Intranasal Medication Administration – Adult/Pediatric – Inpatient/Ambulatory/Primary Care Clinical Practice Guideline Note: Active Table of Contents – Click to follow link Executive Summary ................................................................................................................................ 3 Scope ..................................................................................................................................................... 7 Methodology ......................................................................................................................................... 7 Definitions ............................................................................................................................................. 8 Introduction ........................................................................................................................................... 8 Recommendations ................................................................................................................................. 9 General Recommendations for Intranasal Administration ....................................................................... 9 Drug-Specific Practice Recommendations ............................................................................................. 10 UW Health Implementation ................................................................................................................. 14 Appendix A. Evidence Grading Scheme ................................................................................................. 15 References ........................................................................................................................................... 17 Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority Contact: [email protected] Vermeulen, [email protected] Last Revised: 02/2017 Contact for Content: Philip Trapskin, PharmD, BCPS 608-263-1328 [email protected] Contact for Changes: Philip Trapskin, PharmD, BCPS 608-263-1328 [email protected] Guideline Author: Ashlinn Samuel, PharmD Joshua Vanderloo, PharmD, BCPS Coordinating Team Members: Cindy Gaston, PharmD Aaron Steffenhagen, PharmD, BCPS Joe Halfpap, PharmD, BCPS Review Individuals/Bodies: Michael K. Kim, MD; Gregory A. Hollman, MD; Brian LaRowe, RPh, MSc; Peggy Riley, RN, MN, MPH Committee Approvals/Dates: P&T Committee – February 2017 Release Date: February 2017 Next schedule review: February 2019 2 Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority Contact: [email protected] Vermeulen, [email protected] Last Revised: 02/2017 Executive Summary Guideline Overview This clinical practice guideline is intended to guide clinicians in the use of medications intranasally for systemic effect which are not labelled for intranasal use. Key Revisions (2016 Periodic Review) None Key Practice Recommendations Refer to Table 1. 3 Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority Contact: [email protected] Vermeulen, [email protected] Last Revised: 02/2017 Table 1. Intranasal medication administration for systemic absorption. Appropriate Adverse Effects Related to Drug Preferred Product Dosing Pharmacokinetics Indications Intranasal Administration Bioavailability: 65% (range: 35- 93%)4 Adult: Onset: 30-45 minutes (range: 25-68 1-1.5 mcg/kg 45-60 minutes prior to minutes)2,4,7-10 Premedication surgery or procedure requiring Peak effect: 90-105 minutes (in prior to general sedation15,17,23 adults)10 Dexmedetomidine anesthesia and Duration of action: HCl 100 mcg/mL None specific to intranasal route of Dexmedetomidine procedural Pediatric (≥10 kg and ≥1 year old): . Adult: Easily arousable sedation 1-10 intranasal solution administration sedation for minor 1-2 mcg/kg 45-60 minutes prior to with 1-1.5 mcg/kg dose for ≥180 [785204] 10 surgeries and surgery or procedure requiring minutes procedures1-10 sedation; use 1 mcg/kg for . Pediatric: Dose dependent; 1 procedures of anticipated duration mcg/kg dose 45 minutes (range: <45 minutes1,3,5-9 40-100 minutes)1,7,8 and 2 mcg/kg dose 95 minutes (range: 45-135 minutes)7 Adult: 0.9-2.2 mcg/kg (maximum of 100 18 Self-resolving unpalatable taste, mcg/2 mL) initial dose, may repeat Bioavailability: 55-77% Fentanyl citrate 50 15,16,18 watery eyes, nasal congestion, or with 60 mcg every 5 minutes Onset: 5 to 10 minutes Fentanyl Acute analgesia mcg/mL intranasal 24,25 18 throat irritation in adult patients thereafter Peak effect: ~20 minutes solution [785209] 18 (information regarding pediatric Duration of action: ~50 minutes adverse effects not available)15,19 Pediatric (≥10 kg and ≥1 year old): 1-1.5 mcg/kg/dose11-17 Initial route of administration for Adult: cases of 21 Not recommended Bioavailability: Undetermined suspected or Flumazenil 100 21 Onset: <2 minutes None specific to intranasal route of Flumazenil actual mcg/mL intranasal 21 20,21 Pediatric: Peak effect: 2 minutes administration benzodiazepine solution [785205] 21 40 mcg/kg with a maximum dose of Duration of action: Undetermined overdose when IV 20,21 200 mcg (100 mcg in each nostril) route is not available96,97 Glucagon Not recommended for intranasal use22-33 Haloperidol Not recommended for intranasal use Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority Contact: [email protected] Vermeulen, [email protected] Last Revised: 02/2017 Appropriate Adverse Effects Related to Drug Preferred Product Dosing Pharmacokinetics Indications Intranasal Administration Bioavailability: ~55% (1 mg dose Adult: Hydromorphone 34-36 range 26-71%; 2 mg dose range 36- 1-2 mg per dose 36 Self-resolving unpalatable taste, HCl 1 mg/mL 78%) Hydromorphone Acute analgesia 34,35 nasal itching, nasal congestion, or intranasal solution Onset: 10-20 minutes 34,35 Pediatric: 34,35 nasal stinging [785206] 34-36 Peak effect: 20-50 minutes Not recommended 35 Duration of action: 180 minutes Adult: Not recommended37-49 Pediatric (≥5 kg and ≥6 months 44 Procedural Bioavailability: 50% old): sedation and Onset: ~5 minutes (range: 4-10 Ketamine HCl 100 . Procedural sedation: 6-9 mg/kg 37,38,48 premedication for minutes) None specific to intranasal route of Ketamine mg/mL intranasal 4-8 minutes prior to procedures 37-39,48,49 37-49 reducing Peak effect: Not established administration solution [785203] anticipated to last <30-40 preoperative 37,38,48 Duration of action: 40 minutes 37-49 minutes 37-39,48,49 anxiety (range: 22-69 minutes) . Premedication: 0.5-10 mg/kg (preference of doses ≥3 mg/kg) 15-30 minutes prior to separation from parents40-44,49,50 Adult: . Migraines: 20 mg in nostril of Treatment of affected side if unilateral, 20 mg moderate to in each nostril if bilateral; may severe migraines repeat with second dose if lack of Bioavailability: 26% (range: 5- Lidocaine HCl 40 51-54 56 when alternatives relief within 2-15 minutes 48%) Self-resolving local irritation (burning, mg/mL (4%) 51 Lidocaine are ineffective and . Idiopathic second-division Onset: 5-15 minutes stinging, numbness), bitter taste, intranasal solution 51 for idiopathic trigeminal neuralgia: 8 mg in Peak effect: Undetermined numbness of the throat, and nausea [785202] second-division each nostril for a total dose of 16 Duration of action: Undetermined trigeminal mg55 neuralgia51-55 Pediatric: Not recommended51-55 Adult: 59 Bioavailability: ~78% 0.1 mg/kg55,57 Lorazepam 4 Onset: ~5 minutes (range: 1-25 Acute seizure 57,58 Poor taste, cool feeling in nose and Lorazepam mg/mL injection minutes) 55,57 treatment Pediatric (≥2 months old): 59,60 throat, burning nasal sensation solution Peak effect: 30-105 minutes 0.1 mg/kg (consider maximum of 4 58 Duration of action: ~60 minutes mg dose)57,58 5 Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority Contact: [email protected] Vermeulen, [email protected] Last Revised: 02/2017 Appropriate Adverse Effects Related to Drug Preferred Product Dosing Pharmacokinetics Indications Intranasal Administration Adult: Not routinely recommended due to nasal volume limitations, but may consider 0.2-0.3 mg/kg if alternative Procedural routes unavailable (maximum of 10 sedation prior to mg due to volume administration 63 minor procedures limitations) 64 Bioavailability: 50-83% or imaging and Onset: Average 3-15 minutes (range: pre-induction for Pediatric: 64,67,68,73,83,86,88 Midazolam HCl 5 0.5 to 19 minutes) Self-limiting discomfort, irritation, or general anesthesia . Procedural sedation and pre- Midazolam mg/mL intranasal Peak effect: ~25 minutes (10-48 burning sensation in nasal and alternative induction for general anesthesia: 90,91 60,90 solution [785196] minutes) passages therapy for 0.2-0.5 mg/kg (consider Duration of action: 21 to 60 minutes pediatric seizures maximum dose of 10 mg due to 61,64,67,73,79,92 50,61,62,64-82 (dose-dependent) when the IV route volume limitations) is not available . Seizures: 0.2-0.5 mg/kg63,83-89; 61,62 Reference Status Epilepticus - Pediatric - Emergency Department/Inpatient Clinical Practice Guideline for additional information Morphine Not recommended for intranasal use93-97 Initial route of Adult: administration for 98-104 2 mg (1 mg in each nostril) 105 cases of Bioavailability: 4% Naloxone 1 mg/mL 105 suspected or Onset: Undetermined None specific to intranasal route of Naloxone intranasal solution Pediatric: 105 98-108 actual opioid Peak effect: 6-9 minutes administration [785210] 0.4 mg total dose (0.2 mg in each 105 overdose when the Duration