SOLOSEC Oral granules Ref.[10387] Active ingredients: Secnidazole

Source: FDA, National Drug Code (US)  Revision Year: 2019 

1. Indications and Usage

1.1 Bacterial Vaginosis

SOLOSEC is indicated for the treatment of bacterial vaginosis in adult women [see Use in Specific Populations (8.1) and Clinical Studies (14)].

1.2 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of SOLOSEC and other antibacterial drugs, SOLOSEC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2. Dosage and Administration

2.1 Recommended Dosage

The recommended dosage of SOLOSEC is a single 2-gram packet of granules taken once orally, without regard to the timing of meals [see Clinical Pharmacology (12.3)]. Sections or subsections omitted from the full prescribing information are not listed.

2.2 Instructions for the Preparation and Administration of SOLOSEC

  • Open the SOLOSEC packet by folding over the corner (marked by an arrow) and tearing across the top.
  • Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding [see Clinical Pharmacology (12.3)]. The granules will not dissolve. Consume all of the mixture within 30 minutes without chewing or crunching the granules. A glass of water may be taken after the administration of SOLOSEC to aid in swallowing.
  • The granules are not intended to be dissolved in any liquid

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room temperature].

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