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DOXAPRAM HYDROCHLORIDE 20MG/ML SOLUTION FOR INJECTION

Active substance(s): DOXAPRAM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Dopram® Injection
Doxapram Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE AS IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects talk to your doctor or nurse. This includes any possible side effects not
listed on this leaflet. See section 4.
What is in this leaflet:
1. What Dopram Injection is and what it is used for
2. What you need to know before you are given Dopram Injection
3. How Dopram Injection is given to you
4. Possible side effects
5. How to store Dopram Injection
6. Contents of the pack and other information
1. WHAT DOPRAM INJECTION IS AND WHAT IT IS USED FOR
Dopram Injection is contains the active substance doxapram hydrochloride. It is used to help you
breathe after you have been given an anaesthetic, when your breathing may not be as good as it should
be. Also some pain-killers used in anaesthesia have the side effect of decreasing your breathing and
Dopram Injection can prevent this problem. Your doctor can also use Dopram Injection to speed up
your recovery after an anaesthetic and also from associated sleepiness.
Dopram Injection works by increasing the amount of air that goes in and out of your lungs and
increases your rate of breathing.
Dopram Injection is therefore useful in conditions where breathing properly may be difficult.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOPRAM INJECTION
You should not be given Dopram Injection:
• if you know that you are allergic to Doxapram Hydrochloride or any of the other ingredients
of Dopram Injection
• if you have very high blood pressure
• if you are suffering from sudden, severe wheezing
• if you have heart disease
• if you suffer from epilepsy or a similar condition involving fits or convulsions
• if you have what is called cerebral oedema, where there is build up of fluid in the brain
• if you have suffered from a stroke
• if you suffer from the condition known as hyperthyroidism/ thyrotoxicosis. (when you have an
overactive thyroid gland and your body produces too much of the hormone thyroxine)
• if the airways in your lungs or the muscles in the chest wall that you use to breathe are severely
blocked in any way
• if you have an injury to the head
• if you suffer from a blood clot in the lung (pulmonary embolism).
Make sure your doctor knows if you suffer from any of the above.

Warnings and precautions
Talk to your doctor or nurse before you are given Dopram Injection:
• If you are wheezing or have problems with your breathing, your doctor will probably give you
another drug or oxygen to control this while you are taking Dopram Injection
• If you suffer from any liver problems
• You have been under anaesthetic, the type of anaesthetic used will affect the way your doctor gives
you Dopram Injection. Your doctor will monitor you closely after having an anaesthetic, as the effects
of other drugs used during an operation must be considered when Dopram Injection is being given
• If you have a tumour of the adrenal glands called a phaeochromocytoma
• If you have high blood pressure.
Tell your doctor if any of these apply to you.
Other medicines and Dopram Injection
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This includes medicines obtained without a prescription. This is extremely important
because some medicines can strengthen or weaken the effects of others.
In particular, tell your doctor if you are taking any of the following as it may alter their effect:
• Drugs that stimulate certain nerves known as sympathomimetics. These are often used in the
treatment of asthma, eg salbutamol and terbutaline
• A Monoamine oxidase inhibitor (MAOI) which is a drug used to treat depression (eg. phenelzine,
tranylcypromine)
• Certain anaesthetics such as halothane, cyclopropane and enflurane
• A drug called aminophylline/theophylline which may be used in the treatment of asthma
• Curare type muscle relaxant drugs (which decrease the muscle tone).
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before you are given this medicine.. This may affect their
decision about whether to give you Dopram® Injection or not.
3. HOW DOPRAM INJECTION IS GIVEN TO YOU
Your doctor will give you Dopram Injection by injecting it into one of your veins. The amount you
are given will depend on your condition and on how well you are responding to the medicine.
Adults and the elderly:
Normally you will be given between 1.0 and 1.5 mg of this medicine for each kilogram that you
weigh (e.g. if you weigh 70 kilograms you will probably receive between 70mg and 105mg of this
medicine). This dose may be repeated hourly if necessary.
Use in children and adolescents:
Dopram® Injection is not recommended for use in children.
If you are given more Dopram Injection than you should.
If your doctor accidentally gives you too much of this medicine you may feel the following:

your heartbeat becomes irregular, you develop some shortness of breath and your muscle movements
become more difficult. Tell your doctor immediately if you feel any of these symptoms.
If you have any further questions on the use of this medicine ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side-effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body) should be reported to a doctor immediately.
If you develop sudden and severe increase in blood pressure or difficulty in breathing your doctor will
stop Dopram Injection.
The following side effects have also been reported:

Not known (frequency cannot be estimated from available data)
• feeling feverish, flushed and possibly sweating
• coughing
•shortness of breath
• tightening of the chest and throat
• increased blood pressure
• quicker or slower heartbeat than usual
• warmth at the base of the tummy
•muscle twitches
• chest pain or chest tightness
•salivation
• increased muscle tone/stiffness (Muscle spasticity)
• reflex of toe in response to foot stroke (bilateral
Babinski)
• weakness in the limbs, slurred speech or visual
disturbances which may be caused by reduced
blood supply to the brain
• premature contraction of heart (extrasystoles)

• fits
• headache
• dizziness
• feeling hyperactive
• feeling confused
• having hallucinations (see, hear,
smell, taste, or feel something that is
not there)
• nausea (feeling sick) and vomiting
(being sick)
• series of involuntary muscular
contractions (Clonus)
• increased reflexes in brain function
(increased deep tendon reflexes)
• irregular heart beat
• inability to pass urine or sudden
passing of urine.

Children, Infants and premature newborns:
Although Dopram is not recommended for use in children, its use in children is known to cause the
following side effects:
• Prolonged use of Dopram in premature infants may cause slow development of some parts of the
brain
• Dopram use in premature infants may cause heart related problems including irregular or slow
heartbeats
• Bleeding in stools, painful swelling of the stomach, death of tissue in portions of the bowel, multiple
perforations of the wall of the stomach
• Early teeth eruption.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. HOW TO STORE DOPRAM INJECTION
Your doctor, pharmacist or nurse will know how to store Dopram Injection properly.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and ampoule label after
‘Exp’. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate.
Once opened use immediately.
For single use only. Discard any unused contents.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The active substance is Doxapram hydrochloride. There is 100mg of Doxapram hydrochloride in 5ml
of the injection (20mg in each ml of the injection).
The other ingredient is Water for Injections.
What Dopram Injection looks like and contents of pack
The name of your medicine is Dopram Injection and is supplied in glass ampoules packed in a
cardboard carton.
Each ampoule contains 5ml of a clear colourless sterile solution for injection.
Five ampoules are supplied in a carton.
Marketing authorisation holder
MercuryPharm Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.
Manufacturer
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was revised in September 2016
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only.
Incompatibilities:
Dopram Injection is incompatible with alkaline solutions such as aminophylline, furosemide and
thiopental sodium.
Mercurypharm is licensed to use the registered trademark Dopram.

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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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