secnidazole (Rx)

Brand and Other Names:Solosec

Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and secnidazole

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      Serious - Use Alternative

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              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)

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                  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)

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                  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
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                  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.

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                  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)

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                  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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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.