Dalatsin ®

General characteristics. Structure:

Active agent clindamycin (in the form of phosphate clindamycin) 100 mg;

Excipients: solid fat (Witepsol H-32, mix of triglycerides, diglycerides and monoglycerides) about 2,4 g.

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.
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. After clindamycin use intravaginalno in a dose of 100 mg of 1 times a day (in the form of suppositories) within 3 days about 30% (6-70%) of the entered dose of clindamycin it is soaked up in a system blood stream, at the same time average area under a curve "concentration – time" makes 3,2 mkg • h/ml (0,42–11 mkg • h/ml). Serumal concentration reaches a maximum approximately later 5 h (1-10 h) after administration of vaginal suppository and averages 0,27 mkg/ml (0,03-0,67 mkg/ml) for the 3rd day of therapy.

The elimination half-life averages 11 h (4-35 h). Systemic action of clindamycin at introduction is intravaginalno much weaker, than at introduction of therapeutic doses inside or intravenously.

Use for elderly patients. The insufficient number of patients at the age of 65 years participated in clinical trials of vaginal candles of clindamycin and is more senior that it was possible to estimate a difference in the clinical response to therapy between the specified age group and younger patients.

Indications to use:

Bacterial vaginosis.

Route of administration and doses:

The recommended dose: one suppository intravaginalno preferably before going to bed within 3 consecutive days.
Instructions on use
Administration of suppositories without applicator:

Extract suppository from a foil.
Improve knees to a breast in a dorsal decubitus.
Carefully enter suppository into a vagina by means of a long finger of a hand as it is possible more deeply.
Administration of suppositories by means of the applicator:

The plastic applicator which is in packaging with drug is intended for simplification of administration of suppository in a vagina.
Extract suppository from a foil.
Place the flat end of suppository in an applicator opening.
Improve knees to a breast in a dorsal decubitus.
Holding the applicator horizontally for the ridge end of the case, carefully enter it into a vagina as it is possible more deeply.
Slowly pressing the piston, enter suppository into a vagina.
Carefully take the applicator from a vagina.
After each use the applicator should be washed up warm water with soap and to allow it to dry completely.

Features of use:

Before purpose of drug by means of the corresponding laboratory methods Trichomonas vaginalis, Chlamydia trachomatis, Neisseria 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.
Clindamycin use (as well as practically all antibiotics) inside or is parenterally connected with development of heavy diarrhea and in some cases pseudomembranous colitis. At development of the expressed or long diarrhea drug should be cancelled and if necessary to hold the relevant diagnostic and medical activities.
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 and within 72 hours after use are not recommended. Drug DALAQING use suppositories vaginal in the period of periods is not recommended. It is necessary to postpone the beginning of therapy until the termination of periods. Influence on ability to driving of the car and to control of mechanisms Drug does not exert impact on ability to manage vehicles and to occupation potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Safety of use of clindamycin in the form of candles was investigated on nonpregnant women.
Frequency of emergence of the listed below side effects – less than 10%. From urinogenital system: irritation of a mucous membrane of a vulva and vagina, a colpodynia, vaginal candidiasis, disturbances of a menstrual cycle, allocation from a vagina, a dysuria, pyelonephritis, vaginal infections.
From the alimentary system: diarrhea, nausea, vomiting.
From integuments: skin itch, rash.
Local reactions: pain, an itch, local hypostasis in an injection site.
The general: fungal infections, spasms in a stomach, a headache, the localized abdominal pain, fever, a stitch, generalized pain.

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.
It is established that clindamycin breaks neuromuscular transfer and, therefore, can strengthen action of muscle relaxants of peripheral action therefore it is necessary to use drug with care at the patients receiving drugs of this group. As information on use with other drugs for intravaginalny introduction is absent, combined use of drug with other intravaginalny means is not recommended.

Contraindications:

- hypersensitivity to clindamycin, lincomycin or any component of drug;
- an antibiotic - the associated colitis in the anamnesis;
- age up to 18 years (data on safety, efficiency are absent).

USE AT PREGNANCY AND DURING BREASTFEEDING
Adequate controlled researches on use of drug during pregnancy were not conducted therefore suppositories vaginal women can apply DALAQING during pregnancy only according to absolute indications i.e. when the potential advantage of therapy surpasses by drug for mother 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 during breastfeeding it is necessary or to cancel drug use, or to stop breastfeeding, considering degree of importance of use of drug for mother.

Overdose:

At intravaginalny use of DALAQING suppositories vaginal absorption of clindamycin in the quantities sufficient for development of system reactions is possible.
Accidental hit of drug in digestive tract can cause the system effects similar to those which arise after intake of clindamycin in therapeutic doses. It is possible to refer diarrhea, hemorrhagic diarrhea to possible system side effects, including pseudomembranous colitis (see the sections "Side Effect" and "Special Instructions"). Treatment: symptomatic and supporting.

Storage conditions:

At a temperature not above 25 °C. Not to freeze.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Suppositories vaginal 100 mg.

Primary: on 3 suppositories in strips from the laminated foil.
Secondary: 1 strip with the application instruction in a cardboard pack or 1 strip complete with the applicator with the application instruction in a cardboard pack.