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Metrinox IV

Metrinox IV

metronidazole

Manufacturer:

Euro-Med

Distributor:

Euro-Med
Full Prescribing Info
Contents
Metronidazole.
Description
Metronidazole (INN) is a nitroimidazole anti-infective drug.
Systematic (IUPAC) name: 2-(2-methyl-5-nitro-1H-imidazol-l-yl)ethanol.
Chemical Formula: C6H9N3O3.
Mol. mass: 171.15 g/mol.
Per 100 mL: Metronidazole 500 mg.
Action
Pharmacology: Mechanism of action: Metronidazole is a prodrug.
It is converted in anaerobic organisms by the redox enzyme pyruvate-ferredoxin oxidoreductase. The nitro group of metronidazole is chemically reduced by ferredoxin (or a ferredoxin-linked metabolic process) and the products are responsible for disrupting the DNA helical structure, thus inhibiting nucleic acid synthesis.
Metronidazole is selectively taken up by anaerobic bacteria and sensitive protozoal organisms because of the ability of these organisms to reduce metronidazole to its active form intracellularly.
Pharmacokinetics: Bioavailability: 100% (oral); 59-94% (rectal).
Metabolism: Hepatic.
Half-life: 6-7 hours.
Excretion: Renal (60-80%), biliary (6-15%).
Indications/Uses
Systemic metronidazole is indicated for the treatment of: Vaginitis due to Trichomonas vaginalis (protozoal) infection in both symptomatic patients as well as their asymptomatic sexual contacts; and due to bacterial Gardnerella or Mycoplasma hominis infection in symptomatic patients.
Pelvic inflammatory disease in conjunction with other antibiotics such as ofloxacin, levofloxacin, or ceftriaxone.
Protozoal infections due to Entamoeba histolytica (Amoebic dysentery or Hepatic abscesses), and Giardia lamblia (Giardiasis) should be treated alone or in conjunction with iodoquinol or diloxanide furoate.
Anaerobic bacterial infections such as Bacteroides fragilis spp, Fusobacterium spp, Clostridium spp, Peptostreptococcus spp, Prevotella spp, or any other anaerobes in intraabdominal abscess, peritonitis, empyema, pneumonia, aspiration pneumonia, lung abscess, diabetic foot ulcer, meningitis and brain abscess, bone and joint infections, septicemia, endometritis, tubo-ovarian abscess, or endocarditis.
Pseudomembranous colitis due to Clostridium difficile.
Helicobacter pylori eradication therapy, as part of a multi-drug regimen in peptic ulcer disease.
Prophylaxis for those undergoing potentially contaminated colorectal surgery and may be combined with neomycin.
Acute gingivitis and other dental infections (TGA approved, non-Food and Drug Administration (FDA) approved).
Crohn's disease with colonic or perianal involvement (non-FDA approved).
Dosage/Direction for Use
Missed dose: If the patient misses a dose, use it as soon as remembered. If it is near the time of the next dose, skip the missed dose and resume the usual dosing schedule. Do not double the dose to catch up.
Overdosage
If overdose is suspected, contact the local poison control center or emergency room immediately. Symptoms of overdose may include: severe dizziness, seizures.
Contraindications
Before taking metronidazole, tell the doctor or pharmacist if the patient is allergic to it; or to other nitroimidazoles such as tinidazole; or if the patient has any other allergies.
Warnings
Do not use needles or IV tubing that contains aluminum because this metal may cause medication to discolor.
Treatment of a certain infection (trichomoniasis) may require that sexual partners be treated as well to avoid re-infection. During treatment, avoid sexual intercourse, or always use latex or polyurethane condoms/dental dams.
Do not share this medication with others.
This medication has been prescribed for the current condition only. Do not use it later for another infection unless told to do so by the doctor. A different medication may be necessary in that case.
Laboratory and/or medical tests (e.g., cultures, white blood cell counts) should be performed periodically to monitor the progress or check for side effects. Consult the doctor for more details.
Special Precautions
Avoid alcoholic beverages while using this medication and for at least 3 days after finishing this medicine because severe stomach upset, nausea, vomiting, headache and flushing can occur.
This drug may make the patient dizzy. Use caution while driving, using machinery, or doing any activity that requires alertness.
Use of this medication for prolonged or repeated periods may result in a new infection (e.g., yeast infection in the mouth, bladder, or vagina).
Before using this medication, tell the doctor or pharmacist the patient medical history, especially of: liver problems; severe kidney problems (not producing any urine); nervous system disorders (e.g., seizures); blood disorders; Crohn's disease; history of alcohol use/abuse; swelling (edema); using a feeding/medication tube inserted in the nose (nasogastric tube).
Use in Pregnancy: See Use in Pregnancy & Lactation section for further information.
Use in Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Newborns may be at greater risk for side effects while using this drug, because newborns are less able to remove metronidazole from their bodies.
Use in the Elderly: The elderly may be at greater risk for side effects while using this drug.
Use In Pregnancy & Lactation
Tell the doctor if the patient is pregnant before using this drug. Due to possible harm to the unborn baby, it should not be used during the first 3 months of pregnancy. During the last 6 months, this medication should be used with caution only if the infection has not improved on other antibiotics.
This medication passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult the doctor before breast-feeding.
Adverse Reactions
Common adverse drug reactions (≥1% of patients) associated with systemic metronidazole therapy include: nausea, diarrhea, and/or metallic taste in the mouth.
Intravenous administration is commonly associated with thrombophlebitis. Infrequent adverse effects include: hypersensitivity reactions (rash, itch, flushing, fever), headache, dizziness, vomiting, glossitis, stomatitis, dark urine, and/or paraesthesia.
High doses and/or long-term systemic treatment with metronidazole is associated with the development of black hairy tongue, leukopenia, neutropenia, increased risk of peripheral neuropathy and/or CNS toxicity.
Metronidazole is listed by the International Agency for Research on Cancer (IARC) as a potential human carcinogen. Although some of the testing methods have been questioned, it has been shown to cause cancer in experimental animals. Nevertheless, it appears to have a fairly low potential for cancer risk and under most circumstances the benefits of treatment outweighs the risk.
Drug Interactions
Co-administration of metronidazole and ethanol (alcohol) results, rarely, in a disulfiram-like reaction (nausea, vomiting, flushing, tachycardia).
Consumption of alcohol should be avoided by patients during systemic metronidazole therapy and for at least 24 hours after completion of treatment. However, the occurrence of this reaction in the clinical setting has recently been questioned by some authors.
This drug should not be used with the following medications because very serious interactions may occur: amprenavir solution taken by mouth, disulfiram, lopinavir/ritonavir solution taken by mouth.
If the patient is currently using any of these medications listed previously, tell the doctor or pharmacist before starting metronidazole.
Before using this medication, tell the doctor or pharmacist of all prescription and nonprescription/herbal products the patient may use, especially of: "blood thinners" (e.g., warfarin), busulfan, cimetidine, corticosteroids (e.g., methylprednisolone, prednisone), fluorouracil, lithium, drugs for seizures (e.g., phenobarbital, phenytoin), live bacterial vaccines.
This medication may interfere with certain laboratory tests (including liver function tests, blood triglyceride levels), possibly causing false test results. Make sure laboratory personnel and all the doctors know the patient use this drug.
Storage
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage up to 104 degrees F (40 degrees C) is permitted.
Do not refrigerate or freeze. Do not store in the bathroom.
MIMS Class
Other Antibiotics
ATC Classification
J01XD01 - metronidazole ; Belongs to the class of imidazole derivative antibacterials. Used in the systemic treatment of infections.
Presentation/Packing
Form
Metrinox IV soln for IV infusion 500 mg/100 mL
Packing/Price
1's (P102.48/bottle)
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