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Secnidazole: Drug information

Secnidazole: Drug information
(For additional information see "Secnidazole: Patient drug information" and see "Secnidazole: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Solosec
Pharmacologic Category
  • Antibiotic, Miscellaneous;
  • Antiprotozoal, Nitroimidazole
Dosing: Adult
Bacterial vaginosis

Bacterial vaginosis (alternative agent):

Note: Treatment is generally not warranted for patients who are asymptomatic (Ref).

Oral: 2 g once as a single dose (Ref).

Trichomoniasis, initial treatment

Trichomoniasis, initial treatment (index case and sexual partner) (alternative agent): Oral: 2 g as a single dose (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Secnidazole: Pediatric drug information")

Bacterial vaginosis

Bacterial vaginosis (alternative agent): Children ≥12 years and Adolescents: Oral: 2,000 mg once as a single dose.

Trichomoniasis

Trichomoniasis: Children ≥12 years and Adolescents: Oral: 2,000 mg once as a single dose; sexual partners should be treated at the same time.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

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

Contraindications

Hypersensitivity to secnidazole, other nitroimidazole derivatives, or any component of the formulation; Cockayne syndrome.

Warnings/Precautions

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Solosec: 2 g (1 ea) [contains polyethylene glycol (macrogol)]

Generic Equivalent Available: US

No

Pricing: US

Pack (Solosec Oral)

2 g (per each): $339.90

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

Bacterial vaginosis: Treatment of bacterial vaginosis in patients ≥12 years of age.

Trichomoniasis, initial treatment: Treatment of trichomoniasis caused by Trichomonas vaginalis in patients ≥12 years of age; treat partners of infected patients simultaneously to prevent reinfection.

Metabolism/Transport Effects

None known.

Drug Interactions

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

Pregnancy Considerations

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]).

Breastfeeding Considerations

It is not known if secnidazole is present in breast milk.

Due to the potential for adverse events, the manufacturer recommends breastfeeding be avoided during therapy and for 96 hours after the last dose.

Dietary Considerations

Ethanol: Avoid use of ethanol during therapy and for 2 days after therapy discontinuation.

Mechanism of Action

After entering the bacterial or Trichomonas cells, it is proposed that secnidazole interferes with DNA synthesis of susceptible isolates.

Pharmacokinetics (Adult Data Unless Noted)

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).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CO) Colombia: Daksol | Secnidal | Secnizol;
  • (EC) Ecuador: Libranidazol | Secnil;
  • (EG) Egypt: Fladazole;
  • (FR) France: Secnidazole Dci | Secnol;
  • (LB) Lebanon: Secnol;
  • (LU) Luxembourg: Secnol;
  • (PE) Peru: Secnizol;
  • (PR) Puerto Rico: Solosec;
  • (VE) Venezuela, Bolivarian Republic of: Daksol | Secnidazol gc | Seczol | Unidazol
  1. Camargo RP, Simões JA, Cecatti JG, Alves VM, Faro S. Impact of treatment for bacterial vaginosis on prematurity among Brazilian pregnant women: a retrospective cohort study. Sao Paulo Med J. 2005;123(3):108-112. [PubMed 16021272]
  2. Muzny CA, Schwebke JR, Nyirjesy P, et al. Efficacy and safety of single oral dosing of secnidazole for Trichomoniasis in women: results of a phase 3, randomized, double-blind, placebo-controlled, delayed-treatment study. Clin Infect Dis. 2021;73(6):e1282-e1289. doi:10.1093/cid/ciab242 [PubMed 33768237]
  3. Muzny CA, Van Gerwen OT. Secnidazole for Trichomoniasis in women and men. Sex Med Rev. 2022;10(2):255-262. doi:10.1016/j.sxmr.2021.12.004 [PubMed 35153156]
  4. Solosec (secnidazole) [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals Inc; July 2022.
  5. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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