Trofentyl

Trofentyl

fentanyl

Manufacturer:

Troikaa Pharma

Distributor:

Unimed
Concise Prescribing Info
Contents
Fentanyl citrate
Indications/Uses
Narcotic analgesic supplement in general or regional anaesth. In combination w/ neuroleptics eg, droperidol as premed for anaesth induction & as adjunct in general & regional anaesth maintenance. Anaesth agent w/ O2 in selected high risk patients undergoing major surgery.
Dosage/Direction for Use
Adult Analgesic supplement to general anesth Low dose: 2 mcg/kg. Moderate dose: 2-20 mcg/kg. High dose: 20-50 mcg/kg. Anesth agent 50-100 mcg/kg may be administered w/ O2 & muscle relaxant. May be increased up to 150 mcg/kg to produce anaesth effect. Childn 2-12 yr Anaesth induction & maintenance of anaesth 2-3 mcg/kg. Elderly ≥65 yr, debilitated patient Reduce initial dose.
Special Precautions
Discontinue use if serotonin syndrome is suspected. Avoid rapid bolus inj of opioids. Profound sedation & analgesia; resp depression; adrenal insufficiency; decreased sexual function/reproduction; bradycardia, cardiac arrest; muscular rigidity, non-epileptic myoclonic movements; extrapyramidal symptoms; uncontrolled hypothyroidism, pulmonary disease, decreased resp reserve, alcoholism; myasthenia gravis; increased bile duct pressure, Oddi sphincter spasms; inflammatory or obstructive intestinal diseases. Patients on chronic opioid therapy or w/ history of opioid abuse. Long-term & high-dose use. Concomitant use w/ benzodiazepines, SSRIs, SNRIs & drugs impairing serotonin metabolism eg, MAOIs; non-vagolytic muscle relaxants; neuroleptics. May affect ability to drive & use machines. Hepatic & renal impairment. May decrease sex hormone levels, low libido, erectile dysfunction; impair infertility. Not recommended during pregnancy & w/in 24 hr of treatment during lactation. Childn. Elderly & debilitated patients.
Adverse Reactions
Muscle rigidity; nausea, vomiting. Agitation; dyskinesia, sedation, dizziness; visual disturbance; bradycardia, tachycardia, arrhythmia; hypotension, HTN, venous pain; laryngospasm, bronchospasm, apnoea; allergic dermatitis; post-op confusion.
Drug Interactions
Enhanced or prolonged resp depression w/ opioid premed, barbiturates, benzodiazepines, neuroleptics, general anaesth, other non-selective CNS depressants eg, alcohol; clonidine; Higher incidence of hypotension w/ droperidol. Decreased clearance w/ CYP3A4 inhibitors. Increased exposure &/or prolonged exposure w/ fluconazole or voriconazole. Bradycardia & possible cardiac arrest w/ non-vagolytic muscle relaxants eg, vecuronium. Increased risk of serotonin syndrome w/ serotonergic drugs eg, SSRI, SNRI, MAOI. Increased plasma conc of etomidate. Increased terminal plasma t½ & reduced plasma clearance of midazolam. Incompatibility w/ pentobarbital Na, methohexital Na, thiopental Na, nafcillin.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
Presentation/Packing
Form
Trofentyl soln for inj 50 mcg/mL
Packing/Price
2 mL x 5 × 1's
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