Pharmaniaga Labetalol HCl

Pharmaniaga Labetalol HCl Dosage/Direction for Use



Pharmaniaga LifeScience


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Dosage/Direction for Use
Labetalol hydrochloride injection is intended for i.v. use in hospitalised patients. Patients should always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position within 3 h of i.v. Labetalol hydrochloride administration should be avoided since excessive postural hypotension may occur. It is desirable to monitor the blood pressure and heart rate after injection and during infusion. In most patients, there is a small decrease in the heart rate; severe bradycardia is unusual but may be controlled by injecting atropine 1 to 2 mg intravenously. Respiratory function should be observed particularly in patients with any known impairment.
Once the blood pressure has been adequately reduced by bolus injection or infusion, maintenance therapy with Labetalol hydrochloride tablets should be substituted with a starting dose of 100 mg twice daily. Labetalol hydrochloride injection has been administered to patients with uncontrolled hypertension already receiving other hypotensive agents, including beta-blocking drugs, without adverse effects.
Adults: For Severe Hypertension: Bolus injection: If it is essential to reduce the blood pressure quickly a dose of 50 mg should be given by i.v. injection (over a period of at least 1 min) and, if necessary, repeated at 5 min intervals until a satisfactory response occurs. The total dose should not exceed 200 mg. The maximum effect usually occurs within 5 min and the duration of action is usually about 6 h but may be as long as 18 h.
Intravenous Infusion: A 1 mg/mL solution of Labetalol hydrochloride injection should be used, i.e. the contents of two 20 mL vials or eight 5 mL ampoules (200 mg) diluted to 200 mL with Sodium Chloride and Dextrose Intravenous Infusion.
Severe Hypertension of Pregnancy: Infusion should be started at 20 mg/h, then doubled every 30 min until a satisfactory response is obtained or a dosage of 160 mg/h is reached. Occasionally higher doses may be necessary.
Hypertension Due To Other Causes: Infusion should be started at a rate of 2 mg/min until a satisfactory response is obtained, then stopped. The effective dose is usually 50 to 200 mg but larger doses may be needed, especially in patients with phaeochromocyto­ma. The rate of infusion may be adjusted according to the response at the discretion of the physician.
For Hypotensive Anaesthesia: Induction should be with standard agents (e.g. Sodium thiopentone) and anaesthesia maintained with nitrous oxide and Oxygen with or without Halothane. The recommended starting dose of Labetalol hydrochloride is 10 to 20 mg intravenously depending on the age and condition of the patient. Patients for whom Halothane is contraindicated usually require a higher initial dose of Labetalol hydrochloride (25 to 30 mg). If satisfactory hypotension is not achieved after 5 min, increments of 5 to 10 mg should be given until the desired level of blood pressure is attained.
Halothane and Labetalol hydrochloride act synergistical­ly therefore the Halothane concentration should not exceed 1 to 1.5% as profound falls in blood pressure may be precipitated. Following Labetalol hydrochloride injection the blood pressure can be quickly and easily adjusted by altering the Halothane concentration and/or adjusting table tilt. The mean duration of hypotension following 20 to 25 mg of i.v. Labetalol hydrochloride is 50 min. Hypotension induced by Labetalol hydrochloride injection is readily reversed by Atropine 0.6 mg and discontinuation of Halothane.
Tubocurarine and Pancuronium may be used when assisted or controlled ventilation is required. Intermittent positive pressure ventilation may further increase the hypotension resulting from Labetalol hydrochloride injection and/or Halothane.
For Hypertensive Episodes Following Acute Myocardial Infarction: Infusion should be started at 15 mg/h and gradually increased to a maximum of 120 mg/h depending on the control of blood pressure.
Compatible Solutions: Pharmaniaga Labetalol hydrochloride 25mg/5ml injection is compatible with the following i.v. infusion fluids: 5% Dextrose, 0.18% Sodium Chloride and 4% Dextrose, 0.3% Potassium Chloride and 5% Dextrose, Compound Sodium Lactate.
The solution should be clear, colorless when diluted. Do not use if the solution is discolored or if there is particu­late matter in the solution.
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