Solosec (secnidazole)

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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.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Antimicrobials/Live Typhoid Vaccine

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)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Metronid; Secnidazole; Tinidazole/Slt Anticoag (Vit K Antag)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Possible inhibition of anticoagulant metabolism by metronidazole, secnidazole, or tinidazole. Metronidazole is a weak CYP2C9 inhibitor and may inhibit the metabolism of the more potent warfarin isomer, S-warfarin.(1)

CLINICAL EFFECTS: Concurrent use of anticoagulants with metronidazole, secnidazole, or tinidazole may increase the risk for bleeding.

PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). Patients with a CYP2C9 intermediate metabolizer genotype, and/or 1-2 copies of a reduced function VKORC1 gene are expected to be most susceptible to this interaction. Patients with a pre-existing CYP2C9 poor metabolizer genotype would be less susceptible to this interaction. However, patients with reduced function genotypes (e.g. CYP2C9 *1/*3, *2/*2, *2/*3, and *3/*3) have an inherently higher risk for bleeding at usual anticoagulant doses and thus generally require lower doses to achieve effective and safe anticoagulation. In addition, CYP2C9 poor metabolizers may require more time (>2 to 4 weeks) to achieve maximum INR effect for a given dosage regimen than patients without these CYP2C9 variants.

PATIENT MANAGEMENT: INR values should be closely monitored during and for several days after the conclusion of concurrent metronidazole, secnidazole, or tinidazole. Anticoagulant dosage may need to be adjusted up to 10 days after concurrent therapy ends. If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform agent-specific laboratory test (e.g. INR, aPTT) to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug.

DISCUSSION: In two studies, metronidazole significantly enhanced the hypoprothrombinemic effect of warfarin.(2,3) The onset of the interaction occurred within four(2) to ten days(3) and appeared as excessive bruising of the legs. In eight normal subjects, metronidazole significantly increased the half-life of racemic warfarin and the S-enantiomer of warfarin. The R-enantiomer of warfarin, which is metabolized primarily by the reduction of side chains, was unaffected by metronidazole.(4) In an animal study, metronidazole preferentially inhibited the S-enantiomer of warfarin.(5) This interaction should also be considered during concurrent administration and for eight days after concurrent anticoagulants and tinidazole.(6)

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

Secnidazole is contraindicated in patients with known hypersensitivity to secnidazole, other ingredients in the formulation, or other nitroimidazole derivatives.

• Cockayne syndrome
• Lactation

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

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 no severe adverse reactions for this drug.

More Frequent

• Vulvovaginal candidiasis

Less Frequent

• Diarrhea
• Dysgeusia
• Genital organ pruritus
• Headache disorder
• Nausea
• Vomiting

Rare or Very Rare

• Acute abdominal pain

No enhanced messaging available.

Safety and efficacy of secnidazole have not been established in pediatric patients younger than 18 years of age.

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.