Instructions for Clindacin B prolong (Clindamycin, Butoconazole) vaginal cream
Clindacin B prolong is a local combination drug with antifungal and antibacterial action, used in gynecology.
Release form Clindacin B:
Vaginal cream
Description Clindacin B prolong:
Vaginal cream from almost white to white with a grayish shade, with a specific odor.
100 g
butoconazole nitrate 2 g
clindamycin phosphate 2.376 g,
which corresponds to the content of clindamycin 2
Excipients: preservative Euxyl PE 9010 (phenoxyethanol 90%, ethylhexylglycerol 10%) - 0.5 g, which is equivalent to 0.45 g of phenoxyethanol, propylene glycol - 5 g, isopropyl myristate - 8 g, macrogola cetostearate (macrogola-20 cetostearyl ether) - 2 e alcohol [cetyl alcohol 60%, stearyl alcohol 40%] - 6 g, hydroxypropyl dichloromethane phosphate - 8 g, sodium hydroxide - 0.26 g, purified water - up to 100 g
6 g - aluminum tubes (1) complete with 1 applicator - cardboard packs.
20 g - aluminum tubes (1) complete with 3 applicators - cardboard packs.
G01A Antiseptics and antimicrobials for the treatment of gynecological diseases (excluding combinations with corticosteroids)
Clinical and pharmacological groups / Group affiliation
Drug with antibacterial and antifungal action for local use in gynecology
Active substance Clindacin B prolong:
clindamycin
butoconazole nitrate
Pharmaco-therapeutic group Clindacin:
Antimicrobial and antifungal agent
Storage conditions:
The drug should be stored out of the reach of children at a temperature of 15 ° C to 25 ° C.
pharmachologic effect Clindacin B prolong:
Butoconazole is an imidazole derivative that has fungicidal activity against Candida, Trichophyton, Microsporum, Epidermophyton and some gram-positive bacteria. Most effective for candidiasis.
By blocking the formation of ergosterol from lanosterol in the cell membrane, it increases the permeability of the membrane, which leads to the lysis of the fungal cell.
Clindamycin is a bacteriostatic from the group of lincosamides, has a broad spectrum of action, binds to the 50S subunit of the ribosomal membrane and suppresses protein synthesis in the microbial cell. In relation to a number of gram-positive cocci, a bactericidal effect is possible.
In vitro, the following microorganisms that cause bacterial vaginosis are sensitive to clindamycin: 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. With intravaginal application, the cream does not melt, due to which the active substances are on the vaginal mucosa for 1-3 days.
There is cross-resistance between clindamycin and lincomycin.
Indications Clindacin B prolong:
bacterial vaginosis, fungal and mixed vaginitis caused by microorganisms sensitive to the drug.
Method of application, course and dosage Clindacin B prolong:
It is administered intravaginally with an applicator, 1 time / day, preferably at bedtime.
The recommended dose is 1 full applicator (5 g cream, which corresponds to 100 mg butoconazole nitrate and 100 mg clindamycin).
The course of treatment is daily for 3 days.
Directions for use
The disposable applicators included with the package are designed for accurate dosing and insertion of the cream into the vagina.
Open the tube of cream by removing the cap. Pierce the membrane of the tube with the back of the cap. Screw the plastic applicator onto the threaded neck of the tube.
Pressing gently on the tube from the opposite end, gently squeeze the cream into the applicator. The applicator piston moves on its own as the required volume is filled. The applicator is full when its plunger reaches the stop. Unscrew the applicator and close the tube.
In a supine position, bring your knees up to your chest. Holding the applicator horizontally, gently insert it into the vagina as deep as possible, being careful not to cause discomfort.
Slowly pushing the plunger until it stops, inject the entire volume of the cream into the vagina.
Gently remove the applicator from your vagina and discard it in the trash can.
Overdose Clindacin B prolong
With intravaginal use of the drug, an overdose has not been established. Absorption of clindamycin is possible 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 oral administration of clindamycin in therapeutic doses. Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis (see sections "Side effects" and "Special instructions").
Treatment: symptomatic and supportive.
Drug interactions Clindacin B prolong
There is cross-resistance between clindamycin and lincomycin .
Anatagonism between clindamycin and erythromycin has been demonstrated in vitro .
It has been established that systemic use of clindamycin disrupts neuromuscular transmission and, therefore, can enhance the effect of peripheral muscle relaxants , so the drug should be used with caution in patients receiving drugs of this group.
Combined use with other drugs for intravaginal administration is not recommended.
Incompatible with solutions containing a complex of B vitamins, aminoglycosides, ampicillin, calcium gluconate and magnesium sulfate.
Application during pregnancy and lactation
The use of the drug during pregnancy and lactation is possible only if the potential benefit to the mother outweighs the risk to the fetus or child.
Adequate controlled trials on the drug to I trimester has been conducted, however Klindatsin ®B prolong can be prescribed to women in the first trimester of pregnancy only for absolute indications, i.e. when the potential benefit of drug therapy to the mother outweighs the potential risk to the fetus. In animal studies, with the introduction of clindamycin s / c or inside, no negative effects on the fetus were found, except for cases of taking the drug in doses toxic to the mother. When using clindamycin intravaginally in the II or III trimester of pregnancy, there was no increase in the incidence of congenital fetal anomalies. Abnormal delivery occurred in 1.1% of women compared with 0.5% in the placebo group if clindamycin vaginal cream was applied in the second trimester for 7 days. The use of the drug in the II and III trimester of pregnancy is possible if the potential benefit to the mother outweighs 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 oral or parenteral administration, therefore, during breastfeeding, either discontinue the drug or stop breastfeeding, given the importance of the drug to the mother.
Side effect Clindacin B prolong:
The drug is usually well tolerated, but the following undesirable effects are possible.
Butoconazole
From the genitals and mammary gland: irritation at the injection site, burning, itching, soreness and swelling of the vaginal mucosa.
From the digestive system: pain / cramps in the lower abdomen.
From the immune system: the development of allergic reactions.
Clindamycin
The safety of clindamycin vaginal cream was assessed both in non-pregnant patients and in patients in the II and III trimesters of pregnancy.
Adverse drug reactions registered with the use of clindamycin, vaginal cream
Determination of the frequency of adverse reactions: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from available data).
Infectious and parasitic diseases: often - fungal infections caused by fungi of the genus Candida; infrequently - bacterial infections; frequency unknown - candidiasis of the skin.
From the immune system: infrequently - hypersensitivity.
From the endocrine system: the frequency is unknown - hyperthyroidism.
From the nervous system: often - headache, dizziness, dysgeusia.
On the part of the organ of hearing and vestibular apparatus: infrequently - vertigo.
From the respiratory system: often - upper respiratory tract infections; infrequently - nosebleeds.
From the digestive system: often - abdominal pain, constipation, diarrhea, nausea, vomiting; infrequently - bloating, flatulence, bad breath; frequency unknown - pseudomembranous colitis *, gastrointestinal disorders, dyspepsia.
On the part of the skin and subcutaneous tissues: often - itching of the skin, rash; infrequently - urticaria, erythema; frequency unknown - maculopapular rash.
From the musculoskeletal system: often - back pain.
From the urinary system: often - urinary tract infections, glucosuria, proteinuria; infrequently - dysuria.
Pregnancy, postpartum and perinatal conditions: often abnormal delivery.
On the part of the genitals and mammary gland: very often - vulvovaginal candidiasis; often - vulvovaginitis, vulvovaginal disorders, menstrual irregularities, vulvovaginal pain, metrorrhagia, vaginal discharge; infrequently - trichomonas vulvovaginitis, vaginal infections, pelvic pain; frequency unknown - endometriosis.
General disorders and reactions at the site of management: frequency unknown - inflammation, pain.
Data of laboratory and instrumental studies: infrequently - deviation of the results of microbiological analyzes from the norm.
Adverse drug reactions identified in the post-registration period.
Contraindications for use Clindacin B
hypersensitivity to clindamycin, lincomycin, butoconazole or any component of the drug;
inflammatory bowel diseases (Crohn's disease, ulcerative, pseudomembranous and associated colitis (including in history));
age under 18;
With care: allergic diseases, concomitant use of muscle relaxants.
special instructions Clindacin B prolong:
Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae and Herpes simplex virus, which often cause vulvovaginitis, must be excluded before prescribing the drug using appropriate laboratory methods.
Intravaginal use of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.
The use of clindamycin (like almost all by mouth or parenteral 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 discontinued and, if necessary, appropriate diagnostic and therapeutic measures should be taken. Patients should be warned not to have sexual intercourse during drug therapy.
Vaginal cream is not recommended to be used concurrently with other intravaginal drugs.
It is not recommended to use the drug during menstruation. The initiation of therapy should be postponed until the end of menstruation.
The drug contains components that can reduce the strength of latex or rubber products, therefore, the use of condoms, vaginal contraceptive diaphragms and other latex products for intravaginal use during drug therapy and within 72 hours after use is not recommended.
If clinical signs of infection persist after completion of treatment, a second microbiological study should be performed to identify the pathogen and confirm the diagnosis.
Cetostearyl alcohol, which is part of the drug, can cause local skin reactions (rash, contact dermatitis). The appearance of irritation of the vaginal mucosa or painful sensations is an indication to discontinue treatment.
Influence on the ability to drive vehicles and mechanisms
There is no reason to believe that the use of the drug. B prolonged vaginal cream may affect the ability to drive a car and use mechanisms.
Terms of sale
The drug is available with a prescription.
Application in children Clindacin B
Contraindicated in children and adolescents under 18 years of age.
Nosology (ICD codes)Vulvar and vaginal candidiasis
Other inflammatory diseases of the vagina and vulva
Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
Other non-inflammatory diseases of the vagina