METROLOTION
Details
- Status
- Prescription
- First Approved
- 1998-11-24
- Routes
- TOPICAL
- Dosage Forms
- LOTION
METROLOTION Approval History
What METROLOTION Treats
3 indicationsMETROLOTION is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Trichomoniasis
- Endocervicitis
- Cervicitis
METROLOTION Boxed Warning
WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below....
WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
METROLOTION FDA Label Details
ProIndications & Usage
FDA Label (PDF)Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, ad...
WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.