Universal reference book for medicines
Product name: EDGIL (EDGIL)

Active substance: metronidazole

Type: Antiprotozoal preparation with antibacterial activity

Manufacturer: AHLCON PARENTERALS (India) produced by EDGE PHARMA PRIVATE (India)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
An antiprotozoal agent.
It is believed that the mechanism of action is associated with a violation of the structure of DNA of sensitive microorganisms. It is active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, as well as obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.).
Metronidazole is resistant to aerobic microorganisms.

In combination with amoxicillin, it shows activity against Helicobacter pylori.
It is believed that amoxicillin inhibits the development of Helicobacter pylori resistance to metronidazole.
PHARMACOKINETICS
Well absorbed after ingestion.
Bioavailability is 80%. It is distributed in tissues and body fluids. It penetrates the placental barrier and the BBB. Binding to blood plasma proteins - 20%. Metabolised in the liver by oxidation and binding to glucuronic acid. T 1/2 is 8 hours. It is excreted in urine (60-80%) and feces (6-15%).
INDICATIONS
Trichomonas vaginitis and urethritis in women, trichomoniasis in men, giardiasis, amoebic dysentery, anaerobic infections caused by microorganisms sensitive to metronidazole, combined therapy of severe mixed aerobic-anaerobic infections.
Prevention of anaerobic infection during surgical interventions (especially on the organs of the abdominal cavity, urinary tract). Chronic alcoholism.
In combination with amoxicillin: chronic gastritis in the phase of exacerbation, peptic ulcer of the stomach and duodenum in the acute phase associated with Helicobacter pylori.

For external and topical application: treatment of pink and vulgar acne, bacterial vaginosis, treatment of long-term healing wounds, trophic ulcers.

DOSING MODE
Inside adults and children over 12 years of age - 7.5 mg / kg every 6 hours or 250-750 mg 3-4 times / day.
Children under 12 years - 5-16.7 mg / kg 3 times / day.
With IV introduction to adults and children over 12 years of age, the initial dose is 15 mg / kg, then 7.5 mg / kg every 6 hours or depending on the etiology of the disease - 500-750 mg every 8 hours. Duration of treatment courses and their frequency conducting is determined individually.

Intravaginal - 500 mg once a night.

In combination with amoxicillin (2.25 g / day), the daily dose of metronidazole is 1.5 g;
frequency of reception - 3 times / day. For patients with severe renal dysfunction (CC less than 30 ml / min) and / or liver, the daily dose of metronidazole is 1 g (amoxicillin 1.5 g / day); frequency of reception - 2 times / day.
Externally and topically apply 2 times / day, the dose is set individually.

The maximum daily intake for adults with oral and / or induction is 4 g.

SIDE EFFECT
On the part of the digestive system: nausea, vomiting, lack of appetite, metallic taste in the mouth.

From the side of the central nervous system and peripheral nervous system: headache, increased excitability, irritability, insomnia, dizziness, ataxia, weakness, confusion, depression, peripheral neuropathy, convulsions, hallucinations.

Allergic reactions: skin rash, itching, urticaria.

On the part of the hematopoiesis system: leukopenia.

Local reactions: irritation.

Other: arthralgia, burning sensation in the urethra.

CONTRAINDICATIONS
Organic lesions of the central nervous system, blood diseases, violations of liver function, I trimester of pregnancy, hypersensitivity to metronidazole.

PREGNANCY AND LACTATION
Metronidazole rapidly penetrates the placental barrier.
In the II and III trimesters of pregnancy metronidazole is used only for vital indications.
Metronidazole is excreted in breast milk.
If it is necessary to use during the lactation period, the question of stopping breastfeeding should be solved.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in violations of liver function.

Caution is used metronidazole in liver diseases.

APPLICATION FOR CHILDREN
In combination with amoxicillin is not recommended for use in patients younger than 18 years.

SPECIAL INSTRUCTIONS
Caution is used metronidazole in liver diseases.

In combination with amoxicillin is not recommended for use in patients younger than 18 years.
During the treatment, systematic monitoring of the peripheral blood pattern is necessary.
During treatment of trichomonas vaginitis in women and trichomoniasis in men, it is recommended to abstain from sexual activity;
simultaneous treatment of both partners is mandatory.
During the application of metronidazole, a darker color of urine is observed.

During the treatment with metronidazole, alcohol should be avoided because
Due to the violation of alcohol oxidation, the accumulation of acetaldehyde may occur.As a result, reactions similar to those characteristic of disulfiram may occur (spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).
DRUG INTERACTION
When used simultaneously with antacids containing aluminum hydroxide, with colestyramin, the absorption of metronidazole from the digestive tract decreases slightly.

With the simultaneous use of metronidazole potentiates the effect of indirect anticoagulants.

With simultaneous use with disulfiram it is possible to develop acute psychoses and impaired consciousness.

It can not be ruled out that the concentration of carbamazepine in the blood plasma increases and the risk of developing toxic effects increases with simultaneous use with metronidazole.

With simultaneous use with lansoprazole, glossitis, stomatitis and / or the appearance of a dark color of the tongue are possible;
with lithium carbonate - it is possible to increase the concentration of lithium in the blood plasma and the development of symptoms of intoxication; with prednisone - increased excretion of metronidazole from the body due to the acceleration of its metabolism in the liver under the influence of prednisone. There may be a decrease in the effectiveness of metronidazole.
With simultaneous use with rifampicin, the clearance of metronidazole increases from the body;
with phenytoin - a slight increase in the concentration of phenytoin in the blood plasma is possible, a case of the development of toxic action is described.
With simultaneous use with phenobarbital, the excretion of metronidazole from the body is significantly increased, apparently, due to the acceleration of its metabolism in the liver under the influence of phenobarbital.
There may be a decrease in the effectiveness of metronidazole.
With simultaneous use with fluorouracil, toxic action is enhanced, but not the effectiveness of fluorouracil.

A case of development of acute dystonia after taking a single dose of chloroquine in a patient receiving metronidazole is described.

With simultaneous use with cimetidine, it is possible to inhibit metronidazole metabolism in the liver, which can lead to a delay in its excretion and an increase in the concentration in the blood plasma.

With the simultaneous use of ethanol in patients receiving metronidazole, it is possible to develop disulfiram-like reactions.

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