Metrogil

Metrogil – drug with antiprotozoan, trikhomonatsidny and antibacterial action.

Form of release and structure

Metrogil is issued in the following dosage forms:

• Solution for intravenous administration: transparent, pale yellow or colourless (on 100 ml in polyethylene bottles, on 1 bottle in a cardboard pack; on 20 ml in ampoules, on 5 ampoules in a cardboard pack or in thermal containers, on 1 thermal container in a cardboard pack);
• Tablets, film coated: biconvex, round, pink (on 200 mg) or orange (on 400 mg) colors (on 10 pieces in blister strip packagings, on 2 or 10 packagings in a cardboard pack);
• Gel vaginal: from colourless till light yellow color, homogeneous (on 30 g in tubas, on 1 tuba in a cardboard pack complete with the applicator);
• Gel for external use: from colourless till yellow color, homogeneous (on 30 g in aluminum tubas, on 1 tuba in a cardboard pack);
• Suspension for oral administration (on 60 or 100 ml in bottles, on 1 bottle in a cardboard pack).

Is a part of 1 ml of injection solution:

• Active ingredient: metronidazole – 5 mg;
• Auxiliary components: monohydrate of citric acid, anhydrous hydrosodium phosphate, sodium chloride, water for injections.

Is a part of 1 tablet:

• Active ingredient: metronidazole – 200 or 400 mg;
• Auxiliary components: magnesium stearate, colloid silicon dioxide, corn starch, the purified water; in addition: tablets on 200 mg – the castor hydrogenated oil and Opadry II dye pink 85G54815; tablets on 400 mg – povidone and Opadry II dye orange 85G53070.

Vaginal is a part of 100 mg of gel:

• Active ingredient: metronidazole – 1 mg;
• Auxiliary components: propylene glycol, пропилгидроксибензоат, sodium hydroxide, dinatrium эдетат, carbomer-940, the purified water.

For external use is a part of 100 mg of gel:

• Active ingredient: metronidazole – 1 mg;
• Auxiliary components: carbomer 940, эдетат dinatrium, propylene glycol, пропилпарагидроксибензоат, methylparahydroxybenzoate, sodium hydroxide, the purified water.

Active ingredient is a part of 1 ml of suspension for oral administration: metronidazole – 40 mg.

Indications to use

Solution for intravenous administration:

• Protozoan infections: mecotic vaginitis, lambliasis, abenteric and intestinal amebiasis (amoebic abscess of a liver, amoebic dysentery), trichomoniasis, balanthidiasis, mecotic urethritis, skin leushmaniosis;
• The infections caused by Bacteroides spp.: infections of joints, bones, the central nervous system (including meningitis), pneumonia, a bacterial endocarditis, brain abscess, abscess of lungs, an empyema;
• The infections caused by types of Bacteroides spp., including the group B. fragilis, Clostridium spp., Peptococcus spp., Peptostreptococcus spp.: infections of an abdominal cavity (including liver abscess, peritonitis), infections of skin, soft tissues, bodies of a basin (including an endometritis, an endomyometritis, abscess of fallopian pipes and ovaries, infections of a vault of the vagina after carrying out surgeries);
• The infections caused by types of Bacteroides spp., including the group B. fragilis, Clostridium spp.: sepsis;
• The pseudomembranous colitis which developed because of use of antibiotic medicines;
• Alcoholism;
• The gastritis or ulcer of a duodenum connected with Helikobakter of a pilora (Helicobacter pylori);
• Complications after carrying out operations, especially interventions in okolorektalny area, on a colon, gynecologic operations, appendectomy (prevention).

Tablets:

• Protozoan infections, including an amebiasis, amoebic dysentery, trichomoniasis, a balanthidiasis, a lambliasis, an urethritis and a mecotic vaginitis;
• Respiratory infections, including necrotic pneumonia, abscess of lungs;
• The mephitic gangrenes caused by Bac.fragilis and other bacteroids, fuzobakteriya, clostridiums, eubakteriya, anaerobic cocci;
• Gas gangrene;
• Septicaemia;
• Tetanus;
• Osteomyelitis;
• Brain abscess, meningitis;
• The period after carrying out surgical interventions on urinary tract and abdominal organs, including pelvic abscesses, peritonitis, intraperitoneal infections, appendicitis, cholecystitis, postoperative wound fevers, liver abscess, postnatal sepsis (prevention and treatment of postoperative mephitic gangrenes).

Gel vaginal:

• Urogenital trichomoniasis;
• The bacterial vaginoses having various etiology (after confirmation by microbiological and clinical data).

Gel for external use:

• Pink eels, including post-steroid;
• Seborrheal dermatitis, fat seborrhea;
• Vulgar acne rash;
• Decubituses, hard healing wounds;
• Trophic ulcers of the lower extremities at a varicosity, a diabetes mellitus;
• Hemorrhoids, anal fissures.

Suspension for oral administration:

• Amebiasis;
• Lambliasis;
• Mephitic bacterial gangrenes;
• Amoebic abscess of a liver.

Contraindications

Solution for intravenous administration:

• Organic lesions of the central nervous system, including epilepsy;
• Blood diseases, including instructions on them in the anamnesis;
• Liver failure (at purpose of high doses);
• I trimester of pregnancy and period of a lactation;
• Hypersensitivity to drug components, and also to other derivatives of a nitroimidazole.

In the II-III trimesters of pregnancy Metrogil's appointment is possible only according to vital indications.

Drug should be used with care at a renal failure.

Tablets:

• Organic lesions of the central nervous system, including epilepsy;
• Blood diseases, including instructions on them in the anamnesis;
• Liver failure (at purpose of high doses);
• I trimester of pregnancy;
• Age up to 12 years;
• Hypersensitivity to drug components, and also to other derivatives of a nitroimidazole.

In the II-III trimesters of pregnancy Metrogil's appointment is possible only according to vital indications, in the period of a lactation breastfeeding should be interrupted.

Drug should be used with care at a renal liver failure.

Gel vaginal:

• Leukopenia, including instructions on it in the anamnesis;
• Lacks of coordination of movements;
• Organic lesions of the central nervous system, including epilepsy;
• Liver failure;
• I trimester of pregnancy;
• Hypersensitivity to drug components, and also to other derivatives of a nitroimidazole.

At use of drug in the form of vaginal gel in the period of a lactation breastfeeding should be interrupted.

Gel for external use:

Contraindication to Metrogil's use is hypersensitivity to drug components.

Gel should be applied with care in the I trimester of pregnancy and to the feeding women.

Suspension for oral administration:

• Organic lesions of the central nervous system;
• Blood diseases;
• I trimester of pregnancy;
• Hypersensitivity to drug components.

In the II-III trimesters of pregnancy Metrogil's appointment is possible only according to vital indications, at administration of drug in the period of a lactation breastfeeding should be interrupted.

Route of administration and dosage

Solution for intravenous administration:
Intravenous administration of Metrogil is shown in cases of a heavy course of infections and lack of an opportunity to accept drug inside.

To adults and children of 12 years Metrogil appoint in an initial dose 500-1000 mg intravenously kapelno (duration of infusions – 30-40 minutes), further each 8 hours with a speed of 5 ml a minute enter 500 mg. After the first 2-3 infusions at good tolerance pass to jet introduction. Therapy duration – 7 days. In case of need intravenous administration can be carried out is longer. The maximum daily dose makes 4000 mg. Further the patient is transferred to a maintenance therapy, appointing administration of drug inside in a daily dose of 1200 mg (3 times a day on 400 mg).

To children up to 12 years Metrogil appoint according to the same scheme, applying a single dose of 7,5 mg/kg.

At treatment it is purulent - septic diseases usually conduct 1 course of treatment.

With the preventive purpose to adults and children of 12 years Metrogil appoint intravenously kapelno 500-1000 mg on the eve of carrying out operation. In day of operation and next day the drug each 8 hours administer 500 mg. In 1-2 days it is necessary to pass to a maintenance therapy inside.

The maximum daily dose at a chronic renal failure and clearance of creatinine is less than 30 ml in a minute and/or should not exceed a liver failure 1000 mg (with frequency rate of use 2 times a day).

Tablets, suspension for oral administration:
Pill Metrogil is taken inside, without chewing, it is more preferable – in time or after food, washing down with milk.

As a rule, to adults and children of 15 years appoint 2-3 times a day 200-400 mg.

The mode of dosing is defined by indications:

• Trichomoniasis: a single dose – 200 mg, frequency rate of reception – 3 times a day, course duration – 7 days; in addition women should apply metronidazole in the form of vaginal ointments or candles. In cases of need carrying out a repeated course of therapy (with a break in 3-4 weeks during which it is necessary to conduct repeated control laboratory researches) or increase in a dose up to 750-1000 mg a day is possible. It is also possible to apply other scheme of administration of drug – once on 2000 mg to the patient and his sexual partner;
• Amoebic abscess of a liver: an adult daily dose – 1200-2400 mg (3 times a day on 400 or 800 mg), therapy it is necessary to carry out along with antibiotic drugs (most often – a tetracycline row); a children's daily dose – 30-35 mg/kg (in 3 receptions); course duration – 5-10 days;
• Amebiasis: an adult daily dose – 1200 mg (3 times a day on 400 mg); a children's daily dose – 30-40 mg/kg (in 3 receptions); course duration – 7-10 days;
• Mephitic bacterial gangrenes: an adult daily dose – 400-1200 mg (2-3 times a day on 200-400 mg); a children's daily dose – 21 mg/kg (each 8 hours on 7 mg/kg); course duration – 7-10 days.

Before performing surgeries on a large intestine and pelvic bodies for prevention of a mephitic gangrene the single dose of Metrogil in a dose of 1000 mg, further – 3 times a day on 200 mg is shown.

The daily dose of metronidazole in a combination with amoxicillin (2250 mg a day) makes 1500 mg (in 3 receptions). At the expressed functional disturbances of kidneys and a liver daily doses should be lowered: metronidazole – to 1000 mg, amoxicillin – to 1500 mg (in 2 receptions).

Gel vaginal:
Metrogil apply intravaginalno.

The recommended single dose – 1 full applicator (5000 mg), frequency rate of use – 2 times a day (in morning and evening).

Therapy duration – 5 days.

Gel for external use:
Metrogil it is necessary to apply with a thin layer 2 times a day (in morning and evening) on previously cleared struck areas of skin.

Therapy duration – as a rule, improvement comes 3-4 months in 3 weeks from the moment of the beginning of therapy.

Side effects

Solution for intravenous administration, a tablet:

• Alimentary system: pseudomembranous colitis, dryness in a mouth, vomiting, nausea, a lock, diarrhea, intestinal gripes, lack of appetite, unpleasant metal smack in a mouth, increase in level of liver enzymes, cholestatic jaundice, hepatitis, stomatitis, a glossitis, pancreatitis;
• Hemopoietic system: thrombocytopenia, leukopenia;
• Urinogenital system: burning sensation in an urethra, a dysuria, candidiasis (fungal flora of a vagina), red-brown coloring of urine, a polyuria, an urine incontience;
• Nervous system: lack of coordination of movements, headache, hallucinations, ataxy, dizziness, epilepsy attacks, consciousness disturbance, hyperexcitability, sleep disorder, depression, weakness, peripheral neuropathy;
• Allergic reactions: acute anaphylaxis, congestion of a nose, arthralgia, dermahemia, skin rash, itch, fever, small tortoiseshell;
• Local reactions (at intravenous administration): thrombophlebitis (pain, puffiness or a hyperemia in the place of an injection);
• Others: flattening of a tooth of T on the electrocardiogram, a neutropenia.

Gel vaginal:

• System reactions: dizziness, dryness in a mouth, a leukocytosis or a leukopenia, a headache, change of flavoring feelings (including metal smack), a loss of appetite, nausea, spastic an abdominal cavity pains, vomiting, diarrhea or a lock, coloring of urine in dark color;
• Local reactions: burning sensation or the speeded-up urination, a vulvitis; the sexual partner has an irritation or burning sensation of a penis; at women is after the end of treatment – vagina candidiasis;
• Allergic reactions: urticaria, skin rash.

Gel for external use:

Risk of emergence of system side effects at use of outside gel Metrogil small. In rare instances during therapy can be observed: allergic reactions (in the form of a small tortoiseshell, skin rash), dacryagogue (when putting gel it is close to eyes), a peeling, a hyperemia, easy burning and a xeroderma.

Special instructions

During Metrogil's use it is not necessary to take alcohol as it can lead to development of the disulfiramopodobny reaction which is shown in the form of abdominal pain of spastic character, vomiting, nausea, a headache, sudden rushes of blood to the person.

Simultaneous use of Metrogil with amoxicillin is not recommended to patients aged up to 18 years.

The possibility of continuation of treatment at a leukopenia is defined by risk of development of infectious process.

During long therapy it is desirable to control indicators of peripheral blood.

At emergence of an ataxy, dizziness and any other deterioration in the neurologic status therapy should be cancelled.

Metrogil's use can immobilize treponemas and lead to the false positive test of Nelson.

During therapy of a mecotic vaginitis at women and a mecotic urethritis at men it is necessary to abstain from sex life and to carry out simultaneous treatment of sexual partners. During periods treatment should not be interrupted. Upon termination of a course it is necessary to carry out control tests throughout three next cycles before and after periods.

After the end of treatment of a lambliasis at preservation of symptoms in 3-4 weeks it is necessary to carry out 3 analyses a calla with breaks in several days (at some successfully treated patients the lactose intolerance caused by an invasion can it is long to remain, reminding lambliasis symptoms).

It is necessary to avoid hit in eyes of vaginal and outside gel. At their accidental hit it is necessary to wash out immediately a large amount of water.

Medicinal interaction

At combined use of Metrogil (inside, intravenously) with some drugs there can be following effects:

• Indirect anticoagulants: strengthening of their action (leads to increase in time of formation of a prothrombin);
• Ethanol: development of its intolerance;
• The medicines stimulating enzymes of a microsomal oxidation in a liver (phenobarbital, Phenytoinum): metronidazole elimination acceleration (can lead to decrease in its concentration in plasma);
• Streptocides: strengthening of antimicrobic action of Metrogil;
• Cimetidinum: metronidazole metabolism inhibition (can lead to increase in its concentration in blood serum and to risk of development of side effects);
• Lithium drugs (high doses): increase in concentration of lithium in a blood plasma with development of symptoms of intoxication.

Simultaneous use of Metrogil with the depolarizing muscle relaxants (bromide a vekuroniya) is not recommended.

At topical administration of Metrogil (outside and vaginal gel) interaction with other medicines is insignificant, however during therapy it is necessary to be careful at joint appointment with warfarin and other indirect anticoagulants.

Injection solution of Metrogil should not be mixed with other drugs.

Terms and storage conditions

To store in protected from light, the place, unavailable to children.

Period of validity:

• Injection solution, gel for external use – 3 years at a temperature up to 30 °C;
• Tablets, coated – 5 years at a temperature up to 30 °C;
• Gel vaginal – 2 years at a temperature up to 25 °C;
• Suspension for intake – 3 years at the room temperature.