Ginalgin - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspvaginal tablets

Composition:

1 tablet contains

Active substances:

metronidazole 250.0 mg.

chlorohinaldol 100.0 mg.

Excipients:

citric acid anhydrous, lactose monohydrate, rice starch, sodium starch glycolate (ultraamylopectin), polyethylene glycol 6000 (carbowax 6000), magnesium stearate. <

Description:Tablets from light yellow to yellow with a creamy shade of color, with a marble surface, a drop-shaped shape, with even edges, engraved "G" on one side; with a weak characteristic odor.

Pharmacotherapeutic group:Antimicrobial combination

ATX: & nbsp

Antiseptics and antimicrobials for the treatment of gynecological diseases

Pharmacodynamics:

Combined drug for intravaginal application. Has antimicrobial, antiprotozoal and antifungal action.

Metronidazole refers to nitro-5-imidazoles.

It restores the 5-nitro group of metronidazole with intracellular transport proteins of anaerobic microorganisms and protozoa that interacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.

It is an effective antimicrobial and antiprotozoal agent of a wide spectrum of action.It is active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, and also with respect to obligate anaerobes (sporo- and non-spore forming) - Bacteroides spp. (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.

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

It also shows activity in relation to the simplest: Entamoeba histolytica, Lamblia intestinalis, Trichomonas vaginalis and some fungi.

Lemon acid, reduces the pH of the vagina, promotes the growth and reproduction of Dodderlein sticks.

Pharmacokinetics:

With intravaginal application metronidazole is subjected to systemic absorption. The maximum concentration in the blood is approximately 50% of the maximum concentration, which is achieved after a single intake of an equivalent dose of metronidazole inside. Almost completely metabolized in the liver with the formation of inactive derivatives.

The half-life is 8 hours. It is excreted mainly with urine.

With intravaginal application chlorohinaldol Absorbs slightly.

Indications:

Treatment

- bacterial vaginitis

- Trichomonas vaginitis

- fungal vaginitis

- Vaginitis caused by mixed flora

Prevention

- before surgical treatment of gynecological diseases

- before childbirth and abortion

- before and after the introduction of intrauterine condoms

- before and after coagulation of the cervix

- before hysterography

Contraindications:Hypersensitivity to the components of the drug; blood diseases; violation of coordination of movements, organic lesions of the central nervous system (including epilepsy); hepatic failure (in the case of high doses), pregnancy, the period of breastfeeding.

Dosing and Administration:

1 vaginal tablet per day, for 7-10 days. Treatment begins on the 2nd - 4th day after menstruation. The tablet should be inserted deep into the vagina, preferably in the evening before bedtime.

If necessary, a repeat course of treatment is possible.

Side effects:

- itching, burning, pain and irritation in the vagina; thick, white, mucous discharge from the vagina without smell or with a faint odor, frequent urination; after the withdrawal of the drug - the development of candidiasis of the vagina.

- burning sensation or irritation of the penis in the sexual partner;

- On the part of the gastrointestinal tract: nausea, taste changes, metallic taste in the mouth, dry mouth, decreased appetite, abdominal cramps, nausea, vomiting, constipation or diarrhea;

- allergic reactions: urticaria, itching of the skin, rash;

- headache, dizziness;

- leukopenia or leukocytosis;

- staining of urine in red-brown color, due to the presence of water-soluble pigment, formed as a result of metronidazole metabolism.

In the event of any undesirable side effects, discontinue treatment and consult a doctor.

Interaction:

During treatment, alcohol intake should be avoided (similarly disulfiram causes alcohol intolerance).

Care should be taken when concurrently prescribed with certain medications:

Warfarin and other indirect anticoagulants. Metronidazole increases the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation.

Disulfiram. The development of neurological symptoms (depression of consciousness, development of mental disorders), therefore, it is not necessary to appoint Ginalgin to the patient who took disulfiram in the last two weeks.

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

Lithium Preparations, the concentration of the latter in the plasma rises.

Reduction of the effect of Ginalgina under the influence of barbiturates, as the inactivation of metronidazole is accelerated in the liver.

Special instructions:

During treatment with the drug it is recommended to abstain from sexual intercourse.

If you have 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, you need to control the general blood test.

Metronidazole can immobilize treponema, which leads to a false positive TPI test (Nelson's test).

During treatment, one should refrain from carrying out potentially dangerous activities requiring special attention and quick reactions (driving, etc.)

Form release / dosage:Tablets are vaginal.

Packaging:

5 tablets in blisters of aluminum foil and a three-layer film consisting of layers: soft aluminum, PVC and polyamide.

2 blisters per cardboard box with instructions for use.

Storage conditions:

List B.

In a dry place, at a temperature of 15 to 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011186

Date of registration:01.06.2010 / 22.05.2014

Expiration Date:Unlimited

The owner of the registration certificate:Meda Pharma GmbH & Co. KGMeda Pharma GmbH & Co. KG Germany

Manufacturer: & nbsp

ICN POLFA RZESZOW, S.A. Poland

Representation: & nbspMEDA PHARMA LLCMEDA PHARMA LLC

Information update date: & nbsp16.04.2017

Illustrated instructions

Instructions

Ginalgin (Ginalgin)