Ginalgin

General characteristics. Structure:

Active agents:
metronidazole of 250,0 mg.
chlorquinaldol of 100,0 mg.
Excipients:
citric acid anhydrous, lactoses monohydrate, rice starch, sodium starch glycollate (ultraaminopectin), polyethyleneglycol - 6000 (carbowax 6000), magnesium stearate.
Description: tablets from color, light yellow to yellow with a cream shade, with a marble surface, teardrop shape, with smooth edges, with an engraving of "G" on one party; with a slight characteristic smell.

Pharmacological properties:

The combined drug for intravaginalny use. Has antimicrobic, antiprotozoan and antifungal effect.
Metronidazole belongs to nitro-5-imidazoles.
Recovers 5 nitrogroup of metronidazole intracellular transport proteins of anaerobic microorganisms and protozoa which interacts with DNA of a cell of microorganisms, inhibiting synthesis of their nucleic acids that leads to death of microorganisms.
Is effective antimicrobic and antiprotozoan broad-spectrum agent. Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, and also concerning strict anaerobes (sporo-and asporous) - Bacteroides spp is active concerning Trichomonas vaginalis. (B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., sensitive strains of Eubacterium. Aerobic microorganisms and facultative anaerobes are not sensitive.
Chlorquinaldol affects the following strains of disease-producing bacteria: Corynebacterium diphtheria, Streptococcus pyogenes, Staphylococcus aureus, Pseudomonas aeruginosa, Proteus vulgaris, Salmonella, Shigella, Escherichia coli.
Shows also activity in relation to protozoa: Entamoeba histolytica, Lamblia intestinalis, Trichomonas vaginalis and some mushrooms.
Citric acid reduces рН vaginas, promotes growth and reproduction of sticks of Doderleyn.

Pharmacokinetics. At intravaginalny use metronidazole is exposed to system absorption. The maximum concentration in blood makes about 50% of the maximum concentration which is reached after a single dose of an equivalent dose of metronidazole inside. Almost it is completely metabolized in a liver with formation of inactive derivatives.
The elimination half-life makes 8 hours. It is removed preferential with urine.
At intravaginalny use chlorquinaldol is absorbed slightly.

Indications to use:

Treatment
• bacterial vaginitis
• mecotic vaginitis
• fungal vaginitis
• the vaginitis caused by the mixed flora

Prevention
• before surgical treatment of gynecologic diseases
• before childbirth and abortions
• before introduction of intrauterine contraceptive means
• before coagulation of a neck of uterus
• before a gisterografiya.

Route of administration and doses:

1 vaginal tablet a day, within 7-10 days. Treatment is begun for 2 - 4 day after periods. The tablet should be entered deeply into a vagina, preferably in the evening before going to bed.
If necessary carrying out a repeated course of treatment is possible.

Features of use:

During treatment drug recommends to abstain from sexual contacts.
At instructions in the anamnesis on changes in composition of peripheral blood, and also when using drug in high doses and/or at its prolonged use control of the general blood test is necessary.
Metronidazole can immobilizovyvat treponemas that leads to the false positive TPI test (Nelson test).
During treatment it is necessary to refrain from potentially dangerous types of activity requiring special attention and bystry reactions (driving).

Side effects:

• an itch, burning, pain and irritation in a vagina; dense, white, mucous allocations from an inodorous vagina or with a slight smell, the speeded-up urination; after drug withdrawal - development of candidiasis of a vagina.
• a burning sensation or irritation of a penis at the sexual partner;
• from digestive tract: nausea, change of flavoring feelings, metal smack in a mouth, dryness in a mouth, a loss of appetite, spastic an abdominal cavity pains, nausea, vomiting, a lock or diarrhea;
• allergic reactions: urticaria, itch of integuments, rash;
• headache, dizziness;
• leukopenia or leukocytosis;
• coloring of urine in red-brown color, owing to presence of the water-soluble pigment which is formed as a result of metronidazole metabolism.

In case of any undesirable side effects it is necessary to stop treatment and to see a doctor.

Interaction with other medicines:

During treatment it is necessary to avoid alcohol intake (similar to Disulfiramum causes intolerance of alcohol).
It is necessary to be careful at co-administration with some medicines:
Warfarin and other indirect anticoagulants. Metronidazole strengthens effect of indirect anticoagulants that leads to increase in time of formation of a prothrombin.
Disulfiramum. Development of neurologic symptoms (consciousness oppression, development of mental disorders) therefore it is not necessary to appoint Ginalgin sick which accepted Disulfiramum within the last two weeks.
Cimetidinum inhibits metronidazole metabolism that can lead to increase in its concentration in blood serum and to increase in risk of development of by-effects.
Lithium drugs. Concentration of the last in plasma increases.
Decrease in effect of Ginalgin under the influence of barbiturates as the metronidazole inactivation in a liver accelerates.

Contraindications:

Hypersensitivity to drug components; blood diseases, incoordination of movements, organic lesions of TsNS (including epilepsy); a liver failure (in case of purpose of high doses); pregnancy, breastfeeding period.

Storage conditions:

List B. In the dry place, at a temperature from 15 °C to 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after the term specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 5 tablets in the blister from the aluminum foil and a three-layered film consisting of layers: soft aluminum, PVC and polyamide.
On 2 blisters in a cardboard pack with the application instruction.