Metrogyl gel for external use 30g 1%

Active ingredient and dosage form

METROGIL
Film Coated Tablets pink, round, biconvex.
1 pill contains Metronidazole 200 mg;
Excipients: corn starch, Magnesium stearate, colloidal silicon dioxide, hydrogenated hydrogenated castor oil, Opadry II pink dye 85G54815, purified water.
10 pieces. in a blister, 2, 10 blisters in a carton box.

Film Coated Tablets orange, round, biconvex.
1 pill contains metronidazole 400 mg;
Excipients: corn starch, povidone, magnesium stearate, colloidal silicon dioxide, Opadry II orange dye 85G53070, purified water;
10 pieces. in a blister, 2, 10 blisters in a carton box.

Solution for IV administration transparent, from colorless to pale yellow.
1 ml contains metronidazole 5 mg;
Excipients: sodium chloride, citric acid, sodium phosphate dibasic, anhydrous, water d / u;
20 ml in ampoules, 5 ampoules in a carton box or
100 ml in a plastic bottle, 1 bottle in a carton box.

Gel for external use 1% uniform, colorless to yellowish.
1 g of gel contains metronidazole 10 mg;
Excipients: propylhydroxybenzoate, methylhydroxybenzoate, propylene glycol, carbomer 940, sodium edetate, sodium hydroxide, purified water;
30 or 50 g in aluminum tubes, 1 tube in a carton box.

Vaginal gel uniform, colorless to pale yellow.
1 g of gel contains metronidazole 10 mg;
Excipients: propyl hydroxybenzoate, propylene glycol, carbomer-940, disodium edetate, sodium hydroxide, water;
30 g in an aluminum tube, 1 tube complete with an applicator in a carton box.

Dental gel opalescent, soft, white or almost white.
1 g of gel contains metronidazole (in the form of benzoate) - 10 mg, Chlorhexidine gluconate (in the form of a 20% solution) - 500 μg;
Excipients: propylene glycol, carbomer-940, disodium edetate, sodium saccharin, levomenthol, sodium hydroxide, water;
5, 10, 20, 30 or 50 g in tubes, in a box of 1 tube.

Dental gel uniform, white or almost white.
1 gel contains metronidazole (in the form of benzoate) - 250 mg, chlorhexidine (in the form of a 20% solution of chlorhexidine gluconate) - 1 mg;
excipients: propylene glycol, carbomer-940, disodium edetate, sodium saccharin, levomenthol, sodium hydroxide, taste base of FK245 toothpaste, purified water.
20 or 50 g in aluminum tubes, 1 tube in a carton box.

Metrogyl tab., Pokr. film coating, 200 mg, 400 mg: - P No. 011666/03 05.02.04
Metrogyl rr d / in / in the introduction of 100 mg / 20 ml, 500 mg / 100 ml: - P №011666 / 01 19.08.05
Metrogyl gel d / external. approx. 1%: - P №011666 / 02-2001 29.01.01PRT
Metrogyl gel vaginal 10 mg / 1 g: - P No. 0,01666/04 06/28/04
METROHYL DENTA dental gel 10 mg + 500 mcg / 1 g: - P No. 015982/01 10.26.04
Metrogyl DENTA PROF. gel stomatologic 250 mg + 1 mg / 1 g: - P No. 015286/01 16.10.03

Mechanism of action

Antibacterial, antiprotozoal (trichomonacid).
The nitro group of metronidazole is restored in anaerobic microorganisms and protozoa, interacts with the cell DNA of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.
Metronidazole active in a relationship Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia, anaerobic bacteria: Bacteroides spp., Fusobacterium spp.
In combination with Amoxicillin, it is active against Helicobacter pylori (amoxicillin inhibits the development of metronidazole resistance).
Aerobic microorganisms and facultative anaerobes are insensitive to metronidazole, but in the presence of mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics that are effective against ordinary aerobes.
It increases the sensitivity of tumors to radiation, causes disulfiram-like reactions, stimulates reparative processes.
When applied topically, it has anti-acne action, the mechanism of which is unknown.

Metrogyl DENTA is a combined antimicrobial drug for the treatment and prevention of infectious and inflammatory diseases of the oral cavity. The action of the drug due to the properties Metronidazole and Chlorhexidine
Chlorhexidine - antiseptic broad spectrum, has a bactericidal effect. It is active against vegetative forms of gram-negative and gram-positive microorganisms, as well as yeast, dermatophytes and lipophilic viruses. In the spores of bacteria it acts only at elevated temperatures.

Indications and usage

Tablets, solution for infusion: prevention and treatment of anaerobic infections in surgical interventions mainly on the abdominal organs and urinary tract;
severe mixed aerobic anaerobic infections (combination therapy), intestinal and liver amebiasis, sepsis, peritonitis, osteomyelitis, gynecological infections, pelvic and brain abscesses, abscess pneumonia, gas gangrene, infections of the skin and soft tissues, bones and joints.
Radiation therapy of patients with tumors - as a radiosensitizing drug in cases where tumor resistance is due to hypoxia in the tumor cells.

Gel for external use: rosacea (including post-steroid), acne vulgaris, infectious skin diseases, pressure sores, trophic ulcers, burn, eczema, seborrheic eczema, seborrhea oily, seborrheic dermatitis, trophic ulcers of the lower extremities (against the background of varicose veins, diabetes), sluggish wounds, bedsores, hemorrhoids, anal fissures.

Vaginal gel: urogenital trichomoniasis (including urethritis, vaginitis), nonspecific vaginitis of various etiologies, confirmed by clinical and microbiological data.

Dental gel:
Infectious and inflammatory diseases of the periodontal and oral mucosa: acute and chronic gingivitis; acute necrotizing gingivitis Vincent; acute and chronic periodontitis; adolescent periodontitis; periodontal disease complicated by gingivitis; aphthous stomatitis; cheilitis; inflammation of the oral mucosa when wearing prostheses; post-extraction alveolitis; periodontitis, periodontal abscess (as part of combination therapy).

Contraindications

- children's age up to 6 years;
- individual intolerance to metronidazole, chlorhexidine, as well as derivatives of nitroimidazole and other components of the drug.
Restrictions on the use of:
Pregnancy, lactation.
Liver diseases with violation of its functions (cumulation is possible), central and peripheral nervous system, blood diseases.
During treatment, you can not drink alcohol.

Dosage and administration

Inside, during or after a meal (or drinking milk), without chewing.
With trichomoniasis - 250 mg 2 times a day for 10 days, or 400 mg 2 times a day for 5-8 days. Women should also be prescribed metronidazole in the form of vaginal suppositories or tablets. If necessary, you can repeat the treatment or increase the dose to 0.75-1 g / day.Between courses, you should take a break of 3-4 weeks with repeated laboratory testing. An alternative treatment regimen is the appointment of 2 g once a patient and his sexual partner. Children 2-5 years - 250 mg / day; 5-10 years - 250-375 mg / day, over 10 years old - 500 mg / day. The daily dose should be divided into 2 doses. The course of treatment is 10 days.
With giardiasis - 500 mg 2 times a day for 5-7 days. Children up to 1 year - 125 mg / day, 2-4 years - 250 mg / day, 5-8 years - 375 mg / day, over 8 years old - 500 mg / day (in 2 doses). The course of treatment is 5 days.
With giardiasis - 15 mg / kg / day in 3 divided doses for 5 days.
In chronic amebiasis daily dose - 1.5 g in 3 doses for 5-10 days, with acute amebic dysentery - 2.25 g in 3 divided doses until the cessation of symptoms.
With ulcerative stomatitis adults are prescribed 500 mg 2 times a day for 3-5 days; children in this case, the drug is not shown.
With pseudomembranous colitis - 500 mg 3-4 times a day.
For eradication of Helicobacter pylori - 500 mg 3 times a day for 7 days (as part of combination therapy, for example, a combination of amoxicillin 2.25 g / day).
In the treatment of anaerobic infection the maximum daily dose is 1.5-2 g.
In the treatment of chronic alcoholism appoint 500 mg / day for a period of up to 6 (not more) months.
For the prevention of infectious complications - 750-1500 mg / day in 3 doses for 3-4 days before the operation or once 1 g on the first day after the operation. 1-2 days after surgery (when oral administration is already allowed) - 750 mg / day for 7 days.
When expressed impaired renal function (CC less than 10 ml / min) daily dose should be reduced by 2 times.

Intravenously
Adults and children over 12 years old in the initial dose of 0.5-1 g intravenously in a drip (duration of infusions - 30-40 min), and then every 8 hours at 500 mg at a rate of 5 ml / min. With good portability after the first 2-3 infusions, they are transferred to the jet injection. The course of treatment is 7 days. If necessary, on / in the introduction continue for a longer time. The maximum daily dose is 4 g. According to the indications, a transition is made to supporting ingestion in a dose of 400 mg 3 times a day.
Children under the age of 12 prescribed by the same scheme in a single dose - 7.5 mg / kg.
With purulent-septic diseases usually spend 1 course of treatment.
For preventive purposes adults and children over 12 years old prescribed in / in drip at 0.5-1 g on the eve of the operation, on the day of surgery and the next day - 1.5 g / day (500 mg every 8 hours). After 1-2 days, go to maintenance therapy inside.
Patients with CKD and CK less than 30 ml / min and / or liver failure the maximum daily dose is no more than 1 g, the frequency of administration is 2 times a day.

As a radiosensitizing drug administered in / in the drip at the rate of 160 mg / kg or 4-6 g / m2 of body surface for 0.5-1 h before the start of irradiation. Apply before each session for 1-2 weeks. In the remaining period of radiation treatment, metronidazole is not used. The maximum single dose should not exceed 10 g, the exchange rate - 60 g. To relieve intoxication caused by irradiation, apply a drip injection of 5% dextrose solution, Hemodez or 0.9% NaCl solution.

Intravaginal, once 2 g or as a course of treatment at 500 mg / day, 2 times a day (morning and evening) for 10 days. During the course of treatment, sexual intercourse should be avoided.

Outdoor use. The gel is applied to a previously cleansed skin with a thin layer 2 times a day, in the morning and in the evening, for 3-9 weeks. If necessary, impose an occlusive dressing. The average duration of treatment is 3-4 months, the therapeutic effect is usually observed after 3 weeks of treatment.

Metrogyl DENTA
The drug is intended only for use in dental practice.
Adults and children over 6 years old with gingivitis Metrogyl Denta is applied to the gum area 2 times / day, it is not recommended to wash off the gel. The duration of therapy is on average 7-10 days. After applying the gel should refrain from drinking and eating for 30 minutes.
With periodontitis after removal of dental deposits, periodontal pockets are treated with the preparation and the gel is applied to the gum area. Exposure time - 30 minutes. The number of procedures depends on the severity of the disease. In the future, the gel can be applied independently by the patient: the drug should be applied to the gum area 2 times / day for 7-10 days.
With aphthous stomatitis The gel is applied to the affected area of ​​the oral mucosa 2 times / day for 7-10 days.
For the prevention of exacerbations of chronic gingivitis and periodontitis The gel is applied to the gum area 2 times / day for 7-10 days. Preventive courses are held 2-3 times a year.
For the prevention of post-extraction alveolitis the drug is treated with a well after tooth extraction, then the gel is applied on an outpatient basis 2-3 times / day for 7-10 days.

From the digestive system: diarrhea, loss of appetite, nausea, vomiting, intestinal colic, constipation, "metallic" taste in the mouth, dry mouth, glossitis, stomatitis, pancreatitis.
The nervous system: dizziness, impaired coordination, ataxia, confusion, irritability, depression, irritability, weakness, insomnia, headache, convulsions, hallucinations, peripheral neuropathy.
Allergic reactions: urticaria, skin rash, skin flushing, nasal congestion, fever, arthralgia.
On the part of the urinary system: dysuria, cystitis, polyuria, urinary incontinence, candidiasis, urine staining in red-brown color.
Local reactions: thrombophlebitis (pain, hyperemia or swelling at the injection site).
Other: neutropenia, leukopenia, flattening of the T wave on the ECG.

With the local use of the drug Metrogyl Denta, the development of systemic side effects is unlikely.

It is not recommended to prescribe the drug Metrogyl in the first trimester of pregnancy. If necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding.

In the course of long-term treatment, systematic monitoring of the peripheral blood pattern is necessary. In case of leukopenia, the possibility of continuing treatment depends on the danger of the infection process.
Treatment should be discontinued with the appearance of ataxia, dizziness, and with the deterioration of the neurological status of patients.
It is necessary to take into account that metronidazole can immobilize treponemas, which leads to Nelson's false-positive test.
During the use of the drug there is a darker staining of urine.
In combination with amoxicillin is not recommended for use in patients younger than 18 years; should not be used for gastrointestinal diseases with prolonged diarrhea or vomiting; with caution prescribed for liver diseases.
The use of Metrogyl Denta gel does not replace hygienic cleaning of teeth.

Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and epileptic seizures.
Treatment: symptomatic; specific antidotes are absent.

It enhances the effect of indirect anticoagulants, which leads to an increase in the time of formation of prothrombin. Similarly, disulfiram causes ethanol intolerance.
Simultaneous use with disulfiram can lead to the development of various neurological symptoms (the interval between administration is at least 2 weeks).
Metronidazole for on / in the introduction is not recommended to be mixed with other drugs.
Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in serum and an increase in the risk of side effects.
The simultaneous administration of drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, as a result of which its concentration in plasma decreases.
When taken simultaneously with Li + drugs, the concentration of the latter in plasma and the development of symptoms of intoxication may increase.
It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide). Sulfonamides enhance the antimicrobial action of metronidazole.

List B. The drug should be kept out of the reach of children at a temperature not exceeding 25 ° C.