Aminophylline Hydrate 25mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMINOPHYLLINE HYDRATE

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

R03DA; R03DA05

INN (International Name):

AMINOPHYLLINE HYDRATE

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Xanthines; aminophylline

Authorization status:

Marketed

Authorization date:

1988-09-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMINOPHYLLINE HYDRATE 25MG/ML SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Aminophylline Hydrate 25mg/ml Solution
for injection. It will be
referred to as Aminophylline Injection for ease here after.
WHAT IS IN THIS LEAFLET
1.
What Aminophylline Injection is and what it is used for
2.
What you need to know before you are given Aminophylline Injection
3.
How Aminophylline Injection is given to you
4.
Possible side effects
5.
How to store Aminophylline Injection
6.
Contents of the pack and other information
1.
WHAT AMINOPHYLLINE INJECTION IS AND WHAT IT IS USED FOR
Aminophylline belongs to a group of medicines called xanthines. It
expands the
air passages of the lungs, which helps relieve chest tightness and
wheezing
(bronchospasm).
This medicine may be used to relieve difficulty in breathing due to
asthma and
long term obstruction to the flow of air in the lungs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMINOPHYLLINE INJECTION
YOU SHOULD NOT BE GIVEN AMINOPHYLLINE INJECTION:

If you are allergic to Aminophylline hydrate or any of the other
ingredients of this
medicine (listed in section 6).

If you are allergic to Xanthine containing medicines

If you are sensitive or allergic to ethylenediamine, theophylline,
caffeine or
theobromine

If you are suffering from porphyria (a condition that affects your
blood).
Speak to your doctor if this applies to you before you are given
Aminophylline Injection.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before you are given
Aminophylline Injection:

If you are elderly

If you have a

Summary of Product characteristics

Health Products Regulatory Authority
21 October 2020
CRN009Y09
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aminophylline Hydrate 25mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10ml of solution contains 250mg of Aminophylline Hydrate
equivalent to 239.73mg of Aminophylline.
Each 1ml of solution contains 25mg Aminophylline Hydrate equivalent to
23.973 mg of Aminophylline.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of bronchospasm, e.g. in asthma, chronic bronchitis
and emphysema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Therapeutic plasma concentrations of theophylline should be maintained
in the range of 10 to 20mcg/ml and levels above
20mcg/ml are more likely to be associated with toxic effects. There is
a marked interpatient variation in the dosage required to
achieve plasma levels of theophylline that are within the desired
therapeutic range.
During therapy, patients should be monitored carefully for signs of
toxicity (see Section 4.4, Special warnings and precautions
for use).
Loading Dose:
Adults:
FOR PATIENTS NOT CURRENTLY RECEIVING XANTHINE THERAPY an initial dose
of 6mg aminophylline/kg should be given at a
rate not exceeding 25mg/minute (containing 20mg/minute theophylline).
Loading doses are usually given over 20 to 30
minutes.
FOR PATIENTS ALREADY RECEIVING XANTHINE THERAPY THE LOADING DOSE MUST
BE REDUCED TO AVOID OVERDOSAGE.
Ideally, the serum theophylline concentration should obtained and a
loading dose given based on the principle that each
0.5mg/kg administered will result in a 1mcg/ml increase in the serum
concentration of theophylline. Where the serum level
cannot be determined and there is urgent clinical need, 3.1mg
aminophylline/kg (2.5mg theophylline/kg) should be given
slowly: this will increase the serum level by about 5mcg/ml. For
optimum therapeutic effect and to av