Isotretinoin

Indications
 Oral
Acne
Adult: Initially, 0.5-1 mg/kg daily in 2 divided doses. Usual duration of treatment: 15-20 wk; may be discontinued if number of cysts is reduced by >70% (whichever is sooner). Patients intolerant to initial dose: Continue treatment at a lower dose. Patients with very severe acne or acne evident on the body instead of face: Up to 2 mg/kg daily. There should be a 2-mth drug-free interval if a 2nd course is necessary.
Renal impairment: Dose reduction may be needed.
Hepatic impairment: Dose reduction may be needed.
Topical/Cutaneous
Acne
Adult: As 0.05% gel: Apply sparingly once or twice daily. Effect may not be evident for 6-8 wk.

Special Populations: Hepatic impairment: Dose reduction is recommended.
Contraindications
 Pregnancy, lactation.
Warnings / Precautions
 Preexisting or predisposition to hypertriglyceridaemia (e.g. DM, obesity or increased alcohol intake). Monitor triglyceride levels. Monitor blood lipids and LFTs at wkly or bi-wkly intervals. Monitor blood glucose in known or suspected DM patients. Genetic predisposition for age-related osteoporosis, history of childhood osteoporosis, osteomalacia or other bone metabolism disorders. Anorexia nervosa. History of psychiatric disorder. May impair night vision. Avoid wax epilation and skin resurfacing procedures for at least 6 mth. Avoid prolonged exposure to UV light or sunlight. Discontinue if hearing impairment, abdominal pain, rectal bleeding, severe diarrhoea or adverse ocular effects occur. Patient should not donate blood during therapy and for at least 1 mth following drug discontinuation.
Adverse Reactions
 Dryness of mucous membranes, dryness of skin with scaling, fragility, erythema, cheilitis, pruritus, epistaxis, conjunctivitis, dry sore mouth and palmo-plantar exfoliation. Corneal opacities, dry eyes, visual disturbances, skeletal hyperostosis and musculoskeletal symptoms. Elevation of serum triglycerides, LFTs, ESR and blood glucose. Hair thinning, photosensitivity, changes in skin pigmentation, paronychia. GI disturbances, hepatitis. Headache, drowsiness, sweating, mood changes, psychotic symptoms, depression, suicidal tendencies, benign intracranial hypertension, seizures. Vasculitis, hypersensitivity reactions, IBS.
Potentially Fatal: Anaphylaxis. Haemorrhagic pancreatitis.
Drug Interactions
 Additive toxicity with vitamin A or its derivatives. Decreased efficacy of microdosed progesterone (use 2 forms of contraception). May increase risk of bone loss with phenytoin. May increase risk of osteoporosis with systemic corticosteroids. Reduces plasma levels of carbamazepine.
Potentially Fatal: Increased risk of pseudotumor cerebri with tetracyclines.
See Below for More isotretinoin Drug Interactions
Food Interactions
 Avoid or limit ethanol intake. Avoid dong quai, St John's wort.
Mechanism of Actions
 Isotretinoin is a synthetic retinoid which reduces sebaceous gland size and sebum production. It also regulates cell proliferation and differentiation.
Absorption: Low oral bioavailability. Peak plasma concentrations in 1-4 hr (oral).
Distribution: Protein-binding: 99.9%, mainly to albumin.
Metabolism: Hepatic, via CYP450 isoenzyme pathway.
Excretion: Via urine and faeces.
Administration
 Should be taken with food.
Storage Conditions
 Oral: Store at 15-30°C (59-86°F). Topical/Cutaneous: Store below 25°C (77°F).
ATC Classification
 D10AD04 - isotretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Storage
 Oral: Store at 15-30°C (59-86°F). Topical/Cutaneous: Store below 25°C (77°F).
Available As
  • Isotretinoin 0.025%
  • Isotretinoin 0.05%
  • Isotretinoin 10 mg
  • Isotretinoin 20 mg
  • Isotretinoin 25 mg
  • Isotretinoin 30 mg
  • Isotretinoin 40 mg
  • Isotretinoin 5 mg

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