Clindacin^® (Cream, Suppositories) Instructions for Use

ATC Code

G01AA10 (Clindamycin)

Active Substance

Clindamycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic for topical use in gynecology

Pharmacotherapeutic Group

Antibiotic-lincosamide

Pharmacological Action

An antibiotic from the lincosamide group, it has a broad spectrum of antimicrobial activity.

The mechanism of action is due to binding to the 50 S subunit of the ribosomal membrane and suppression of protein synthesis in the microbial cell. It acts bacteriostatically. A bactericidal effect is possible against a number of gram-positive cocci.

Active againstStaphylococcus spp. (including Staphylococcus epidermidis, both penicillinase-producing and non-producing), Streptococcus spp. (excluding Enterococcus faecalis), Streptococcus pneumoniae, Corynebacterium diphtheriae, Mycoplasma spp., anaerobic and microaerophilic gram-positive cocci (including Peptococcus spp. and Peptostreptococcus spp.), Clostridium perfringens, Clostridium tetani, Bacteroides spp. (including Bacteroides fragilis and Prevotella melaninogenica), Fusobacterium spp., Propionibacterium spp., Eubacterium spp. and Actinomyces israelii.

Most strains of Clostridium perfringens are sensitive to clindamycin, but other species of Clostridium spp. (including Clostridium sporogenes, Clostridium tertium) are resistant to its action, therefore, in infections caused by Clostridium spp., it is recommended to determine the antibiogram.

There is cross-resistance between clindamycin and lincomycin.

Pharmacokinetics

After a single intravaginal administration of clindamycin at a dose of 100 mg, 4% of the administered dose undergoes systemic absorption. The C_max in plasma is 20 ng/ml.

Indications

• Bacterial vaginosis caused by microorganisms sensitive to the drug.

ICD codes

Dosage Regimen

Suppositories

Prescribed intravaginally, 1 suppository once/day immediately before bedtime, for 3-7 consecutive days.

Before use, one suppository is removed from the contour packaging by first cutting the film along the contour of the suppository, and inserted as deeply as possible into the vagina while lying down.

Cream

Administered intravaginally using an applicator.

The recommended single dose is 100 mg of clindamycin (one full applicator), preferably at bedtime for 3-7 days.

Adverse Reactions

From the reproductive system: cervicitis, vaginitis, vulvovaginal irritation.

From the hematopoietic organs: rarely – reversible leukopenia, neutropenia, eosinophilia, agranulocytosis, thrombocytopenia.

Allergic reactions: maculopapular rash, urticaria, itching.

Other: with systemic absorption, other systemic side effects are possible, including in rare cases – pseudomembranous enterocolitis.

Contraindications

• First trimester of pregnancy;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Intravaginal use of Clindacin^® during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. Clindamycin crosses the placental barrier into the fetal bloodstream.

Clindamycin is excreted in breast milk. The drug should be prescribed with caution during lactation. Breastfeeding should be discontinued during treatment.

Special Precautions

Vaginal suppositories are not recommended to be used simultaneously with other intravaginal medicines.

Effect on ability to drive vehicles and operate machinery

The drug does not affect the ability to concentrate and the speed of psychomotor reactions.

Overdose

Due to low absorption of the drug, overdose is unlikely.

Drug Interactions

Clindacin^® enhances the effect of rifampicin drugs, aminoglycosides – streptomycin, gentamicin.

It enhances the muscle relaxation caused by n-cholinoblockers.

Clindacin^® is incompatible with erythromycin, ampicillin, diphenylhydantoin derivatives, barbiturates, aminophylline, calcium gluconate and magnesium sulfate.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 3 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.