Composition:

Tablet: each DAMIZOL tablet contains: Metronidazole 200mg and Diloxanide furoate 250 mg.

Excipients: Lactose, corn starch, aerosol, magnesium stearate.

MECHANISM OF ACTION:

This combines the complementary action of two well-etablished drugs, diloxanide furoate the luminal emebicide and metronidazol, the potent tissue emebicide, whilst diloxanide fuorote acts exclusively in intestinal amoebiasis, metronidazol is also useful in extra intestinal amoebiasis and particularly hepatic manifestations of the disease. diloxanide fuorote and metronidazol have synergistic activity and their combination rapidly produces high parasitological and clinical cure rates.

PHARMACOKINETICS:

Metronidazole:

Absorption: Rapid & complete absorption

Distribution: Body tissue & fluids

Metabolism: Liver

Onset of Action: Within few hours

Duration of Action: 8 hours

Diloxanide Furoate:

Absorption: Rapid

Excretion: Urine

INDICATIONS:

Hepatic amoebiasis and other systemic diseases due to E.histolytica, giardiasis, chronic amoebiasis, acute amoebiasis

CONTRAINDICATIONS:                                                                                                                             

Children under 2 years age, hypersensitive to any component in the product

DOSAGE:

Prolonged administration e.g.as as prophylactic is not recommended.

Adults: 1 tablet 3 times daily for 5 days or as directed by the physician.

SIDE EFFECTS:

Nausea, flatulence, vomiting, unpleasant metallic taste, headache, dryness of the mouth, vertigo, drowsiness, itching, skin rash, anorexia.

WARNING:

Metronidazole has been shown to be carcinogenic in mice & possibly carcinogenic in rats.

UNNECESSARY USE SHOULD THEREFORE BE AVOIDED.

Sever renal dysfunction, sever obstructive hepatic disease, alcoholic cirrhosis

PRECAUTIONS:

• Cases of aseptic meningitis, encephalopathy, peripheral neuropathy (including optic neuropathy) which is characterized by numbness or paresthesia of an extremity, and convulsive seizures have been reported with Metronidazole. The appearance of abnormal neurologic symptoms demands prompt evaluation of the continuation of therapy.
• The drug should be taken as directed; skipping doses or not completing the full course of therapy may decrease the effectiveness of treatment and increase the likelihood of developing bacterial resistance.

Pregnancy:  Contraindicated.

Lactation:  lactation should be discontinued during treatments.

DRUG INTERACTIONS:

Warfarin & other coumarin anticoagulant:

[Potentiates anticoagulant effect, increasing prothrombin time by Metronidazole]

Alcohol:

A disufram like reaction occurs: Abdominal cramps, nausea, vomiting, headache & Flushing.

Disulfram:

Acute psychotic reaction or confusion state.

Lithium:

increase Lithium level.

Phenobarbitone & Phenytoin:

Increase metabolism of Metronidazole.

OVERDOSAGE:

Symptoms of over-dosage include: nausea, vomiting, and ataxia. There is no specific antidote for Metronidazole overdose; management should consist of symptomatic and supportive therapy.

Storage Conditions:

Store at temperature below 25^°c.

Packaging:

A carton box containing 30 DAMIZOL Tablets.