Aknil Gel(Isotretinoin 0.05% w/w)
Therapeutic Group: Topical Retinoid
Presentation
Aknill Gel: Each gram gel contains Isotretinoin USP 0.5 mg
Description
Isotretinoin is structurally and pharmacologically related to vitamin A which regulates epithelial cell growth and differentiation. Isotretinoin has topical anti-inflammatory actions. Topically applied Isotretinoin inhibits leukotriene-B4 induced migration of polymorphonuclear leukocytes which accounts for topical Isotretinoin's anti-inflammatory action.
Indications
For the treatment of mild to moderate inflammatory and non-inflammatory acne vulgaris.
Dosage & Administration
Adolescents & Adults: Apply once or twice daily, preferably after washing and drying the skin.
Patients should be advised that 6-8 weeks of treatment may be required before the full effect is observed.
Use in Children: The safety and efficacy of topical Isotretinoin in children prior to puberty have not been established, therefore Isotretinoin is not recommended for use in this population.
Use in the Elderly
There is no specific recommendation as acne vulgaris is rarely present in the elderly.
Side Effects
Local skin reaction, e.g. stinging, burning, redness, irritation at site of application. Increased sensitivity of skin to sunlight.Skin peeling.
Precautions
This preparation is for external use only.Avoid contact of this medicine with the eyes, mouth, mucous membranes (e.g. linings of the nose) and broken areas of skin or areas affected by eczema.If you experience severe redness, peeling, or severe irritation of the skin you should apply for this medicine less frequently or stop using it temporarily. If the irritation persists you should stop using the medicine completely and consult your doctor
Use in Pregnancy & Lactation
Topical Isotretinoin is not given in pregnancy. While using the Isotretinoin gel, an effective method of contraception should be used to prevent pregnancy. Treatment should be discontinued for one cycle prior to intended conception. There is insufficient information on the excretion of topically applied isotretinoin in human milk. So, breastfeeding should be stopped while using the gel.
Drug Interaction
Concomitant application of oxidizing agents, such as benzoyl peroxide should be avoided since they may reduce the efficacy of topical isotretinoin. If combination therapy is required the products should be applied at different times of the day (e.g. one in the morning and the other in the evening).
Storage
Do not store above 30 o C. Keep away from light and out of the reach of children.
Commercial Pack
Aknill Gel: Each alumunium tube contains 10 gm gel.