Composition
1 suppository contains clindamycin (in the form of phosphate) 100 mg;
excipients:
solid fat (Witepsol H-32, a mixture of triglycerides, diglycerides and monoglycerides).
Pharmacological action
Dalacin is an antibiotic of the lincosamide group for topical use.
The mechanism of action is associated with the suppression of protein synthesis in the microbial cell due to interaction with the 50S subunit of ribosomes.
It has a bacteriostatic effect; in higher concentrations, it has a bactericidal effect against some microorganisms.
The drug is active against microorganisms that cause bacterial vaginosis: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Peptostreptococcus spp., Bacteroides spp.
Indications
Bacterial vaginosis.
Use during pregnancy and lactation
Adequate and controlled studies on the use of the drug in the first trimester of pregnancy have not been conducted. The use of Dalacin in the first trimester of pregnancy is possible only if the intended benefit outweighs the potential risk to the fetus.
When using clindamycin preparations in the second and third trimesters of pregnancy in dosage forms for intravaginal use, there was no increase in the frequency of congenital fetal abnormalities. If Dalacin is used in the second and third trimesters of pregnancy (although official studies on the use of suppositories during pregnancy have not been conducted), then an adverse effect on the fetus is unlikely.
Currently, there are no data on the elimination of clindamycin in breast milk with intravaginal use of Dalacin. However, it has been established that when clindamycin is administered orally or parenterally, some of it is found in breast milk.
Therefore, when deciding whether to prescribe Dalacin during lactation (breastfeeding), it is necessary to compare the expected benefit for the mother and the possible risk for the child.
Contraindications
Hypersensitivity to clindamycin, lincomycin or any component of the drug Dalacin.
Side effects
The frequency of occurrence of the following side effects is less than 10%.
From the side of the reproductive system: Â irritation of the vulvar and vaginal mucosa, vaginal pain, vaginal discharge, vaginal candidiasis, vulvovaginitis, trichomonas vaginitis, vaginal infections, menstrual disorders, uterine bleeding, abnormal labor, endometriosis.
From the urinary system: dysuria, urinary tract infections (including pyelonephritis), proteinuria.
From the digestive system: Â generalized abdominal pain, localized abdominal pain, abdominal cramps, bloating, dyspepsia, nausea, vomiting, diarrhea, constipation, flatulence, bad breath, taste distortion.
From the central nervous system: Â dizziness, headache.
Dermatological reactions: Â rash, pruritus, maculopapular rash, erythema, candidiasis of the skin.
Allergic reactions: Â urticaria.
From the endocrine system: Â glucosuria, hyperthyroidism.
From the body as a whole: Â fungal infections, fever, side pain, back pain, lower abdominal pain, generalized pain, bacterial infections, inflammatory edema, upper respiratory tract infections, nosebleeds, abnormal microbiological results.
Local reactions: Â itching and pain at the injection site.
Interaction
An antagonistic interaction between clindamycin and erythromycin has been demonstrated in vitro.
Clindamycin has been shown to disrupt neuromuscular transmission with systemic use, so it is possible to enhance the effect of peripheral muscle relaxants. This fact should be taken into account when prescribing the latter with Dalacin.
No interactions have been observed in pharmacodynamic, pharmacokinetic, or clinical studies of these dosage forms.
How to take, course of use and dosage
A single dose (1 suppository) is injected into the vagina before bedtime for 3 consecutive days.
Suppositories can be administered without an applicator or with an applicator.
After each use, the applicator should be washed with warm water and soap and dried well.
Special instructions
Before prescribing the drug, the following possible pathogens of vulvovaginitis should be excluded using special laboratory methods: Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus.
Intravaginal use of Dalacin can lead to increased growth of microorganisms that are insensitive to the drug, especially yeast-like fungi.
When using the drug, systemic absorption of clindamycin is possible. With the systemic use of clindamycin, severe diarrhea and, in some cases, pseudomembranous colitis may develop. In this regard, if severe or prolonged diarrhea occurs during Dalacin therapy, it is necessary to cancel the drug, conduct diagnostic procedures and, if necessary, prescribe appropriate treatment.
Dalacin in the form of vaginal suppositories and vaginal cream contains components that can reduce the strength of latex or rubber products (condoms, birth control vaginal diaphragms). Therefore, the use of such products during treatment with Dalacin in the form of vaginal suppositories and vaginal cream is not recommended.
Form of production
Vaginal suppositories
Storage conditions
At a temperature not exceeding 25 °C (do not freeze)
Shelf life
3 years
Active ingredient
Clindamycin
Conditions of release from pharmacies
By prescription
Dosage form
vaginal suppositories
Description
For adults, For women
Indications
Vaginosis
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Side effects of Dalacin, vaginal suppositories 100mg, 3pcs.
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