Nicardipine Hydrochloride in Sodium Chloride
Generic: NICARDIPINE HYDROCHLORIDE
Basic Information
Manufacturer
WG Critical Care, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d
Indications & Usage
1 INDICATIONS AND USAGE • Nicardipine hydrochloride in sodium chloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible.
(1.1) 1.1 Hypertension Nicardipine hydrochloride in sodium chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.
For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1)].
(1.1) 1.1 Hypertension Nicardipine hydrochloride in sodium chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.
For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1)].
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions are headache (15%), hypotension (6%), tachycardia (4%) and nausea/vomiting (5%).
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience 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.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of Nicardipine hydrochloride in sodium chloride injection.
Adverse experiences were generally not serious and most were expected consequences of vasodilation.
Adverse experiences occasionally required dosage adjustment.
Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia.
The table below shows percentage of patients with adverse events where the rate is >3% more common on Nicardipine hydrochloride in sodium chloride injection than placebo.
Adverse Event Nicardipine Hydrochloride in Sodium Chloride Injection (N=144) Placebo (N=100) Body as a Whole Headache, n (%) 21 (15) 2 (2) Cardiovascular Hypotension, n (%) 8 (6) 1 (1) Tachycardia, n (%) 5 (4) 0 Digestive Nausea/vomiting, n (%) 7 (5) 1 (1) Other adverse events have been reported in clinical trials or in the literature in association with 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.
6.2 Post-Marketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.
The following adverse reaction has been identified during post-approval use of Nicardipine hydrochloride in sodium chloride injection: decreased oxygen saturation (possible pulmonary shunting).
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience 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.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of Nicardipine hydrochloride in sodium chloride injection.
Adverse experiences were generally not serious and most were expected consequences of vasodilation.
Adverse experiences occasionally required dosage adjustment.
Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia.
The table below shows percentage of patients with adverse events where the rate is >3% more common on Nicardipine hydrochloride in sodium chloride injection than placebo.
Adverse Event Nicardipine Hydrochloride in Sodium Chloride Injection (N=144) Placebo (N=100) Body as a Whole Headache, n (%) 21 (15) 2 (2) Cardiovascular Hypotension, n (%) 8 (6) 1 (1) Tachycardia, n (%) 5 (4) 0 Digestive Nausea/vomiting, n (%) 7 (5) 1 (1) Other adverse events have been reported in clinical trials or in the literature in association with 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.
6.2 Post-Marketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure.
The following adverse reaction has been identified during post-approval use of Nicardipine hydrochloride in sodium chloride injection: decreased oxygen saturation (possible pulmonary shunting).