discover [1:<18 years of age for management of benzodiazepine overdosage, for neonatal resuscitation, nor for reversal of sedation when benzodiazepines are used for induction of general anesthesia. 1 No substantial differences in safety and efficacy relative to adults for the reversal of conscious sedation. 1 Risks associated with flumazenil use in the adult population also apply to pediatric patients. 1 Geriatric Use No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity to flumazenil cannot be ruled out. 1 Hepatic Impairment Systemic clearance of flumazenil may be decreased. 1 (See Special Populations under Pharmacokinetics.) Dose adjustments may be necessary. 1 (See Hepatic Impairment under Dosage and Administration.) Common Adverse Effects Dizziness, injection site pain, increased sweating, headache, and abnormal or blurred vision. 1 Interactions for Romazicon Extensively metabolized in the liver, but the precise enzymes responsible are unknown. 1 Specific Drugs Drug Interaction Comment Alcohol Pharmacokinetic interaction not observed b Anesthetics, inhalational No deleterious interactions observed when flumazenil was administered after inhalation anesthetics 1 Benzodiazepines Pharmacokinetic interaction unlikely 1 May precipitate dose-dependent manifestations of withdrawal in patients with established physical dependence on benzodiazepines 1 Concomitant use contraindicated 1 Cyclic antidepressants Increased risk of seizures 1 Concomitant use contraindicated 1 Neuromuscular blocking agents Do not administer until the effects of neuromuscular blockade have been fully reversed 1 Nonbenzodiazepine hypnotics Flumazenil blocks the effects of nonbenzodiazepine hypnotics b Opiate agonists No deleterious interactions observed when flumazenil was administered after opiates 1 Skeletal muscle relaxants No deleterious interactions observed when flumazenil was administered after skeletal muscle relaxants 1 Romazicon Pharmacokinetics Absorption Onset Reversal of benzodiazepine-induced effects usually is evident within 1 2 minutes following completion of IV injection, with an 80% response occurring within 3 minutes, and the peak effect occurring at 6 10 minutes. 1 Duration Duration and degree of reversal of benzodiazepine-induced effects appear to be related to the dose of flumazenil and plasma concentrations of benzodiazepine. 1 b Food Ingestion of food during an IV infusion of the drug results in a 50% increase in clearance, most likely because of the increased hepatic blood flow that accompanies a meal. 1 Distribution Extent Extensively distributed in extravascular space. b Plasma Protein Binding Approximately 50% 1 (mainly albumin). b Elimination Metabolism Completely (99%) metabolized in the liver. 1 b Elimination Route Principally by hepatic metabolism and is dependent on hepatic blood flow;> <1% of the administered dose excreted in urine as unchanged drug. 1 Half-life Terminal half-life is approximately 0.7 1.3 hours. 1 Special Populations In patients with mild to moderate or severe hepatic impairment, clearance is reduced to 40 60 or 25% of that of patients with normal hepatic function, respectively. 1 In children 1 17 years of age, half-life of flumazenil is more variable (averaging 40 minutes; range: 20 75 minutes) than that in adults. 1 b Stability Storage Parenteral Injection 15 30 C. 1 Discard unused solution 24 hours after initial entry into a syringe or mixture with any of the compatible solutions. 1 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility HID 1 Compatible Dextrose 5% in water Lactated Ringer s Sodium chloride 0.9% Drug Compatibility Admixture CompatibilityHID Compatible Aminophylline Cimetidine HCl Dobutamine HCl Dopamine HCl Famotidine Heparin sodium Lidocaine HCl Procainamide HCl Ranitidine HCl Actions Antagonizes CNS effects (e.g., sedation, impaired recall, psychomotor impairment, respiratory depression) of benzodiazepines by competitively inhibiting the activity of the drugs at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex. 1 Does not antagonize the CNS effects of drugs affecting GABA-ergic neurons by means other than the benzodiazepine receptor (e.g., barbiturates, alcohol, general anesthetics) and does not reverse the effects of opioids. 1 Advice to Patients Risk of impaired memory and judgment. 1 Risk of increased adverse effects in regular users of benzodiazepines; importance of informing clinicians of history of benzodiazepine, alcohol, and/or sedative use prior to use of flumazenil. 1 Importance of avoiding activities that require complete alertness, and not operating hazardous machinery or a motor vehicle until at least 18 24 hours after discharge and it is certain that no residual sedative effects of the benzodiazepine remain. 1 Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Flumazenil Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection, for IV use 0.1 mg/mL (0.5 and 1 mg)* Flumazenil Injection (with parabens) Abraxis, Apotex, Baxter, Bedford, Sabex, Sicor Romazicon (with parabens) Roche AHFS DI Essentials. Copyright 2017, Selected Revisions August 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 1. Roche Laboratories, Inc. Romazicon (flumazenil) prescribing information. Nutley, NJ; 2000 May. 2. Weinbroum AA, Flaishon R, Sorkine P et al. A risk-benefit assessment of flumazenil in the management of benzodiazepine overdose. Drug Saf . 1997; 17:181-96. [PubMed 9306053] 3. Shannon M, Albers G, Burkhart K et al for the Flumazenil Pediatric Study Group. Safety and efficacy of flumazenil in the reversal of benzodiazepine-induced conscious sedation. J Pediatr . 1997; 131:582-6. [PubMed 9386663] 4. Mathieu-Nolf M, Babé MA, Coquelle-Couplet V et al. Flumazenil use in an emergency department: a survey. J Toxicol Clin Toxicol . 2001; 39:15-20. [PubMed 11327221] HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:735-6. b. Roche Laboratories, Inc. Romazicon (flumazenil) prescribing information. Nutley, NJ; 2003 Dec. Next Interactions Print this page Add to My Med List More about Romazicon (flumazenil) Side Effects During Pregnancy Dosage Information Drug Interactions Compare Alternatives Support Group En Español 0 Reviews Add your own review/rating Drug class: antidotes Consumer resources Romazicon Professional resources Romazicon (FDA) Flumazenil (AHFS Monograph) Related treatment guides Reversal of Sedation Benzodiazepine Overdose> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Antidotes Related Drugs Benzodiazepine Overdose flumazenil , More... Reversal of Sedation flumazenil , More... Romazicon Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! undoubtedly
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