ATROPINE Solution for injection Ref.[8249] Active ingredients: Atropine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK

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.

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: 100 micrograms

6 months – 1 year: 200 micrograms

Over one year: 10-20 micrograms/kg bodyweight

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.

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.

Treatment of poisoning by certain cholinesterase inhibitors

Adults

From 1.2mg, increased according to patients response.

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 administration

By subcutaneous, intramuscular or intravenous injection.

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, hypertension, nausea, and vomiting. Restlessness, tremor, confusion, excitement, hallucinations and delirium may result from CNS stimulation; this is followed by increasing drowsiness, stupor and general central depression terminating in death from circulatory and respiratory failure.

Management

In severe cases, physostigmine, 1 to 4 mg, should be administered intravenously, intramuscularly or subcutaneously, the dose may be repeated if necessary since it is rapidly eliminated from the body. Diazepam may be administered for sedation of the delirious patient but the risk of central depression occurring late in the course of atropine poisoning contraindicates large doses of sedative. An adequate airway should be maintained and respiratory failure may be treated with oxygen and carbon dioxide inhalation. Fever is reduced by the application of cold packs or sponging with tepid water. Adequate fluid intake is important. Urethral catheterisation may be necessary. If photophobia is present or likely, the patient should be nursed in a darkened room.

Shelf life

Unopened: 4 years*.

After reconstitution: 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.

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