Remikaf

Remikaf

remifentanil

Manufacturer:

Kimia Farma

Marketer:

Pharmasolindo
Concise Prescribing Info
Contents
Remifentanil HCl
Indications/Uses
Analgesic agent for use during induction & maintenance of general anesth for inpatient & outpatient procedures; continuation into the immediate post-op period in adult patients. Analgesic component of monitored anesth care in adult patients.
Dosage/Direction for Use
IV Individualized dosage. Adult Induction of anesth (through intubation) Initial dose: 1 mcg/kg over 30-60 sec. Continuous infusion: 0.5-1 mcg/kg/min. Maintenance of anesth w/ nitrous oxide (66%) Continuous infusion: 0.4 mcg/kg/min. Range of infusion dose: 0.1-2 mcg/kg/min. Supplemental bolus dose: 1 mcg/kg; w/ isoflurane (0.4-1.5 MAC) Continuous infusion: 0.25 mcg/kg/min. Range of infusion dose: 0.05-2 mcg/kg/min. Supplemental bolus dose: 1 mcg/kg; w/ propofol (100-200 mcg/kg/min) Continuous infusion: 0.25 mcg/kg/min. Range of infusion dose: 0.05-2 mcg/kg/min. Supplemental bolus dose: 1 mcg/kg. Continuation as an analgesic into the immediate post-op period Continuous infusion: 0.1 mcg/kg/min. Range of infusion dose: 0.025-0.2 mcg/kg/min. Ped 1-12 yr Initial dose: 1 mcg/kg over 30-60 sec. Maintenance of anesth w/ halothane (0.3-1.5 MAC) Continuous infusion: 0.25 mcg/kg/min. Range of infusion dose: 0.05-1.3 mcg/kg/min. Supplemental bolus dose: 1 mcg/kg; w/ sevoflurane (0.3-1.5 MAC) Continuous infusion: 0.25 mcg/kg/min. Range of infusion dose: 0.05-1.3 mcg/kg/min. Supplemental bolus dose: 1 mcg/kg; w/ isoflurane (0.4-1.5 MAC) Continuous infusion: 0.25 mcg/kg/min. Range of infusion dose: 0.05-1.3 mcg/kg/min. Supplemental bolus dose: 1 mcg/kg. From birth-2 mth Maintenance of anesth w/ nitrous oxide (70%) Continuous infusion: 0.4 mcg/kg/min. Range of infusion dose: 0.4-1 mcg/kg/min. Supplemental bolus dose: 1 mcg/kg. Continuation as an analgesic into the immediate post-op period Initially 0.1 mcg/kg/min, adjusted every 5 min in 0.025 mcg/kg/min increments. Adult Monitored anesth care single dose Remikaf alone: 1 mcg/kg over 30-60 sec given 90 sec before local anesth or 0.1 mcg/kg/min 5 min before local anesth. Remikaf + 2 mg midazolam: 0.5 mcg/kg over 30-60 sec given 90 sec before local anesth or 0.05 mcg/kg/min 5 min before local anesth. Continuous infusion Remikaf alone: 0.05 mcg/kg/min (range: 0.025-0.2 mcg/kg/min) after local anesth. Remikaf + 2 mg midazolam: 0.025 mcg/kg/min (range: 0.025-0.2 mcg/kg/min) after local anesth. Elderly >65 yr Decrease by 50%. Coronary artery bypass surgery Induction of anesth (through intubation) Continuous infusion: 1 mcg/kg/min. Maintenance of anesth Continuous infusion: 1 mcg/kg/min. Range of infusion dose: 0.125-4 mcg/kg/min. Supplemental bolus dose: 0.5-1 mcg/kg. Continuation as an analgesic into ICU Continuous infusion: 1 mcg/kg/min. Range of infusion dose: 0.05-1 mcg/kg/min.
Contraindications
Hypersensitivity. Epidural or intrathecal administration due to glycine content.
Special Precautions
Expose patients & other users to risks of opioid addiction, abuse & misuse. Decrease rate of infusion by 50% or discontinue temporarily to generally manage resp depression in spontaneously breathing patients. Sedative effects of opioids may exacerbated by CO2 retention from opioid-induced resp depression. Closely monitor patients for resp depression when initiating therapy & following dosage increase. Not to be used in diagnostic or therapeutic procedures outside the monitored anesth care setting. Continuously monitor patients receiving monitored anesth care. Monitor O2 saturation on continuous basis. Increased risk of decreased resp drive eg, apnea even at recommended dose in patients w/ significant COPD/cor pulmonale & those w/ substantially decreased resp reserve, hypoxia, hypercapnia, or pre-existing resp depression. Avoid alcohol 24 hr after surgery. Discontinue use if serotonin syndrome is suspected. Continuous infusions should be administered only by an infusion device. IV bolus administration should be used only during maintenance of general anesth. Discontinuation of infusion should be preceded by establishment of adequate post-op analgesia. The IV tubing should be cleared to prevent the inadvertent administration upon discontinuation. May cause chest wall rigidity eg, inability to ventilate. Stop or decrease rate of administration in spontaneously breathing patients w/ muscle rigidity. Not to be administered in the same IV tubing w/ blood due to potential inactivation by nonspecific esterases in blood products. Bradycardia. Hypotension. Intraoperative awareness in patients <55 yr when co-administered w/ propofol infusion rates of ≤75 mcg/kg/min. Risks of use in spontaneously breathing patients w/ increased ICP, brain tumors, head injury or impaired consciousness. May obscure the clinical course in patient w/ head injury. May cause spasm of the oddi sphincter. May increase serum amylase. Monitor patients w/ biliary tract disease eg, acute pancreatitis. Increased frequency of seizures in patients w/ seizure disorders & risk of seizures occurring in other clinical settings associated w/ seizures. Monitor patients w/ history of seizure disorders. Standard monitoring should be maintained in post-op period to ensure adequate recovery w/o stimulation. Other analgesics should be administered prior to discontinuation in patients undergoing surgical procedures where post-op pain is generally anticipated. Use in morbidly obese patients. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid w/drawal syndrome. Not recommended in pregnant women during or immediately prior to labor when other analgesic techniques are more appropriate. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation & resp depression. Monitor infants exposed through breast milk for excess sedation & resp depression. W/drawal symptoms can occur in breastfed infants when maternal administration of opioid analgesic or when breast-feeding is stopped. Greater risk for resp depression in elderly, cachectic or debilitated patients. Reduced clearance approx 25% in elderly >65 yr. Rapid fall of blood conc after termination of administration in elderly.
Adverse Reactions
Asystole, serotonin syndrome, anaphylaxis. Nausea, hypotension, vomiting, muscle rigidity.
Drug Interactions
Concomitant use w/ benzodiazepines or other CNS depressants eg, benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesth, antipsychotics, other opioids or alcohol increased risk of hypotension, resp depression, profound sedation, coma & death due to additive pharmacologic effect. Concomitant use w/ serotonergic drugs eg, SSRIs, serotonin & norepinephrine reuptake inhibitors, TCAs, triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system eg, mirtazapine, trazodone, tramadol & drugs that impair metabolism of serotonin eg, MAOIs (those intended to treat psychiatric disorders & also others eg, linezolid & IV methylene blue) may result to serotonin syndrome. Concomitant use w/ butorphanol, nalbuphine, pentazocine, buprenorphine may reduce analgesic effect &/or precipitate w/drawal symptoms.
MIMS Class
Anaesthetics - Local & General
ATC Classification
N01AH06 - remifentanil ; Belongs to the class of opioid anesthetics. Used as general anesthetics.
Presentation/Packing
Form
Remikaf inj 1 mg
Packing/Price
(vial) 3 mL x 10 × 1's
Form
Remikaf inj 2 mg
Packing/Price
(vial) 5 mL x 10 × 1's
Form
Remikaf inj 5 mg
Packing/Price
(vial) 10 mL x 10 × 1's
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