LABELATOL Solution for injection Ref.[7721] Active ingredients: Labetalol

Dosage

Labetalol injection is intended for intravenous use in hospitalized patients.

Populations

Adults

Severe hypertension:

Bolus injection:

If it is essential to reduce blood pressure quickly, a dose of 50mg of labetalol hydrochloride should be given by intravenous injection (over a period of at least one minute) and, if necessary, may be repeated at five minute intervals until a satisfactory response occurs. The total dosage should not exceed 200mg.

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:

(instructions for dilution – refer to section 6.6)

A labetalol infusion solution containing 1mg/ml needs to be used. This solution can be made by diluting the contents of four 10ml ampoules (200mg) to 200ml with Sodium Chloride and Dextrose Injection, 5% dextrose Intravenous Infusion, Potassium Chloride and Glucose solution or Ringer Lactate.

The rate of infusion of Labetalol hydrochloride should be about 160mg/hour, but may be adjusted according to the response at the discretion of the physician. The effective dose is usually in the range of 50-200mg but infusion needs to be administered until a satisfactory result has been achieved. A larger dose may be required, especially in patients with phaeochromocytoma.

In severe cases of hypertension of pregnancy a lower, increasing infusion rate needs to be administered. The infusion needs to be started at the rate of 20mg/hour, and this dose may be doubled every 30 minutes until a satisfactory result has been obtained, or a dosage of 160mg/hour is reached.

Hypotensive Anaesthesia:

To control hypotension during anesthesia, the recommended starting dose of Labetalol injection is 10-20mg intravenously, depending on the age and condition of the patient.

If satisfactory hypotension is not achieved after five minutes, increments of 5-10mg should be given until the desired level of blood pressure is attained.

The mean duration of hypotension following 20 to 25mg of labetalol is 50 minutes.

Hypertension due to other causes:

The rate of infusion of Labetalol hydrochloride should be 120-160mg/hour, until a satisfactory result has been achieved. Then stop the infusion. The effective dose is usually in the range of 50 to 200mg, but a larger dose may be required, especially in patients with phaeochromocytoma.

Pediatric population

The safety and efficacy of Labetalol administered to children from 0 to 18 years of age have not been established. No data are available

Method of administration

Precautions to be taken before administering the medicinal product:

Patients should always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position within 3 hours of intravenous labetalol administration should be avoided since excessive postural hypotension may occur.

Symptoms of overdosage

Acute cardiac insufficiency is to be expected, e.g. excessive hypotension and sometimes bradycardia. Oliguric renal failure has been reported after massive overdosage on labetalol orally. In one case, the use of dopamine to increase the blood pressure may have aggravated the renal failure.

Treatment

The patient should be placed on their back, with the legs up.

Parental adrenal/anticholinergic treatment should be provided if necessary to improve blood flow.

Haemodialysis removes less than 1% labetalol hydrochloride from the circulation.

Further treatment should be provided as clinically appropriate or as advised by a national anti-toxins laboratory, if available.

Shelf life: 2 years.

Chemical and physical in-use stability diluted in dextrose 5% (w/v); sodium chloride 0.18% (w/v) and dextrose 4.3% (w/v); potassium chloride 0.3% (w/v) and dextrose 5% (w/v) and Ringer Lactate has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately after dilution. If not used immediately in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Any unused dilution should be disposed after 24 hours.

The medicinal product does not require any special temperature storage conditions.

Store in the original package to protect ampoules from light.

For storage of the product once opened or diluted, refer to section 6.3.

Type I amber glass ampoules: 10 ampoules of 10ml (per pack). Ampoules have a white break ring.

Labetalol Synchrony 5mg/ml solution for injection is compatible with the following solutions for infusion:

• Dextrose 5% (w/v)
• Sodium Chloride 0.18% (w/v) and dextrose 4.3% (w/v)
• Potassium Chloride 0.3% (w/v) and dextrose 5% (w/v)
• Ringer Lactate

For intravenous infusion of Labetalol Synchrony 5mg/ml solution for injection a solution containing 1mg/ml needs to be used. This solution can be made by diluting the contents of four 10ml ampoules (200mg) to 200ml with the solution for infusion.

Any unused product and waste should be disposed in accordance with local requirements.