AMENTRO-DF Tablet

In the treatment of acute and chronic intestinal amoebiasis, amoebic hepatitis, amoebic liver abscess, and other systemic infections caused by E.histolytica and giardiasis.

Dosage

Adults: 1 tablet thrice daily for 5 days.

Children: 1/2 tablet thrice daily for 5 days.

Hypersensitivity to the components of the formulation.

No serious side effects have been reported and the bacterial flora of the gut is not upset. Flatulence sometimes occurs but may usually be disregarded. Occasionally, vomiting, pruritus and urticaria may occur.

During intensive and/or prolonged metronidazole therapy, a few instances of peripheral neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced. A moderate leucopenia has been reported in some patients but the white cell count has always returned to normal before or after treatment has been completed.

Anticoagulants: Metronidazole increases blood levels of warfarin and other oral coumarin anticoagulants, resulting in prolongation of prothrombin time.

Drugs affecting liver enzyme activity: 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. 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.

Alcohol: Alcoholic beverages should not be consumed during metronidazole therapy and for at least one day afterwards because abdominal cramps, nausea, vomiting, headaches and flushing may occur.

Pregnancy

The drug should be avoided during pregnancy, particularly during the first trimester.

Lactation

Metronidazole is secreted in breast milk. The drug should be avoided by nursing mothers.

Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy.

Amentro-DF should therefore, be administered with caution to patients with hepatic encephalopathy.

Metronidazole is converted to a product that interacts with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms. It is effective against a wide range of organisms.

Diloxanide is generally administered in combination with a 5-nitromidazole like metronidazole or tinidazole for patients with active amoebic infections. After oral intake, the ester is hydrolyzed in the lumen or the mucosa of the gut. The free diloxanide acts directly as an amoebicide.