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Secnidazole

Class: Antiprotozoals, Miscellaneous
Chemical Name: (2S)-1-(2-methyl-5-nitroimidazol-1-yl)propan-2-ol;(2R)-1-(2-methyl-5-nitroimidazol-1-yl)propan-2-ol
Molecular Formula: C14H22N6O6
Brands: Solosec

Introduction

Secnidazole is a nitroimidazole antimicrobial.1

Uses for Secnidazole

Secnidazole has the following uses:

Secnidazole 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 secnidazole and other antibacterial drugs, secnidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.1

Secnidazole Dosage and Administration

General

Secnidazole is available in the following dosage form(s) and strength(s):

Oral granules: 2 g secnidazole, in a unit-of-use child-resistant foil packet.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

  • Administer a single packet of granules (containing 2 g of secnidazole) once orally, without regard to the timing of meals.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 secnidazole to aid in swallowing.1

  • Secnidazole is not intended to be dissolved in any liquid.1

Cautions for Secnidazole

Contraindications

History of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.1

Warnings/Precautions

Vulvo-Vaginal Candidiasis

The use of secnidazole may result in vulvo-vaginal candidiasis. In controlled clinical trials of non-pregnant women with bacterial vaginosis, vulvo-vaginal candidiasis developed in 19/197 (9.6%) of subjects who received 2 g secnidazole and 4/136 (2.9%) subjects who received placebo. Symptomatic vulvo-vaginal candidiasis may require treatment with an antifungal agent.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 of these nitroimidazoles indicate a risk to patients taking a single dose of secnidazole to treat bacterial vaginosis. Avoid chronic use of secnidazole. 1

Drug Resistance

Prescribing secnidazole in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.1

Specific Populations

Pregnancy

Limited available data with secnidazole 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. 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.1

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. In rabbits, no evidence of adverse developmental outcomes was observed when oral doses of secnidazole were administered to dams during organogenesis (gestational days 7-20) at doses up to 100 mg/kg/day (about 0.1 times the clinical dose, based on AUC comparisons). Secnidazole was associated with maternal toxicity (reduced food consumption and markedly reduced body weight gain) in dams at 100 mg/kg/day. In a peri- and post-natal development study in rats, secnidazole was administered at 30, 100 and 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation. Secnidazole was not associated with any adverse effects on gestation, parturition, lactation or on subsequent development of first generation (F1) and second generation (F2) offspring at these doses, equivalent to up to 1.4 times the clinical dose based on AUC comparisons. Maternal toxicity (reduced gestational body weight gain) was evident at doses of 100 mg/kg and above (about 0.3 times the clinical dose based on AUC comparisons).1

Lactation

There is no information on the presence of secnidazole in human milk, the effects on the breast- fed child, or the effects on milk production. Other nitroimidazole derivatives are present in human milk. Because of the potential for serious adverse reactions, including tumorigenicity, advise patients that breastfeeding is not recommended during treatment with secnidazole and for 96 hours (based on half-life) after administration of secnidazole.1

A nursing mother may choose to pump and discard her milk during treatment with secnidazole and for 96 hours after administration of secnidazole and feed her infant stored human milk or formula.1

Pediatric Use

The safety and effectiveness of secnidazole in pediatric patients below the age of 18 years have not been established.1

Geriatric Use

Clinical studies with secnidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.1

Common Adverse Effects

Most common adverse reactions observed in clinical trials (incidence ≥ 2%) were vulvo-vaginal candidiasis, headache, nausea, dysgeusia, vomiting, diarrhea, abdominal pain, and vulvovaginal pruritus.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.1

Actions and Spectrum

Mechanism of Action

Secnidazole is a 5-nitroimidazole antimicrobial. 5-nitroimidazoles enter the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes to radical anions. It is believed that these radical anions interfere with bacterial DNA synthesis of susceptible isolates.1

Spectrum

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis; standard methodology for the susceptibility testing of potential bacterial pathogens, Gardnerella vaginalis or Mobiluncus spp. has not been defined.1

The following in vitro data are available but their clinical significance is unknown. Secnidazole is active in vitro against most isolates of the following organisms reported to be associated with bacterial vaginosis: 1

  • Bacteroides spp.1

  • Gardnerella vaginalis1

  • Prevotella spp.1

  • Mobiluncus spp.1

  • Megasphaera-like type I/II1

Resistance

The development of resistance to secnidazole by bacteria associated with bacterial vaginosis was not examined. Bacterial isolates exhibiting reduced in vitro susceptibility to metronidazole also show reduced susceptibility to secnidazole. The clinical significance of such an effect is unknown.1

Advice to Patients

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling.1

Instruct the patient to sprinkle the entire contents of the packet of secnidazole onto applesauce, yogurt or pudding and take all the mixture within 30 minutes without chewing or crunching the granules.1

Instruct the patient that after consuming the mixture, they may take a glass of water to aid in swallowing.1

Instruct the patient that secnidazole is not intended to be dissolved in any liquid.1

Advise the patient that secnidazole may be taken without regard to the timing of meals.1

Advise women not to breastfeed during treatment with secnidazole and to discontinue breastfeeding for 96 hours following the administration of secnidazole. Also, advise a nursing mother that she may choose to pump and discard her milk for 96 hours after administration of secnidazole and feed her infant stored human milk or formula. 1

Advise the patient that use of secnidazole may result in vulvo-vaginal candidiasis that may require treatment with an antifungal agent.1

Patients should be counseled that antibacterial drugs including secnidazole should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When secnidazole is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by secnidazole or other antibacterial drugs in the future.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Secnidazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Granules

2 g (of secnidazole)/4.8 g

Solosec

Symbiomix Therapeutics

AHFS Drug Information. © Copyright 2017, Selected Revisions October 9, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Symbiomix Therapeutics. Solosec (secnidazole) ORAL prescribing information. 2017 Sep.

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