Bacterial vaginosis (alternative agent): Children ≥12 years and Adolescents: Oral: 2,000 mg once as a single dose.
Trichomoniasis: Children ≥12 years and Adolescents: Oral: 2,000 mg once as a single dose; sexual partners should be treated at the same time.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Secnidazole: Drug information")
Trichomoniasis, initial treatment (index case and sexual partner) (alternative agent): Oral: 2 g as a single dose (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Nonapproved dosing regimens are included in the reported incidences. Adverse reactions reported in adolescents and adults.
1% to 10%:
Gastrointestinal: Diarrhea (3%), nausea (4%)
Genitourinary: Vulvovaginal candidiasis (3% to 10%)
Nervous system: Headache (4%)
Postmarketing: Gastrointestinal: Dysgeusia
Hypersensitivity to secnidazole, other nitroimidazole derivatives, or any component of the formulation; Cockayne syndrome.
Concerns related to adverse effects:
• Carcinogenic: Carcinogenicity has been observed in mice and rats with nitroimidazole agents that are structurally similar to secnidazole in animal studies; it is unknown whether secnidazole is associated with carcinogenicity in humans. Avoid chronic use.
Disease-related concerns:
• Candidiasis: Vulvovaginal candidiasis may occur; antifungal treatment may be necessary if patient is symptomatic.
Other warnings/precautions:
• Ethanol use: Abdominal pain, diarrhea, dizziness, headache, nausea, and vomiting have been reported with secnidazole and concomitant alcohol consumption; avoid alcoholic beverages or products containing ethanol or propylene glycol during therapy and for at least 2 days after therapy completion.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Packet, Oral:
Solosec: 2 g (1 ea) [contains polyethylene glycol (macrogol)]
No
Pack (Solosec Oral)
2 g (per each): $339.90
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Oral: Administer without regard to timing of meals. Sprinkle entire contents of one packet onto applesauce, yogurt, or pudding; granules will not dissolve. Consume entire mixture within 30 minutes; do not chew or crunch the granules. May consume water after administration to aid in swallowing.
Oral: Administer without regard to timing of meals. Sprinkle entire contents of one packet onto applesauce, yogurt, or pudding; granules will not dissolve. Consume entire mixture within 30 minutes; do not chew or crunch granules. May consume water after administration to aid in swallowing.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Treatment of bacterial vaginosis; treatment of trichomoniasis (All indications: FDA approved in ages ≥12 years and adults).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Alcohol (Ethyl): May enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Mycophenolate: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy
Products Containing Ethanol: May enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination
Products Containing Propylene Glycol: May enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Ethanol: Avoid use of ethanol during therapy and for 2 days after therapy discontinuation.
Information related to the use of secnidazole in pregnancy is limited (Camargo 2015).
Bacterial vaginosis is associated with adverse pregnancy outcomes. Pregnant patients may be treated with any regimen approved for nonpregnant patients. However, data are insufficient to recommend use of secnidazole; use of other agents in pregnant patients is preferred (CDC [Workowski 2021]).
Monitor for nausea, abdominal pain, and vulvovaginal candidiasis.
After entering the bacterial or Trichomonas cells, it is proposed that secnidazole interferes with DNA synthesis of susceptible isolates.
Distribution: Vd: ~42 L.
Protein binding: <5%.
Metabolism: Hepatic via CYP-450; undergoes oxidation with ≤1% conversion to metabolites.
Half-life elimination: ~17 hours.
Time to peak: Median: 4 hours (range: 3 to 4 hours).
Excretion: Urine (~15% unchanged).
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