Product Description.:
INDERAL LA 120
capsule , blue , oblong oblong
INDERAL LA 120 in dark blue on white band3 white stripes
Inderal? (propranolol hydrochloride) is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride.
Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80.
Inderal LA is formulated to provide a sustained release of propranolol hydrochloride. Inderal LA is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration.
The inactive ingredients contained in Inderal LA capsules are: cellulose, ethylcellulose, gelatin capsules, hypromellose, and titanium dioxide. In addition, Inderal LA 60 mg, 80 mg, and 120 mg capsules contain D&C Red No. 28 and FD&C Blue No. 1 Inderal LA 160 mg capsules contain FD&C Blue No. 1.
These capsules comply with USP Dissolution Test 1.
INDICATIONS AND USAGE
Hypertension
Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Inderal LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Migraine
Inderal LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
Hypertrophic Subaortic Stenosis
Inderal LA improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
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
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