Metronidazole pills 250 mg 40 pcs
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Active ingredients
Metronidazole
Release form
Pills
Composition
1 tab. metronidazole 250 mg. Excipients: potato starch, stearic acid, talc.
Pharmacological effect
Anti-protozoan and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action consists in the biochemical reduction of 5-nitro groups by intracellular transport proteins of anaerobic microorganisms and protozoa. The recovered 5-nitro group interacts with deoxyribonucleic acid (DNA) microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. Active against Trichomonas vaginalis, Entamoeba histolytica, as well as Gram-negative anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp. and some gram-positive anaerobes (sensitive strains of Eubacterium spp., Clostridium spp., Peptococcus niger., 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 inhibits the development of metronidazole resistance). Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole, but in the presence of mixed flora (aerobic and anaerobic) metronidazole acts synergistically with antibiotics that are effective against conventional aerobes. Increases the sensitivity of tumors to radiation, causes sensitization to alcohol (disulfiramopodobnoe action), stimulates reparative processes.
Pharmacokinetics
Absorption - high (bioavailability of at least 80%). It has a high penetrating ability, reaching bactericidal concentrations in most tissues and body fluids, including lungs, kidneys, liver, skin, cerebrospinal fluid, brain, bile, saliva, amniotic fluid, abscesses, vaginal secretions, semen, breast milk. It penetrates the hematoencephalic and placental barrier. Vd: adults - approximately 0.55 l / kg, newborns - 0.54-0.81 l / kg. Cmax of the drug in the blood ranges from 6 to 40 mcg / ml depending on the dose. The time to reach Cmax is 1-3 hours. Communication with plasma proteins is 10-20%. In the body, about 30-60% of metronidazole is metabolized by hydroxylation, oxidation and glucuronidation. The main metabolite (2-hydroxymetronidazole) also has an antiprotozoal and antimicrobial effect.T1 / 2 with normal liver function - 8 hours (from 6 to 12 hours), with alcoholic liver damage - 18 hours (from 10 to 29 hours), for newborns: born during the gestation period - 28-30 weeks - about 75 hours, respectively, 32–35 weeks — 35 hours, 36–40 weeks — 25 hours. 60–80% (20% unchanged) is excreted by the kidneys, 6–15% through the intestines. Renal clearance - 10.2 ml / min. In patients with impaired renal function, after repeated administration, cumulation of metronidazole in serum may be observed (therefore, in patients with severe renal insufficiency, the frequency of administration should be reduced). Metronidazole and the major metabolites are rapidly removed from the blood during hemodialysis (T1 / 2 is reduced to 2.6 hours). With peritoneal dialysis is displayed in small quantities.
Indications
Protozoal infections: extraintestinal amebiasis, including amebic liver abscess, intestinal amebiasis (amoebic dysentery), trichomoniasis (including trichomonas vaginitis, trichomonas urethritis). Infections caused by Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus): infections of bones and joints, infections of the central nervous system (CNS), including meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema and lung abscess, sepsis. Infections caused by Clostridium spp., Peptococcus niger and Peptostreptococcus spp .: abdominal infections (peritonitis, liver abscess), pelvic infections (endometritis, abscess of the fallopian tubes and ovaries, vaginal arch infection) Pseudomembranous colitis (associated with the use of antibiotics). Gastritis or duodenal ulcer associated with Helicobacter pylori. Prevention of postoperative complications (especially interventions on the colon, near-rectal area, apendectomy, gynecological surgery). Radiation therapy of patients with tumors - as a radiosensitizing agent, in cases where the resistance of the tumor is due to hypoxia in the tumor cells.
Contraindications
Hypersensitivity, leukopenia (including history), organic lesions of the central nervous system (CNS) (including epilepsy), liver failure (in the case of large doses), pregnancy (I term), lactation. With care: pregnancy (II-III trimesters), renal / hepatic failure.
Use during pregnancy and lactation
Contraindicated in the first trimester of pregnancy, during lactation.With care: pregnancy (II-III trimesters).
Dosage and administration
Inside, during or after a meal, (or squeezed milk), not liquid. With trichomoniasis - 250 mg 2 times a day. within 10 days or 400 mg 2 times a day. within 5-8 days. Women should also be prescribed metronidazole in the form of vaginal suppositories or pills. 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 tests. An alternative treatment regimen is the appointment of 2 g once a patient and his sexual partner. Children 2-5 years old - 250 mg / day; 5-10 years - 250-375 mg / day, over 10 years - 500 mg / day. The daily dose should be divided into 2 doses. The course of treatment is 10 days. Children up to 1 year old - 125 mg / day, 2-4 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. Adults with asymptomatic amebiasis (if a cyst is detected) the daily dose is 1-1.5 g (500 mg 2-3 times per day) for 5-7 days. In chronic amebiasis, the daily dose is 1.5 g in 3 doses for 5–10 days, and in acute amebic dysentery it is 2.25 g in 3 doses until the symptoms stop. With 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 methods of therapy. Children 1-3 years old - 1/4 adult dose, 3-7 years old - 1/3 adult dose, 7-10 years old - 1/2 adult dose. For ulcerative stomatitis, adults are prescribed 500 mg 2 times a day. within 3-5 days; children in this case, the drug is not shown. With pseudomembranous colitis - 500 mg 3-4 times per day. For eradication of Helicobacter pylory - 500 mg 3 times a day. within 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. For the prevention of infectious complications, 750-1500 mg / day. 3 doses for 3-4 days before surgery, or 1 g once a day. after operation. 1-2 days after surgery (when oral administration is already allowed) - 750 mg / day. within 7 days. In cases of pronounced impaired renal function (creatinine clearance less than 10 ml / min), the daily dose should be halved.
Side effects
On the part of the digestive system: diarrhea, anorexia, nausea, vomiting, intestinal colic, constipation, "metallic" taste in the mouth, dry mouth, glossitis, stomatitis, pancreatitis. Nervous system disorders: dizziness, incoordination, 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 urogenital 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 with other drugs
It enhances the effect of indirect anticoagulants, which leads to an increase in the time of formation of prothrombin. Similar to disulfiram, it causes intolerance to ethanol. Simultaneous use with disulfiram can lead to the development of various neurological symptoms (the interval between administration is at least 2 weeks). 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 appointment of drugs that stimulate the enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin), can accelerate the elimination of metronidazole, resulting in a decrease in its concentration in plasma. When taken simultaneously with lithium preparations, 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.
special instructions
Ethanol is contraindicated during the treatment period (a disulfiram-like reaction may develop: spastic abdominal pain, nausea, vomiting, headache, sudden flushing). In combination with amoxicillin is not recommended for use in patients younger than 18 years. With prolonged therapy, it is necessary to control the blood picture. In case of 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. It can immobilize treponema and lead to a false-positive Nelson test. It paints urine in a dark color. When treating Trichomonas vaginitis in women and Trichomonas urethritis in men, it is necessary to abstain from sex. Necessarily simultaneous treatment of sexual partners.The treatment does not stop during menstruation. After treatment of trichomoniasis, control tests should be carried out during three regular cycles before and after menstruation. After giardiasis treatment, if symptoms persist, after 3–4 weeks to perform 3 stool tests at intervals of several days (in some successfully treated patients, lactose intolerance caused by invasion may persist for several weeks or months, resembling the symptoms of giardiasis). During the period of treatment it is recommended to stop breastfeeding.