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CAUSES BIRTH DEFECTS
Pregnancy Category X
- ABSORICA must not be used by female patients who are or may become pregnant [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
- There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking ABSORICA in any amount, even for short periods of time [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
- Potentially any fetus exposed during pregnancy can be affected [see Use in Specific Populations].
- There are no accurate means of determining whether an exposed fetus has been affected [see WARNING AND PRECAUTIONS and Use in Specific Populations].
- Birth defects which have been documented following isotretinoin 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 [see Use in Specific Populations].
- 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 abnormalities previously noted [see Use in Specific Populations].
- If pregnancy does occur during the treatment of a female patient who is taking ABSORICA, ABSORICA must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Use in Specific Populations].
Special Prescribing Requirements
- Because of the risk of teratogenicity and to minimize fetal exposure, ABSORICA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE™. Under the ABSORICA REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program [see WARNINGS AND PRECAUTIONS].
ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems:
- 10 mg – iron oxide (yellow) and titanium dioxide;
- 20 mg – iron oxide (red), and titanium dioxide;
- 25 mg – FD&C Blue #1, FD&C Yellow #5, FD&C Yellow #6 and titanium dioxide;
- 30 mg – iron oxide (black, red and yellow) and titanium dioxide;
- 35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide;
- 40 mg – iron oxide (black, red and yellow) and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is:
Meets USP Dissolution Test 3
Last reviewed on RxList: 9/17/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Absorica Information
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