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warnings and cautions
5 WARNINGS AND PRECAUTIONS Monitor patients for symptomatic postural hypotension and syncope after initial dosing or dose increments. ( 5.1 ) Monitor heart rate and rhythm for bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest in patients receiving Labetalol Hydrochloride Tablets. ( 5.2 ) Beta-blockade can depress myocardial contractility and precipitating more severe failure. Avoid use in patients with overt heart failure. ( 5.3 ). Monitor heart rate and rhythm for bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest in patients receiving Labetalol Hydrochloride Tablets. ( 5.2 ) Beta-blockade can depress myocardial contractility and precipitating more severe failure. Avoid use in patients with overt heart failure. ( 5.3 ) Acute exacerbation of coronary artery disease upon cessation of therapy. Do not abruptly discontinue. ( 5.4 ) Avoid use in patients with bronchospastic disease. ( 5.5 ) Beta‑adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia) of acute hypoglycemia. ( 5.6 ) Exacerbation of pheochromocytoma: Paradoxical increases in blood pressure may occur. ( 5.7 ) Hepatic necrosis and death have been reported. If the patient develops signs or symptoms of liver injury, institute appropriate treatment and investigate the probable cause. ( 5.8 ) Do not routinely withdraw chronic beta blocker therapy prior to surgery. ( 5.10 ) 5.1 Hypotension Monitor patients for symptomatic postural hypotension and syncope after initial dosing or dose increments with Labetalol Hydrochloride Tablets. Elderly patients are generally more likely than younger patients to experience orthostatic symptoms [see Dosage and Administration (2.1) , Use in Specific Populations (8.5) , Clinical Pharmacology (12.2) ]. 5.2 Bradycardia Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of beta blockers. Monitor heart rate and rhythm in patients receiving Labetalol Hydrochloride Tablets. 5.3 Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Beta‑blockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure. Avoid Labetalol Hydrochloride Tablets in patients with overt congestive heart failure. If patients develop signs or symptoms of heart failure during administration, discontinue Labetalol Hydrochloride Tablets and treat appropriately. 5.4 Ischemic Heart Disease Abrupt cessation of therapy with beta blocking agents in patients with coronary artery disease can cause exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore, even in the absence of overt angina pectoris, after the discontinuation of Labetalol Hydrochloride Tablets observe patients for development or worsening of angina. If patient experiences angina or angina markedly worsens or if acute coronary insufficiency develops, promptly reinstitute Labetalol Hydrochloride Tablets and manage as unstable angina. 5.5 Reactive Airway Disease and Nonallergic Bronchospasm Avoid use in patients with reactive airways disease. If Labetalol Hydrochloride Tablets are used, use the smallest effective dose, to minimize inhibition of endogenous or exogenous beta agonists. 5.6 Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment. 5.7 Use in Patients with Pheochromocytoma Labetalol hydrochloride has been shown to be effective in lowering blood pressure and relieving symptoms in patients with pheochromocytoma; higher than usual doses may be required. However, paradoxical hypertensive responses have been reported in a few patients with this tumor; therefore, blood pressure when administering labetalol hydrochloride to patients with pheochromocytoma. 5.8 Hepatic Injury Severe hepatocellular injury occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. If the patient develops signs or symptoms of liver injury, institute appropriate treatment and investigate the probable cause. Do not restart labetalol in patients without another explanation for the observed liver injury. 5.9 Use in Patients at Risk of Severe Acute Hypersensitivity Reactions Patients at risk of anaphylactic reactions may be more reactive to allergen exposure (accidental, diagnostic, or therapeutic). Patients using beta-blockers may be unresponsive to the usual doses of epinephrine used to treat anaphylactic or anaphylactoid reactions. Avoid Labetalol Hydrochloride Tablets in patients at high risk of anaphylactic reactions. 5.10 Major Surgery Do not routinely withdraw chronic beta blocker therapy prior to surgery. The effect of labetalol’s alpha adrenergic activity has not been evaluated in this setting. A synergism between labetalol hydrochloride and halothane anesthesia has been shown [ see Drug Interactions (7.3) ]. 5.11 Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been observed during cataract surgery in some patients treated with alpha-1 blockers (labetalol is an alpha/beta blocker). This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. Inform the patient’s ophthalmologist to be prepared for possible modifications to the surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.
warnings and cautions
5.1 Hypotension Monitor patients for symptomatic postural hypotension and syncope after initial dosing or dose increments with Labetalol Hydrochloride Tablets. Elderly patients are generally more likely than younger patients to experience orthostatic symptoms [see Dosage and Administration (2.1) , Use in Specific Populations (8.5) , Clinical Pharmacology (12.2) ].
warnings and cautions
5.2 Bradycardia Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of beta blockers. Monitor heart rate and rhythm in patients receiving Labetalol Hydrochloride Tablets.
warnings and cautions
5.3 Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Beta‑blockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure. Avoid Labetalol Hydrochloride Tablets in patients with overt congestive heart failure. If patients develop signs or symptoms of heart failure during administration, discontinue Labetalol Hydrochloride Tablets and treat appropriately.
6 ADVERSE REACTIONS Hypotension [see Warnings and Precautions (5.1) Bradycardia [see Warnings and Precautions (5.2) ] Cardiac failure [see Warnings and Precautions (5.3) ] Ischemic heart disease [see Warnings and Precautions (5.4) ] Nonallergic bronchospasm [see Warnings and Precautions (5.5) )] Use in patients with pheochromocytoma [see Warnings and Precautions (5.7) ] Hepatic injury [see Warnings and Precautions (5.8) ] Risk of severe acute hypersensitivity reaction [see Warnings and Precautions (5.9) ] Most commonly observed adverse reactions: fatigue, nausea, dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Innogenix, LLC at 1-844-466-6469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment 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. In controlled clinical trials of 3 to 4 months' duration, discontinuation of Labetalol Hydrochloride Tablets due to one or more adverse effects was required in 7% of all patients. The incidence rates of adverse reactions listed in Table 1 were derived from multicenter, controlled clinical trials comparing labetalol hydrochloride and placebo over treatment periods of 3 and 4 months. Table 1: Adverse Reactions Occurring in at Least 2% of Patients and More Frequent on Labetalol Labetalol HCl (n=227) Placebo (n=98) Body as a whole Fatigue 5% 0% Headache 2% 1% Gastrointestinal Nausea 6% 1% Dyspepsia 3% 1% Central and Peripheral Nervous Systems Dizziness 11% 3% Autonomic Nervous System Nasal stuffiness 3% 0% Respiratory Dyspnea 2% 0% Special Senses Vertigo 2% 1% The adverse effects were reported spontaneously and are representative of the incidence of adverse effects that may be observed in a properly selected hypertensive patient population, i.e., a group excluding patients with bronchospastic disease, overt congestive heart failure, or other contraindications to beta‑blocker therapy. Clinical trials also included studies utilizing daily doses up to 2,400 mg in more severely hypertensive patients. Certain of the side effects increased with increasing dose, as shown in Table 2 that depicts the entire US therapeutic trials data base for adverse reactions that are clearly or possibly dose related.