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.
MRP
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