Clinical Considerations 

 

A nursing mother may choose to pump and discard her milk during treatment with SOLOSEC and for 96 hours after administration of SOLOSEC and feed her infant stored human milk or formula.

 

8.4 Pediatric Use

 

The safety and effectiveness of SOLOSEC in pediatric patients below the age of 18 years have not been established.

8.5 Geriatric Use

 

Clinical studies with secnidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

 

11 DESCRIPTION 

 

The active ingredient in SOLOSEC Oral Granules is secnidazole (also named 1-(2- hydroxypropyl)-2-methyl-5-nitroimidazole and 1-(2-methyl-5-nitro-1H-imidazol-1-yl) propan-2- ol), a nitroimidazole antimicrobial.

 

The molecular formula of secnidazole is C7H11N3O3, the molecular weight is 185.18 and the chemical structure is:

 

image of the structure of secnidazole 

 

Figure 1: Structure of Secnidazole 

 

Each packet of SOLOSEC contains 4.8 g of off-white to slightly yellowish granules, which contain 2 g of secnidazole and the following inactive ingredients: Eudragit NE30D (ethyl acrylate methyl methacrylate copolymer), polyethylene glycol 4000, povidone, sugar spheres, and talc.

 

12 CLINICAL PHARMACOLOGY 

12.1 Mechanism of Action

 

SOLOSEC is a nitroimidazole antimicrobial drug [See Microbiology (12.4)]. 

 

12.2 Pharmacodynamics

 

Secnidazole exposure-response relationships and the time course of pharmacodynamic response are unknown.

 

Cardiac Electrophysiology 

 

The effect of secnidazole on the QTc interval was eva luated 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 secnidazole concentrations, there was no clinically relevant increase in the QTc interval following either dose.

 

12.3 Pharmacokinetics

 

A single oral dose of 2 g of SOLOSEC in healthy adult female subjects, following an overnight fast and admixed with (4 oz) of applesauce, resulted in a mean (SD) secnidazole peak plasma concentration (Cmax) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC0-inf) of 1331.6 (230.16) mcg•hr/mL. Median (range) time to peak concentration (Tmax) was 4.0 (3.0-4.0) hours. Following administration of the 2 g dose, mean secnidazole plasma concentrations decreased to 22.1 mcg/mL at 24 hours, 9.2 mcg/mL at 48 hours, 3.8 mcg/mL at 72 hours, and 1.4 mcg/mL at 96 hours.

 

Absorption 

 

Effect of Food