Treclin

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TRECLIN

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COMPOSITION

COMPOSITION

Treclin Gel

Each 1 gm contains:
Tretinoin - 0.025%
Clindamycin - 1.0%

DESCRIPTION

Treclin Gel contains clindamycin phosphate USP, which is a water soluble ester of semi synthetic antibiotic produced by 7(S)- chloro-substitution of 7(R)- hydroxyl group of parent antibiotic lincomycin.

Tretinoin is all-trans-retinoic acid. It is a member of the retinoid family of compounds, and a metabolite of naturally occurring Vitamin A.

HIGHLIGHTS (USPs) *

Innovative topical combination in the treatment of mild to moderate acne
Works faster in resolution of symptoms of acne
Greater reduction of inflamed acne lesions
Less development of resistance of clindamycin
Decrease in irritation caused by tretinoin
Increase Patient compliance

CLINICAL PHARMACOLOGY

Clindamycin inhibits bacteria protein synthesis by binding to the 50S ribosomal sub-unit and affecting the process of peptide chain initiation. In vitro studies indicated that clindamycin inhibited all tested Propionibacterium acnes cultures at a minimum inhibitory concentration (MIC) of 0.4 μg/ml.

Although the exact mode of action of tretinoin is unknown it is suggested that topical tretinoin decreases cohesiveness of follicular epithelial cells thereby decreasing comedone formation. Tretinoin also increases the turnover rate of thin, loosely-adherent corneocytes (skin cells). This causes extrusion of the comedones.

INDICATIONS AND USAGE

Treclin Gel is indicated for topical application in the treatment of acne vulgaris. or as indicated by the physician.

CONTRAINDICATIONS

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components or lincomycin or in patients with a history of regional enteritis or ulcerative colitis, or a history or antibiotic-associated colitis.

PRECAUTIONS

Treclin should be prescribed with caution in atopic individuals. Tretinoin may lead to may excessively dry, red, swollen, or blistered skin in certain individuals.. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established.

Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of tretinoin and patients with sunburn should be advised not to use the product until fully recovered.

Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.

Tretinoin should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes.

Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Drug Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.

Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect. Particular caution
should be exercised with the concomitant use of topical preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid tretinoin gel.

Pregnancy

There are no adequate and well-controlled studies in pregnant women on the use of clindamycin and tretinoin. Treclin gel should not be used during pregnancy.

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

Tretinoin may lead to may excessively dry, red, swollen, or blistered skin in certain individuals. True contact allergy to tropical tretinoin is rarely encountered.
Temporary hyper or hypo pigmentation has been reported with repeated applications of tretinoin gel.
Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin gel.
Adverse effects of tretinoin gel have been reversible upon discontinuation of therapy.

DOSAGE AND ADMINISTRATION

Apply a thin film of Treclin once daily in the treatment of mild to moderate acne, preferably in the evening.

OVERDOSAGE

Overuse of tretinoin may lead to marked redness, peeling of the skin.

1. What is Treclin Gel?
A: It is a combination of Tretinoin, which belong to the class of drugs called retinoids, and Clindamycin an antibiotic for topical application for acne vulgaris.

2. What is the active ingredient?
A: Tretinoin - 0.025% w/w
Clindamycin - 1% w/w

3. How is it available?
A: Treclin is available in gel form in a tube of 10 gm.

4. What are its indications or uses?
A: Treclin gel is indicated for topical application in the treatment of Acne
vulgaris.

5. What is the right dosage?
A: A thin layer of Treclin gel is to be applied once daily on the skin where acne
lesions appear, preferably in the evening.

6. What is to be done in case of a missed dosage?
A: If you missed a dose then skip the missed dose and continue your regular
dosing schedule. Do not take a double dose to make up for a missed one.

7. What are the precautions while taking the Treclin?
A: Unprotected exposure to sunlight, including sunlamps, should be minimized
Patients with sunburn should be not use the product until fully recovered.
Weather extremes, such as wind or cold, also may be irritating to patients under treatment with Treclin.
Treclin should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes.
Should be used in pregnant and nursing mothers only if required or as directed by the physician.

8. Which drugs should be avoided along with Treclin?
A: Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents.
Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin.
Particular caution should be exercised with the concomitant use of topical preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid.

9. Who cannot take the medicine?
A: Children below 12 years of age
History of hypersensitivity to preparations containing clindamycin or
lincomycin or tretinoin.

10. What is the time of taking the medicine, dosage and the usual duration?
A: A thin layer of Treclin is to be applied topically on acne lesions at night or as directed by physician.

11. What are the possible common and rare adverse effects of the medicine?
A: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate.
Temporary hyper- or hypopigmentation has been reported with repeated application.
Some individuals have been reported to have increased susceptibility to sunlight while under treatment.
To date, all adverse effects of tretinoin have been reversible upon discontinuation of therapy.

12. How to store the Treclin Gel?
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

13. What is the Price per unit?
A: Treclin Gel 10 gm Tube - Rs. 50/-