Trade Name: Metronidazole

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Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 250 mg/1

Storage and handling

METRONIDAZOLE Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
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  • No data
  • Metronidazole Tablets USP
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Array
  • Metronidazole has been shown to be carcinogenic in mice and rats (see n n n ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the n n n section below.n nn
  • Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:n n n n n
  • Metronidazole tablets USP, contain 250 mg or 500 mg of metronidazole. Inactive ingredients include hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide and hydrogenated vegetable oil.
  • Absorption
  • Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between one and two hours after administration.
  • Plasma concentrations of metronidazole are proportional to the administered dose. Oral administration of 250 mg, 500 mg, or 2,000 mg produced peak plasma concentrations of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively. Studies reveal no significant bioavailability differences between males and females; however, because of weight differences, the resulting plasma levels in males are generally lower.
  • Distribution
  • Metronidazole is the major component appearing in the plasma, with lesser quantities of metabolites also being present. Less than 20% of the circulating metronidazole is bound to plasma proteins. Metronidazole appears in cerebrospinal fluid, saliva, and breast milk in concentrations similar to those found in plasma. Bactericidal concentrations of metronidazole have also been detected in pus from hepatic abscesses.
  • Metabolism/Excretion
  • The major route of elimination of metronidazole and its metabolites is via the urine (60% to 80% of the dose), with fecal excretion accounting for 6% to 15% of the dose. The metabolites that appear in the urine result primarily from side-chain oxidation [1-(u00df-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl-acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Both the parent compound and the hydroxyl metabolite possess n n n antimicrobial activity. n nn
  • Renal clearance of metronidazole is approximately 10 mL/min/1.73 mn n n . The average elimination half-life of metronidazole in healthy subjects is eight hours. n nn
  • Renal Impairment
  • Decreased renal function does not alter the single-dose pharmacokinetics of metronidazole.
  • Subjects with end-stage renal disease (ESRD; CLn n n = 8.1u00b19.1 mL/min) and who received a single intravenous infusion of metronidazole 500 mg had no significant change in metronidazole pharmacokinetics but had 2-fold higher Cmax of hydroxy-metronidazole and 5-fold higher Cmax of metronidazole acetate, compared to healthy subjects with normal renal function (CLn n n = 126u00b116 mL/min). Thus, on account of the potential accumulation of metronidazole metabolites in ESRD patients, monitoring for metronidazole associated adverse events is recommended (see n n n ). n nn
  • Effect of Dialysis
  • Following a single intravenous infusion or oral dose of metronidazole 500 mg, the clearance of metronidazole was investigated in ESRD subjects undergoing hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). A hemodialysis session lasting for 4 to 8 hours removed 40% to 65% of the administered metronidazole dose, depending on the type of dialyzer membrane used and the duration of the dialysis session. If the administration of metronidazole cannot be separated from the dialysis session, supplementation of metronidazole dose following hemodialysis should be considered (see n n n ). A peritoneal dialysis session lasting for 7.5 hours removed approximately 10% of the administered metronidazole dose. No adjustment in metronidazole dose is needed in ESRD patients undergoing CAPD.n nn
  • Hepatic Impairment
  • Following a single intravenous infusion of 500 mg metronidazole, the mean AUCn n n of metronidazole was higher by 114% in patients with severe (Child-Pugh C) hepatic impairment, and by 54% and 53% in patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment, respectively, compared to healthy control subjects. There were no significant changes in the AUCn n n of hydroxyl-metronidazole in these hepatically impaired patients. A reduction in metronidazole dosage by 50% is recommended in patients with severe (Child-Pugh C) hepatic impairment (see n n n ). No dosage adjustment is needed for patients with mild to moderate hepatic impairment. Patients with mild to moderate hepatic impairment should be monitored for metronidazole associated adverse events (see n n n and n n n ). n nn
  • Geriatric Patients
  • Following a single 500 mg oral or IV dose of metronidazole, subjects >70 years old with no apparent renal or hepatic dysfunction had a 40% to 80% higher mean AUC of hydroxy-metronidazole (active metabolite), with no apparent increase in the mean AUC of metronidazole (parent compound), compared to young healthy controls <40 years old. In geriatric patients, monitoring for metronidazole associated adverse events is recommended (see n n n ). n nn
  • Pediatric Patients
  • In one study, newborn infants appeared to demonstrate diminished capacity to eliminate metronidazole. The elimination half-life, measured during the first 3 days of life, was inversely related to gestational age. In infants whose gestational ages were between 28 and 40 weeks, the corresponding elimination half-lives ranged from 109 to 22.5 hours.
  • Microbiology
  • Mechanism of Action
  • Metronidazole, a nitroimidazole, exerts antibacterial effects in an anaerobic environment against most obligate anaerobes. Once metronidazole enters the organism by passive diffusion and activated in the cytoplasm of susceptible anaerobic bacteria, it is reduced; this process includes intracellular electron transport proteins such as ferredoxin, transfer of an electron to the nitro group of the metronidazole, and formation of a short-lived nitroso free radical. Because of this alteration of the metronidazole molecule, a concentration gradient is created and maintained which promotes the drugu2019s intracellular transport. The reduced form of metronidazole and free radicals can interact with DNA leading to inhibition of DNA synthesis and DNA degradation leading to death of the bacteria. The precise mechanism of action of metronidazole is unclear.
  • Drug Resistance
  • A potential for development of resistance exists against metronidazole.
  • Resistance may be due to multiple mechanisms that include decreased uptake of the drug, altered reduction efficiency, overexpression of the efflux pumps, inactivation of the drug, and/or increased DNA damage repair.
  • Metronidazole does not possess any clinically relevant activity against facultative anaerobes or obligate aerobes.
  • Arrayn- Activity n n n and in Clinical Infections n n n
  • Metronidazole has been shown to be active against most isolates of the following bacteria both n n n and in clinical infections as described in the n n n section.n nn
  • Gram-positive anaerobes
  • Clostridium
  • Eubacterium
  • Peptococcus
  • Peptostreptococcus
  • Gram-negative anaerobes
  • Bacteroides fragilis n- B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B.vulgatus
  • Fusobacterium
  • Protozoal parasites
  • Entamoeba histolytica
  • Trichomonas vaginalis
  • The following n n n data are available, n n n n
  • Metronidazole exhibits n n n minimal inhibitory concentrations (MICu2019s) of 8 mcg/mL or less against most (u2265 90%) isolates of the following bacteria; however, the safety and effectiveness of metronidazole in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials. n nn
  • Gram-negative anaerobes
  • Bacteroides fragilis n- B. caccae, B. uniformis
  • Prevotella n- P. bivia, P. buccae, P. disiens
  • Susceptibility Tests:
  • When available, the clinical microbiology laboratory should provide results of n n n susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial or community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment. n nn
  • Arrayn- For Anaerobes:
  • Quantitative methods are used to determine antimicrobial inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. For anaerobic bacteria, the susceptibility to metronidazole can be determined by the reference broth and/or agar methodn n n . n nn
  • The MIC values should be interpreted according to the criteria provided in the following Table
  • Susceptibility Test Interpretive Criteria for Metronidazole against Anaerobes*u2020
  • A report of u201cSusceptibleu201d (S) indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the infection site necessary to inhibit growth of the pathogen. A report of u201cIntermediateu201d (I) implies that an infection due to the isolate may be appropriately treated in the body sites where the drugs are physiologically concentrated or when a high dosage of drug is used. A report of u201cResistantu201d (R) indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration usually achievable at the infection site; other therapy should be selected.
  • Quality Control
  • Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.n n n Standard metronidazole powder should provide a value within the MIC ranges noted in the following table:n nn
  • Acceptable Quality Control Ranges for Metronidazole against Anaerobes
  • For protozoal parasites:
  • Standardized tests do not exist for use in clinical microbiology laboratories.
  • Symptomatic Trichomoniasis. n- T. vaginalis
  • Asymptomatic Trichomoniasis. n- T. vaginalis
  • Treatment of Asymptomatic Sexual Partners. n- T. vaginalis
  • Amebiasis.
  • In amebic liver abscess, metronidazole tablet USP therapy does not obviate the need for aspiration or drainage of pus.
  • Anaerobic Bacterial Infections.
  • INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by n n n species including the n n n group (n n n ), n n n species, n n n species, n n n and n n n species. n nn
  • SKIN AND SKIN STRUCTURE INFECTIONS caused by n n n species including the n n n group, n n n species, n n n species, and n n n species. n nn
  • GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by n n n species including the n n n group, n n n species, n n n species, and n n n species. n nn
  • BACTERIAL SEPTICEMIA caused by n n n species including the n n n group and n n n species. n nn
  • BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by n n n species including the n n n group. n nn
  • CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by n n n species including the n n n group. n nn
  • LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by n n n species including the n n n group. n nn
  • ENDOCARDITIS caused by n n n species including the n n n group. n nn
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • Hypersensitivity
  • Metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.
  • In patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see n n n ). n nn
  • Psychotic Reaction with Disulfiram
  • Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see n n n ). n nn
  • Interaction with Alcohol
  • Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see n n n ). n nn
  • Central and Peripheral Nervous System Effects
  • Encephalopathy and peripheral neuropathy: Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) have been reported with metronidazole.
  • Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible.
  • Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.
  • Convulsive seizures have been reported in patients treated with metronidazole.
  • Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.
  • The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see n n n ). n nn
  • General
  • Hepatic Impairment
  • Patients with hepatic impairment metabolize metronidazole slowly, with resultant accumulation of metronidazole in the plasma. For patients with severe hepatic impairment (Child-Pugh C), a reduced dose of metronidazole tablet is recommended. For patients with mild to moderate hepatic impairment, no dosage adjustment is needed but these patients should be monitored for metronidazole associated adverse events (see n n n and n n n ). n nn
  • Renal Impairment
  • Patients with end-stage renal disease may excrete metronidazole and metabolites slowly in the urine, resulting in significant accumulation of metronidazole metabolites. Monitoring for metronidazole associated adverse events is recommended (see n n n ). n nn
  • Fungal Superinfections
  • Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole tablets and requires treatment with a candidacidal agent.
  • Use in Patients with Blood Dyscrasias
  • Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of or history of blood dyscrasia. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metronidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended before and after therapy.
  • Drug-Resistant Bacteria and Parasites
  • Prescribing metronidazole tablets in the absence of a proven or strongly suspected bacterial or parasitic infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria and parasites.
  • Information for Patients
  • Interaction with Alcohol
  • Discontinue consumption of alcoholic beverages or products containing propylene glycol while taking metronidazole tablets and for at least three days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur (see n n n , n n n ). n nn
  • Treatment of Bacterial and Parasitic Infections
  • Patients should be counseled that metronidazole tablets should only be used to treat bacterial and parasitic infections. Metronidazole tablets do not treat viral infections (n n n the common cold). When metronidazole tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by metronidazole tablets in the future. n nn
  • Drug Interactions
  • Disulfiram
  • Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks (see n n n . n nn
  • Alcoholic Beverages
  • Abdominal cramps, nausea, vomiting, headaches, and flushing may occur if alcoholic beverages or products containing propylene glycol are consumed during or following metronidazole therapy (see n n n ). n n n n n
  • Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When metronidazole tablets are prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored.
  • Lithium
  • In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.
  • Busulfan
  • Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Metronidazole should not be administered concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to metronidazole are available, and concomitant administration with busulfan is medically needed, frequent monitoring of busulfan plasma concentration should be performed and the busulfan dose should be adjusted accordingly.
  • Drugs that Inhibit CYP450 Enzymes
  • The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole.
  • Drugs that Induce CYP450 Enzymes
  • The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported.
  • Drug/Laboratory Test Interactions
  • Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD+n n n n NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7. n nn
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Tumors affecting the liver, lungs, mammary, and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters.
  • Pulmonary tumors have been observed in all six reported studies in the mouse, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). Malignant liver tumors were increased in male mice treated at approximately 1500 mg/mn n n (similar to the maximum recommended daily dose, based on body surface area comparisons). Malignant lymphomas and pulmonary neoplasms were also increased with lifetime feeding of the drug to mice. Mammary and hepatic tumors were increased among female rats administered oral metronidazole compared to concurrent controls. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative. n nn
  • Metronidazole has shown mutagenic activity in n n n assay systems including the Ames test. Studies in mammals n n n have failed to demonstrate a potential for genetic damage.n nn
  • Metronidazole failed to produce any adverse effects on fertility or testicular function in male rats at doses up at 400 mg/kg/day (similar to the maximum recommended clinical dose, based on body surface area comparisons) for 28 days. However, rats treated at the same dose for 6 weeks or longer were infertile and showed severe degeneration of the seminiferous epithelium in the testes as well as marked decreases in testicular spermatid counts and epididymal sperm counts. Fertility was restored in most rats after an eight week, drug-free recovery period.
  • Pregnancy:
  • Teratogenic Effects: Pregnancy Category B
  • There are no adequate and well controlled studies of metronidazole tablets in pregnant women. There are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole during pregnancy. Many studies included first trimester exposures. One study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to metronidazole n n n however, these findings were not confirmed. In addition, more than ten randomized placebo-controlled clinical trials enrolled more than 5000 pregnant women to assess the use of antibiotic treatment (including metronidazole) for bacterial vaginosis on the incidence of preterm delivery. Most studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes following metronidazole exposure during pregnancy. Three studies conducted to assess the risk of infant cancer following metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited. n nn
  • Metronidazole crosses the placental barrier and its effects on the human fetal organogenesis are not known. Reproduction studies have been performed in rats, rabbits, and mice at doses similar to the maximum recommended human dose based on body surface area comparisons. There was no evidence of harm to the fetus due to metronidazole.
  • Nursing Mothers
  • Metronidazole is present in human milk at concentrations similar to maternal serum levels, and infant serum levels can be close to or comparable to infant therapeutic levels. Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Alternatively, a nursing mother may choose to pump and discard human milk for the duration ofu00a0u00a0 metronidazole therapy, and for 24 hours after therapy ends and feed her infant stored human milk or formula.
  • Geriatric Use
  • In elderly geriatric patients, monitoring for metronidazole associated adverse events is recommended (see n n n ). Decreased liver function in geriatric patients can result in increased concentrations of metronidazole that may necessitate adjustment of metronidazole dosage (see n n n ). n nn
  • Pediatric Use
  • Safety and effectiveness in pediatric patients have not been established, except for the treatment of amebiasis.
  • The following reactions have been reported during treatment with metronidazole:
  • Central Nervous System: n- WARNINGS
  • Gastrointestinal:
  • u00a0
  • Mouthn- Candida
  • u00a0
  • Dermatologic
  • u00a0
  • Hematopoietic
  • u00a0
  • Cardiovascular
  • u00a0
  • Hypersensitivity
  • u00a0
  • Renal
  • u00a0
  • Othern- Candida
  • Patients with Crohnu2019s disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohnu2019s disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohnu2019s disease is not an approved indication for metronidazole tablets.
  • Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia.
  • Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.
  • Treatment of Overdosage:
  • Trichomoniasis:
  • In the Female:
  • One-day treatment u2212
  • Seven-day course of treatment u2212
  • The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts tou00a0 obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.
  • Pregnant patients should not be treated during the first trimester (see n n n ). In pregnant patients for whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see n n n ). n nn
  • When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.
  • In the Male: Treatment should be individualized as it is for the female.
  • Amebiasis
  • u00a0
  • Adults:
  • For acute intestinal amebiasis (acute amebic dysentery):
  • For amebic liver abscess:
  • Pediatric patients
  • Anaerobic Bacterial Infections
  • In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially.
  • The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.
  • The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.
  • u00a0
  • Dosage Adjustments
  • u00a0
  • Patients with Severe Hepatic Impairment
  • For patients with severe hepatic impairment (Child-Pugh C), the dose of metronidazole tablets should be reduced by 50% (see n n n ).n nn
  • Patients Undergoing Hemodialysis:
  • Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patientu2019s clinical situation (see n n n ). n nn
  • Metronidazole Tablets, USP:
  • 250 mg - White to off white, circular, biconvex, uncoated tablet, debossed with u201cHP64u201d on one side and plain on other side.
  • NDC Number Size
  • 66267-804-06 Bottle of 6
  • 66267-804-08 Bottle of 8
  • Arrayn- Storage and Stability:
  • Call your doctor for medical advice about side effects. You may report side effects to Heritage Pharmaceuticals Inc. at 1.866.901.DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Rx only
  • Manufactured for:
  • Heritage Pharmaceuticals Inc.
  • Eatontown, NJ 07724
  • 1-866-901-DRUG (3784)n n n n
  • Made in India
  • Revised: 10/2015n n n n
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Metronidazole (Metronidazole) which is also known as Metronidazole and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 250 mg/1.

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