CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (nicardipine hydrochloride)
Cardene helps patients with chronic stable angina, specifically chest pain triggered by physical effort. It also treats high blood pressure and can be used alone or in combination with other medications like beta-blockers. When using this drug to manage blood pressure, it is important to account for the significant differences between its peak and trough effects on a patient's readings.
How CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Works
This medication works by blocking the movement of calcium ions into cardiac and vascular smooth muscle cells through specific channels. By inhibiting this influx, the drug helps relax coronary vascular smooth muscle, which is more sensitive to the medication than the heart muscle itself. This relaxation occurs without changing the concentration of calcium in the blood or significantly affecting the heart's contraction strength.
Details
- Status
- Prescription
- First Approved
- 1992-01-30
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Approval History
What CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Treats
2 indicationsCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Angina
- Hypertension
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
| NCT01810302 results posted | 034-2013 | Ph 2 | terminated | Safety Study of Nicardipine to Treat Cerebral Vasospasm |
Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
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.
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER is indicated for the treatment of Angina; Hypertension.
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Patents & Exclusivity
Patents (6 active)
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Deep insights for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 22 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.