Expiration date: 08/2025
Clinical and pharmacological group
(Antibiotic for topical use in gynecology)
Product form, composition and packaging
Vaginal cream 2% from white to white with a yellowish or creamy shade of color, with a weak specific odor.
Auxiliary substances: sodium benzoate, macrogol-1500 (polyethylene oxide-1500), emulsifier ?1, castor oil, propylene glycol.
20 g - tubes aluminum (1) complete with applicator - packs of cardboard.
40 g - tubes aluminum (1) complete with applicator - packs of cardboard.
Pharmacological action
Clindamycin phosphate is inactive in vitro, but rapidly hydrolyzed in vivo to form clindamycin, which has antibacterial activity. Clindamycin inhibits protein synthesis in the microbial cell by interaction with the 50S ribosome subunit, has a bacteriostatic effect, and at higher concentrations against some microorganisms – bactericidal.
In vitro, the following microorganisms causing bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.
Pharmacokinetics
In healthy volunteers after intravaginal administration of 5 g of cream of clindamycin phosphate (clindamycin 20 mg/g), Cmax of clindamycin averaged 20 ng/ml (range of 3 to 93 ng/ml). Approximately 3% (0.1 to 7%) of the administered dose is absorbed systematically.
In women suffering from bacterial vaginatae, upon insertion in the vagina 5 g of the cream clindamycin phosphate (clindamycin 20 mg/g) amount absorbed of clindamycin is 4% (from 0.8 to 8%), i.e. roughly corresponds to the same indicators in healthy volunteers.
Dosage
Recommended in the dose: intravaginally one full applicator (5 g cream) preferably at bedtime for 3 or 7 consecutive days.
Overdose
Clindamycin vaginal cream is intended for intravaginal use only.
About to overdose have been reported. Accidental ingestion of the drug in the gastrointestinal tract can cause systemic effects similar to those that occur after ingestion of clindamycin in therapeutic doses.
Treatment: symptomatic and supportive.
Drug interaction
There is cross-resistance between clindamycin linkomitinom. In vitro antagonism between clindamycin and erythromycin was demonstrated.
No interactions were observed in the pharmacodynamic, pharmacokinetic or clinical studies of this drug form.
Information about the use of other drugs together with the drug is missing. Joint use with other drugs for intravaginal administration is not recommended.
Pregnancy and lactation
When using clindamycin intravaginal in the II and III trimester of pregnancy increase in the frequency of congenital fetal abnormalities was not noted. If Clindamycin vaginal cream is used during second and third trimester of pregnancy, adverse effect on the fetus is unlikely.
Adequate controlled studies on the use of the drug in the first trimester of pregnancy was not carried out, so the vaginal cream Clindamycin can be prescribed to women in the first trimester of pregnancy only for absolute indications, i.e. when the potential benefit of therapy with the drug exceeds the potential risk to the fetus.
It is unknown whether clindamycin is released into breast milk after intravaginal use. Clindamycin is found in breast milk after oral or parenteral administration, so when deciding on the possibility of prescribing clindamycin in the form of a vaginal cream during breastfeeding should evaluate the expected potential benefits of therapy with the drug and the possible risk to the child.
Side effect
The frequency of occurrence of the side effects listed below is less than 10%.
From the urinary system: vaginal candidiasis, irritation of the vulva and vagina mucosa, vulvovaginitis, Trichomonas vaginitis, vaginal infections, menstrual disorders, vaginal pain, uterine bleeding, dysuria, vaginal discharge, urinary tract infections, abnormal childbirth, endometriosis, glucosuria, proteinuria.
Common: fungal infection, generalized abdominal pain, localized abdominal pain, bacterial infection, abdominal cramps, headache, lower abdominal pain, halitosis, inflammatory swelling, upper respiratory tract infection, generalized pain, back pain, bloating, rejecting the results of microbiological tests from the norm, allergic reactions.
From the digestive system: diarrhea, nausea, vomiting, constipation, dyspepsia, flatulence, gastro-intestinal disorders.
From the skin: itching, rash, macular rash, erythema, itching at the site of administration, candidiasis (skin), urticaria.
From the Central nervous system: dizziness.
From the endocrine system: hyperthyroidism.
From the respiratory system: nasal bleeding.
Other: perversion of taste.
Storage conditions and terms
List B. In a dry, dark, inaccessible to children place at temperature not above 20°C. shelf Life - 2 years.
Indications
- bacterial vaginosis.
Contraindications
- hypersensitivity to clindamycin, lincomycin or any component of the drug.
Special instruction
Prior to the appointment of the drug using appropriate laboratory methods should be excluded Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex, often causing vulvovaginitis.
Intravaginal use of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.
Given the possibility of a minimum systemic absorption of the drug (approximately 4 %), it is impossible to exclude the occurrence of diarrhea in the background of the drug. In this case, the drug should be canceled.
Patients should be warned that during therapy with the drug should not enter into sexual intercourse, as well as use other means for intravaginal administration (tampons, douching).
The drug contains components that can reduce the strength of latex or rubber products, so the use of condoms, vaginal diaphragm and other latex products for intravaginal use during therapy with the drug is not recommended.
Influence on the ability to drive vehicles and control mechanisms
There is no reason to believe that the use of the drug Clindamycin cream vaginal can affect the ability to drive a car and management mechanisms.
