Pharmacological properties
Pharmacodynamics. Clindamycin is classified as a lincosamide antibiotic. It inhibits protein synthesis in the microbial cell by binding to the 50S subunits of the ribosome. When applied topically intravaginally, it has a bactericidal effect. Clindamycin is active against many gram-positive and gram-negative anaerobes, gram-positive aerobes. It is highly active against microorganisms that cause bacterial vaginosis: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma spp., Ureaplasma spp., Chlamydia trachomatis, Peptostreptococcus spp., Bacteroides spp., Haemophylus spp., Corynebacterium spp.
Pharmacokinetics. Clindamycin phosphate is rapidly hydrolyzed in the body to form clindamycin, which exhibits antibacterial activity. With intravaginal administration, about 30% (6-70%) of clindamycin enters the systemic bloodstream, but systemic cumulation with prolonged use has not been detected. T ½ with vaginal administration is 1.5-2.6 hours.
Indication
Treatment of bacterial vaginosis (previous names - hemophilic vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterial vaginitis or anaerobic vaginosis).
Application
Intravaginally, 1 suppository once a day at night for 3 consecutive days. The suppositories are removed from the blister pack and inserted deep into the vagina while lying on your back with your knees bent and pulled to your chest, or in a squatting position. Official recommendations for the appropriate use of antibacterial agents should be followed.
Contraindication
Hypersensitivity to lincomycin, clindamycin or other components of the drug that contain solid fat. Regional enteritis, ulcerative colitis and antibiotic-associated colitis in history.
Side effects
These adverse reactions occur in less than 10% of patients.
From the genitourinary system: vulvovaginal disorders, vulvovaginal irritation, vaginal pain, vaginal candidiasis, menstrual disorders, vaginal discharge, dysuria, pyelonephritis, vaginitis/vaginal infections.
General disorders and administration site conditions: injection site pain, fever, generalized pain, localized edema, lateral abdominal pain, headache.
Infections and infestations: vaginal candidiasis, fungal infections.
Gastrointestinal: nausea, vomiting, diarrhea, abdominal cramps.
Skin and mucous membranes: pruritus (not at the injection site), rash, pruritus (at the injection site). The following medically significant adverse reactions have been reported with systemic clindamycin in less than 0.01% of patients.
Blood and lymphatic system disorders: transient neutropenia (leukopenia), agranulocytosis, thrombocytopenia.
Immune system disorders: anaphylactoid reactions.
Hepatobiliary disorders: jaundice.
Skin and subcutaneous tissue disorders: erythema multiforme, Stevens-Johnson syndrome-like, toxic epidermal necrolysis.
Special instructions
Before or immediately after starting clindamycin in the form of vaginal suppositories, it may be necessary to conduct a laboratory analysis for the presence of other infectious agents, including trichomonas vaginalis, candida albicans, chlamydia trachomatis, and gonococci.
The use of vaginal suppositories with clindamycin may cause the growth of non-susceptible microorganisms, including yeast fungi.
The use of clindamycin, as well as other antibacterial agents, can cause diarrhea, and in some cases - pseudomembranous colitis, which can be both moderate and life-threatening. If severe or prolonged diarrhea develops during the use of Milagin, this drug should be discontinued, appropriate diagnostic procedures should be performed and, if necessary, antibacterial treatment should be prescribed. Drugs that inhibit peristalsis are contraindicated in this case. If there is a history of antibiotic-induced colitis, Milagin should be used with caution. In such cases, it is recommended to carefully weigh the benefits of treating bacterial vaginosis and the potential risk of developing pseudomembranous colitis.
Patients should be warned that during therapy with Milagin, they should refrain from sexual intercourse and not use products intended for intravaginal administration (e.g. tampons, douches).
The drug contains components that may reduce the strength of latex or rubber products, such as condoms or contraceptive vaginal diaphragms. Therefore, the use of such products during and for 72 hours after treatment with Milagin is not recommended. Almost 30% (6.5-70%) of the clindamycin dose is absorbed into the systemic circulation after the use of vaginal suppositories.
Pregnancy and breastfeeding. Milagin is not recommended for use in the first trimester of pregnancy due to the lack of research.
Intravaginal use of clindamycin phosphate suppositories in the II trimester of pregnancy, as well as systemic use of clindamycin in the II and III trimesters, did not lead to any pathological effects on the fetus, therefore it can be used if clearly necessary.
Children: There are no data on the use of the drug in pediatric practice.
The ability to influence the reaction speed when driving vehicles or working with other mechanisms. Does not affect.
Interactions
There are no data on concomitant use with other drugs for intravaginal administration.
It is not recommended to use latex condoms during treatment with the drug. There is no data on the effect of the drug on latex diaphragms.
Clindamycin phosphate has neuromuscular blocking properties that may enhance and prolong the action of other neuromuscular blocking agents.
Overdose
With vaginal use of clindamycin, cases of overdose have not been described. In case of accidental ingestion of the drug, side effects characteristic of systemic use of clindamycin may develop. Treatment is symptomatic.
Storage conditions
At a temperature not exceeding 25 °C.
