Metronidazole Reneval, tablets 250 mg 24 pcs

Pharmacotherapeutic group:

an antimicrobial and antiprotozoal agent.

The ATX code: J01XD01

Pharmacological properties

Antiprotozoal and antimicrobial drug, a 5-nitroimidazole derivative. Its mechanism of action consists in biochemical reduction of 5-nitrogroup by intracellular transport proteins of anaerobic microorganisms and protozoa.

The reduced 5-nitrogroup interacts with the deoxyribonucleic acid (DNA) of the microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of the bacteria.

Active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia intestinalis, Lamblia spp, as well as obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp, Veillonela spp., Prevotella (P.bivia, P.buccae, P.disiens), and some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). The minimum suppressive concentration for these strains is 0.125-6.25 µg/ml.

In combination with amoxicillin it shows activity against Helicobacter pylori (amoxicillin suppresses development of resistance to metronidazole). Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against common aerobes. It increases the sensitivity of tumors to radiation, causes sensitization to alcohol (disulfiram-like effect), stimulates reparative processes.

Indications

Protozoal infections: Extraintestinal amoebiasis, including amebic liver abscess, intestinal amoebiasis (amebic dysentery), trichomoniasis, giardiasis, balanceidiasis, giardiasis, cutaneous leishmaniasis, trichomonadic vaginitis, trichomonadic urethritis. Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus): bone and joint infections, central nervous system (CNS) infections, including meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema and lung abscess.

Infections caused by Bacteroides species, including B. Infections caused by B. fragilis, Clostridium, Peptococcus and Peptostreptococcus species: abdominal infections (peritonitis, liver abscess), pelvic infections (endometritis, endomiometritis, abscess of fallopian tubes and ovaries, infections of the vaginal roof after surgery), skin and soft tissue infections, Infection caused by Bacteroides species, including B. Fragilis and Clostridium species: sepsis.

Pseudomembranous colitis (associated with antibiotic use). Gastritis or duodenal ulcer associated with Helicobacter pylori, alcoholism.

Prevention of postoperative complications (especially interventions on the colon, perirectal area, apendectomy, gynecological operations).

The radiation therapy of patients with tumors – as a radiosensitizing agent in cases where tumor resistance is caused by hypoxia in the tumor cells.

Active ingredient

Composition

1 tablet contains:

The active ingredient:

Metronidazole 250 mg.

Associates:

Magnesium stearate;

propylene glycol;

titanium dioxide;

talc;

Hypromellose (methylhydroxypropylcellulose);

gelatin;

lactose monohydrate;

Microcrystalline cellulose;

Potato starch.

How to take, the dosage

Overly, with or after meals, (or with milk), without chewing. In trichomoniasis – 250 mg 2 times a day for 10 days or 400 mg 2 times a day for 5-8 days. For women, metronidazole in the form of vaginal suppositories or tablets should be prescribed additionally. If necessary, it is possible to repeat the course of treatment or to increase the dose to 0.75-1 g/day. A break of 3 to 4 weeks should be taken between courses of treatment with repeated laboratory tests. An alternative therapy regimen is to administer 2 g once to the patient and his sexual partner.

In children 3-5 years old – 250 mg/day; 5-10 years old – 250-375 mg/day, over 10 years old – 500 mg/day. The daily dose should be divided into two doses. The course of treatment is 10 days.

In giardiasis – 500 mg 2 times a day for 5-7 days.

In children from 3 to 5 years old – 250 mg/day, 5-8 years old – 375 mg/day, older than 8 years old – 500 mg/day (in 2 doses). The course of treatment is 5 days.
In case of giardiasis it is 15 mg/kg/day in 3 intakes during 5 days.

Adults: In asymptomatic amoebiasis (in case of cysts) the daily dose is 1-1.5 g (500 mg 2-3 times a day) for 5-7 days.
In chronic amoebiasis the daily dose is 1.5 g in 3 shots for 5-10 days, in acute amoebic dysentery – 2.25 g in 3 shots until cessation of symptoms.

In case of liver abscess the maximum daily dose is 2.5 g in 1 or 2-3 doses, for 3-5 days, in combination with antibiotics (tetracyclines) and other therapies.

In children 3 years of age – 1/4 dose of an adult, 3-7 years – 1/3 dose of an adult, 7-10 years – 1/2 dose of an adult.

In balanceidiasis – 750 mg 3 times a day for 5-6 days.

In ulcerative stomatitis adults are prescribed 500 mg 2 times a day for 3-5 days; children in this case the drug is not indicated.
In pseudomembranous colitis 500 mg 3-4 times a day.

For eradication of Helicobacter pylori – 500 mg 3 times per day within 7 days (in combination therapy, for example, in combination with amoxicillin 2.25 g/day). In treatment of anaerobic infection the maximum daily dose is 1.5-2 g. In treatment of chronic alcoholism 500 mg/day is prescribed for a period of up to 6 (not more than) months.

For prevention of infectious complications 750-1500 mg/day in 3 doses 3-4 days before surgery or 1 g once a day after surgery. 1-2 days after surgery (when oral administration is already allowed) – 750 mg/day for 7 days. In case of marked renal dysfunction (CKD less than 10 ml/min) the daily dose should be halved.

Interaction

Enhances the effect of indirect anticoagulants, which leads to increased prothrombin formation time.

Like disulfiram, it causes ethanol intolerance. Simultaneous use with disulfiram may lead to the development of various neurological symptoms (interval between prescriptions – at least 2 weeks).

Cimetidine inhibits metabolism of metronidazole, which may increase its serum concentrations and increase the risk of side effects. Concomitant administration of drugs stimulating enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin) may accelerate elimination of metronidazole, resulting in lower plasma concentrations.

Concomitant use with lithium preparations may increase the plasma concentration of the latter and the development of intoxication symptoms.
It is not recommended to combine with nondepolarizing myorelaxants (vecuronium bromide).

Sulfonamides increase the antimicrobial effects of metronidazole.

Special Instructions

Ethanol intake is contraindicated during treatment (development of disulfiram-like reaction is possible: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).

In combination with amoxicillin is not recommended in patients under 18 years of age.

In prolonged therapy the blood count should be monitored.

In case of leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

The emergence of ataxia, dizziness and any other deterioration in the neurological status of patients requires discontinuation of treatment.
May immobilize treponemes and lead to a false positive Nelson’s test. Stains the urine a dark color.

When treating trichomonas vaginitis in women and trichomonas urethritis in men it is necessary to abstain from sexual activity. The simultaneous treatment of sexual partners is mandatory. The treatment does not stop during menstruation. After the therapy of trichomoniasis should be tested for three consecutive cycles before and after menstruation.

After treatment of giardiasis, if symptoms persist, three stool tests should be carried out after 3-4 weeks, at intervals of several days (in some successfully treated patients lactose intolerance caused by the infestation may persist for weeks or months, resembling symptoms of giardiasis). During lactation, it is recommended to stop breastfeeding.

Impact on driving and other machinery

Due to the possibility of dizziness and other side effects associated with taking the drug, it is recommended to refrain from driving and other machinery.

Contraindications

Hypersensitivity, leukopenia (including in anamnesis), organic CNS lesions (including epilepsy), hepatic failure (in case of high doses), pregnancy (I trimester), lactation.

With caution – pregnancy (II-III trimesters), renal/liver failure.

Children under 3 years of age (for this dosage form).

Side effects

Digestive system disorders: diarrhea, anorexia, nausea, vomiting, intestinal colic, constipation, “metallic” taste in the mouth, dry mouth, glossitis, stomatitis, pancreatitis.

Nervous system disorders: dizziness, impaired coordination of movements, ataxia, confusion, irritability, depression, increased excitability, weakness, insomnia, headache, seizures, hallucinations, excitability, weakness, insomnia, headache, seizures, hallucinations, peripheral neuropathy.

Allergic reactions: urticaria, skin rash, skin hyperemia, nasal congestion, fever, arthralgia.

Urinary system disorders: dysuria, cystitis, polyuria, urinary incontinence, candidiasis, red-brown coloring of urine.

Others: neutropenia, leukopenia, flatness of the T wave on the electrocardiogram.

Similarities