Labetalol 5 mg/ml solution for injection/ infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Labetalol hydrochloride

Available from:

S.A.L.F. S.p.A. Laboratorio Farmacologico

ATC code:

C07AG01

INN (International Name):

Labetalol hydrochloride

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

labetalol

Authorization status:

Marketed

Authorization date:

2019-08-19

Patient Information leaflet

_Labetalol – PIL_
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LABETALOL 5 MG / ML SOLUTION FOR INJECTION_/_INFUSION
labetalol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet; you may need to read it again.
-
If you have further questions, ask your doctor, pharmacist or nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1. What Labetalol is and what it is used for
2. What you need to know before you are given Labetalol
3. How Labetalol is given
4. Possible side effects
5. How to store Labetalol
6. Contents of the pack and other information
1. WHAT LABETALOL IS AND WHAT IT IS USED FOR
Labetalol contains the active substance labetalol. It is used to treat
severe hypertension (high blood
pressure), including severe hypertension of pregnancy
(pregnancy-induced high blood pressure)
when rapid control of blood pressure is necessary. Labetalol may also
be used to control blood
pressure during anaesthesia.
Labetalol belongs to a group of medicines called alpha and
beta-blocking agents. These medicines
lower blood pressure by blocking the receptors in the cardiovascular
(circulatory) system, causing a
decrease in blood pressure in the blood vessels far from the heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LABETALOL
DO NOT TAKE LABETALOL
-
if you are allergic to labetalol or any of the other ingredients of
this medicine (listed in section
6)
-
if you have certain heart diseases for example heart block or sick
sinus syndrome (unless you
have a pacemaker), cardiogenic shock or heart failure which is not
under control
-
if you have ongoing low blood pressure
-
If you have an extremely slow heart rate (severe bradycardia)
-
if you have a condition known as Prinzmetal angina
-
if you have asthma or a similar lung disease (obstructive airway
disease).
-
if you have a particular type

Summary of Product characteristics

Health Products Regulatory Authority
01 April 2022
CRN00CRTS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Labetalol 5 mg/ml solution for injection/ infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 5 mg of labetalol hydrochloride.
Excipient with known effect: 1 ml contains 49.5 mg Glucose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
A clear, colourless solution in a clear glass ampoule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Severe hypertension including severe hypertension of pregnancy, when
rapid control of the blood pressure is essential
- May be used to achieve a controlled hypotension during anaesthesia
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Labetalol injection is intended for I.V. use in hospitalised patients.
POPULATIONS
ADULTS:
INDICATION
DOSAGE
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 (during 1 minute) and, if
necessary, be repeated at 5-minute 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 should be used, i.e. the contents
of two 20 ml ampoules (200 mg) diluted to 200 ml with the
compatible I.V. infusion fluids indicated in section 6.6.
The infusion rate will normally be about 160 mg/h but may be
adjusted accorded to the response at the discretion of the
physician. The effective dose is usually 50 to 200 mg, but the
infusion should be continued until a satisfactory response is
obtained and larger doses may be needed, especially in patients
with phaeochromocytoma.
Health Products Regulatory Authority
01 April 2022
CRN00CRTS
Page 2 of 9
In case of severe hypertension of pregnancy, a slower and
increasing rate of infusion should be used. In