Hyoscine Hydrobromide 600 micrograms/ml Solution for Injection

Each 1ml ampoule contains 600 micrograms of hyoscine hydrobromide.

For excipients, see 6.1.

Solution for Injection.

A clear colourless solution, practically free from particles.

Due to its anticholinergic activity, hyoscine injection is used as a preoperative medication to control bronchial, nasal, pharyngeal and salivary secretions, to prevent bronchospasm and laryngospasm and to block cardiac vagal inhibiting reflexes during induction of anaesthesia and intubation.

Dosage

Adults

For pre-medication a dose of 200 to 600 micrograms is given by the subcutaneous or intramuscular route 30 to 60 minutes before induction of anaesthesia.

The injection may if required also be given by the intravenous route for acute use.

Children

A dose of 15 micrograms/kg is recommended in children.

Elderly

Hyoscine is not recommended for use in the elderly.

Hypersensitivity to hyoscine. Narrow angle glaucoma.

Caution is necessary in treating patients with cardiovascular disease, gastrointestinal obstruction, paralytic ileus, prostatic enlargement, Down's Syndrome, myasthenia gravis, renal or hepatic impairment.

Because hyoscine may cause drowsiness, patients must not drive or operate machinery. Patients should avoid alcohol.

Heat prostration can occur at high ambient temperatures, due to decreased sweating.

The antimuscarinic side-effects can be increased by concomitant administration of disopyramide, tricyclic and MAOI drugs, antihistamines, phenothiazines, amantadine and alcohol. Reduced effect of sub-lingual nitrates.

Use of hyoscine during pregnancy may cause respiratory depression in the neonate, and should only be given during pregnancy when the potential benefit clearly outweighs the foetal hazard.

Because hyoscine may cause drowsiness, patients must not drive or operate machinery.

The most common side effects are drowsiness, dry mouth, dizziness, blurred vision and difficulty with micturition. Other reported effects include bradycardia, idiosyncratic reactions and mental confusion or excitement.

Symptoms of overdose may include dilated pupils, tachycardia, rapid respiration, hyperpyrexia, restlessness, excitement, delirium and hallucinations. In the unlikely event of overdosage, supportive therapy should be implemented. Physostigmine by slow intravenous injection in a dose of 1 to 4mg has been used to reverse the anticholinergic effects, but this drug is rapidly metabolised. Neostigmine by slow intravenous injection in a dose of 0.5 to 2 mg antagonises only the peripheral effects. Diazepam may be given to control excitement.

Hyoscine is an anticholinergic drug which inhibits the muscarinic actions of acetylcholine at post-ganglionic parasympathetic neuroeffector sites including smooth muscle, secretory glands and CNS sites. Small doses effectively inhibit salivary and bronchial secretions and sweating and provide a degree of amnesia. Hyoscine is a more powerful suppressor of salivation than atropine and usually slows rather than increases heart rate.

Hyoscine is rapidly absorbed following IV or IM injection and is reversibly bound to plasma protein. Hyoscine is reported to cross the placenta and blood brain barrier. Hyoscine is almost completely metabolised by the liver and excreted in the urine. In one study in man, 3.4% of a single dose, administered by subcutaneous injection was excreted unchanged in urine within 72 hours.

None stated

Hydrobromic acid (47%)

Sodium hydroxide

Water for injections

None stated

24 months

Do not store above 25°C

Store in the original container.

1ml neutral glass (Type I) ampoules in packs of 5 or 10.

None stated.

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK

PL 29831/0115

2 May 2007