Clenzit (Gel) Instructions for Use

ATC Code

D10AX30 (Other combined drugs for the topical treatment of acne)

Active Substances

Clindamycin (Rec.INN registered by WHO)

Adapalene (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antibacterial and comedolytic action for the treatment of acne

Pharmacotherapeutic Group

Remedy for acne

Pharmacological Action

Adapalene – a retinoid metabolite that acts on the pathological mechanism of Acne vulgaris development, is a potent modulator of cellular differentiation and keratinization, and possesses comedolytic and anti-inflammatory activity.

The mechanism of action of adapalene is based on interaction with specific γ-receptors of skin epidermal cells. As a result of adapalene’s action, the ‘cohesiveness’ of epithelial cells in the sebaceous hair follicle orifice decreases and the formation of microcomedones is reduced. Adapalene exerts an anti-inflammatory effect in vivo and in vitro by acting on inflammatory factors through inhibition of leukocyte migration to the inflammation site, suppresses the chemotactic and chemokinetic responses of human polymorphonuclear leukocytes, and suppresses the metabolism of arachidonic acid to inflammatory mediators, AP-1 factors, and the expression of Toll-like receptors 2.

Clindamycin phosphate is inactive in vitro, but after application to the skin, it is rapidly hydrolyzed by phosphatases in the sebaceous gland ducts to form clindamycin, which has antibacterial activity. The sensitivity of all tested strains of Propionibacterium acnes to clindamycin in vitro has been demonstrated (MIC 0.4 µg/ml).

After application of clindamycin to the skin, the amount of free fatty acids on the skin surface decreases from approximately 14% to 2%.

Pharmacokinetics

Adapalene

The absorption of adapalene through the skin is very low (about 4% of the applied dose). Excretion from the body occurs mainly through bile.

Clindamycin

After topical application of 1% clindamycin phosphate gel, very low concentrations of clindamycin are detected in blood serum and urine.

The activity of clindamycin in comedones of patients with acne vulgaris has been demonstrated. The average concentration of the antibiotic in comedone contents after application of a clindamycin solution in isopropyl alcohol and water (10 mg/ml) for 4 weeks averaged 597 µg/g of comedone contents (0-1490 µg/g).

Pharmacokinetics in special patient groups

Clinical trials did not include a sufficient number of patients aged over 65 years to assess whether there are differences in pharmacokinetics in elderly patients compared to younger ones.

Indications

• Acne.

Consult a doctor before use.

ICD codes

Dosage Regimen

Gel

The drug is for external use. Before applying Clenzit-C gel, cleanse and dry the skin. Apply the gel lightly and evenly to the affected areas of the skin once a day before bedtime, avoiding contact with the eyes and lips.

The therapeutic effect develops after 1-4 weeks. The course of therapy is 2-4 weeks. Sustained improvement occurs after 3 months of treatment. Repeat courses of treatment – after consultation with a doctor.

The drug should be used only according to the method of application and in the doses indicated in the instructions for use. Excessive application of the gel does not lead to a faster onset of the positive effect.

Adverse Reactions

Clenzit-C is usually well tolerated. When using the drug, adverse reactions characteristic of individual components may develop.

Adapalene

Adapalene may cause the following undesirable drug reactions

* Post-marketing surveillance data.

Most cases of ‘application site burn’ were superficial burns, but there are also reports of second-degree burns or severe burn reactions.

Clindamycin

* Adverse reactions reported during post-marketing use of the drug.

If any of the side effects mentioned in the instructions worsen or any other side effects not listed in the instructions are noted, the patient should immediately inform the doctor.

Contraindications

• Hypersensitivity to adapalene, clindamycin or lincomycin in the anamnesis or to any of the excipients;
• Pregnancy;
• Breastfeeding period;
• In patients with a history of antibiotic-associated colitis;
• Age under 12 years (data on safety and efficacy are lacking).

With caution dermatitis, eczema, allergic diseases, simultaneous use of muscle relaxants.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and breastfeeding.

Pediatric Use

The use of the drug is contraindicated in children under 12 years of age.

Special Precautions

At the initial stages of treatment, an exacerbation of acne may be observed, which disappears during the course of treatment.

If a hypersensitivity reaction or severe skin irritation is suspected, the use of the drug should be discontinued.

In some cases, depending on the degree of skin irritation, the frequency of application may be reduced or treatment suspended until the signs of irritation disappear. Resumption of treatment is possible after consultation with a doctor.

Avoid contact of the gel with the eyes, oral cavity, nasal cavity, and other mucous membranes. Wash hands thoroughly after applying the gel. The drug should not be applied to skin damaged by trauma (cuts or abrasions), sunburn, or eczematous skin. If the drug accidentally gets into the eyes, mouth, nose, or skin abrasions, rinse immediately with plenty of warm water.

Avoid excessive exposure to sunlight or ultraviolet radiation. In case of prolonged sun exposure, do not apply the gel the day before, on the day of sun exposure, and the following day.

Simultaneous use of peeling cosmetics, abrasive cleansers, as well as agents with drying, astringent, or irritating effects (for example, cologne, perfume, and other ethanol-containing products) is not recommended.

Cases of diarrhea and colitis with topical use of clindamycin are extremely rare; nevertheless, caution should be exercised, and if severe or prolonged diarrhea develops, the drug should be discontinued and, if necessary, appropriate diagnostic and therapeutic measures should be taken. Pseudomembranous colitis can occur both during long-term use and 2-3 weeks after cessation of treatment; it manifests as diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by blood and mucus in the stool). In mild cases of these phenomena, it is sufficient to discontinue treatment and use ion-exchange resins (cholestyramine, colestipol); in severe cases, replacement of fluid, electrolyte, and protein losses is indicated, and oral vancomycin or metronidazole is prescribed. Drugs that inhibit intestinal peristalsis should not be used.

Clenzit-C gel contains methylparahydroxybenzoate, which may cause allergic reactions during or after treatment, and propylene glycol, which may have an irritating effect on the skin.

Effect on ability to drive vehicles and operate machinery

There is no reason to believe that the use of Clenzit-C may affect the ability to drive a car and operate machinery.

Overdose

Symptoms

Adapalene. Excessive application of the drug to the skin will not lead to faster results or a more pronounced effect; however, it may cause redness, scaling, or discomfort.

Clindamycin . With topical application, clindamycin can be absorbed in amounts that cause systemic effects. Possible systemic side effects include diarrhea, including pseudomembranous colitis.

Treatment

In case of overdose, symptomatic and supportive therapy is indicated. In case of accidental ingestion of the drug, gastric lavage should be performed and a doctor should be consulted immediately.

Drug Interactions

Studies of interaction with other medicinal products have not been conducted.

Adapalene

Nevertheless, other topical retinoids or antibiotics, or drugs with a similar mechanism of action should not be used simultaneously.

Caution should be exercised when using cosmetics with exfoliating, irritating, or drying effects simultaneously due to the possible additional irritating effect.

The absorption of adapalene through the skin is low, so the development of interactions with systemic drugs is unlikely.

Clindamycin

After topical application of clindamycin, very low concentrations of clindamycin are detected in blood serum and urine. There is cross-resistance of microorganisms to clindamycin and lincomycin. Antagonism between clindamycin and erythromycin has been noted. Simultaneous administration with drugs containing erythromycin is not recommended.

It has been established that clindamycin impairs neuromuscular transmission and, therefore, may enhance the effect of other peripheral muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature between 2°C (35.6°F) and 25°C (77°F).

Shelf Life

The shelf life is 2 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.