Retigel Topical Gel 0.05%

Retigel Topical Gel 0.05% Uses, Dosage, Side Effects, Food Interaction and all others data.

Trade Name Retigel Topical Gel 0.05%
Generic Isotretinoin (Topical)
Weight 0.05%
Type Topical Gel
Therapeutic Class Topical retinoid and related preparations
Manufacturer UniMed UniHealth Pharmaceuticals Ltd.
Available Country Bangladesh
Last Updated: October 19, 2023 at 6:27 am
Retigel Topical Gel 0.05%
Retigel Topical Gel 0.05%

Uses

Isotretinoin topical gel is indicated for the treatment of mild to moderate inflammatory and non-inflammatory acne vulgaris.

Dosage

Retigel Topical Gel 0.05% dosage

Apply Isotretinoin 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 therapeutic effect 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.

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.

Precaution

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.

Interaction

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.

Pregnancy & Breastfeeding use

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 0.05% gel is negligible. It is not known, however, whether Isotretinoin is excreted in human milk. Isotretinoin should not be used during lactation.

Contraindication

Isotretinoin 0.05% gel is contra-indicated in patients with known hypersensitivity to Isotretinoin.

Acute 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.

Storage Condition

Store in a cool and dry place, protected from light.

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