Nicardipine Hydrochloride 30 mg/1
Nicardipine Hydrochloride · CAPSULE · Zydus Pharmaceuticals USA Inc.
Nicardipine Hydrochloride is a capsule containing nicardipine hydrochloride at 30 mg/1, taken oral. Manufactured by Zydus Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Nicardipine Hydrochloride
- Generic Name
- Nicardipine Hydrochloride
- NDC Code (Product)
70710-2011- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218638
- Marketing Start
- 08/01/2025
Recall History
Eugia US LLC
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Mylan Institutional LLC
Subpotent Drug and Failed Impurities/Degradation Specifications
Eugia US LLC
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
American Regent, Inc.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc.
Lack of Assurance of Sterility.
West-ward Pharmaceutical Corp.
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 (See DOSAGE AND ADMINISTRATION ).
Dosage & Administration
DOSAGE AND ADMINISTRATION Angina The dose should be individually titrated for each patient beginning with 20 mg three times daily. Doses in the range of 20 to 40 mg three times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride capsuels dose to ensure achievement of steady-state plasma drug concentrations. Concomitant Use With Other Antianginal Agents Sublingual NTG may be taken as required to abort acute anginal attacks during nicardipine hydrochloride capsules therapy. Prophylactic Nitrate Therapy: nicardipine hydrochloride capsules may be safely coadministered with short- and long-acting nitrates. Beta-blockers : Nicardipine hydrochloride capsules may be safely coadministered with beta-blockers (see Drug Interactions ). Hypertension The dose of nicardipine hydrochloride capsules should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing. To assess the adequacy of blood pressure re…
Warnings
WARNINGS Increased Angina About 7% of patients in short-term, placebo-controlled angina trials have developed increased frequency, duration or severity of angina on starting nicardipine hydrochloride capsules or at the time of dosage increases, compared with 4% of patients on placebo. Comparisons with beta-blockers also show a greater frequency of increased angina, 4% vs 1%. The mechanism of this effect has not been established (see ADVERSE REACTIONS ). Use in Patients With Congestive Heart Failure Although preliminary hemodynamic studies in patients with congestive heart failure have shown that nicardipine hydrochloride capsules reduced afterload without impairing myocardial contractility, it has a negative inotropic effect in vitro and in some patients. Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker. Beta-Blocker Withdrawal Nicardipine hydrochloride capsules are not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker, preferably over 8 to 10 days.
Contraindications
CONTRAINDICATIONS Nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. Because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.
Drug Interactions
Drug Interactions Beta Blockers In controlled clinical studies, adrenergic beta-receptor blockers have been frequently administered concomitantly with nicardipine hydrochloride capsules. The combination is well tolerated. Cimetidine Cimetidine increases nicardipine hydrochloride capsules plasma levels. Patients receiving the two drugs concomitantly should be carefully monitored. Digoxin Some calcium blockers may increase the concentration of digitalis preparations in the blood. Nicardipine hydrochloride capsules usually do not alter the plasma levels of digoxin; however, serum digoxin levels should be evaluated after concomitant therapy with nicardipine hydrochloride capsules are initiated. Maalox ® Coadministration of Maalox TC had no effect on nicardipine hydrochloride capsules absorption. Fentanyl Anesthesia Severe hypotension has been reported during fentanyl anesthesia with concomitant use of a beta-blocker and a calcium channel blocker. Even though such interactions were not seen during clinical studies with nicardipine hydrochloride capsules, an increased volume of circulating fluids might be required if such an interaction were to occur. Cyclosporine Concomitant administrat…
Adverse Reactions
ADVERSE REACTIONS In multiple-dose U.S. and foreign controlled short-term (up to 3 months) studies 1910 patients received nicardipine hydrochloride capsules alone or in combination with other drugs. In these studies adverse events were reported spontaneously; adverse experiences were generally not serious but occasionally required dosage adjustment and about 10% of patients left the studies prematurely because of them. Peak responses were not observed to be associated with adverse effects during clinical trials, but physicians should be aware that adverse effects associated with decreases in blood pressure (tachycardia, hypotension, etc.) could occur around the time of the peak effect. Most adverse effects were expected consequences of the vasodilator effects of nicardipine hydrochloride capsules. Angina The incidence rates of adverse effects in anginal patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride capsules (n=520) and placebo (n=310), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator (except for certain ca…
Frequently Asked Questions
What is Nicardipine Hydrochloride used for?
Nicardipine Hydrochloride contains Nicardipine Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Nicardipine Hydrochloride a controlled substance?
Nicardipine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Nicardipine Hydrochloride?
The generic name for Nicardipine Hydrochloride is Nicardipine Hydrochloride. There are 8 other brand versions of Nicardipine Hydrochloride.
What is the NDC code for Nicardipine Hydrochloride 30 mg/1?
The NDC (National Drug Code) for Nicardipine Hydrochloride 30 mg/1 is 70710-2011, listed by Zydus Pharmaceuticals USA Inc..
Other Nicardipine Brands
See all →- NICARDIPINE HYDROCHLORIDE20 mg/135573-457
- CARDENE IV.1 mg/mL43066-026
- Nicardipine Hydrochloride in Sodium Chloride.1 mg/mL44567-850
- Nicardipine Hydrochloride in Sodium Chloride.2 mg/mL44567-851
- NICARDIPINE HYDROCHLORIDE25 mg/10mL65219-818
- CARDENE IV.2 mg/mL43066-016
- Cardene IV.2 mg/mL43066-024
- CARDENE IV2.5 mg/10mL43066-029
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)