Isotretinoin, Oral

What are other names for this medicine?

Type of medicine: retinoid

Generic and brand names: isotretinoin, oral; Accutane; Amnesteem; Claravis; Sotret

What is this medicine used for?

This medicine is used to treat severe cases of acne when other medicines don't work. This medicine may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine or food
• acute pancreatitis
• an eating disorder such as anorexia nervosa
• asthma
• osteoporosis or other bone disorder
• diabetes
• heart disease
• depression or thoughts of suicide
• high levels of cholesterol or triglycerides in your blood
• kidney or liver disease
• problems with alcohol abuse

Females of childbearing age: DO NOT take this medicine if you are pregnant or plan to become pregnant. This medicine has been reported to cause birth defects. Read the information that comes in the medicine package. You must meet certain conditions and sign a consent form. Do not start this medicine until you have had 2 negative pregnancy tests. A pregnancy test must be repeated each month before you are issued a new prescription for more medicine. You must use 2 reliable birth control methods for at least 1 month before you start taking this medicine, while you are taking this medicine, and for at least 1 month after you stop taking it. Do not breast feed while you are taking this medicine.

How should I take it?

Read the Medication Guide in the medicine package each time you fill your prescription. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Taking too much of it or too often may increase the risk of side effects.

Take this medicine with a meal and a full glass of water. Do not crush or chew the capsules. Swallow them whole.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take a double dose. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, dizziness, vomiting, stomach pain, flushing, loss of balance.

What should I watch out for?

Do not drink alcohol or any products containing alcohol during treatment, and for at least 2 months after stopping treatment. Discuss these and other warnings with your healthcare provider.

Do not take vitamin A while you are taking this medicine. You may get too much vitamin A in your body.

Do not have cosmetic procedures such as waxing, dermabrasion, or laser procedures while you are taking this medicine and for at least 6 months after you stop taking it.

Your acne may get worse when you first start taking this medicine. This should last only a short while. Talk with your healthcare provider about this.

Do not donate blood while you are taking this medicine and for 1 month after you stop.

You will need to have blood tests regularly to see how this medicine affects you. Continued treatment with this medicine may affect bone density. Your healthcare provider may order tests to determine if this medicine is affecting your bones. Keep all appointments for tests.

This medicine may make your skin more sensitive to the sun and may cause you to sunburn more easily. While you are taking this medicine, avoid long exposure to the sun. While you are in the sun, wear protective clothing and sunscreen lotion until you know how you will react to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

Diabetics: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

This medicine may cause depression, mood swings, and thoughts of suicide. If you have these reactions, contact your healthcare provider right away.

You may have dry eyes, mouth, nose, and skin while you are taking this medicine. If any of these reactions becomes a problem, contact your healthcare provider. Using Vaseline for your lips, creams or ointments for your skin, and artificial tears for your eyes may help.

This medicine may cause vision changes. Do not drive unless you can see clearly, especially at night.

Contact lenses may be uncomfortable while you are taking this medicine.

Do not give this medicine to anyone else.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Chest pain, irregular heartbeat, unexplained muscle aches or weakness, joint pain, back pain, seizures, eye irritation or inflammation, depression, mood swings, thoughts of suicide, vision problems, loss of hearing, ringing in the ears, dizziness, severe nausea, vomiting, unusual bleeding or bleeding, severe headache, heartburn, severe diarrhea, abdominal pain, rectal bleeding, yellow eyes or skin, dark urine, frequent urination, increased thirst.

Other: Dry skin, dry eyes, dry mouth, dry nose, mild rash, peeling skin, increased sensitivity to sun, change in menstrual cycle, nausea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• birth control pills, shots, and implants (talk to your healthcare provider if you need birth control)
• antibiotics such as demeclocycline (Declomycin), doxycycline (Vibramycin, Vibra-Tabs, Doryx, Doxychel), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Sumycin)
• antiseizure medicines such as carbamazepine (Tegretol) and phenytoin (Dilantin)
• corticosteroids such as cortisone (Cortone), prednisone (Meticorten), dexamethasone (Hexadrol), hydrocortisone (Hydrocortone, Cortef), triamcinolone (Aristocort, Kenacort), prednisolone (Delta-Cortef), and methylprednisolone (Medrol)
• herbal remedies such as St. John's wort and dong quai
• vitamin A

Do not drink alcohol in any form while taking this medicine.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.