INDERAL XL- propranolol hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Available from:

Mist Pharmaceuticals, LLC

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDERAL® XL is 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 beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different m

Product summary:

INDERAL XL (propranolol hydrochloride) Extended-Release Capsules are supplied as capsules containing either 80 mg, or 120 mg propranolol hydrochloride imprinted with “Inderal XL”. Storage: Store at 25ºC (77ºF); excursions permitted to 15º and 30ºC (59º and 86ºF) [see USP Controlled Room Temperature] in a tightly closed container.

Authorization status:

New Drug Application

Summary of Product characteristics

INDERAL XL- PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
MIST PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INDERAL XL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR INDERAL XL.
INDERAL XL (PROPRANOLOL HYDROCHLORIDE) EXTENDED-RELEASE CAPSULES, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2003
WARNING: CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FOLLOWING ABRUPT CESSATION OF THERAPY WITH BETA-BLOCKERS,
EXACERBATIONS OF ANGINA PECTORIS AND
MYOCARDIAL INFARCTION HAVE OCCURRED. WARN PATIENTS AGAINST
INTERRUPTION OR DISCONTINUATION OF THERAPY
WITHOUT PHYSICIAN ADVICE. (5.1)
INDICATIONS AND USAGE
INDERAL XL is a beta adrenergic blocker 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. (1)
Limitation of Use: INDERAL XL is not indicated for the treatment of
hypertensive emergencies. (1)
DOSAGE AND ADMINISTRATION
Administer once daily at bedtime consistently either on an empty
stomach or with food. (2)
Initiate dosage at 80 mg and titrate up to 120 mg if needed. (2)
DOSAGE FORMS AND STRENGTHS
Capsules: 80 mg, 120 mg. (3)
CONTRAINDICATIONS
Cardiogenic shock and decompensated heart failure. (4)
Sinus bradycardia, sick sinus syndrome, and greater than first-degree
block unless a permanent pacemaker is in place.
(4)
Bronchial asthma. (4)
Hypersensitivity to propranolol or any of the components of INDERAL
XL. (4)
WARNINGS AND PRECAUTIONS
May worsen congestive heart failure. (5.2)
Avoid discontinuing therapy prior to major surgery. (5.3)
Diabetes: May mask symptoms of hypoglycemia. (5.4)
Bradycardia. (5.6)
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥3% and greater than
placebo) included the following: fatigue,
dizziness, and constipation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT M