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.
Psychiatry Advisor Articles
- ACOG Update: Marijuana Use Discouraged During Pregnancy, Breastfeeding
- Asenapine Prevents Recurrence of Mood Events in Bipolar Disorder
- Depression Profiles in Patients With Type 1 Diabetes vs Type 2 Diabetes
- No Evidence of Personality Changes Prior to Developing Cognitive Impairment, Dementia
- Retirement Saving Behavior Associated With Psychological Distress
- Suicidal Behavior, Thoughts Associated With Perfectionist Tendencies
- Physicians Spend Nearly 6 Hours on EHR Tasks Per Day
- CBT, Acceptance Commitment Therapy Helpful for Those With Chronic Pain
- Depression Reduced by Social Belonging, Feelings of Inclusion
- Sleep Disturbance May Be Causal Factor in Psychotic Experiences
- Venlafaxine XR Safe, Effective in Treating Generalized Anxiety Disorder
- Enhanced Vaccination Effectiveness in Older Adults Linked to Positive Mood
- Subjective Cognitive Decline Linked to Alzheimer Biomarker
- Unnecessary Costs Associated With Low-Cost, Low-Value Health Services
- Is Hypertension Linked to an Increased Risk of Dementia?