Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: hameln pharma plus gmbh, Langes Feld 13, D-31789, Hameln, Germany
Alfentanil 5 mg/ml solution for injection is a potent opioid analgesic with a very rapid onset of action.
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.
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.
Alfentanil 5 mg/ml solution for injection is not recommended for use in children in intensive care. Currently available data are described in section 5.2 but no recommendation on a posology can be made.
The elderly (>65 years of age) and those patients with liver impairment and hypothyroidism will require lower doses. Obese patients may require a dose based on their lean body mass.
Present data suggest that clearance of alfentanil is unaltered in renal failure. However, there is an increased free fraction and hence dosage requirements may be less than in the patient with normal renal function.
For intravenous infusion.
The manifestations of alfentanil overdose are generally an extension of its pharmacological action, which include the
following:
| Action | |
|---|---|
| Bradycardia Anticholinergics such as atropine or glycopyrrolate. | |
| Hypoventilation or apnoea | O2 administration, assisted or controlled respiration and an opioid antagonist may be required. |
| Muscle rigidity | Intravenous neuromuscular blocking agent may be given. |
The suggested treatments given above do not preclude the use of other clinically indicated counter measures.
Body temperature and adequate fluid intake should be maintained and the patient observed for 24 hours.
A specific opioid antagonist (e.g. naloxone) should be available to treat respiratory depression.
Shelf-life before first opening: 3 years.
Shelf-life after dilution: Chemical and physical in-use stability of the dilutions (see section 6.6) has been demonstrated for 48 hours.
From the microbiological point of view, the dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
No special precautions for storage.
Clear glass ampoules (Ph Eur Type I, one point cut) containing 5 mg/1 ml.
Original pack containing 5 or 10 ampoules of 1 ml each.
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) to a convenient concentration. Such dilutions are compatible with plastic bags and giving sets.
Any unused solution from opened ampoules should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
