Mahakam Beta Farma


Mahakam Beta Farma
Concise Prescribing Info
Opioid analgesic supplement in general or regional anesth. Anesth premed w/ a neuroleptic for induction of anesth & adjunct in the maintenance of general & regional anesth. Anesth agent w/ O2 in selected high-risk patients undergoing major surgery.
Dosage/Direction for Use
Individualized dosage. As analgesic supplement to general anesth Low dose: 2 mcg/kg. Moderate dose: 2-20 mcg/kg. High dose: 20-50 mcg/kg. Major surgery: 20-50 mcg/kg w/ nitrous oxide or O2. Supplemental doses of 25-250 mcg should be tailored to the needs of the patient. As anesth agent 50-100 mcg/kg w/ O2 & muscle relaxant. Ped 2-12 yr 2-3 mcg/kg for induction & maintenance.
Known intolerance to any of its component or to other opioids.
Special Precautions
Patients should remain under appropriate surveillance for resp depression. Resuscitation equipment & opioid antagonist should be readily available. Hyperventilation during anesth may alter patient's response to CO2. Induction of muscle rigidity which may involve thoracic muscle & non-epileptic myoclonic movements can occur. Bradycardia & cardiac arrest can occur if the patient has received insufficient amount of anticholinergic or when combined w/ non-vagolytic muscle relaxants. Appropriate measures to maintain arterial BP should be taken. Avoid use of rapid bolus inj in patients w/ compromised intracerebral compliance. Patients on chronic opioid therapy or w/ a history of opioid abuse may require higher doses. Patients w/ uncontrolled hypothyroidism; pulmonary disease (eg, COPD); decreased resp reserve; potentially compromised respiration; alcoholism. Higher incidence of hypotension in co-administration w/ neuroleptics. Serotonin syndrome may occur in combination w/ drugs that affect the serotonergic neurotransmitter systems eg, SSRIs, SNRIs, MAOIs. Consider discontinuation when serotonin syndrome is suspected. Patients should only drive or operate a machine ≥24 hr after administration. Impaired hepatic or renal function. Should not be used during pregnancy. Breast-feeding is not recommended for 24 hr following administration. Childn <2 yr. Elderly & debilitated patients.
Adverse Reactions
Sedation, dizziness, dyskinesia, headache; visual disturbance; bradycardia, tachycardia, arrhythmia; hypotension, HTN, vein pain, BP fluctuation, phlebitis; apnea, bronchospasm, laryngospasm, hiccups, hyperventilation; nausea, vomiting; allergic dermatitis; muscle rigidity; post-op confusion/agitation, neurological anesth complication, procedural complication, anesth airway complication; euphoric mood; chills, hypothermia.
Drug Interactions
Barbiturates, benzodiazepines, neuroleptics, general anesth & other non-selective CNS depressants eg, alcohol may potentiate the resp depression of opioids. Decreased clearance w/ CYP3A4 inhibitors. Co-administration w/ SSRIs, SNRIs or MAOIs may increase the risk of serotonin syndrome. Increased &/or prolonged exposure w/ voriconazole or fluconazole. Reduced plasma clearance & vol of distribution of etomidate. Increased t½ of midazolam.
ATC Classification
N01AH01 - fentanyl ; Belongs to the class of opioid anesthetics. Used as general anesthetics.
Etanyl inj 50 mcg/mL
10 mL x 2 × 1's (Rp282,000/boks);2 mL x 5 × 1's (Rp185,000/boks)
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