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isotretinoin (oral) (cont.)

What should I discuss with my healthcare provider before taking isotretinoin (Amnesteem, Claravis, Sotret)?

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. 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.

To make sure you can safely take isotretinoin, tell your doctor if you have any of these other conditions:

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.

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 should I take isotretinoin (Amnesteem, Claravis, Sotret)?

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

Each prescription of isotretinoin must be filled within 7 days of the date it was prescribed 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 medication for the entire length of time prescribed by your doctor. Your acne may seem to get worse at first, but should then begin to improve.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

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

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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