Each capsule contains:
Systemic treatment of nodulo-cystic and conglobate acne,
severe acne, acne which has not responded to adequate
course of systemic antibacterial or acne associated with
Isotretinoin is an oral drug used for the treatment and
prevention of severe acne.
Acne is caused by inflammation of the skin. It
primarily affects teenagers, but it also affects adults.
Severe acne causes permanent scarring of the skin. The
inflammation is caused in part by an increased secretion
of sebum (oily substance) from glands in the skin
(sebaceous glands). The sebum provokes inflammation, and
the inflammation resolves (heals) with the formation of
a scar (keratinization). The exact mechanism of action
of isotretinoin is not known; however, it may reduce
acne by reducing the secretion of sebum. If less sebum
is secreted it is likely that there will be less
inflammation and keratinization.
Most adverse effects resemble vitamin A toxicity.
Adverse drug reactions
associated with isotretinoin therapy include:
Common: mild acne flare, dryness of skin, lips and
itch, skin fragility, skin peeling, rash, flushing,
dry eyes, eye irritation,
reduced tolerance to
headaches, hair thinning,
The following adverse effects have been reported to
persist, even after discontinuing therapy:
(hair loss), arthralgias, decreased night vision,
disease and depression (in some cases). High dosages of
isotretinoin have been reported to cause
disease of severe facial skin redness and irritation).
supplements have been advocated by some to reduce the
toxicity of high-dose retinoids without reducing drug
efficacy, it does not appear to be effective.
Patients receiving isotretinoin therapy are not
permitted to donate
blood during and for at least one month
after discontinuation of isotretinoin therapy.
Adults: Initially 500 mcg/kg daily (in 1-2 divided
doses) with food, for 4 weeks. If good response,
continue for further 8-12 weeks; if little response
increase to 1 mg/kg daily 8-12 weeks. If intolerant,
reduce dose to 100-200 mcg/kg daily. Usually given for
16 weeks, repeat course is not normally required.
Children: Not recommended.