Isotretinoin Treatment Report

Precautions

Instructions

Side Effects

Interactions

Isotretinoin is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Read all of the iPLEDGE program brochures and agreements carefully. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.

It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

Do not use this medication if you are allergic to isotretinoin or to parabens, or if you are pregnant or may become pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking isotretinoin, tell your doctor if you are allergic to any foods or drugs, or if you have:

• a personal or family history of depression or mental illness;
• heart disease, high cholesterol or triglycerides;
• osteoporosis or other bone disorders;
• diabetes;
• asthma;
• an eating disorder (anorexia nervosa); or
• liver disease.

Isotretinoin can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby’s ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential.

Even women who have had their tubes tied are required to use birth control while taking isotretinoin.

You must have a negative pregnancy test 30 days before you start taking isotretinoin. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

• tubal ligation (tubes tied);
• vasectomy of the male sexual partner;
• an IUD (intrauterine device);
• estrogen-containing birth control pills (not mini-pills); and
• hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

• a male latex condom plus spermicidal foam or gel;
• a diaphragm plus spermicidal foam or gel;
• a cervical cap plus spermicidal foam or gel; and
• a vaginal sponge containing spermicide.

Do not take St. John's wort, an herbal supplement, if you are using any type of hormonal birth control, including pills, patches, implants, injections, or a vaginal ring. Breakthrough bleeding may occur.

Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

It is not known whether isotretinoin passes into breast milk. Do not take isotretinoin without first talking to your doctor if you are breast-feeding a baby.

Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.

Isotretinoin can weaken bones. Avoid sports or activities that may result in injury or bone fracture.

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking isotretinoin and for at least 6 months after you stop taking it. Scarring may result.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Isotretinoin can make your skin more sensitive to sunlight and sunburn may result.

Isotretinoin can cause side effects that may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

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Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

• depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
• sudden numbness or weakness, especially on one side of the body;
• blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
• hearing problems, hearing loss, or ringing in your ears;
• seizure (convulsions);
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
• fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding; or
• joint stiffness, bone pain or fracture.

Less serious side effects may include:

• discomfort with contact lenses;
• joint pain, back pain;
• feeling dizzy, drowsy, or nervous;
• dryness of the lips, mouth, nose, or skin; or
• cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

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Before taking isotretinoin, tell your doctor if you are also taking:

• steroids (prednisone and others);
• seizure medication such phenytoin (Dilantin); or
• a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap).

This list is not complete and there may be other drugs that can interact with isotretinoin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Accutane, Amnesteem, Claravis, Sotret, and isotretinoin

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