(isotretinoin) 10 mg, 20 mg and 40 mg Capsules, USP
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT
CONTRAINDICATIONS AND WARNINGS
Zenatane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Zenatane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
Birth defects which have been documented following Zenatane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.
Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.
If pregnancy does occur during treatment of a female patient who is taking Zenatane, Zenatane must be discontinued immediately and she should be referred to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Special Prescribing Requirements
Because of Zenatane teratogenicity and to minimize fetal exposure, Zenatane approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Zenatane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Zenatane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS).
Table 1: Monthly Required iPLEDGE Interactions
|Female Patients of Childbearing Potential||Male Patients, And Female Patients Not of Childbearing Potential|
|Confirms patient counseling||X||X|
|Enters the two contraception methods chosen by the patient||X|
|Enters pregnancy test results||X|
|Answers educational questions before every prescription||X|
|Enters two forms of contraception||X|
|Contacts system to get an authorization||X||X|
Isotretinoin USP, a retinoid, is available as Zenatane (isotretinoin capsules USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain gelatin, glycerin, methylparaben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1- 27794 containing iron oxide black, N-butyl alcohol, propylene glycol, industrial methylene spirit and shellac.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform; sparingly soluble in alcohol, in isopropyl alcohol and in polyethylene glycon 400. The structural formula is:
Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.
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