Product Description.:
TEVA, 4364
tablet , yellow , scored , round round
Labetalol HCl is an adrenergic receptor blocking agent that has both selective alpha1- and nonselective beta-adrenergic receptor blocking actions in a single substance.
Labetalol HCl has the molecular formula C19H24N2O3?HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R? stereoisomer, makes up 25% of racemic labetalol.
Labetalol HCl is a white or off-white crystalline powder, soluble in water.
Each tablet, for oral administration, contains 100 mg, 200 mg, or 300 mg labetalol hydrochloride, USP.
In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
INDICATIONS AND USAGE
Labetalol HCl Tablets are indicated in the management of hypertension. Labetalol HCl Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
CONTRAINDICATIONS
Labetalol HCl Tablets are contraindicated in bronchial asthma, overt cardiac failure, greater than first degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product
PRECAUTIONS
Impaired Hepatic Function
Labetalol should be used with caution in patients with impaired hepatic function since metabolism of the drug may be diminished.
Jaundice or Hepatic Dysfunction
Information for Patients
As with all drugs with beta-blocking activity, certain advice to patients being treated with labetalol is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. While no incident of the abrupt withdrawal phenomenon (exacerbation of angina pectoris) has been reported with labetalol, dosing with labetalol HCl tablets should not be interrupted or discontinued without a physician?s advice. Patients being treated with labetalol HCl tablets should consult a physician at any signs or symptoms of impending cardiac failure or hepatic dysfunction (see WARNINGS). Also, transient scalp tingling may occur, usually when treatment with labetalol HCl tablets is initiated
