Composition, form of production and packaging
Vaginal cream of white color.
1 g
clindamycin (in the form of phosphate) 20 mg
Excipients: sorbitan monostearate 20 mg, polysorbate 60-50 mg, propylene glycol 50 mg, stearic acid 21.4 mg, cetostearyl alcohol 32.1 mg, cetyl palmitate 32.1 mg, mineral oil 64.2 mg, benzyl alcohol 10 mg, water Purified - qs
20 grams - tubes of polyethylene / aluminum foil (1) complete with applicators (3 pcs.) - packs of cardboard.
40 g - tubes of polyethylene / aluminum foil (1) complete with applicators (7 pcs.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antibiotic group lincosamides for topical use.
Clindamycin phosphate is inactive in vitro, but it rapidly hydrolyses in vivo to form clindamycin, which has antibacterial activity.
Clindamycin inhibits protein synthesis in a microbial cell due to interaction with the ribosome 50S subunit.
In vitro, the following microorganisms that cause bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.
PHARMACOKINETICS
Suction
After intravaginal application of clindamycin in a dose of 100 mg / day once for 7 days, C max of clindamycin in blood plasma is achieved after 10 h (4-24 h) and is on the 1st day on the average 18 ng / ml (4-47 ng / ml), and on the 7th day - 25 ng / ml (6-61 ng / ml), while the systemic absorption is about 4% (0.6-11%) of the administered dose.
In women with bacterial vaginosis, about 4% of clindamycin (with a smaller spread of 2-8%) undergoes a similar systemic dosing regimen, C max is reached after 14 hours (4-24 hours) after administration and on the first day is on the average 13 ng / ml (6-34 ng / ml), and on the 7th day - 16 ng / ml (7-26 ng / ml).
Systemic exposure to clindamycin for intravaginal application is less pronounced than when administered intravenously or intravenously.
Excretion
T 1/2 is 1.5-2.6 hours. After repeated intravaginal administration, clindamycin is almost not cumulative.
Pharmacokinetics in specific patient groups
In clinical studies of clindamycin, 2% of the vaginal cream involved an inadequate number of patients 65 years of age or older, so that the difference in clinical response to therapy between this age group and younger patients could be assessed. In the available reports, there was no difference in the response of elderly patients and younger patients from clinical experience.
INDICATIONS
bacterial vaginosis.
DOSING MODE
1 complete applicator (5 g of cream, approximately 100 mg of clindamycin) is inserted into the vagina preferably at bedtime for 3 or 7 consecutive days.
Terms of use
In the package with 20 g of cream there are 3 plastic applicators, and in the package with 40 g - 7 applicators intended for the correct introduction of cream into the vagina.
1. Remove the cap of the tube with cream. Screw the plastic applicator onto the threaded neck of the tube.
2. While 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. Holding the applicator horizontally, you should carefully insert it into the vagina as deeply as possible, without causing unpleasant sensations.
5. Slowly push the piston against the stop, insert the cream into the vagina.
6. Carefully remove the applicator from the vagina and discard it.
SIDE EFFECT
The safety of clindamycin in the form of a vaginal cream was evaluated in both non-pregnant patients and in patients during the II and III trimesters of pregnancy.
Table. Unwanted drug reactions
Very often (? 1/10) Frequently (from? 1/100 to <1/10) Infrequently (from? 1/1000 to <1/100) Frequency is unknown (can not be estimated based on available data)
Infectious and parasitic diseases
Fungal infections, infections caused by fungi of the genus Candida Bacterial infections Candidiasis of the skin
From the immune system
Hypersensitivity
From the endocrine system
Hyperthyroidism
From the nervous system
Headache Dizziness Dysgeusia
From the side of the hearing and vestibular organs
Vertigo
From the respiratory system
Upper respiratory tract infection Nasal bleeding
From the digestive system
Abdominal pain Constipation Diarrhea Nausea Vomiting Bloating Meteorism Unpleasant odor of the mouth Pseudomembranous colitis * Gastrointestinal disorders Dyspepsia
From the skin and subcutaneous tissues
Skin itching Rash Urticaria Erythema Maculo-papular rash
From the musculoskeletal system
Backache
From the urinary system
Urinary Tract Infections Glucosuria Proteinuria Dysuria
Pregnancy, postpartum and perinatal conditions
Pathological birth
On the part of the reproductive system
Vulvovaginal candidiasis Vulvovaginitis Vulvovaginal disorders Violation of the menstrual cycle Vulvovaginal pain Metrorrhagia Vaginal discharge Trichomonas vulvovaginalis Vulvovaginal infections Pelvic pain Endometriosis
General disorders and reactions at the site of administration
Inflammation Pain
Laboratory and instrumental research data
Deviation of the results of microbiological analyzes from the norm
* Undesirable drug reactions detected in the post-marketing period.
CONTRAINDICATIONS
- an antibiotic-associated colitis in the anamnesis;
- age under 18 years (data on safety, efficiency are absent);
- Hypersensitivity to clindamycin, lincomycin or any component of the drug.
PREGNANCY AND LACTATION
Adequate and controlled studies on the use of the drug in the first trimester of pregnancy have not been conducted. The use of Dalacin in the first trimester of pregnancy is possible only on absolute indications, i.e. if the intended benefit of therapy with the drug for the mother exceeds the potential risk to the fetus.
In studies on animals with the introduction of clindamycin c / o or inside any adverse effects on the fetus is not found, except for cases of taking the drug in doses toxic to the mother.
When clindamycin was administered intravaginally in the II and III trimesters of pregnancy, there was no increase in the frequency of congenital abnormalities of the fetus. Abnormal births occurred in 1.1% of women compared with 0.5% in the placebo group, if Dalacin В® vaginal cream was used in the II trimester for 7 days. The use of the drug in the II-III trimester of pregnancy is possible if the potential benefit to the mother exceeds the risk to the fetus.
It is not known whether clindamycin is excreted in breast milk after intravaginal application. Clindamycin is found in breast milk after oral administration or parenteral administration. Therefore, during lactation, you should either abolish the drug or stop breastfeeding, given the importance of the drug for the mother.
APPLICATION FOR CHILDREN
Contraindicated use of the drug in children and adolescents under the age of 18 years (safety data, no efficacy).
APPLICATION IN ELDERLY PATIENTS
In clinical studies of clindamycin, 2% of the vaginal cream involved an inadequate number of patients 65 years of age or older, so that the difference in clinical response to therapy between this age group and younger patients could be assessed. In the available reports, there was no difference in the response of elderly patients and younger patients from clinical experience.
SPECIAL INSTRUCTIONS
Prior to the appointment of the drug with the help of special laboratory methods, the following possible causative agents of vulvovaginitis should be excluded: Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus.
Intravaginal application of Dalacin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.
With the use of clindamycin (as well as almost all antibiotics), the development of severe diarrhea and, in some cases, pseudomembranous colitis, is possible internally or intravaginally. In this regard, if there is a marked or prolonged diarrhea on the background of Dalatine therapy, it is necessary to cancel the drug and, if necessary, to carry out diagnostic and therapeutic measures.
The patient should be informed that, during the use of the vaginal cream, sexual contact should be avoided, as well as the use of other types of products intended for intravaginal administration (eg tampons, douching).
It is not recommended to use Dalacin В® during menstruation. It is necessary to postpone the initiation of therapy until the end of menstruation.
Dalacin В® contains components that can reduce the strength of products made of latex or rubber (condoms, birth control vaginal diaphragms). Therefore, the use of such products during treatment with Dalacin and within 72 hours after use is not recommended.
Impact on the ability to drive vehicles and manage mechanisms
There is no reason to believe that the use of the drug may affect the ability to drive and control machinery.
OVERDOSE
With intravaginal application of Dalacin В® cream, clindamycin can be absorbed in amounts sufficient to develop systemic reactions.
Accidental ingestion of the drug in the gastrointestinal tract can also cause systemic effects similar to those that occur after ingestion of clindamycin in therapeutic doses. Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis.
Treatment: if necessary, conduct symptomatic and supportive therapy.
DRUG INTERACTION
There is cross-resistance between clindamycin and lincomycin.
In vitro, antagonism between clindamycin and erythromycin has been demonstrated.
It has been established that clindamycin disrupts neuromuscular transmission and, therefore, can enhance the action of muscle relaxants of peripheral action, so the drug should be used with caution in patients receiving drugs of this group.
Joint use with other drugs for intravaginal administration is not recommended.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Do not freeze. Shelf life - 2 years.
