Amodis 400mg Tablet

Indications

Amodis is indicated in the treatment of following diseases:

• The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
• The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
• In the treatment of urogenital trichomoniasis.
• Bacterial vaginosis (also known as non-specific vaginitis).
• All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
• Giardiasis.
• Acute ulcerative gingivitis.
• Anaerobically infected leg ulcers and pressure sores.
• Acute dental infections due to anaerobic organisms.
• Antibiotic associated pseudomembranus colitis.

Pharmacology

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

Contraindications

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Side Effects

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

Pregnancy & Lactation

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Precautions & Warnings

• If for compelling reasons, Amodis must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
• Amodis should be administered with caution to patients with hepatic encephalopathy.
• Patients should be warned that Amodis may darken urine.

Overdose Effects

Single oral doses of Amodis, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for Amodis overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

Therapeutic Class

Amoebicides, Anti-diarrhoeal Antiprotozoal

Storage Conditions

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.