sek-NID-a-zole

Therapeutic Classification: anti-infectives

Pharmacologic Classification: imidazoles

• Bacterial vaginosis.
• Trichomoniasis.

• Disrupts DNA synthesis in susceptible organisms.

• Resolution of bacterial vaginosis.
• Resolution of trichomoniasis.

Spectrum:

• Active against Bacteroides spp., Gardnerella vaginalis, Prevotella spp., Mobiluncus spp., and Trichomonas vaginalis.

Absorption: Rapidly and completely absorbed following oral administration.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Primarily metabolized by CYP450 system in liver; 15% excreted unchanged in urine.

Half-life: 17 hr.

(plasma concentrations)

Contraindicated in:

• Hypersensitivity; cross-sensitivity with other imidazoles may occur
• Cockayne syndrome (↑ risk of hepatotoxicity and death)
• Lactation: Lactation.

Use Cautiously in:

• OB: Safety not established in pregnancy
• Pedi: Children <12 yr (safety and effectiveness not established).

GI: abdominal pain, diarrhea, metallic taste, nausea, vomiting.

GU: vulvovaginal candidiasis, vulvovaginal pruritus.

Neuro: headache.

Drug-Drug:

• Alcohol or preparations containing ethanol or propylene glycol may lead to nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache. Avoid use during secnidazole therapy and for ≥2 days after completing therapy.

Bacterial Vaginosis

• PO (Adults and Children ≥12 yr): 2-g single dose.

Trichomoniasis

• PO (Adults and Children ≥12 yr): 2-g single dose. Any sexual partners should also be treated with a 2-g single dose.

• Oral granules: 2 g/pkt;

• Assess for symptoms of bacterial vaginosis (thin white or gray vaginal discharge; pain, itching, or burning in the vagina; strong fish-like odor, especially after sex; burning on urination; and itching around the outside of the vagina) before and periodically following secnidazole.
• Assess for symptoms of trichomoniasis (foul-smelling vaginal discharge, genital itching, painful urination) before and periodically following secnidazole.

• Obtain specimen for culture and sensitivity before starting therapy.

• PO: Administer packet once without regard to meals. Open packet and sprinkle entire contents onto applesauce, yogurt, or pudding. Granules will not dissolve. Consume all of the mixture within 30 min without chewing or crunching granules. May be followed with a glass of water to aid in swallowing. Granules are not intended to be dissolved in any liquid.

• Instruct patient in correct technique for taking secnidazole. Advise patient to read Patient Information before taking secnidazole.
• Advise patient to notify health care professional if signs and symptoms of vulvovaginal candidiasis (vaginal itching, white or yellowish discharge [discharge may be lumpy or look like cottage cheese]) occur. May require treatment with antifungal agents.
• Advise patient to avoid alcohol during and for 2 days after last dose of secnidazole. May cause nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache when taken with alcohol.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications during therapy.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected. Advise female patient to avoid breastfeeding for at least 96 hr (4 days) following secnidazole dose.

• Resolution of bacterial vaginosis.
• Resolution of trichomoniasis.

Solosec

NDC Code^*

• 27437- Lupin Pharmaceuticals, Inc.
  • 27437-051- SOLOSEC
    • 27437-051-01- 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-01) > 2 g in 1 PACKET

• 27437- Lupin Pharmaceuticals, Inc.
  • 27437-051- SOLOSEC
    • 27437-051-02- 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-02) > 2 g in 1 PACKET