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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: Alfentanil is indicated in adults as: • an analgesic for induction of anaesthesia and/or maintenance of general anaesthesia. Alfentanil is indicated for use in neonates, infants, children and adolescents less than 18 years of age as: • an opioid analgesic together with a hypnotic to induce anaesthesia; • an opioid…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage of alfentanil should be individualised according to age, body weight, physical status, underlying pathological conditions, use of other drugs and type of surgery and anaesthesia. Adult patients The usual recommended dosage regimen is given in Table 1.
5 ml) Assisted ventilation 30-50 mcg/kg 15 mcg/kg • Short procedures and outpatient surgery 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, 500 mcg (1 ml) alfentanil may be expected to have a peak effect in 90 seconds and to provide analgesia for 5-10 minutes.
5 ml) alfentanil. For procedures of longer duration, additional administrations will be required. In ventilated patients, the last dose of alfentanil 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 mcg/kg/minute. Adequate plasma concentrations of alfentanil will only be achieved rapidly if this infusion is preceded by a loading dose of 50-100 mcg/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 mcg to 1 mg corresponding to 1-2 ml) or low concentrations of a volatile agent for brief periods.
, have received a loading dose of 18-28 mcg/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. Special populations Paediatric population Assisted ventilation equipment should be available for use in children of all ages, even for short procedures in spontaneously breathing children.
2). • Neonates (0 to 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.
The safety of alfentanil was evaluated in 1,157 subjects, who participated in 18 clinical studies. Alfentanil was administered to induce anaesthesia or as an analgesic/anaesthetic adjuvant to local or general anaesthesia during short, medium-length and long surgical procedures.
These people were given at least one dose of alfentanil and generated safety data. 4%). The following table shows undesirable effects from the use of alfentanil reported either in clinical studies or from post-marketing experience. Table 2 Undesirable effects Immune system disorders Not known (cannot be estimated from available data) Allergic reactions such as anaphylaxis, anaphylactoid reaction, urticaria).
Psychiatric disorders Common (≥1/100 to <1/10) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from available data) Euphoria. Agitation, crying. Disorientation. Nervous system disorders Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not known (cannot be estimated from available data) Movement disorders, dizziness, drowsiness, dyskinesia.
Headache, somnolence, unresponsive to stimuli. Loss of consciousness (during postoperative period), convulsions, myoclonus. Eye disorders Common (≥1/100 to <1/10) Not known (cannot be estimated from available data) Visual disturbances.
Miosis. Cardiac disorders Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not known (cannot be estimated from available data) Bradycardia, tachycardia. Arrhythmia, decreased heart rate. Cardiac arrest. Vascular disorders Common (≥1/100 to <1/10) Rare (≥1/10,000 to <1/1,000) Hypotension, hypertension.
Vein pain. Respiratory, thoracic and mediastinal disorders Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from available data) Apnoea. Hiccups, hypercapnia, laryngospasm, respiratory depression (including fatal outcome) Bronchospasm, epistaxis.
4. 2). Renal impairment Clearance of alfentanil is unaltered in renal failure. 2). Elderly and debilitated patients The initial dose must be reduced in elderly (>65 years) and debilitated patients. The effect of the initial dose must be borne in mind when determining such supplementary doses.
Patients with concurrent comorbidity Alfentanil must be titrated with care in patients with the following conditions: • uncontrolled hypothyroidism; • lung disease, particularly in the case of reduced respiratory capacity; • alcoholism or impaired liver and kidney function.
These patients also require prolonged postoperative monitoring. Method of administration For intravenous use. Alfentanil should be given as bolus injections (short procedures) or bolus supplemented by repeat administration of alfentanil, or by infusion (long painful procedures).
Alfentanil should only be given by individuals trained in the administration of general anaesthetics and the management of the respiratory effects of potent opioids. 6. 1. 4 Special warnings and precautions for use Respiratory depression Respiratory depression is dose dependent and can be reversed with a specific opioid antagonist (naloxone).
Several doses of naloxone may be necessary, as the respiratory depression may last longer than the effect of the opioid antagonist. Profound analgesia is accompanied by marked respiratory depression and loss of consciousness, which can persist or recur throughout the postoperative period.
Patients must therefore be kept under adequate monitoring. Resuscitation equipment and opioid antagonists must be readily available. Hyperventilation under anaesthesia can alter the patient’s response to CO2 and thus affect respiration postoperatively.
Muscular rigidity Muscular rigidity, which may also involve thoracic muscles, can occur and may lead to respiratory depression. v. injection (normally sufficient in small doses), premedication with benzodiazepines and the use of muscle relaxants.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• 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 to propofol or inhalation anaesthesia) or as an analgesic is considered appropriate. Supplemental boluses of 5-10 mcg/kg alfentanil at appropriate intervals can be administered. 5 to 2 mcg/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 mcg/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
Respiratory arrest, coughing. Gastrointestinal disorders Very common (≥1/10) Nausea, vomiting. Skin and subcutaneous tissue disorders Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from available data) Allergic dermatitis, hyperhidrosis.
Pruritus. Erythema, rash. Musculoskeletal and connective tissue disorders Common (≥1/100 to <1/10) Muscular rigidity. General disorders and administration site conditions Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not known (cannot be estimated from available data) Chills, injection site pain, fatigue.
Pain. Fever. Injury, poisoning and procedural complications Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Procedural pain. Postoperative agitation, airway complications from anaesthesia, postoperative confusion. Rare (≥1/10,000 to <1/1,000) Neurological anaesthesia complications, procedural complications, endotracheal intubation complications.
Paediatric population The frequency, type and severity of adverse reactions in children are expected to be as in adults, with the exception of the following: Mild to moderate muscle rigidity has frequently been seen in neonates, although the number of neonates included in clinical studies was small.
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.
Non-epileptic (myo)clonic movements may occur. v. administration, indicating the use of muscle relaxants. Alfentanil should not, therefore, be used for patients with myasthenia gravis, as the use of muscular relaxants is unsuitable in these subjects.
Heart disease Bradycardia and possibly cardiac arrest can occur if the patient has been given too low dose of anticholinergic, or if alfentanil is combined with non-vagolytic muscular relaxants. Bradycardia can be treated with atropine.
Special dosage considerations Opioids can induce hypotension, particularly in hypovolemic patients and patients with heart failure. Induction doses must be adjusted and administered slowly so as to avoid cardiovascular depression. Suitable measures must be taken to maintain stable arterial pressure.
Caution is required in patients with craniocerebral traumas and raised intracranial pressure. Fast bolus injections of opioids must be avoided in the case of compromised cerebral blood flow, as the brief drop in arterial pressure may be accompanied by a short-lived reduction in cerebral perfusion pressure.
Alfentanil must be titrated with care in patients with the following conditions: • uncontrolled hypothyroidism; • lung disease, particularly in the case of impaired respiratory capacity; • alcoholism or impaired liver or kidney function.
These patients also require prolonged post-operative monitoring. Particular caution should be observed in patients with obstructive airways disease or respiratory depression (if not being ventilated). 5). Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence and opioid use disorder (OUD) may develop upon repeated administration of opioids.
Abuse or intentional misuse of opioids may result in overdose and/or death. g. major depression, anxiety and personality disorders). Alfentanil can produce dependence because of its chemical structure and morphinomimetic characteristics.
When alfentanil will be given only intraoperatively (as intended) as anaesthetic agent addiction is not to be expected. 2). Paediatric population When administering alfentanil to neonates and very young children, there may be an increased risk of respiratory complications as compared to use in older children and adults.
Younger children should therefore be monitored immediately after the start of alfentanil administration. Assisted ventilation equipment should be available for use on children, regardless of age, even during short-duration procedures in children with spontaneous breathing.
Owing to the risk of muscular rigidity in neonates and infants being given alfentanil, the concurrent use of a muscle relaxant should be considered. All children should be monitored for a sufficient period of time after cessation of treatment with alfentanil to ensure that there is spontaneous respiration again.
Owing to varying pharmacokinetics in neonates, it may be necessary to give a lower dose of […]