Dalacin, vaginal cream 2% 20 g

Pharmacotherapeutic group: antibiotic – lincosamide.

ATX code: G01AA10.

Pharmacological properties

Pharmacodynamics

Clindamycin phosphate is inactive in vitro but is rapidly hydrolyzed in vivo to form clindamycin, which has antibacterial activity. Clindamycin belongs to the group of antibiotics-linkosamides, which inhibits protein synthesis in the microbial cell through interaction with the 50S ribosome subunit and affects the translation process.

Clindamycin, like most protein synthesis inhibitors, is primarily a bacteriostatic whose effectiveness is related to the duration of maintenance of the concentration of the active substance at a higher level than the MAC (Minimum Inhibitory Concentration) of the infecting organism.

Resistance to clindamycin is in most cases due to modification of ribosomal target sites usually through chemical modification of RNA nitrogen bases or point mutations of RNA or sometimes protein mutations. Under in vitro conditions, cross-resistance between lincosamides, macrolides, and Streptogramine B has been demonstrated in some organisms. There is a cross-resistance between clindamycin and lincomycin.Under in vitro conditions, the following microorganisms causing bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.Bacterial culture and sensitivity studies are not usually performed to establish the diagnosis and guide treatment for bacterial vaginosis. There is no standard methodology for evaluating the sensitivity of potential bacterial vaginosis pathogens (Gardnerella vaginalis, Mobiluncus spp.) Methods for determining the sensitivity of Bacteroides spp and Gram-positive anaerobic cocci, also Mycoplasma spp. described by the Clinical and Laboratory Standards Institute (CLSI), and borderline sensitivity values for clindamycin for Gram-negative and Gram-positive anaerobic bacteria are published by the European Committee on Antimicrobial Susceptibility Testing (EUCAST). For clinical isolates that are sensitive to clindamycin but resistant to erythromycin, clindamycin resistance should also be tested using the D-test. However, borderline values are intended to guide systemic antibiotic treatment rather than local treatment.

Pharmacokinetics

. After administration of clindamycin intravaginally at a dose of 100 mg/day once (as 2% clindamycin phosphate cream) for 7 days, serum concentrations peak about 10 h (4-24 h) after administration and average 18 ng/mL (4-47 ng/mL) on day one and 25 ng/mL (6-61 ng/mL) on day 7, with systemic absorption of about 4% (0.6-11%) of the administered dose.

In women with bacterial vaginosis, about 4% of clindamycin is absorbed with a similar dosing regimen (with a smaller variation of 2-8%), with serum concentrations peaking about 14 h (4-24 h) after administration and averaging 13 ng/mL (6-34 ng/mL) on day 1 and 16 ng/mL (7-26 ng/mL) on day 7.

The systemic effects of clindamycin when administered intravaginally are weaker than when administered orally or intravenously. After intravaginal administration of repeated doses, clindamycin almost does not accumulate in the blood. The systemic half-life is 1.5-2.6 h.

Application in older patients

In clinical trials of clindamycin 2% vaginal cream, not enough patients 65 years of age or older have participated to be able to evaluate the difference in clinical response to therapy between this age group and younger patients. In the available reports from clinical experience, there was no difference in response between older patients and younger patients.

Indications

Vaginosis, Bacterial vaginosisBacterial vaginosis.

Active ingredient

Clindamycin

Composition

Active ingredient clindamycin phosphate 23.76 mg (as clindamycin 20.0 mg); excipients: sorbitan monostearate 20.0 mg, polysorbate 60 50.0 mg, propylene glycol 50.0 mg, stearic acid 21.4 mg, cetoasteryl alcohol 32.1 mg, cetyl palmitate 32.1 mg, mineral oil 64.2 mg, benzyl alcohol 10.0 mg, purified water q.s.

How to take, the dosage

Recommended dose: Intravaginally one full applicator (5 g cream, approximately 100 mg clindamycin) preferably before bedtime for 3 or 7 consecutive days.

Terms for Use

The 20 g package of cream contains 3 plastic applicators and the 40 g package contains 7 applicators for proper insertion of the cream into the vagina.

• Remove the cap of the tube of cream. Screw the plastic applicator onto the threaded neck of the tube.
• Twist the tube from the opposite end and gently squeeze the cream into the applicator. The applicator is full as you reach the stop.
• Unscrew the applicator from the tube and close the cap
• Lying flat on your back, bring your knees to your chest.
• Holding the applicator horizontally, gently insert it into your vagina as deeply as possible without discomfort.
• Slowly press the plunger until it stops, push the cream into your vagina.
• Carefully remove the applicator from the vagina and discard it.

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Interaction

There is a cross-resistance between clindamycin and lincomycin. It has been found that clindamycin when used systemically impairs neuromuscular transmission and, therefore, may increase the effect of peripheral myorelaxants; therefore, the drug should be used with caution in patients receiving this group of drugs. Concomitant use with other drugs for intravaginal administration is not recommended.

Special Instructions

Before prescribing the drug, appropriate laboratory methods must rule out Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus, often causing vulvovaginitis.

Intravaginal use of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.

The use of clindamycin (like almost all antibiotics) orally or parenterally is associated with the development of severe diarrhea and in some cases pseudomembranous colitis. If severe or prolonged diarrhea develops, the drug should be discontinued and appropriate diagnostic and treatment measures should be taken if necessary.

Patients should be warned not to have sexual intercourse or use other intravaginal devices (tampons, douches) during therapy with the drug.

The use of DALATIN cream during menstruation is not recommended. The start of therapy should be postponed until after menstruation.

The product contains ingredients that may reduce the strength of latex or rubber products, so the use of condoms, vaginal birth control diaphragms and other latex products for intravaginal use during therapy with the product and for 72 hours after use is not recommended.

Impact on driving and operating machinery

There is no reason to believe that the use of DALACIN Vaginal Cream may affect driving and operating machinery.

Synopsis

white cream.

Contraindications

– hypersensitivity to clindamycin, lincomycin or any component of the drug;

– in patients with a history of antibiotic-associated colitis.

– Under 18 years of age (no safety, efficacy data available).