• Acne

Absorica Generic Name & Formulations

General Description

Isotretinoin 10mg, 20mg, 25mg+, 30mg, 35mg, 40mg; hard gelatin caps; contains soy, + tartrazine.

Pharmacological Class


See Also

How Supplied


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


Severe recalcitrant nodular acne unresponsive to conventional therapy (eg, systemic antibiotics).

Limitations of Use

Do not initiate second course of therapy (only if necessary) until ≥2 months after completing first course.

Absorica Dosage and Administration


Do not substitute with other forms of isotretinoin. Swallow caps with a full glass of liquid. Give 0.5–1mg/kg/day in 2 divided doses; treat for 15–20 weeks or less if nodule count reduced by >70%; max 2mg/kg/day.


<12yrs: not established.

Absorica Contraindications


Pregnancy. Vitamin A allergy.

Absorica Boxed Warnings

Boxed Warning

Embryo-fetal toxicity.

Absorica 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).



Absorica Pharmacokinetics



  • 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.


Plasma protein bound: >99.9%.


Hepatic (CYP2C8, 2C9, 3A4, 2B6). 


Fecal, renal. Half-life: ~24 hours (32 mg), ~18 hours (40 mg). 

Absorica Interactions


Avoid tetracyclines (increased risk of pseudotumor cerebri), Vit. A, or alcohol consumption (for ≥36hrs before lipid test). Caution with concomitant phenytoin. Avoid St. John's wort with hormonal contraceptives. Low-dose progestin-only contraceptives (eg, minipills) provide inadequate contraception. Caution with drugs that can disturb bone metabolism (eg, anticonvulsants, systemic corticosteroids).

Absorica Adverse Reactions

Adverse Reactions

Dry lips, skin, and eyes, back pain, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, blood creatinine kinase increased, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, visual acuity reduced; auditory or lipid disturbances, skin reactions, pancreatitis, pseudotumor cerebri, hepatotoxicity, inflammatory bowel disease, psychiatric disorders, osteopenia, osteoporosis, hyperostosis, premature epiphyseal closure, reversible corneal opacities, decreased night vision, glucose intolerance.

Absorica Clinical Trials

See Literature

Absorica Note

Not Applicable

Absorica Patient Counseling

See Literature