NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (nicardipine hydrochloride) · Cipla
Nicardipine hydrochloride helps patients with high blood pressure and chronic stable angina, a condition involving chest pain during physical exertion. It is used as a standalone therapy or in combination with other medications, such as beta-blockers, to manage these cardiovascular conditions. When used to lower blood pressure, it is important to monitor the drug's effect throughout the dosing cycle due to potential differences in its impact between peak and trough levels.
How NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Works
This medication works by blocking the movement of calcium ions into cardiac and vascular smooth muscle cells through specific channels. By preventing this influx, the drug helps relax the smooth muscle in blood vessels, particularly those in the heart, with minimal impact on the heart's contraction strength. This selective relaxation of the vascular system helps improve blood flow and manage pressure.
Details
- Status
- Prescription
- First Approved
- 2008-07-24
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Approval History
What NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Treats
2 indicationsNICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Competitive Set
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What's emerging in NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE treats. First-in-class if their pivotal trials read out positive.
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Cipla's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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
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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.
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (Se...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.