Applies to the following strengths: 60 mg; 10 mg; 20 mg; 40 mg; 80 mg; 120 mg; 160 mg; 1 mg/mL; 20 mg/5 mL; 80 mg/mL; 40 mg/5 mL; 4.28 mg/mL
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Usual Adult Dose for:
- Angina Pectoris
- Myocardial Infarction
- Migraine Prophylaxis
- Benign Essential Tremor
- Aortic Stenosis
- Atrial Fibrillation
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Hypertension
Immediate-release: 40 mg orally 2 times a day
Sustained-release: 80 mg orally once a day
XL sustained-release: 80 mg orally once a day at bedtime
Immediate-release: 120 to 240 mg orally per day
Sustained-release: 120 to 160 mg orally per day
XL sustained-release: 80 to 120 mg orally once a day at bedtime
IR/SR: 640 mg orally per day
XR: 120 mg orally per day
-The XL sustained-release formulation should be administered once daily at bedtime (approximately 10 PM) and should be taken consistently either on an empty stomach or with food.
-Dose titration should be done gradually until adequate blood pressure control is achieved.
-The recommended dosing is the same whether used alone or added to a diuretic.
-The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks.
-While twice daily dosing of the immediate release formulation is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12 hour dosing interval. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. If control is not adequate, a larger dose, or 3 times daily therapy may achieve better control.
Usual Adult Dose for Angina Pectoris
Immediate-release: Total daily doses of 80 to 320 mg orally 2 to 4 times a day have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG.
Sustained-release: Initial dose: 80 mg orally once a day. Dosage should be gradually increased at 3 to 7 day intervals. The average optimal dosage appears to be 160 mg once a day.
Maximum dose: 320 mg per day
-If treatment is to be discontinued, dosage should be reduced gradually over a period of a few weeks.
Usual Adult Dose for Arrhythmias
Immediate-release: 10 to 30 mg orally 3 to 4 times a day, before meals and at bedtime
IV: 1 to 3 mg at a rate not exceeding 1 mg/min. Sufficient time should be allowed for the drug to reach the site of action even when a slow circulation is present. A second dose may be given after 2 minutes. Thereafter, additional drug should not be given in less than 4 hours.
-IV administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia.
-IV doses should be administered under careful monitoring, such as electrocardiography, and central venous pressure.
-The rate of IV administration should not exceed 1 mg (1 mL) per minute to decrease the possibility of lowering blood pressure and causing cardiac standstill.
-Transfer from IV to oral therapy should be considered as soon as possible.
Usual Adult Dose for Myocardial Infarction
Initial dose: 40 mg orally 3 times a day for 1 month, then increase to 60 to 80 mg orally 3 times a day as tolerated.
Maintenance dose: 180 mg to 240 mg orally per day in divided doses (2 to 4 times daily)
Maximum dose: 240 mg orally per day
Usual Adult Dose for Migraine Prophylaxis
Initial dose: 80 mg orally per day in divided doses
Maintenance dose: 160 to 240 mg orally per day in divided doses
Initial dose: 80 mg orally once a day
Maintenance dose: 160 to 240 mg once a day
-The dosage should be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within 4 to 6 weeks after reaching the maximum dose, therapy should be discontinued.
-Withdrawal of therapy should be accomplished over a period of several weeks.
Usual Adult Dose for Benign Essential Tremor
Initial dose: 40 mg orally 2 times a day
Maintenance dose: 120 to 320 mg orally per day
-Optimum reduction of essential tremor is usually achieved with a dose of 120 mg orally per day.
-Occasionally, it may be necessary to administer 240 to 320 mg orally per day.
Usual Adult Dose for Aortic Stenosis
Immediate-release: 20 to 40 mg orally 3 to 4 times a day, before meals and at bedtime
Sustained-release: 80 to 160 mg orally once a day
Use: Hypertrophic Subaortic Stenosis
Usual Adult Dose for Pheochromocytoma
Preoperatively: 60 mg orally daily in divided doses for 3 days prior to surgery as adjunctive therapy to alpha-adrenergic blockade
Management of Inoperable Tumor: 30 mg orally daily in divided doses as adjunctive therapy to alpha-adrenergic blockade
Usual Adult Dose for Atrial Fibrillation
Immediate-release: 10 mg to 30 mg orally 3 or 4 times a day before meals and at bedtime
Usual Pediatric Dose for Arrhythmias
Oral: Children: Initial: 0.5 to 1 mg/kg/day in divided doses every 6 to 8 hours; titrate dosage upward every 3 to 5 days; usual dose: 2 to 4 mg/kg/day; higher doses may be needed; do not exceed 16 mg/kg/day
IV: Children: 0.01 to 0.1 mg/kg slow IV over 10 minutes; maximum dose: 1 mg (infants); 3 mg (children)
Usual Pediatric Dose for Hypertension
Immediate release formulations:
Initial: 0.5 to 1 mg/kg/day in divided doses every 6 to 12 hours; increase gradually every 5 to 7 days
Usual dose: 1 to 5 mg/kg/day
Maximum dose: 8 mg/kg/day
Children and Adolescents 1 to 17 years:
Immediate release formulations:
Initial: 1 to 2 mg/kg/day divided in 2 to 3 doses/day; titrate dose to effect
Maximum dose: 4 mg/kg/day up to 640 mg/day; sustained release formulation may be dosed once daily (National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents).
Usual Pediatric Dose for Thyrotoxicosis
Neonates: Oral: 2 mg/kg/day in divided doses every 6 to 12 hours; occasionally higher doses may be required
Adolescents: Oral: 10 to 40 mg/dose every 6 hours
Usual Pediatric Dose for Hemangioma
Propranolol oral solution 4.28 mg/mL:
Initiate treatment at ages 5 weeks to 5 months:
Initial dose: 0.15 mL/kg (0.6 mg/kg) orally 2 times a day (at least 9 hours apart)
-After 1 week: Increase the daily dose to 0.3 mL/kg (1.1 mg/kg) orally 2 times a day (at least 9 hours apart)
-After 2 weeks: Increase the dose to 0.4 mL/kg (1.7 mg/kg) orally 2 times a day (at least 9 hours apart) maintain for 6 months
-Dose should be periodically adjusted as the weight of the child increases.
-Administration directly into the mouth of the child is recommended; however, the product may be diluted in a small quantity of milk or fruit juice, given in a bottle.
-This drug should be administered during or right after a feeding to reduce the risk of hypoglycemia.
-The dose should be skipped if the child is not eating or is vomiting.
-Heart rate and blood pressure should be monitored for 2 hours after drug initiation or dose increases.
-If hemangiomas recur, treatment may be reinitiated.
Uses: For the treatment of proliferating infantile hemangioma requiring systemic therapy.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Because propranolol is extensively metabolized by the liver, consideration should be given to lowering the dosage in patients with hepatic insufficiency.
-The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks.
-Some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12-hour dosing interval. This can be evaluated by measuring blood pressure near the end of the dosing interval. If control is not adequate, a larger dose, or 3-times-daily therapy may achieve better control.
-The sustained release dose may be increased to 120 mg once a day or higher, until adequate blood pressure control is achieved.
US BOXED WARNINGS:
-DISCONTINUING THERAPY: When beta-blockers are abruptly discontinued, exacerbations of angina pectoris and myocardial infarction have occurred.
When this drug is chronically administered, particularly in patients with ischemic heart disease, the dose should be reduced gradually over a period of 1 to 2 weeks and patients should be monitored. If angina markedly worsens or acute coronary insufficiency develops, therapy should be temporarily reinstated unstable angina should be managed. Patients should be warned not to abruptly discontinue therapy without physician advice.
Extended-release formulation: Safety and efficacy have not been established in patients younger than 18 years.
Propranolol is not significantly dialyzable.
The extended release product InnoPran XL (R) should be taken once daily in the evening.
Compared with Caucasian patients, Black patients have a reduced blood pressure response to monotherapy with beta-blockers; however, the reduced response is largely eliminated if combination therapy that includes an adequate dose of a diuretic is instituted.
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