Propranolol

Propranolol is a beta-blocker used to treat high blood pressure, irregular heartbeats, shaking (tremors), and other conditions. It is used after a heart attack to improve the chance of survival. It is also used to prevent migraine headaches and chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Preventing chest pain can help improve your ability to exercise.

• Propranolol works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This effect reduces heart rate, blood pressure, and strain on the heart.
• Propranolol has also been used to control symptoms of anxiety or overactive thyroid (hyperthyroidism).
• The oral formulation of propranolol is used for infants and children to treat a certain benign tumor (proliferating infantile hemangioma). It helps to shrink the tumor.
• Propranolol is available under the following different brand names: Inderal, Inderal LA, InnoPran XL, and Hemangeol.

Dosage Forms and Strengths

Oral solution

• 4.28 mg/mL (Hemangeol) (pediatric)
• 20 mg/5mL
• 40 mg/5mL

Injectable solution

• 1 mg/mL

Tablet

• 10 mg

Capsule, extended-release

• 10 mg
• 80 mg
• 120 mg
• 160 mg

Hypertension

Adult Immediate release

• 40 mg orally every 12 hours initially, increasing every 3-7 days; maintenance: 80-240 mg orally every 8-12 hours; not to exceed 640 mg/day

Inderal LA

• 80 mg/day orally initially; maintenance: 120-160 mg/day; not to exceed 640 mg/day

InnoPran XL

• 80 mg/day orally initially; may be increased every 2-3 weeks until response achieved; maintenance: not to exceed 120 mg/day orally

Pediatric (Off-label)

• 0.5-1 mg/kg/day orally divided every 6-12 hours initially; increase gradually every 5-7 days; usual range: 2-4 mg/kg/day orally divided every 12 hours

Geriatric

• Immediate-release: 40 mg orally every 12 hours initially, increased every 3-7 days; maintenance: 80-240 mg orally every 8-12 hours; not to exceed 640 mg/day
• Inderal LA: 80 mg/day orally initially; maintenance: 120-160 mg/day; not to exceed 640 mg/day
• InnoPran XL: 80 mg/day orally initially; may be increased every 2-3 weeks until response achieved; maintenance: not to exceed 120 mg/day orally
• Consider lower initial dose

Migraine

Prophylaxis

• 80 mg/day orally divided every 6-8 hours initially; may be increased by 20-40 mg/day every 3-4 weeks; not to exceed 160-240 mg/day divided every 6-8 hours
• Inderal LA: 80 mg/day orally; maintenance: 160-240 mg/day
• Withdraw therapy if satisfactory response not seen after 6 weeks

Angina

• 80-320 mg/day orally divided every 6-12 hours
• Inderal LA: 80 mg/day orally; not to exceed 320 mg/day

Pheochromocytoma

• 30-60 mg/day orally in divided doses

Hypertrophic Subaortic Stenosis

• 20-40 mg orally every 6-8 hours

Supraventricular Arrhythmia

Adult

• Orally: 10-30 mg every 6-8 hours
• Intravenously (IV): 1-3 mg at 1 mg/min initially; repeat every 2-5 minutes to a total of 5 mg
• Once response or a maximum dose is achieved, do not give an additional dose for at least 4 hours

Pediatric (Off-label)

• Orally: 0.5-1 mg/kg/day divided every 6-8 hours; may be increased every 3-7 days; usual range: 2-6 mg/kg/day; not to exceed 16 mg/kg/day or 60 mg/day
• Intravenously (IV): 0.01-0.1 mg/kg over 10 minutes; repeat every 6-8 hours as needed; not to exceed 1 mg for infants or 3 mg for children

Geriatric

• Orally: 10 mg every 6-8 hours; may be increased every 3-7 days
• Intravenously (IV): 1-3 mg at 1 mg/min initially; repeat every 2-5 minutes to a total of 5 mg
• Once response or a maximum dose is achieved, do not give an additional dose for at least 4 hours

Portal Hypertension

• Prevention of variceal bleeding
• 10-60 mg orally every 6-8 hours; 10 mg orally every 8 hours initially; titrate dose to reduce resting heart rate by 25%

Essential Tremor

• 40 mg orally every 12 hours initially; maintenance: 120-320 mg/day orally divided every 8-12 hours

Antipsychotic-Induced Akathisia

• 30-120 mg orally every 8-12 hours

Malignant Glioma (Orphan)

• Orphan designation for the treatment of malignant glioma (plus etodolac)
• Sponsor
  • Vicus Therapeutics, LLC; 55 Madison Avenue, Suite 400; Morristown, NJ 07960

Esophageal Variceal Bleeding (Off-label)

• 20-180 mg orally every 12 hours; adjust to the maximum tolerated dose

Panic Disorder (Off-label)

• 40-320 mg/day orally

Aggressive Behavior (Off-label)

• 80-300 mg/day orally

Infantile Hemangiomas

• Hemangeol: Indicated for the treatment of proliferating hemangioma requiring systemic therapy
• Initiate treatment at aged 5 weeks to 5 months
• Starting dose: 0.6 mg/kg (0.15 mL/kg) orally twice daily for 1 week, THEN increase dose to 1.1 mg/kg (0.3 mL/kg) twice daily; after 2 more weeks, increase to maintenance dose of 1.7 mg/kg (0.4 mL/kg) twice daily Administration (infantile hemangiomas)
  • Use supplied oral dosing syringe for administration and give directly into the child's mouth; if necessary, the product may be diluted in a small quantity of milk or fruit juice and given in a baby's bottle
  • Administer doses at least 9 hours apart during or after feedings
  • To reduce the risk of hypoglycemia, administer during or right after a feeding; skip the dose if the child is not eating or is vomiting
  • Readjust dose periodically as the child's weight increases
  • Monitor HR and BP for 2 hours after initial dose and after increasing dose
  • If hemangiomas recur, treatment may be reinitiated

Hypercyanotic Spells, Pediatric (Off-label)

• Orally: 1 mg/kg/day divided q6hr; after 1 week, may be increased by 1 mg/kg/day to a maximum of 10-15 mg/kg/day if patient refractory; allow 24 hours between dosing changes
• Intravenously (IV): 0.01-0.2 mg/kg over 10 minutes; not to exceed 5 mg

Thyrotoxicosis, Pediatric (Off-label)

• 10-40 mg orally every 6 hours; adjust the dose to effect

Common side effects or health problems may include:

• Aggravated congestive heart failure
• Slow heart rate
• Low blood pressure (hypotension)
• Joint disease
• Raynaud's phenomenon
• High or low blood sugar (hyper/hypoglycemia)
• Depression
• Fatigue
• Insomnia
• Numbness and tingling
• Psychotic disorder
• Itching
• Nausea
• Vomiting
• High levels of fat in the blood
• High levels of potassium in the blood
• Cramping
• Bronchospasm
• Shortness of breath
• Pulmonary edema
• Respiratory distress
• Wheezing

Postmarketing side effects of propranolol reported include:

• Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid; agranulocytosis, erythematous rash, fever with a sore throat
• Skin: Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, hives
• Musculoskeletal: Myopathy, myotonia

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any drug before seeking medical advice from your doctor, healthcare provider, or pharmacist first. To do so may result in serious consequences or side effects.

• Propranolol has no known severe interactions with other drugs.
• Propranolol has serious interactions with at least 39 different drugs.
• Propranolol has moderate interactions with at least 246 different drugs.
• Propranolol has mild interactions with at least 35 different drugs.
• Propranolol has mild interactions with at least 65 different drugs.

This document does not contain all possible interactions from the use of this medication. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• May exacerbate ischemic heart disease after abrupt withdrawal.
• Hypersensitivity to catecholamines has been observed during withdrawal.
• Exacerbation of angina and, in some cases, myocardial infarction occurrence after abrupt discontinuance.
• When discontinuing long-term administration of beta-blockers (particularly with ischemic heart disease), gradually reduce the dose over 1-2 weeks and carefully monitor.
• If angina markedly worsens or acute coronary insufficiency develops, reinstate beta-blocker administration promptly, at least temporarily (in addition to other measures appropriate for unstable angina).
• Warn patients against interruption or discontinuance of beta-blocker therapy without physician advice.
• Because coronary artery disease is common and may be unrecognized, slowly discontinue beta-blocker therapy, even in patients treated only for hypertension.
• This medication contains propranolol. Do not take Inderal, Inderal LA, InnoPran XL, or Hemangeol if you are allergic to propranolol or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Asthma, COPD
• Severe sinus bradycardia or 2°/3° heart block (except in patients with functioning artificial pacemaker)
• Cardiogenic shock
• Uncompensated congestive heart failure
• Hypersensitivity
• Overt heart failure
• Sick sinus syndrome without a permanent pacemaker
• Infantile hemangioma
  • Premature infants with corrected age under 5 weeks
  • Infants weighing less than 2 kg
  • Hypersensitivity
  • Asthma or history of bronchospasm
  • Heart rate less than 80 bpm
  • Greater than first-degree heart block
  • Decompensated heart failure
  • Blood pressure less than 50/30 mm Hg
  • Pheochromocytoma

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Propranolol (Vasostrict, ADH)?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Propranolol (Vasostrict, ADH)?"

Cautions

• Do not use InnoPran XL in pediatric patients.
• Long-term beta-blocker therapy should not be routinely discontinued before 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.
• Use caution in bronchospastic disease, cerebrovascular insufficiency, congestive heart failure, diabetes mellitus, hyperthyroidism/thyrotoxicosis, liver disease, renal impairment, peripheral vascular disease, myasthenic conditions.
• Sudden discontinuance can exacerbate angina and lead to myocardial infarction.
• Use in pheochromocytoma.
• Increased risk of stroke after surgery.
• Hypersensitivity reactions, including anaphylactic and anaphylactoid reactions, have been reported.
• Cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported.
• Exacerbation of myopathy and myotonia has been reported.
• Less effective than thiazide diuretics in black and geriatric patients.
• May worsen bradycardia or hypotension; monitor HR and BP.
• Avoid beta-blockers without alpha1-adrenergic receptor blocking activity in patients with prinzmetal variant angina; unopposed alpha-1 adrenergic receptors may worsen anginal symptoms.
• May induce or exacerbate psoriasis; cause and effect not established.
• Prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations, and sweating May cause or worsen bradycardia or hypotension.
• Infantile hemangiomas and PHACE syndrome:
  • By dropping blood pressure, propranolol may increase the risk of stroke in patients with PHACE syndrome who have severe cerebrovascular anomalies
  • Investigate infants with large facial infantile hemangioma for potential arteriopathy associated with PHACE syndrome before therapy

Pregnancy and Lactation

• Use propranolol with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies are done. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported, but no adequate and well-controlled studies have been conducted.
• The use of propranolol during lactation is controversial; an insignificant amount is excreted in breast milk. Consult your doctor before breastfeeding.