Apalene C Gel

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APALENE C

For Doctors
For patients

ADAPALENE - 0.1% w/w
CLINDAMYCIN-1%
In an adequate gel base q.s.

Adapalene is naphthoic acid derivative with retinoid like activity,& clindamycin with antibacterial properties are used for the topical treatment of mild to moderate acne vulgaris.

HIGHLIGHTS (USPs)

Significantly larger and faster effect on acne lesions
Can be used at the onset of therapy
Better clinical response than that obtained by using the anti
biotic alone
Adapalene with significant anti-inflammatory effect enhances
the therapeutic action of clindamycin on inflammatory acne

CLINICAL PHARMACOLOGY

Biochemical and pharmacological profile studies have demonstrated that adapalene is a 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 retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased > microcomedone formation. Absorption of adapalene through human skin is low. Only trace amounts (<0.25 ng/mL) of parent substance have been found in the plasma of acne patients following chronic topical application of adapalene in controlled clinical trials. Excretion appears to be primarily by the biliary route.

Although clindamycin phosphate is inactive in vitro,rapid in vitro hydrolysis convert this compound to clindamycin which has antibacterial activity, Clindamycin inhibit bacterial protein synthesis by binding to the 50S ribosomal subunit & affecting the process of peptide chain initiation.

INDICATIONS AND USAGE

For topical treatment of comedon, papular and pustular acne of the face, chest or back or as indicated by physician.

CONTRAINDICATIONS

Apalene C Gel should not be administered to individuals who are hypersensitive to adapalene, clindamycin or any of the components in the vehicle gel.

PRECAUTIONS

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.

Apalene C Gel should not come into contact with the eyes, lips mouth and mucous membranes, angles of the nose or broken skin (cuts and abrasions). Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning or pruritus may be experienced during treatment. These are most likely to occur during the first two to four weeks and will usually lessen with continued use of the medication. Depending upon the severity of adverse events, patients should be instructed to reduce the frequency of application or discontinue use.

Drug Interactions

As Apalene C Gel has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Apalene C Gel. There are no known interactions with other medications, which might be used topically and concurrently with Apalene C Gel. However, other retinoids or drugs with a similar mode of action should not be used concurrently with adapalene.

Pregnancy

Pregnancy category C: There are no studies in pregnant Women. Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk.

Nursing Mothers

It is not known whether this drug is excreted in human milk hence caution should be exercised.

Pediatric Use

Safety and efficacy in children below the age of 12 years have not been studied.

ADVERSE REACTIONS

Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 10-40% of patients. Pruritus or burning immediately after application also occurs in approximately 20% of patients.

ADVERSE REACTIONS

Excellent allergological and cosmetological tolerance

DOSAGE AND ADMINISTRATION

A thin film of Apalene Gel should be applied to the affected areas once a day before bedtime and after washing avoiding the eyes, lips and mucousmembranes. The affected areas should be dry before application.

OVERDOSAGE

Apalene C Gel is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur.

PRESENTATION

Apalene C Gel is available in 15 gm tube.

1. What is Apalene C?
A: It contains adapelene, which belongs to the class of drugs called retinoid & Clindamycin is antibacterial, are topical used for the treatment of acne.

2. What is the active ingredient?
A: Apalene C Gel contains: Adapalene 0.1 % w/w & Clindamycin 1%

3. How is it available?
A: Apalene C is available in gel form in tube of 15 gm.

4. What are its indications or uses?
A: Apalene C gel is used for the topical treatment of mild to moderate acne vulgaris.

5. What is the right dosage?
A: Apply thin layer of Apalene C gel to the affected area(s) exactly as directed by your doctor. It is usually applied once a day, preferably at bedtime. Never use more than the prescribed dose.

6. What is to be done in case of a missed dosage?
A: If you miss a dose of Apalene C, skip the missed dose and go back to your regular dosing schedule. Do not double dose.

7. What are the precautions while taking the product?
A: Certain signs and symptoms such as erythema, dryness, scaling, burning, or pruritis may be experienced during treatment. These are most likely to occur during the first 2-4 weeks of treatment, are mostly mild to moderate in intensity, and will usually lessen with continued use of the medication.

Exposure to sunlight, including sunlamps, should be minimized during the use of Apalene C. 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 while under treatment with Apalene C.
Apalene C Gel should not come into contact with the eyes, lips, mouth and mucous membranes, angles of the nose or broken skin (cuts and abrasions).

8. Which drugs should be avoided along with it?
A: There are no known interactions with other medications, which might be used topically and concurrently with Apalene Gel. However, other retinoids or drugs with a similar mode of action should not be used concurrently with Apalene C. As Apalene C has the potential to produce local irritation in some patients,concomitant use of other potentially irritating topical products, such as medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime, should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Apalene C. If thesepreparations have been used, it is advisable not to start therapy with Apalene C until the effects of such preparations in the skin have subsided.

9. Who cannot take the medicine?
A: Pregnant Women and Nursing Mothers Children below 12 years of age

10. What is the time of taking the medicine, dosage and the usual duration?
A: Before applying, wash the affected area with a non-medicated soap and water or with a mild cleanser and then gently pat dry with a towel. A thin film of Apalene C Gel should be applied to the affected areas once a day before bedtime avoiding the eyes, lips and mucous membranes.

11. What are the possible common and rare adverse effects of the medicine?
A:Few of the most common side effects with this medicine include:

Rednes
Dryness
Peeling
Stinging

If you are experiencing darkening or lightening, severe burning, itching, crusting or swelling of the treated areas, talk to doctor immediately.

12. How to store the medicine?
A: Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed.