Retigel Topical Gel 20gm
1 pcProduct Information
RETIGEL
Retigel®(Isotretinoin)
Presentation
Retigel gel : Yellowish gel; each gram gel contains Isotretinoin BP 0.5mg.
Indications
Treatment of mild to moderate inflammatory and non-inflammatory acne vulgaris.
Dosage and administration
Apply Retigel (Isotretinoin BP 0.05%) gel cautiously over the affected area once or twice daily. Patients should be advised that
6-8 weeks of treatment may be required before a therapeuticeffect is observed.
The safety and efficacy of Isotretinoin have not been established in children since acne vulgaris rarely present in this age
group. There are no specific recommendations for use in the elderly. Acne vulgaris does not present in the elderly.
Contra-indication, warnings etc.
Contra-indications: Isotretinoin BP 0.05% gel is contra-indicated in patients with known hypersensitivity to Isotretinoin.
Warning & precautions: Contact with the mouth, eyes and mucous membranes and with abraded or eczematous skin should be avoided.
Care should be taken not to let the medication accumulate in skin fold areas and in the angles of the nose. Application to
sensitive areas of skin, such as the neck, should be made with caution. Although Tretinoin has not been shown to initiate or
promote carcinogenesis in humans, Tretinoin applied topically to albino hairless mice had resulted in a dose-related acceleration
in ultraviolet-B radiation induced cutaneous tumours. The same author also observed the opposite effect in another study of low,
non-irritating concentrations of Tretinoin. The significance of these findings as related to man is unknown; however, caution
should be observed in patients with a personal or family history of cutaneous epithelioma. Exposure to sunlight of areas treated
with Isotretinoin should be avoided or minimised. When exposure to strong sunlight cannot be avoided a sunscreen product
and protective clothing should be used. Patients with sunburn should not use Isotretinoin due to the possibility of increased
sensitivity to sunlight. The use of sunlamps should be avoided during treatment.
Drug interactions: Concomitant topical medication should be used with caution during therapy with Isotretinoin. Particular caution
should be exercised when using preparations containing a peeling agent (for example Benzoyl Peroxide) or abrasive cleansers. Use
in pregnancy and lactation: Pregnancy Category B. There is inadequate evidence of the safety of topically applied Isotretinoin in
human pregnancy. Isotretinoin has been associated with teratogenicity in humans when administered systemically. Reproduction
studies conducted in rabbits using Isotretinoin applied topically at up to 60 times the human dose have, however, revealed no harm
to the foetus. The use of Isotretinoin should be avoided during pregnancy. Percutaneous absorption of Isotretinoin from
Isotretinoin BP 0.05% gel is negligible. It is not known, however, whether Isotretinoin is excreted in human milk. Isotretinoin
should not be used during lactation.
Side-effects: In normal use, Isotretinoin may cause stinging, burning or irritation; erythema and peeling at the site of
application may occur. If undue irritation occurs, treatment should be interrupted temporarily and resumed once the reaction
subsides. If irritation persists, treatment should be discontinued. Reactions will normally resolve on discontinuation of therapy.
Overdose: Acute overdosage of Isotretinoin has not been reported to date. Accidental ingestion of Isotretinoin resulting in
overdosage of Isotretinoin could be expected to induce symptoms of hypervitaminosis A. These include severe headaches, nausea or
vomiting, drowsiness, irritability and pruritus.
Pharmaceutical precautions
Store in a cool and dry place, protected from light.
Packaging quantity
Retigel Gel: Cartons containing 20gm gel in lami-tube.