Usual Adult Dose for Hypertension

ORAL:
Initial dose: 100 mg orally 2 times a day (alone or added to a diuretic regimen)
Titration: Dosage may be increased in increments of 100 mg orally 2 times a day every 2 or 3 days
Maintenance dose: 200 to 400 mg orally 2 times a day
Maximum dose: Some patients may require 1200 to 2400 mg orally per day (titration increments should not exceed 200 mg orally 2 times a day)

PARENTERAL:
REPEATED IV INJECTION:

• Immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to evaluate response.
• Initial dose: 20 mg by slow IV injection over a 2-minute period
• Additional injections of 40 to 80 mg can be given at 10 minute intervals until a desired supine blood pressure is achieved or a total of 300 mg has been used
• The maximum effect usually occurs within 5 minutes of each injection

• The solution for injection should be prepared according to the manufacturer suggested guidelines for a resultant solution of 1 mg/mL or 2 mg/3 mL:
• For 1 mg/mL, the diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.
• For 2 mg/3 mL, the diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.
• Rate of infusion: The rate of infusion of the diluted solution may be adjusted according to the blood pressure response, at the discretion of the physician. To facilitate a desired rate of infusion, the diluted solution can be infused using a controlled administration mechanism, (e.g., graduated burette or mechanically driven infusion pump).
• Since the half-life of this drug is 5 to 8 hours, steady-state blood levels (in the face of a constant rate of infusion) would not be reached during the usual infusion time period; the infusion should be continued until a satisfactory response is obtained and should then be stopped and the oral formulation should be started.
• The effective IV dose is usually in the range of 50 to 200 mg.
• A total dose of up to 300 mg IV may be required in some patients.

• The injection solution is intended for IV use in hospitalized patients.
• Patients should always be kept in a supine position during the period of IV drug administration. A substantial fall in blood pressure on standing should be expected in these patients.
• Blood pressure should be monitored during and after completion of the infusion or IV injections.

• Subsequent oral dosing with the tablet formulation should begin when it has been established that the supine diastolic blood pressure has begun to rise.
• The recommended initial dose is 200 mg orally, followed in 6 to 12 hours by an additional dose of 200 or 400 mg orally, depending on the blood pressure response.
• Thereafter, inpatient titration with labetalol hydrochloride tablets may proceed as follows:

• While in the hospital, the dosage of the tablets may be increased at 1 day intervals to achieve the desired blood pressure reduction.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dialysis

This drug is not removed by hemodialysis or peritoneal dialysis; a supplemental dose is not needed.

Other Comments

Storage requirements:

• Consult the manufacturer product information.

• Consult the manufacturer product information.

• Consult the manufacturer product information.