With intravaginal use of the drug, an overdose has not been established. It is possible to absorb 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 "Side effects" and "Special instructions").
Treatment: symptomatic and supportive.
hypersensitivity to clindamycin, lincomycin, butoconazole or any component of the drug,
inflammatory bowel diseases (Crohn's disease, ulcerative, pseudomembranous and antibiotic-associated colitis (including in the anamnesis),
children under 18 years of age.
With caution: allergic diseases, simultaneous administration of muscle relaxants.
There is cross-resistance between clindamycin and lincomycin.
In the conditions of in vitro anatagonism between clindamycin and erythromycin has been demonstrated.
It has been established that clindamycin, when used systemically, 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.
Co-administration with other drugs for intravaginal administration is not recommended.
It is incompatible with solutions containing a complex of B vitamins, aminoglycosides, ampicillin, calcium gluconate and magnesium sulfate.
Cream from almost white to white with a grayish tinge of color with a specific smell.
The drug is usually well tolerated, but the following undesirable effects may occur.
Butoconazole nitrate in the form of a vaginal cream
From the genitals and breast: irritation at the injection site, burning, itching, soreness and swelling of the vaginal mucosa.
From the gastrointestinal tract: pain/cramps in the lower abdomen.
On the part of the immune system: the development of allergic reactions.
Clindamycin in the form of a vaginal cream
The safety of clindamycin vaginal cream was evaluated both in non-pregnant patients and in patients during the second and third trimesters of pregnancy.
Depending on the frequency of occurrence, the following groups of side effects are distinguished: 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 rarely — <1/10000, the frequency is unknown (it is impossible to estimate based on available data).
Infectious and parasitic diseases: often-fungal infections, infections caused by fungi of the genus Candida rarely is a bacterial infection, the frequency is unknown — candidiasis of the skin.
On the part of 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 the vestibular apparatus: rarely-vertigo.
From the respiratory system, chest and mediastinal organs: often infection of the upper respiratory tract, rarely, a nosebleed.
From the gastrointestinal tract: 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-itchy skin, rash, infrequently-urticaria, erythema, frequency unknown-maculopapular rash.
From the musculoskeletal system and connective tissue: often-back pain.
From the kidneys and urinary tract: often-urinary tract infections, glucosuria, proteinuria, infrequently-dysuria.
Pregnancy, postpartum and perinatal conditions: often-abnormal birth.
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 injection site: the frequency is 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-registration period.
According to the recipe.
Before prescribing the drug using appropriate laboratory methods should be excluded Trichomonas vaginalis, Chlamidia trachomatis, Neisseria gonorrhoeae and Herpes simplex virus, often causing vulvovaginitis.
Intravaginal use of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.
The use of clindamycin (as well as 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 discontinued and, if necessary, appropriate diagnostic and therapeutic measures should be carried out.
Patients should be warned that during therapy with the drug should not engage in sexual intercourse.
Vaginal cream is not recommended to be used simultaneously 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, 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 clinical signs of infection persist after treatment is completed, a second microbiological examination 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 to stop treatment.
Influence on the ability to drive vehicles, mechanisms. There is no reason to believe that the use of the drug Clindacin® B prolong vaginal cream can affect the ability to drive a car and control mechanisms.
Bacterial vaginosis, fungal and mixed vaginitis caused by drug-sensitive microorganisms.
Butoconazole - imidazole derivative, has fungicidal activity against fungi Candida, Trichophyton, Microsporum, Epidermophyton 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 fungus cell.
Clindamycin - a bacteriostatic antibiotic from the lincosamide group, it has a wide 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 the conditions of 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, and therefore the active substances are on the vaginal mucosa for 1-3 days.
There is cross-resistance between clindamycin and lincomycin.
Butoconazole
With intravaginal administration, about 1.7% of the administered dose of butoconazole is absorbed. Cmax in the blood plasma, 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
Suction. After applying clindamycin intravaginally at a dose of 100 mg / day once (in the form of 2% clindamycin phosphate cream) for 7 days.max clindamycin in the blood plasma is reached after 10 h (4-24 h) 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 the systemic absorption is about 4% (0.6 — 11%) of the administered dose.
In women with bacterial vaginosis, with a similar dosage regimen, about 4% of clindamycin is subjected to systemic absorption (with a smaller spread of 2-8%), Cmax it is achieved in 14 hours (4-24 hours) after administration and is on the 1st day on average 13 ng/ml (6-34 ng / ml), and on the 7th day-16 ng/ml (7-26 ng/ml).
The systemic effect of clindamycin with intravaginal administration is less pronounced than with oral or intravenous administration.
Output. T1/2 It is 1.5-2.6 h. After repeated intravaginal administration, clindamycin almost does not accumulate.
Special patient groups
In clinical studies of clindamycin 2% vaginal cream, an insufficient number of patients 65 years and older participated 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 the response of older patients and younger ones.
At a temperature of 15-25 °C.
Keep out of reach of children.
Shelf life of the drug Clindacin® B prolong2 года.Do not use after the expiration date indicated on the package.
| Vaginal cream | 100 g |
| active substance: | |
| butoconazole nitrate (based on 100% substance) | 2 g |
| clindamycin phosphate (based on 100% substance) | 2,376 g |
| (equivalent to 2 g of clindamycin) | |
| 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 (macrogol 20 cetostearyl ether) — 2 g, cetostearyl alcohol (cetyl alcohol-60%, stearyl alcohol-40%) - 6 g, hydroxypropyldic starch phosphate-8 g, sodium hydroxide-0.26 g, purified water-up to 100 g |
Vaginal cream, 2% is 2%. 6 or 20 g in an aluminum tube. Each tube of 6 g together with 1 applicator or a tube of 20 g together with 3 applicators is placed in a pack of cardboard.
The use of the drug during pregnancy and lactation is possible only if the potential benefit to the mother exceeds 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 conducted, so the drug Clindacin® B prolong can be prescribed to women in the first trimester of pregnancy only for absolute indications, t.e. when the potential benefit of drug therapy to the mother outweighs the potential risk to the fetus. In animal studies, when clindamycin is administered either orally or orally, no negative effects on the fetus were found, except in cases of taking the drug in doses that are toxic to the mother. When using clindamycin intravaginally in the second or third trimesters of pregnancy, there was no increase in the frequency of fetal congenital anomalies. Abnormal labor occurred in 1.1% of women compared to 0.5% in the placebo group if clindamycin in the form of a vaginal cream was applied in the second trimester for 7 days. The use of the drug in the II-III trimesters of pregnancy is possible if the potential benefit to the mother exceeds the risk to the fetus
It is not known whether clindamycin is released into breast milk after intravaginal administration. Clindamycin is found in breast milk after oral or parenteral administration, so during breastfeeding, either discontinue the use of the drug or stop breastfeeding, given the importance of the drug for the mother.
Intravaginal, using the applicator.
It is used 1 time a 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 using the applicator
The disposable applicators attached to the package are designed for the correct insertion of the cream into the vagina.
1. Open the tube with the cream by removing the cap. Puncture the tube membrane with the back of the cap. Screw the plastic applicator onto the threaded neck of the tube.
2. Gently pressing on 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 the plunger reaches the stop. Unscrew the applicator and close the tube with the cap.
3. In the supine position, pull your knees up to your chest. Holding the applicator horizontally, gently insert it into the vagina as deep as possible, trying not to cause unpleasant sensations.
4. Slowly pressing the plunger until it stops, enter the entire volume of the cream into the vagina.
5. Carefully remove the applicator from the vagina and throw it in the trash container.
