Clindacin B prolonged vaginal cream, 20g

• bacterial vaginosis, fungal and mixed vaginitis caused by microorganisms sensitive to the drug.

It is administered intravaginally using 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.

1. 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.

2. 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.

3. In a supine position, bring your knees to your chest. Holding the applicator horizontally, gently insert it into the vagina as deep as possible, being careful not to cause discomfort.

4. Slowly pushing the plunger until it stops, inject the entire volume of the cream into the vagina.

5. Gently remove the applicator from your vagina and discard it in the trash can.

per 100 g

Active ingredients:

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%, ethylhexylglycerol 10%) - 0.5 g, which is equivalent to 0.45 g of phenoxyethanol, propylene glycol - 5 g, isopropyl myristate - 8 g, macrogol cetostearate (macrogola-20 cetostearyl ether) - 2 g, cetoste alcohol 60%, stearyl alcohol 40%) - 6 g, hydroxypropyl dichloromethane phosphate - 8 g, sodium hydroxide - 0.26 g, purified water - up to 100 g.

• hypersensitivity to clindamycin, lincomycin, butoconazole or any component of the drug;

• inflammatory bowel diseases (Crohn's disease, ulcerative, pseudomembranous and antibiotic-associated colitis (including a history));

• age under 18;

With care: allergic diseases, concomitant use of muscle relaxants.

Description:

Vaginal cream from almost white to white with a grayish shade, with a specific odor.

Ingredients: per 100 g

Active ingredients:

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%, ethylhexylglycerol 10%) - 0.5 g, which is equivalent to 0.45 g of phenoxyethanol, propylene glycol - 5 g, isopropyl myristate - 8 g, macrogol cetostearate (macrogola-20 cetostearyl ether) - 2 g, cetoste alcohol 60%, stearyl alcohol 40%) - 6 g, hydroxypropyl dichloromethane phosphate - 8 g, sodium hydroxide - 0.26 g, purified water - up to 100 g.

Clinical and pharmacological group: Drug with antibacterial and antifungal action for local use in gynecology

Pharmaco-therapeutic group: Antimicrobial and antifungal agent

pharmachologic effect

Pharmacodynamics

Butoconazole is an imidazole derivative that has fungicidal activity against Candida, Trichophyton, Microsporum, Epidermaphyton 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 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 relation to a number of gram-positive cocci, a bactericidal effect is possible.

Under in vitro conditions, 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.

Pharmacokinetics

Butoconazole

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 hours and is 2-18.6 ng / ml. Butoconazole is extensively metabolized, partially excreted by the kidneys and intestines.

Clindamycin

Suction

After using clindamycin intravaginally at a dose of 100 mg / day once (in the form of 2% clindamycin phosphate cream) for 7 days Cmax of clindamycin in blood plasma is achieved after 10 hours (4-24 hours) and is on the 1st day on average 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 dosing regimen, about 4% of clindamycin is subjected to systemic absorption (with a smaller spread of 2-8%), Cmax is reached 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).

The systemic effect of clindamycin with intravaginal use is less pronounced than with oral or intravenous administration.

Withdrawal

T1 / 2 is 1.5-2.6 hours. After repeated intravaginal administration, clindamycin almost does not cumulate.

Pharmacokinetics in special patient groups

In clinical studies of clindamycin 2% vaginal cream, an insufficient number of patients aged 65 years and older participated in order to assess the difference in clinical response to therapy between this age group and younger patients. In the available reports from clinical experience, there was no difference in response between older patients and younger patients.

Indications of the drug ClindacinЃ B prolong

• bacterial vaginosis, fungal and mixed vaginitis caused by microorganisms sensitive to the drug.

Dosage regimen

It is administered intravaginally using 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.

1. 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.

2. 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.

3. In a supine position, bring your knees to your chest. Holding the applicator horizontally, gently insert it into the vagina as deep as possible, being careful not to cause discomfort.

4. Slowly pushing the plunger until it stops, inject the entire volume of the cream into the vagina.

5. Gently remove the applicator from your vagina and discard it in the trash can.

Side effect

The drug is usually well tolerated, but the following undesirable effects may occur.

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? 1/10 000 up to <1/1000), very rare (<1/10 000), the frequency is unknown (cannot be estimated from the 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

• hypersensitivity to clindamycin, lincomycin, butoconazole or any component of the drug;

• inflammatory bowel diseases (Crohn's disease, ulcerative, pseudomembranous and antibiotic-associated colitis (including a history));

• age under 18;

With care: allergic diseases, concomitant use of muscle relaxants.

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 studies on the use of the drug in the first trimester of pregnancy have not been carried out, therefore, ClindacinЃ 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 the drug should be discontinued or breastfeeding should be discontinued, given the importance of the drug to the mother.

Application in children

Contraindicated in children and adolescents under 18 years of age.

special instructions

Trichomonas vaginalis, Chlamidia 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 antibiotics) 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. You should postpone the start of therapy 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 serves as an indication for discontinuation of treatment.

Influence on the ability to drive vehicles and mechanisms

There is no reason to believe that the use of the drug ClindacinЃ B Prolong vaginal cream may affect the ability to drive a car and use mechanisms.

Overdose

With intravaginal use of the drug, overdose has not been established. 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 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

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.

Storage conditions of the drug ClindacinЃ B prolong

The drug should be stored out of the reach of children at a temperature of 15 ? C to 25 ? C.

Shelf life of the drug ClindacinЃ B prolong

Shelf life is 2 years. Do not use after the expiration date.

Terms of sale

The drug is available with a prescription.