Trandate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Labetalol hydrochloride 5 mg/mL;  ;  ;  

Available from:

Viatris Limited

INN (International Name):

Labetalol hydrochloride 5 mg/mL

Dosage:

5 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Labetalol hydrochloride 5 mg/mL       Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Units in package:

Ampoule, glass, 5 x 20ml, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Teva Pharmaceutical Fine Chemicals SrL

Therapeutic indications:

-Hypertensive episodes following acute myocardial infarction. -Severe hypertension when rapid control of blood pressure is essential.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 20ml - 5 dose units - 24 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1977-09-15

Patient Information leaflet

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
TRANDATE
®
_LABETALOL SOLUTION FOR INJECTION 5 MG/ML_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given TRANDATE.
This leaflet answers some common
questions about TRANDATE.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of giving you TRANDATE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT TRANDATE IS
USED FOR
TRANDATE is used to
Rapidly lower very high blood
pressure (called severe
hypertension)
Lower blood pressure during an
operation requiring certain types of
anaesthetics (medicines that put
you to sleep during an operation)
Quickly lower high blood pressure, if
necessary, after a heart attack
TRANDATE contains the active
ingredient labetalol_._ It belongs to a
group of medicines called
antihypertensives. Within this group
it belongs to a class called beta-
blockers.
It works to decrease high blood
pressure by reducing the rate and
force of the heartbeat and by
widening the arteries and allowing
the blood to flow more easily.
Blood pressure is a measurement of
the force exerted by the blood
circulating in your arteries. It is
shown as two values. The first
measures blood pressure while the
heart muscle is contracting to
squeeze out blood (systolic
pressure). This is the higher figure.
The second measures blood
pressure when the heart muscle
relaxes between contractions
(diastolic pressure). This is the
lower figure.
Blood pressure varies from one
person to the next, but usually
increases as we get older. If you
have blood pressure which is higher
than normal when measured on
three separate occasions, your
doctor may diagnose hypertension.
High blood pressure does not
necessarily cause symptoms.
However,

Summary of Product characteristics

Page 1 of 8
NEW ZEALAND DATA SHEET
TRANDATE
®
1. PRODUCT NAME
Trandate, 5 mg/mL, solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 100 mg of labetalol hydrochloride
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection. 20 mL glass ampoules each containing 100 mg (5
mg/mL) labetalol
hydrochloride in an aqueous colourless solution.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Severe hypertension when rapid control of blood pressure is essential.
Anaesthesia when a hypotensive technique is indicated.
Hypertensive episodes following acute myocardial infarction.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
TRANDATE Injection is intended for intravenous use in hospitalised
patients.
Patients should always receive the medicine whilst in the supine or
left lateral position.
Raising
the
patient
into
the
upright
position
within
three
hours
of
intravenous
TRANDATE
administration should be avoided since excessive postural hypotension
may occur.
For instructions on the dilution of this medicine before
administration, see section 6.6.
ADULTS
_BOLUS INJECTION_
If it is essential to reduce the blood pressure quickly a dose of 50
mg should be given by intravenous
injection (over a period of at least one minute) and, if necessary,
repeated at five minute intervals
until a satisfactory response occurs. The total dose should not exceed
200 mg. The maximum effect
usually occurs within 5 minutes and the duration of action is usually
about 6 hours but may be as
long as 18 hours.
Page 2 of 8
_INTRAVENOUS INFUSION _
A 1 mg/mL solution of TRANDATE should be used, i.e. the contents of
two ampoules (200 mg)
diluted to 200 mL with Sodium Chloride and Dextrose Injection BP or 5%
Dextrose Intravenous
Infusion BP.
Hypertension in pregnancy - Infusion should be started at 20 mg/hour,
then doubled every
30 minutes until a satisfactory response is obtained or a dosage of
160 mg/hour is reached.
Occasionally higher doses may be necessary.
Hypertensive episo