What should I know about isotretinoin before taking it?

Before taking this medicine. 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.

What are the side effects of isotretinoin in dogs?

In Summary Commonly reported side effects of isotretinoin include: cheilitis, epistaxis, hypertriglyceridemia, pruritus, xerosis cutis, decreased hdl cholesterol, increased liver enzymes, increased serum triglycerides, musculoskeletal signs and symptoms, dry nose, xeroderma, and xerostomia. Other side effects include: increased serum cholesterol.

What is the P450 isoform of isotretinoin?

In vitro studies indicate that the primary P450 isoforms involved in isotretinoin metabolism are 2C8, 2C9, 3A4 and 2B6. Isotretinoin and its metabolites are further metabolized into conjugates, which are then excreted in urine and feces.

Why is isotretinoin only available under a restricted distribution program?

Special Prescribing Requirements Because of isotretinoin’s teratogenicity and to minimize fetal exposure, isotretinoin is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE®.

Is it safe to use isotretinoin outside of the iPLEDGE Program?

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. You should not breast-feed while using this medicine. Isotretinoin is not approved for use by anyone younger than 12 years old.

Can I use two different forms of birth control with isotretinoin?

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.