LABETALOL SXP labetalol hydrochloride 50 mg/10 mL solution for injection glass ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

labetalol hydrochloride, Quantity: 50 mg

Available from:

Southern XP IP Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

10 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The emergency treatment of severe hypertension when prompt and urgent reduction of blood pressure is essential

Product summary:

Visual Identification: Labetalol HCl solution for injection 50 mg/10 mL, is a clear colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-11-14

Patient Information leaflet

LABETALOL SXP
1
LABETALOL SXP
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN LABETALOL SXP?
LABETALOL SXP contains the active ingredient labetalol hydrochloride.
LABETALOL SXP is used to quickly decrease high blood pressure.
For more information, see Section 1. Why am I being given LABETALOL
SXP?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN LABETALOL SXP?
You should not be given LABETALOL SXP if you have ever had an allergic
reaction to labetalol hydrochloride or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given LABETALOL SXP?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LABETALOL SXP and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW AM I GIVEN LABETALOL SXP?
•
Your doctor will calculate your dose,
depending why your
blood pressure needs to be lowered, your age
and how quickly
this needs to
happen.
•
LABETALOL SXP is usually only given in hospital as either an injection
into a vein or by a slow drip, by a doctor
or nurse while
you are lying down.
More instructions can be found in Section 4. How am I given LABETALOL
SXP?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN LABETALOL SXP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist that you visit that you have
been given LABETALOL SXP.
• Remind you doctor if you are breastfeeding or pregnant while being
given LABETALOL SXP.
• If you feel light headed or dizzy after receiving LABETALOL SXP,
tell your doctor immediately.
•
Tell your doctor if you have any other medical conditions.
•
If you are having surgery, remind your

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
LABETALOL SXP (LABETALOL HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Labetalol Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Labetalol hydrochloride solution for injection contains 50 mg of
labetalol hydrochloride in 10 mL of
solution.
For the full list of excipients, see section 6.1 List of Excipients.
The solution is preservative-free.
3
PHARMACEUTICAL FORM
Clear, colourless sterile solution for injection intended for
parenteral intravenous administration
presented in 10.8 mL clear, type 1 glass ampoules
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The emergency treatment of severe hypertension when prompt and urgent
reduction of blood
pressure is essential
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults
Labetalol hydrochloride solution for injection is intended for IV use
in hospitalised patients.

Dosage must be individualised depending on the severity of
hypertension and the response
of the patient during dosing

Blood pressure should be monitored during and after the completion of
labetalol treatment.

Patients should always be kept supine during the period of IV drug
administration. A
substantial drop in blood pressure on standing should be expected in
these patients. The
patient’s ability to tolerate an upright position on standing should
be established before
permitting any ambulation.
Bolus dosing
Initial treatment should be by slow IV bolus injection over about 2
minutes, commencing with a
20 mg dose. Blood pressure should be closely monitored and, if
necessary, an additional 40 mg slow
bolus dose should be given 10-20 minutes after the initial dose. Up to
a further 3 x 80 mg slow bolus
doses may be given at 10-20 minute intervals if required to adequately
control blood pressure. The
maximum total dose given should not exceed 300 mg over a 24-hour
period.
2
Intravenous infusion
If bolus treatment is unsuccessful in reducing blood pressure,
patients can be commenced on an IV
infusion of labetalol. A 1 mg/mL infusion should be prepared by
dilution wit