ATROPINE Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Atropine Sulphate 600 micrograms/ml Solution for Injection.
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.
Pharmaceutical form
Clear, colourless, sterile, aqueous solution intended for parenteral administration to human beings.
Therapeutic indications
In anaesthesia, to reduce the risk of vagal inhibition of the heart and to reduce salivary and bronchial secretions. In the treatment of cholinergic crisis of myasthenia gravis. In conjunction with neostigmine ...
Posology and method of administration
Posology 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 Full-term Infants: ...
Contraindications
Hypersensitivity to Atropine Sulphate or to any of the excipients listed in section 6.1 Myasthenia gravis (except when given with an anticholinesterase). No absolute contraindication to atropine in Advanced ...
Special warnings and precautions for use
Atropine sulphate should be used with caution in children, older people and those with Downs syndrome. It should be given with caution to patients with diarrhoea, urinary retention or fever. Paradoxical ...
Interaction with other medicinal products and other forms of interaction
Drugs with anticholinergic effects including antihistamines, tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, disopyramide, domperidone, phenothiazines, amantadine, butyrophenones, antispasmodics, ...
Fertility, pregnancy and lactation
Pregnancy Atropine sulphate crosses the placenta. Studies in humans have not been done and only limited information is available from animal studies. Animal studies are insufficient with respect to reproductive ...
Effects on ability to drive and use machines
Atropine may cause blurred vision, drowsiness, confusion, hallucinations and other neuro-psychiatric effects (see sections 4.8 and 4.9). Patients should be advised that they should not drive, operate machinery ...
Undesirable effects
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 ...
Overdose
Symptoms Marked dryness of the mouth accompanied by a burning sensation, difficulty in swallowing, pronounced photophobia, flushing and dryness of the skin, raised body temperature, rash, tachycardia, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anticholinergic agents ATC code: A03BA01 Mechanism of action Atropine is an antimuscarinic agent which competitively antagonizes acetylcholine at postganglionic nerve endings, ...
Pharmacokinetic properties
Absorption Following intravenous administration, the peak increase in heart rate occurs within 2 to 4 minutes. Plasma levels after intramuscular and intravenous injection are comparable at one hour. Distribution ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and limited studies on carcinogenic potential. No adequate studies of ...
List of excipients
Dilute sulphuric acid BP Water for injections BP (in bulk)
Incompatibilities
Atropine Sulphate Injection is incompatible with alkalis, tannic acid and mercury salts.
Shelf life
<u>Unopened:</u> 4 years*. <u>After reconstitution:</u> not applicable. * If only part of an ampoule is used, the remainder should be discarded.
Special precautions for storage
Store below 25°C. Protect from light.
Nature and contents of container
1ml, clear One point cut (OPC) glass ampoules, glass Type I Ph. Eur. Borosilicate glass packed in cardboard cartons to contain 10 1ml ampoules.
Special precautions for disposal and other handling
For S.C., I.M. or I.V. injection. Use as directed by the physician. Keep out of reach of children. If only part used, discard the remaining solution.
Marketing authorization holder
Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0560
Date of first authorization / renewal of the authorization
26/02/1991
Date of revision of the text
21/06/2019
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