Dalatsin ®

General characteristics. Structure:

Active agent clindamycin (in the form of phosphate clindamycin) 20,0 mg;

Excipients: sorbitan monostearate of 20,0 mg, mg polysorbate 60 50,0, propylene glycol of 50,0 mg, stearic acid of 21,4 mg, cetostearyl alcohol of 32,1 mg, cetyl palmitate of 32,1 mg, mineral oil of 64,2 mg, benzyl alcohol of 10,0 mg, water the cleared q.s.

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/days once (in the form of 2% cream of clindamycin of phosphate) within 7 days serumal concentration reaches a maximum approximately later 10 h (4-24 h) after introduction and averages in the first day 18 ng/ml (4-47 ng/ml), and for the seventh day - 25 ng/ml (6-61 ng/ml), at the same time system absorption makes about 4% (0,6-11%) of the entered dose.
At women with bacterial vaginoses at the similar mode of dosing about 4% of clindamycin are soaked up (with smaller dispersion of 2-8%), serumal concentration reaches a maximum approximately later 14 h (4-24 h) after introduction and averages in the first day 13 ng/ml (6-34 ng/ml), and for the seventh day - 16 ng/ml (7-26 ng/ml).
Systemic action of clindamycin at introduction is intravaginalno weaker, than at introduction inside or intravenously. After intravaginalny introduction of repeated doses clindamycin almost does not kumulirutsya in blood. The system elimination half-life makes 1,5-2,6 h.

Use for elderly patients. The insufficient number of patients at the age of 65 years participated in clinical trials of clindamycin of 2% of cream vaginal 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. In the available messages from clinical experience the difference in the answer of elderly patients and more young people was not noted.

Indications to use:

Bacterial vaginosis.

Route of administration and doses:

The recommended dose: intravaginalno one full applicator (5 g of cream, about 100 mg of clindamycin) preferably before going to bed within 3 or 7 days in a row.

Instructions on use
In packaging from 20 g of cream there are 3 plastic applicators, and in packaging from 40 g - 7 applicators intended for the correct administration of cream in a vagina.

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 and throw out it.

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 DALAQING use cream in the period of periods is not recommended. It is necessary to postpone the beginning of therapy until the termination of periods.
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.
Influence on ability to driving of the car and to control of mechanisms
There are no bases to believe that drug DALAQING use vaginal cream can exert impact on ability to driving of the car and to control of mechanisms.

Side effects:

Frequency of emergence of the listed below side effects – less than 10%.
From 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.
From the alimentary system: diarrhea, nausea, vomiting, lock, dyspepsia, meteorism, gastrointestinal frustration.
From integuments: skin itch, rash, makulopapulezny rash, erythema, candidiasis (skin), small tortoiseshell.
From sense bodys: вертиго.
From a nervous system: headache, dizziness, food faddism.
From endocrine system: hyperthyroidism.
From respiratory system: nasal bleeding.
Local reactions: an itch and inflammatory hypostasis in an injection site.
The general: fungal infections, a generalized abdominal pain, the localized abdominal pain, bacterial infections, spasms in a stomach, pain in the bottom of a stomach, abdominal distention, an unpleasant smell from a mouth, upper respiratory tract infections, generalized pain, a dorsodynia, a deviation of results of microbiological analyses from norm, allergic reactions.

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.
Combined use with other drugs for intravaginalny introduction is not recommended.

Contraindications:

hypersensitivity to clindamycin, lincomycin or any component of drug;
at patients about 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 in the I trimester of pregnancy were not conducted therefore cream vaginal women can appoint DALAQING in the I trimester of pregnancy only according to absolute indications i.e. when the potential advantage of therapy surpasses by drug for mother potential risk for a fruit.
At clindamycin use intravaginalno in II or the III trimester of pregnancy of increase in frequency of congenital anomalies of a fruit it was not noted. Abnormal childbirth took place at 1,1% of women in comparison with 0,5% in group of placebo if DALAQING cream vaginal was applied in the II trimester within 7 days.
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 of cream absorption of clindamycin in the quantities sufficient for development of system reactions is possible.
Accidental hit of drug in digestive tract can also 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:

Cream of vaginal 2%.
Primary: on 20 and 40 g of cream in tubas from polyethylene / aluminum foil;
Secondary: 1 tuba on 20 g complete with 3 applicators or 1 tuba on 40 g complete with the 7th
applicators with the application instruction in a cardboard pack.