SOTRET- isotretinoin capsule, gelatin coated 
SOTRET- isotretinoin capsule, liquid filled 
Ranbaxy Laboratories Inc.




(Isotretinoin Capsules)

Read the Medication Guide that comes with Sotret 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 Sotret?

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

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

  1. Serious mental health problems. Sotret may cause:

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

What is Sotret?

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

What should I tell my doctor before taking Sotret?

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. Sotret 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. Sotret 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 Sotret 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 Sotret?

You will not be prescribed Sotret 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 Sotret.

If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using Sotret and call your doctor right away.

What should I avoid while taking Sotret?

What are the possible side effects of Sotret?

Stop Sotret 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.

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

The common, less serious side effects of Sotret are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.

These are not all of the possible side effects with Sotret. Your doctor or pharmacist can give you more detailed information.

How should I store Sotret?

General Information about Sotret

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Sotret for a condition for which it was not prescribed. Do not give Sotret 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 Sotret. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Sotret that is written for health care professionals. You can also call iPLEDGE program at 1-866-495-0654 or visit

What are the ingredients in Sotret?

Active Ingredient: Isotretinoin

Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil, hydrogenated vegetable oil, iron oxide black, soybean oil and white wax. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20 mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 30 mg - FD&C Yellow No. 6, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

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 for:

Ranbaxy Laboratories Inc.

Jacksonville, FL 32257 USA

by: Ranbaxy Laboratories Limited

New Delhi –110 019, India

November 2006

Revised: 11/2006
Ranbaxy Laboratories Inc.