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Indications:

Oral Angina pectoris caused by coronary atherosclerosis (excluding InnoPran XL ); cardiac arrhythmias (excluding ER); essential tremor (excluding ER); hypertension; hypertrophic subaortic stenosis (excluding InnoPran XL ); migraine prophylaxis (excluding InnoPran XL ); MI (excluding ER); pheochromocytoma (excluding ER). IV Cardiac arrhythmias.

Contraindications:

Hypersensitivity to propranolol; greater than first-degree heart block; sinus bradycardia; cardiogenic shock; bronchial asthma.

Adverse reactions:

Cardiovascular Arterial insufficiency usually of the Raynaud type, bradycardia, CHF, edema, hypotension, intensification of AV block. CNS Dizziness, fatigue (7%); decreased performance on neuropsychometric tests, disorientation, emotional lability, hallucinations, insomnia, lassitude, lethargy, light-headedness, mental depression progressing to catatonia, paraesthesia of the hands, short-term memory loss, slightly clouded sensorium, vivid dreams, weakness. Dermatologic Alopecia, erythema multiforme, exfoliative dermatitis, psoriasiform rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. EENT Dry eyes, visual disturbances. GI Abdominal cramping, constipation, diarrhea, epigastric distress, ischemic colitis, mesenteric arterial thrombosis, nausea, vomiting. Genitourinary Impotence. Hematologic Agranulocytosis, nonthrombocytopenic and thrombocytopenic purpura. Hypersensitivity Agranulocytosis, anaphylactic/anaphylactoid reactions, erythematous rash, fever combined with aching and sore throat, laryngospasm, pharyngitis, respiratory distress. Lab Tests Elevated levels of serum potassium, transaminases, and alkaline phosphatase. Metabolic Hyperglycemia, hypoglycemia. Respiratory Bronchospasm, difficulty breathing, dyspnea, wheezing. Miscellaneous Peyronie disease, SLE-like reactions, systemic lupus erythemato

Interactions:

ACE inhibitors (eg, captopril) Increased risk of hypotension, especially in patients with acute MI; bronchial hyperreactivity may be increased. Alcohol Pharmacologic and therapeutic effects are difficult to predict. Reported increased plasma concentrations, and increased and decreased clearance of propranolol. Aluminum salts (eg, aluminum carbonate, aluminum hydroxide) Greatly reduces GI absorption of propranolol. Antiarrhythmic agents (eg, amiodarone, propafenone, quinidine) Inhibition of propranolol metabolism; may increase pharmacologic and toxic effects. Amiodarone has additive negative chronotropic properties to those of propranolol. Barbiturates (eg, pentobarbital, phenobarbital, primidone), levothyroxine, phenytoin, rifampin May result in decreased effects of propranolol. Bile acid sequestrants (eg, cholestyramine, colestipol) GI absorption of propranolol may be decreased. Calcium channel blockers (eg, diltiazem, nicardipine, nifedipine, verapamil), flecainide, haloperidol, phenothiazines (eg, chlorpromazine, thioridazine), selective 5-HT 1 receptor antagonists (eg, rizatriptan, zolmitriptan), sulfonylureas (eg, chlorpropamide, tolbutamide) Increased serum levels and effects of both drugs. Cigarette smoking Increases clearance of propranolol by as much as 100%. Cimetidine, ciprofloxacin, diphenhydramine, fluconazole, hydralazine, imipramine, isoniazid, methimazole, propafenone, propylthiouracil, ritonavir, SSRIs (eg, fluoxetine, fluvoxamine, paroxetine), teniposide, terbinafine, zileuton Increased effects of propranolol. Clonidine Attenuation or reversal of antihypertensive effect; potentially life-threatening increases in BP, especially on withdrawal. Diazepam Inhibition of diazepam metabolism. Digoxin Progressive bradycardia may occur. Dobutamine, isoproterenol May reverse effects of propranolol. Epinephrine Initial hypertensive episode followed by bradycardia. Ergot derivatives (eg, dihydroergotamine, ergotamine) Peripheral ischemia, manifested by cold extremities and possible gangrene. HMG-CoA reductase inhibitors (eg, lovastatin, pravastatin) Plasma concentrations may be increased. Insulin Prolonged hypoglycemia with masking of symptoms. Lidocaine (IV) Increased lidocaine levels, leading to toxicity. MAOIs, tricyclic antidepressants Coadministration may exacerbate the hypotensive effects of MAOIs. NSAIDs (eg, ibuprofen, indomethacin, naproxen), salicylates (eg, aspirin) Some agents may impair antihypertensive effect. Prazosin Increased orthostatic hypotension. Reserpine Hypotension, marked bradycardia, vertigo, syncopal attacks, and orthostatic hypotension may result from excessive reduction of resting sympathetic nervous activity caused by reserpine-induced catecholamine depletion. Sympathomimetics (eg, albuterol, formoterol) Pharmacologic effects may be antagonized by propranolol resulting in bronchospasm. Theophylline Reduced elimination of theophylline; propranolol concentrations may be increased. Warfarin The anticoagulant effect of warfarin may be increased. Laboratory Test Interactions May interfere with glaucoma screening tests.

Warnings:

Warnings Angina pectoris In patients with angina pectoris or coronary artery disease (CAD), abrupt withdrawal may cause exacerbation of angina, occurrence of MI, and ventricular arrhythmias. Monitor patients closely. Because CAD is common and unrecognized, it may be prudent not to discontinue beta-blocker therapy abruptly in patients treated only for hypertension. When discontinuance is planned, the dosage should be gradually reduced over at least a few weeks. Pregnancy Category C (first trimester); Category D (second and third trimesters). Lactation Excreted in breast milk. Children Safety and efficacy not established. Elderly Use with caution because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy. Renal Function Use with caution. Hepatic Function Reduce dose. Discontinuation of therapy A beta-blocker withdrawal syndrome (eg, hypertension, tachycardia, anxiety, angina, MI) may occur 1 to 2?wk after sudden discontinuation of systemic beta-blockers. If possible, gradually withdraw therapy over 1 to 2?wk. Anaphylaxis Deaths have occurred; aggressive therapy may be required. CHF Avoid in patients with overt CHF; administer cautiously in patients whose CHF is controlled by digitalis and diuretics. Diabetes mellitus May mask symptoms of hypoglycemia (eg, tachycardia, BP changes). May potentiate insulin-induced hypoglycemia. Hypertensive emergencies Not indicated for treatment of hypertensive emergencies. IOP May cause reduction of IOP. Major surgery Withdrawal of treatment prior to surgery is controversial; it is thought that continued treatment may augment the risk of general anesthesia and surgical procedures. Nonallergic bronchospastic diseases Give drug with caution in patients with bronchospastic diseases. Peripheral vascular disease May precipitate or aggravate symptoms of arterial insufficiency. Thyrotoxicosis May mask clinical signs (eg, tachycardia) of developing or continuing hyperthyroidism. Abrupt withdrawal may exacerbate symptoms of hyperthyroidism, including thyroid storm. Wolff-Parkinson-White syndrome In several cases, tachycardia was replaced by severe bradycardia requiring treatment with a pacemaker.

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