ISOTRETINOIN- isotretinoin capsule, liquid filled 
Amneal Pharmaceuticals NY LLC

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MEDICATION GUIDE

Isotretinoin (EYE so TRET i noyn) Capsules

Read the Medication Guide that comes with isotretinoin capsules 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 isotretinoin capsules?

  1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take isotretinoin capsules. Patients must not become pregnant:
    • for one month before starting isotretinoin capsules
    • while taking isotretinoin capsules
    • for one month after stopping isotretinoin capsules.

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

    • FDA MedWatch at 1-800-FDA-1088, and
    • the iPLEDGE Pregnancy Registry at 1-866-495-0654
  2. Serious mental health problems. Isotretinoin capsules may cause:

Stop isotretinoin capsules 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 isotretinoin capsules, you may also need follow-up mental health care if you had any of these symptoms.

What are isotretinoin capsules?

Isotretinoin capsules are 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. Isotretinoin capsules can cause serious side effects (see “What is the most important information I should know about isotretinoin capsules?”). Isotretinoin capsules 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 isotretinoin capsules?

What should I tell my doctor before taking isotretinoin capsules?

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

Tell your doctor if you are pregnant or breast-feeding. Isotretinoin capsules must not be used by women who are pregnant or breast-feeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Isotretinoin capsules 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 isotretinoin capsules 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 isotretinoin capsules?

You will not be prescribed isotretinoin capsules 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 isotretinoin capsules.

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

What should I avoid while taking isotretinoin capsules?

What are the possible side effects of isotretinoin capsules?

Stop isotretinoin capsules 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.

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

These are not all of the possible side effects with isotretinoin capsules. 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 or Amneal Pharmaceuticals at 1-877-835-5472.

How should I store isotretinoin capsules?

General Information about isotretinoin capsules.

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use isotretinoin capsules for a condition for which it was not prescribed. Do not give isotretinoin capsules 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 isotretinoin capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about isotretinoin capsules 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 isotretinoin capsules?

Active Ingredient: Isotretinoin

Inactive Ingredients: Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, gelatin, glycerin, hydrogenated vegetable oil, purified water, soybean oil, titanium dioxide and white wax (beeswax).

In addition, the 10 mg capsule contains iron oxide black and iron oxide yellow. The 20 mg capsule contains iron oxide black, iron oxide red and iron oxide yellow. The 30 mg capsule contains FD&C yellow #6 aluminum lake. The 40 mg capsule contains FD&C yellow #6 aluminum lake.

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

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

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ  08807

Rev. 08-2018-02

Revised: 8/2018
Amneal Pharmaceuticals NY LLC