Absorica Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
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.
Absorica Indications
Indications
Limitations of Use
Absorica Dosage and Administration
Adult
Children
Absorica Contraindications
Contraindications
Absorica Boxed Warnings
Boxed Warning
Absorica Warnings/Precautions
Warnings/Precautions
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).
REMS
Absorica Pharmacokinetics
Absorption
Absorica:
-
Mean Tmax: 6.4 hours under fed conditions; 2.9 hours under fasting conditions.
Absorica LD:
-
Mean Tmax: 5 hours under fed conditions; 3.5 hours under fasting conditions.
Distribution
Plasma protein bound: >99.9%.
Elimination
Fecal, renal. Half-life: ~24 hours (32 mg), ~18 hours (40 mg).
Absorica Interactions
Interactions
Absorica Adverse Reactions
Adverse Reactions
Absorica Clinical Trials
See Literature
Absorica Note
Not Applicable
Absorica Patient Counseling
See Literature