AMNESTEEM - isotretinoin capsule 
Physicians Total Care, Inc.




(Isotretinoin Capsules)

Read the Medication Guide that comes with Amnesteem 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 Amnesteem?

  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 Amnesteem. Female patients must not get pregn1:
    • for 1 month before starting Amnesteem
    • while taking Amnesteem
    • for 1 month after stopping Amnesteem.

    If you get pregnant while taking Amnesteem, 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. Amnesteem may cause:
    • depression
    • psychosis (seeing or hearing things that are not real)
    • suicide. Some patients taking Amnesteem have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives.

    Stop Amnesteem 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:

    • start to feel sad or have crying spells
    • lose interest in activities you once enjoyed
    • sleep too much or have trouble sleeping
    • become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
    • have a change in your appetite or body weight
    • have trouble concentrating
    • withdraw from your friends or family
    • feel like you have no energy
    • have feelings of worthlessness or guilt
    • start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
    • start acting on dangerous impulses
    • start seeing or hearing things that are not real

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

What is Amnesteem?

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

What should I tell my doctor before taking Amnesteem?

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. Amnesteem 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. Amnesteem 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 Amnesteem 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 Amnesteem?

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 Amnesteem.

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

What should I avoid while taking Amnesteem?

What are the possible side effects of Amnesteem?

These are not all of the possible side effects with Amnesteem. 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 Amnesteem?

General Information about Amnesteem

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

You can also call iPLEDGE program at 1-866-495-0654 or visit

What are the ingredients in Amnesteem?

Active Ingredient: Isotretinoin

Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil, soybean oil and yellow wax. Gelatin capsules contain glycerin, with the following dye systems: 10 mg – black ink and red iron oxide paste; 20 mg – black ink, red iron oxide paste, titanium dioxide and yellow iron oxide paste; 40 mg – black ink, red iron oxide paste, titanium dioxide and yellow iron oxide paste.

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

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

Manufactured by:
Catalent Pharma Solutions

74 rue Principale
67930 Beinheim

Packaged by:
Catalent Pharma Solutions
Philadelphia, PA 19114 U.S.A.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A. 


Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

Revised: 6/2012
Physicians Total Care, Inc.