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LABETALOL HYDROCHLORIDE 5MG/ML SOLUTION FOR INJECTION

Active substance(s): LABETALOL HYDROCHLORIDE

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4. Possible side effects

Like all medicines Labetalol Injection can cause side
effects, although not everybody gets them.
Remember:
You should avoid sitting upright for three hours after
being given Labetalol Injection as you may feel very
dizzy and lightheaded.
Stop using Labetalol Injection and seek immediate
medical help if you have an allergic reaction. This
includes any of the following symptoms:
• Difficulty in breathing
• Swelling of your eyelids, face or lips
• Rash or itching
Most of the side effects related to Labetalol Injection will
wear off after the first few weeks. These include:
• headaches, tiredness or dizziness
• depression or exhaustion (lethargy)
• tingling of the scalp, or a blocked nose
• swollen ankles or sweating
• difficulty passing urine or not being able to pass urine
• not being able to ejaculate
• stomach pain, feeling sick or being sick
If any of these side effects occur, speak to your doctor
immediately:
• problems with the immune system (e.g. systemic lupus
erythematosus) causing shortness of breath, joint pain,
or a rash on the cheeks and arms that worsen with sun
exposure
• thrombocytopenia causing nosebleeds or bleeding in
the mouth or bruising because your blood does not
clot as it should
• drug fever making you feel hot and flu-like
• muscle disease (toxic myopathy) causing weakness
and wasting of the muscles in the arms and legs
• flat topped bumps on your skin that join up into scaly
patches (lichenoid rash)

• blurred vision or dry eyes
• cramps
• liver problems or jaundice causing discomfort and
tenderness in the upper abdomen, yellowing of the
skin and whites of the eyes
• slowing of the heart and heart block (where the heart
signals are delayed causing your heartbeat to slow to
20-40 beats per minute)
• cough or breathing problems that may indicate
inflammation of the lungs (interstitial lung disease)
Other side effects that may occur include:
• the shakes after taking labetalol when pregnant
• dizziness when standing up (when taken at very high
doses)
• low blood pressure (hypotension)
• poor circulation in the hands, cold or blue extremities,
numbness or tingling of the extremities
• increase of existing leg pain on walking
• mental disturbances such as delusions and altered thought
patterns, hallucinations or confusion
• sleep disturbances including nightmares
• diarrhoea
• wheezing or shortness of breath (in patients with
asthma)
• the symptoms of an overactive thyroid (increased
heart rate) or low blood sugar (as seen in blood test
results) may be hidden
• high blood potassium levels (hyperkalaemia)
especially if you have reduced kidney function
• hair loss; this may grow back after stopping treatment
• worsening of psoriasis
• heart failure causing shortness of breath with swelling
of the feet and ankles
Rare side effects on your baby
If you are being treated for high blood pressure during
pregnancy, your baby may suffer the following effects
for a few days after birth:
• low blood pressure
• slow heartbeat

• shallow or slow breathing
• low blood sugar
• feeling cold
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
Also you can help to make sure that medicines remain
as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.

5. How to store Labetalol Injection

Keep out of the sight and reach of children.
Do not use Labetalol Injection after the expiry date
which is stated on the carton and the ampoule label.
The expiry date refers to the last day of that month.
Store below 30°C.
Keep the ampoules in the original packaging in order to
protect from light.
For single use only. Once opened use immediately.
Discard any unused material.
Medicines should not be disposed of via wastewater or
household waste.
Return any medicine you no longer need to your
pharmacist.
Your doctor or nurse will make sure your medicine is
correctly stored and disposed of.

fax:
01283 495290

Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Unit 5, Faraday Court,
First Avenue, Centrum 100, Burton upon Trent,
Staffordshire, DE14 2WX, UK.
Tel: 01283 495 280
Fax: 01283 495 290
Email: medinfo@focuspharma.co.uk
Manufacturer
Recipharm Ltd, Vale of Bardsley, Ashton-under-Lyne,
OL7 9RR, UK.
For any information about this medicinal product,
please contact the Marketing
Authorisation Holder, details provided above.
This leaflet was last revised in 04/2013.

For information in large print, audio CD or Braille
please telephone 00 44 (0)1283 495 280 or
email medinfo@focuspharma.co.uk.

What Labetalol Injection contains
- The active ingredient is labetalol hydrochloride. Each
1ml of liquid contains 5mg of the active ingredient.
- The other ingredients are dilute hydrochloric acid
(E507), sodium hydroxide (E524), for pH adjustment,
and water for injections.

Approved
for
Print

Unit 5 Faraday Court, First Avenue, Centrum 100,
Burton upon Trent, Staffordshire DE14 2WX.

What Labetalol Injection looks like
Labetalol Hydrochloride 5mg/ml Solution for Injection is
a clear colourless solution.
Labetalol Injection comes in 20ml glass ampoules, with
five ampoules in each pack.

6. Further information

CLEARLY MARK ANY AMENDMENTS
AND RESUBMIT

tel:
01283 495280

pharmaceuticals ltd

Labetalol Injection is usually only given to patients in
hospital by a doctor or anaesthetist. It may be given as
an injection into a vein, or by a slow drip, depending on
how quickly your blood pressure needs to be reduced.
IMPORTANT: Your doctor will decide how the Labetalol
Injection will be given to you and the correct dose for
you.

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(continued overleaf)

maximum effect usually occurs within five minutes
and the effective duration of action is usually
about six hours but may be as long as eighteen
hours.
Intravenous infusion
An alternative method of administering labetalol is
intravenous infusion of a solution made by diluting
the contents of two ampoules (200mg) to 200ml
with Sodium Chloride and Dextrose Injection BP or
5% Dextrose Intravenous Infusion BP. The resultant
infusion solution contains 1mg/ml of labetalol
hydrochloride. It should be administered using a
paediatric giving set fitted with a 50ml graduated
burette to facilitate dosage.
In the hypertension of pregnancy:
The infusion can be started at the rate of 20mg per
hour and this dose may be doubled every thirty
minutes until a satisfactory reduction in blood
pressure has been obtained or a dosage of 160mg
per hour is reached.
Occasionally, higher doses may be necessary.
In hypertensive episodes following acute
myocardial infarction:
The infusion should be commenced at 15mg per
hour and gradually increased to a maximum of
120mg per hour depending on the control of blood
pressure.
In hypertension due to other causes:
The rate of infusion of labetalol hydrochloride
should be about 2mg (2ml 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 50-200mg depending
on the severity of the hypertension.
Children:
Safety and efficacy have not been established.
INCOMPATIBILITIES
Labetalol Injection has been shown to be
incompatible with sodium bicarbonate injection BP
4.2% w/v.
STORAGE AND DISPOSAL OF LABETALOL
HYDROCHLORIDE 5MG/ML SOLUTION FOR INJECTION
Protect from light. Store below 30°C.
For single use only. Discard any unused material.
Shelf life: Unopened: 24 months
Once opened, the product should be used
immediately.

3. To lower high blood pressure for other reasons
• 2mg of Labetalol Injection will be given per minute.
• When your blood pressure is low enough, the
doctor will stop your drip.
• Your doctor may change the rate at which the drip
goes in depending on how well you are responding
to the medicine.
• The total dose given is usually between 50mg and
200mg, but occasionally higher doses may be
needed.
To lower blood pressure during an operation
• Whilst you are under anaesthetic, 10-20mg Labetalol
Injection (depending on your age and health) will be
injected into your vein.
• If after five minutes your blood pressure has not been
reduced, a dose of 5-10mg can be given every five
minutes until your blood pressure is low enough.
Maintaining your blood pressure
• After you have had Labetalol Injection your doctor
may suggest you take labetalol tablets to keep your
blood pressure low.
• If this applies to you, your doctor or pharmacist will tell
you exactly how many tablets to take and when to
take them.
People with liver or kidney problems:
If you have problems with your liver or kidneys, your
doctor may give you a lower dose of Labetalol Injection.
The elderly (65 years and over):
Your doctor may start you on a lower dose than the
usual adult dose to make sure that the medicine is
working properly.
Children:
Labetalol Injection is not recommended for use in children.
If you are given more Labetalol Injection than you
should
If you think you may have been given too much
Labetalol Injection, tell your doctor immediately.
If you have any further questions about the use of this
medicine, ask your doctor.

3. How you will be given Labetalol Injection

Remember: You should only be given this drug if you are
lying down.
You should avoid sitting upright for three hours after
being given Labetalol Injection as you may feel very
dizzy and lightheaded.
While you are having Labetalol Injection your doctor
may check your heart rate, blood pressure and
breathing, to check your medicine is working properly.
Adults:
Injection into a vein (to reduce blood pressure very
quickly)
• A dose of 50mg of Labetalol Injection will be given into
your vein over a period of one minute.
• If necessary this dose can be repeated every five
minutes up to three times until your blood pressure has
been lowered.
• The total dose should not exceed 200mg.
Slow drip into a vein (to reduce blood pressure more
slowly)
• A solution containing 1mg/ml Labetalol Injection will be
made up by the doctor or nurse.
• The solution will then be given to you via a drip into
your vein.
• The amount of the solution you will be given will
depend on why your blood pressure needs to be
lowered:
1. To lower high blood pressure in pregnancy
• 20mg of Labetalol Injection will be given over one
hour.
• The dose may then be doubled every 30 minutes until
your blood pressure has been reduced or the dose has
reached 160mg per hour.
• Your doctor may occasionally need to use a higher
dose.
2. To lower high blood pressure after a heart attack
• 15mg of Labetalol Injection will be given over one
hour.
• The dose may then be gradually increased up to a
maximum of 120mg per hour if needed.
(continued overleaf)

GENERAL INFORMATION
Labetalol Hydrochloride 5mg/ml Solution for
Injection is for single use only. Once opened, the
product should be used immediately. Discard any
unused material.
THERAPEUTIC INDICATIONS
Labetalol Injection is indicated for the treatment of:
1. Severe hypertension, including severe
hypertension of pregnancy, when rapid control
of blood pressure is essential.
2. Anaesthesia when a hypotensive technique is
indicated.
3. Hypotensive episodes following acute
myocardial infarction.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
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.
Bolus injection
If it is essential to reduce blood pressure quickly, as
for example, in hypertensive encephalopathy, a
dose of 50mg of labetalol hydrochloride should be
given by intravenous injection over a period of at
least one minute. If necessary, doses of 50mg may
be repeated at five minute intervals until a
satisfactory response occurs. The total dose should
not exceed 200mg. After bolus injection, the

2. Before you are given Labetalol Injection

Do not use Labetalol Injection if:
• you are allergic to labetalol hydrochloride;
• you are allergic to any of the other ingredients of
Labetalol Injection (see section 6);
• your heart cannot maintain adequate circulation of
blood (cardiogenic shock);
• you have heart failure that is out of control or not
responding to treatment with digitalis;
• you have a heart defect that leads to a decreased
function of the heart (heart block);
• your heart has difficulty pumping the proper amount
In this leaflet:
of blood to the body’s tissues;
1. What Labetalol Injection is for
• you have a problem that is common in the elderly,
2. Before you are given Labetalol Injection
related to poor control of the working of your heart
3. How you will be given Labetalol Injection
(sick sinus syndrome);
4. Possible side effects
• you suffer from angina (chest pains) when at rest;
5. How to store Labetalol Injection
• you suffer from wheezing, obstructive airways disease or
6. Further information
asthma – taking labetalol can make your breathing worse;
• you
have
a
tumour
near
your
kidneys
(phaeochromocytoma);
1.What Labetalol Injection is for
• you have increased acid levels in the blood
Labetalol Injection belongs to a group of medicines
(metabolic acidosis);
called beta blockers.
• you have a weak heart or a very slow heartbeat (less
Labetalol Injection works by causing the heart to beat
than 45 or 50 beats per minute);
more slowly and with less force. It also widens the arteries • you have low blood pressure (hypotension);
in the body. This helps to lower the pressure of the blood as
it travels around the body. The result is a rapid lowering of • you have liver disease or your liver was affected when
taking labetalol in the past;
a person’s blood pressure.
• you have very bad circulation, especially in your
Labetalol Injection is given in hospital and can be used to:
hands and feet.
• lower very high blood pressure, especially in pregnant
This medicine is not suitable for children.
women;
If any of the above applies to you, talk to your doctor.
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• In this leaflet Labetalol Hydrochloride 5mg/ml Solution
for Injection will be called Labetalol Injection.

• Hormones such as oestrogen and progesterone used
as contraceptives or for hormone replacement
therapy.
• Any other medicine, including medicines obtained
without a prescription.
Taking Labetalol Injection, at the same time as the drugs
mentioned for treating your heart or blood pressure, can
lead to a severe drop in blood pressure, reduced heart
rate, heart failure or heart block. It is important to tell your
doctor if you are taking these or any of the other drugs
listed above.
The results of blood or urine tests may be affected by
taking labetalol. If you need to have a blood or urine test,
tell your doctor that you have been given Labetalol
Injection.
Pregnancy and breast-feeding
Labetalol Injection should only be used during the first
three months of pregnancy if it is absolutely necessary.
Therefore, tell your doctor if you are pregnant or trying to
become pregnant.
Labetalol Injection is not recommended whilst breastfeeding.
Driving and using machines
You may feel dizzy or tired when taking Labetalol
Injection. If this happens to you, do not drive or operate
machinery.
Important information about some of the other
ingredients in Labetalol Injection
This medicinal product contains less than 1mmol (23mg) of
sodium (salt) per 20ml vial, i.e. essentially sodium (salt) free.

Following Labetalol Injection the blood pressure
can be quickly and easily adjusted by altering the
halothane concentration and/or adjusting table
tilt.
The mean duration of hypotension following
20-25mg of labetalol hydrochloride is fifty minutes.
Hypotension induced by Labetalol Injection is
readily reversed by atropine 0.6mg and
discontinuation of halothane.
Tubocurarine and pancuronium may be used
when assisted or controlled ventilation is required.
Intermittent Positive Pressure Ventilation (IPPV) may
further increase the hypotension resulting from
Labetalol Injection and/or halothane.

BACK

FRONT

Labetalol Hydrochloride 5mg/ml Solution
for Injection

Check with your doctor before you are given Labetalol
Injection if:
• you are about to receive an anaesthetic: as labetalol
may mask the effects of a sudden loss of blood;
• you suffer or have suffered from any serious allergic
reactions in the past;
• you have ever suffered from a skin condition called
psoriasis;
• you have kidney or liver problems;
• you are receiving a procedure called MIBG scintigraphy
(often used to detect certain tumours);
• you are elderly (65 years and over).
Tell your doctor if you are taking any of the following
medicines:
• Medicines used to treat your heart or blood pressure
(such as digitalis, clonidine, hydralazine, disopyramide,
quinidine, amiodarone or calcium antagonists such as
verapamil, diltiazem, nifedipine, ACE inhibitors,
angiotensin-II antagonists, xamoterol).
• Medicines to treat depression (such as monoamine oxidase
inhibitors or tricyclic antidepressants).
• Anxiolytic and hypnotic medicines for anxiety and
sedation.
• NSAIDs, corticosteroids or other medicines to treat
pain or inflammatory conditions.
• Cimetidine used to treat stomach ulcers.
• Insulin or oral anti-diabetic drugs.
• Anaesthetic
drugs
(such
as
cyclopropane,
trichloroethylene, alcohol, barbiturates).
• Phenothiazines such as chlorpromazine.
• Antimalarial medicines such as halofantrine,
mefloquine or quinine.
• Medicines for stimulating the heart e.g. adrenaline.
• Ergot derivatives used to treat Parkinson’s disease.
• Tropisetron used to treat nausea.
• Alprostadil and moxisylyte to treat impotence.
• Aldesleukin for the treatment of secondary cancer of
the kidney.

For most patients it is unnecessary to administer
more than 200mg 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 1-2mg 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 100mg 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.
In hypotensive anaesthesia:
Induction should be with standard agents (e.g.
sodium thiopentone) and anaesthesia maintained
with nitrous oxide and oxygen with or without
halothane. The recommended starting dose of
Labetalol Injection is 10-20mg intravenously
depending on the age and condition of the
patient.
Patients for whom halothane is
contra-indicated usually require a higher initial
dose of labetalol hydrochloride (25-30mg). 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.
Halothane and labetalol act synergistically
therefore the halothane concentration should not
exceed 1-1.5% as profound falls in blood pressure
may be precipitated.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

• keep your blood pressure down during an operation;
• lower high blood pressure after a heart attack.
It is very important that the doctor treats your high blood
pressure, because left untreated it can cause damage
to your blood vessels in the long-term. This could lead to
heart attacks, kidney failure, stroke or blindness.

Technical Leaflet intended for healthcare professionals only
LABETALOL HYDROCHLORIDE 5MG/ML SOLUTION FOR INJECTION

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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