AO14's Educational Thread on Accutane
ISOTRETINOIN (13-cis-RETINOIC ACID)
(eye-soe-tret′i-noyn)
Accutane, Claravis
Classifications: SKIN & MUCOUS MEMBRANE AGENT; ANTIACNE (RETINOID); RETINOID
Pregnancy Category: X
Availability
10 mg, 20 mg, 40 mg capsules
Actions
Highly toxic metabolite of retinol (vitamin A). Principal actions: regulation of cell (e.g., epithelial) differentiation and proliferation and of altered lipid composition on skin surface.
Therapeutic Effects
Decreases sebum secretion by reducing sebaceous gland size; inhibits gland cell differentiation; blocks follicular keratinization. Has antiacne properties and may be used as a chemotherapeutic agent for epithelial carcinomas.
Uses
Treatment of severe recalcitrant cystic or conglobate acne in patient unresponsive to conventional treatment, including systemic antibiotics.
Unlabeled Uses
Lamellar ichthyosis, oral leukoplakia, hyperkeratosis, acne rosacea, scarring gram-negative folliculitis; adjuvant therapy of basal cell carcinoma of lung and cutaneous T-cell lymphoma (mycosis fungoides); psoriasis; chemoprevention for prostate cancer.
Contraindications
Pregnancy (category X); sensitivity to parabens (preservatives in the formulation), lactation.
Cautious Use
Coronary artery disease; diabetes mellitus; obesity; alcoholism; rheumatologic disorders; history of pancreatitis, hepatitis; retinal disease; elevated triglycerides.
Route & Dosage
Cystic Acne
Adult: PO 0.5–1 mg/kg/d in 2 divided doses (max: recommended dose 2 mg/kg/d)
Administration
Oral
Give with or shortly after meals.
Reassess regimen after 2 wk of treatment and dose adjusted as warranted.
Note: A single course of therapy provides adequate control in many patients. If a second course is necessary, it is delayed at least 8 wk because improvement may continue without the drug.
Store in tight, light-resistant container. Capsules remain stable for 2 y.
Adverse Effects (≥1%)
Body as a Whole: Most are dose-related (i.e., occurring at doses >1 mg/kg/d), reversible with termination of therapy. CNS: Lethargy, headache, fatigue, visual disturbances, pseudotumor cerebri, paresthesias, dizziness, depression, psychosis, suicide (rare). Special Senses: Reduced night vision, dry eyes, papilledema, eye irritation, conjunctivitis, corneal opacities. GI: Dry mouth, anorexia, nausea, vomiting, abdominal pain, nonspecific GI symptoms, acute hepatotoxic reactions (rare), inflammation and bleeding of gums, increased AST, ALT, acute pancreatitis. Hematologic: Decreased Hct, Hgb, elevated sedimentation rate. Musculoskeletal: Arthralgia; bone, joint, and muscle pain and stiffness; chest pain, skeletal hyperostosis (especially in athletic people and with prolonged therapy), mild bruising. Skin: Cheilitis, skin fragility, dry skin, pruritus, peeling of face, palms, and soles; photosensitivity (photoallergic and phototoxic), erythema, skin infections, petechiae, rash, urticaria, exaggerated healing response (painful exuberant granulation tissue with crusting), brittle nails, thinning hair. Respiratory: Epistaxis, dry nose. Metabolic: Hyperuricemia, increased serum concentrations of triglycerides by 50% –70%, serum cholesterol by 15%–20%, VLDL cholesterol by 50–60%, LDL cholesterol by 15%–20%.
Interactions
Drug: VITAMIN A SUPPLEMENTS increase toxicity.
Pharmacokinetics
Absorption: Rapid absorption after slow dissolution in GI tract; 25% of administered drug reaches systemic circulation. Peak: 3.2 h. Distribution: Not fully understood; appears in liver, ureters, adrenals, ovaries and lacrimal glands. Metabolism: Metabolized in liver; enterohepatically cycled. Elimination: Excreted in urine and feces in equal amounts. Half-Life: 10–20 h.
Assessment & Drug Effects
Lab tests: Determine baseline blood lipids at outset of treatment, then at 2 wk, 1 mo, and every month thereafter throughout course of therapy; liver function tests at 2- or 3-wk intervals for 6 mo and once a month thereafter during treatment.
Report signs of liver dysfunction (jaundice, pruritus, dark urine) promptly.
Monitor closely for loss of glycemic control in diabetic and diabetic-prone patients.
Note: Persistence of hypertriglyceridemia (levels above 500–800 mg/dL) despite a reduced dose indicates necessity to stop drug to prevent onset of acute pancreatitis.
Patient & Family Education
Maintain drug regimen even if during the first few weeks transient exacerbations of acne occur. Recurring symptoms may signify response of deep unseen lesions.
Discontinue medication at once and notify physician to rule out benign intracranial hypertension if visual disturbances occur along with nausea, vomiting, and headache.
Note: Visual disturbances may also signify development of corneal opacities, which should be ruled out by ophthalmic examination. Discontinue drug if corneal opacities are present. Return for a follow-up examination.
Rule out pregnancy within 2 wk of starting treatment. Use a reliable contraceptive 1 mo before, throughout, and 1 mo after therapy is discontinued.
Reduce weight and restrict alcohol and dietary fat intake as prophylactic measures against development of hypertriglyceridemia.
Do not self-medicate with multivitamins, which usually contain vitamin A. Toxicity of isotretinoin is enhanced by vitamin A supplements.
Avoid or minimize exposure of the treated skin to sun or sunlamps. Photosensitivity (photoallergic and phototoxic) potential is high; risk of skin cancer may be increased by this drug. Notify physician of abdominal pain, rectal bleeding, or severe diarrhea, which are possible symptoms of drug-induced inflammatory bowel disease. Drug treatment will be discontinued.
Keep lips moist and softened (use thin layer of lubricant such as petroleum jelly); dry mouth and cheilitis (inflamed, chapped lips), frequent adverse effects of isotretinoin, are distressing and are potential preconditions to infections.
Notify physician of joint pain, such as pain in the great toe (symptom of gout and hyperuricemia).
Do not share drug with friend(s) because it is associated with adverse effects that necessitate medical supervision.
Do not breast feed while taking this drug.
My Experience with Accutane: Now most members on this board say that this drug is too Potent, indeed it is, but not as HARSH as others make it out to be. I hope members on this board that have had acne before or if acne was introduced because of steroids learn that this is the BEST drug for almost curing acne. Currently I am on a 20 week cycle at 80mgs/ed(40mg morn./40mg at night). I am on week 6 and boy the results are AMAZING, and thats because its supposed to make your acne worse from weeks 4-6, my whole face is smooth like a baby but still a lil red, but nothing like before. I love this drug. If you have acne and tried numerous products like proactiv, chemical peels, retien-a, b-5, etc. if they havent worked then i seriously recommend looking up a DERM in your area and paying them a visit. I advise you to become educated on this drug(ie dosages, length of therapy, side effects, etc.). I hope this thread helps members and visitors alike that your acne can be treated successfully with this drug. BEST of luck to the members on this board and visitors as well, hopefully my post gave you an idea on how to make this drug work for you.
