AMINOPHYLLINE INJECTION BP 250MG/10ML

Active substance: THEOPHYLLINE

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Transcript
1. What Aminophylline Injection is and what it is
used for

• oxpentifylline (a medicine used to treat a disease of the
blood vessels usually affecting the legs, known as peripheral
vascular disease.)
• other medicines used to treat breathing difficulties
(xanthines leukotriene antagonists, beta-adrenergic receptor
agonists and corticosteroids) e.g. doxapram
• disulfiram (a medicine used to treat alcoholism)
• the flu vaccine
• anticonvulants (medicines used to stop fits) e.g.
carbamazepine, phenytoin, phenobarbitone and primidone
• ritonavir (a medicine used to treat HIV)
• aminoglutethimide (a medicine used to treat cancer and
Cushing’s disease)
• medicines that make you sleep (barbiturates)
• medicines that make you pass more urine than usual
(diuretics)
• beta-blockers (medicines used to treat high blood pressure)
e.g. propanolol
• steroids such as the adrenocorticoids glucocorticoids and
mineralocorticoids
• lithium (a medicine used to treat a type of depression)
• anaesthetics e.g. halothane and ketamine
• benzodiazepines (a type of medicine used to help you relax
and to sleep).
If you smoke you should tell your doctor before being given
Aminophylline Injection as tobacco can affect the way in which
this medicine works.

Aminophylline is one of a group of medicines that widens the
tubes that allow air to get to the lungs.

If you have any doubts about whether this medicine should be
administered to you, consult your doctor or nurse.

Aminophylline Injection is used to treat wheezing and difficulty
breathing (reversible airways obstruction) and to treat an asthma
attack that is not able to be helped by standard asthma
medication (e.g. inhalers)

Pregnancy and breast-feeding
If you are pregnant or are breast-feeding, your doctor will advise
you whether you can be given Aminophylline Injection.

PACKAGE LEAFLET: INFORMATION FOR THE USER

C91235

Aminophylline Injection BP 250mg in 10ml
Theophylline
Ethylene Diamine
Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
nurse.
• If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
nurse.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Aminophylline Injection is and what it is used for
Before you are given Aminophylline Injection
How Aminophylline Injection will be given
Possible side effects
How to store Aminophylline Injection
Further information

2. Before you are given Aminophylline Injection
You should not be given Aminophylline Injection if you:
• are allergic (hypersensitive) to Theophylline or Ethylene
Diamine, or to any of the other ingredients listed in section 6
of this leaflet.
• suffer from a blood disorder known as acute porphyria
• have been given ephedrine.
Take special care with Aminophylline Injection if you:
• have a stomach ulcer
• suffer from thyroid problems
• have high blood pressure
• suffer from liver problems
• have an irregular heart beat or other heart problems
• suffer from epilepsy (fits)
• have fluid on the lungs or other lung problems
• have a fever
• have low levels of oxygen in your body (hypoxia)
• are suffering from a viral infection
• are a smoker
• suffer from alcoholism
• are taking St Johns Wort.
If any of the above applies to you please tell your doctor before
you are given Aminophylline Injection.

Driving and using machines
There are no known effects of using Aminophylline Injection on
driving or using machines.

3. How Aminophylline Injection is given
Your doctor will give you Aminophylline Injection into the vein
(intravenous) either by injection or infusion (drip).
Adults and the elderly
Your doctor will give you 250- 500 mg ( 5 mg per kilogram of
bodyweight ) given over a 20 minute period by slow intravenous
injection, followed by 500 micrograms per kilogram of
bodyweight every hour by intravenous infusion.
Children (6 months to 16 years)
5 mg per kilogram of bodyweight given over a 20 minute period
by slow intravenous infusion followed by a further intravenous
infusion of 1mg per kilogram of bodyweight per hour if they are
between the ages of 6 months and 9 years, or 800 micrograms
per kilogram of bodyweight per hour if they are between the
ages of 10 and 16 years.
If you are given more Aminophylline than you should be
As this medicine will be given to you whilst you are in hospital, it
is unlikely that you will be given too little or too much, however,
tell your doctor or pharmacist if you have any concerns.

Taking other medicines
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.

4. Possible side effects

Medicines that may interact with Aminophylline Injection
include:
• medicines used to treat heartburn and stomach ulcers e.g.
nizatidine and cimetidine
• antibiotics (medicines used to treat bacterial infections) e.g.
ciprofloxacin, norfloxacin, clarithromycin, erythromycin, and
troleandomycin
• medicines used to treat tuberculosis (TB) e.g. isoniazid and
rifampicin
• antifungals (medicines used to treat fungal infections) e.g.
fluconazole and ketoconazole
• viloxazine and fluvoxamine (medicines used to treat
depression)
• combined oral contraceptives (birth control) and oestrogens
• carbimazole (a medicine used to treat thyroid problems)
• thiabendazole (a medicine to treat worm infections)
• calcium channel blockers (medicines used to treat high
blood pressure) e.g. diltiazem and verapamil
• anti-arrhythemics (medicines used to stabilise the heart
beat) e.g. mexiletine and propafenone
• medicines used to treat gout e.g allopurinol and
sulfinpyrazone
• pain killers e.g. aspirin and ibuprofen
• cytotoxics (medicines used to treat cancer) e.g.
methotrexate, and interferon alfa (a medicine used to
prevent tumours or viruses)

If you experience any of the following side effects you should tell
your doctor immediately. These are symptoms of an allergic
reaction.
• difficulty in breathing with or without swelling of the face,
lips, tongue and/or throat
• swelling of the face, lips tongue and/or throat, which may
cause difficulty in swallowing
• severe itching of the skin (with raised lumps).

Like all medicines, Amionophylline Injection can cause side
effects, although not everybody gets them.

Other possible side effects include:
• feeling sick
• stomach pain
• a fast or irregular heart beat
• low blood pressure
• difficulty sleeping
• flushing
• feeling dizzy
• feeling worried or restless
• headache
• fits
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 nurse.

Continued overleaf

5. How to store Aminophylline Injection
Keep out of the reach and sight of children.
This medicine should not be used after the expiry date which is
printed on the label. Your doctor or nurse will check that the
expiry date on the label has not been passed before giving you
Aminophylline Injection. The expiry date refers to the last day of
the month.
Store protected from light

6. Further Information
What Aminophylline Injection contains
The active substances are Theophylline BP 2.11% w/v and
Ethylene Diamine, Anhydrous BP 0.523% w/v.
The other ingredient is water for injections.
What Aminophylline Injection looks like and contents of the
pack
Aminophylline is a clear, colourless solution supplied in glass
ampoules. Each ampoule contains 10ml of the solution.
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals
Bampton Road
Romford, RM3 8UG
United Kingdom

C91235

Date of last revision: July 2008
PL 01883/6167R

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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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