6 ADVERSE REACTIONS 

 

6.1 Clinical Trials Experience 

 

6.2 Postmarketing Experience 

 

7 DRUG INTERACTIONS 

 

7.1 Oral Contraceptives 

 

8 USE IN SPECIFIC POPULATIONS 

 

8.1 Pregnancy 

 

8.2 Lactation 

 

8.4 Pediatric Use 

 

8.5 Geriatric Use 

 

11 DESCRIPTION 

 

12 CLINICAL PHARMACOLOGY 

 

12.1 Mechanism of Action 

 

12.2 Pharmacodynamics 

 

12.3 Pharmacokinetics 

 

12.4 Microbiology 

 

13 NONCLINICAL TOXICOLOGY 

 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 

 

14 CLINICAL STUDIES 

 

16 HOW SUPPLIED / STORAGE AND HANDLING 

 

17 PATIENT COUNSELING INFORMATION 

* Sections or subsections omitted from the full prescribing information are not listed.  

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)]. 

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.

 

3 DOSAGE FORMS AND STRENGTHS 

Oral Granules: 2 g, of off-white to slightly yellowish granules with 4.8 g net weight, packed in a unit-of-use child-resistant foil packet.

 

4 CONTRAINDICATIONS 

 

Hypersensitivity 

 

SOLOSEC is contraindicated in patients who have shown hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.

 

5 WARNINGS AND PRECAUTIONS 

5.1 Vulvo-Vaginal Candidiasis