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TRANDATE 5MG/ML SOLUTION FOR INJECTION

Active substance(s): LABETALOL HYDROCHLORIDE / LABETALOL HYDROCHLORIDE / LABETALOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Trandate 5mg/ml Solution for Injection
Labetalol hydrochloride
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 Trandate 5mg/ml Solution for Injection will be called Trandate Injection.
In this leaflet:
1. What Trandate Injection is for
2. Before you are given Trandate Injection
3. How you will be given Trandate Injection
4. Possible side effects
5. How to store Trandate Injection
6. Further information

1. What Trandate Injection is for
Trandate Injection belongs to a group of medicines called beta blockers.
Trandate Injection works by causing the heart to beat more slowly and with less force. It also
widens the arteries 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 a person’s blood pressure. Trandate
Injection is given in hospital and can be used to:
• lower very high blood pressure, especially in pregnant women;
• 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.
2. Before you are given Trandate Injection
Do not use Trandate Injection if:
• you are allergic to labetalol hydrochloride;
• you are allergic to any of the other ingredients of Trandate 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 of blood to the body’s tissues;
• you have a problem that is common in the elderly, related to poor control of the working of
your heart (sick sinus syndrome);
• you suffer from angina (chest pains) when at rest;
• you suffer from wheezing, obstructive airways disease or asthma – taking Trandate can
make your breathing worse;

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you have a tumour near your kidneys (phaeochromocytoma);
you have increased acid levels in the blood (metabolic acidosis);
you have a weak heart or a very slow heartbeat (less than 45 or 50 beats per minute);
you have low blood pressure (hypotension);
you have liver disease or your liver was affected when taking labetalol in the past;
you have very bad circulation, especially in your hands and feet.

This medicine is not suitable for children.
If any of the above applies to you, talk to your doctor.
Check with your doctor before you are given Trandate Injection if:
• you are about to receive an anaesthetic: as Trandate 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.
• Hormones such as oestrogen and progesterone used as contraceptives or for hormone
replacement therapy.
• Any other medicine, including medicines obtained without a prescription.
Taking Trandate 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 Trandate. If you need to have a
blood or urine test, tell your doctor that you have been given Trandate Injection.

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Pregnancy and breast-feeding
Trandate 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.
Trandate Injection is not recommended whilst breast-feeding.
Driving and using machines
You may feel dizzy or tired when taking Trandate Injection. If this happens to you, do not
drive or operate machinery.
Important information about some of the other ingredients in Trandate Injection
This medicinal product contains less than 1mmol (23mg) of sodium (salt) per 20ml vial, i.e.
essentially sodium (salt) free.
3. How you will be given Trandate Injection
Trandate 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 Trandate Injection will be given to you and the correct
dose for you.
Remember: You should only be given this drug if you are lying down.
You should avoid sitting upright for three hours after being given Trandate Injection as you
may feel very dizzy and lightheaded.
While you are having Trandate 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 Trandate 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 Trandate 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 Trandate 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.

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2. To lower high blood pressure after a heart attack
• 15mg of Trandate Injection will be given over one hour.
• The dose may then be gradually increased up to a maximum of 120mg per hour if
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needed.
To lower high blood pressure for other reasons
• 2mg of Trandate 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 Trandate 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 Trandate Injection your doctor may suggest you take Trandate 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
Trandate 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:
Trandate Injection is not recommended for use in children.
If you are given more Trandate Injection than you should
If you think you may have been given too much Trandate Injection, tell your doctor
immediately.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects
Like all medicines Trandate Injection can cause side effects, although not everybody gets them.
Remember:
You should avoid sitting upright for three hours after being given Trandate Injection as
you may feel very dizzy and lightheaded.

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Stop using Trandate 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 Trandate 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 trandate 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

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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 Trandate Injection
Keep out of the sight and reach of children.
Do not use Trandate 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.
6. Further information
What Trandate 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.
What Trandate Injection looks like
Trandate 5mg/ml Solution for Injection is a clear colourless solution.
Trandate Injection comes in 20ml glass ampoules, with five ampoules in each pack.

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Marketing Authorisation Holder
RPH Pharmaceuticals AB
Lagervägen 7
136 50 Jordbro
Sweden
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 May 2017.
<-------------------------------------------------------------------------------------------------------->
Technical Leaflet intended for healthcare professionals only
TRANDATE 5MG/ML SOLUTION FOR INJECTION

GENERAL INFORMATION
Trandate 5mg/ml Solution for Injection is for single use only. Once opened, the product should
be used immediately. Discard any unused material.

THERAPEUTIC INDICATIONS
Trandate 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:
Trandate Injection is intended for intravenous use in hospitalised patients. The plasma
concentrations achieved after intravenous dose of Trandate 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 Trandate
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 Trandate 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

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bolus injection, the 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 Trandate 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 Trandate. 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 Trandate 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. 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 Trandate
tablets should be instituted with a starting dose of one 100mg tablet twice daily (see Trandate
tablet SmPC for further details). Trandate 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 Trandate Injection is 10-20mg intravenously
depending on the age and condition of the patient. Patients for whom halothane is contraindicated usually require a higher initial dose of Trandate (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 Trandate act synergistically therefore the halothane concentration should not
exceed 1-1.5% as profound falls in blood pressure may be precipitated.

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Following Trandate 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 Trandate is fifty minutes.
Hypotension induced by Trandate 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 Trandate Injection and/or halothane.

Children:
Safety and efficacy have not been established.
INCOMPATIBILITIES
Trandate Injection has been shown to be incompatible with sodium bicarbonate injection BP
4.2% w/v.
STORAGE AND DISPOSAL OF TRANDATE 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.

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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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