ISOTRETINOIN (ORAL)

(EYE so TRET i noyn) Brand: Amnesteem, Claravis, Sotret

What is the most significant information I must know about isotretinoin?

• Isotretinoin can reason severe, life-threatening birth defects. Never use isotretinoin if you are pregnant.

• Women of child-bearing potential should agree in writing to use two specific forms of birth control and have regular pregnancy trials till, during, and after taking isotretinoin.

• Isotretinoin is accessible only under a particular program called iPLEDGE. It is dangerous to try and purchase isotretinoin on the Internet or from vendors external of the United States.

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

• Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it.

What is isotretinoin?

• Isotretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

• Isotretinoin is used to treat severe nodular acne that has not responded to another treatments, including antibiotics.

• Isotretinoin may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking isotretinoin?

• Isotretinoin is accessible only under a particular program called iPLEDGE. You should be registered in the program and sign documents stating that you understand the dangers of this medicine and that you agree to use birth control as required by the program. 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 external of the United States. The sale and distribution of isotretinoin external of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safety use of this medication.

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

• To create certain you can safely take isotretinoin, speak your doctor if you have any of these another conditions:

· a private or family history of depression or mental illness;

· heart malady, tall cholesterol or triglycerides;

· osteoporosis or another bone disorders;

· an intestinal mess such as inflammatory bowel malady, ulcerative colitis, or Crohn's disease;

· diabetes;

· asthma;

· an eating mess (anorexia nervosa); or

· liver disease.

• Isotretinoin can reason severe, life-threatening birth defects if the mother takes the medicine during pregnancy. Even one doze of isotretinoin can reason major birth defects of the baby's ears, eyes, person, 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 should have a negative pregnancy test 30 days till you start taking isotretinoin. A pregnancy test is also required till every prescription is refilled, right after you take your recent doze of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

• You should agree in writing to use two specific forms of birth control beginning 30 days till you start taking isotretinoin and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control should 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.

• 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.

How must I take isotretinoin?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Every prescription of isotretinoin should be filled within 7 days of the date it was predesigned by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

• Always take isotretinoin with a full glass of water to prevent the capsule from melting in your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as quickly as possible.

• Take isotretinoin with food or milk.

• Take this medicine for the entire length of time predesigned by your doctor. Your acne may seem to get worse at first, but must then begin to improve.

• To be certain this medicine is not causing deleterious effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

• Never share this medication with other face, even if they have the same symptoms you have.

• Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

• Skip the missed doze and take the medication at your following regularly scheduled time. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.

What must I avoid while taking isotretinoin?

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

• 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 child 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 create your skin more sensitive to sunlight and sunburn may result.

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

What are the possible side effects of isotretinoin?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, 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, quick 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, light bruising or bleeding;

· severe blistering, peeling, and red skin rash; or

· joint stiffness, bone pain or fracture.

• Smaller serious side effects may include:

· 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect isotretinoin?

• Speak your doctor about all another medicines you use, especially:

· steroids (prednisone and others);

· seizure medicine such as 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 another drugs may interact with isotretinoin. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about isotretinoin.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.