ACCUTANE- isotretinoin capsule, gelatin coated 
JG Pharma Inc.

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MEDICATION GUIDE

ACCUTANE® (ACK – U – TANE)

(isotretinoin capsules)

Read the Medication Guide that comes with Accutane 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 Accutane?

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 Accutane. Patients must not get pregnant:

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

2. Serious mental health problems. Accutane may cause:

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

What is Accutane?

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

What should I tell my doctor before taking Accutane?

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. Accutane must not be used by women who are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non­prescription medicines, vitamins and herbal supplements. Accutane 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 Accutane 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 Accutane?

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

What should I avoid while taking Accutane?

What are the possible side effects of Accutane?

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

These are not all of the possible side effects with Accutane. 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 JG Pharma, Inc. at 1-844-325-3350.

How should I store Accutane?

General Information about Accutane

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

You can also call iPLEDGE REMS at 1-866-495-0654 or visit www.ipledgeprogram.com.

What are the ingredients in Accutane?

Active Ingredient: isotretinoin USP

Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferric oxide yellow (for 30 mg), gelatin, glycerin, methylparaben, propyl paraben, lake blend blue (LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac.

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

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

To reorder additional Medication Guides contact JG Pharma’s Customer Service at 1-844-256-4677.

Rx Only

Distributed by:

JG Pharma Inc.,

Scottsdale, AZ 85258

Issued: 04/2022                                                                                                                                JG Pharma

Accutane is a registered trademark of JG Pharma, Inc. and/or its affiliates.

Revised: 8/2022
JG Pharma Inc.