DOPRAM Sterile solution for injection Ref.[9341] Active ingredients: Doxapram

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

Doxapram acts as a ventilatory stimulant and Dopram Injection is used following anaesthesia to stimulate ventilation in the post-operative period as an aid to the reduction of post-operative pulmonary complications, and to permit the use of effective doses of narcotic analgesics without associated problems of ventilatory depression. Dopram Injection is also used to increase CNS arousal and spontaneous respiratory activity from inhalational anaesthesia when this would be beneficial.

Posology and method of administration

Posology

Adults and Elderly

The recommended dosage is 1.0 to 1.5mg/kg body weight, administered over a period of 30 seconds or more, which may be repeated at one hour intervals, if necessary.

Paediatric population

Not recommended.

Hepatic impairment

There are no studies to support dosage recommendations in patients with hepatic impairment. However, as Doxapram is metabolized primarily by liver it should be used with care in patients with hepatic dysfunction (see section 4.4).

Renal impairment

There are no studies to support dosage recommendations in patients with renal impairment.

Method of administration

Dopram Injection is recommended for intravenous use only.

Overdose

Symptoms

Overdosage may result in hypertension, tachycardia and other arrhythmias; skeletal muscle hyperactivity including enhanced deep tendon reflexes, and dyspnoea. Serious symptoms of overdosage may include clonic and generalized seizures.

Management

Intravenous diazepam, phenytoin, and short-acting barbiturates, oxygen and resuscitative equipment should be readily available to manage overdoses.

Shelf life

4 years.

Special precautions for storage

Do not store above 25°C.

Do not refrigerate.

Nature and contents of container

Primary container: Clear type I one point-cut (OPC) glass ampoules

Secondary container: Cardboard carton

Presentation: Each ampoule contains 5ml

Special precautions for disposal and other handling

Not applicable.

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