| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | For oral administration |
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Indications:
Metronidazole is the drug of choice for symtopmatic intestinal and extraintestinal amebiasis as well as infections with Trichomonas vaginalis and Giardia lamblia. It is quickly and reliably effective against Gardnerella vaginosis.
Contra-indications:
Hypersensitivity to metronidazole. Safety in pregnancy and lactation has not been established. Patients with blood dyscrasias or with active disease of the central nervous system.
Adverse Effects:
The adverse effects of metronidazole are generally dose-related. The most common are gastro-intestinal disturbances, especially nausea and an unpleasant metallic taste; nausea is sometimes accompanied by headache, anorexia and vomiting. Diarrhoea, dry mouth, a furred tongue, glossitis and stomatitis may also occur. There have also been rare reports of antibiotic-associated with metronidazole.
Peripheral neuropathy, usually presenting as numbness or tingling in the extremities, and epileptiform seizures are serious adverse effects on the nervous system that have been associated especially with high doses of metronidazole or prolonged treatment. Psychiatric disturbances such as confusion and hallucinations have been reported. Weakness, dizziness, ataxia, drowsiness, insomnia, and changes in mood or mental state such as depression or confusion have also been reported.
| Testing terms | Standards | Results |
| Description | Canary yellow, circular tablets | Complies |
| Identification | Metronidazole: Positive | Complies |
| Uniformity of weight | ±5.0% of the average weight | Complies |
| Disintegration | ≤30min | 5min |
| Friability | ≤1.0%w/w | Complies |
| Related substances | To comply with BP2009 | Complies |
| Assay | 95.0%-105.0% | 99.4% |
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