Absorica Generic Name & Formulations
Mechanism of Action
Isotretinoin is a retinoid, which when administered at the recommended dosage, inhibits sebaceous gland function and keratinization. Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with isotretinoin capsules and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation. The exact mechanism of action of Absorica in the treatment of severe recalcitrant nodular acne is unknown.
Limitations of Use
Absorica Dosage and Administration
Absorica Boxed Warnings
Must register patient in iPLEDGE program (see full labeling for restrictions and stipulations on use). Be fully familiar with drug's toxicity before use. Embryo-fetal toxicity: obtain 2 negative pregnancy tests prior to initiation of drug, monthly thereafter, and 1 month after treatment. Counsel patient about need for contraception; use 2 effective methods of contraception 1 month before, during, and 1 month after therapy; get written informed consent (see full labeling). Monitor blood lipids prior to treatment then at intervals until lipid response is known (usually within 4 weeks). Increased risk for hypertriglyceridemia (eg, diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). History of psychiatric disorders; monitor and discontinue immediately if signs/symptoms develop. Discontinue and refer to specialist if papilledema or hearing disturbances occur. Discontinue if visual difficulties, severe skin reactions (eg, SJS, TEN), pancreatitis or hepatitis symptoms, abdominal pain, rectal bleeding, severe diarrhea, or uncontrolled hypertriglyceridemia occur. History of osteoporosis conditions (eg, osteomalacia, anorexia nervosa), fractures, or other bone metabolism disorders. Monitor bone growth, glucose, CPK, LFTs (at baseline, then periodically). Do not donate blood during and for 1 month after therapy. Aspirin hypersensitivity. Reduced tolerance to contact lenses. Max 1/℞. Nursing mothers: not recommended (during and ≥8 days after the last dose).
Mean Tmax: 6.4 hours under fed conditions; 2.9 hours under fasting conditions.
Mean Tmax: 5 hours under fed conditions; 3.5 hours under fasting conditions.
Plasma protein bound: >99.9%.
Fecal, renal. Half-life: ~24 hours (32 mg), ~18 hours (40 mg).
Absorica Adverse Reactions
Absorica Clinical Trials
Absorica Patient Counseling