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Basic Drug Info
Drug Name:Propranolol Hydrochloride
Manufacturer:Mylan Pharmaceuticals Inc.
Other Info:Mylan Pharmaceuticals Inc.Morgantown, WV 26505OCTOBER 2004PRAN:R25



Clinical Trials:


Indications and Usage

Propranolol hydrochloride tablets are indicated in the management of hypertension.

It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic.

Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

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.
Sinus bradycardia -- A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI)

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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 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.
Branded Drugs
The following US Branded drugs contain Propranolol Hydrochloride


INDERIDE LA 120/50 -- WYETH AYERST LABORATORIES

INDERIDE LA 160/50 -- WYETH AYERST LABORATORIES

INDERIDE LA 80/50 -- WYETH AYERST LABORATORIES

INDERIDE-40/25 -- AKRIMAX PHARMACEUTICALS LLC

INDERIDE-80/25 -- AKRIMAX PHARMACEUTICALS LLC

PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE -- DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- ACTAVIS ELIZABETH LLC

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- BARR LABORATORIES INC

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- IVAX PHARMACEUTICALS INC

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- MYLAN PHARMACEUTICALS INC

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- PLIVA INC

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- SANDOZ INC

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- WARNER CHILCOTT DIV WARNER LAMBERT CO

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- WATSON LABORATORIES INC

INDERAL LA -- WYETH PHARMACEUTICALS INC

INNOPRAN XL -- SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

PROPRANOLOL HYDROCHLORIDE INTENSOL -- ROXANE LABORATORIES INC

INDERAL -- WYETH AYERST LABORATORIES

INDERAL -- AKRIMAX PHARMACEUTICALS LLC


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