INDERAL® LA (propranolol HCl) is a long-acting beta blocker that:

  • has been available for more than twenty five years

  • is indicated for

    • Hypertension
    • Prevention of Migraine Headaches
    • Angina Pectoris
    • Hypertrophic Subaortic Stenosis

Evidence Suggests that Non-Selective Beta Blockers Reduce Mortality in Hypertension Patients1

1. De Peuter OR et al. Neth J Med. 2009;67:284-94

INDERAL® LA (propranolol HCl) is contraindicated in patients with the following conditions:

  • Cardiogenic shock
  • Sinus bradycardia and greater than first-degree block
  • Bronchial asthma
  • Known hypersensitivity to propranolol hydrochloride

Healthcare Providers who have questions about INDERAL® LA (propranolol HCl) may request clinical information at 1-800-308-6755 or drugsafety@anipharmaceuticals.com.

To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or drugsafety@anipharmaceuticals.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

For materials or more information, please visit www.anipharmaceuticals.com

INDICATIONS AND USAGE: INDERAL® LA (propranolol HCl) is a beta adrenergic blocker indicated for the treatment of high blood pressure (hypertension), angina pectoris and hypertrophic subaortic stenosis. INDERAL® LA is also indicated for the prevention of migraine headache. Lowering blood pressure can reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

LIMITATION OF USE: INDERAL® LA is not indicated in the management of hypertensive emergencies.

Important Safety Information About INDERAL® LA

Contraindications

Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

Warnings and Precautions

Angina Pectoris: There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks, and the patient should be cautioned against interruption or cessation of therapy without the physician’s advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of unstable angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications.

Hypersensitivity and Skin Reactions: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol.

Cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol.

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, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensated and are receiving diuretics as needed. 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.

Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema): In general, patients with bronchospastic lung disease should not receive beta-blockers. Propranolol should be administered with caution in this setting since it may provoke a bronchial asthmatic attack by blocking bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta-receptors.

Major Surgery: Chronically administered beta-blocking therapy should not be routinely withdrawn prior to 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.

Diabetes and Hypoglycemia: Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia, especially in labile insulin-dependent diabetics. In these patients, it may be more difficult to adjust the dosage of insulin.

Propranolol therapy, particularly when given to infants and children, diabetic or not, has been associated with hypoglycemia especially during fasting as in preparation for surgery. Hypoglycemia has been reported in patients taking propranolol after prolonged physical exertion and in patients with renal insufficiency.

Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T4 and reverse T3, and decreasing T3.

Wolff-Parkinson-White Syndrome: Beta-adrenergic blockade in patients with Wolff-Parkinson-White syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker. In one case, this result was reported after an initial dose of 5 mg propranolol.

General: Propranolol should be used with caution in patients with impaired hepatic or renal function.

Beta-adrenergic receptor blockade can cause reduction of intraocular pressure. Patients should be told that Inderal LA may interfere with the glaucoma screening test. Withdrawal may lead to a return of increased intraocular pressure.

While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Adverse Reactions

The most commonly reported adverse reactions included the following: fatigue, dizziness, and constipation.

You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or ANI Pharmaceuticals, Inc. at 1-800-308-6755.

Click here for Full Prescribing Information.

INDERAL® LA (propranolol HCl) is a registered trademark of ANI Pharmaceuticals, Inc.
Marketed and distributed by: ANI Pharmaceuticals, Inc.

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*Terms and conditions

Out-of-pocket expenses greater than $0 will be covered up to a maximum of $100 of actual out-of-pocket expense for a prescription size of 28-59 capsules of INDERAL® LA (propranolol HCl). Out-of-pocket expenses greater than $0 will be covered up to a maximum of $200 of actual out-of-pocket expense for a prescription size of 60-89 capsules. Out-of-pocket expenses greater than $0 will be covered up to a maximum of $300 of actual out-of-pocket expense for a prescription size of 90+ capsules. This program can be terminated at any time at the discretion of ANI Pharmaceuticals, Inc.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided in this site is intended only for residents of the United States.