Clindamycin-VERTEX (Cream) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

ATC Code

G01AA10 (Clindamycin)

Active Substance

Clindamycin (Rec.INN WHO registered)

Dosage Form

Clindamycin-Vertex

Vaginal cream 2%: tubes 20 g and 40 g

Dosage Form, Packaging, and Composition

Vaginal cream homogeneous white or almost white in color with a characteristic odor.

Excipients: liquid paraffin (mineral oil), polysorbate 60, propylene glycol, cetearyl alcohol, cetyl palmitate, stearic acid, sorbitan stearate, benzyl alcohol, purified water.

20 g – aluminum tube (1) – cardboard packs.
40 g – aluminum tube (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, excluding combinations with corticosteroids; antibiotics

Pharmacological Action

An antibiotic of the lincosamide group. It inhibits protein synthesis in the microbial cell by interacting with the 50S ribosomal subunit and affects the translation process. Like most protein synthesis inhibitors, it is mainly bacteriostatic, and its effectiveness is associated with the duration of maintaining the concentration of the active substance at a level higher than the MIC of the infecting organism.

In vitro, the following microorganisms causing bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.

Resistance to clindamycin in most cases arises due to modification of ribosomal target sites, usually through chemical modification of RNA nitrogenous bases or point mutations of RNA, or sometimes protein mutations. In vitro, cross-resistance between lincosamides, macrolides, and streptogramins B has been demonstrated in some organisms. There is cross-resistance between clindamycin and lincomycin.

Pharmacokinetics

The systemic exposure of clindamycin with intravaginal application is less pronounced than with oral or intravenous administration.

After a single daily intravaginal application of clindamycin at a dose of 100 mg/day (in the form of 2% clindamycin phosphate cream) for 7 days, the C_max of clindamycin in blood plasma is reached after 10 hours (4-24 hours) and averages 18 ng/ml (4-47 ng/ml) on day 1, and 25 ng/ml (6-61 ng/ml) on day 7, with systemic absorption being about 4% (0.6-11%) of the administered dose.

In women with bacterial vaginosis, with a similar dosing regimen, about 4% of clindamycin is systemically absorbed (with a smaller range of 2-8%), C_max is reached 14 hours (4-24 hours) after administration and averages 13 ng/ml (6-34 ng/ml) on the first day, and 16 ng/ml (7-26 ng/ml) on day 7.

T_1/2 is 1.5-2.6 hours. After repeated intravaginal administration, Clindamycin almost does not accumulate.

Indications

Bacterial vaginosis.

ICD codes

Dosage Regimen

Administer intravaginally once daily at bedtime for three to seven consecutive days.

Apply one full applicator (containing 5 grams of cream, equivalent to 100 mg of clindamycin) per dose.

Complete the entire prescribed course of treatment, even if symptoms improve earlier.

Avoid sexual intercourse and the use of tampons or douches during therapy.

Do not use during menstruation; postpone treatment start until menstruation has ended.

Discontinue use immediately if severe diarrhea or abdominal cramps occur and contact a physician.

Adverse Reactions

Infections and parasitic diseases frequent – fungal infections, infections caused by Candida fungi; infrequent – bacterial infections; frequency unknown – skin candidiasis.

Immune system disorders infrequent – hypersensitivity reactions.

Nervous system disorders frequent – headache, dizziness, dysgeusia.

Ear and labyrinth disorders infrequent – vertigo.

Respiratory system disorders frequent – upper respiratory tract infections; infrequent – epistaxis.

Gastrointestinal disorders frequent – abdominal pain, constipation, diarrhea, nausea, vomiting; infrequent – abdominal distension, flatulence, halitosis; frequency unknown – pseudomembranous colitis, dyspepsia.

Renal and urinary disorders frequent – pyelonephritis, urinary tract infections, glucosuria, proteinuria; infrequent – dysuria.

Reproductive system and breast disorders frequent – vulvovaginitis, vulvovaginal disorders, menstrual cycle disorder, vulvovaginal pain, metrorrhagia, vaginal discharge; infrequent – vulvovaginal infections, trichomonal vulvovaginitis, pelvic pain; frequency unknown – endometriosis.

Skin and subcutaneous tissue disorders frequent – skin itching, rash; infrequent – urticaria, erythema; frequency unknown – maculopapular rash.

General disorders and administration site conditions frequent – back pain; infrequent – pain at the application site, itching at the application site, localized edema, pain, hyperthermia.

Investigations infrequent – abnormal microbiological test results.

Contraindications

Hypersensitivity to clindamycin or lincomycin; history of antibiotic-associated colitis; age under 18 years.

Use in Pregnancy and Lactation

During pregnancy, use is possible if the intended benefit to the mother outweighs the potential risk to the fetus. During lactation, either Clindamycin should be discontinued or breastfeeding should be stopped, taking into account the importance of therapy for the mother.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Before prescribing the drug, the following possible pathogens of vulvovaginitis should be ruled out using special laboratory methods: Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and Herpes simplex virus.

Intravaginal use of clindamycin may lead to increased growth of microorganisms not susceptible to the drug, especially yeast-like fungi.

If diarrhea or symptoms of colitis appear, Clindamycin should be discontinued.

The patient should be informed that during clindamycin therapy, sexual intercourse and the use of other means intended for intravaginal administration (e.g., tampons, douches) should be avoided.

The use of clindamycin for intravaginal administration during menstruation is not recommended. The start of therapy should be postponed until the end of menstruation.

Drug Interactions

There is cross-resistance between clindamycin and lincomycin.

Concomitant use with other drugs for intravaginal administration is not recommended.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.