Nadolol

Angina Pectoris Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris. Hypertension Nadolol tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Nadolol. …

• DOSAGE MUST BE INDIVIDUALIZED
• NADOLOL MAY BE ADMINISTERED WITHOUT REGARD TO MEALS
• Angina Pectoris The usual initial dose is 40 mg nadolol once daily
• Dosage may be gradually increased in 40 to 80 mg increments at 3 to 7 day intervals until optimum clinical response is obtained or there is pronounced slowing of the heart rate
• The usual maintenance dose is 40 or 80 mg administered once daily
• Doses up to 160 or 240 mg administered once daily may be needed
• The usefulness and safety in angina pectoris of dosage exceeding 240 mg per day have not been established
• If treatment is to be discontinued, reduce the dosage gradually over a period of one to two weeks (see WARNINGS )
• Hypertension The usual initial dose is 40 mg nadolol once daily, whether it is used alone or in addition to diuretic therapy
• Dosage may be gradually increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved
• The usual maintenance dose is 40 or 80 mg administered once daily
• Doses up to 240 or 320 mg administered once daily may be needed
• Dosage Adjustment in Renal Failure Absorbed nadolol is excreted principally by the kidneys and, although nonrenal elimination does occur, dosage adjustments are necessary in patients with renal impairment
• The following dose intervals are recommended: Creatinine Clearance (mL/min/1.73m 2 ) Dosage Interval (hours) > 50 24 31 to 50 24 to 36 10 to 30 24 to 48 < 10 40 to 60

• Safety and effectiveness
• In pediatric patients have not been established

• Interruption or Discontinuation of Therapy Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of nadolol therapy without the physician's advice
• Although cardiac failure rarely occurs in properly selected patients, patients being treated with beta-adrenergic blocking agents should be advised to consult the physician at the first sign or symptom of impending failure
• The patient should also be advised of a proper course in the event of an inadvertently missed dose. …

Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see WARNINGS ).

When administered concurrently, the following drugs may interact with beta-adrenergic receptor blocking agents: Anesthetics, general exaggeration of the hypotension induced by general anesthetics (see WARNINGS: Major Surgery ). Antidiabetic drugs (oral agents and insulin) hypoglycemia or hyperglycemia; adjust dosage of antidiabetic drug accordingly (see WARNINGS: Diabetes and Hypoglycemia ). Catecholamine-depleting drugs (e.g., reserpine) additive effect; monitor closely for evidence of hypotension and/or excessive bradycardia (e.g., vertigo, syncope, postural hypotension). …

Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, they can be used with caution in patients with a history of failure who are well-compensated, usually with digitalis and diuretics. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle. IN PATIENTS WITHOUT A HISTORY OF HEART FAILURE, continued use of beta-blockers can, in some cases, lead to cardiac failure. …

Most adverse effects have been mild and transient and have rarely required withdrawal of therapy. Cardiovascular Bradycardia with heart rates of less than 60 beats per minute occurs commonly, and heart rates below 40 beats per minute and/or symptomatic bradycardia were seen in about 2 of 100 patients. Symptoms of peripheral vascular insufficiency, usually of the Raynaud type, have occurred in approximately 2 of 100 patients. Cardiac failure, hypotension, and rhythm/conduction disturbances have each occurred in about 1 of 100 patients. …

Pregnancy In animal reproduction studies with nadolol, evidence of embryo-and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any of these species. There are no adequate and well-controlled studies in pregnant women. …

Nadolol can be removed from the general circulation by hemodialysis. In addition to gastric lavage, the following measures should be employed, as appropriate. In determining the duration of corrective therapy, note must be taken of the long duration of the effect of nadolol. Excessive Bradycardia Administer atropine (0.25 to 1.0 mg). If there is no response to vagal blockade, administer isoproterenol cautiously. Cardiac Failure Administer a digitalis glycoside and diuretic. It has been reported that glucagon may also be useful in this situation. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.