HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use SOLOSEC ™ safely and effectively. See full prescribing information for SOLOSEC. 

SOLOSEC ™ (secnidazole) oral granules 

Initial U.S. Approval: 2017 

INDICATIONS AND USAGE 

SOLOSEC™ is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in adult women. (1) 

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 bacteria. 

DOSAGE AND ADMINISTRATION 

Administer a single 2-gram packet of granules once orally, without regard to the timing of meals. (2.1)

Sprinkle entire contents of packet onto applesauce, yogurt or pudding and 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. (2.2)

SOLOSEC is not intended to be dissolved in any liquid. (2.2)

DOSAGE FORMS AND STRENGTHS 

Oral granules: 2 g secnidazole, in a unit-of-use child-resistant foil packet. (3) 

CONTRAINDICATIONS 

History of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives. (4) 

WARNINGS AND PRECAUTIONS 

Vulvo-vaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent (5.1)

Potential Risk for Carcinogenicity: Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to secnidazole. It is unclear if the positive tumor findings in lifetime rodent studies indicate a risk to patients taking a single dose of SOLOSEC to treat bacterial vaginosis. Avoid chronic use (5.2)

ADVERSE REACTIONS 

Most common adverse reactions observed in clinical trials (incidence ≥ 2%) were vulvo-vaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus. (6.1) 

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 

USE IN SPECIFIC POPULATIONS 

Lactation: Breastfeeding is not recommended. Discontinue breastfeeding for 96 hours after administration of SOLOSEC. (8.2) 

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

 

Revised: 10/2017

 

FULL PRESCRIBING INFORMATION: CONTENTS* 

 

1 INDICATIONS AND USAGE 

 

1.1 Bacterial Vaginosis 

 

1.2 Usage 

 

2 DOSAGE AND ADMINISTRATION 

 

2.1 Recommended Dosage 

 

2.2 Instructions for the Preparation and Administration of SOLOSEC 

 

3 DOSAGE FORMS AND STRENGTHS 

 

4 CONTRAINDICATIONS 

 

5 WARNINGS AND PRECAUTIONS 

 

5.1 Vulvo-Vaginal Candidiasis 

 

5.2 Potential Risk for Carcinogenicity 

 

5.3 Drug Resistance