Drug Catalog - Product Detail
LABETALOL HCL 300MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 58657-0607-01 | METHOD PHARMACEUTICALS | 100 | 300MG | NA |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION: Labetalol hydrochloride tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure: Labetalol HCl has the empirical formula C19H24N2O3•HCl and a molecular weight of 364.9. 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 of labetalol HCl. In addition, each 100 mg tablet has the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), synthetic red iron oxide, synthetic yellow iron oxide, and titanium dioxide. In addition, each 200 mg tablet has the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide, and triacetin. In addition, each 300 mg tablet has the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), and titanium dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Labetalol hydrochloride tablets, USP are available as follows: Labetalol hydrochloride tablets, 100 mg, beige, film coated, round, scored, debossed MP 277 Bottles of 100 CRC NDC 58657-605-01 Bottles of 500 NDC 58657-605-50 Labetalol hydrochloride tablets, 200 mg, white, film coated, round, scored, debossed MP 271 Bottles of 100 CRC NDC 58657-606-01 Bottles of 500 NDC 58657-606-50 Labetalol hydrochloride tablets, 300 mg, blue, film coated, round, unscored, debossed MP 272 Bottles of 100 CRC NDC 58657-607-01 Bottles of 500 NDC 58657-607-50 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. TOXI-LAB is a registered trademark of Varian, Inc. EMIT and EMIT-d.a.u. are registered trademarks of Siemens Healthcare Diagnostics, Inc. Manufactured by: Frontida BioPharm, Inc Philadelphia, PA 19124 Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 Rev: 04/2017
Indications & Usage
INDICATIONS AND USAGE: Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
Dosage and Administration
DOSAGE AND ADMINISTRATION: DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. every 2 or 3 days. The usual maintenance dosage of labetalol HCl is between 200 and 400 mg twice daily. Since the full antihypertensive effect of labetalol HCl is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary. Patients with severe hypertension may require from 1,200 mg to 2,400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg twice daily. When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic. When transferring patients from other antihypertensive drugs, labetalol hydrochloride tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased. Elderly Patients: As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. as required for control of blood pressure. Since some elderly patients eliminate labetalol more slowly, however, adequate control of blood pressure may be achieved at a lower maintenance dosage compared to the general population. The majority of elderly patients will require between 100 and 200 mg b.i.d.