Gynalgin, Vaginal tablets, 10pcs

Composition

Active ingredients:

metronidazole 250 mg;

chlorquinaldol 100 mg;

Auxiliary substances:

citric acid anhydrous,

lactose monohydrate;

rice starch;

sodium starch glycolate (ultraamylopectin);

polyethylene glycol 6000 (carbovax 6000);

magnesium stearate

Pharmacological action

Gynalgin – trichomonacid, antiprotozoal, antifungal, bactericidal, antibacterial.

Combined drug for intravaginal use.

Metronidazole belongs to nitro-5-imidazoles. The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of the microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.

Metronidazole is an effective broad-spectrum antimicrobial and antiprotozoal agent. The drug is highly active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as against obligate anaerobes (spore – and non-spore-forming)  — Bacteroides spp. (B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., sensitive strains Eubacterium.

Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole.

Chlorhynaldol acts on the following strains of pathogenic bacteria: Corynebacterium diphtheriae, Streptococcus pyogenes, Staphylococcus aureus, Pseudomonas aeruginosa, Proteus vulgaris, Salmonella, Shigella, Escherichia coli.

It is also active against protozoa: Entamoeba histolytica, Lamblia intestinalis, Trichomonas vaginalis and some fungi.

Citric acid lowers the pH of the vagina, promotes the growth and reproduction of Doderlein sticks.

Pharmacokinetics

Metronidazole undergoes systemic absorption during intravaginal use. _Cmax in the blood after intravaginal use is approximately 50% of the_cmaxachieved after a single oral equivalent dose of metronidazole.

Metronidazole is almost completely metabolized in the liver to form inactive derivatives.

T_1/2 — 8 hours. Metronidazole is mainly excreted in the urine.

With intravaginal use, chlorquinaldol is slightly absorbed.

Indications

Infectious and inflammatory diseases of the vagina caused by drug-sensitive pathogens.

Use during pregnancy and lactation

Contraindicated in pregnancy. Breast-feeding should be discontinued for the duration of treatment.

Contraindications

• Hypersensitivity to metronidazole or other nitroimidazole derived;
• individual intolerance chloranilide and other ingredients included in the composition of the vaginal tablets, blood disease, leukopenia (including in the anamnesis);
• impaired coordination of movements, organic lesions of the Central nervous system (including epilepsy);
• hepatic failure (in case of appointment of large doses), pregnancy, breastfeeding.

Side effects

Itching, burning, pain and irritation in the vagina; a thick, white mucous discharge from the vagina is odorless or with a faint odor, frequent urination; after discontinuation of the drug — development of vaginal candidiasis; burning sensation or irritation of the penis from a sexual partner; headache, dizziness, leukopenia or leukocytosis; nausea, change in taste, metallic taste in mouth, dry mouth, loss of appetite, spastic abdominal pain, vomiting, constipation or diarrhea; allergic reactions: hives, itching skin, rash.

In rare cases, urine may turn red-brown due to the presence of a water-soluble pigment formed as a result of metronidazole metabolism.

Interaction

Metronidazole enhances the effect of indirect anticoagulants (for example, warfarin), which leads to an increase in the time of prothrombin formation.

Concomitant use with disulfiram may lead to the development of various neurological symptoms (depression of consciousness, development of mental disorders), so do not prescribe Gynalgin to patients who have taken disulfiram for the last 2 weeks.

Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and increase the risk of side effects.

When taken simultaneously with lithium preparations, the concentration of the latter in plasma may increase.

It is possible to reduce the effect of Gynalgin under the influence of barbiturates, since the inactivation of metronidazole in the liver is accelerated.

How to take, course of use and dosage

Intravaginally. The tablet is inserted deep into the vagina, preferably in the evening before going to bed,1 tablet 1 time a day for 7-10 days. Treatment begins 2-4 days after menstruation.

If necessary, it is possible to conduct a second course of treatment.

Special instructions

Alcohol intake should be avoided (similar to disulfiram causes alcohol intolerance). During treatment with the drug, it is recommended to refrain from sexual contact.

If there is a history of changes in the composition of peripheral blood, as well as when using the drug in high doses and/or with its long-term use, it is necessary to monitor the general blood test. Metronidazole can immobilize treponemes, resulting in a false positive TPI test (Nelson’s test). Patients, especially drivers of vehicles and persons operating other mechanisms, should pay attention to the possibility of dizziness associated with taking the drug.

Form of production

Vaginal tablets

Storage conditions

Store in a dry place at a temperature of 15-25 °C.

Shelf life

3 years

Active ingredient

Metronidazole, Chlorquinaldone

Conditions of release from pharmacies

By prescription

Dosage form

vaginal tablets

Description

For adults

Indications

Fungus, Vaginitis, Inflammation of the female genital organs, Thrush