Generic Name and Formulations:
Isotretinoin 10mg, 20mg, 25mg+, 30mg, 35mg, 40mg; caps; contains soy, + tartrazine.
Ranbaxy Pharmaceuticals, Inc.
Indications for ABSORICA:
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 ≥8 weeks after completing first course.
Swallow caps with a full glass of liquid. 0.5–1mg/kg per day in 2 divided doses; treat for 15–20 weeks or less if nodule count reduced by >70%; max 2mg/kg per day.
Do not substitute with other forms of isotretinoin. Must register patient in iPLEDGE program (see full labeling for restrictions and stipulations on use). Be fully familiar with drug's toxicity before use. Counsel patient about need for contraception; obtain 2 negative pregnancy tests prior to initiation of drug and monthly thereafter; 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 initially and weekly or biweekly for 1st 4 weeks. History of psychiatric disorders; monitor and discontinue if signs and 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. Osteoporosis risk (eg, osteomalacia, anorexia nervosa) or risk of metabolic bone disorders. Monitor bone growth, glucose, sed rate, CBCs, LFTs (weekly or biweekly). Do not donate blood during and for 1 month after therapy. Aspirin hypersensitivity. Reduced tolerance to contact lenses. Max 1/℞. Nursing mothers: not recommended.
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) may provide inadequate contraception. Caution with drugs that can disturb bone metabolism (eg, anticonvulsants, systemic corticosteroids).
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, blood dyscrasias, glucose intolerance, palpitation, thrombotic disease.
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Adjunctive Therapies for Bipolar Disorder Show Promise, Need More Evidence
- Improving Performance of Everyday Activities Is Critical in Schizophrenia
- Analysis Finds Lithium Maintenance Most Effective as Monotherapy in Bipolar Disorder
- Web-Based Intervention Targets Parental Behaviors That May Affect Adolescent Anxiety, Depression
- Abnormalities of Cortical Thickness in Bipolar Disorder With Auditory Hallucinations
- The Way to the Head May Be Through the Gut: Probiotics for Depression
- Suicide-Screening Toolkit Can Help Identify Youths at High Risk for Suicide
- Agoraphobia: An Evolving Understanding of Definitions and Treatment
- Parental Pressure to Diet Linked With Long-term Harm in Adolescents
- Does Access to Medical Cannabis Reduce Risk for Opioid Abuse?
- Antidepressants Increase Seizure Risk in Youth and Severely Depressed
- Examining Associations Between Diabetes and Effects on Cognition
- Untreated Depression Common in Women of Childbearing Age
- Incidence of Psychiatric Disorders in Rheumatoid Arthritis
- Effect of Antidepressant Class, Dose on Pediatric Anxiety Disorders