Active Ingredient: Alfentanil
It is indicated for analgesia and suppression of respiratory activity in mechanically ventilated patients on intensive care and to provide analgesic cover for painful manoeuvres. It will aid compliance with mechanical ventilation, and tolerance of the endotracheal tube. Intravenous bolus doses of alfentanil (0.5 mg/ml) may be used to provide additional pain relief during brief painful procedures such as physiotherapy, endotracheal suction, etc. Despite being mechanically ventilated, patients may be awake in the presence of adequate analgesia.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
30 ug per kg of body weight
30 ug per kg of body weight once every day
At the proposed doses, Alfentanil 5 mg/ml solution for injection has no sedative activity. Therefore supplementation with an appropriate hypnotic or sedative agent is recommended. Admixture is not advisable due to the need to individually titrate both agents.
Alfentanil given by infusion should only be given in areas where facilities are available to deal with respiratory depression and where continuous monitoring is performed. Alfentanil should only be prescribed by physicians familiar with the use of potent opioids when given by continuous iv infusion.
Alfentanil 5 mg/ml solution for injection should be diluted with sodium chloride intravenous infusion BP, glucose intravenous infusion BP, or compound sodium lactate intravenous infusion BP (Hartmann’s solution). Such dilutions are compatible with plastic bags and giving sets. These dilutions should be used within 24 hours of preparation.
Once the patient has been intubated, mechanical ventilation can be initiated using the following dosage regimen:
The recommended initial infusion rate for mechanically ventilated adult patients is 2 mg per hour (equivalent to 0.4 ml per hour) of undiluted Alfentanil 5 mg/ml solution for injection. For a 70 kg patient, this corresponds to approximately 30 micrograms per kilogram per hour.
More rapid control may initially be gained by using a loading dose. For example, a dose of 5 mg may be given in divided doses over a period of 10 minutes, during which time careful monitoring of blood pressure and heart rate should be performed. If hypotension or bradycardia occurs, the rate of administration should be reduced accordingly and other appropriate measures instituted.
The dose to produce the desired effects should then be individually determined and reassessed regularly to ensure that the optimum dose is being used.
In clinical trials, patient requirements have generally been met with doses of 0.5 to 10 mg alfentanil per hour.
Additional bolus doses of 0.5–1.0 mg alfentanil may be given to provide analgesia during short painful procedures.
The maximum recommended duration of treatment with alfentanil infusions is 4 days.
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