NICARDIPINE HYDROCHLORIDE
Generic: NICARDIPINE HYDROCHLORIDE
Basic Information
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
9d898911-d811-2a78-e053-2995a90af784
Indications & Usage
1 INDICATIONS & USAGE 1.1 Hypertension Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable.
For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6)].
For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6)].
Adverse Reactions
6 ADVERSE REACTIONS 6.1 Adverse Reactions Observed in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of nicardipine.
Adverse experiences were generally not serious and most were expected consequences of vasodilation.
Adverse reactions occasionally required dosage adjustment.
Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia.
Adverse reactions that occurred more often on nicardipine than on placebo by at least 2% were headache (13%) and nausea/vomiting (4%).
The following adverse reactions have been reported in clinical trials or in the literature during the use of intravenously administered nicardipine.
Body as a Whole: fever, neck pain Cardiovascular: angina pectoris, atrioventricular block, ST segment depression, inverted T wave, deep-vein thrombophlebitis Digestive: dyspepsia Hemic and Lymphatic: thrombocytopenia Metabolic and Nutritional: hypophosphatemia, peripheral edema Nervous: confusion, hypertonia Respiratory: respiratory disorder Special Senses: conjunctivitis, ear disorder, tinnitus Urogenital: urinary frequency Sinus node dysfunction and myocardial infarction, which may be due to disease progression, have been seen in patients on chronic therapy with orally administered nicardipine.
Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of nicardipine.
Adverse experiences were generally not serious and most were expected consequences of vasodilation.
Adverse reactions occasionally required dosage adjustment.
Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia.
Adverse reactions that occurred more often on nicardipine than on placebo by at least 2% were headache (13%) and nausea/vomiting (4%).
The following adverse reactions have been reported in clinical trials or in the literature during the use of intravenously administered nicardipine.
Body as a Whole: fever, neck pain Cardiovascular: angina pectoris, atrioventricular block, ST segment depression, inverted T wave, deep-vein thrombophlebitis Digestive: dyspepsia Hemic and Lymphatic: thrombocytopenia Metabolic and Nutritional: hypophosphatemia, peripheral edema Nervous: confusion, hypertonia Respiratory: respiratory disorder Special Senses: conjunctivitis, ear disorder, tinnitus Urogenital: urinary frequency Sinus node dysfunction and myocardial infarction, which may be due to disease progression, have been seen in patients on chronic therapy with orally administered nicardipine.