Buy Metronidazole Avexima vaginal suppositories 500 mg No. 10 in pharmacies
Instructions for use
Metronidazole sup. vag. 500 mg No. 10
Dosage forms suppositories 500 mg Synonyms Bacimex Klion Metrogyl Metronidazole Nycomed Rosamet Rosex Trichopex Trichopol Trichosept Flagyl Efloran Group Drugs for the treatment of trichomoniasis, amoebiasis and other protozoal infections International nonproprietary name Metronidazole Composition Active substance - metronidazole. Manufacturers Altfarm (Russia)
Pharmacological action Antibacterial, antiprotozoal (trichomonacid), antiulcer, antialcohol. The nitro group of the molecule, which is an electron acceptor, is integrated into the respiratory chain of protozoa and anaerobes, which disrupts the respiratory processes and causes cell death. In addition, in some species of anaerobes it has the ability to suppress DNA synthesis and cause its degradation. After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. The maximum concentration is reached after 1-2 hours. Penetrates well into tissues and body fluids, creating bactericidal concentrations in saliva, seminal fluid, and vaginal secretions; penetrates the BBB and placental barriers and is secreted into breast milk. With repeated doses it accumulates. Subject to biotransformation in the liver. Excreted by the kidneys and intestines, about 20% unchanged. The spectrum of action includes protozoa: Trichomonas vaginalis, Entamoeba histolytica; anaerobic gram-negative microorganisms: bacteroids, including the Bacteroides fragilis group (B. fragilis, B. caccae, B. uniformis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus); fusobacteria Prevotella (P. bivia, P. buccae, P. disiens); anaerobic gram-positive rods: Clostridium, Eubacterium; anaerobic gram-positive cocci: Peptococcus, Peptostreptococcus; Trichomonacid effect is observed at a drug concentration of 2.5 μg/ml for 24 hours. Shows activity against Helicobacter pylori. Side effects Headache, dizziness, syncope, ataxia, disturbances of consciousness, epileptic seizures, neutropenia (leukopenia), nausea, vomiting, abdominal pain, diarrhea, unpleasant metallic taste, erythematous rashes, skin itching, dark urine discoloration, allergic reactions, thrombophlebitis (after intravenous administration). Indications for use Amebiasis, trichomoniasis, giardiasis, giardiasis, intra-abdominal infections (peritonitis, abscess), anaerobic infections of bones and joints, skin and soft tissues, female genital organs (endometritis, tubo-ovarian abscess), central nervous system (meningitis, brain abscess), lower respiratory pathways (pneumonia, empyema, lung abscess), endocarditis, pseudomembranous colitis, Helicobacter pylori eradication, chronic alcoholism, prevention of postoperative anaerobic infection. For external and local use: rosacea and vulgar acne, bacterial vaginosis, long-term non-healing wounds, trophic ulcers. Contraindications Hypersensitivity (including to other nitroimidazole derivatives), pregnancy, lactation, childhood (excluding cases of amoebiasis). Directions for use and dosage : Intravaginal: 500 mg at night for 10 days. Overdose Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and epileptic seizures. Treatment: symptomatic; There are no specific antidotes. Interaction Enhances the effects of indirect anticoagulants and lithium salts. Phenytoin and phenobarbital reduce the effect (due to activation of the liver microsomal system and accelerate metabolism and excretion), and cimetidine increases (inhibits the enzymatic systems of the liver and, as a result, slows down biotransformation). Incompatible with alcohol (when taken together, an Antabuse-like syndrome develops). Special instructions When treating with metronidazole, excessive development of fungal flora of the vagina (candidiasis) is sometimes observed, which requires the use of antifungal drugs. Storage conditions: In a cool, dry place, protected from light. List B.
Instructions for use METRONIDAZOLE tablets
To avoid the development of resistance of microorganisms, metronidazole should only be used to treat infections caused by metronidazole-sensitive strains (according to microbiological examination of the material or epidemiological data).
Trichomoniasis with clinical symptoms.
Metronidazole is indicated for the treatment of trichomoniasis with clinical symptoms in women and men, if the presence of trichomonas has been confirmed by appropriate laboratory tests (smear and/or culture).
Asymptomatic trichomoniasis.
Metronidazole is indicated for the treatment of women with asymptomatic trichomoniasis (endocervicitis, cervicitis or cervical erosion). Because there is evidence that the presence of trichomonas may interfere with the accurate evaluation of cytological smears, additional smears should be performed after eradication of the parasite.
Treatment of a spouse without clinical manifestations.
T. vaginalis infection is a sexually transmitted disease. Thus, asymptomatic sexual partners should be treated at the same time to prevent reinfection from the partner, even if the pathogen is not isolated. The decision about whether to treat an asymptomatic male partner in whom trichomonas is not detected, or where testing has not been performed, is an individual one. In making this decision, it should be noted that there is evidence that a woman can become infected again if her husband is not treated. In addition, because there are significant difficulties in isolating the pathogen from an asymptomatic patient, negative smear and culture results should not be relied upon. In any case, in case of re-infection, the spouses should be treated with metronidazole at the same time.
Amoebiasis.
Metronidazole is indicated for the treatment of acute intestinal amebiasis (amebic dysentery) and liver abscess caused by amoebae. When treating a liver abscess caused by amoebas with metronidazole, the need for aspiration or drainage of pus cannot be excluded.
Anaerobic bacterial infections.
Metronidazole is indicated for the treatment of severe infections caused by susceptible anaerobic bacteria. Necessary surgical procedures must be performed in combination with metronidazole therapy. In case of mixed aerobic and anaerobic infection, appropriate antimicrobial agents should be used in addition to metronidazole. When treating severe anaerobic infections, metronidazole is usually given first. Intra-abdominal infections, including peritonitis, intra-abdominal abscess and liver abscess, are caused by Bacteroides, including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium, Eubacterium, Peptococcus niger and Peptostreptococcus .
Infections of the skin and skin structures,
caused by Bacteroides (including the B. fragilis group), Clostridium, Peptococcus niger, Peptostreptococcus and Fusobacterium.
Gynecological infections,
including endometritis, endomyometritis, tubo-ovarian abscess and infections after gynecological surgery caused by Bacteroides (including B. fragilis group), Clostridium, Peptococcus niger and Peptostreptococcus.
Bacterial septicemia,
caused by Bacteroides (including the B. fragilis group) and Clostridium.
Bone and joint infections
caused by Bacteroides species (including the B. fragilis group) as adjunctive therapy.
CNS infections
including meningitis and brain abscess caused by Bacteroides (including B. fragilis group).
Lower respiratory tract infections,
including pneumonia, empyema and lung abscess caused by Bacteroides (including B. fragilis group).
Endocarditis,
caused by Bacteroides (including the B. fragilis group).
Metronidazole-Nycomed tablets PPO 500mg No. 20
Compound
One tablet contains:
Active substance:
Metronidazole 500 mg
Excipients: potato starch 159.0 mg, microcrystalline cellulose 140.0 mg, lactose monohydrate 100.0 mg, gelatin 12.0 mg, magnesium stearate 0.5 mg.
Shell: hypromellose (methylhydroxypropylcellulose) 10.3 mg, titanium dioxide 6.6 mg, talc 6.6 mg, propylene glycol 2.0 mg.
Pharmacokinetics
When taken orally, metronidazole is rapidly and almost completely absorbed (approximately 80% in 1 hour). Eating does not affect the absorption of metronidazole. Bioavailability of at least 80%. After oral administration of 500 mg of metronidazole, the plasma concentration is 10 mcg/ml after 1 hour, and 13.5 mcg/ml after 3 hours. The half-life is 8-10 hours, the connection with blood proteins is insignificant and does not exceed 10-20%. Metronidazole quickly penetrates into tissues (lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, seminal fluid, vaginal secretions), into breast milk and passes through the placental barrier. About 30-60% of metronidazole is metabolized by hydroxylation, oxidation and glucuronidation. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects. Metronidazole is excreted by 40-70% through the kidneys (unchanged - about 35% of the dose taken). In patients with impaired renal function, a course of taking metronidazole may increase its concentration in the blood serum.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to metronidazole, or protozoal infections: extraintestinal amebiasis (including amoebic liver abscess), intestinal amebiasis (amoebic dysentery), trichomoniasis. Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgates), bone and joint infections, central nervous system (CNS) infections (including meningitis, brain abscess), bacterial endocarditis, pneumonia, empyema and lung abscess, sepsis. Infections caused by Clostridium spp., Peptococcus niger, Peptostreptococcus spp.: abdominal infections (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infections of the vaginal vault). Antibiotic-associated pseudomembranous colitis. Gastritis or duodenal ulcer associated with Helicobacter pylori (as part of complex therapy). Crohn's disease. Prevention of postoperative complications (especially after operations on the colon, in the pararectal area, appendectomy, gynecological operations).
Contraindications
Hypersensitivity to metronidazole, other components of the drug, leukopenia (including a history), organic lesions of the central nervous system (including 4 epilepsy), liver failure (in case of high doses), lactation period, lactase deficiency, galactose intolerance, glucose-galactose malabsorption. Children's age (up to 6 years).
Directions for use and doses
Metronidazole is intended to be taken orally, before or after meals. The drug must be taken with a sufficient amount of water. For intestinal amebiasis, Metronidazole Nycomed is used for 7 days, 1500 mg per day in three doses. For acute amoebic dysentery, the daily dose for adults is 1500 - 3000 mg, divided into three doses. Children from 6 to 15 years old - 35 - 50 mg/kg/day, divided into 2-3 doses. For liver abscess and other extraintestinal forms of amebiasis, the maximum daily dose is 1500 - 3000 mg, divided into 3 doses over 3-5 days, in combination with tetracycline antibiotics and other methods of therapy. Children from 6 to 15 years old - 35 - 50 mg/kg/day, divided into 2-3 doses. For trichomoniasis in women (urethritis and vaginitis), Metronidazole Nycomed is prescribed as a single dose of 2 g or as a course of treatment for 6 days: 500 mg 2 times a day. 5 For trichomoniasis in men (urethritis), Metronidazole Nycomed is prescribed as a single dose of 2 g or as a course of treatment for 6 days, 500 mg 2 times a day. Treatment of anaerobic infections usually begins with intravenous infusions, followed by a transition to tablets. For adults, the dose of Metronidazole Nycomed is 500 mg 3 times a day. The duration of treatment is up to 7 days. For the treatment of pseudomembranous colitis, 500 mg of the drug Metronidazole Nycomed is prescribed 3-4 times a day. The duration of treatment is determined by the doctor. To eradicate Helicobacter pylori, 500 mg of Metronidazole Nycomed is prescribed 3 times a day as part of combination therapy (for example, with amoxicillin). To prevent postoperative complications, 1500 mg per day is prescribed in 3 divided doses 3-4 days before surgery. 1-2 days after surgery (when oral administration is already allowed) - 1000 mg of Metronidazole Nycomed per day for 7 days. For Crohn's disease, adults are prescribed 500 mg 2 times a day; children – 15 mg/kg/day in 2 divided doses.
Storage conditions
At a temperature not higher than 25? C. Keep out of the reach of children.
Best before date
5 years. Do not use after expiration date.
special instructions
Since simultaneous use of metronidazole with alcohol may have an effect similar to that of disulfiram (feeling hot, vomiting, tachycardia), patients should be warned that during treatment with Metronidazole Nycomed they should not drink alcoholic beverages or medications containing alcohol. When treating trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to abstain from sexual intercourse. 9 Simultaneous treatment of sexual partners is mandatory. Treatment does not stop during menstruation. After treatment for trichomoniasis, control tests should be carried out during 3 consecutive cycles before and after menstruation. It must be taken into account that metronidazole can immobilize treponemes, which leads to a false-positive Nelson test. You should carefully weigh the indications for long-term use of the drug and avoid its long-term use without strict indications. If, in the presence of strict indications, the drug was used for a longer period than usually recommended, then treatment should be carried out under the monitoring of hematological parameters and adverse reactions, such as peripheral or central neuropathy (paresthesia, ataxia, dizziness, convulsions), if they occur, treatment should be discontinued.
Description
Film-coated tablets, white, oval in shape
Conditions for dispensing from pharmacies
Available with prescription
Dosage form
Film-coated tablets
Manufacturer and organization accepting consumer complaints
Takeda Pharmaceuticals LLC
119048 Moscow, st. Usacheva, 2, building 1. 11
Tel. +7 (495) 933 5511
Fax: +7 (495) 502 1625
Internet address: www.takeda.ru
Pharmacodynamics
Metronidazole is a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group 2 of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with deoxyribonucleic acid (DNA) of 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 (susceptible strains of Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.). The minimum inhibitory concentration for these strains is 0.125-6.25 μg/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 insensitive to metronidazole, but in the presence of mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics that are effective against common aerobes.
Side effects
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, glossitis, stomatitis, metallic taste in the mouth, decreased appetite, anorexia, dry oral mucosa, constipation, pancreatitis (reversible cases), discoloration tongue / “coated tongue” (due to the growth of fungal microflora).
Immune system disorders: angioedema, anaphylactic shock.
Nervous system disorders: peripheral sensory neuropathy, headache, convulsions, dizziness, the development of encephalopathy and subacute cerebellar syndrome (violation of 6 coordination and synergism of movements, ataxia, dysarthria, gait disturbances, nystagmus, tremor) has been reported, which are reversible after withdrawal metronidazole, aseptic meningitis.
Mental disorders: mental disorders, including confusion, hallucinations, depression, insomnia, irritability, increased excitability.
Visual disturbances: transient visual disturbances, such as diplopia and myopia, blurred contours of objects, decreased visual acuity, impaired color perception; neuropathy/optic neuritis.
Blood and lymphatic system disorders: agranulocytosis, leukopenia, neutropenia, thrombocytopenia.
Disorders of the liver and biliary tract: increased activity of liver enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase), development of cholestatic or mixed hepatitis and hepatocellular liver damage, sometimes accompanied by jaundice; In patients treated with metronidazole in combination with other antibacterial agents, cases of liver failure requiring liver transplantation have been observed.
Skin and subcutaneous tissue disorders: rash, itching, skin flushing, urticaria, pustular skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic skin reactions.
Renal and urinary tract disorders: brownish-reddish coloration of urine due to the presence of a water-soluble metabolite of metronidazole in the urine, dysuria, polyuria, cystitis, urinary incontinence, candidiasis.
General disorders and disorders at the injection site: fever, nasal congestion, arthralgia, weakness.
Laboratory and instrumental data: flattening of the T wave on the electrocardiogram.
Use during pregnancy and breastfeeding
Since metronidazole crosses the placental barrier and its effect on human fetal organogenesis is unknown, the use of metronidazole during pregnancy is not recommended. Metronidazole passes into breast milk, so its use should be avoided during breastfeeding.
Interaction
With disulfiram
The development of psychotic reactions has been reported in patients receiving concomitant metronidazole and disulfiram (the interval between the administration of these drugs should be at least 2 weeks).
With ethanol
Disulfiram-like reactions may occur (skin hyperemia, vomiting, tachycardia).
With indirect anticoagulants (warfarin)
When taking metronidazole simultaneously with indirect anticoagulants, it is possible to enhance the anticoagulant effect and increase the hemorrhagic risk associated with a slowdown in their hepatic metabolism, which can lead to an increase in prothrombin time. In case of simultaneous use, more frequent monitoring of prothrombin time and, if necessary, dose adjustment of anticoagulants is required.
With lithium preparations
When taking metronidazole simultaneously with lithium preparations, the concentration of the latter in the blood plasma may increase. When used concomitantly, monitor plasma concentrations of lithium, creatinine, and electrolytes.
With cyclosporine
When metronidazole is taken concomitantly with cyclosporine, the serum concentration of cyclosporine may increase. If simultaneous use of these two drugs is necessary, monitoring of serum concentrations of cyclosporine and creatinine is required.
With cimetidine
Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increased risk of side effects.
With drugs that induce microsomal oxidation enzymes in the liver (phenobarbital, phenytoin)
The simultaneous administration of metronidazole with drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, resulting in a decrease in its plasma concentration.
With fluorouracil
Metronidazole reduces the clearance of fluorouracil, leading to increased toxicity.
With bisulfan
Metronidazole increases the concentration of bisulfan in the blood plasma, which can lead to the development of severe toxic effects of bisulfan.
With non-depolarizing muscle relaxants (vecuronium bromide)
It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide). Sulfonamides enhance the antimicrobial effect of metronidazole.
Overdose
Symptoms: nausea, vomiting, ataxia.
Treatment: no specific antidote, symptomatic and supportive therapy
Impact on the ability to drive vehicles and operate machinery
It is recommended to refrain from driving or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, taking into account the side effect profile.
