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Each capsule contains
Composition
Isotretinoin ..................................................20
mg
Indications
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 psychological problems.
Description
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.
Adverse effects
Most adverse effects resemble vitamin A toxicity. Adverse drug
reactions associated with isotretinoin therapy include:
Common: mild acne flare, dryness of skin, lips and mucous
membranes, cheilitis, itch, skin fragility, skin peeling, rash,
flushing, photosensitivity, nose bleeds, dry eyes, eye irritation,
conjunctivitis, reduced tolerance to contact lenses,
hyperlipidaemia, raised liver enzymes, headaches, hair thinning,
myalgia and/or arthralgia.
The following adverse effects have been reported to persist, even
after discontinuing therapy: alopecia (hair loss), arthralgias,
decreased night vision, degenerative disc disease, keloids, bone
disease and depression (in some cases). High dosages of
isotretinoin have been reported to cause rosacea (a disease of
severe facial skin redness and irritation).
While vitamin E 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.
Dosage
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.
Presentations
10 caps.
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Quality
