SECNIDAZOLE

Antifungal

Brand names: Solosec

Oral

Mechanism of Action

12.1 Mechanism of Action SOLOSEC is a nitroimidazole antimicrobial drug [see Microbiology (12.4) ].

Indications

SOLOSEC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available

they should be considered in selecting or modifying antibacterial therapy. In the absence of such data

local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Contraindications

• 4. CONTRAINDICATIONS SOLOSEC is contraindicated: In patients who have shown hypersensitivity to secnidazole
• another nitroimidazole drug
• structurally related to secnidazole
• in patients with Cockayne syndrome [see Adverse Reactions (6.2) ] . History of hypersensitivity to secnidazole
• or other nitroimidazole derivatives. ( 4 ) Patients with Cockayne syndrome. ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS Vulvovaginal Candidiasis: This may develop with SOLOSEC and require treatment with an antifungal agent
1 ) Potential Risk for Carcinogenicity : Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to secnidazole
It is unclear if the positive tumor findings in lifetime rodent studies indicate a risk to patients taking a single dose of SOLOSEC to treat bacterial vaginosis
2 Potential Risk for Carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives which are structurally related to secnidazole

Known Side Effects

7 documented side effects by frequency

Vomiting

>10%

Nausea

>10%

Drug Not Working

1-10%

Diarrhea

1-10%

Headache

1-10%

Abdominal Pain

0.1-1%

General Unwellness

0.1-1%

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14 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral