Clindamycin

General characteristics. Structure:

Active ingredient: 2 g of clindamycin of phosphate (in terms of clindamycin).

Excipients: Natrium benzoicum, macrogoal-1500 (poly(ethylene oxide)-1500), emulsifier No. 1, castor oil, propylene glycol.

Vaginal use cream with bacteriostatic and bactericidal properties.

Pharmacological properties:

Pharmacodynamics. Clindamycin phosphate is inactive in vitro, but in vivo with formation of the clindamycin having antibacterial activity is quickly hydrolyzed. Clindamycin inhibits protein synthesis in a microbic cell due to interaction with 50S in subunit of ribosomes, has bacteriostatic action, and in higher concentration concerning some microorganisms — bactericidal.

In the conditions of in vitro the following microorganisms causing bacterial vaginoses are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.

Pharmacokinetics. Healthy volunteers after intravaginalny use have 5 g of cream of clindamycin of phosphate (clindamycin of 20 mg/g), peak serumal concentration of clindamycin averaged 20 ng/ml (an interval from 3 to 93 ng/ml). About 3% (from 0,1 to 7,0%) of the entered dose are absorbed systemically.

At the women having bacterial vaginoses after introduction to a vagina of 5 g of cream of clindamycin of phosphate (clindamycin of 20 mg/g), amount of the soaking-up clindamycin makes 4% (from 0,8 to 8,0%), i.e. approximately corresponds to similar indicators at healthy the volunteer.

Indications to use:

Bacterial vaginosis.

Route of administration and doses:

The recommended dose: intravaginalno one full applicator (5 g of cream) preferably before going to bed within 3 or 7 days in a row. Instructions on use:
• Remove a tube cap with cream. Screw the plastic applicator on the tube neck supplied with a carving.
• Skatyvy a tube since the opposite end, carefully squeeze out cream in the applicator.
The applicator is filled when its piston reaches against the stop.
• Unscrew the applicator from a tube and wrap a cap.

• Improve knees to a breast in a dorsal decubitus.
• Holding the applicator horizontally, carefully enter it into a vagina as it is possible more deeply, without causing unpleasant feelings.
• Slowly pressing the piston against the stop, enter cream into a vagina.
• Carefully take the applicator from a vagina.

Features of use:

Before purpose of drug by means of the corresponding laboratory methods Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans and Herpes simplex virus which are often causing a vulvovaginitis have to be excluded.

Intravaginalny use of clindamycin can lead to the strengthened growth of insensitive microorganisms, especially drozhzhepodobny mushrooms.

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.

Patients should be warned that during therapy by drug it is not necessary to enter the sexual intercourses, and also to apply other means to intravaginalny introduction (tampons, syringing).

Drug contains components which can reduce durability of products from latex or rubber therefore use of condoms, vulval contraceptive diaphragms and other means from latex for intravaginalny use during therapy by drug are not recommended.

Influence on ability to driving of the car and control of mechanisms. There are no bases to believe that drug Clindamycin use cream vaginal can exert impact on ability to driving of the car and control of mechanisms.

Use at pregnancy and in the period of a lactation. At clindamycin use intravaginalno in II and the III trimester of pregnancy of increase in frequency of congenital anomalies of a fruit it was not noted. If Clindamycin cream vaginal is applied during II and III trimesters of pregnancy, then adverse influence on a fruit is represented improbable.
Adequate controlled researches on use of drug in the I trimester of pregnancy were not conducted therefore cream vaginal women can appoint Clindamycin in the I trimester of pregnancy only according to absolute indications i.e. when the potential advantage of therapy surpasses by drug potential risk for a fruit.

It is unknown whether clindamycin in breast milk after intravaginalny use is emitted. Clindamycin is found in breast milk after peroral or parenteral administration therefore at the solution of a question of a possibility of purpose of clindamycin in the form of vaginal cream during breastfeeding it is necessary to estimate the expected potential advantage of therapy by drug and possible risk for the child.

Side effects:

Frequency of emergence of the listed below side effects - less than 10%. Urinogenital system: vaginal candidiasis, irritation of a mucous membrane of a vulva and vagina, a vulvovaginitis, a mecotic vaginitis, vaginal infections, disturbances of a menstrual cycle, a colpodynia, uterine bleeding, a dysuria, allocations from a vagina, infections of urinary tract, abnormal childbirth, endometriosis, a glucosuria, a proteinuria.

The system general: fungal infections, bacterial infections, inflammatory hypostasis, generalized pain, dorsodynia, allergic reactions.

Digestive tract: an unpleasant smell from a mouth, diarrhea, nausea, vomiting, a lock, dyspepsia, abdominal distention, a meteorism, gastrointestinal frustration, spasms in a stomach.

Skin: a skin itch, rash, makulopapulezny rash, an erythema, an itch in an injection site, candidiasis (skin), a small tortoiseshell.

TsNS: dizziness, headache.

Endocrine system: hyperthyroidism.

Respiratory system: nasal bleeding, upper respiratory tract infections.

Others: a deviation of results of microbiological analyses from norm, a food faddism.

Interaction with other medicines:

There is a cross resistance between clindamycin and lincomycin. In the conditions of in vitro antagonism between clindamycin and erythromycin is shown.

No interactions were observed in pharmakodinamichesky, pharmacokinetic or clinical trials of this dosage form.

Information on use of other medicines together with drug is absent. Combined use with other drugs for intravaginalny introduction is not recommended.

Contraindications:

Hypersensitivity to clindamycin, lincomycin or any component of drug.

Overdose:

Clindamycin cream vaginal is intended only for intravaginalny use.
About overdose by drug it was not reported.

Accidental hit of drug in digestive tract can cause the system side effects similar to those which arise after intake of clindamycin in therapeutic doses (an abdominal pain, nausea, vomiting, diarrhea, dysbacteriosis, an esophagitis, disturbances of function of a liver, a hyperbilirubinemia, fungal and bacterial infections, inflammatory hypostasis, generalized pain, a dorsodynia).

Treatment: symptomatic and supporting.

Storage conditions:

List B. In dry, protected from light, the place, unavailable to children, at a temperature not above 20 °C. Period of validity 2 years. Not to apply after expiry date.

Issue conditions:

According to the recipe

Packaging:

Cream of vaginal 2% on 20 g or 40 g in tubas aluminum. 1 tuba together with the applicator and the application instruction is placed in a pack from a cardboard.