Nicardipine

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 it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see 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 mg 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 capsules 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 co‑administered with short- and long-acting nitrates
• Beta-blockers: Nicardipine hydrochloride capsules may be safely co-administered 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 hour to 2 hours after dosing
• To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing)
• Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 hour to 2 hours after dosing, particularly during initiation of therapy (see PRECAUTIONS: Blood Pressure , INDICATIONS and CLINICAL PHARMACOLOGY: Effects in Hypertension ). …

Safety and efficacy in patients under the age of 18 have not been established.

Pharmacokinetic parameters did not differ between elderly hypertensive patients (≥ 65 years) and healthy controls after 1 week of nicardipine hydrochloride treatment at 20 mg tid. Plasma nicardipine hydrochloride concentrations in elderly hypertensive subjects were similar to plasma concentrations in healthy young adult subjects when nicardipine hydrochloride was administered at doses of 10 mg, 20 mg, and 30 mg tid, suggesting that the pharmacoki …

• 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

Beta-Blockers In controlled clinical studies, adrenergic beta-receptor blockers have been frequently administered concomitantly with nicardipine hydrochloride. The combination is well tolerated. Cimetidine Cimetidine increases nicardipine hydrochloride 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 usually does not alter the plasma levels of digoxin; however, serum digoxin levels should be evaluated after concomitant therapy with nicardipine hydrochloride is initiated. …

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 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 ). …

In multiple-dose US and foreign controlled short-term (up to 3 months) studies 1,910 patients received nicardipine hydrochloride 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. …

Pregnancy Nicardipine was embryocidal when administered orally to pregnant Japanese White rabbits, during organogenesis, at 150 mg/kg/day (a dose associated with marked body weight gain suppression in the treated doe) but not at 50 mg/kg/day (25 times the maximum recommended antianginal or antihypertensive dose in man). …

Overdosage with a 600-mg single dose (15 times to 30 times normal clinical dose) has been reported. Marked hypotension (blood pressure unobtainable) and bradycardia (heart rate 20 bpm in normal sinus rhythm) occurred, along with drowsiness, confusion and slurred speech. Supportive treatment with a vasopressor resulted in gradual improvement with normal vital signs approximately 9 hours posttreatment. Based on results obtained in laboratory animals, overdosage may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. …

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