venlafaxine

Vinblastine

Vincristine

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.

Acenocoumarol

Alprazolam

Amitriptyline

Amlodipine

Amprenavir

Bupropion

Carbamazepine

Cerivastatin

Clarithromycin

Clonazepam

Clozapine

Cyclosporine

Dalfopristin

Delavirdine

Desipramine

Desogestrel

Dexamethasone

Didanosine

Dienogest

Diltiazem

Disopyramide

Drospirenone

Dutasteride

Efavirenz

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Fluoxetine

Fosamprenavir

Imipramine

Indinavir

Itraconazole

Ketoconazole

Lamotrigine

Levonorgestrel

Levothyroxine

Maraviroc

Medroxyprogesterone Acetate

Meperidine

Mestranol

Methadone

Methamphetamine

Metoprolol

Mexiletine

Nefazodone

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Paroxetine

Phenobarbital

Phenytoin

Posaconazole

Prednisone

Quinupristin

Rifapentine

Risperidone

Tacrolimus

Tadalafil

Tenofovir Disoproxil Fumarate

Theophylline

Trazodone

Valproic Acid

Verapamil

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.

Proper Use of Norvir

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

It is important that ritonavir be taken with food.

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

For patients taking the oral liquid:

Shake the bottle well before using.

Use a specially marked measuring syringe or cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

You can mix the oral liquid with chocolate milk or nutritional drinks (such as Ensure® or Advera®) to make it taste better. You should drink this medicine within one hour of mixing.

This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. It is best to take the doses at evenly spaced times, day and night. For example, if you are to take two doses each day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Ritonavir must be taken with other medicines. Tell your doctor about all of the medications you are taking since the dose of ritonavir or other medications you take may need to be adjusted.

If you are taking ritonavir with a medication called didanosine (Videx®), take the ritonavir 2 hours and 30 minutes before or after the didanosine.

Read and carefully follow the patient information leaflet before starting ritonavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions.

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 treatment of HIV infection:
- For oral dosage forms (capsules, solution, or tablets):
  - Adults—600 milligrams (mg) two times per day.
  - Children 1 month of age and older—Dose is based on body size and must be determined by your doctor. The dose is usually 350 to 400 milligrams per square meter (mg/[m]2) of body size two times per day. However, the dose is usually not more than 600 mg two times per day.
  - Children younger than 1 month of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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.

Store the capsules in the refrigerator or at room temperature in a closed container. If stored at room temperature, use the medicine within 30 days. Keep away from heat and direct light.

Store the oral liquid or tablets in a closed container at room temperature, away from heat and direct light. Do not refrigerate.

Precautions While Using Norvir

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

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

Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), amiodarone (Cordarone®), astemizole (Hismanal®), bepridil (Vascor®), cisapride (Propulsid®), ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, or Ergomar®), flecainide (Tambocor®), lovastatin (Altocor®, Mevacor®), oral midazolam (Versed®), pimozide (Orap®), propafenone (Rythmol®), quinidine (Quinaglute®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), terfenadine (Seldane®), triazolam (Halcion®), or voriconazole (Vfend®). Using these medicines together with ritonavir may increase your chance of having serious side effects.

Check with your doctor right away if you or your child 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.

Pancreatitis may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may decrease the effects of some birth control pills. To avoid getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; fever; chills; cough; diarrhea; itching; joint or muscle pain; rash; red skin lesions, often with a purple center; sore throat; sores, ulcers, or white spots in the mouth or on the lips; swelling of your hands, face, tongue, or throat; or unusual tiredness or weakness.

This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you or your child have concerns.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Norvir 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

Fainting

feeling faint, dizzy, or lightheaded

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

headache

sweating

Rare

Confusion

dehydration

dry or itchy skin

fruity mouth odor

increased hunger

increased thirst

increased urination

nausea

vomiting

weight loss

Incidence not known

Bloating

chills

constipation

convulsions

cough

darkened urine

decreased urination

difficulty with breathing

dry mouth

fast heartbeat

fever

hives or welts

increase in heart rate

indigestion

itching

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

loss of appetite

loss of bladder control

muscle spasm or jerking of all extremities

noisy breathing

pains in the stomach, side, or abdomen, possibly radiating to the back

rapid breathing

redness of the skin

shortness of breath

skin rash

sudden loss of consciousness

sunken eyes

thirst

tightness in the chest

unusual tiredness or weakness

wheezing

wrinkled skin

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:

More common

Acid or sour stomach

belching

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

change in sense of taste

diarrhea

dizziness

general feeling of discomfort or illness

heartburn

lack or loss of strength

sleepiness or unusual drowsiness

sleeplessness

trouble sleeping

unable to sleep

weakness

Less common

Body aches or pain

congestion

delusions

dementia

difficulty with moving

discouragement

dryness or soreness of the throat

excess air or gas in the stomach or intestines

fear

feeling sad or empty

full feeling

hoarseness

increased urge to urinate during the night

irritability

lack of appetite

loss of interest or pleasure

mood or mental changes

muscle pain or stiffness

nervousness

pain in the joints or in unspecified location

passing gas

runny nose

tender, swollen glands in the neck

throat irritation

tiredness

trouble concentrating

trouble with swallowing

voice changes

waking to urinate at night

Incidence not known

Gaining weight around your neck, upper back, breast, face, or waist

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: Norvir 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 Norvir resources

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

Norvir Prescribing Information (FDA)

Norvir Consumer Overview

Norvir Monograph (AHFS DI)

Norvir MedFacts Consumer Leaflet (Wolters Kluwer)

Ritonavir Professional Patient Advice (Wolters Kluwer)

Compare Norvir with other medications

HIV Infection

Friday, March 16, 2012

Synarel

Generic Name: nafarelin (Nasal route)

naf-a-REL-in

Commonly used brand name(s)

In the U.S.

Synarel

Available Dosage Forms:

Spray

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Synarel

Nafarelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. Nafarelin nasal spray is used for the treatment of:

Central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and in girls (before 8 years of age).

Endometriosis, a painful condition caused by extra tissue growing inside or outside of the uterus (womb).

When given regularly to boys and girls experiencing early puberty, nafarelin slows down the development of genital areas in both sexes and breast development in girls. This medicine delays puberty in a child only as long as the child continues to take it.

When given regularly to women, nafarelin prevents the growth of tissue caused by endometriosis in adult women during treatment and for 6 months after treatment is discontinued. Reducing the amount of estrogen in the body is one way of treating endometriosis.

Suppressing estrogen can cause thinning of the bones or slowing of growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect for girls and boys whose bones grow too fast when puberty begins too early. Boys and girls may benefit by adding inches to their adult height when nafarelin causes their bones to grow at the proper and expected rate for children.

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

Before Using Synarel

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nafarelin nasal spray in children. Nafarelin will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using nafarelin nasal spray around the time of puberty causes changes in boys' and girls' future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child's doctor the benefit of this medicine as well as the risk of using it.

Appropriate studies have not been performed on the relationship of age to the effects of nafarelin nasal spray for the treatment of endometriosis in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of nafarelin nasal spray in geriatric patients.

Pregnancy

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

Breast Feeding

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Proper Use of Synarel

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the amount that is absorbed from the nose and the chance of unwanted effects. Do not change your dose or stop using this medicine without checking with your doctor first.

This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.

To use nafarelin spray:

Before you use each new bottle of nafarelin, the spray pump needs to be started. To do this, point the bottle away from you and pump the bottle firmly about 7 times. This only needs to be done once for each new bottle of nafarelin. Be careful not to breathe in this spray. You could inhale extra doses of nafarelin, since the medicine is dissolved in the spray.

Before you take your daily doses of nafarelin, blow your nose gently. Hold your head forward a little. Put the spray tip into one nostril. Aim the tip toward the back and outside of your nostril. You do not need to put the tip too far into your nose.

Close your other nostril off by pressing on the outside of your nose with a finger. Then, sniff in the spray as you pump the bottle once.

Take the spray bottle out of your nose. Tilt your head back for 30 seconds, to let the spray get onto the back of your nose.

Repeat these steps for each dose of medicine.

Each time you use the spray bottle, wipe off the tip with a clean tissue or cloth. Keep the white safety clip and plastic cap on the bottle when you are not using it.

Be sure to clean the tip of the spray bottle before and after every use. To do this, hold the bottle sideways. Rinse the tip with warm water, while wiping the tip with your finger or a soft cloth for about 15 seconds. Dry the tip with a soft cloth or tissue. Replace the cap right after use. Be careful not to get water into the bottle, since this could dilute the medicine.

Do not try to make the tiny hole in the spray tip larger. Doing so, may deliver a wrong dose of the medicine.

If you are also using a topical nasal decongestant, do not use it at the same time you are using this medicine. Wait at least 2 hours after using nafarelin spray before using the nasal decongestant.

It is important to avoid sneezing when spraying and immediately after using the medicine. If you sneeze, the medicine may not be absorbed as well.

Many boys and girls who have central precocious puberty will not feel sick or will not understand the importance of taking the medicine regularly. It is very important that the medicine is used exactly as directed and that the proper amount is used at the proper time. It works best when there is a constant amount in the blood. To help keep the amount constant, nafarelin must be given on a regular schedule.

Dosing

For nasal dosage form (spray):
- For treatment of central precocious puberty:
  - Children—Two sprays in each nostril two times a day, taken in the morning and in the evening. This provides a total dose of 8 sprays a day. Some patients may need a larger dose by using 3 sprays in alternating nostrils three times a day to provide a total of 9 sprays per day.
- For treatment of endometriosis:
  - Adults—One spray in one nostril in the morning and one spray into the other nostril in the evening, taken for 6 months. Begin your treatment on Day 2, 3, or 4 of your menstrual period.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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.

After you prime the bottle, there will only be 60 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 60 sprays (for 30 days) even if some liquid remains in the bottle.

Precautions While Using Synarel

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.

For female patients: You should not take this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

For children using nafarelin spray for central precocious puberty: The medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.

For adult women using nafarelin spray for endometriosis:

For the first few days of treatment, the symptoms of your condition may get worse. This is normal. Do not stop using this medicine. Talk with your doctor if you have concerns about this.

During the time you are receiving nafarelin, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstruation does not begin within 2 to 3 months after you stop using this medicine, check with your doctor.

During the time you are using nafarelin spray, you should use birth control methods that do not contain hormones, such as condoms, IUD, a diaphragm or a cervical cap with a spermicide. If you have any questions about this, check with your doctor.

Use a water-based vaginal lubricant product if dryness of the vagina causes problems, such as pain during sexual intercourse. Make sure the lubricant you choose can be used with a latex birth control device if you are using one. Some lubricants contain oils, which can break down the latex rubber of condoms, a cervical cap, or a diaphragm, and cause them to rip or tear.

If you suspect you may have become pregnant, stop using this medicine and check with your doctor. There is a chance that continued use of nafarelin during pregnancy could cause birth defects or a miscarriage.

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.

Synarel Side Effects

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

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

More commonFor adults (female)

Breast enlargement

light vaginal bleeding between regular menstrual periods called spotting

longer or heavier menstrual periods

vaginal bleeding between regular menstrual periods called breakthrough bleeding

For children (male)

Body odor

growth of pubic hair

For children (female)

Body odor

breast enlargement

growth of pubic hair

light vaginal bleeding between regular menstrual periods called spotting

longer or heavier menstrual periods

vaginal bleeding between regular menstrual periods called breakthrough bleeding

Less common

Chest pain

hives or welts

itching skin

redness of the skin

skin rash

shortness of breath

Less common or rareFor adults (female)

Fast or irregular heartbeat

numbness or tingling of the hands or feet

pain in the eyes or joints

patchy brown or dark brown discoloration of the skin

pelvic bloating or tenderness

unexpected or excess milk flow from breasts

unusual tiredness or weakness

For children (male and female)

Chest pain

hives

shortness of breath

Incidence not known

Anxiety or mental depression

changes in vision

chest pain or discomfort

cold, clammy, or pale skin

confusion

convulsions

headache

irregular heartbeats

nightmares or unusually vivid dreams

slow heart rate

vomiting

weakness

Incidence not known - For adults (female)

Cough

difficulty with speaking

dizziness or lightheadedness

double vision

fainting

fast heartbeat

inability to move the arms, legs, or facial muscles

inability to speak

nausea

pain or discomfort in the arms, jaw, back, or neck

pain, redness, or swelling in the arm or leg

slow speech

sudden shortness of breath or troubled breathing

sweating

vomiting

yellow eyes or skin

More commonFor adults (female)

Acne

dandruff

hot flashes

increase or decrease in sexual desire

increased hair growth, often abnormally distributed

mood swings

muscle pain

oily skin

pain during sexual intercourse

rapid weight gain

reduced breast size

stopping of menstrual periods

swelling of the feet or lower legs

vaginal dryness

For children (male)

Acne

dandruff

mood swings

oily skin

For children (female)

Acne

dandruff

hot flashes

mood swings

oily skin

Less common or rareFor adults (female)

Breast pain

headache (mild and transient)

irritated or runny nose

mental depression (mild and transient)

skin rash

For children (male)

Irritated or runny nose

For children (female)

Irritated or runny nose

white or brownish vaginal discharge

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: Synarel side effects (in more detail)

More Synarel resources

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

Synarel Prescribing Information (FDA)

Synarel Concise Consumer Information (Cerner Multum)

Synarel Monograph (AHFS DI)

Synarel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Synarel with other medications

Endometriosis
Precocious Puberty

Thursday, March 15, 2012

Stromectol

Pronunciation: EYE-ver-MEK-tin
Generic Name: Ivermectin
Brand Name: Stromectol

Stromectol is used for:

Treating infections caused by certain parasites.

Stromectol is an anthelmintic. It works by killing sensitive parasites.

Do NOT use Stromectol if:

you are allergic to any ingredient in Stromectol

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

Before using Stromectol:

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

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

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

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

if you have any other parasite infection (eg, Loa loa infection) or you have recently traveled to areas where parasite infection is likely

if you have asthma or a weakened immune system (eg, HIV infection)

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

Warfarin because the risk of its side effects may be increased by Stromectol.

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

How to use Stromectol:

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

Take Stromectol by mouth on an empty stomach with water.

Some patients who take Stromectol will need repeated follow-up and retreatment to make sure the infection is cleared up completely. Follow your doctor's instructions. Be sure to keep all doctor and lab appointments.

Stromectol is usually given as a single dose. If you forget to take Stromectol, take it as soon as your remember.

Ask your health care provider any questions you may have about how to use Stromectol.

Important safety information:

Stromectol may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Stromectol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Stromectol may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Rarely, some patients taking Stromectol who have also had a certain other parasite infection (loiasis) have developed a serious and sometimes fatal brain problem. Tell your doctor if you have any other parasite infection. Tell your doctor if you have been in an area where Loa loa infection is likely (eg, West or Central Africa). Tell your doctor at once if you have symptoms such as unusual back pain, eye bleeding, shortness of breath, failure to control bladder or bowel, trouble walking or standing, mental changes (eg, confusion), unusual weakness, or seizures.

Lab tests, including stool examinations, may be performed while you use Stromectol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Stromectol should be used with extreme caution in CHILDREN weighing less than 33 pounds (15 kilograms); safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Do not use Stromectol if you are pregnant. If you think you may be pregnant, contact your doctor right away. Stromectol is found in breast milk. If you are or will be breast-feeding while you use Stromectol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Stromectol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye pain, swelling, or redness; fainting; fast heartbeat; fever; joint pain; red, swollen, blistered, or peeling skin; seizures; severe dizziness or lightheadedness; swelling of the skin, arms, legs, ankles, or feet; tender or swollen lymph glands (eg, in the neck, groin, underarms); vision changes; yellowing of the eyes or skin.

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

See also: Stromectol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal skin sensations; diarrhea; loss of coordination; nausea; seizures; severe headache or dizziness; stomach pain; swelling; trouble breathing; unusual weakness; vomiting.

Proper storage of Stromectol:

Store Stromectol at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Stromectol out of the reach of children and away from pets.

General information:

If you have any questions about Stromectol, please talk with your doctor, pharmacist, or other health care provider.

Stromectol is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Stromectol resources

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

Stromectol Prescribing Information (FDA)

Stromectol Advanced Consumer (Micromedex) - Includes Dosage Information

Stromectol Concise Consumer Information (Cerner Multum)

Stromectol Monograph (AHFS DI)

Ivermectin Prescribing Information (FDA)

Compare Stromectol with other medications

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Thyroid

THYE-roid

Oral route(Tablet)

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects .

Commonly used brand name(s)

In the U.S.

Armour Thyroid

Nature-Throid NT-1

Nature-Throid NT-1/2

Nature-Throid NT-2

Nature-Throid NT-3

Nature-Thyroid

Westhroid

Available Dosage Forms:

Tablet

Capsule

Therapeutic Class: Thyroid Supplement

Uses For thyroid

Thyroid is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. It is also used to help decrease the size of enlarged thyroid glands (known as goiter) and to treat thyroid cancer .

Thyroid is also used in some medical tests to help diagnose problems with the thyroid gland .

thyroid is available only with your doctor's prescription .

Before Using thyroid

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 thyroid, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of thyroid in children .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of thyroid in the elderly. However, elderly patients are more likely to have age-related heart and blood vessel problems, which may require caution in patients receiving thyroid .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

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 thyroid, 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 thyroid 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.

Acenocoumarol

Anisindione

Dicumarol

Kelp

Phenindione

Phenprocoumon

Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of thyroid

thyroid usually needs to be taken for life. Do not stop taking thyroid or change your doses without first checking with your doctor. It may take several weeks before you start to notice an improvement in your symptoms .

Dosing

The dose of thyroid 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 thyroid. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablet):
- For the treatment of hypothyroidism:
  - Adults—At first, 30 milligrams (mg) once a day. Then, your doctor may increase your dose a little at a time up to the usual maintenance dose of 60 to 120 mg a day. A lower starting dose of 15 mg/day may be given to patients for certain conditions.
  - Children 0 to 6 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 15 to 30 mg once a day.
  - Children 6 to 12 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 30 to 45 mg once a day.
  - Children 1 to 5 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 45 to 60 mg once a day.
  - Children 6 to 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 60 to 90 mg once a day.
  - Children over 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is over 90 mg once a day .

Missed Dose

If you miss a dose of thyroid, 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

DRUG: GENERAL, STORAGE DRUG: GENERAL, STORAGE

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

Keep out of the reach of children.

Precautions While Using thyroid

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects .

Thyroid should not be used for the treatment of obesity or for the purpose of losing weight. thyroid is ineffective for weight reduction and when taken in larger amount, it may cause more serious medical conditions .

Hypothyroidism can sometimes cause infertility in men and women. Thyroid should not be used for the treatment of infertility unless it is caused by hypothyroidism .

Call your doctor right away if you start to have chest pain, fast, irregular, pounding, or racing heartbeat or pulse, excessive sweating, heat intolerance, nervousness, or any other unusual medical condition .

For patients with diabetes, it is very important that you keep track of your blood or urine sugar levels as instructed by your doctor. Check with your doctor immediately if you notice any changes in your sugar levels .

A temporary loss of hair may occur during the first few months of thyroid therapy. Ask your doctor about this if you have any concerns .

thyroid 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.

Get emergency help immediately if any of the following symptoms of overdose occur:

Changes in appetite

changes in menstrual periods

chest pain

diarrhea

fast or irregular heartbeat

fever

hand tremors

headache

irritability

leg cramps

nervousness

sensitivity to heat

shortness of breath

sweating

trouble sleeping

vomiting

weight loss

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: thyroid side effects (in more detail)

More thyroid resources

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

Armour Thyroid Prescribing Information (FDA)

Armour Thyroid Concise Consumer Information (Cerner Multum)

Armour Thyroid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare thyroid with other medications

Hashimoto's disease
Hypothyroidism, After Thyroid Removal
Thyroid Cancer
TSH Suppression
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Monday, March 12, 2012

Sumavel DosePro injection

Generic Name: sumatriptan (injection) (soo ma TRIP tan)

Brand Names: Alsuma, Imitrex, Imitrex Statdose, Imitrex Statdose Refill, Sumavel DosePro Needle-free System

What is sumatriptan injection?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches and cluster headaches. Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

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

What is the most important information I should know about sumatriptan injection?

You should not use this medication if you are allergic to sumatriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, severe liver disease, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches. Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), rizatriptan (Maxalt), naratriptan (Amerge), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine). Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using sumatriptan, tell your doctor if you have liver or kidney disease, seizures, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After using a sumatriptan injection, you must wait one (1) hour before using a second injection. Do not use more than two injections in 24 hours.

What should I discuss with my health care provider before using sumatriptan injection?

You should not use this medication if you are allergic to sumatriptan, or if you have:

coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

a history of heart disease, heart attack, or stroke, including "mini-stroke";

severe or uncontrolled high blood pressure;

severe liver disease;

ischemic bowel disease; or

a headache that seems different from your usual migraine headaches.

Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

To make sure you can safely use sumatriptan, tell your doctor if you have any of these other conditions:

liver disease;

kidney disease;

epilepsy or other seizure disorder;

high blood pressure, a heart rhythm disorder; or

coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. It is not known whether sumatriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Your name may need to be listed on a sumatriptan pregnancy registry when you start using this medication.

Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using a sumatriptan injection. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby. This medicine should not be given to anyone under 18 or over 65 years of age.

How should I use sumatriptan injection?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

Sumatriptan is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use sumatriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Sumatriptan injection comes in a vial (bottle), in a prefilled cartridge to be loaded into an auto-injector syringe (Imitrex Statdose), or in a needle-free injector device (Sumavel DosePro Needle-free System). Each vial, cartridge, or needle-free device is for one use only.

After using an injection: If your headache does not completely go away after the injection, call your doctor before using a second sumatriptan injection. If your headache goes away and then comes back, you may use a second injection if it has been at least one hour since your first injection. Do not use more than two (2) injections in 24 hours. If your symptoms do not improve, contact your doctor before using any more injections.

Store at room temperature away from moisture, heat, and light. Throw away any unused medicine after the expiration date on the label has passed.

What happens if I miss a dose?

Since sumatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using sumatriptan.

After using a sumatriptan injection, you must wait one (1) hour before using a second injection. Do not use more than two (2) injections in 24 hours.

What happens if I overdose?

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

Overdose symptoms may include tremors or shaking, skin redness, breathing problems, blue-colored lips or fingernails, vision problems, watery eyes or mouth, weakness, lack of coordination, or seizure (convulsions).

What should I avoid while using sumatriptan injection?

Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including:

sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig); or

ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Sumatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Sumatriptan injection 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. Stop using sumatriptan and call your doctor if you have a serious side effect such as:

feeling of pain or tightness in your jaw, neck, or throat;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden and severe stomach pain and bloody diarrhea;

seizure (convulsions);

numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or

(if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

mild headache (not a migraine);

pressure or heavy feeling in any part of your body;

discomfort in your nose or throat;

dizziness, spinning sensation;

muscle pain, neck pain or stiffness;

warmth, redness, or mild tingling under your skin; or

pain, redness, bleeding, swelling, or bruising where you injected the medicine.

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 sumatriptan injection?

Tell your doctor about all other medicines you use, especially:

an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

This list is not complete and other drugs may interact with sumatriptan. 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 Sumavel DosePro resources

Sumavel DosePro Side Effects (in more detail)
Sumavel DosePro Use in Pregnancy & Breastfeeding
Sumavel DosePro Drug Interactions
14 Reviews for Sumavel DosePro - Add your own review/rating

Compare Sumavel DosePro with other medications

Cluster Headaches
Migraine

Where can I get more information?

Your pharmacist can provide more information about sumatriptan.

See also: Sumavel DosePro side effects (in more detail)

Sunday, March 11, 2012

Topamax

Generic Name: Topiramate
Class: Anticonvulsants, Miscellaneous
VA Class: CN400
Chemical Name: 2,3:4,5-bis-O-(1-Methylethylidene)-β-d-fructopyranose sulfamate
Molecular Formula: C₁₂H₂₁NO₈S
CAS Number: 97240-79-4

Special Alerts:

[Posted 03/04/2011] ISSUE: FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

BACKGROUND: Topiramate is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topiramate is also approved for use to prevent migraine headaches. The new data was from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

RECOMMENDATION: Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy. For more information visit the FDA website at: and .

[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)

Felbamate (marketed as Felbatol)

Gabapentin (marketed as Neurontin)

Lamotrigine (marketed as Lamictal)

Levetiracetam (marketed as Keppra)

Oxcarbazepine (marketed as Trileptal)

Pregabalin (marketed as Lyrica)

Tiagabine (marketed as Gabitril)

Topiramate (marketed as Topamax)

Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)

Zonisamide (marketed as Zonegran)

For more information visit the FDA website at: and .

[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.

For more information visit the FDA website at: and .

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)

Felbamate (marketed as Felbatol)

Gabapentin (marketed as Neurontin)

Lamotrigine (marketed as Lamictal)

Levetiracetam (marketed as Keppra)

Oxcarbazepine (marketed as Trileptal)

Pregabalin (marketed as Lyrica)

Tiagabine (marketed as Gabitril)

Topiramate (marketed as Topamax)

Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)

Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for topiramate to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Anticonvulsant and antimigraine agent; sulfamate-substituted derivative ofd-fructose;¹ ² ³ ⁴ ⁵ ¹⁷ ¹⁸ differs structurally from other currently available anticonvulsant agents.¹ ² ³ ⁴ ⁵ ¹⁷ ¹⁸

Uses for Topamax

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.

Seizure Disorders

Management (in combination with other anticonvulsants) of partial seizures in adults and children 2–16 years of age.¹ ² ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ²² ²⁵ ²⁹ ³⁰ ³¹ ³² ³³ ³⁴ ³⁷ ³⁸

Management (in combination with other anticonvulsants) of primary generalized tonic-clonic seizures in adults and children 2–16 years of age.¹ ³⁰ ³¹ ³⁹

Management (in combination with other anticonvulsants) of seizures associated with Lennox-Gastaut syndrome in adults and children ≥2 years of age.¹

Migraine Prophylaxis

Prophylaxis of migraine headache in adults.¹

Efficacy in the acute management (i.e., abortive therapy) of migraine headache not established.¹

Topamax Dosage and Administration

General

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.

Monitoring of plasma topiramate concentrations is not necessary when topiramate is added to an existing anticonvulsant regimen; however, addition of topiramate to phenytoin therapy may require adjustment of phenytoin dosage.¹ ² ⁴

Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy may require adjustment of topiramate dosage.¹ ² ⁴ ¹¹ (See Specific Drugs under Interactions.)

Adjust dosage carefully and individualize according to patient response and tolerance.¹ ² ⁴

Too rapid titration (e.g., over 3–6 weeks) to achieve target dosage and/or excessive target dosage may contribute to a higher incidence of adverse effects.¹ ² ⁴

Administration

Oral Administration

Administer orally without regard to meals.¹ ² ⁴

Capsule/sprinkle formulation is bioequivalent to immediate-release tablet and may be substituted as a therapeutic equivalent.¹

Capsules

Swallow capsules whole.¹

Alternatively, open capsule and sprinkle entire contents on soft food (e.g., applesauce, custard, ice cream, oatmeal, yogurt, pudding); swallow immediately without chewing.¹

Drinking fluids immediately may help to ensure that all of the mixture is swallowed.¹

Do not store the sprinkle/food mixture for use at a later time.¹

Tablets

Tablets preferably should be swallowed intact and not broken or chewed because of the bitter taste.¹ ² ⁴ ²⁴

If patient has difficulty in swallowing tablets, the tablets may be crushed and mixed with oatmeal or applesauce; use immediately since stability cannot be ensured.²⁴

If tablets are broken, use immediately since stability beyond a brief period cannot be ensured.²⁴ Discard any unused portion.²⁴

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.

Pediatric Patients

Seizure Disorders

Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Seizures Associated with Lennox-Gastaut Syndrome

Oral

Initially, 25 mg (or less based on a range of 1–3 mg/kg daily) given nightly for the first week in children 2–16 years of age.¹ Increase dosage at 1- or 2-week intervals in increments of 1–3 mg/kg daily, administered in 2 divided doses, to achieve optimal clinical response.¹

Maintenance, 5–9 mg/kg daily in 2 divided doses.¹

Alternatively, some clinicians recommend an initial dosage of 0.5–1 mg/kg daily, with slow titration (in increments of 1–3 mg/kg every other week or in increments of 0.5–1 mg/kg per week) to obtain optimal efficacy with minimal adverse effects.³³ ³⁶

Adults

Seizure Disorders

Partial Seizures

Oral

Initially, 25–50 mg daily.¹ ² ⁴ ²⁴ Increase dosage at weekly intervals in increments of 25–50 mg to achieve optimal clinical response.¹ ² ⁴ ²⁴

Recommended maintenance dosage is 200–400 mg daily, administered in 2 equally divided doses (morning and evening).¹ ² ⁴ ²⁴

Titration in increments of 25 mg/week is associated with a lower incidence of cognitive and psychiatric adverse effects and lower discontinuance rates²⁴ ⁴¹ but may delay the time to reach an effective dosage.¹ ²⁴ ⁴¹

Dosages >400 mg daily generally have not produced substantial additional improvement, but may improve seizure control in some patients, if tolerated.¹ ² ⁴ ⁷ ²⁴ ²⁵

Primary Generalized Tonic-Clonic Seizures

Oral

Initially, 25–50 mg daily.¹ ² ⁴ ²⁴ Increase dosage at weekly intervals in increments of 25–50 mg to achieve optimal clinical response.¹ ² ⁴ ²⁴

Recommended maintenance dosage is 400 mg daily, administered in 2 equally divided doses (morning and evening).¹ ² ⁴ ²⁴

Seizures Associated with Lennox-Gastaut Syndrome

Oral

Manufacturer makes no specific dosage recommendations; in 1 controlled trial, topiramate was initiated at dosage of 1 mg/kg and titrated over 2 weeks to target dosage of approximately 6 mg/kg daily.¹ ²⁴

Migraine Prophylaxis

Oral

Recommended total daily dosage is 100 mg, administered in 2 divided doses.¹ Titrate therapy using the following schedule in Table 1.

Table 1. Topiramate Dosage Titration Schedule for Migraine Prophylaxis in Adults
Week	Morning Dose	Evening Dose
1	None	25 mg
2	25 mg	25 mg
3	25 mg	50 mg
4	50 mg	50 mg

Titrate dosage based on clinical outcome.¹ Use longer intervals between dose adjustments if required.¹

Prescribing Limits

Adults

Seizure Disorders

Oral

Dosages >1.6 g daily in patients with seizure disorders have not been studied.¹ ² ⁴

Special Populations

Hepatic Impairment

Clearance may be decreased; however, manufacturer makes no specific recommendations regarding dosage adjustment.¹

Renal Impairment

If Cl_cr is <70 mL/minute per 1.73 m², decrease daily adult dosage by 50%.¹ ² ⁴ Patients with renal impairment will require a longer time to reach steady state at each dosage level.¹ ² ⁴

Patients undergoing hemodialysis may require a supplemental dose following dialysis session; base amount on duration of dialysis, clearance rate of dialysis system, and the patient’s effective renal clearance of topiramate.¹ ² ⁴

Geriatric Patients

If Cl_cr <70 mL/minute per 1.73 m², dosage adjustment may be necessary.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Topamax

Contraindications

Known hypersensitivity to topiramate or any ingredient in the formulation.¹

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.

Metabolic Acidosis

Hyperchloremic, non-anion gap, metabolic acidosis reported.¹ ⁴³ (See Pediatric Use under Cautions.) Possible hyperventilation, nonspecific symptoms (e.g., fatigue, anorexia), cardiac arrhythmias, or stupor.¹ ⁴³ Generally occurs early in therapy but can occur at any time.¹ ⁴³

Potential for serious sequelae (e.g., nephrolithiasis, nephrocalcinosis, osteomalacia and/or osteoporosis with increased risk for fractures) resulting from chronic, untreated metabolic acidosis.¹ ⁴³

Measure serum bicarbonate concentrations at baseline and periodically during therapy.¹ ⁴³

If metabolic acidosis develops and persists, consider reducing dosage or discontinuing therapy (by gradually tapering dose).¹ ⁴³ If therapy is continued in patient with persistent acidosis, consider alkali treatment.¹ ⁴³

Cognitive/Neuropsychiatric Effects

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.

Confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech or language problems (e.g., word-finding difficulties), psychiatric/behavioral disturbances (e.g., depression, mood problems), somnolence, and fatigue associated with use in adults.¹

Psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems associated with use in children 2–16 years of age; incidence of these effects is lower in children than in adults.¹

Withdrawal Seizures

Discontinue drug gradually to minimize the potential for increased seizure frequency.¹

Ocular Effects

Acute myopia with secondary angle-closure glaucoma reported.¹ Symptoms (e.g., acute onset of decreased visual acuity and/or ocular pain) typically occur within 1 month of initiating therapy.¹

If adverse ocular signs or symptoms are detected, discontinue topiramate immediately and institute appropriate measures.¹

Oligohidrosis and Hyperthermia

Possible oligohidrosis and hyperthermia, particularly in pediatric patients; rarely may require hospitalization.¹ ⁴²

Monitor patients, particularly pediatric patients, closely for decreased sweating and increased body temperature, particularly in warm or hot weather.¹ Ensure proper hydration before and during exercise or exposure to warm temperatures.⁴²

Consider risk of hyperthermia when used concomitantly with other drugs that predispose to heat-related disorders.¹ (See Drugs Predisposing to Heat-related Disorders under Interactions.)

Sudden, Unexplained Deaths in Epilepsy

Higher incidence of sudden and unexplained deaths than would be expected in a healthy (nonepileptic) population; however, incidence is within range of estimates for patients with epilepsy or refractory epilepsy.¹

General Precautions

Hyperammonemia

Hyperammonemia, with or without encephalopathy, reported following concomitant use with valproic acid.¹

Manifestations of hyperammonemic encephalopathy include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting.¹ In most cases, manifestations abated following discontinuance of either topiramate or valproic acid.¹

If unexplained lethargy, vomiting, or changes in mental status occur, consider possibility of hyperammonemic encephalopathy and measure ammonia concentration.¹

Kidney Stones

Increased incidence (1.5%) of kidney stone formation in clinical trials in adults; incidence higher in men than women.¹ Kidney stones also reported in children 2–16 years of age.¹

Avoid use in patients receiving other carbonic anhydrase inhibitors and in those on ketogenic diet.¹

Maintain adequate fluid intake to decrease stone formation.¹

Paresthesia

Common adverse effect; often associated with other carbonic anhydrase inhibitors.¹

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarity in spelling between Topamax (topiramate) and Toprol-XL (a trade name for metoprolol succinate, a β-adrenergic blocking agent) may result in errors.⁴⁷ ⁴⁸ ⁴⁹ ⁵⁰ These medication errors have been associated with serious adverse events sometimes requiring hospitalization as a result of either lack of the intended medication (e.g., seizure or hypertension recurrence) or exposure to the wrong drug (e.g., bradycardia in a patient erroneously receiving metoprolol).⁴⁷ ⁴⁸ ⁴⁹ ⁵⁰

Specific Populations

Pregnancy

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.

Category C.¹

Lactation

Distributed into milk in rats; limited data suggest that drug may be distributed extensively into milk in humans.¹ Use only if potential benefits outweigh the risks.¹

Pediatric Use

Safety and efficacy for management of seizure disorders not established in children <2 years of age.¹ ² Safety and efficacy for migraine prophylaxis not established in pediatric patients.¹

Hyperchloremic, non-anion gap, metabolic acidosis reported.¹ ⁴³ (See Metabolic Acidosis under Cautions.)

Decreases in serum bicarbonate concentrations reported in 67 or 10% of pediatric patients receiving topiramate (approximately 6 mg/kg daily) or placebo, respectively.¹ ⁴³

Cases of moderately severe metabolic acidosis reported in infants as young as 5 months of age, especially at dosages >5 mg/kg daily.¹ Potential for serious sequelae (e.g., osteomalacia [rickets], reduced growth rates, decrease in maximal height achieved) resulting from chronic, untreated metabolic acidosis.¹ ⁴³

Measure serum bicarbonate concentrations at baseline and periodically during therapy.¹ ⁴³

Incidence of adverse nervous system effects appears to be lower in children than adults.¹

Oligohydrosis and hyperthermia typically reported in children.¹ ⁴² (See Oligohidrosis and Hyperthermia under Cautions.)

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.¹

Clearance may be decreased in patients with reduced renal function.¹ ² (See Special Populations under Pharmacokinetics.) Monitor renal function.¹

Dosage adjustment may be necessary in geriatric patients with impaired renal function.¹ (See Special Populations under Dosage and Administration.)

Hepatic Impairment

Clearance may be decreased; use with caution.¹

Renal Impairment

Clearance decreased; dosage adjustment recommended for adults.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Adults receiving dosages of 50–200 mg daily (for migraine prophylaxis): paresthesia, fatigue, infection, taste perversion, nausea, anorexia, diarrhea, dizziness, weight loss, somnolence, difficulty with memory, difficulty with concentration/attention, sinusitis.¹

Adults receiving dosages of 200–400 mg daily (for management of seizure disorders): somnolence, dizziness, ataxia, speech disorders and related speech problems, psychomotor slowing, abnormal vision, difficulty with memory, paresthesia, diplopia.¹

Adults receiving dosages of 200–1000 mg daily (for management of seizure disorders): fatigue, nervousness, difficulty with concentration or attention, confusion, depression, anorexia, language problems, anxiety, mood problems, weight loss.¹

Children 2–16 years of age receiving dosages of 5–9 mg/kg daily (for management of seizure disorders): fatigue, somnolence, anorexia, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, weight loss.¹

Interactions for Topamax

Does not inhibit CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, or 3A4/5.¹

Drugs Predisposing to Heat-related Disorders

Potential pharmacologic interaction (increased risk of hyperthermia) with drugs that predispose to heat-related disorders (e.g., carbonic anhydrase inhibitors, drugs with anticholinergic activity); use with caution.¹

Specific Drugs

Drug	Interaction	Comments
Amitriptyline	Increased plasma amitriptyline concentrations¹	Adjust amitriptyline dosage based on patient’s clinical response, not on plasma amitriptyline concentrations¹
Carbamazepine	Decreased plasma concentrations of topiramate¹
Carbonic anhydrase inhibitors (e.g., acetazolamide, dichlorphenamide)	Possible increased risk of kidney stone formation; possible increased risk of hyperthermia¹	Avoid concomitant use¹
CNS depressants (including alcohol)	Enhanced CNS depression¹	Use with extreme caution¹
Digoxin	Possible decrease in serum digoxin concentrations¹	Clinical significance unknown¹
Dihydroergotamine	Pharmacokinetic interaction unlikely¹
Haloperidol	No effect on pharmacokinetics of haloperidol¹
Lamotrigine	Increased plasma topiramate concentrations¹
Lithium	Decreased plasma lithium concentrations¹
Metformin	Possible increase in plasma metformin concentrations;¹ possible decrease in topiramate clearance¹	Clinical significance unknown; monitor blood glucose control carefully when topiramate is added or discontinued in patients receiving metformin¹
Oral contraceptives	Decrease in ethinyl estradiol concentrations reported in patients also receiving valproic acid, resulting in potential decrease in oral contraceptive efficacy and possible breakthrough bleeding ¹
Phenytoin	Possible increase in serum phenytoin concentrations (generally in those receiving twice-daily phenytoin regimen); decreased plasma topiramate concentrations¹
Propranolol	Pharmacokinetic interaction unlikely¹
Risperidone	Decreased plasma risperidone concentrations¹	Closely monitor clinical response¹
Sumatriptan	No effect on pharmacokinetics of sumatriptan¹
Valproic acid	Possible decrease in plasma concentrations of valproic acid and topiramate; possible hyperammonemia with or without encephalopathy (see Hyperammonemia under Cautions)¹

Topamax Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration, with peak plasma concentrations achieved in about 2 hours.¹

Capsule/sprinkle formulation is bioequivalent to immediate-release tablet.¹

Food

Food does not affect bioavailability.¹ ⁴⁶

Distribution

Extent

Appears to cross the placenta.⁴⁵

Distributes into breast milk.⁴⁵

Plasma Protein Binding

Approximately 15–41%.¹ Fraction bound decreases with increasing plasma topiramate concentrations.¹

Elimination

Metabolism

Not extensively metabolized.¹ Six minor metabolites identified; none constitutes more than 5% of administered dose.¹

Elimination Route

Eliminated principally in urine as unchanged drug (approximately 70%).¹

Half-life

21 hours.¹ ⁴⁶

Special Populations

In pediatric patients, clearance is 50% higher, resulting in a shorter elimination half-life and lower plasma concentrations, relative to adults.¹

In geriatric patients with reduced renal function (Cl_cr reduced by 20% compared with younger adults), clearance was decreased.¹ ¹

In patients with hepatic impairment, clearance may be decreased; mechanism not fully understood.¹

In patients with moderate or severe renal impairment, clearance is reduced by 42 or 54%, respectively.¹ In patients undergoing hemodialysis, clearance is 4–6 times more rapid than in healthy individuals.¹ ² ⁴

Stability

Storage

Oral

Capsules

Tight containers at ≤25° C.¹ Protect from moisture.¹

Tablets

Tight containers at 15–30° C.¹ Protect from moisture.¹

Actions

Mechanism of action is unknown; however, properties that may contribute to anticonvulsant and antimigraine activities, including blocking sodium channels, enhancing the inhibitory action of GABA by acting at some subtypes of GABA-A receptor, antagonizing AMPA/kainate subtype of glutamate receptor, and inhibiting carbonic anhydrase enzymes have been demonstrated in electrophysiologic and biochemical studies.¹ ² ⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ¹⁹

Advice to Patients

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.

Importance of taking topiramate exactly as prescribed.¹ Importance of not abruptly discontinuing therapy.¹

Importance of seeking immediate medical attention if blurred vision or periorbial pain develops.¹

Importance of maintaining adequate fluid intake, particularly in patients with predisposing factors, to minimize the risk of kidney stone formation.¹

Importance of considering an increase in food intake if patient is losing weight while taking topiramate.¹

Importance of reviewing the manufacturer’s patient information for instructions regarding administration of the capsule/sprinkle formulation.¹

Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.¹

Importance of monitoring for evidence of decreased sweating and increased body temperature, particularly in children during hot weather.¹ ⁴² Importance of proper hydration before and during exercise and exposure to warm temperatures.⁴²

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

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

Topiramate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	15 mg	Topamax Sprinkle (with povidone)	Ortho-McNeil
		25 mg	Topamax Sprinkle (with povidone)	Ortho-McNeil
	Tablets, film-coated	25 mg	Topamax	Ortho-McNeil
		50 mg	Topamax	Ortho-McNeil
		100 mg	Topamax	Ortho-McNeil
		200 mg	Topamax	Ortho-McNeil

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Topamax 100MG Tablets (JANSSEN): 60/$536.97 or 180/$1,589.92

Topamax 200MG Tablets (JANSSEN): 60/$626.00 or 180/$1,790.90

Topamax 25MG Tablets (JANSSEN): 60/$201.99 or 180/$574.97

Topamax 50MG Tablets (JANSSEN): 60/$382.01 or 180/$1,105.93

Topiramate 100MG Tablets (GLENMARK PHARMACEUTICALS): 60/$49.99 or 180/$129.98

Topiramate 15MG Sprinkle Capsules (TEVA PHARMACEUTICALS USA): 60/$70.99 or 180/$199.96

Topiramate 200MG Tablets (GLENMARK PHARMACEUTICALS): 60/$49.99 or 180/$129.98

Topiramate 25MG Sprinkle Capsules (TEVA PHARMACEUTICALS USA): 60/$85.99 or 180/$235.96

Topiramate 25MG Tablets (GLENMARK PHARMACEUTICALS): 60/$29.99 or 180/$79.97

Topiramate 50MG Tablets (GLENMARK PHARMACEUTICALS): 60/$39.99 or 180/$99.97

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.

References

1. Ortho-McNeil. Topamax (topiramate) tablets and capsules prescribing information. Raritan, NJ: 2004 Aug.

2. Ortho-McNeil. Topamax (topiramate) clinical review. Raritan, NJ: undated.

3. Pugh CB, Garnett WR, Current issues in the treatment of epilepsy. Clin Pharm. 1991; 10:335-58.

4. Ortho-McNeil. Topamax (topiramate) tablets product information reference source. Raritan, NJ; 1997 Jan.

5. Rogawski MA, Porter RJ. Antiepileptic drugs: Pharmacological mechanisms and clinical efficacy with consideration of promising developmental stage compounds. Pharmacol Rev. 1990; 42:223-86. [IDIS 273932] [PubMed 2217531]

6. Faught E, Wilder BJ, Ramsay RE et al et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology. 1996; 46:1684-90. [IDIS 368533] [PubMed 8649570]

7. Privitera M, Fincham R, Penry J et al et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 600-, 800-, and 1,000-mg daily dosages. Neurology. 1996; 46:1678-83. [IDIS 368532] [PubMed 8649569]

8. Sharief M, Viteri C, Ben-Menachem E et al. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Epilepsy Res. 1996; 25:217-24. [PubMed 8956919]

9. Tassinari CA, Michelucci R, Chauvel P et al. Double-blind, placebo-controlled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy. Epilepsia. 1996; 37:763-8. [IDIS 372665] [PubMed 8764816]

10. Ben-Menachem E, Henriksen O, Dam M et al. Double-blind, placebo-controlled trial of topiramate as add-on therapy in patients with refractory partial seizures. Epilepsia. 1996; 37:539-43. [IDIS 368333] [PubMed 8641230]

11. Bourgeois BFD. Drug interaction profile of topiramate. Epilepsia. 1996; 37(Suppl 2):S14-17.

12. McNamara JO. Drugs effective in the treatment of the epilepsies. In: Hardman JG, Limbird LE, Molinoff PB et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 9th ed. New York: Macmillan Publishing Company; 1996:461-86.

13. Membrane potentials and action potentials. In: Guyton AC. Textbook of medical physiology. 8th ed. Philadelphia: WB Saunders; 1991:51-66.

14. Lipton SA, Rosenberg PA. Excitatory amino acids as a final common pathway for neurologic disorders. N Engl J Med. 1994; 330:613-22. [IDIS 326265] [PubMed 7905600]

15. Dichter MA, Brodie MJ. New antiepileptic drugs. N Engl J Med. 1996; 334:1583-90. [IDIS 366423] [PubMed 8628341]

16. White HS, Brown SD, Wolf HH et al. The anticonvulsant topiramate potentiates GABA-evoked chloride current in mouse cortical neurons. Epilepsia. 1994; 35(Suppl 8):S67.

17. Shank RP, Gardocki JF, Vaught JL et al. Topiramate: preclinical evaluation of structurally novel anticonvulsant. Epilepsia. 1994; 35:450-60. [PubMed 8156972]

18. Edmonds HL Jr, Jiang YD, Zhang PY et al. Anticonvulsant activity of topiramate and phenytoin in a rat model of ischemia-induced epilepsy. Life Sci. 1996; 59:PL127-31. [PubMed 8761322]

19. White HS. Clinical significance of animal seizure models and mechanism of action studies of potential antiepileptic drugs. Epilepsia. 1997; 38(Suppl 1):S9-17. [PubMed 9092952]

20. Nakamura J, Tamura S, Kanda T et al. Inhibition by topiramate of seizures in spontaneously epileptic rats and DBA/2 mice. Eur J Pharmacol. 1994; 254:83-9. [PubMed 8206119]

21. Kanda T, Kurokawa M, Tamura S et al. Topiramate reduces abnormally high extracellular levels of glutamate and aspartate in the hippocampus of spontaneously epileptic rats (SER). Life Sci. 1996; 59:1607-16. [PubMed 8913326]

22. Reife RA, Pledger GW. Topiramate as adjunctive therapy in refractory partial epilepsy: pooled analysis of data from five double-blind, placebo-controlled trials. Epilepsia. 1997; 38(Suppl 1):S31-3. [IDIS 384611] [PubMed 9092956]

23. Wasserstein AG, Rak I, Reife RA. Nephrolithiasis during treatment with topiramate. Epilepsia. 1995; 36(Suppl 3):S153.

24. Ortho-McNeil, Raritan, NJ: Personal communication.

25. Marson AG, Kadir ZA, Chadwick DW. New antiepileptic drugs: a systematic review of their efficacy and tolerability. BMJ. 1996; 313:1169-74. [IDIS 375403] [PubMed 8916746]

26. Rosenfeld WE, Liao S, Kramer LD et al. Comparison of the steady-state pharmacokinetics of topiramate and valproate in patients with epilepsy during monotherapy and concomitant therapy. Epilepsia. 1997; 38:324-3

Saturday, March 17, 2012

Norvir

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Friday, March 16, 2012

Synarel

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Thursday, March 15, 2012

Stromectol

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Do NOT use Stromectol if:

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If OVERDOSE is suspected:

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Thyroid

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Monday, March 12, 2012

Sumavel DosePro injection

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