Instructions for DALACIN (Clindamycin)
Pharmacological properties DALACIN:
Clindamycin is an antimicrobial agent that is effective against infections caused by strains of anaerobic bacteria that are susceptible to it, 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.
Does not work on Trichomonas vaginalis and Candida albicans.
Cross-resistance of microorganisms to clindamycin and lincomycin was noted
In healthy volunteers after intravaginal administration of 100 mg of clindamycin phosphate once a day at a concentration equivalent to 20 mg of 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 the introduction of 5 g of clindamycin phosphate cream (clindamycin 20 mg / g) into the vagina, the amount of absorbed is 4% (0.8–8.0%), that is, approximately corresponds to those in healthy volunteers.
Indications DALACIN:
Bacterial vaginosis, hemophilic vaginitis, gardnerellosis vaginitis, nonspecific vaginitis, corynebacteral vaginitis, anaerobic vaginitis caused by microorganisms sensitive to the drug.
Application
The recommended dose is 1 full applicator of 2% clindamycin phosphate cream intravaginally, preferably at bedtime for 3–7 days.
Contraindications DALACIN:
Hypersensitivity to clindamycin or lincomycin , I trimester of pregnancy, lactation period.
Side effects DALACIN:
The safety of the drug was studied in clinical studies in both non-pregnant and pregnant patients in the II and III trimester of pregnancy. Were identified such side effects associated with the 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; vaginal discharge; urinary tract infections; pathological childbirth; endometriosis; glucosuria and proteinuria. Dizziness, headache were also noted; heartburn, nausea, vomiting, diarrhea, constipation, abdominal pain; allergic reactions (rash, urticaria); candidiasis; fungal infections; generalized or localized abdominal pain; bacterial infections; pain in the pelvic area; bad breath; upper respiratory tract infections; pain throughout the body; backache; deviations in microbiological tests.
special instructions DALACIN:
Before starting treatment, it is necessary to exclude the presence of pathogenic microflora insensitive to the drug in the laboratory - Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans and Herpes simplex virus .
The use of clindamycin can lead to the overgrowth of microorganisms insensitive to it, especially yeast. With the use of almost all, diarrhea and cases of pseudomembranous colitis were noted. In the event of severe or prolonged diarrhea, the drug should be canceled (even despite the minimal amount absorbed after intravaginal use) and, if necessary, appropriate diagnostic and therapeutic measures should be taken.
According to clinical trials, intravaginal use of clindamycin phosphate cream in pregnant women in the second trimester, as well as systemic use of clindamycin in the second and third trimesters, did not lead to any pathological effects.
In the first trimester of pregnancy, adequate and well-controlled studies were not carried out, therefore, during this period, the drug should be used only if there are compelling indications.
Whether clindamycin is excreted in breast milk after intravaginal use of clindamycin phosphate is unknown. It was reported, however, about the penetration of clindamycin into breast milk after oral administration or parenteral administration, which must be taken into account when considering the appointment of the drug during lactation.
Interactions
There is cross-resistance between clindamycin and lincomycin . Antagonism between and erythromycin has been demonstrated in vitro . No interactions were observed in pharmacodynamic, pharmacokinetic or clinical studies. There is no information on the use of other drugs in conjunction with clindamycin phosphate cream . Vaginal cream contains mineral oil that can reduce the strength of products made from latex or rubber, such as condoms or vaginal contraceptive diaphragms. Therefore, it is not recommended to use these products during drug treatment.
Overdose DALACIN:
Not possible with intravaginal use. In case of accidental ingestion of the drug inside, the effects may occur that occur at therapeutic concentrations of clindamycin in the blood.
