Drug Interaction:
Increased irritation may result from concomittant use of potentially irritating topical products such as abrasive soaps, products with pronounced drying effect and those containing alcohol or astringents.
Caution to be excercised while using preparations containing sulfur, resorcinol, or salicylic acid in combination.
If these preparations have been used, it is advisable not to start therapy with until effects of such preparations in the skin have subsided.
Indication:
BRIEF SUMMARY
ADAPALENE -(Oct 2008)
Indn- For the treatment of Acne Vulgaris
Comp- Acne vulgaris After washing affected areas apply a thin film of adapalene 0.1% once a day before bedtime
ADR- Erythema, cutaneous dryness, sensations of stinging and burning and pruritus to be expected in 10 to 40% of the cases treated with formulations containing 0.1% of the drug.
CI- Hyperesensitivity
Special precautions-
Excessive exposure to sunlight or UV radiation should be avoided.Women of child bearing age should use an effective means of contraception while receiving the drug.The medicine should be kept away from the eyes, lips, nostrils, and mucous membranes
Pat Infn-
1. Medication is for external use only. 2. Avoid contanct with eyes, lips, angles, of the nose, and mucous membranes. Medication is for external use only 3. Cleanse area with a mild or soapless cleaner before applying this medication .4. Moisturizers may be used if necessary , however products containg alpha- hydroxy or glycolic acids should be avoided. 5. This medication should not be applied to cuts, abarasions, eczematous or sunburned skin.
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U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
229. Adapalene 0.1% 24-10-08
+Benzoyl Peroxide 2.5% gel
For the treatment of Acne Vulgaris
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Adapalene 0.1% + Benzoyl peroxide 2.5% Gel 24-10-2008
For the treatment of Acne Vulgaris
Adapalene 0.1% Clindamycin Phosphate eq to 01-05-2003
Clindamycin 10mg per Gel
For the treatment of acne vulgaris
Acne vulgaris
Adverse Reaction:
Mild skin irritation with formulations containing 0.03 or 0.1% of the drug.
Erythema, cutaneous dryness, sensations of stinging and burning and pruritus to be expected in 10 to 40% of the cases treated with formulations containing 0.1% of the drug.
Contra-Indications:
Hyperesensitivity
Special precautions:
Excessive exposure to sunlight or UV radiation should be avoided.
Women of child bearing age should use an effective means of contraception while receiving the drug.
The medicine should be kept away from the eyes, lips, nostrils, and mucous membranes
It should not be applied to cuts, abrasions, scaly or flaky skin, or patches of sunburned skins.
The extremes of winter weather, including high winds and cold tempuratures, can cause extra skin irritations and dryness.
Solution should be discontinued if hypersensitivity to any of the ingredients is noted. Safety and efficacy of drug in children less than than 12 years of age not established.
Dosages/ Overdosage Etc:
Indication-
Acne vulgaris
Dosage-
After washing affected areas apply a thin film of adapalene 0.1% once a day before bedtime.
Patient Information:
1. Medication is for external use only.
2. Avoid contanct with eyes, lips, angles, of the nose, and mucous membranes.
3. Cleanse area with a mild or soapless cleaner before applying this medication.
4. Moisturizers may be used if necessary , however products containg alpha- hydroxy or glycolic acids should be avoided.
5. This medication should not be applied to cuts, abarasions, eczematous or sunburned skin.
6.Wax epilation should not performed on treated skin due to potential for skin erosions.
7.During early weeks of therapy, an apparent exaccerbatioin of acne may occur. This is due to action of this medication on previuosly unseen lesions and should not be considered a reason to discontinue therapy.
Overal benefits may be seen after 2 weeks of therapy,but 8 weeks are required to beneficial results
Pharmacology/ Pharmacokinetics:
Pharmacology:
The drug binds to retionic acid receptors found predominantly in the terminal differentiation of epidermis. It is more active than tretinoin in modulating cellular differentiation. Adapalene inhibits cell proliferation and is similar to that of tretionin. Adapalene is > 3 times more active than tretionin in modulating cell differentiation - in vitro-.
Pharmacokinetics:
The release of adapalene assessed by diffusion through a siliastic membrane was greater from lotion and hydroalcoholic gel formulations than from aqueous gel and cream formiulations, 24 hours after topical application of radiolabelled adapalene to the skin of hairless animal model. Excretion appears to be primarily by the billiary route.
Pregnancy and lactation:
Women of child bearing age should use an effective means of contraception while receiving the drug.
Manufacturer Details