Клиндацин®
Producer: JSC Chemical and Pharmaceutical Plant AKRIKHIN Russia
Code of automatic telephone exchange: G01AA10
Release form: Soft dosage forms. Cream.
General characteristics. Structure:
Active ingredient: 20 mg of clindamycin of phosphate in 1 g of cream.
Excipients: Natrium benzoicum, castor oil, propylene glycol, eat emulsifier 3398, macrogoal (poly(ethylene oxide) 1500).
Pharmacological properties:
Pharmacodynamics. An antibiotic of group of linkozamid for vaginal use. The mechanism of effect of drug is connected with disturbance of intracellular synthesis of protein in a microbic cell at the level of 50S subunit of ribosomes.
Clindamycin possesses a broad spectrum of activity, has bacteriostatic action, in higher concentration concerning some microorganisms — bactericidal. It is active concerning the microorganisms causing bacterial vaginoses: Gardnerella vaginalis, Mobiluncus spp., Bacteroides spp., Mycoplasma hominis, Peptostreptococcus spp. Trichomonas vaginalis and Candida albicans are not sensitive to clindamycin.
Pharmacokinetics. After single intravaginalny introduction of 100 mg of clindamycin, on average 4% of the entered dose are exposed to system absorption. The maximum concentration of clindamycin in a blood plasma makes 20 ng/ml.
Indications to use:
The bacterial vaginosis caused by microorganisms, sensitive to drug.
Route of administration and doses:
It is entered intravaginalno by means of the applicator. The recommended single dose makes 100 mg of clindamycin (one full applicator), preferably before going to bed within 3-7 days.
Instructions on use. The one-time applicators which are applied to packaging with Klindatsinom® are intended for the correct administration of cream in a vagina.
1. Remove a tube cap with cream. Screw the plastic applicator on the tube neck supplied with a carving.
2. Squeezing a tube since the opposite end, softly squeeze out cream in the applicator. The piston of the applicator moves independently in process of filling of necessary volume. The applicator is filled when its piston reaches against the stop.
3. Lying on spin, take the applicator horizontally and enter it into a vagina as it is possible further, but so that not to cause unpleasant feelings.
4. Slowly press the piston against the stop.
5. Carefully take the applicator from a vagina and you will throw out it.
Features of use:
At prolonged use of drug the excess growth of microorganisms, insensitive to it, in particular sort Candida mushrooms is possible.
Considering a possibility of the minimum system absorption of drug (about 4%), it is impossible to exclude emergence against the background of diarrhea drug use. In this case drug should be cancelled.
It is not recommended to apply along with other intravaginalny means.
Efficiency and safety of clindamycin at intravaginalny use for children is not established.
Use at pregnancy and in the period of a lactation. Clinical trials on use of clindamycin for women in the I trimester of pregnancy were not conducted therefore use of drug is possible only in that case when the expected advantage for mother exceeds risk for a fruit. Use in II and III trimesters of pregnancy is possible as any adverse influence on a fruit is not revealed.
It is unknown whether clindamycin with mother's milk at intravaginalny use therefore it is necessary to compare advantage of use of drug during breastfeeding and possible risk for the baby is emitted.
Side effects:
Development of allergic reactions, emergence of irritation in an injection site, a cervicitis, a vaginitis, vulvovaginal candidiasis is possible.
Interaction with other medicines:
Between clindamycin and erythromycin antagonistic interaction is noted.
There is a cross resistance between clindamycin and lincomycin.
Contraindications:
Hypersensitivity to clindamycin or lincomycin.
Overdose:
At intravaginalny use of drug the overdose is not established.
Storage conditions:
List B. In the dry, protected from light place, at a temperature not above 20 °C. To store in the place, unavailable to children. Not to use after expiry date. A period of validity - 3 years.
Issue conditions:
According to the recipe
Packaging:
Cream of vaginal 2%. On 20 or 40 g in a tuba aluminum. Each tuba complete with 3 or 7 applicators and the application instruction is placed in a pack from a cardboard.