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ALFENTANIL is a brand name for Alfentanil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: In adults, as an analgesic supplement for use before and during anaesthesia. It is indicated for: • Short procedures and outpatient surgery. • Procedures of medium and long duration when given as a bolus followed by supplemental doses or by continuous infusion. Alfentanil 500 micrograms/ml is indicated for use in…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Alfentanil 500 micrograms/ml by the intravenous route can be administered to both adults and children. Alfentanil 500 micrograms/ml should be used as bolus injections (short procedures) or bolus supplemented by increments or by infusion (long painful surgical procedures).
The dosage of Alfentanil 500 micrograms/ml should be individualised according to age, bodyweight, physical status, underlying pathological condition, use of other drugs and type of surgery and anaesthesia. 5 ml) Assisted ventilation 30 – 50 microgram/kg 15 microgram/kg If desired, Alfentanil 500 micrograms/ml can be mixed with sodium chloride injection BP, glucose injection BP or Ringer-Lactate injection BP (Hartmann’s solution).
Such dilutions are compatible with plastic bags and giving sets. These dilutions should be used within 24 hours of preparation. In obese patients (more than 20 % above ideal total body weight), the dosage of alfentanil should be determined on the basis of lean body weight.
In spontaneously breathing patients, the initial bolus dose should be given slowly over about 30 seconds (dilution may be helpful). After intravenous administration in unpremedicated adult patients, 1 ml Alfentanil 500 micrograms/ml may be expected to have a peak effect in 90 seconds and to provide analgesia for 5 – 10 minutes.
Periods of more painful stimuli may be overcome by the use of small increments of Alfentanil 500 micrograms/ml. For procedures of longer duration, additional increments will be required. In ventilated patients, the last dose of Alfentanil 500 micrograms/ml should not be given later than about 10 minutes before the end of surgery to avoid the continuation of respiratory depression after surgery is complete.
5 – 1 micrograms/kg/minute. Adequate plasma concentrations of alfentanil will only be achieved rapidly if this infusion is preceded by a loading dose of 50 – 100 micrograms/kg given as a bolus or fast infusion over 10 minutes. Lower doses may be adequate, for example where anaesthesia is being supplemented by other agents.
The infusion should be discontinued up to 30 minutes before the anticipated end of surgery. Increasing the infusion rate may prolong recovery. Supplementation of the anaesthetic, if required, for periods of painful stimuli, is best managed by extra bolus doses of Alfentanil 500 micrograms/ml (1 – 2 ml) or low concentrations of a volatile agent for brief periods.
Adverse Reactions The most frequently reported Adverse reactions (incidence ≥10%) are: nausea and vomiting. Undesirable effects listed below in Table 1 have been reported in clinical trials (1157 subjects) and/or from spontaneous reports from post- marketing experience.
The following terms and frequencies are applied:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data). Adverse reactions from spontaneous reports during worldwide postmarketing experience with alfentanil that met threshold criteria are included.
Unlike for clinical trials, precise frequencies cannot be provided for spontaneous reports. The frequency for these reports is therefore classified as 'not known'. 4) Nervous System Disorders Movement Disorder; Dizziness; Sedation; Dyskinesia Headache; Somnolence; Unresponsive to Stimuli Loss of Consciousness (postoperative period); Convulsion; Myoclonus Eye Disorders Visual Disturbance Miosis Cardiac Disorders Bradycardia; Tachycardia Arrhythmia; Heart Rate Decreased Cardiac Arrest Vascular Disorders Hypotension; Hypertension; Blood Pressure Decreased; Blood Pressure Increased Vein Pain Respiratory, Thoracic and Mediastinal Disorders Apnoea Hiccups; Hypercapnia; Laryngospasm; Respiratory Depression (including fatal outcome) Bronchospasm; Epistaxis Respiratory Arrest; Cough Gastrointestinal Disorders Nausea; Vomiting Skin and Subcutaneous Tissue Disorders Dermatitis Allergic; Hyperhidrosis Pruritus Erythema; Rash Musculoskeletal and Connective Tissue Disorders Muscle Rigidity Renal and urinary disorders Urinary retention General Disorders and Administration Site Conditions Chills; Injection Site Pain; Fatigue Pain, Drug withdrawal syndrome Pyrexia Injury, Poisoning and Procedural Complications Procedural Pain Agitation Postoperative; Airway Complication of Anaesthesia; Confusion Anaesthetic Complication Neurological; Procedural Complication; Endotracheal Postoperative Intubation Complication Paediatric population Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, with the exception of the following: Mild to moderate muscle rigidity has been seen frequently in neonates, although the number of neonates included in clinical studies was small.
4. Elderly or debilitated patients Elderly (>65 years of age) and debilitated patients may require lower or less frequent dosing owing to a longer half-life of alfentanil in this age group (dilution may be helpful). Method of administration Alfentanil is administered intravenously by injection or infusion and should only be given by individuals trained in the administration of general anaesthetics and the management of the respiratory effects of potent opioids.
Pulse oximetry or some other means for measuring respiratory function is recommended. Visually inspect parenteral products for particulate matter and discoloration prior to administration. Infuse iv slowly over 3 minutes. Injections rates of < 1 minute are associated with an increased incidence of hypotension.
Continuous infusions longer than 4 days have not been studied. 1. Obstructive airway disease or respiratory depression if not ventilating. Concurrent administration with monoamine oxidase inhibitors or within 2 weeks of their discontinuation.
Administration in labour or before clamping of the cord during Caesarean section due to the possibility of respiratory depression in the new-born infant. 4 Special warnings and precautions for use Warnings: Following administration of alfentanil, a fall in blood pressure may occur.
The magnitude of this effect may be exaggerated in the hypovolaemic patient or in the presence of concomitant sedative medication. Appropriate measures to maintain a stable arterial pressure should be taken. Significant respiratory depression and loss of consciousness will occur following administration of alfentanil in doses in excess of 1 mg and is dose-related.
g. naloxone). Additional doses of the antagonists may be necessary because the respiratory depression may last longer than the duration of action of the opioid antagonist. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
1. Obstructive airway disease or respiratory depression if not ventilating. Concurrent administration with monoamine oxidase inhibitors or within 2 weeks of their discontinuation. Administration in labour or before clamping of the cord during Caesarean section due to the possibility of respiratory depression in the new-born infant.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, have received a loading dose of 18 – 28 micrograms/kg/min for up to 30 minutes without requiring mechanical ventilation. In heart surgery, when used as a sole anaesthetic, doses in the range of 12 – 50 mg/hour have been used. Paediatric patients Assisted ventilation equipment should be available for use in children of all ages, even for short procedures in spontaneously breathing children.
2).
Neonates (0-27 days):
The pharmacokinetics are very variable in neonates, particularly in those born preterm. Clearance and protein binding are lower, and a lower dose of alfentanil may be required. Neonates should be closely monitored and the dose of alfentanil titrated according to the response.
Infants and toddlers (28 days to 23 months):
Clearance may be higher in infants and toddlers compared to that in adults. For maintenance of analgesia, the rate of infusion of alfentanil may need to be increased.
Children (2 to 11 years):
Clearance may be slightly higher in children and the rate of infusion may need to be increased.
Adolescents:
The pharmacokinetics of alfentanil in adolescents are similar to those in adults and no specific dosing recommendations are required. Dosing recommendations for paediatric patients The wide variability in response to alfentanil makes it difficult to provide dosing recommendations for younger children.
e. to supplement propofol or inhalation anaesthesia) or as an analgesic is considered appropriate. Supplemental boluses of 5 to 10 micrograms/kg alfentanil at appropriate intervals can be administered. 5 to2 micrograms/kg/min may be administered.
The dose must be titrated up or down according to the needs of the individual patient. When combined with an intravenous anaesthetic agent the recommended dose is approximately 1 microgram/kg/min. There may be a higher risk of respiratory complications and muscle rigidity when alfentanil is administered to neonates and very young children.
Necessary precautions are detailed in section
Severe rigidity and jerking can occur less commonly and may be accompanied by transient impaired ventilation, especially with high doses of alfentanil or with a rapid rate of intravenous injection. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Alfentanil and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Alfentanil concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Like other opioids, alfentanil may cause bradycardia, an effect that may be marked and rapid in onset but which can be antagonised by atropine.
Particular care must be taken following treatment with drugs which may depress the heart or increase vagal tone, such as anaesthetic agents or beta-blockers, since they may predispose to bradycardia or hypotension. Heart rate and blood pressure should therefore be monitored carefully.
If hypotension or bradycardia occur, appropriate measures should be instituted. Cardiac arrest following bradycardia has been reported on very rare occasions in non- atropinised patients. Therefore it is advisable to be prepared to administer an anticholinergic drug.
Precautions:
It is wise to reduce the dosage in the elderly and debilitated patients. In hypothyroidism, pulmonary disease, decreased respiratory reserve, alcoholism and liver or renal impairment the dosage should be titrated with care and prolonged monitoring may be required.
Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses. Alfentanil may induce muscle rigidity during induction. Rigidity, which may also involve the thoracic muscles, can be avoided by the following measures: • Slow IV injection (usually sufficient for lower doses); • Premedication with a benzodiazepine; • Administration of a muscle relaxant just prior to administration of alfentanil.
Non-epileptic (myo)clonic movements can occur. As with all potent opioids, profound analgesia is accompanied by marked respiratory depression, which may persist into or recur in the early postoperative period. Care should be taken after infusions or large doses of alfentanil to ensure that adequate spontaneous breathing has been established and maintained in the absence of stimulation before discharging the patient from the recovery area.
Resuscitation equipment and narcotic antagonists should be readily available. Hyperventilation during anaesthesia may alter the patient's response to CO2, thus affecting respiration postoperatively. The use of rapid bolus injections of opioids should be avoided in patients with compromised intracerebral compliance; in such patients a transient decrease in the mean arterial pressure has occasionally been accompanied by a transient reduction of the cerebral perfusion pressure.
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