PHENYLEPHRINE Injection Ref.[7441] Active ingredients: Phenylephrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Therapeutic indications

Phenylephrine Injection is indicated in adults and children for the treatment of hypotensive states e.g. circulatory failure, during spinal anaesthesia or drug induced hypotension.

Posology and method of administration

Posology

Adults

Phenylephrine Injection may be administered subcutaneously or intramuscularly in a dosage of 2 to 5 mg with further doses of 1 to 10 mg if necessary according to response, or in a dose of 100 to 500 micrograms by slow intravenous injection as a 0.1% solution, repeated as necessary after at least 15 minutes.

Alternatively, 10 mg in 500 ml of glucose 5% injection or sodium chloride 0.9% injection may be infused intravenously, initially at a rate of up to 180 micrograms per minute, reduced according to response to 30-60 micrograms per minute.

Paediatric population

100 mcg/kg body weight subcutaneously or intramuscularly.

Elderly

There is no need for dosage reduction in the elderly.

Method of administration

For subcutaneous, intramuscular, slow intravenous injection or intravenous infusion.

Overdose

Symptoms

Symptoms of overdosage include headache, vomiting, hypertension and reflex bradycardia and other cardiac arrhythmias. In severe cases confusion, hallucinations and seizures may occur.

Management

Treatment should consist of symptomatic and supportive measures. The hypertensive effects may be treated with an alpha adrenoreceptor blocking drug, such as phentolamine, 5 to 60 mg i.v. over 10-30 minutes, repeated as necessary.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store at 2-25°C. Protect from light.

Nature and contents of container

1 ml neutral glass ampoule with red imprint break ring.

Pack size: 6 × 1ml and 10 × 1ml ampoules.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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