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Trandate (Labetalol Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

TRANDATE Tablets are indicated in the management of hypertension. TRANDATE 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 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 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 TRANDATE Tablets are usually lower in patients also receiving a diuretic.

When transferring patients from other antihypertensive drugs, TRANDATE 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.

HOW SUPPLIED

TRANDATE Tablets, 100 mg, light orange, round, scored, film-coated tablets engraved on one side with "TRANDATE 100," bottles of 100 (NDC 65483-391-10) and 500 (NDC 65483-391-50) and unit dose packs of 100 tablets (NDC 65483-391-11).

TRANDATE Tablets, 200 mg, white, round, scored, film-coated tablets engraved on one side with "TRANDATE 200," bottles of 100 (NDC 65483-392-10) and 500 (NDC 65483-392-50) and unit dose packs of 100 tablets (NDC 65483-392-22).

TRANDATE Tablets, 300 mg, mid-orange, round, scored, film-coated tablets engraved on one side with "TRANDATE 300," bottles of 100 (NDC 65483-393-10) and 500 (NDC 65483-393-50) and unit dose packs of 100 tablets (NDC 65483-393-33).

TRANDATE Tablets should be stored between 2° and 30°C (36° and 86°F). TRANDATE Tablets in the unit dose boxes should be protected from excessive moisture.

Prometheus Laboratories Inc.
Manufactured in Canada by WellSpring Pharmaceutical Canada Corp.
Oakville, ON L6H 1M5
for Prometheus Laboratories Inc.
San Diego, CA 92121

TRANDATE is a registered trademark of Prometheus Laboratories, Inc.

TOXI-LAB is a registered trademark of Varian, Inc.

EMIT and EMIT-d.a.u. are registered trademarks of Siemens Healthcare Diagnostics, Inc.

© 2010 Prometheus Laboratories Inc.
All rights reserved
November 2010

TR002C

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