Labetalol Hydrochloride
Generic: LABETALOL HYDROCHLORIDE
Basic Information
Manufacturer
Hikma Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
99a715a0-4579-410c-b102-7ef6fab8db55
Indications & Usage
1 INDICATIONS AND USAGE Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.
Labetalol Hydrochloride (HCl) is a beta-adrenergic blocker.
Labetalol HCl injection is indicated in severe hypertension, to lower blood pressure.
( 1 )
Labetalol Hydrochloride (HCl) is a beta-adrenergic blocker.
Labetalol HCl injection is indicated in severe hypertension, to lower blood pressure.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypotension [see Warnings and Precautions (5.1) ] Bradycardia [see Warnings and Precautions (5.2) ] Depression of myocardial contractility in patients with overt congestive heart failure [see Warnings and Precautions (5.3) ] Aggravation of angina [see Warnings and Precautions (5.4) ] Significant decline in cardiac output following coronary bypass [see Warnings and Precautions (5.3) ] Bronchospasm in patients with reactive airway disease [see Warnings and Precautions (5.5) ] Paradoxical hypertensive responses in patients with pheochromocytoma [see Warnings and Precautions (5.7) ] Hepatic injury [see Warnings and Precautions (5.8) ] Acute hypersensitivity reaction [see Warnings and Precautions (5.9) ] Most common adverse events: Symptomatic postural hypotension.
( 6 ) Nausea13%, dizziness 9% ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For product Inquiry call 1-877-845-0689.
6.1 Clinical Trial 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.
Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol withdrawal.
Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl.
Moderate hypotension occurred in 1 of 100 patients while supine.
Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
The following also were reported with labetalol HCl with the incidence as noted: Central and Peripheral Nervous Systems Dizziness in 9% Paresthesia, most frequently described as tingling of the scalp/skin in 7% Gastrointestinal System Nausea in 13% Vomiting in 4% Metabolic Disorders Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8%; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.
Respiratory System Bronchospasm In addition, a number of other less common adverse events have been reported: Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block.
Liver and Biliary System Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
Hypersensitivity Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.
The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.
Clinical Laboratory Tests Among patients dosed with labetalol tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.
( 6 ) Nausea13%, dizziness 9% ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For product Inquiry call 1-877-845-0689.
6.1 Clinical Trial 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.
Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol withdrawal.
Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl.
Moderate hypotension occurred in 1 of 100 patients while supine.
Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
The following also were reported with labetalol HCl with the incidence as noted: Central and Peripheral Nervous Systems Dizziness in 9% Paresthesia, most frequently described as tingling of the scalp/skin in 7% Gastrointestinal System Nausea in 13% Vomiting in 4% Metabolic Disorders Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8%; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.
Respiratory System Bronchospasm In addition, a number of other less common adverse events have been reported: Cardiovascular: Hypotension, and rarely, syncope, bradycardia, heart block.
Liver and Biliary System Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
Hypersensitivity Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.
The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.
Clinical Laboratory Tests Among patients dosed with labetalol tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.