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

1. Dopram should be administered concurrently with oxygen to patients with severe irreversible airways obstruction or severely decreased lung compliance, due to the increased work of breathing in these patients.
2. In patients presenting with bronchoconstriction, Dopram should always be used in conjunction with β-adrenoceptor bronchodilator drugs in order to reduce the amount of respiratory effort.
3. As Dopram is metabolised primarily by the liver, use with care in patients with hepatic dysfunction.
4. Dopram should be administered cautiously to patients receiving sympathomimetic agents since an additive pressor effect may occur.
5. Dopram should be used with great care in patients who are being treated concurrently with monoamine oxidase inhibiting drugs. Animal studies have shown that the action of doxapram is potentiated after pre-treatment with a MAOI.
6. In patients who have received anaesthetics known to sensitize the myocardium to catecholamines, such as halothane, cyclopropane, and enflurane, initiation of Dopram therapy should be delayed for at least 10 minutes following discontinuance of anaesthesia, since an increase in adrenaline release has been noted with Dopram administration.
7. The respiratory stimulant effect of Dopram may not outlast the residual effects of the depressant drugs. Since respiratory depression may recur after stimulation with Dopram, the patient should be closely monitored until fully alert for ½ to 1 hour. Dopram may temporarily mask the residual effects of curare-type muscle relaxant drugs.
8. Dopram should be administered with caution in patients with hypermetabolic states such as phaeochromocytoma.
9. If sudden hypertension or dyspnoea develops, Doxapram should be stopped.
10. Monitoring of the blood pressure and deep tendon reflexes is recommended to prevent overdosage.
11. To avoid side effects, it is advisable to use the minimum effective dosage.
12. Doxapram should not be used in conjunction with mechanical ventilation.
13. An adequate airway is essential and airway protection should be considered since Doxapram may stimulate vomiting.
14. Dopram should be used with caution in hypertensive patients (Dopram is contraindicated in severe hypertension, see section 4.3) and in patients with impaired cardiac reserve.
15. The administration of this agent does not diminish the need for continuous monitoring of all aspects of patient response, including frequent analysis of arterial-blood gases.

Clinical data suggest that concurrent use of aminophylline/theophylline and Dopram may be associated with increased CNS stimulation, agitation, muscle fasciculation and hyperactivity. Care should thus be taken when these two drugs are used concomitantly.

Dopram should also be administered with great care to patients being treated concurrently with monoamine oxidase inhibitors (MAOIs). Animal studies have shown that the action of Dopram may be potentiated after pre-treatment with a MAOI (see section 4.4).

Dopram may potentiate the effects of sympathomimetic agents (see section 4.4).

Doxapram may temporarily mask the residual effects of curare-type muscle relaxant drugs (see section 4.4).

Pregnancy

Although there is no recognised hazard, this product is not recommended for use in pregnancy unless there are compelling clinical reasons to do so. The physician must weigh the benefit to the risk.

Breast-feeding

It is not known whether this drug is excreted in human milk. Therefore, caution should be exercised when Dopram is administered to a lactating mother.

Dopram has no or negligible influence on the ability to drive and use machines.

Adverse reactions listed by System Organ Class.

The following adverse reactions have been observed at the frequencies defined using the following convention:

Not known: cannot be estimated from the available data.

Nervous system disorders: Dopram may produce adverse effects due to general stimulation of the central, peripheral and autonomic nervous systems: pyrexia, sweating, flushing, salivation, headache, dizziness, hyperactivity, confusion, hallucinations, perineal warmth, muscle fasciculation, muscle spasticity, clonus, bilateral babinski, increased deep tendon reflexes and convulsions have been reported.

Doxapram can induce a significant decrease in maximal cerebral blood flow velocity.

Cardiac disorders: Cardiovascular effects have been observed and include a moderate increase in blood pressure, arrhythmias, sinus tachycardia, bradycardia and extrasystoles, chest pain or chest tightness.

Respiratory, thoracic and mediastinal disorders: Respiratory problems such as dyspnoea, cough, bronchospasm and laryngospasm may occur.

Gastrointestinal disorders: Effects on the gastrointestinal tract such as nausea and vomiting may also occur.

Renal and Urinary disorders: Urinary retention, stimulation of urinary bladder with spontaneous voiding.

Paediatric Population

Dopram is not recommended in children (see section 4.2). The following adverse reactions have been reported in off-licence use of doxapram in preterm neonates and infants:

• neurodevelopmental delay
• significant prolongation of QT interval, in some cases associated with atrioventricular block.
• bleeding in stools, abdominal distension and necrotizing enterocolitis and multiple gastric perforations
• early teeth eruption involving lower central incisors

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

Dopram is incompatible with alkaline solutions such as aminophylline, frusemide and thiopentone sodium.