Clindes - instructions for use, doses, side effects, contraindications

Excipients: water 453.0 mg, sorbitol 368.0 mg, disodium edetate 0.5 mg, mineral oil 70.0 mg, lecithin soy (phospholipon 90G) 10.0 mg, polyglyceryl-3-oleate 27.0 mg, glyceryl monostearate 27.0 mg, wax microcrystalline 4.0 mg, methyl parahydroxybenzoate 2.0 mg, propyl parahydroxybenzoate 0.5 mg, silicon colloidal dioxide 10.0 mg.

Description:

Homogeneous cream of white color, free from foreign particles and without visible stratification.

Pharmacotherapeutic group:Antibiotic-Lincosamide

ATX: & nbsp

J.01.F.F.01 Clindamycin

Pharmacodynamics:

Clindamycin selectively binds to 50S-subunit of a ribosome in a microbial cell and inhibits the synthesis of bacterial proteins. Despite the fact that clindamycin phosphate is inactive in vitro, fast hydrolysis in vivo turns this compound into a clindamycin, which has antibacterial activity. In conditions in vitro To clindamycin, the majority of microorganisms that cause bacterial vaginosis are sensitive: Bacteroides spp, Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Peptostreptococcus spp.

Pharmacokinetics:

After a single application of the Clindes preparation, 100 mg in the form of a vaginal cream in healthy women, the average area range under the concentration-time curve (AUC_0-∞) and the maximum concentration of drug substance in the blood (C_mOh) were 175 (38.6 to 541) ng / ml hour and 6.6 (0.8 to 39) ng / ml, respectively. The average value of C_mOh Clindamycin for the Clindes drug was approximately 0.1%, 7.6%, 0.3% of the mean value observed after application of 150 mg of the comparative preparation in the form of oral capsules (2.5 μg / ml), 600 mg of the reference preparation as an intravenous injection (10.9 μg / ml) from a single dose of 100 comparators in the form of a vaginal cream 86.5 ng / ml), respectively.The maximum concentration of clindamycin in the blood plasma is reached approximately 20 hours after the application of the drug Klindes.

Indications:

Bacterial vaginosis.

Contraindications:

Hypersensitivity to clindamycin, lincomycin, or to any of the components of the drug, Crohn's disease, ulcerative colitis or colitis associated with the use of antibiotics in the anamnesis.

Children under 12 years of age (efficacy and safety not established).

Pregnancy and lactation:

The use of vaginal cream Clindes during pregnancy or breast-feeding is possible only if the potential benefit to the mother exceeds the risk to the fetus or the baby.

Dosing and Administration:

Intravaginal.

Treatment consists of the application of the contents of one applicator (about 5 g of cream), injected into the vagina once a day, once. This amount of cream contains approximately 100 mg of clindamycin phosphate. If symptoms persist, repeat the microbiological examination.

Instructions for use of the applicator:

1. Remove the foil from the packaging and remove the applicator.Do not remove the special cap with holes placed on the applicator. Do not use the applicator, if the cap was removed. The applicator is designed for a single application. Do not heat the applicator in your hands before use.

2. Carefully insert the applicator as deep as possible into the vagina. Firmly holding the applicator with one hand and pulling the other by the ring, pull the plunger out of the applicator to the limit to release the cream into the vagina.

3. Remove the empty applicator from the vagina and discard it.

Side effects:

Disorders from the kidneys and urinary tract: Rirritation of the vulvar and vaginal mucosa, vulvovaginitis, vaginal candidiasis, cervicitis, urinary tract infections, proteinuria.

Disturbances from the nervous system: dizziness, headache.

Disorders from the gastrointestinal tract: heartburn, abdominal pain, esophagitis, nausea, vomiting, diarrhea, constipation, pseudomembranous colitis.

Violations from the blood and lymphatic system: eosinophilia, agranulocytosis, thrombocytopenia, transient neutropenia, and leukopenia.

Disturbances from the skin and subcutaneous tissues: rash, hives, itchy skin, maculopapular rash, erythema, itching at the injection site.

General disorders: nasopharyngitis, back pain, polyarthritis.

Overdose:

The drug Klindes vaginal cream is intended for intravaginal use. No drug overdose has been reported.

Accidental ingestion of the drug into the gastrointestinal tract can cause systemic effects similar to those that occur after ingestion of clindamycin at therapeutic doses.

Treatment: symptomatic and supportive.

Interaction:

Clindamycin disrupts neuromuscular transmission, therefore, it can enhance the action of muscle relaxants of peripheral action. It should be carefully combined clindamycin with preparations of this group.

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

Cross-resistance between clindamycin and lincomycin is known.

AT conditions in vitro antagonism between clindamycin and erythromycin has been demonstrated.

Special instructions:

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

Patients should be instructed not to have sexual intercourse, not to use vaginal tampons and syringings during treatment with Clindes.

The Clindes product contains components that can damage latex or rubber products, such as condoms or vaginal contraceptive diaphragms. Therefore, the use of similar methods contraception is not recommended during the period of application or for five days after completion of treatment with Clindes.

The use of clindamycin (as almost all antibiotics) with its systemic absorption may cause the development of diarrhea and colitis, including pseudomembranous colitis. With the development of severe diarrhea, the drug should be discontinued and the necessary diagnostic and therapeutic measures taken.

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

In case of adverse reactions from the side of the nervous system (dizziness) for patients using Clindes, it is recommended to refrain from driving and other mechanisms, as well as activities that require concentration.

Form release / dosage:

Cream vaginal, 20 mg / g.

Packaging:

5 g of cream in a disposable plastic applicator with a cap of natural polypropylene.

1 applicator in a polystyrene foam box packed in a laminated package.

1 pack together with the instruction on medical application in a cardboard bundle.

Storage conditions:

Store at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:PL-000516

Date of registration:01.03.2011

Expiration Date:01.03.2016

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

KV PHARMACEUTICAL COMPANY USA

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp28.01.2018

Illustrated instructions

Instructions

Clindes (Clindesse)