Please wait while the formulary information is being retrieved.
Drug overview for SOLOSEC (secnidazole):
Generic name: SECNIDAZOLE (sek-NID-a-zole)
Drug class: Amebicides, Systemic
Therapeutic class: Anti-Infective Agents
Secnidazole, a nitroimidazole derivative, is an antiprotozoal and antibacterial agent.
No enhanced Uses information available for this drug.
Generic name: SECNIDAZOLE (sek-NID-a-zole)
Drug class: Amebicides, Systemic
Therapeutic class: Anti-Infective Agents
Secnidazole, a nitroimidazole derivative, is an antiprotozoal and antibacterial agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
SOLOSEC 2 GM GRANULE PACKET
The following indications for SOLOSEC (secnidazole) have been approved by the FDA:
Indications:
Bacterial vaginosis
Trichomoniasis
Professional Synonyms:
Bacterial vaginitis
Trichomonas vaginalis infection
Indications:
Bacterial vaginosis
Trichomoniasis
Professional Synonyms:
Bacterial vaginitis
Trichomonas vaginalis infection
The following dosing information is available for SOLOSEC (secnidazole):
No enhanced Dosing information available for this drug.
Secnidazole is administered orally without regard to meals. Secnidazole is commercially available as single-dose packets containing oral granules that are taken by sprinkling onto applesauce, yogurt, or pudding. The granules will not dissolve and are not intended to be administered in any liquid.
The entire contents of a single-dose packet of secnidazole granules (2 g of secnidazole) should be sprinkled onto applesauce, yogurt, or pudding and the entire mixture should be consumed within 30 minutes without chewing or crunching the granules. A glass of water may be taken after administration of secnidazole granules to aid in swallowing.
The entire contents of a single-dose packet of secnidazole granules (2 g of secnidazole) should be sprinkled onto applesauce, yogurt, or pudding and the entire mixture should be consumed within 30 minutes without chewing or crunching the granules. A glass of water may be taken after administration of secnidazole granules to aid in swallowing.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| SOLOSEC 2 GM GRANULE PACKET | Maintenance | Adults take 1 packet (2 gram) and sprinkle contents onto applesauce, yogurt or pudding and take within 30 minutes by oral route once |
No generic dosing information available.
The following drug interaction information is available for SOLOSEC (secnidazole):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Secnidazole/Alcohol; Propylene Glycol SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Alcohol and propylene glycol may potentiate the adverse effects of secnidazole.(1) CLINICAL EFFECTS: Concurrent use of alcohol or preparations containing ethanol or propylene glycol in patients taking secnidazole may increase the risk of side effects, including nausea, vomiting, diarrhea, abdominal pain, headache and dizziness.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Counsel patients to avoid alcohol and preparations containing ethanol or propylene glycol until at least 2 days after completing therapy with secnidazole.(1) Significant quantities of alcohol may be present in medicinal products. Alcohol is is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (3): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation DISCUSSION: In vitro studies showed that secnidazole had no effect on aldehyde dehydrogenase activity. However, postmarketing observations of adverse reactions of nausea, vomiting, diarrhea, abdominal pain, dizziness, and headache with concomitant use of secnidazole and alcohol have been reported.(1) |
ALCOHOL,DEHYDRATED, DILUENT FOR ISTODAX, DILUENT FOR MELPHALAN, DILUENT FOR ROMIDEPSIN, GENADUR, PROPYLENE GLYCOL |
The following contraindication information is available for SOLOSEC (secnidazole):
Drug contraindication overview.
Secnidazole is contraindicated in patients with known hypersensitivity to secnidazole, other ingredients in the formulation, or other nitroimidazole derivatives.
Secnidazole is contraindicated in patients with known hypersensitivity to secnidazole, other ingredients in the formulation, or other nitroimidazole derivatives.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Cockayne syndrome |
| Lactation |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for SOLOSEC (secnidazole):
Adverse reaction overview.
Adverse effects reported in 2% or more of patients receiving secnidazole in clinical trials include vulvovaginal candidiasis, headache, GI effects (nausea, vomiting, diarrhea, dysgeusia, abdominal pain ), and vulvovaginal pruritus.
Adverse effects reported in 2% or more of patients receiving secnidazole in clinical trials include vulvovaginal candidiasis, headache, GI effects (nausea, vomiting, diarrhea, dysgeusia, abdominal pain ), and vulvovaginal pruritus.
There are 0 severe adverse reactions.
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Vulvovaginal candidiasis |
Diarrhea Dysgeusia Genital organ pruritus Headache disorder Nausea Vomiting |
| Rare/Very Rare |
|---|
|
Acute abdominal pain |
The following precautions are available for SOLOSEC (secnidazole):
Safety and efficacy of secnidazole have not been established in pediatric patients younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are insufficient data on use of secnidazole in pregnant women. In animal reproduction studies, there was no evidence of adverse developmental outcomes when oral secnidazole was administered to pregnant rats and rabbits during organogenesis at doses up to fourfold greater than the recommended human dose.
It is not known whether secnidazole is distributed into human milk, affects the breast-fed infant, or affects milk production. Other nitroimidazole derivatives are distributed into human milk. Due to the potential for serious adverse effects, including tumorigenicity, breast-feeding is not recommended during secnidazole treatment and for 96 hours after administration of the drug. In this situation, a nursing mother may choose to pump and discard her breast milk during and for 96 hours after secnidazole treatment and feed her infant stored human milk or formula during this period.
Clinical studies of secnidazole did not include a sufficient number of patients 65 years of age and older to determine if geriatric adults respond differently than younger adults.
The following prioritized warning is available for SOLOSEC (secnidazole):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for SOLOSEC (secnidazole)'s list of indications:
| Bacterial vaginosis | |
| N76.0 | Acute vaginitis |
| Trichomoniasis | |
| A59 | Trichomoniasis |
| A59.0 | Urogenital trichomoniasis |
| A59.00 | Urogenital trichomoniasis, unspecified |
| A59.01 | Trichomonal vulvovaginitis |
| A59.02 | Trichomonal prostatitis |
| A59.03 | Trichomonal cystitis and urethritis |
| A59.09 | Other urogenital trichomoniasis |
| A59.8 | Trichomoniasis of other sites |
| A59.9 | Trichomoniasis, unspecified |
Formulary Reference Tool