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Kerlone (Betaxolol Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Kerlone is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.

DOSAGE AND ADMINISTRATION

The initial dose of Kerlone in hypertension is ordinarily 10 mg once daily either alone or added to diuretic therapy. The full antihypertensive effect is usually seen within 7 to 14 days. If the desired response is not achieved the dose can be doubled after 7 to 14 days. Increasing the dose beyond 20 mg has not been shown to produce a statistically significant additional antihypertensive effect; but the 40-mg dose has been studied and is well tolerated. An increased effect (reduction) on heart rate should be anticipated with increasing dosage. If monotherapy with Kerlone does not produce the desired response, the addition of a diuretic agent or other antihypertensive should be considered (see, Drug interactions ).

Dosage adjustments for specific patients

Patients with renal failure

In patients with renal impairment, clearance of betaxolol declines with decreasing renal function.

In patients with severe renal impairment and those undergoing dialysis the initial dose of Kerlone is 5 mg once daily. If the desired response is not achieved, dosage may be increased by 5 mg/day increments every 2 weeks to a maximum dose of 20 mg/day.

Patients with hepatic disease

Patients with hepatic disease do not have significantly altered clearance. Dosage adjustments are not routinely needed.

Elderly patients

Consideration should be given to reduction in the starting dose to 5 mg in elderly patients. These patients are especially prone to beta-blocker-induced bradycardia, which appears to be dose related and sometimes responds to reductions in dose.

Cessation of therapy

If withdrawal of Kerlone therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed and advised to limit physical activity to a minimum.

HOW SUPPLIED

Kerlone 10-mg tablets are round, white, film coated, with KERLONE 10 debossed on one side and scored on the other, supplied as:

NDC Number        Size

0025-5101-31     bottle of 100

Kerlone 20-mg tablets are round, white, film coated, with KERLONE 20 debossed on one side and β on the other, supplied as:

NDC Number        Size

0025-5201-31     bottle of 100

Store at controlled room temperature 15°–25°C (59°–77°F).

Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

Revised: September 2008

©2008 sanofi-aventis U.S. LLC

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