Pharmalene

Each gram of gel contains: Adapalene 1 mg.

Pharmacology: The chemical name of Adapalene is 6-[3-(1-Adamantyl)-4-Methoxyphenyl]-2-Naphthoic Acid. Adapalene is a chemically stable compound with Retinoid-like pharmacological activity. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a potent modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.
Mechanistically, Adapalene binds to specific Retinoid acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of Adapalene is unknown, it is indicated that topical Adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Pharmacokinetics: Adsorption of Adapalene through human skin is low. Excretion is primarily by the biliary route.

Pharmalene is used topically for the treatment of acne vulgaris.

Pharmalene should be applied to affected areas of the skin, once daily in the evening before bedtime and after washing. A thin film of Pharmalene should be applied, avoiding the eyes, lips, and mucous membranes. If product enters the eye wash immediately with warm water. Ensure that the affected areas are dry before application.
During the early weeks of therapy with Adapalene, an apparent exacerbation of acne may occur. This effects is attributable to the action of the drug on previously unseen lesions and should not be considered a reason to discontinue therapy.
Since it is customary to alternates therapies in the treatment of acne, it is recommended that the physician assess the continued improvement of the patient after 3 months of treatment with Pharmalene.
With patients for whom it is necessary to reduce the frequency of application or to temporarily discontinue treatment, frequency of application may be restored or therapy resumed once it is judged that the patient can again tolerate the treatment.
The product can be used within 60 days after opened.

Phamalene is for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur.
The acute oral toxicity of Adapalene 0.1 % in mice and rats is greater than 10 ml/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

Pharmalene should not be administered to the individuals who are hypersensitive to Adapalene or any of componentsof the products.

If patients use cosmetics, these should be a non-comedogenic and non-astringent.
Moisturizers may be used if necessary, however, products containing Alpha hydroxy or Glycolic acids should be avoided.
Depending upon the severity of side effects, patients should be instructed to reduce the frequency of application or discontinue use.
If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued.
Exposure to sunlight, including sunlamps, should be minimized during the use of Adapalene.
Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution.
Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.
Weather extremes, such as wind or cold, also may be irritating to patients under treatment with Adapalene.
Avoid contact with eyes, lips, angles of the nose, and mucous membranes.
Exposure of the eye this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.
The product should not be applied to cuts, abrasions, eczematous, or sunburned skin, nor should it be used in patients with severe acne, or acne involving large areas of the body.
Wax epilation should not be performed on treated skin due to the potential for skin erosions.
Adapalene did not exhibit mutagenic and genotoxic effects.
In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal modulas of male rats was observed.
Because of the risk of teratogenicity shown in animal studies and since there is no informations on the use of Adapalene in pregnant women, it should not be used in woman of childbearing age unless they are using an effective means of contraception.
This product should not be used during pregnancy, unless considered essential by the physician.
The preparation should be used with caution in nursing mothers.
Safety and effectiveness in pediatric below the age of 12 years have not been established.

Erythema, scaling, dryness, pruritus, burning/stinging, skin irritation, sunburn, and acne flare.
Those are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter.
All adverse effects with use of Adapalene 0.1 % were reversible upon discontinuation of therapy.

Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime rind) should be approached with caution.
Particular caution should be exercised in using preparations containing Sulfur, Resorcinol or Salicylic acid in combination with Pharmalene. If these preparation have been used, It is advisable not to start therapy with Pharmalene until the effects of such preparations in the skin have subsided.
Retinoids or drugs with a similar mode of action should not be used concurrently with Adapalene.

Store at temperature below 30°C, protect from light.

Acne Treatment Preparations

D10AD03 - adapalene ; Belongs to the class of topical retinoid preparations used in the treatment of acne.

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