CLARAVIS- isotretinoin capsule 
Barr Laboratories, Inc.

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MEDICATION GUIDE

Claravis™

(isotretinoin capsules, USP)

Read the Medication Guide that comes with Claravis before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Claravis?

  1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Claravis. Female patients must not get pregnant: 

If you get pregnant while taking Claravis, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:

2. Serious mental health problems. Claravis may cause:

Stop Claravis and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:

After stopping Claravis, you may also need follow-up mental health care if you had any of these symptoms.

 What is Claravis?

Claravis is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Claravis can cause serious side effects (see “What is the most important information I should know about Claravis?”). Claravis can only be:

What is severe nodular acne?

Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.

 Who should not take Claravis?

What should I tell my doctor before taking Claravis?

Tell your doctor if you or a family member has any of the following health conditions:

Tell your doctor if you are pregnant or breastfeeding. Claravis must not be used by women who are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Claravis and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

These medicines should not be used with Claravis unless your doctor tells you it is okay.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

How should I take Claravis?

You will not be prescribed Claravis if you cannot agree to or follow all the instructions of the iPLEDGE program.

 

You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Claravis.

If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using Claravis and call your doctor right away.

What should I avoid while taking Claravis?

What are the possible side effects of Claravis?

Stop Claravis and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.

Claravis may stop long bone growth in teenagers who are still growing.

These are not all of the possible side effects with Claravis. Your doctor or pharmacist can give you more detailed information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Claravis?

General Information about Claravis.

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Claravis for a condition for which it was not prescribed. Do not give Claravis to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Claravis. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Claravis that is written for healthcare professionals. You can also call iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com.

What are the ingredients in Claravis?

Active Ingredient:Isotretinoin

Inactive Ingredients: Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, gelatin, hydrogenated vegetable oil, polysorbate 80, soybean oil, titanium dioxide, white wax (beeswax), and vitamin E.

In addition, the 10 mg capsule contains black iron oxide and FD&C yellow no. 6. The 20 mg capsule contains black iron oxide, red iron oxide and yellow iron oxide. The 30 mg capsule contains red iron oxide and yellow iron oxide. The 40 mg capsule contains colloidal silicon, sodium lauryl sulfate, and FD&C yellow no. 6.

The edible imprinting ink contains: 10 mg strength, D&C red no. 7 calcium lake, ethylene glycol monoethyl ether, FD&C yellow no. 6 aluminum lake, shellac glaze and titanium dioxide; 20 mg strength, ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide; the 30 mg strength, D&C yellow no. 10 aluminum lake, FD&C blue no.1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide black, propylene glycol, and shellac glaze; the 40 mg strength, ammonium hydroxide, FD&C blue no. 2 aluminum lake, iron oxide black, propylene glycol, and shellac glaze.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Dilantin is a registered trademark of Warner-Lambert Company LLC.

 

BARR LABORATORIES, INC.

Pomona, NY 10970

Rev. B 5/2012

Revised: 09/2013
 
Barr Laboratories, Inc.