Banbakt

White to light yellow color torpedo shaped suppositories.
Each vaginal suppository contains: Clindamycin phosphate USP equivalent to Clindamycin 100 mg.
Excipients/Inactive Ingredients: Hard fat.

Pharmacotherapeutic group: Gynecological anti-infective and antiseptics. Anti-infectives and antiseptics, excl. combinations with corticosteroids. Antibiotics. Clindamycin. ATC code: G01AA10.
Pharmacology: Pharmacodynamics: Clindamycin belongs to the antibiotics of the group of linzamides. Suppresses protein synthesis in a microbial cell, interacting with 50S subunits of ribosomes. With local intravaginal application, clindamycin phosphate is hydrolyzed to clindamycin, which exhibits antibacterial activity. Clindamycin is active in vitro against the following registered strains of microorganisms associated with bacterial vaginosis: Bacteroides spp., Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Peptostreptococcus spp.
The data of the original clindamycin on the susceptibility of bacteria associated with bacterial vaginosis. (See table.)

Click on icon to see table/diagram/image

There is evidence of cross-resistance between clindamycin and lincomycin.
There is evidence of antagonism between clindamycin and erythromycin in vitro. Clinical significance of these data is unknown.
Pharmacokinetics: Clindamycin phosphate is rapidly hydrolyzed in the body with the formation of clindamycin, which exhibits antibacterial activity. Studies of the original clindamycin showed approximately 30% (6-70%) of the drug penetrates into the systemic circulation by intravaginal administration. The mean area under the curve (AUC) after three-day use of suppositories was 3.2 μg·h/ml (from 0.42 to 11 μg·h/ml). The maximum concentration in the blood is observed on day 3 for 5 hours (within 1 to 10 hours) after the use of suppositories and is on average 0.27 μg/ml (0.03-0.67 μg/ml). The average half-life after the use of suppositories is 11 hours (within 4 to 35 hours), it is believed that it is limited by the rate of absorption. The systemic absorption of clindamycin in the form of suppositories is 7 times higher than with the use of a similar dose of clindamycin in the form of a vaginal cream. In general, the systemic effect of clindamycin in the form of vaginal suppositories is 2-20 times lower than the therapeutic dose of oral clindamycin hydrochloride and 40-50 times lower than the therapeutic dose of parenteral clindamycin phosphate.

Clindamycin (Banbakt) suppository is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

Dosage: One suppository intravaginally 1 time per day at bedtime for 3 consecutive days.
Use in Paediatric Patients: There is no data on the use of the medicine in pediatric practice.
Use in Elderly Patients: The use of Clindamycin (Banbakt) suppositories has not been studied in patients over 65 years of age.
Use in Patients with Renal Impairment: The use of Clindamycin (Banbakt) suppositories has not been studied in patients with impaired renal function.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Route of administration: Vaginal.
Remove the suppository from the strip and insert it deep into the vagina in lying position with the knees bent or in squatting position.
Do not cut the suppositories into parts as such change in storage conditions may cause misdistribution of the active substance.

Cases of overdose with recommendations for the use of the medicinal product are unknown.
Clindamycin phosphate, contained in the drug and used vaginally, can be absorbed in an amount sufficient to develop systemic effects.
In case of overdose, the use of general symptomatic and supportive treatment is indicated in case of need.
In case of accidental intake of the medicinal product, it is possible that the effects associated with the therapeutic concentrations of clindamycin in the blood may occur internally.

Hypersensitivity to clindamycin, lincomycin or to other components of the drug.
History of colitis associated with the use of antibiotics.

General: The safety and efficacy of intravaginal administration of clindamycin have not been studied in the following populations: pregnant women, breast feeding women, women with impaired liver function, immunodeficiency states or colitis.
Before or after initiation of therapy with Clindamycin (Banbakt) suppositories, other infections including Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and gonococcal infections may need to be investigated by adequate laboratory tests.
The use of Clindamycin (Banbakt) suppositories may result in the overgrowth of nonsusceptible organisms, particularly yeasts.
Pseudomembranous colitis: The use of clindamycin, as well as other antibacterial agents, can cause diarrhea, and in some cases pseudomembranous colitis, which can be both moderate and life threatening. If the use of Clindamycin (Banbakt) suppositories develops severe or prolonged diarrhea, then the medicinal product should be discontinued, carry out appropriate diagnostic procedures and, if necessary, antibiotic treatment should be prescribed. Medicines that suppress the peristalsis are contraindicated in this case. Clindamycin (Banbakt) suppositories should be used with caution in case of history of colitis caused by antibiotics. In such cases, it is recommended to carefully evaluate the benefits of bacterial vaginosis treatment and the potential risk of pseudomembranous colitis.
Inflammatory bowel disease: Clindamycin is recommended in the form of vaginal suppositories with caution for patients with inflammatory bowel disease, in particular Crohn's disease or nonspecific ulcerative colitis.
Sexual intercourse: Patients should be advised that during therapy with Clindamycin (Banbakt) suppositories sexual intercourse should be avoided. The medicinal product contains ingredients that can reduce the strength of latex or rubber products, such as condoms or birth control vaginal diaphragms (see Interactions). Therefore, the use of such products during and within 72 hours after treatment with Clindamycin (Banbakt) suppositories is not recommended, because its contraceptive efficacy and protective properties from sexually transmitted diseases can be reduced.
Use of products for intravaginal administration: During use of vaginal suppositories Clindamycin (Banbakt) suppositories it is not recommended to use other products intended for intravaginal administration (such as tampons, douching agents).
Effects on Ability to Drive and Use Machines: There are no data that suggests clindamycin affects the ability to drive and use machines.

Pregnancy: Animal studies demonstrated reproductive toxicity of clindamycin, which was used parenterally or orally.
During the first trimester of pregnancy, vaginal suppositories with clindamycin are not recommended because of lack of appropriate studies.
Intravaginal use of clindamycin in the form of a cream during the second trimester of pregnancy, as well as systemic application of clindamycin phosphate during the second and third trimesters did not lead to any pathological effects on the fetus. Therefore, vaginal suppositories with clindamycin can be used during the second and third trimesters of pregnancy only when clearly needed. During pregnancy, it is recommended to administer vaginal suppositories without the use of an applicator.
Lactation: It is not known if clindamycin is excreted in breast milk following the use of vaginally administered clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Therefore, a full assessment of benefit-risk should be made when consideration is given to using vaginal clindamycin phosphate in a nursing mother.
Fertility: Studies in animals revealed no evidence on impaired fertility.

Immune system disorders: hypersensitivity reactions.
Infections and infestations: vaginal candidiasis, fungal infections, pseudomembranous colitis (see Precautions).
Nervous system disorders: headache.
Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain.
Skin and subcutaneous tissue disorders: itching (not in place of application), rashes.
Renal and urinary disorders: pyelonephritis, dysuria.
Reproductive system and breast disorders: vulvovaginal disorder, vulvovaginal irritation, vaginal pain, vaginal candidiasis, menstrual irregularities, vaginal discharge, vaginitis/vaginal infections.
General disorders and administration site conditions: pain (at the application site), itching (at the place of application), fever, generalized pain, localized edema, pain on the side of the abdomen.

There is no data on the concomitant use of clindamycin in the form of vaginal suppositories with other drugs for intravaginal administration (see Precautions).
Clindamycin phosphate has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. It is not recommended to use latex condoms during treatment. There is no data on the effect of the drug on the latex diaphragms (Precautions).

Store at temperatures not exceeding 30°C. Do not freeze.
Shelf Life: 24 months.

Preparations for Vaginal Conditions

G01AA10 - clindamycin ; Belongs to the class of antibiotics. Used in the treatment of gynecological infections.

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