Indications

1. Metronidazole is the drug of choice for the treatment of trichomoniasis。

2. Serious anaerobic bacterial infections

3. Eradication of Helicobacter pylori infection

4. Clostridium difficile colitis

5. Bacterial vaginosis

6. Antibiotic prophylaxis

7. Treatment of Crohn’s disease

Dosage and Administration

Usage:Oral

Adults For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days. For amebic liver abscess 750 mg orally three times daily for 5 to 10 days. Children 35 to 50 mg/kg/24 hours divided into three doses, orally for 10 days.

Precautions & Warning:

Patients with severe hepatic disease metabolize Metronidazole slowly, with resultant accumulation of Metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Metronidazole and requires treatment with a condidacidal agent.

Information for patients

Alcoholic beverages should be avoided while taking Metronidazole syrup and for at least three days afterward.

Contraindications:

1.Hypersensitivity to metronidazole

This is very rare and usually is manifested as a maculopapular rash on the trunk and neck. A fixed drug eruption caused by metronidazole has also been reported. Acute neurological deterioration within hours of ingestion of metronidazole can also occur.

2.Concurrent use of alcohol

Metronidazole produces a disulfiram-like effect with hypotension and flushing when used concurrently with ethyl alcohol. Patients should abstain from alcoholic beverages for at least 48 h following discontinuation of therapy with metronidazole.

3.History of serious neurological disease

Because of its potential neurotoxicity, metronidazole may aggravate pre-existing neurological disease, including in patients with a convulsion disorder. This is a relative contraindication, since metronidazole is very effective in the treatment of cerebral abscesses and meningitis caused by susceptible anaerobes.

Adverse Reactions:

1.Symptomatic adverse effects

Gastrointestinal upset, including anorexia, nausea, vomiting, and epigastric pain, is the most common adverse effect but is usually mild; however, metronidazole may occasionally cause acute pancreatitis and this should be excluded where abdominal pain in sever or persistent.

2.Severe or irreversible adverse effects

Patients who have received unusually large doses of metronidazole have developed various central neurological effects, including seizures, ataxia, headaches, and encephalopathy

Drug interactions:

1.Potentially hazardous interactions

Metronidazole interacts with racemic and (S)-(-)- warfarin and increases the blood levels of warfarin, causing a hypothrombinemic effect. It is postulated that metronidazole inhibits ring oxidation of (S)-(-)-warfarin and therefore, impairs total body clearance of warfarin.

2.Other significant interactions

Premedication with metronidazole did not affect the metabolic disposition of phenytoin, diazepam or antipyrine, the metabolism of which depends upon oxidative drug metabolism (a cytochrome P450 system). Theophylline pharmacokinetics were also not affected, although theophylline is metabolized by dealkylation and hydroxylation in the liver. Cimetidine, in contrast, prolongs the half-life of metronidazole through reduction of its total plasma clearance. Metronidazole and disulfiram when given concurrently have caused an acute psychosis

Storage instructions:

Store under normal storage conditions (15ºC-30ºC) Protect from light.