Labetalol (Labetalol Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

DOSAGE AND ADMINISTRATION

DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dose 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 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 1200 mg to 2400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered b.i.d., the same total daily dose administered t.i.d. may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg b.i.d.

When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol tablets are usually lower in patients also receiving a diuretic.

When transferring patients from other antihypertensive drugs, labetalol tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased.

Elderly Patients

As in the general 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 as a lower maintenance dosage compared to the general population. The majority of elderly patients will require between 100 and 200 mg b.i.d.

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 30 unit of use            NDC 53489-354-07
Bottles of 60 unit of use            NDC 53489-354-06
Bottles of 100                            NDC 53489-354-01
Bottles of 250                            NDC 53489-354-03
Bottles of 500                            NDC 53489-354-05
Bottles of 1000                          NDC 53489-354-10

Labetalol hydrochloride tablets, 200 mg, white, film coated, round, scored, debossed MP 271

Bottles of 30 unit of use            NDC 53489-355-07
Bottles of 60 unit of use            NDC 53489-355-06
Bottles of 100                            NDC 53489-355-01
Bottles of 250                            NDC 53489-355-03
Bottles of 500                            NDC 53489-355-05
Bottles of 1000                          NDC 53489-355-10

Labetalol hydrochloride tablets, 300 mg, blue, film coated, round, unscored, debossed MP 272

Bottles of 30 unit of use            NDC 53489-356-07
Bottles of 60 unit of use            NDC 53489-356-06
Bottles of 100                            NDC 53489-356-01
Bottles of 250                            NDC 53489-356-03
Bottles of 500                            NDC 53489-356-05
Bottles of 1000                          NDC 53489-356-10

Store at controlled room temperature 15°-30°C (59°-86°F).

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured by:
Mutual Pharmaceutical Co., Inc.
Philadelphia, PA 19124 USA

Rev: June 2000Ch