Atropine Sulphate 600 micrograms/ml Solution for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATROPINE SULFATE

Available from:

Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATC code:

A03BA01

INN (International Name):

ATROPINE SULFATE 600 µg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ATROPINE SULFATE 600 µg/ml

Prescription type:

POM

Therapeutic area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Authorization status:

Withdrawn

Authorization date:

2006-08-31

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, nurse or
pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Atropine Sulphate 600 micrograms/ml
Solution for Injection.
It will be referred to as Atropine Sulphate Injection for ease
hereafter.
WHAT IS IN THIS LEAFLET:
1. What Atropine Sulphate Injection is and what it is used for
2. What you need to know before you are given Atropine Sulphate
Injection
3. How you are given Atropine Sulphate Injection
4. Possible side effects
5. How to store Atropine Sulphate Injection
6. Contents of the pack and other information
1. WHAT ATROPINE SULPHATE INJECTION IS AND WHAT IT IS USED FOR
Atropine Sulphate Injection contains the active substance Atropine
Sulphate which belongs
to a group of medicines called cholinesterase inhibitors. It has the
effect of reversing the
action of certain muscle-relaxing drugs. The effects of atropine
include an increase in heart
rate, a decrease in production of saliva, sweat, bronchial and
intestinal secretions, and a
decrease in the movements of the intestine.
Atropine Sulphate Injection is used in the following conditions:
• during anaesthesia to dry up secretions in the mouth and chest and
to keep heart beat
normal
• in the treatment of poisoning caused by certain substances like
pesticides
• to reverse the effects of certain drugs given during surgery to
relax muscles
• to prevent slowing of the heartbeat during CPR (emergency
procedure undertaken to
revive the heart when it has suddenly stopped)
• to reverse over activity of certain substances (cholinergic
crises)

Summary of Product characteristics

Page 1 of 10
1
NAME OF THE MEDICINAL PRODUCT
Atropine Sulphate 600 micrograms/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 600 micrograms of Atropine Sulphate B.P.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Clear, colourless, sterile, aqueous solution intended for parenteral
administration to
human beings.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1) In anaesthesia, to reduce the risk of vagal inhibition of the heart
and to reduce salivary
and bronchial secretions.
2) In the treatment of cholinergic crisis of myasthenia gravis.
3) In conjunction with neostigmine used to reverse the effects of
non-depolarising
muscle relaxants.
4) In the treatment of poisoning by certain cholinesterase inhibitors
e.g. organo-
phosphorous compounds.
5) During cardiopulmonary resuscitation to counteract excessive vagal
tone on the heart.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY
1) Use in Anaesthesia
Adults (including older people) : The usual dose is 0.3 to 0.6mg (300
micrograms to 600
micrograms).
_Paediatric population_:
Premature Infants : 65 micrograms
Page 2 of 10
Full-term Infants : 100 micrograms
6 months - 1 year : 200 micrograms
Over one year : 10 - 20 micrograms/kg bodyweight
2) Treatment of cholinergic crisis of myasthenia gravis
Adults : The usual dose is 0.4 to 2.0mg intravenously, which may be
increased according
to patients response.
3) In conjunction with neostigmine used to reverse the effects of
non-depolarising
muscle relaxants
Adults : The usual dose is 0.6 to 1.2mg given by slow intravenous
injection.
Atropine should be administered before neostigmine.
4) Treatment of poisoning by certain cholinesterase inhibitors
Adults : From 1.2mg, increased according to patients response.
5) Use during Cardiopulmonary Resuscitation
Adults : A dose of 0.2 to 0.5mg may be given intravenously and
repeated if necessary.
Persistent bradycardia should be controlled by the insertion of a
pacemaker as soon as
possible.
Method of