Dosing & Uses
Dosage Forms & Strengths
oral granules
- 2 grams/packet
Bacterial Vaginosis
Indicated for bacterial vaginosis in females
1 packet (2 grams) of granules PO once as a single dose, without regard to timing of meals
Trichomoniasis
Indicated for treatment of trichomoniasis caused by Trichomonas vaginalis
Because trichomoniasis is transmitted sexually with potentially serious sequelae, treat partners of infected patients simultaneously in order to prevent reinfection
1 packet (2 grams) of granules PO once as single dose, without regard to timing of meals
Dosage Forms & Strengths
oral granules
- 2 grams/packet
Bacterial Vaginosis
<12 years: Not established
≥12 years: 1 packet (2 grams) of granules PO once as a single dose, without regard to timing of meals
Trichomoniasis
<12 years: Not established
>12 years: 1 packet (2 grams) of granules PO once as a single dose, without regard to timing of meals; since trichomoniasis is a sexually transmitted disease, treat sexual partners with same dose and at same time
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (1)
- ethanol
ethanol increases toxicity of secnidazole by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid alcoholic beverages and preparations containing ethanol or propylene glycol during secnidazole therapy and for 2 days after treatment is stopped. Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache reported when coadministered. .
Monitor Closely (0)
Minor (0)
Adverse Effects
1-10%
Vulvovaginal candidiasis (8.4-9.6%)
Nausea (3.6-5.3%)
Headache (3.6%)
Dysgeusia (3.4%)
Diarrhea (2.5%)
Vomiting (2.5%)
Abdominal pain (2%)
Vulvovaginal pruritus (2%)
Postmarketing Reports
Reported adverse reactions were nausea, dysgeusia, abdominal pain, headache, dizziness, and vomiting when taken concomitantly with alcohol
Severe irreversible hepatotoxicity/acute liver failure (patients with Cockayne syndrome)
Warnings
Contraindications
Hypersensitivity to secnidazole, excipients of the formulation, or other nitroimidazole derivatives
Patients with Cockayne syndrome
Cautions
Vulvovaginal candidiasis may occur; symptomatic vulvovaginal candidiasis may require treatment with an antifungal agent
Carcinogenicity has been seen in mice and rats treated long term with nitroimidazole derivatives, which are structurally related to secnidazole; avoid long-term use of secnidazole
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
Avoid chronic use; carcinogenicity reported in mice and rats treated chronically with nitroimidazole derivatives, structurally related to secnidazole; significance unclear
Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes reported after initiation of metronidazole in patients with Cockayne syndrome
Drug interaction overview
-
Alcohol
- Avoid alcoholic beverages and preparations containing ethanol or propylene glycol during secnidazole therapy and for 2 days after treatment is stopped
- Nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache reported when coadministered
Pregnancy
Pregnancy
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
Lactation
There is no information on the presence of secnidazole in human milk, the effects on the breastfed 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 hr after administration of secnidazole
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Secnidazole is a nitroimidazole derivative; 5-antimicrobials#nitroimidazoles enters 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
Absorption
Peak plasma time: 4 hr (fasted or when mixed with applesauce, pudding, or yogurt); 6 hr (high-fat meal)
Peak plasma concentration: 41.2 mcg/mL (fasted); 40.1 mcg/mL (high-fat meal); 44.1 mcg/mL (mixed with applesauce); 45.6 mcg/mL (mixed with pudding); 43.4 mcg/mL (mixed with yogurt)
AUC: 1261.5 mcg·hr/mL (fasted); 1248.2 mcg·hr/mL (high-fat meal); 1523 mcg·hr/mL (mixed with applesauce); 1447 mcg·hr/mL (mixed with pudding); 1478 mcg·hr/mL (mixed with yogurt)
Distribution
Vd: 42 L
Protein binding: <5%
Metabolism
Metabolized in vitro via oxidation by hepatic CYP450 enzyme system with ≤1% conversion to metabolites
Elimination
Clearance: 25 mL/min
Renal clearance: 3.9 mL/min
Excretion: Urine (15% unchanged)
Administration
Oral Administration
Sprinkle 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
Drink a glass of water to aid in swallowing the mixture; secnidazole mixture is not intended to be dissolved in any liquid
Take 1 entire packet of secnidazole at one time; do not take only part of the medicine and save a portion for later
Advise the patient that secnidazole may be taken without regard to the timing of meals
Avoid consumption of alcoholic beverages and preparations containing ethanol orpropylene glycol during treatment with secnidazole and for at least 2 days aftercompleting therapy
Storage
Store room temperature at 20-25°C (68-77°F); excursions permitted to 15-30ºC (59-86ºF)
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