Dalacin, vaginal cream 2%, 20g+3 applicators

Composition

the Active ingredient is clindamycin phosphate from 23.76 mg (in the form of 20.0 mg of clindamycin);excipients: glycerol monostearate sorbitan of 20.0 mg, Polysorbate 60 of 50.0 mg,50.0 mg propylene glycol, stearic acid 21,4 mg, cetostearyl alcohol and 32.1 mg, cetylpalmitate 32.1 mg, mineral oil of 64.2 mg, benzyl alcohol 10.0 mg, purified water q. s.

Pharmacological properties

Pharmacotherapeutic group: antibiotic – lincosamide.

ATX Code: G01AA10.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Clindamycin phosphate is inactive in vitro, but is rapidly hydrolyzed in vivo to form clindamycin, which has antibacterial activity. Clindamycin belongs to the group of antibiotics-lincosamides, which inhibits protein synthesis in the microbial cell by interacting with the 50S subunit of ribosomes and affects the translation process.

Clindamycin, like most protein synthesis inhibitors, is mainly a bacteriostatic, the effectiveness of which is associated with the duration of maintaining the concentration of the Active ingredient at a higher level than the MPC (Minimum suppressive concentration) of the infecting organism.

Clindamycin resistance in most cases occurs due to modification of target ribosome sites, usually through chemical modification of nitrogenous bases of RNA or point mutations of RNA or sometimes mutations of proteins. In vitro cross-resistance between lincosamides, macrolides, and streptogramins B has been demonstrated in some organisms. There is cross-resistance between clindamycin and lincomycin. 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. To establish the diagnosis and direction of treatment of bacterial vaginosis, culture and sensitivity studies of bacteria are usually not carried out. There is no standard methodology for assessing the sensitivity of potential pathogens of bacterial vaginosis (Gardnerella vaginalis, Mobiluncus spp. ). Methods for determining the sensitivity of Bacteroides spp and gram-positive anaerobic cocci, also Mycoplasma spp. They are described by the Clinical and Laboratory Standards Institute (CLSI), and the borderline values of the sensitivity of gram – negative and gram-positive anaerobic bacteria to clindamycin are published by the European Committee on Antimicrobial Susceptibility Testing (EUCAST). For clinical isolates that were found to be sensitive to clindamycin but resistant to erythromycin, a clindamycin resistance test should also be performed using the D-test. However, the borderline values are intended to determine the direction of systemic antibiotic treatment rather than local treatment.

Pharmacokinetics

After applying clindamycin intravaginally at a dose of 100 mg/day once (as a 2% clindamycin phosphate cream) for 7 days, the serum concentration reaches a maximum approximately 10 hours (4-24 hours) after use and averages 18 ng/ml (4-47 ng/ml) on the first day, and 25 ng/ml (6-61 ng/ml) on the seventh day, while 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 absorbed (with a smaller spread of 2-8%), the serum concentration reaches a maximum approximately 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 seventh day.

The systemic effect of clindamycin when administered intravaginally is weaker than when administered orally or intravenously. After intravaginal use of repeated doses, clindamycin almost does not accumulate in the blood. The systemic half-life is 1.5-2.6 hours.

Use in elderly patients

Clinical trials of clindamycin 2% vaginal cream involved an insufficient number of patients aged 65 years and older 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.

Indications

Bacterial vaginosis.

Use during pregnancy and lactation

Adequate controlled studies on the use of the drug in the first trimester of pregnancy have not been conducted, so DALACIN vaginal cream can be prescribed to women in the first trimester of pregnancy only for absolute indications, i. e. when the potential benefit of drug therapy for the mother outweighs the potential risk to the fetus.

In animal studies, when clindamycin is administered subcutaneously 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 clindamycin was administered intravaginally in the second or third trimester of pregnancy, there was no increase in the incidence of congenital fetal abnormalities. Abnormal labor occurred in 1.1% of women compared to 0.5% in the placebo group if DALACIN vaginal cream was used in the second trimester for 7 days. The use of the drug in the II-III trimester of pregnancy is possible if the potential benefit to the mother outweighs the risk to the fetus.

It is not known whether clindamycin is excreted in breast milk after intravaginal use. Clindamycin was detected in breast milk at a concentration of 0.5-3.8 mcg / ml after systemic use.

Clindamycin has the potential to have undesirable effects on the gastrointestinal microflora in children who are breastfed, such as diarrhea or blood in the stool, or rash. If a nursing mother requires the use of clindamycin orally or intravenously, this is not a reason to stop breastfeeding, but you can give preference to an alternative medication. Consideration should be given to the developmental and health benefits of breastfeeding, as well as the clinical need for clindamycin use in the mother and any potential adverse effects associated with clindamycin or the underlying maternal disease on the breastfed child.

Contraindications

–hypersensitivity to clindamycin, lincomycin or any component of the drug;

– in patients with a history of antibiotic-associated colitis.

– age up to 18 years (no safety or efficacy data available).

Side effects

The safety of clindamycin vaginal cream was evaluated both in non-pregnant patients and in patients during the second and third trimesters of pregnancy.

* adverse drug reactions detected in the post-marketing period.

Interaction

There is cross-resistance between clindamycin and lincomycin.. 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.

How to take, course of use and dosage

Recommended dose: intravaginally, one full applicator (5 g of cream, approximately 100 mg of clindamycin) preferably at bedtime for 3 or 7 consecutive days.

Instructions for use

In a package with 20 g of cream there are 3 plastic applicators, and in a package with 40 g-7 applicators designed for the correct introduction of the cream into the vagina.

• Remove the cap of the cream tube. Screw the plastic applicator onto the threaded tube neck.
• Rolling the tube from the opposite end, gently squeeze the cream into the applicator. The applicator is full when its plunger reaches its stop.
• Unscrew the applicator from the tube and wrap the cap.
• In the supine position, pull your knees up to your chest.
• Holding the applicator horizontally, gently insert it into the vagina as deeply as possible, without causing unpleasant sensations.
• Slowly depressing the plunger until it stops, insert the cream into the vagina.
• Carefully remove the applicator from your vagina and discard it.

Overdose

With intravaginal use of DALACIN cream, clindamycin can be absorbed 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 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.

Description

white cream.

Special instructions

Before prescribing the drug, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans 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 engage in sexual intercourse during therapy with the drug, as well as to use other means for intravaginal use (tampons, douching).

It is not recommended to use the drug DALACIN cream 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.

Influence on the ability to drive a car and manage mechanisms

There is no reason to believe that the use of the drug DALACIN vaginal cream can affect the ability to drive a car and manage mechanisms.

Form of production

Vaginal cream 2%.20 or 40 g of cream in a laminate tube. 1 tube of 20 g each complete with 3 applicators in a pencil case or 1 tube of 40 g each complete with 7 applicators in a pencil case with instructions for use in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 ° C. Do not freeze!Keep out of reach of children!

Shelf

life is 2 years. Do not use after the expiration date indicated on the package!

Active ingredient

Clindamycin

Conditions of release from pharmacies

By prescription

Dosage form

vaginal cream

Purpose

Adults, For women

Indications

Bacterial Vaginosis, Vaginosis