CITANEST FORTE DENTAL (epinephrine bitartrate)
Citanest Forte (prilocaine hydrochloride and epinephrine bitartrate) is indicated for the production of local anesthesia in dental procedures via nerve block or infiltration techniques. It provides regional pain management, ensuring patient comfort during standard dental operations by numbing specific areas of the oral cavity.
How CITANEST FORTE DENTAL Works
This medication utilizes a dual-action mechanism. Prilocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby effecting local anesthesia. Epinephrine acts as a vasoconstrictor, which decreases local blood flow to delay the systemic absorption of prilocaine, prolonging the duration of the anesthetic effect and increasing the intensity of the block.
Details
- Status
- Prescription
- First Approved
- 1965-11-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
CITANEST FORTE DENTAL Approval History
What CITANEST FORTE DENTAL Treats
2 indicationsCITANEST FORTE DENTAL is approved for 2 conditions since its original approval in 1965. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Local anesthesia for dental procedures
- Nerve block and infiltration in dentistry
CITANEST FORTE DENTAL Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Trial Timeline
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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.
CITANEST FORTE DENTAL FDA Label Details
Indications & Usage
FDA Label (PDF)CITANEST FORTE DENTAL is indicated for the treatment of Local anesthesia for dental procedures; Nerve block and infiltration in dentistry.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.