Composition, form of production and packaging
Vaginal suppositories are solid, torpedo-shaped, with a smooth surface, white or almost white in color.
1 supp.
clindamycin (in the form of phosphate) 100 mg
Excipients: solid fat (Witepsol H-32, a mixture of triglycerides, diglycerides and monoglycerides) - about 2.4 g.
3 pcs. - strips of laminated foil (1) - packs of cardboard.
3 pcs. - strips of laminated foil (1) complete with applicator - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antibiotic group lincosamides for topical use.
Clindamycin phosphate is inactive in vitro, but it rapidly hydrolyses in vivo to form clindamycin, which has antibacterial activity. Clindamycin inhibits the synthesis of proteins in a microbial cell due to interaction with the 50S-subunit of the ribosomes.
In vitro, the following microorganisms that cause bacterial vaginosis are sensitive to clindamycin: Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, Bacteroides spp., Peptostreptococcus spp.
PHARMACOKINETICS
Suction
After clindamycin is administered intravaginally at a dose of 100 mg once a day (in the form of suppositories), about 30% (6-70%) of the administered dose of clindamycin is absorbed into the systemic circulation, with an AUC of 3.2 Ојg / h / ml (0.42 -11 Ојg / h / ml). C max in the blood serum is reached after about 5 hours (1-10 hours) after the administration of the vaginal suppository and on the third day of therapy is on average 0.27 Ојg / ml (0.03-0.67 Ојg / ml).
The systemic effect of clindamycin upon administration is intravaginally much weaker than when administered at therapeutic doses orally or intravenously.
Excretion
On average, T 1/2 is 11 hours (4-35 hours).
Pharmacokinetics in specific patient groups
In clinical studies of clindamycin in the form of vaginal suppositories, an insufficient number of patients aged 65 years and older participated in order to assess the difference in the clinical response to therapy between this age group and younger patients.
INDICATIONS
bacterial vaginosis.
DOSING MODE
The recommended dose is 1 suppository intravaginally preferably at bedtime for 3 consecutive days.
Terms of use
Introduction of suppositories without an applicator
1. Remove the suppository from the foil.
2. In the supine position on the back, pull the knees to the chest.
3. Carefully insert the suppository into the vagina with the middle finger as deeply as possible.
Introduction of suppositories with the help of an applicator
1. The plastic applicator, which is in the package with the drug, is intended to facilitate the introduction of the suppository into the vagina.
2. Remove the suppository from the foil.
3. Place the flat end of the suppository in the opening of the applicator.
4. In the supine position on your back, pull your knees to your chest.
5. Holding the applicator horizontally on the ribbed end of the body, gently insert it into the vagina as far as possible.
6. Slowly pressing the piston, insert the suppository into the vagina.
7. Carefully remove the applicator from the vagina.
8. After each use, the applicator should be washed with warm water and soap and let it dry completely.
SIDE EFFECT
The safety of clindamycin in the form of vaginal suppositories was evaluated in non-pregnant women.
Table. Unwanted drug reactions
Frequently (from? 1/100 to <1/10) Infrequently (from? 1/1000 to <1/100) Frequency is unknown (can not be estimated based on available data)
Infectious and parasitic diseases
Fungal infections, infections caused by fungi of the genus Candida
From the nervous system
Headache
From the digestive system
Abdominal pain, diarrhea, nausea Vomiting Pseudomembranous colitis
From the skin and subcutaneous tissues
Itching Skin Rash
From the musculoskeletal system
Pain in the side
From the urinary system
Pyelonephritis, dysuria
On the part of the reproductive system
Vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal disorders Vaginal infections, vaginal discharge, menstrual irregularities
General disorders and reactions at the site of administration
Pain at the injection site, itching (at the injection site), localized edema, pain, hyperthermia
CONTRAINDICATIONS
- Hypersensitivity to clindamycin, lincomycin or any component of the drug;
- an antibiotic-associated colitis in the anamnesis;
- age under 18 years (safety and efficacy data are not available).
PREGNANCY AND LACTATION
When clindamycin was administered intravaginally in the second or third trimester of pregnancy, there was no increase in the frequency of congenital abnormalities of the fetus. If DalacinВ® vaginal suppositories are used during the II or III trimesters of pregnancy (although no official studies on the use of suppositories in pregnant women have been conducted), adverse effects on the fetus are unlikely. The use of the drug in the II-III trimester of pregnancy is possible if the potential benefit to the mother exceeds the risk to the fetus.
Adequate controlled studies on the use of the drug in the first trimester of pregnancy have not been carried out, so DalacinВ® vaginal suppositories can be prescribed to women in the first trimester of pregnancy only in absolute indications, i.Рµ. when the potential benefit of drug therapy exceeds the potential risk to the fetus.
In studies on animals with the introduction of clindamycin c / o or inside any adverse effects on the fetus is not found, except for cases of taking the drug in doses toxic to the mother.
It is not known whether clindamycin is excreted in breast milk after intravaginal application. Clindamycin is found in breast milk after oral or parenteral administration, so during breastfeeding, either stop using the drug or stop breastfeeding, given the importance of the drug to the mother.
APPLICATION FOR CHILDREN
Contraindicated use of the drug under the age of 18 years (data on safety and efficacy not available).
APPLICATION IN ELDERLY PATIENTS
In clinical studies of clindamycin in the form of vaginal suppositories, an insufficient number of patients aged 65 years and older participated in order to assess the difference in the clinical response to therapy between this age group and younger patients.
SPECIAL INSTRUCTIONS
Prior to prescribing with appropriate laboratory methods, vulvovaginitis caused by Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be excluded.
Intravaginal application of clindamycin can lead to increased growth of insensitive microorganisms, especially yeast-like fungi.
The use of clindamycin (as well as practically all antibiotics) inside 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, carried out the appropriate diagnostic and treatment measures.
Patients should be warned that during therapy with the drug, sexual intercourse should be avoided, as well as other means for intravaginal administration (tampons, douching).
The preparation contains components that can reduce the strength of latex or rubber products (condoms, contraceptive vaginal diaphragms). Therefore, the use of such products during treatment with Dalacin and within 72 hours after use is not recommended.
It is not recommended to use the preparation Dalacin В® suppositories vaginal during the period of menstruation. It is necessary to postpone the initiation of therapy until the end of menstruation.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and engage in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
With intravaginal application of suppositories of Dalacin В®, clindamycin can be absorbed in amounts sufficient for the development of systemic reactions.
Accidental ingestion of the drug in the gastrointestinal tract can cause systemic effects similar to those that occur after ingestion of clindamycin in therapeutic doses.Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis.
Treatment: symptomatic and maintenance therapy.
DRUG INTERACTION
There is cross-resistance between clindamycin and lincomycin.
In vitro, antagonism between clindamycin and erythromycin has been demonstrated.
It was found that clindamycin disrupts neuromuscular transmission and, consequently, can enhance the action of muscle relaxants of peripheral action, so the drug should be used with caution in patients receiving drugs of this group.
Since there is no information on the use with other drugs for intravaginal administration, the joint use of the drug with other intravaginal agents is not recommended.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Do not freeze. Shelf life - 3 years.
