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Cardene Indications, Dosage, Storage, Stability - Nicardipine
INDICATIONS
I. Stable Angina
Nicardipine HCl is indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine HCl may be used alone or in combination with beta-blockers.
II. Hypertension
Nicardipine HCl is indicated for the treatment
of hypertension. Nicardipine HCl may be used alone or in combination
with other anti hypertensive
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
.)
DOSAGE AND ADMINISTRATION
Angina
The dose should be individually titrated for each patient beginning with 20 mg to 40 mg three times daily. Doses in the range of 20-40 mg three times a day have been shown to be effective. At least three days should be allowed before increasing the nicardipine HCl dose to ensure achievement of steady state plasma drug concentrations.
Concomitant Use with Other Antihypertensive Agents
Sublingual NTG may be taken as required to abort acute anginal attacks during nicardipine HCl therapy.
Prophylactic Nitrate Therapy - nicardipine HCl may be safely coadministered with short- and long-acting nitrates.
Beta-blockers - nicardipine HCl may be safely coadministered with beta-blockers. (See DRUG INTERACTIONS.)
Hypertension
The dose of nicardipine
HCl 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 1-2 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 1-2 hours after dosing, particularly during initiation
of therapy. (See PRECAUTIONS,
Blood Pressure, INDICATIONS
AND USAGE and CLINICAL PHARMACOLOGY,
Effects in Hypertension.) At
least three days should be allowed before increasing the nicardipine
HCl dose to ensure achievement
of steady state plasma
drug concentrations.
Concomitant use with other Antihypertensive Agents
Diuretics - Nicardipine HCl may be safely coadministered with thiazide diuretics.
Beta-blockers - Nicardipine HCl may be safely coadministered with beta-blockers (See DRUG INTERACTIONS.)
Special Patient Populations
Renal Insufficiency - Although there is no evidence that nicardipine HCl impairs renal function, careful dose titration beginning with 20 mg TID is advised. (See PRECAUTIONS.)
Hepatic Insufficiency - Nicardipine HCl should be administered cautiously in,patients with severely impaired hepatic function. A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule. (See PRECAUTIONS.)
Congestive Heart Failure - Caution is advised when titrating nicardipine HCl dosage in patients with congestive heart failure. (See WARNINGS).
HOW SUPPLIED
Store bottles at room temperature and dispense in light resistant containers.
Store blister packages at room temperature and protect from excessive humidity and light. To protect from light, product should remain in manufacturer's package until consumed.
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