Trandate (labetalol) Tablets are indicated in the management of hypertension. Trandate (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 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 (labetalol) Tablets are usually
lower in patients also receiving a diuretic.
When transferring patients from other antihypertensive drugs, Trandate (labetalol) Tablets
should be introduced as recommended and the dosage of the existing therapy progressively
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.
Trandate (labetalol) Tablets, 100 mg, light orange, round, scored, film-coated tablets
engraved on one side with “TRANDATE (labetalol) 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 (labetalol) Tablets, 200 mg, white, round, scored, film-coated tablets engraved
on one side with “TRANDATE (labetalol) 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 (labetalol) Tablets, 300 mg, mid-orange, round, scored, film-coated tablets engraved
on one side with “TRANDATE (labetalol) 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 (labetalol) Tablets should be stored between 2° and 30°C (36° and
86°F). Trandate (labetalol) Tablets in the unit dose boxes should be protected from
Prometheus Laboratories Inc. Manufactured in Canada by WellSpring Pharmaceutical
Canada Corp. Oakville, ON L6H 1M5 for Prometheus Laboratories Inc. San Diego,
CA 92121. Revised: November 2010