ATROPINE Tablet Ref.[8248] Active ingredients: Atropine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF

Therapeutic indications

Non ulcer dyspepsia

Irritable bowel syndrome

Diverticular disease

Posology and method of administration

Adults: 0.6mg-1.2mg as a single night time dose.

Elderly and Children: Atropine should be used with caution employing a suitably reduced dose.

Overdose

There is considerable variation in susceptibility to atropine; recovery has occurred even after 1g, whereas deaths have been reported from doses of 100mg or less for adults and 10mg for children.

Symptoms of overdose

In overdose, the peripheral effects become more pronounced such as dilation of pupils, continuing blurred vision, or changes in near vision, severe dryness of mouth, nose or throat, dizziness and drowsiness. Other symptoms such as rapid respiration, increased respiratory rate, difficulty in breathing, increased heartbeat, hypertension, hyperthermia, fever, muscle weakness, inhibition of micturition, nausea and vomiting may occur. A rash may appear on the face, neck or upper trunk, and there may be unusual warmth, dryness or flushing of the skin. Toxic doses also cause CNS stimulation marked by nervousness, restlessness, irritability, confusion, excitement, ataxia, incoordination, slurred speech, paranoid and psychotic reactions, hallucinations and delirium and occasionally seizures. In severe overdose, central stimulation may give way to CNS depression, coma, circulatory and respiratory failure and death.

Treatment of overdose

If a patient presents within an hour of an overdose of atropine by mouth, the stomach may be emptied (but only if a life-threatening amount has been ingested) or activated charcoal given to reduce absorption. Diazepam may be given to control marked excitement and convulsions. Hypoxia and acidosis should be corrected. If metabolic acidosis persists despite correction of hypoxia and adequate fluid resuscitation consider correction with intravenous sodium bicarbonate. Antiarrhythmics are not recommended if arrhythmias develop. Phenothiazines should not be given as they may exacerbate antimuscarinic effects. Supportive therapy should be given as required.

Shelf life

Three years in polypropylene/polyethylene containers.

Two years in strip packs.

Special precautions for storage

Do not store above 25°C.

Store in the original container.

Nature and contents of container

Polyethylene or polypropylene containers with tamper evident closure strips of 28, 30, 56, 60, 84, 90 or 100 tablets.

Strip packs of 28, 30, 56, 60, 84 or 90 tablets.

Special precautions for disposal and other handling

None.

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