Brand Name
Solosec
Generic Name
Secnidazole
View Brand Information FDA approval date: May 31, 2018
Classification: Nitroimidazole Antimicrobial
Form: Granule
What is Solosec (Secnidazole)?
SOLOSEC ® is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age and older.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole
Summary: This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men.
Related Latest Advances
Brand Information
Solosec (secnidazole)
1DOSAGE 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.
2CONTRAINDICATIONS
SOLOSEC is contraindicated:
- In patients who have shown hypersensitivity to secnidazole, or other nitroimidazole derivatives.
- In patients with Cockayne syndrome: Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to secnidazole, in patients with Cockayne syndrome
3ADVERSE REACTIONS
The following important adverse reactions are discussed in greater detail in other sections of labeling:
- Vulvovaginal Candidiasis
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been reported during use of SOLOSEC and other 2 g formulations of secnidazole outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
4DESCRIPTION
The active ingredient in SOLOSEC Oral Granules is secnidazole (also named 1-(2-hydroxypropyl)-2-methyl-5-nitroimidazole and 1-(2-methyl-5-nitro-1
The molecular formula of secnidazole is C
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. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).
5REFERENCES
- Özbilgin A, Özbel Y, Alkan MZ et al. Trichomoniasis in non-gonococcic urethritis among male patients.
- Dyudyun AD, Polyon NM, Gorbuntsov VV. Secnidazole in complex treatment of patients with urogenital trichomoniasis.
- Siboulet A, Catalan F, Videau D, Niel G. Urogenital trichomoniasis. Trials with a long half-life imidazole: secnidazole.
- Videau D, Niel G, Siboulet A, Catalan F. Secnidazole: A 5-nitroimidazole derivative with a long half-life.
- Krieger JN, Verdon M, Siegel N, Holmes KK. Natural history of urogenital trichomoniasis in men. J Urol. 1993 Jun;149(6):1455-8.
6HOW SUPPLIED / STORAGE AND HANDLING
SOLOSEC (secnidazole) Oral Granules, 2 g, consists of off-white to slightly yellowish granules containing secnidazole. SOLOSEC is supplied in one unit-of-use child-resistant foil packet of granules in an individual carton. Each packet contains 4.8 g of granules containing 2 g secnidazole. SOLOSEC is supplied as follows:
NDC 69751-400-01 carton containing one unit-of-use child-resistant 2 g foil packet.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
8INSTRUCTIONS FOR USE
SOLOSEC®
(SO-lo-sec)
For oral use (by mouth) only.
How to take SOLOSEC?
- Open the SOLOSEC packet by folding over the corner marked by an arrow (see
- Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding. The granules will not dissolve. Take within 30 minutes without chewing or crunching the granules.
- You can drink a glass of water after taking SOLOSEC to help with swallowing.
- You should not try to dissolve the medicine in water or any other liquid.
Important Information
- SOLOSEC may be taken before, after or during a meal.
- Take 1 entire packet of SOLOSEC at one time.
- Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC.
How should I store SOLOSEC?
- Store SOLOSEC at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep SOLOSEC and all medicines out of the reach of children.
This Patient Information and Instructions for Use have been approved by the US Food and Drug Administration. Issued: 10/2024
Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc.
San Diego, CA 92130
© 2024 Evofem, Inc. All Rights Reserved.
PN-5055 R02
9PRINCIPAL DISPLAY PANEL - 2 g Packet Carton
NDC 69751-400-01
Rx Only
solosec
Oral Granules
1 Unit-of-Use Packet
EVOFEM
