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Ultiva痛速寧

Ultiva

remifentanil

Manufacturer:

Aspen Pharmacare Asia

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Remifentanil HCl
Indications/Uses
Opioid analgesic adjunct for use w/ other agents during induction &/or maintenance of general anaesth in conjunction w/ controlled ventilation. Provision of analgesia in mechanically ventilated intensive care patients ≥18 yr.
Dosage/Direction for Use
IV General anaesth Adult Induction: 0.5-1 mcg/kg/min as continuous infusion, w/ or w/o initial slow bolus inj of 1 mcg/kg over not less than 30 sec. Maintenance in ventilated patients: Rate of administration can be titrated upward in 25-100% increments or downward in 25-50% decrements, every 2-5 min to attain the desired level of μ-opioid response. In response to light anaesth, supplemental slow bolus inj may be administered over not less than 30 sec every 2-5 min. Paed patient 1-12 yr Maintenance: 0.25 mcg/kg/min as continuous infusion, w/ or w/o bolus inj of 1 mcg/kg over not less than 30 sec. Titrate dose to the depth of analgesia appropriate for the surgical procedure. Elderly >65 yr Initial starting dose should be ½ the recommended adult dose, then titrated to individual patient need. Cardiac anaesth Adult Induction: 1 mcg/kg/min as continuous infusion. Maintenance: Infusion rate can be titrated according to patient need. Supplemental slow bolus doses may also be given as required. High risk cardiac patients should be administered a max bolus dose of 0.5 mcg/kg. Continuation of post-op analgesia prior to extubation: Maintain infusion at the final intra-operative rate during transfer to post-op care area. Intensive care Adult Initiate at 0.1-0.15 mcg/kg/min (6-9 mcg/kg/hr). Titrate in increments of 0.025 mcg/kg/min (1.5 mcg/kg/hr) to achieve the desired level of analgesia. Allow at least 5 min between dose adjustments. Additional analgesia for ventilated patients undergoing stimulating procedures: Maintain at least 0.1 mcg/kg/min (6 mcg/kg/hr) for at least 5 min prior to start of stimulating procedure. Further dose adjustments may be made every 2-5 min in increments of 25-50% in anticipation of, or in response to, additional requirement for analgesia.
Contraindications
Hypersensitivity to remifentanil HCl or other fentanyl analogues. Epidural & intrathecal use. As sole agent for induction of anaesth.
Special Precautions
Not indicated for post-op analgesia or during spontaneous ventilation anaesth. Use of bolus inj during induction in cardiac surgical patients is not recommended. Not recommended for a duration of treatment >3 days in mechanically ventilated intensive care patients. Bolus doses are not recommended in the intensive care setting. Administer analgesics prior to discontinuation of Ultiva for patients undergoing surgical procedures where post-op pain is anticipated. Consider possibility of tolerance, hyperalgesia & associated haemodynamic changes when used in ICU. Patients must be given alternative analgesic & sedative agents prior to discontinuation of Ultiva. Always balance the benefit of adequate post-op analgesia against the potential risk of resp depression when other opioid agents are administered as part of the regimen for transition to alternative analgesia. Reserve concomitant prescribing w/ sedatives in patients for whom alternative treatment options are not possible. Patients w/ known hypersensitivity to opioids of a different class may exhibit hypersensitivity reaction following administration of Ultiva. Repeated administration at short-term intervals for prolonged periods may result in w/drawal syndrome after cessation of therapy. Muscle rigidity, sometimes severe, may occur. Administer a neuromuscular blocking agent &/or additional hypnotic agents to treat excessive muscle rigidity; alternatively, an opioid antagonist may be administered, however this may reverse or attenuate the analgesic effect of Ultiva. Profound analgesia is accompanied by marked resp depression. Caution in patients w/ resp dysfunction. Ensure full consciousness & adequate spontaneous ventilation are achieved during post-op recovery. Risk of CV effects eg, hypotension & bradycardia. Debilitated, hypovolaemic, hypotensive & elderly patients may be more sensitive to the CV effects of Ultiva. Administer Ultiva into a fast-flowing IV line or via a dedicated IV line to avoid resp depression, apnoea &/or muscle rigidity if line is flushed w/ IV fluids or other drugs. Tolerance, physical & psychological dependence, & opioid use disorder (OUD) may develop upon repeated administration. Increased risk of OUD in patients w/ personal or family history of substance use disorders (including alcohol use disorder), in current tobacco users, or in patients w/ personal history of other mental health disorders (eg, major depression, anxiety & personality disorders). Patients should not drive or operate machinery after anaesth. Patients w/ severe hepatic impairment may be slightly more sensitive to the resp depressant effects of remifentanil. Should be used during pregnancy only if potential benefit justifies potential risk to foetus. Monitor for signs of excess sedation or resp depression in case of administration during labour & delivery. Nursing mothers should discontinue breast-feeding for 24 hr following administration. Co-administration w/ IV anaesth agent for induction of anaesth is not recommended in paed patients 1-12 yr. Not recommended in neonates & infants <1 yr. Limited clinical trial experience for total IV anaesth in infants. Insufficient data for use during cardiac surgery in paed patients. No data available in paed intensive care patients. Dose should be reduced & based upon ideal body wt for obese patients. Limited clinical experience in patients undergoing neurosurgery. Caution in ASA III/IV patients during general anaesth.
Adverse Reactions
Skeletal muscle rigidity; hypotension; nausea, vomiting. Bradycardia; post-op HTN; acute resp depression, apnoea, cough; pruritus; post-op shivering.
Drug Interactions
Increased incidence of adverse effects associated w/ concomitantly administered CNS depressants if their doses are not reduced. Increased risk of sedation, resp depression, coma & death w/ sedatives eg, benzodiazepines or related drugs. Increased risk of opioid overdose, resp depression & death w/ gabapentinoids (gabapentin & pregabalin). Increased risk of serotonin syndrome w/ serotonergic agents eg, SSRIs, SNRIs or MAOIs. Exacerbated CV effects w/ cardiac depressants eg, β-blockers, Ca channel blockers. Avoid alcoholic drink after receiving Ultiva.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01AH06 - remifentanil ; Belongs to the class of opioid anesthetics. Used as general anesthetics.
Presentation/Packing
Form
Ultiva powd for conc for soln for infusion (vial) 1 mg
Packing/Price
5 × 1's
Form
Ultiva powd for conc for soln for infusion (vial) 2 mg
Packing/Price
5 × 1's
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