Metronidazole Renewal pills 250mg, 24pcs

Composition

1 tablet contains:  

Active ingredient:

Metronidazole 250 mg.

Auxiliary substances:

magnesium stearate;

propylene glycol;

titanium dioxide;

talc;

hypromellose (methylhydroxypropylcellulose);

gelatin;

lactose monohydrate;

microcrystalline cellulose;

potato starch.

Pharmacological action

Pharmacotherapeutic group:

antimicrobial and antiprotozoal agents.

ATX code:  J01XD01

Pharmacological Properties

An antiprotozoal and antimicrobial drug derived from 5-nitroimidazole. The mechanism of action consists in the biochemical reduction of the 5-nitro group by intracellular transport proteins of anaerobic microorganisms and protozoa.

The reduced 5-nitro group interacts with the deoxyribonucleic acid (DNA) of the microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of 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 inhibitory concentration for these strains is 0.125-6.25 mcg/ml.

In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin suppresses the 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 that are effective against conventional aerobes. Increases the sensitivity of tumors to radiation, causes sensitization to alcohol (disulfiram-like effect), and stimulates reparative processes.

Indications

Protozoal infections: extra-intestinal amoebiasis, including amoebic liver abscess, intestinal amoebiasis (amoebic dysentery), trichomoniasis, giardiasis, balantidiasis, giardiasis, cutaneous leishmaniasis, trichomonas vaginitis, trichomonas urethritis. Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus): infections of the bones and joints, infections of the central nervous system( CNS), including meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema and lung abscess.

Infections caused by Bacteroides species, including the B. fragilis group, Clostridium, Peptococcus, and Peptostreptococcus species: abdominal infections (peritonitis, liver abscess), pelvic infections (endometritis, endomyometritis, fallopian tube and ovarian abscess, vaginal vault infections after surgery), skin and soft tissue infections, Infections caused by Bacteroides species, including the B. Fragilis group, and pelvic organ infections (endometritis, endomyometritis, fallopian tube and ovarian abscess). Clostridium: sepsis.

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

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

Radiation therapy of patients with tumors – as a radiosensitizing agent, in cases when the tumor resistance is due to hypoxia in the tumor cells.

Contraindications

Hypersensitivity, leukopenia (including in the anamnesis), organic lesions of the central nervous system (including epilepsy), liver failure (in the case of high doses), pregnancy (I trimester), lactation.

With caution – pregnancy (II-III trimesters), renal / hepatic insufficiency.

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

Side effects

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

From the nervous system: dizziness, impaired coordination of movements, ataxia, confusion, irritability, depression, increased excitability, weakness, insomnia, headache, convulsions, hallucinations, excitability, weakness, insomnia, headache, convulsions, hallucinations, peripheral neuropathy.

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

From the genitourinary system: dysuria, cystitis, polyuria, urinary incontinence, candidiasis, urine staining in red-brown color.

Other: neutropenia, leukopenia, flattening of the T wave on the electrocardiogram.

Interaction

Increases the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation.

Similar to disulfiram, it causes ethanol intolerance. Concomitant use with disulfiram may lead to the development of various neurological symptoms (the interval between use is at least 2 weeks).

Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and increase the risk of side effects. Concomitant use of drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) may accelerate the elimination of metronidazole, resulting in a decrease in its concentration in plasma.

When taken concomitantly with lithium preparations, the concentration of the latter in plasma may increase and symptoms of intoxication may develop. It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide).

Sulfonamides enhance the antimicrobial effect of metronidazole.

How to take, course of use and dosage

Inside, during or after a meal, (or with milk), without chewing. For trichomoniasis – 250 mg 2 times a day for 10 days or 400 mg 2 times a day for 5-8 days. Women should be additionally prescribed metronidazole in the form of vaginal suppositories or tablets. If necessary, you can repeat the course of treatment or increase the dose to 0.75-1 g / day. Between courses, you should take a break of 3-4 weeks. with repeated control laboratory tests. An alternative treatment regimen is to prescribe 2 g once to the patient and his sexual partner.

Children 3-5 years – 250 mg / day; 5-10 years-250-375 mg/day, older than 10 years-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 from 3 to 5 years – 250 mg / day,5-8 years – 375 mg/day, older than 8 years-500 mg/day (in 2 doses). The course of treatment is 5 days. With giardiasis – 15 mg / kg / day in 3 doses for 5 days.

Adults: with asymptomatic amoebiasis (if a cyst is detected) 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 doses for 5-10 days, in acute amoebic dysentery-2.25 g in 3 doses until symptoms stop.

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), etc. methods of therapy.

Children 3 years – 1/4 adult dose,3-7 years-1/3 adult dose,7-10 years-1/2 adult dose.

With balantidiasis-750 mg 3 times a day for 5-6 days.

With ulcerative stomatitis, adults are prescribed 500 mg 2 times a day for 3-5 days; in this case, the drug is not indicated for children. 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 a combination therapy, for example, in combination with 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,500 mg/day is prescribed for a period of up to 6 (no more) months.

For the prevention of infectious complications – 750-1500 mg / day in 3 doses 3-4 days before surgery, or once 1 g in the first day after surgery. 1-2 days after surgery (when oral use is already allowed) – 750 mg/day for 7 days. With severe renal impairment (creatinine clearance less than 10 ml / min), the daily dose should be halved.

Special instructions

During the treatment period, taking ethanol is contraindicated (a disulfiram-like reaction may develop: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).

In combination with amoxicillin, it is not recommended for use in patients under 18 years of age.

With long-term therapy, it is necessary to monitor the blood picture.

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

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

When treating trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to refrain from sexual activity. Simultaneous treatment of sexual partners is mandatory. Treatment does not stop during menstruation. After trichomoniasis therapy, follow-up tests should be performed for three consecutive cycles before and after menstruation.

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

Influence on the ability to drive a car and other mechanisms

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

Active ingredient

Metronidazole

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor, Pregnant women in the second and third trimester as prescribed by a doctor

Indications

Gastrointestinal infections caused by Helicobacter Pylori, Amoebiasis and Giardiasis, Vaginitis, Trichomoniasis, Inflammation of the female genital organs, Alcoholism, Urinary tract infections, Stomach and Duodenal ulcers, Pneumonia, Urethritis