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admin | Bv Homeopathic Treatment | 28.04.2016
From FDA reports: drug interactions between Valproic Acid Syrup, Cholestyramine, Metronidazole, Potassium Chloride, Vancomycin, Vitamin D, Ciprofloxacin, Clindamycin, Levofloxacin for a Male patient aged 59This is a personalized study for a 59 year old male patient. How to use the study: print a copy of the study and bring it to your health teams to ensure drug risks and benefits are fully discussed and understood. WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health. If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.
Rx only Rev. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms, with an average elimination half-life in healthy humans of 8 hours.
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. Metronidazole is the major component appearing in the plasma, with lesser quantities of the 2-hydroxymethyl metabolite also being present. Metronidazole appears in cerebrospinal fluid, saliva, and human milk in concentrations similar to those found in plasma.
Metronidazole capsules have been shown to have a rate and extent of absorption similar to metronidazole tablets and were bioequivalent at an equal single dose of 750 mg.
Administration of metronidazole capsules with food does not affect the extent of absorption of metronidazole; however, the presence of food results in a lower Cmax and a delayed Tmax compared to fasted conditions.
Metronidazole exerts antimicrobial effects in an anaerobic environment by the following possible mechanism: Once metronidazole enters the organism, the drug is reduced by intracellular electron transport proteins. Metronidazole has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Metronidazole is active against most obligate anaerobes, but does not possess any clinically relevant activity against facultative anaerobes or obligate aerobes.
Quantitative methods that are used to determine minimum inhibitory concentrations provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds.
For protozoal parasites: Standardized tests do not exist for use in clinical microbiology laboratories.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in the blood. Standardized susceptibility test procedures require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures.
Amebiasis: Metronidazole capsules are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole therapy does not obviate the need for aspiration or drainage of pus. In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. BONE AND JOINT INFECTIONS (as adjunctive therapy) caused by Bacteroides species including the B.
CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Metronidazole capsules are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. In patients with trichomoniasis, metronidazole capsules are contraindicated during the first trimester of pregnancy. Central and Peripheral Nervous System Effects: Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Prescribing metronidazole in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Alcoholic beverages should be avoided while taking metronidazole capsules and for at least three days afterward. Patients should be counseled that antibacterial drugs including metronidazole should only be used to treat bacterial infections. Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of or history of blood dyscrasia. Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time.
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.
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.
Alcoholic beverages should not be consumed during metronidazole therapy and for at least three days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.


Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. 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 hexokinase glucose. Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats, but similar studies in the hamster gave negative results.
Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative. Metronidazole use in the second and third trimesters of pregnancy should be restricted to those patients in whom alternative treatment has been inadequate.
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. Safety and effectiveness in pediatric patients have not been established, except in the treatment of amebiasis. Central Nervous System: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity.
Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever. Patients with Crohn's disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors.
In elderly patients, the pharmacokinetics of metronidazole may be altered, and, therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.
A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain treatment. 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.
For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days. In the treatment of most serious anaerobic infections, intravenous metronidazole, is usually administered initially.
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. The dose of metronidazole should not be specifically reduced in anuric patients because accumulated metabolites may be rapidly removed by dialysis.
Metronidazole Capsules USP, 375 mg are light green opaque in color with “375 mg” imprinted in band on the body and “PLIVA” imprinted in band on the cap in black ink, supplied in bottles of 50.
Storage and Stability: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Other drugs that have the same active ingredients are also considered.GAO report, it is estimated that 1-10 percent of adverse events are included in FDA system. All information is observation-only, and has not been supported by scientific studies or clinical trials unless otherwise stated. Inactive ingredients include corn starch, gelatin, magnesium stearate, pregelatinized starch, titanium dioxide, FD&C Green No.
The metabolites that appear in the urine result primarily from side-chain oxidation [1-(?-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.
Bactericidal concentrations of metronidazole have also been detected in pus from hepatic abscesses.
However, plasma clearance of metronidazole is decreased in patients with decreased liver function. Because of this alteration to the metronidazole molecule, a concentration gradient is maintained which promotes the drug's intracellular transport.
For anaerobic bacteria, the susceptibility to metronidazole can be determined by the reference agar dilution method or by alternate standardized test methods1. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. Metronidazole capsules are indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Metronidazole capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
This may be followed by oral therapy with metronidazole capsules at the discretion of the physician.
The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole therapy.
Accordingly, for such patients, doses below those usually recommended should be administered cautiously. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metronidazole have been observed in clinical studies. This possible drug interaction should be considered when metronidazole is prescribed for patients on this type of anticoagulant therapy. 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.
Metronidazole should not be given to patients who have taken disulfiram within the last 2 weeks. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only).


There were statistically significant increases in the incidence of various neoplasms, particularly in mammary and hepatic tumors, among female rats administered metronidazole over those noted in the concurrent female control groups.
Reproduction studies have been performed in rats at doses up to five times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to metronidazole. Use of metronidazole in the first trimester should be carefully evaluated because metronidazole crosses the placental barrier and its effects on human fetal organogenesis are not known.
Metronidazole is secreted in human milk in concentrations similar to those found in plasma. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur. Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy. There have been some reports in the medical literature of breast and colon cancer in Crohn's disease patients who have been treated with metronidazole at high doses for extended periods of time. 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. National Committee for Clinical Laboratory Standards, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria - Third Edition.
Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below. Both the parent compound and the metabolite possess in vitro bactericidal activity against most strains of anaerobic bacteria and in vitro trichomonacidal activity.
Presumably, free radicals are formed which, in turn, react with cellular components resulting in death of the microorganism. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.
Indicated surgical procedures should be performed in conjunction with metronidazole therapy.
Metronidazole should be administered with caution to patients with central nervous system diseases. Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole and requires treatment with a candidacidal agent. Total and differential leukocyte counts are recommended before and after therapy for trichomoniasis and amebiasis, especially if a second course of therapy is necessary, and before and after therapy for anaerobic infections. 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. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD+ - NADH).
Therefore, in elderly patients, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly. In addition, patients have reported dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia. Rare cases of pancreatitis, which generally abated on withdrawal of the drug, have been reported. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. 10, and synthetic black iron oxide, pharmaceutical glaze, propylene glycol, FD&C Blue No. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole capsules.
Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lymphomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. However, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed.
A report of "Resistant" indicates that usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and other therapy should be selected.
The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. Because animal reproduction studies are not always predictive of human response, and because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed. Determination of metronidazole and its major metabolites in biological fluids by high pressure liquid chromatography, Br.



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