Klindacin B prolong vaginal cream 2%+2% tube 20g +, applicator

Composition

Vaginal cream from almost white to white with a grayish tinge of color, with a specific smell.

Excipients: Euxyl PE 9010 preservative (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 (macrogol-20 cetostearyl ether) – 2 g, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol alcohol 40%) – 6 g, hydroxypropyl di starch phosphate – 8 g, sodium hydroxide – 0.26 g, purified water – up to 100 g.

Pharmacological action

Pharmaco-therapeutic group: Antimicrobial and antifungal agent Pharmacological Activitypharmacodynamicabutoconazole is an imidazole derivative that has fungicidal activity against Candida, Trichophyton, Microsporum, Epidermaphyton and some Gram-positive bacteria. It is most effective for candidiasis. Blocking the formation of ergosterol from lanosterol in the cell membrane increases the permeability of the membrane, which leads to lysis of the fungal cell. Clindamycin is a bacteriostatic antibiotic from the lincosamide group, 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. 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. 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, so the active substances are on the vaginal mucosa for 1-3 days. There is cross-resistance between clindamycin and lincomycin. Pharmacokinetics of butoconazole With intravaginal use, 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 undergoes intensive metabolism, partially excreted by the kidneys and intestines. Clindamycin resorption After use of clindamycin intravaginally at a dose of 100 mg/day once (in the form of 2% clindamycin phosphate cream) for 7 days, the cmax of clindamycin in blood plasma is reached in 10 hours (4-24 hours) and averages 18 ng/ml (4-47 ng/ml) on day 1, and 25 ng/ml (6-61 ng/ml) on day 7, with systemic absorption of about 4% (0.6-11%) of the administered dose. In women with bacterial vaginosis with a similar dosage regimen, about 4% of clindamycin is absorbed systemically (with a smaller spread of 2-8%), Cmax is reached 14 hours (4-24 hours) after use and averages 13 ng/ml (6-34 ng/ml) on the first day, and 16 ng/ml (7-26 ng/ml) on the 7th day. The systemic effect of clindamycin with intravaginal use is less pronounced than with oral or intravenous use. Excretion of T 1/2 is 1.5-2.6 h. After repeated intravaginal use, clindamycin almost does not accumulate. Pharmacokinetics in special patient groups In clinical trials of clindamycin 2% vaginal cream, an insufficient number of patients aged 65 years and older participated to assess the difference in clinical response to therapy between the specified age group and younger patients. In the available reports from clinical experience, there was no difference in the response of older patients and younger ones.

Indications

Bacterial vaginosis, fungal and mixed vaginitis caused by drug-sensitive microorganisms.

Contraindications

-Hypersensitivity to clindamycin, lincomycin, butoconazole or any component of the drug;- Crohn’s disease; – inflammatory bowel diseases (Crohn’s disease, ulcerative, pseudomembranous and antibiotic-associated colitis (including in the anamnesis));- under 18 years of age.

With caution:  allergic diseases, simultaneous use of muscle relaxants.

Side effects

The drug is usually well tolerated, but the following undesirable effects may occur: : Butoconazole from the genitals and breast: irritation at the injection site, burning, itching, soreness and swelling of the vaginal mucosa. From the digestive system: pain/cramps in the lower abdomen. Immune system disorders: development of allergic reactions. Clindamycin safety of clindamycin vaginal cream was evaluated both in non-pregnant patients and in patients in the second and third trimesters of pregnancy. Adverse drug reactions reported with the use of clindamycin, vaginal cream. Determination of the frequency of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare ( Infectious and parasitic diseases: often-fungal infections caused by fungi of the genus Candida; infrequently-bacterial infections; frequency unknown-candidiasis of the skin. Immune system disorders: infrequently-hypersensitivity. Endocrine system disorders: frequency unknown-hyperthyroidism. From the nervous system: often-headache, dizziness, dysgeusia. From the side 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. From the skin and subcutaneous tissues: often-pruritus 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. From the genitals and breast: very often-vulvovaginal candidiasis; often-vulvovaginitis, vulvovaginal disorders, menstrual disorders, vulvovaginal pain, metrorrhagia, vaginal discharge; infrequently-trichomonas vulvovaginitis, vaginal infections, pelvic pain; frequency unknown-endometriosis. General disorders and reactions at the site of use: frequency unknown-inflammation, pain. Data from laboratory and instrumental studies: infrequently-deviation of the results of microbiological tests from the norm. * Adverse drug reactions detected in the post-marketing period.

Interaction

There is cross-resistance between clindamycin and lincomycin. Anatagonism between clindamycin and erythromycin was demonstrated in vitro. Clindamycin has been found to interfere with neuromuscular transmission when administered systemically and, consequently, may enhance the effect of peripheral muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group. Concomitant use with other intravaginal medications is not recommended. Incompatible with solutions containing a complex of B vitamins, aminoglycosides, ampicillin, calcium gluconate and magnesium sulfate.

How to take, course of use and dosage

Enter intravaginally with an applicator,1 time/day, preferably before bedtime. The recommended dose is 1 full applicator (5 g of 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 The single-use applicators included with 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 tube membrane with the back of the cap. Screw the plastic applicator onto the threaded tube neck. 2. Gently press the tube from the opposite end and gently squeeze the cream into the applicator. The applicator plunger moves independently as it fills the required volume. The applicator is full when its plunger reaches its stop. Unscrew the applicator and close the tube. 3. While lying on your back, pull your knees up to your chest. Holding the applicator horizontally, carefully insert it into the vagina as deep as possible, trying not to cause unpleasant sensations. 4. Slowly push the plunger until it stops, insert the entire volume of cream into the vagina. 5. Carefully remove the applicator from your vagina and throw it in the trash can.

Overdose

With intravaginal use of the drug, overdose has not been established. It is possible to absorb clindamycin in sufficient quantities 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 use 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.

Special instructions

Before prescribing the drug, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae and Herpes simplex virus, which often cause vulvovaginitis, should be excluded using appropriate laboratory methods. Intravaginal use of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi. The use of clindamycin (as with almost all antibiotics) orally or parenterally is associated with the development of severe diarrhea and, in some cases, pseudomembranous colitis. If severe or prolonged diarrhea develops, 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 therapy with the drug. Vaginal cream is not recommended to be used simultaneously with other intravaginal medications. 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, so the use of condoms, vaginal contraceptive diaphragms and other latex products for intravaginal use during therapy with the drug and for 72 hours after use is not recommended. If clinical signs of infection persist after treatment is completed, a second microbiological examination should be performed to identify the pathogen and confirm the diagnosis. The cetostearyl alcohol included in the preparation can cause local skin reactions (rash, contact dermatitis). The appearance of irritation of the vaginal mucosa or painful sensations serves as an indication for discontinuing treatment. Effect on the ability to drive motor vehicles and control mechanisms: There is no reason to believe that the use of the drug Clindacin® B Prolong vaginal cream may affect the ability to drive a car and manage mechanisms.

Storage conditions

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

Shelf

life is 2 years.

Active ingredient

Butoconazole, Clindamycin

Conditions of release from pharmacies

By prescription

Dosage Form

Cream vaginal