Secnidazole

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

• SOLOSEC ® is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) Treatment of trichomoniasis in patients 12 years of age and older.

• 4. CONTRAINDICATIONS SOLOSEC is contraindicated: In patients who have shown hypersensitivity to secnidazole, or other nitroimidazole derivatives.contraindicated

Bacterial Vaginosis (female patients 12 years of age and older): Administer a single 2-gram packet of granules once orally, without regard to the timing of meals. ( 2.1 ) Trichomoniasis (patients 12 years of age and older): Administer a single 2-gram packet of granules once orally, without regard to the timing of meals. Treat sexual partners with the same dose and at the same time. ( 2.2 ) 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. ( 2.3 ) SOLOSEC is not intended to be dissolved in any liquid. ( 2.3 ) 2.1 Recommended Dosage for Bacterial Vaginosis The recommended dosage of SOLOSEC for the treatment of bacterial vaginosis in female patients 12 years of age and older 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 Recommended Dosage for Trichomoniasis The recommended dosage of SOLOSEC for the treatment of trichomoniasis in patients 12 years of age and older is a single 2-gram packet of granules taken once orally, without regard to the timing of meals [see Clinical Pharmacology (12.3) ] . Since trichomoniasis is a sexually transmitted disease, treat sexual partners with the same dose and at the same time [see Indications and Usage (1.2) ] .

Vulvovaginal Candidiasis: This 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 ) 5.1 Vulvovaginal Candidiasis The use of SOLOSEC may result in vulvovaginal candidiasis. In controlled clinical trials of non-pregnant women with bacterial vaginosis, vulvovaginal candidiasis developed in 19/197 (9.6%) of patients who received 2 g SOLOSEC and 4/136 (2.9%) subjects who received placebo. In a controlled clinical trial of non-pregnant female patients with trichomoniasis, vulvovaginal candidiasis developed in 2/74 (2.7%) of patients who received 2 g SOLOSEC and 0/73 (0%) subjects who received placebo [see Adverse Reactions (6.1) ] . Symptomatic vulvovaginal candidiasis may require treatment with an antifungal agent. 5.2 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 of these nitroimidazoles indicate a risk to patients taking a single dose of SOLOSEC to treat bacterial vaginosis.

The following important adverse reactions are discussed in greater detail in other sections of labeling: Vulvovaginal Candidiasis [Warnings and Precautions (5.1)] Bacterial Vaginosis : Most common adverse reactions observed in clinical trials of bacterial vaginosis (incidence ≥ 2%) were vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus. ( 6.1 ). Trichomoniasis : Most common adverse reaction observed in the clinical trial of trichomoniasis (incidence ≥ 2%) was vulvovaginal candidiasis. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free-phone 1-833-EVFMBIO (1-833-383-6246) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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. Bacterial Vaginosis The safety data described below reflect exposure to 629 patients, of whom 558 received a 2 g dose of SOLOSEC. SOLOSEC was evaluated in four clinical trials of female patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and two uncontrolled safety trials (Trial 3 n=321, Trial 4 n=40). Most Common Adverse Reactions in Trials 1 and 2 All patients in Trial 1 and Trial 2 received a single oral dose of study medication or placebo.

Lactation: Breastfeeding is not recommended. Discontinue breastfeeding for 96 hours after administration of SOLOSEC. ( 8.2 ) 8.1 Pregnancy Risk Summary Limited available data with SOLOSEC use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes . In animal reproduction studies, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, pregnant rats were dosed orally with secnidazole during organogenesis (gestational days 6-17) at 100, 300 and 1000 mg/kg/day, up to 4 times the clinical dose based on AUC comparisons. Animals showed no evidence of adverse developmental outcomes, but maternal toxicity (including reduced body weight gain) was observed at and above 300 mg/kg/day.

Metabolism

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 (C max ) of 45.4 (7.64) mcg/mL and mean (SD) systemic exposure (AUC 0-inf ) of 1331.6 (230.16) mcg∙hr/mL. Median (range) time to peak concentration (T max ) was 4.0 (3.0-4.0) hours.

• Sep 15, 2017NDANDA209363Evofem Inc

1. 1Vomiting7828%
2. 2Nausea5118%
3. 3Drug Ineffective3011%
4. 4Diarrhoea238.2%
5. 5Wrong Technique In Product Usage Process227.9%
6. 6Product Taste Abnormal217.5%
7. 7Headache207.1%
8. 8Dysgeusia186.4%
9. 9Abdominal Pain176.1%
10. 10Malaise134.6%
11. 11No Adverse Event134.6%
12. 12Abdominal Discomfort113.9%
13. 13Chromaturia113.9%
14. 14Bacterial Vaginosis103.6%
15. 15Foetal Exposure During Pregnancy103.6%

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Secnidazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
  Recruiting · Phase 4 · Interventional · 1,200 enrolled · Tulane University
  NCT06261840updated 2026-05-06
• Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
  Completed · Phase 2 · Phase 3 · Interventional · 24 enrolled · Indiana University
  NCT05033743updated 2024-02-05
• A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
  Completed · Phase 3 · Interventional · 147 enrolled · Lupin Research Inc
  NCT03935217updated 2023-10-04
• Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
  Completed · Phase 3 · Interventional · 325 enrolled · Symbiomix Therapeutics
  NCT02452866updated 2021-04-13
• Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV
  Completed · Phase 4 · Interventional · 40 enrolled · Lupin Research Inc
  NCT03937869updated 2020-12-19
• A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
  Completed · Phase 2 · Interventional · 215 enrolled · Symbiomix Therapeutics
  NCT02147899updated 2020-11-13
• A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
  Terminated · Phase 3 · Interventional · 100 enrolled · Quanta Medical
  NCT01733966updated 2018-09-17
• Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge
  Completed · Phase 3 · Interventional · 118 enrolled · Universidad Nacional de Colombia
  NCT02111629updated 2014-04-11
• Studies of Immune Responses to Orally Administered Vaccines in Developing Country
  Completed · Phase 1 · Phase 2 · Interventional · 1,016 enrolled · International Centre for Diarrhoeal Disease Research, Bangladesh
  NCT01019083updated 2011-07-12
• Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh
  Completed · Interventional · 410 enrolled · University of Cambridge
  NCT00607074updated 2008-02-05

Frequently asked questions

How does Secnidazole work?

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

What is Secnidazole used for?

According to FDA labeling, Secnidazole carries indications including: SOLOSEC ® is a nitroimidazole antimicrobial indicated for: Treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) Treatment of trichomoniasis in patients 12 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Secnidazole?

Secnidazole is classified as Nitroimidazole derivatives, Nitroimidazole Antimicrobial, Decreased DNA Replication.

What are the brand names for Secnidazole?

Secnidazole is marketed under brand names including Solosec.

What are the contraindications for Secnidazole?

Secnidazole labeling lists contraindications including: 4. CONTRAINDICATIONS SOLOSEC is contraindicated: In patients who have shown hypersensitivity to secnidazole, or other nitroimidazole derivatives.. Always consult the full prescribing information and a clinician.