Labetalol

Labetalol Manufacturers

• Sun Pharmaceutical Industries, Inc.
  

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  Labetalol | Sun Pharmaceutical Industries, Inc.

  

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  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 mg 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 labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic.

  When transferring patients from other antihypertensive drugs, labetalol hydrochloride 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.

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• Sagent Pharmaceuticals
  

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  Labetalol | Sagent Pharmaceuticals

  

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  Labetalol hydrochloride injection is intended for IV use in hospitalized patients. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing.

  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. The patient's ability to tolerate an upright position should be established before permitting any ambulation, such as using toilet facilities.

  Either of two methods of administration of labetalol hydrochloride injection may be used: a) repeated IV injection, or b) slow continuous infusion.

  Repeated Intravenous Injection

  Initially, labetalol hydrochloride injection should be given in a 20 mg dose (which corresponds to 0.25 mg/kg for an 80 kg patient) by slow IV injection over a 2-minute period.

  Immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to evaluate response. Additional injections of 40 or 80 mg can be given at 10-minute intervals until a desired supine blood pressure is achieved or a total of 300 mg of labetalol HCl has been injected. The maximum effect usually occurs within 5 minutes of each injection.

  Slow Continuous Infusion

  Labetalol hydrochloride injection is prepared for continuous IV infusion by diluting the vial contents with commonly used IV fluids (see below). Examples of two methods of preparing the infusion solution are:

  Add 40 mL of labetalol hydrochloride injection to 160 mL of a commonly used IV fluid such that the resultant 200 mL of solution contains 200 mg of labetalol HCl, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.

  Alternatively, add 40 mL of labetalol hydrochloride injection to 250 mL of a commonly used IV fluid. The resultant solution will contain 200 mg of labetalol HCl, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.

  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 labetalol 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 oral labetalol HCl started (see below). The effective IV dose is usually in the range of 50 to 200 mg. A total dose of up to 300 mg may be required in some patients.

  Blood Pressure Monitoring

  The blood pressure should be monitored during and after completion of the infusion or IV injection. Rapid or excessive falls in either systolic or diastolic blood pressure during IV treatment should be avoided. In patients with excessive systolic hypertension, the decrease in systolic pressure should be used as an indicator of effectiveness in addition to the response of the diastolic pressure.

  Initiation of Dosing with Labetalol Tablets

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

  Inpatient Titration Instructions

  *If needed, the total daily dose may be given in three divided doses.

  Regimen Daily Dose* 200 mg b.i.d. 400 mg 400 mg b.i.d. 800 mg 800 mg b.i.d. 1600 mg 1200 mg b.i.d. 2400 mg

  The dosage of labetalol tablets used in the hospital may be increased at 1-day intervals to achieve the desired blood pressure reduction.

  For subsequent outpatient titration or maintenance dosing, see DOSAGE AND ADMINISTRATION in the labetalol tablets Product Information for additional recommendations.

  Compatibility with commonly used intravenous fluids

  Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

  Labetalol hydrochloride injection was tested for compatibility with commonly used IV fluids at final concentrations of 1.25 to 3.75 mg of labetalol HCl per milliliter of the mixture. Labetalol hydrochloride injection was found to be compatible with and stable (for 24 hours refrigerated or at room temperature) in mixtures with the following solutions:

  Ringer's Injection, USP

  Lactated Ringer's Injection, USP

  5% Dextrose and Ringer's Injection

  5% Lactated Ringer's and 5% Dextrose Injection

  5% Dextrose Injection, USP

  0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  2.5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.33% Sodium Chloride Injection, USP.

  Labetalol hydrochloride injection was NOT compatible with 5% sodium bicarbonate injection, USP.

  Care should be taken when administering alkaline drugs, including furosemide, in combination with labetalol. Compatibility should be assured prior to administering these drugs together.

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