DOPRAM

5mg/kg body weight, administered over a period of 30 seconds or more, which may be repeated at one hour intervals, if necessary.

Hepatic impairment:

There are no studies to support dosage recommendations in patients with hepatic impairment. 4).

Renal impairment:

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

Paediatric population:

Not recommended. Method of administration Dopram Injection is recommended for intravenous use only.

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. System Organ Class Frequency Adverse reactions Nervous system disorders Not known *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.

Cardiac disorders Not known 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 Not known Respiratory problems such as dyspnoea, cough, bronchospasm and laryngospasm may occur.

Gastrointestinal disorders Not known Effects on the gastrointestinal tract such as nausea and vomiting may also occur. Renal and urinary disorders Not known Urinary retention, stimulation of urinary bladder with spontaneous voiding.

*Dopram may produce adverse effects due to general stimulation of the central, peripheral and autonomic nervous systems. Doxapram can induce a significant decrease in maximal cerebral blood flow velocity. 2). The following adverse reactions have been reported in off license 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.

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 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.

1. 1 2. Severe hypertension 3. Status asthmaticus 4. Coronary artery disease 5. Epilepsy and other convulsive disorders 6. Cerebral oedema 7. Cerebrovascular accident 8. Hyperthyroidism /Thyrotoxicosis 9. Physical obstruction of the respiratory tract, or conditions resulting in restriction of chest wall, muscles of respiration or alveolar expansion.

10. Head injury 11. Proven/suspected pulmonary embolism