Clindovit^® (Gel) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Contact Information

AKRIKHIN JSC (Russia)

ATC Code

D10AF01 (Clindamycin)

Active Substance

Clindamycin (Rec.INN registered by WHO)

Dosage Form

Clindovit®

Gel for external use 1%: tube 30 g

Dosage Form, Packaging, and Composition

Gel for external use 1% colorless, almost transparent, with a specific odor; the presence of opalescence is allowed.

Excipients : methylparahydroxybenzoate (nipagin), allantoin, disodium lauriminodipropionate tocopheryl phosphate, propylene glycol, macrogol 400 (polyethylene oxide 400), carbomer copolymer, carbomer interpolymer, sodium hydroxide, purified water.

30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic of the lincosamide group

Pharmacotherapeutic Group

Antibiotic-lincosamide

Pharmacological Action

Antibiotic from the lincosamide group.Active against all strains of Propionibacterium acnes, MIC – 0.4 µg/ml.

It inhibits protein synthesis in the microbial cell by interacting with the 50S ribosomal subunits.

Clindamycin phosphate is not active 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. After application to the skin, the amount of free fatty acids on the skin surface decreases from approximately 14% to 2%.

Pharmacokinetics

After application to the skin, Clindamycin quickly accumulates in the comedones of patients with acne, where it exhibits antibacterial activity. The average concentration of the antibiotic in the contents of comedones after gel application significantly exceeds the MIC for all strains of Propionibacterium acnes, the causative agent of acne.

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

Indications

• Treatment of acne vulgaris.

ICD codes

Dosage Regimen

Use the gel externally only.

Cleanse and thoroughly dry the affected skin area before each application.

Apply a thin layer of gel to the affected skin two to three times daily.

Avoid contact with eyes, lips, and mucous membranes.

Wash hands immediately after applying the gel.

Continue treatment for 6 to 8 weeks to achieve the full therapeutic effect.

If necessary, treatment can be extended for up to 6 months under medical supervision.

Discontinue use and consult a physician if severe skin irritation occurs.

Do not apply to broken or severely inflamed skin without medical advice.

Adverse Reactions

The drug is usually well tolerated.

Local reactions possible irritation (at the application site), burning, itching, dry skin, erythema, peeling, increased sebum secretion, contact dermatitis.

Systemic reactions: pseudomembranous enterocolitis (the likelihood of development exists with systemic absorption of clindamycin).

Contraindications

• Crohn’s disease;
• Ulcerative colitis (including history);
• Pseudomembranous colitis (including history);
• Hypersensitivity to clindamycin or lincomycin.

Use with caution in patients under 12 years of age (data on safety and efficacy are lacking), during lactation (breastfeeding), as well as in patients predisposed to the development of allergic reactions, and with the simultaneous use of muscle relaxants.

Use in Pregnancy and Lactation

Clindovit^® can be used externally during pregnancy if the intended therapeutic benefit for the mother outweighs the potential risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Pediatric Use

Use with caution in patients under 12 years of age (data on safety and efficacy are lacking).

Special Precautions

When using the drug, contact with the eyes and oral cavity should be avoided, and hands should be washed after applying the gel.

Overdose

There is no information on overdose with Clindovit^®.

Drug Interactions

Clindamycin and erythromycin are antagonists, so the simultaneous administration of these antibiotics is not recommended.

There is cross-resistance between clindamycin and lincomycin.

Clindamycin may enhance the effect of muscle relaxants by impairing neuromuscular transmission.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.