SECNIDAZOLE is a nitroimidazole antimicrobial drug. INDICATIONS

• Amoebiasis
• Giardiasis
• Trichomoniasis
• Bacterial vaginosis

PHARMACOLOGY
Secnidazole exposure-response relationships and the time course of pharmacodynamic response are unknown.
Cardiac Electrophysiology
The effect of senidazole on the QTc interval was evaluated in a Phase 1 randomized, double blind, placebo- and positive-controlled four-period crossover thorough QTc study in 52 healthy adult subjects following single oral granule doses of 2 g and 6 g (3-times the recommended dose). Although there was a positive relationship of the QTc interval with senidazole concentrations, there was no clinically relevant increase in the QTc interval following either dose.
DRUG INTERACTIONS:
There was no clinically significant drug interaction between senidazole and the combination oral contraceptive, ethinyl estradiol plus norethindrone. SECNIDAZOLE can be co-administered with combination oral contraceptives (e.g., ethinyl estradiol plus - norethindrone).
DRUG Form: Film coated tablet.
Inadvisable Indication combinations

• Disulfiram: Acute transient delusional disorder (bouffées delirantes), mental confusion.
• Alcohol: Antabuse effect (heat sensation, redness, vomiting, tachycardia).
• Alcoholic drinks or medicinal products containing alcohol should be avoided.
• Combinations requiring precautions for use
• Oral anticoagulants (described for warfarin)

Potentiation of the oral anticoagulant effect, with increased risk of bleeding, due to decreased hepatic catabolism. Prothrombin times should be checked more frequently and INR monitored. Oral anticoagulant dosage should be adjusted during treatment with secnidazole and for 8 days after its discontinuation.
CONTRAINDICATIONS:

• Hypersensitivity to imidazole derivatives or to any of the ingredients in the medicinal product.
• Lactation
• Wheat allergy (a condition that is different from celiac disease).

WARNING AND PRECAUTIONS:

• Drinking alcoholic beverages should be avoided during treatment with secnidazole.
• This medicine should not be administered in patients with a history of blood dyscrasia.
• This medicinal product can be administered in patients with celiac disease. Wheat starch can contain gluten, but only traces, and is therefore considered sate for patients with celiac disease.

DOSAGE AND ADMINISTRATION:

• Urethritis and vaginitis due to Trichomonas vaginalis

Adults: 2 g taken as a single dose at the beginning of a meal.

• Intestinal amebiasis

Symptomatic acute amebiasis (E. histolytica form)

Adults: 2 g taken as a single dose at the beginning of a meal. Children: 30 mg/kg/day taken as a single dose. Duration of treatment: one day only.

Asymptomatic amebiasis (minuta and cyst forms): same daily dose for 3 days.

• Hepatic amebiasis

Adults: 1.5 g daily taken as one or several doses at the beginning of a meal for 5 days. Children: 30 mg/kg/day taken as one or several doses at the beginning of a meal for 5 days.