Pfizer Fentanyl Citrate

Pfizer Fentanyl Citrate

fentanyl

Manufacturer:

Siegfried Hameln

Distributor:

Pfizer
Concise Prescribing Info
Contents
Fentanyl citrate
Indications/Uses
Analgesic action of short duration during premed, induction & maintenance of anesth & in the immediate post-op period. May be used as an opioid analgesic supplement in general & regional anesth. In combination w/ neuroleptic agents eg, droperidol as premed for the induction of anesth & as an adjunct in the maintenance of general & regional anesth.
Dosage/Direction for Use
Adult Premed 50-100 mcg (1-2 mL) IM 30-60 min prior to surgery (modified for high risk patients). Adjunct to general anesth induction 50-100 mcg (1-2 mL) IV repeated at 2-3 min intervals until the desired effect is achieved. 25-50 mcg (0.5-1 mL) IV/IM (recommended for high-risk patients) when movement &/or changes in vital signs indicate surgical stress or lightening of analgesia. Adjunct to regional anesth 50-100 mcg IM or slow IV inj. Post-op 50-100 mcg IM repeated in 1-2 hr as needed. Childn 2-12 yr Induction & maintenance 20-30 mcg/10 kg.
Contraindications
Hypersensitivity or intolerance to fentanyl or other opioid analgesics. Severe resp disease, acute resp disease, resp depression, patients who may be susceptible to resp depression eg, comatose patients who may have head injury, brain tumor or increased ICP. Patients suffering from bronchial asthma. Receiving MAOIs w/in the previous 14 days. History of myasthenia gravis. Use in chronic non-cancer pain. Childn <2 yr.
Special Precautions
Use only in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain. Assess patient's risk of hazardous & harmful use before prescribing & monitor patient regularly during treatment. Serious, life-threatening or fatal resp depression may occur. Concomitant use w/ other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, TCAs, antipsychotics, antihistamines, centrally-active anti-emetics, general anesth, tranquilizers, or other CNS depressants, including alcohol. Increased risk of addiction in patients w/ personal or family history of substance abuse (including alcohol & prescription & illicit drugs) or mental illness; w/ longer drug use & higher doses. Closely monitor patients for resp depression during initiation of therapy or following an increase in dose. Higher risk of life-threatening resp depression in frail, or debilitated patients, in patients w/ existing impairment of resp function (eg, COPD; asthma). May cause central sleep apnea & sleep-related hypoxemia. Profound analgesia is accompanied by marked resp depression which can persist or recur in the post-op period. Hyperventilation during anesth may alter the patient's responses to CO2. Can produce tolerance & physical dependence. Do not cease abruptly but w/drawn by tapering dose gradually. Patients on chronic opioid therapy or w/ a history of opioid abuse may require higher doses. Reduce & taper off dose if opioid induced hyperalgesia is suspected. Non-epileptic myoclonic movements can occur. Severe CV depression. Patients w/ cardiac arrhythmias. May produce bradycardia & possibly asystole if the patient has received an insufficient amount of anticholinergic agent or when combined w/ non-vagolytic muscle relaxants. May induce hypotension particularly in hypovolemic patients. IV administration of fentanyl may cause muscle rigidity particularly of the respiration muscles & alter the rate of respiration. Dosage reduction in patients suffering from hypothyroidism, chronic hepatic disease & alcoholism. Certain forms of conduction anesth eg, spinal & some peridural anesth can alter respiration. Concomitant use w/ neuroleptics eg, droperidol; serotonergic drugs eg, SSRIs, SNRIs & drugs which impair metabolism of serotonin (including MAOIs). Obese patients. Discontinue use if serotonin syndrome is suspected. Hepatic & renal impairment. May impair ability to drive & use machines. Pregnancy. Not recommended for administration during childbirth (including cesarean section). Breast-feeding is not recommended for 24 hr following administration. Elderly. Neonatal opioid w/drawal syndrome.
Adverse Reactions
Resp depression, apnea, muscle rigidity, myoclonic movements & bradycardia. Elevated BP, hypotension, blurred vision, dizziness, nausea, emesis, laryngospasm, diaphoresis, itching, euphoria & spasm of the sphincter of Oddi.
Drug Interactions
Additive or potentiating effects w/ CNS depressants eg, other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, TCAs, antipsychotics, antihistamines, centrally-active anti-emetics, general anesth, tranquilizers, other CNS depressants, including alcohol. Increased plasma conc resulting in increased or prolonged opioid effects w/ CYP3A4 inhibitors eg, macrolides (erythromycin), azole-antifungal agents (ketoconazole), PIs (ritonavir), grapefruit juice. Decreased plasma conc resulting in decreased efficacy or onset of w/drawal syndrome in patients who have developed physical dependence w/ CYP3A4 inducers eg, rifampin, carbamazepine, phenytoin. Untoward incidents resulting from concurrent administration w/ MAOIs (eg, pethidine). May increase risk of serotonin syndrome w/ serotonergic agents eg, SSRI, SNRI or MAOIs. Hypotension w/ neuroleptics eg, droperidol. CV depression w/ nitrous oxide (w/ high doses of fentanyl). Profound bradycardia, sinus arrest & hypotension w/ amiodarone.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01AH01 - fentanyl ; Belongs to the class of opioid anesthetics. Used as general anesthetics.
Presentation/Packing
Form
Pfizer Fentanyl Citrate soln for inj 50 mcg/mL
Packing/Price
10 mL x 5 × 1's;2 mL x 5 × 1's
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