Butoconazole + Clindamycin - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Antiseptics and disinfectants

Included in the formulation

Clindacin® B Prolong

cream

AKRIKHIN HFK, JSC Russia

АТХ:

G.01 Antiseptics and antimicrobials for the treatment of gynecological diseases

Pharmacodynamics:

Butoconazole - a synthetic imidazole for topical application.

Inhibition of sterol-14-demethylase (cytochrome P450 isoenzyme) of fungal cells: a disruption in the synthesis of ergosterol involved in the construction of fungal membranes; disruption of the accumulation of 14α-methylsterols in the dense packing of hydrocarbon chains of phospholipids necessary for the normal functioning of membrane proteins, including ATPase and respiratory chain enzymes. Blocking the formation of ergosterol from the lanosterol in the cell membrane increases the permeability of the membrane, which leads to lysis of the fungal cell. AT Candida albicans - inhibition of the transformation of blastophores into an invasive mycelium.

Clindamycin is a bacteriostatic antibiotic from the group of lincosamides, possesses predominantly Gram-positive action spectrum, binds to the 50S subunit of the ribosomal membrane and suppresses protein synthesis in a microbial cell. With respect to a number of gram-positive cocci, a bactericidal effect is possible. Active with respect to Staphylococcus spp.(incl. Staphylococcus epidermidis, producing and non-producing penicillinase), 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 sp Italic p. (including Bacteroides fragilis and Prevotella melaninogenica), Fusobacterium spp., Propionibacterium spp., eubacterium and Actinomyces israelii. Most strains Clostridium perfringens sensitive to clindamycin, but other species Clostridium spp. (incl. Clostridium sporogenes, Clostridium tertium) are resistant to its action, in connection with which in infections caused by Clostridium spp., the definition of antibioticogram is recommended.

Pharmacokinetics:With intravaginal administration, about 1.7% of the administered dose of butoconazole and 4% of the administered dose of clindamycin are absorbed. The maximum concentration in blood plasma of butoconazole is reached after 13 hours and is 2-18.6 ng / ml. The maximum concentration in the blood plasma of clindamycin is 20 ng / ml.
Butoconazole undergoes intensive metabolism, partially excreted by the kidneys and intestines.

Indications:Bacterial, fungal and mixed vaginosis caused by microbial susceptible to the drug.

ICD-10

I.B35-B49.B37.3 Candidiasis of the vulva and vagina (N77.1 *)

XIV.N70-N77.N76 Other inflammatory diseases of the vagina and vulva

Contraindications:

Crohn's disease; ulcerative colitis (including in the anamnesis); pseudomembranous colitis (including in the anamnesis); children's age till 18 years; increased sensitivity to clindamycin, lincomycin, butoconazole or any component of the drug.

Carefully:

Allergic diseases, simultaneous reception of muscle relaxants.

Pregnancy and lactation:

Recommendations Food and Drug Administration (US Food and Drug Administration) category C (intravaginal butoconazole). Adequate and well-controlled studies in the first trimester were not carried out on a human; in the II and III trimesters, violations from the fetus and the mother were not detected. In animals, induced embryotoxicity, but not teratogenicity. Do not apply in the I trimester.

There is no information on the penetration into breast milk.

Combination "butoconazole + clindamycin" (intravaginally); use during pregnancy and lactation is possible only if the potential benefit to the mother exceeds the risk to the fetus or child.

Dosing and Administration:Introduced intravaginally with the help of an applicator. It is used once, preferably before bedtime.The recommended dose is 1 complete applicator (5 g of cream, which corresponds to 100 mg of butoconazole nitrate and 100 mg of clindamycin). The course of treatment is daily for 3 days.

Side effects:Locally: there may be irritation at the injection site, burning, itching, soreness and swelling of the vaginal mucosa, pain / spasms in the lower abdomen, the development of allergic reactions.

Overdose:With topical application is not marked.

Interaction:

Erythromycin: decreased efficiency.

Incompatible with solutions containing a complex of B vitamins, aminoglycosides, ampicillin, calcium gluconate and magnesium sulfate.

Special instructions:

If clinical symptoms persist after the treatment is complete, a microbiological study should be repeated to confirm the diagnosis.

If there is irritation of the vaginal mucosa or painful sensations, the application should be discontinued. Vaginal cream is not recommended for use with other intravaginal drugs.

Instructions

Butoconazole + Clindamycin (Butoconazolum + Clindamycinum)