Clindamycin - instructions for use, dose, side effects, contraindications

Clindamycin phosphate is inactive in vitro, but quickly hydrolyzed in vivo with the formation of clindamycin, which has antibacterial activity. Clindamycin inhibits the synthesis of proteins in a microbial cell due to interaction with 50S-a subunit of ribosomes, has a bacteriostatic effect, and in higher concentrations against some microorganisms - bactericidal.

In conditions in vitro to clindamycin, the following microorganisms that cause bacterial vaginosis are sensitive: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.

Pharmacokinetics:

In healthy volunteers after intravaginal application, 5 g of clindamycin phosphate cream (clindamycin 20 mg / g), the peak serum clindamycin concentration averaged 20 ng / ml (range from 3 to 93 ng / ml). Approximately 3% (0.1 to 7.0%) of the administered dose is absorbed systemically.

In women with bacterial vaginosis, after insertion into the vagina, 5 g of clindamycin phosphate (clindamycin 20 mg / g), the amount of absorbable clindamycin is 4% (from 0.8 to 8.0%), i.e. approximately corresponds to similar indicators in healthy volunteers.

Indications:

Bacterial vaginosis.

Contraindications:

Hypersensitivity to clindamycin, lincomycin or any component of the drug.

Pregnancy and lactation:

When clindamycin was administered intravaginally in the second and third trimester of pregnancy, there was no increase in the frequency of congenital abnormalities of the fetus. If Clindamycin the vaginal cream is used during the II and III trimesters of pregnancy, then the adverse effect on the fetus seems unlikely.

Adequate controlled studies on the use of the drug in the first trimester of pregnancy have not been conducted, therefore Clindamycin vaginal cream can be prescribed to women in the first trimester of pregnancy only in absolute indications, i.e. when the potential benefit of drug therapy exceeds the potential risk to the fetus.

It is not known whether clindamycin in breast milk after intravaginal application. Clindamycin is found in breast milk after oral or parenteral administration, therefore, when considering whether to prescribe clindamycin in the form of a vaginal cream during breastfeeding, the expected potential benefit of drug therapy and the possible risk to the child should be assessed.

Dosing and Administration:

Recommended dose: intravaginally one complete applicator (5 g of cream) preferably at bedtime for 3 or 7 consecutive days.

Directions for use:

1. Remove the cap of the tube with cream. Screw the plastic applicator onto the threaded neck of the tube.

2. Rolling the tube from the opposite end, gently squeeze the cream into the applicator. The applicator is full when its piston comes to a stop.

3. Unscrew the applicator from the tube and wrap the cap.

4. In the supine position on your back, pull your knees to your chest.

5. Hold the applicator horizontally, gently enter it into the vagina as deeply as possible, without causing unpleasant sensations.

6. Slowly pressing the piston against the stop, enter the cream into the vagina.

7. Carefully remove the applicator from the vagina.

Side effects:

The incidence of the side effects listed below is less than 10%.

Genitourinary system: vaginal candidiasis, vulvar and vaginal mucosa irritation, vulvovaginitis, trichomonas vaginitis, vaginal infections, menstrual disorders, vaginal pain, uterine bleeding, dysuria, vaginal discharge, urinary tract infections, abnormal births, endometriosis, glucosuria, proteinuria.

System common: fungal infections, bacterial infections, inflammatory edema, generalized pain, back pain, allergic reactions.

Gastrointestinal tract: bad breath, diarrhea, nausea, vomiting, constipation, dyspepsia, abdominal distension, flatulence, gastrointestinal disorder, stomach cramps.

Leather: pruritus, rash, maculopapular rash, erythema, itching at the injection site, candidiasis (skin), urticaria.

CNS: dizziness, headache.

Endocrine system: hyperthyroidism.

Respiratory system: nosebleeds, upper respiratory tract infections.

Other: deviation of the results of microbiological tests from the norm, distortion of taste.

Overdose:

Clindamycin Cream vaginal is intended only for intravaginal use.

No drug overdose has been reported.

Accidental ingress of the drug in the gastrointestinal tract may cause systemic side effects similar to those which occur after the ingestion of clindamycin in therapeutic doses (abdominal pain, nausea, vomiting, diarrhea, goiter, esophagitis, liver function abnormalities, hyperbilirubinemia, fungal and bacterial infections, inflammatory edema, generalized pain,backache).

Treatment: symptomatic and supportive.

Interaction:

There is cross-resistance between clindamycin and linkomycin.

In conditions in vitro antagonism between clindamycin and erythromycin.

No interactions were observed in pharmacodynamic, pharmacokinetic or clinical studies of this dosage form.

Information on the use of other drugs with the drug is absent.

Joint use with other drugs for intravaginal administration is not recommended.

Special instructions:

Before prescribing the drug using appropriate laboratory methods should be excluded Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans and Herpes simplex virus, often causing vulvovaginitis.

Intravaginal application of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.

Given the possibility of minimal systemic absorption of the drug (approximately 4%), it can not be ruled out that there is a diarrhea against 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 engage in sexual intercourse, and also use other means for intravaginal administration (tampons, douching).

The preparation contains components that can reduce the strength of products made of latex or rubber, so the use of condoms, vaginal contraceptive diaphragms and other means from latex for intravaginal use during therapy with the drug is not recommended.

Effect on the ability to drive transp. cf. and fur:

There is no reason to believe that the use of the drug Clindamycin Vaginal cream can affect the ability to drive cars and control mechanisms.

Form release / dosage:The cream is vaginal, 2%.

Packaging:

For 20 g or 40 g in tubes are aluminum.

1 Tubu together with the applicator and instructions for use are placed in a pack of cardboard.

Storage conditions:

In a place inaccessible to children, at a temperature of no higher than 25 ° C.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001489/09

Date of registration:03.03.2009

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Representation: & nbspVERTEKS CJSC VERTEKS CJSC Russia

Information update date: & nbsp29.07.2015

Illustrated instructions

Instructions

Clindamycin (Clindamycin)