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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) • May worsen congestive heart failure. ( 5.2 ) • Avoid discontinuing therapy prior to major surgery. ( 5.3 ) • Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor. ( 5.4 ) • Bradycardia. ( 5.6 ) 5.1 Cardiac Ischemia after Abrupt Discontinuation Following abrupt discontinuation of therapy with beta-blockers, exacerbations of angina pectoris and myocardial infarction have occurred. When discontinuing chronically administered INDERAL XL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1-2 weeks and monitor the patients. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of INDERAL XL therapy even in patients treated only for hypertension. 5.2 Cardiac Failure Beta-blockers, like INDERAL XL, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of INDERAL XL or to discontinue it. 5.3 Maintain During Major Surgery Chronically administered beta-blocking therapy, including INDERAL XL, should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. 5.4 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. 5.5 Thyrotoxicosis INDERAL XL may mask clinical signs of hyperthyroidism, such as tachycardia. Avoid abrupt withdrawal of beta-blockade, which may precipitate a thyroid storm. 5.6 Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of INDERAL XL. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders (including Wolff-Parkinson-White) may be at increased risk. The concomitant use of beta-adrenergic blockers and non-dihydropyridine calcium channel blockers (e.g., verapamil and diltiazem), digoxin or clonidine increases the risk of significant bradycardia. Monitor heart rate and rhythm in patients receiving INDERAL XL. If severe bradycardia develops, reduce or stop INDERAL XL. 5.7 Reduced Effectiveness of Epinephrine in Treating Anaphylaxis Beta-adrenergic blocker-treated patients treated with epinephrine for a severe anaphylactic reaction may be less responsive to the typical doses of epinephrine. In these patients, consider other medications (e.g., intravenous fluids, glucagon).
6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥3% and greater than placebo) included the following: fatigue, dizziness, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 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. Adverse reactions occurring at a rate of ≥3%, excluding those reported more commonly in placebo, encountered in the INDERAL XL placebo-controlled hypertension trials and plausibly related to treatment are shown in Table 1. Table 1. Treatment-Emergent Adverse Reactions Reported In ≥3% of Subjects INDERAL XL Body System Placebo (N=88) 80 mg (N=89) 120mg (N=85) Fatigue 3 (3%) 4 (5%) 6 (7%) Dizziness (except vertigo) 2 (2%) 6 (7%) 3 (4%) Constipation 0 3 (3%) 1 (1%) 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during post-marketing use of INDERAL XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions were observed and have been reported with use of formulations of sustained- or immediate-release propranolol. Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress. Autoimmune: Systemic lupus erythematosus (SLE). Cardiovascular: exacerbation of peripheral arterial disease, arterial insufficiency, usually of the Raynaud type. Central Nervous System: Light-headedness, mental depression, insomnia, lassitude, weakness, fatigue, visual disturbances, hallucinations, vivid dreams, short-term memory loss, emotional lability, slightly clouded sensorium, paresthesia of hands. Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, mesenteric arterial thrombosis, ischemic colitis. Genitourinary: Male impotence; Peyronie’s disease. Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura. Musculoskeletal: Myopathy, myotonia. Skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasisiform rashes.