Dalacin cream vaginal 2% 40g with applicati. N7
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Clindamycin
Release form
Cream
Composition
1 g: Active substances: clindamycin (in the form of phosphate) - 20 mg.; Auxiliary substances: 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, purified water - qs
Pharmacological effect
An antibiotic of the group of lincosamides for local use.; Clindamycin phosphate is not active in vitro, but quickly hydrolyzes in vivo to form clindamycin, which has antibacterial activity.; Clindamycin inhibits protein synthesis in the microbial cell through interaction with the 50S-subunit of ribosomes. In vitro to clindamycin The following microorganisms that cause bacterial vaginosis are sensitive: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.
Pharmacokinetics
Absorption; After intravaginal use of clindamycin at a dose of 100 mg / day once a day for 7 days Cmax of clindamycin in the blood plasma is reached in 10 hours (4-24 hours) and averages 18 ng / ml (4-47 ng / ml), and on the 7th day - 25 ng / ml (6-61 ng / ml), while systemic absorption is about 4% (0.6-11%) of the administered dose. In women with bacterial vaginosis, with a similar about 4% of clindamycin (with a smaller spread of 2-8%) is subjected to a systemic dosing regimen, Cmax is reached 14 hours (4-24 hours) after administration and is on the first day in the middle 13 ng / ml (6-34 ng / ml) and 16 ng / ml (7-26 ng / ml) on the 7th day; systemic effects of clindamycin when administered intravaginally less pronounced than when administered orally or / in.; Exit; T1/2 is 1.5-2.6 hours. After repeated intravaginal administration, clindamycin almost does not accumulate.; Pharmacokinetics in special groups of patients; In clinical studies of clindamycin 2% of vaginal cream participated an insufficient number of patients aged 65 years and older, so that it is possible to assess the difference in clinical response to therapy between the indicated age group and younger patients. In available reports from clinical experience, there was no difference in the response of elderly patients and younger patients.
Indications
- bacterial vaginosis.
Contraindications
- antibiotic-associated colitis in history; - age up to 18 years (data on safety, efficiency are absent); - hypersensitivity to clindamycin, lincomycin or any component of the drug.
Use during pregnancy and lactation
Adequate and controlled studies on the use of the drug in the first trimester of pregnancy has not been conducted. The use of Dalacin in the first trimester of pregnancy is possible only by absolute indications, i.e. in the event that the intended benefit of drug therapy for the mother outweighs the potential risk to the fetus. In animal studies with the administration of clindamycin s / c or inside, no negative effects on the fetus were found, except in cases of taking the drug in doses that are toxic to maternal.; When using clindamycin intravaginally in the second and third trimesters of pregnancy, there was no increase in the incidence of congenital abnormalities of the fetus. Abnormal delivery occurred in 1.1% of women compared to 0.5% in the placebo group if Dalacin; 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 use. Clindamycin is found in breast milk after ingestion or parenteral administration. Therefore, during lactation, you should either cancel the use of the drug, or stop breastfeeding, given the degree of importance of the use of the drug for the mother.
Dosage and administration
1 full applicator (5 g of cream, about 100 mg of clindamycin) is injected into the vagina, preferably at bedtime for 3 or 7 days in a row.; Terms of use of the drug; In the package with 20 g of cream there are 3 plastic applicators, and in the package with 40 g 7 applicators designed for the correct insertion of the cream into the vagina.; 1. Remove the cap of the tube of cream. Screw the plastic applicator onto the threaded neck of the tube.; 2. When rolling the tube from the opposite end, you should gently squeeze the cream into the applicator. The applicator is full when its piston reaches the stop; 3. Unscrew the applicator from the tube and wrap the cap.; 4. In the supine position, tighten your knees to your chest.; 5. Holding the applicator horizontally, you should gently push it into the vagina as deeply as possible without causing unpleasant sensations; 5. Slowly pressing the piston until it stops, insert the cream into the vagina.; 6. Carefully remove the applicator from the vagina and discard it.
Side effects
Most often - dry skin.; Less commonly: abdominal pain, skin irritation, gastrointestinal disorders (diarrhea, nausea, vomiting), contact dermatitis, a burning sensation in the eyes, folliculitis caused by gram-negative flora, increased production of the sebaceous glands. ; In extremely rare cases, colitis may develop. ; Clindamycin phosphate, when applied topically, can be absorbed in quantities that cause systemic effects.
Overdose
With intravaginal application of the cream Dalacin; absorption of clindamycin in quantities sufficient for the development of systemic reactions is possible.; 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, symptomatic and supportive therapy is carried out.
Interaction with other drugs
There is cross-resistance between clindamycin and lincomycin.; Antagonism between clindamycin and erythromycin has been demonstrated in vitro. Clindamycin has been found to impair neuromuscular transmission and, therefore, may enhance the action of peripheral muscle relaxants, therefore the drug should be used with caution in patients receiving drugs this group.; Combined use with other drugs for intravaginal administration is not recommended.
special instructions
Before prescribing 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; With clindamycin (like almost all antibiotics), inside or intravaginally, severe diarrhea and, in some cases, pseudomembranous colitis may develop. In this regard, when severe or prolonged diarrhea occurs during Dalacin therapy, the drug should be discontinued and, if necessary, diagnostic and therapeutic measures should be taken. The patient should be informed that during the use of vaginal cream, sexual intercourse, as well as other types should be avoided. products intended for intravaginal administration (for example, tampons, douches); Dalacin is not recommended; during menstruation.It is necessary to postpone the start of therapy until the end of menstruation.; Dalacin; contains components that can reduce the strength of latex or rubber products (condoms, vaginal contraceptive contraceptives). Therefore, the use of such products during treatment with Dalacin and for 72 hours after application is not recommended.; Influencing the ability to drive motor vehicles and control mechanisms; There is no reason to believe that the use of the drug may affect the ability to drive a car and control mechanisms.