propranolol hydrochloride (redirected from Innopran XL)

propranolol hydrochloride

[-pran′əlol]

a nonselective beta-adrenergic receptor blocking agent.

indications It is prescribed in the treatment of hypertension, angina pectoris, catecholamine-induced cardiac arrhythmias, pheochromocytoma, essential tremor, and migraine headache and for various unlabeled uses such as treatment of anxiety and aggressive behavior.

contraindications Asthma, COPD, pulmonary edema, bradycardia, second or third degree heart block, congestive heart failure unless secondary to a tachyarrhythmia treatable with beta-blockers, pregnancy (especially second and third trimester), or known hypersensitivity to this drug prohibits its use.

adverse effects Among the more serious adverse effects are heart failure, heart block, increased airway resistance, augmentation of hypoglycemic response, GI disturbances, and hypersensitivity reactions. Withdrawal syndrome has been observed in some patients.

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propranolol hydrochloride Warning - High-alert drug!

Angilol (UK), Apo-Propranolol (CA), Bedranol (UK), Beta-Prograne (UK), Betachron E-R, Half Beta-Prograne (UK), Half Inderal (UK), Inderal, Inderal LA, Innopran XL, Novopranol (CA), PMS Propranolol (CA), Slo-Pro (UK), Syprol (UK)

Pharmacologic class: Beta-adrenergic blocker (nonselective)

Therapeutic class: Antianginal, antiarrhythmic (class II), antihypertensive, vascular headache suppressant

Pregnancy risk category C

FDA Boxed Warning

• In patients with angina pectoris, exacerbations of angina and, in some cases, myocardial infarction (MI) have followed abrupt drug withdrawal. For planned withdrawal, reduce dosage gradually over at least a few weeks and caution patient not to interrupt or stop therapy without physician's advice. If therapy is interrupted and angina exacerbation occurs, consider reinstituting drug and taking other measures to manage unstable angina. As coronary artery disease may be unrecognized, it may be prudent to follow same advice in patients at risk for occult atherosclerotic heart disease who receive drug for other indications.

Action

Blocks stimulation of beta₁-adrenergic (myocardial) and beta₂-adrenergic (pulmonary, vascular, and uterine) receptor sites. This action decreases cardiac output, slows heart rate, and reduces blood pressure.

Availability

Capsules (extended-release, sustained-release): 60 mg, 80 mg, 120 mg, 160 mg

Injection: 1 mg/ml

Oral solution: 4 mg/ml, 8 mg/ml, 80 mg/ml

Tablets: 10 mg, 20 mg, 40 mg, 60 mg, 90 mg

⊘Indications and dosages

➣ Angina pectoris

Adults: 80 to 320 mg P.O. daily in three to four divided doses or 160 mg (extended- or sustained-release) P.O. daily; maximum daily dosage is 320 mg.

➣ Hypertension

Adults: 40 mg P.O. b.i.d. or 80 mg (extended- or sustained-release) P.O. daily. Maximum daily dosage is 640 mg; usual maintenance dosage is 120 to 240 mg/day.

➣ Prophylaxis after MI

Adults: 180 to 240 mg P.O. daily in three to four divided doses; maximum daily dosage is 240 mg.

➣ Hypertrophic subaortic stenosis

Adults: 20 to 40 mg P.O. three to four times daily (before meals and at bedtime) or 80 to 160 mg (extended- or sustained-release) P.O. daily

➣ Adjunctive therapy in pheochromocytoma

Adults: 60 mg P.O. daily in divided doses for 3 days, given after primary therapy with alpha-adrenergic blocker

➣ To prevent migraine or vascular headache

Adults: 80 mg P.O. (extended- or sustained-release) daily; may increase as needed up to 240 mg/day. Effective range is 160 mg to 240 mg/day.

➣ Essential tremor

Adults: 40 mg P.O. b.i.d.; if necessary, 240 mg to 320 mg/day. Maximum daily dosage is 320 mg.

➣ Arrhythmias

Adults: 10 to 30 mg P.O. (tablets or oral solution) three or four times daily

➣ Life-threatening arrhythmias; arrhythmias occurring during anesthesia

Adults: 1 to 3 mg slow I.V. injection. If necessary, give second dose after 2 minutes and additional doses at intervals of no less than 4 hours until desired response occurs.

Contraindications

• Hypersensitivity to drug, its components, or other beta-adrenergic blockers
• Uncompensated heart failure
• Cardiogenic shock
• Sinus bradycardia, heart block greater than first degree
• Bronchospastic disease

Precautions

Use cautiously in:
• renal or hepatic impairment, sinus node dysfunction, pulmonary disease, diabetes mellitus, hyperthyroidism, Raynaud's syndrome, hypertensive emergencies, myasthenia gravis
• concurrent thioridazine use
• history of severe allergic reactions
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

☞ Take apical pulse for 1 full minute. Withhold dose and notify prescriber if patient has bradycardia or tachycardia.
☞ Be aware that I.V. use is usually reserved for arrhythmias that are life-threatening or occur during anesthesia.
• Inject I.V. dose directly into large vein or into tubing of compatible I.V. solution (dextrose 5% in water, normal or half-normal saline solution, or lactated Ringer's solution).
• Don't give as continuous I.V. infusion.
• For intermittent I.V. infusion, dilute with normal saline solution and infuse in 0.1- to 0.2-mg increments over 10 to 15 minutes.
☞ Keep I.V. isoproterenol, atropine, or glucagon at hand in case of emergency.
☞ Don't stop giving drug suddenly. Dosage must be tapered.

Route	Onset	Peak	Duration
P.O.	30 min	60-90 min	6-12 hr
P.O. (extended, sustained)	Unknown	6 hr	24 hr
I.V.	Immediate	1 min	4-6 hr

Adverse reactions

CNS: fatigue, asthenia, anxiety, dizziness, drowsiness, insomnia, memory loss, depression, mental status changes, nervousness, paresthesia, nightmares

CV: peripheral vasoconstriction, orthostatic hypotension, bradycardia, arrhythmias, heart failure, myocardial infarction and sudden death (with abrupt withdrawal in angina therapy)

EENT: blurred vision, dry eyes, nasal congestion, rhinitis, sore throat

GI: nausea, vomiting, diarrhea, constipation, dry mouth

GU: erectile dysfunction, decreased libido

Hematologic: purpura, thrombocytopenic purpura

Metabolic: fluid retention, hyperglycemia, hypoglycemia (increased in children), thyrotoxicosis (with abrupt withdrawal in hypertension therapy)

Musculoskeletal: joint pain, back pain, myalgia, muscle cramps

Respiratory: wheezing, bronchospasm, pulmonary edema

Skin: pruritus, rash

Other: fever

Interactions

Drug-drug. Antacids (aluminum-based): decreased propranolol absorption

Anticholinergics, tricyclic antidepressants: antagonism of cardiac beta-adrenergic blocking effect

Chlorpromazine: additive hypotension

Cimetidine: increased propranolol blood level and risk of toxicity

Digoxin: additive bradycardia

Diuretics, other antihypertensives: increased hypotensive effect

Glucagon, isoproterenol: antagonism of propranolol's effects

Insulin, oral hypoglycemics: impaired glucose tolerance, increased risk of hypoglycemia

Neuromuscular blockers: increased neuromuscular blockade (with high propranolol doses)

Nonsteroidal anti-inflammatory drugs: decreased hypotensive effect

Theophylline: decreased theophylline clearance, antagonism of theophylline's bronchodilating effect

Thioridazine: increased thioridazine blood level, leading to prolonged QT interval

Drug-diagnostic tests . Alkaline phosphatase, blood urea nitrogen, eosinophils, lactate dehydrogenase, serum transaminases, triiodothyronine: increased levels

Glucose: decreased or increased level

Platelets, thyroxine: decreased levels

Drug-behaviors. Acute alcohol ingestion: additive hypotension

Patient monitoring

• Monitor vital signs, ECG, and central venous pressure.
• Assess fluid balance. Check for signs and symptoms of heart failure.
• Monitor CBC and liver and thyroid function tests.
• Watch closely for signs and symptoms of hypoglycemia, which drug may mask.
• Monitor blood glucose level in diabetic patient, to identify need for altered insulin or oral hypoglycemic dosage. Be aware that in labile diabetes, hypoglycemia may be accompanied by steep blood pressure rise.

Patient teaching

• Advise patient to take with meals at same time every day to minimize GI upset.
☞ Caution patient not to stop taking drug suddenly. Tell him dosage must be tapered.
• Tell patient to monitor pulse and to promptly report bradycardia or tachycardia.
• Inform patient that drug may cause muscle aches or bone pain. Advise him to discuss activity recommendations and pain management with prescriber.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.