Zenatane(Oral)

Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or 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. You must have a negative pregnancy test before you start taking isotretinoin, 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 your last dose.Both a primary and a secondary form of birth control must be used together.

Primaryforms 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.

Secondaryforms of birth control include:

• a male latex condom with or without spermicide;
• a diaphragm plus a spermicide;
• a cervical cap plus a spermicide; and
• a vaginal sponge containing a 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.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

You should not use isotretinoin if you are allergic to it.

Tell your doctor if you have ever had:

• depression or mental illness;
• asthma;
• liver disease;
• diabetes;
• heart disease or high cholesterol;
• osteoporosis or low bone mineral density;
• an eating disorder such as anorexia;
• a food or drug allergy; or
• an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.

You should not breastfeed while using this medicine.

Isotretinoin is not approved for use by anyone younger than 12 years old.