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RAPIFEN 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 opioid 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. At very high doses, Rapifen may be used in adults…
Verbatim from this product's MHRA label. Tap a section to expand.
4). For intravenous administration. Rapifen by the intravenous route can be administered to both adults and children. Rapifen should be used as bolus injections (short procedures) or bolus supplemented by increments or by infusion (long painful surgical procedures).
The dosage of Rapifen 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 mcg/kg 15 mcg/kg If desired, Rapifen can be mixed with sodium chloride injection BP, dextrose injection BP or compound sodium 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 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 Rapifen 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 Rapifen.
For procedures of longer duration, additional increments will be required. In ventilated patients, the last dose of Rapifen 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 microgram/kg/minute. Adequate plasma concentrations of alfentanil will only be achieved rapidly if this infusion is preceded by a loading dose of 50-100 microgram/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 Rapifen (1-2 ml) or low concentrations of a volatile agent for brief periods.
Patients with severe burns presenting for dressing, etc, 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.
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 Table 1 Adverse Reactions reported in clinical trials and/or postmarketing Frequency Category Skin and Subcutaneous Tissue Disorders Dermatitis Allergic; Hyperhidrosis Pruritus Erythema; Rash Musculoskeletal and Connective Tissue Disorders Muscle Rigidity 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 Postoperative Anaesthetic Complication Neurological; Procedural Complication; Endotracheal 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 and debilitated patients Elderly (>65 years of age) and debilitated patients may require lower or less frequent dosing owing to a longer half-life of Rapifen in this age group (dilution may be helpful). 3 Contraindications Obstructive airways 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 newborn infant.
Patients with a known intolerance to alfentanil and other morphinomimetics. 4 Special warnings and precautions for use Warnings: 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). For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.
Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Obstructive airways 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 newborn infant.
Patients with a known intolerance to alfentanil and other morphinomimetics.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 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 Rapifen may be required. Neonates should be closely monitored and the dose of Rapifen 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 Rapifen 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 Rapifen 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 mcg/kg Rapifen at appropriate intervals can be administered. 5 to2 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 Rapifen 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 Rapifen 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.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with alfentanil.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
Neonatal Withdrawal Syndrome If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. 6). Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
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. Following administration of Rapifen, 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 Rapifen 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. 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.
Risk from concomitant use of Central Nervous System (CNS) depressants, especially benzodiazepines or related drugs Concomitant use of Rapifen and CNS depressants especially benzodiazepines or related drugs in spontaneous breathing patients, may increase the risk of profound sedation, respiratory depression, coma and death.
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