Active Ingredient: Labetalol
Severe hypertension, when rapid control of blood pressure is essential.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A :
Intravenous bolus, 50 milligrams labetalol, once every 5 minutes, 1 to 4 doses in total.
Regimen B :
Intravenous, 2 milligrams labetalol, once every minute.
Labetalol injection is intended for intravenous use in hospitalised patients. The plasma concentrations achieved after intravenous dose of labetalol in severe hypertension are substantially greater than those following oral administration of the drug and provide a greater degree of blockade of alpha-adrenoceptors necessary to control the more severe disease. Patients should, therefore, always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position, within three hours of intravenous labetalol administration, should be avoided since excessive postural hypotension may occur.
| Indication | Dosage |
| Severe hypertension | Bolus injection: If it is essential to reduce blood pressure quickly, as for example in hypertensive encephalopathy, a dose of 50 mg of labetalol hydrochloride should be given by intravenous injection (over a period of at least one minute). If necessary, doses of 50 mg may be repeated at five minute intervals until a satisfactory response occurs. The total dosage should not exceed 200 mg. After bolus injection, the maximum effect usually occurs within five minutes and the effective duration of action is usually about 6 hours but may be as long as 18 hours. |
| Intravenous infusion An alternative method of administering labetalol is intravenous infusion of a solution made by diluting the contents of four 10ml ampoules (200 mg) to 200ml with Sodium Chloride and Dextrose Injection, 5% dextrose Intravenous Infusion, Potassium Chloride and Glucose solution or Ringer Lactate. The resultant infusion solution contains 1 mg/ml of labetalol hydrochloride. It should be administered using a paediatric giving set fitted with a 50 ml graduated burette to facilitate dosage. The rate of infusion of labetalol hydrochloride should be about 2 mg (2 ml of infusion solution) per minute, until a satisfactory response is obtained; the infusion should then be stopped. The effective dose is usually in the range of 50-200 mg depending on the severity of the hypertension. For most patients it is unnecessary to administer more than 200 mg but larger doses may be required, especially in patients with phaeochromocytoma. The rate of infusion may be adjusted according to the response, at the discretion of the physician. The blood pressure and pulse rate should be monitored throughout the infusion. It is desirable to monitor the 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 1-2 mg intravenously. Respiratory function should be observed particularly in patients with any known impairment. Once the blood pressure has been adequately reduced, maintenance therapy with labetalol tablets should be instituted with a starting dose of one 100 mg tablet twice daily (see labetalol tablet SmPC for further details). Labetalol Injection has been administered to patients with uncontrolled hypertension already receiving other hypotensive agents, including beta-blocking drugs, without adverse effects. |
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