Doxapram

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.

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

Doxapram 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: Doxapram 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

Doxapram is not recommended in children. 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