2010/06/09

DALACIN VAGINAL CREAM

Pharmacological properties: clindamycin - antimicrobial means effective in infections caused by susceptible strains of anaerobic to him, as well as gram-positive aerobic bacteria. In vitro active against microorganisms that cause bacterial vaginosis, - Gardnerella vaginalis; Mobiluncus spp; Bacteroides spp; Mycoplasma hominis; Peptostreptococcus spp.

It operates on Trichomonas vaginalis and Candida albicans.

Was noted cross-resistance of microorganisms to clindamycin and lincomycin.

In healthy volunteers after intravaginal application of clindamycin phosphate 100 mg 1 time a day at a concentration equivalent to 20 mg clindamycin in 1 g of cream, the peak concentration of clindamycin in serum reached an average of 20 ng / ml (range - 3-93 ng / ml). Approximately 3% (0,1-7,0%) of the administered dose is absorbed systemically. In women with bacterial vaginosis after vaginal insertion of 5 g of cream clindamycin phosphate (clindamycin 20 mg / d) intake of clindamycin was 4% (0,8-8,0%), approximately in line with those in healthy volunteers.

INDICATIONS: bacterial vaginosis, caused by microorganisms sensitive to the drug.

APPLICATION: The recommended dose is 1 full applicator 2% clindamycin phosphate cream intravaginally preferably at bedtime for 3-7 days.

CONTRAINDICATIONS: Hypersensitivity to clindamycin or lincomycin, I trimester of pregnancy, lactation.

SIDE EFFECTS: The safety of the drug has been studied in clinical trials as in nonpregnant and pregnant patients in II and III trimester of pregnancy. Were identified such side effects associated with use of the drug (observed in less than 10% of patients) - vaginal candidiasis; irritation of the vulva and vagina; vulvovaginitis, vaginitis caused by Trichomonas vaginalis; menstrual disorders, pain in the vagina, metrorrhagia, dysuria, discharge from vagina, urinary tract infections, abnormal childbirth; endometriosis; Glycosuria and proteinuria. Also noted dizziness, headache, heartburn, nausea, vomiting, diarrhea, constipation, abdominal pain, allergic reaction (rash, urticaria), candidiasis, fungal infections, generalized or localized abdominal pain, bacterial infections, pelvic pain, an unpleasant breath, upper respiratory tract infection, pain throughout the body, back pain, abnormalities in microbiological tests.

Cautions: Before starting treatment is necessary laboratory exclude the presence of pathogenic organisms, insensitive to the drug, - Trichomonas vaginalis, Chlamydia trachomatis, N. Gonorrhoeae, Candida albicans, and Herpes simplex virus.

The use of clindamycin may result in excessive growth of microorganisms insensitive to it, especially yeast. In the application of virtually all antibiotics mentioned diarrhea and cases of pseudomembranous colitis. In the event of a pronounced or prolonged diarrhea medicine should be repealed (even though the minimum quantity, absorbing after intravaginal application) and if necessary, to conduct appropriate diagnostic and therapeutic measures.

According to clinical trials Vaginal application of clindamycin phosphate cream in pregnant women in the II trimester, as well as systemic application of clindamycin in the II and III trimester does not lead to the appearance of any pathological effects.

In the I trimester of pregnancy adequate and well-controlled studies had been conducted, so this period the drug should be used only for compelling testimony.

Whether clindamycin is excreted in breast milk after intravaginal application of clindamycin phosphate is unknown. Reported, however, the penetration of clindamycin into breast milk after oral or parenteral administration, which should take into account when considering the appointment of the drug during lactation.

Interactions: There is cross-resistance between clindamycin and lincomycin. In vitro demonstrated antagonism between clindamycin and erythromycin. There were no interactions in pharmacodynamic, pharmacokinetic or clinical studies were not observed. Information on the use of other drugs in conjunction with the cream clindamycin phosphate is absent. Vaginal Cream contains mineral oil, which can reduce the strength of products made from latex or rubber: condoms or vaginal contraceptive diaphragms. Therefore, use of these products during drug treatment is not recommended.

OVERDOSE: If intravaginal application impossible. If you accidentally taking the drug inside may cause effects that arise when therapeutic concentrations of clindamycin in the blood.

STORAGE: at room temperature (20-25 ° C). Do not freeze!