Información de la droga para Trandate (Prometheus Laboratories Inc.): DOSAGE AND ADMINISTRATION

  • TRANDATE 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 TRANDATE Injection may be used: a) repeated IV injection, or b) slow continuous infusion.

    Repeated Intravenous Injection: Initially, TRANDATE 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: TRANDATE 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 TRANDATE 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 TRANDATE 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 TRANDATE Tablets: Subsequent oral dosing with TRANDATE 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 TRANDATE Tablets may proceed as follows:

    Inpatient Titration Instructions

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

    RegimenDaily 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.d2400 mg

    The dosage of TRANDATE 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 TRANDATE 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.

    TRANDATE 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. TRANDATE 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; and 5% dextrose and 0.33% sodium chloride injection, USP.

    TRANDATE 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.

  • Drug Information Provided by National Library of Medicine (NLM).