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Pharmaco-therapeutic group: Antimicrobial and antifungal agent
Butoconazole is an imidazole derivative and has fungicidal activity against the fungi Candida, Trichophyton, Microsporum, Epidermaphyton and some gram-positive bacteria. Most effective for candida.
By blocking the formation of ergosterol from lanosterol in the cell membrane, increases the permeability of the membrane, which leads to the lysis of the fungal cell.
Clindamycin is a bacteriostatic antibiotic from the group of lincosamides, has a broad spectrum of activity, binds to the 50S subunit of the ribosomal membrane and inhibits protein synthesis in the microbial cell. In respect of a number of gram-positive cocci possible bactericidal action.
The following microorganisms that cause bacterial vaginosis are sensitive to clindamycin in vitro: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.
The hydrophilic cream base provides the preparation with a gel-like consistency at a temperature of 35-40 ° C. When intravaginal application of the cream does not melt, so that the active substances are on the mucous membrane of the vagina for 1-3 days.
There is cross-resistance between clindamycin and lincomycin.
With intravaginal administration, about 1.7% of the administered dose of butoconazole is absorbed. Cmax in the blood plasma of butoconazole is reached after 13 h and is 2-18.6 ng / ml. Butoconazole is intensively metabolized, partially excreted by the kidneys and intestines.
After applying clindamycin intravaginally at a dose of 100 mg / day once (as 2% clindamycin phosphate cream) for 7 days Cm of clindamycin in plasma is reached after 10 hours (4-24 hours) and averages 18 ng on day 1 / 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 dosing regimen, about 4% of clindamycin is exposed to systemic absorption (with a smaller spread of 2–8%), Cmax is achieved 14 hours (4-24 hours) after administration and averages 13 ng / ml on the first day (6-34 ng / ml), and on the 7th day - 16 ng / ml (7-26 ng / ml).
Systemic effects of clindamycin when intravaginal use is less pronounced than with the introduction inside or IV.
T1 / 2 is 1.5-2.6 hours. After repeated intravaginal administration, clindamycin almost does not accumulate.
Pharmacokinetics in Special Patient Groups
In clinical studies of clindamycin 2% vaginal cream, there were an insufficient number of patients aged 65 years and older to assess the difference in clinical response to therapy between this age group and younger patients. In available reports from clinical experience, there was no difference in the response of elderly patients and younger patients.
Bacterial vaginosis, fungal and mixed vaginitis caused by microorganisms sensitive to the drug.
Cream vaginal from almost white to white with a grayish shade of color, with a specific smell.
|butoconazole nitrate||2 g|
|clindamycin phosphate||2.376 mg,|
|which corresponds to the content of clindamycin||2 g|
Excipients: preservative Euxyl PE 9010 (phenoxyethanol 90% etilgeksilglitserol 10%) - 0.5 g, equivalent to 0.45 g of phenoxyethanol, propylene glycol - 5 g isopropyl myristate - 8 g, macrogol tsetostearat (macrogol-20 cetostearyl ether) - 2 g, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) - 6 g, hydroxypropyl dicarmal phosphate - 8 g, sodium hydroxide - 0.26 g, purified water - up to 100 g
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Dosage and Administration
Enter intravaginally using an applicator, 1 time / day, preferably before bedtime.
The recommended dose is 1 full applicator (5 g cream, which corresponds to 100 mg of butoconazole nitrate and 100 mg of clindamycin).
The course of treatment is daily for 3 days.
Instructions for use
Disposable applicators attached to the package are designed for precise dosing and insertion of the cream into the vagina.
1. Open the cream tube by removing the cap. Pierce the membrane of the tube with the reverse side of the cap. Screw the plastic applicator onto the threaded neck of the tube.
2. Pressing the tube from the opposite end gently squeeze the cream into the applicator. The applicator piston moves independently as the required volume is filled. The applicator is filled when its piston reaches the stop. Unscrew the applicator and close the tube.
3. In the supine position, tighten your knees to your chest. Holding the applicator horizontally, gently push it into the vagina as deeply as possible, taking care not to cause any discomfort.
4. Slowly pressing on the piston until it stops, enter the entire volume of the cream into the vagina.
5. Carefully remove the applicator from the vagina and discard it in the trash.
The drug is usually well tolerated, however, the following undesirable effects may occur:
On the part of the genital organs and the mammary gland: irritation at the injection site, burning, itching, soreness and swelling of the vaginal mucosa.
On the part of the digestive system: pain / cramps in the lower abdomen often.
On the part of the immune system: the development of allergic reactions.
The safety of clindamycin vaginal cream was assessed both in non-pregnant patients and in patients in the second and third trimesters of pregnancy.
Adverse drug reactions reported with clindamycin, vaginal cream
Determination of the frequency of undesirable reactions: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10 000 to <1/1000), very rarely (<1/10 000), frequency unknown (impossible to estimate based on available data).
Infectious and parasitic diseases: often - fungal infections caused by Candida fungi; infrequently - bacterial infections; frequency is unknown - skin candidiasis.
On the part of the immune system: infrequently - hypersensitivity.
On the part of the endocrine system: the frequency is unknown - hyperthyroidism.
Of the nervous system: often - headache, dizziness, dysgeusia.
From the organ of hearing and vestibular apparatus: infrequently - vertigo.
Respiratory system disorders: often - upper respiratory tract infections; infrequently - nosebleeds.
On the part of the digestive system: often - abdominal pain, constipation, diarrhea, nausea, vomiting; infrequently - abdominal distension, flatulence, bad breath; frequency unknown - pseudomembranous colitis *, gastrointestinal disorders, dyspepsia.
On the part of the skin and subcutaneous tissues: often - itchy skin, rash; infrequently - urticaria, erythema; frequency is unknown - makulo-papular rash.
On the part of the musculoskeletal system: often - back pain.
On the part of the urinary system: often - urinary tract infections, glycosuria, proteinuria; infrequently - dysuria.
Pregnancy, postpartum and perinatal conditions: often - abnormal birth.
On the part of the genital organs and the mammary gland: very often - vulvovaginal candidiasis; often - vulvovaginitis, vulvovaginal disorders, menstrual disorders, vulvovaginal pain, metrorrhagia, vaginal discharge; infrequently - trichomonas vulvovaginitis, vaginal infections, pain in the pelvis; frequency unknown - endometriosis.
Common disorders and reactions at the site of reference: frequency unknown - inflammation, pain.
Data from laboratory and instrumental examinations: infrequently - deviation of microbiological test results from the norm.
* Adverse drug reactions identified in the post-registration period.
With care: allergic diseases, simultaneous taking of muscle relaxants.
There is cross-resistance between clindamycin and lincomycin.
In vitro antagonism between clindamycin and erythromycin has been demonstrated.
It is established that clindamycin in systemic use violates neuromuscular transmission and, therefore, may enhance the action of peripheral muscle relaxants, so the drug should be used with caution in patients receiving drugs in this group.
Combined use with other drugs for intravaginal administration is not recommended.
Incompatible with solutions containing the complex of vitamins of group B, aminoglycosides, ampicillin, calcium gluconate and magnesium sulfate.
Before prescribing, Trichomonas vaginalis, Chlamidia trachomatis, Neisseria gonorrhoeae and Herpes simplex virus, often causing vulvovaginitis, should be excluded using appropriate laboratory methods.
Intravaginal use of clindamycin can lead to enhanced growth of insensitive microorganisms, especially yeast-like fungi.
The use of clindamycin (like almost all antibiotics) orally or parenterally is associated with the development of severe diarrhea and in some cases pseudomembranous colitis. With the development of severe or prolonged diarrhea, the drug should be canceled and, if necessary, carry out appropriate diagnostic and therapeutic measures. Patients should be warned that during drug therapy should not engage in sexual intercourse.
Vaginal cream is not recommended to be used simultaneously with other intravaginal drugs.
The use of the drug during menstruation is not recommended. It is necessary to postpone the start of therapy until the end of menstruation.
The drug contains components that can reduce the strength of latex or rubber products, so the use of condoms, vaginal contraceptive diaphragms and other latex products for intravaginal use during drug therapy and for 72 hours after use is not recommended.
If the clinical signs of infection persist after completion of treatment, a microbiological examination should be repeated to identify the causative agent and confirm the diagnosis.
Cetostearyl alcohol contained in the preparation can cause local skin reactions (rash, contact dermatitis). The appearance of irritation of the mucous membrane of the vagina or painful sensations serves as an indication for stopping the treatment.
Influence on ability to drive motor transport and control mechanisms
There is no reason to believe that the use of Clindacin® B Prolong vaginal cream can affect the ability to drive a car and control mechanisms.
With intravaginal use of the drug overdose is not installed. Possible absorption of clindamycin in quantities sufficient for the development of 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 (see the “Side Effects” and “Special Instructions” sections).
Treatment: symptomatic and supportive.
- Brand name: Clindacin
- Active ingredient: Butoconazole, Clindamycin
- Manufacturer: Vertex