REMS FDA Documents (opioids)

Search results for:

demo

demo
Brand names: DemoDrug
No brands, forms, or strengths have been added for this generic.
Display Miscellaneous Therapeutic Agents Class: 920000
High Alert Drug : Policy
Medication comments:

inhouse This redlock symbol signifies that the link it is displayed with is only accessible within the IHS network ("inside the firewall") or has a UserName and Password requirement.

sample notes:

Refrigerator item 

Sample STOP note.
Sample SLOW note.
sample link types:

sample policy

sample jQuery tabs (these tabs are used if a drug is part of more than 2 of these collections):
How to make 3% saline using NS and concentrated NaCl:
component volume
Normal Saline    500 ml
Sodium Chloride 23.4%   51.5 ml
total volume 551.5 ml
High Alert Drug: Factor Xa inhibitors
 • Nurses and pharmacists verify dose and that patient is not on heparin or other anticoagulant prior to administration.
 • Two RNs independently verify dose prior to administration if the dosing requires manipulation (i.e. drawing up a portion of a vial, or giving a portion of a syringe}.
 • Anticoagulation comparison chart available on nursing units for reference.
 • Pharmacists/nurses provide patient education for oral anticoagulants.
 • Pharmacists monitor labs for appropriate dosing and prevention of adverse events.
 • Reversal agents and order sets for oral anticoagulants
Per policy, these medications require cardiac and/or special monitoring ("Y" = allowed)  
generic (Brand) / Notes ICU / CCU / ED 2N (Tele) HB-SNF Med / Surg ICS BirthPlace
abciximab (ReoPro) IV Key: order set Y Y N N N N
Iredell Memorial Hospital ICU Adult Infusion Guidelines
Note: This information is intended to serve as a guide outlining the most commonly accepted infusion rates to date. However, it is recognized that some patients may require safe and therapeutic doses outside of the stated range for medical management. Unless otherwise specified by the physician, infusions are to be initiated at the lowest dose and titrated accordingly to specified parameters while documenting patient response and tolerability.
Drug Name Onset Preparation Compatible fluids
CISatracurium (Nimbex) 2-3 min 100 mg/250 ml D5W NS and D5W
"Normal Dosage" Titration Guidelines (for increasing and decreasing doses)
1 - 10 mcg/kg/min by 1 mcg/kg/min q 10 min to TOF as specified by MD
Per policy, use of these medications is restricted as noted below:
Generic (Brand) Restrictions
pamidronate (Aredia) Outpatient Only (for osteoporosis)
Per policy, these drugs are subject to renal dosing adjustments by pharmacy.
Generic + Route
(Brand)
• Indications		 Usual Adult Dose
Comments		 Renal Dosage Adjustments
acyclovir IV
(Zovirax©)
• Chickenpox		 20 mg/kg q8h
Actual weight, use IBW for obese pts		 CrCl > 50: No adjustment necessary
CrCl 25 - 50: 20 mg/kg q12h
CrCl 10 - 24.5: 20 mg/kg q24h
CrCl < 10: 10 mg/kg q24h
acyclovir IV
(Zovirax©)
• Herpes Zoster
• HSV encephalitis		 10 mg/kg q8h
Actual weight, use IBW for obese pts		 CrCl > 50: No adjustment necessary
CrCl 25 - 50: 10 mg/kg q12h
CrCl 10 - 24.5: 10 mg/kg q24h
CrCl < 10: 5 mg/kg q24h
acyclovir IV
(Zovirax©)
• Herpes Simplex		 5 mg/kg q8h
Actual weight, use IBW for obese pts		 CrCl > 50: No adjustment necessary
CrCl 25 - 50: 5 mg/kg q12h
CrCl 10 - 24.5: 5 mg/kg q24h
CrCl < 10: 2.5 mg/kg q24h
acyclovir PO
(Zovirax©)		 200 - 800 mg 5x/day CrCl > 25: No adjustment necessary
CrCl 10 - 25: 200 - 800 mg q8h
CrCl < 10: 200 - 800 mg q12h
Per policy, orders for these non-formulary agents will be changed to formulary equivalents.  
Non-Formulary Agent Formulary Equivalent
omeprazole (PriLOSEC) 10-40 mg PO pantoprazole (Protonix) 40 mg PO at same frequency (esomeprazole (NexIUM) 40 mg packets if patient receives medication through a tube)
Per policy, these drugs may be converted from IV to PO in patients who meet criteria.  
 ciprofloxacin (Cipro) - may convert from 400 mg IV to 500 mg PO.
 ciprofloxacin (Cipro) - may convert from 200 mg IV to 250 mg PO.
Per policy, these hazardous drugs have special waste requirements.
Generic (Brand) Waste Requirements
aclidinium (Tudorza Pressair) Inhaler canister ⇒  BLACK BUCKET 
Medications Requiring Filters
Medication Preparation Filter Administration Filter
cabazitaxel (Jevtana) Not required. Use a 0.22 micron inline filter.
Filter Drugs - 2024 
Medication: mannitol
Filter size: See comments
Administration: Administer with an in-line filter when infusing concentrated mannitol (20% or more) due to the potential for crystal formation; some resources state to administer with an in-line filter for concentrations of 15% or more.5,7 No current manufacturer provides a filter size recommendation.108-111 One source currently suggests a filter size between 0.2 and 5 microns.7
IMH Comment: Use a 0.2 micron filter
 Per policy, these antibiotic medications may be given IV push.  Adult Patients Only!
generic (Brand) Strength Copy/Paste comments for PharmNet
cefTAZidime (Fortaz) 1 gm vial Dilute with 10 ml Sterile Water for Injection and give over 3-5 mins.
 Keep separate from aminoglycosides.
cefTAZidime (Fortaz) 2 gm vial Dilute with 10 ml Sterile Water for Injection and give over 3-5 mins.
 Keep separate from aminoglycosides.
 Available ED To-Go packages.
Description (Qty)
APAP/butalbital/caffeine (Fioricet) 325 mg - 50 mg - 40 mg tablets (#4)
USP <800> Hazardous Drugs 
Per Policy, these drugs have special handling requirements (any drug with an "AOR" is exempt from these requirements under normal circumstances).
generic (Brand) Route Risk Level AOR? Warnings
(hover over entry for details)
 ziv-aflibercept (Zaltrap) IV High No  Notes FDA-C
Receiving • Gloves: Single
Pharmacy:
Preparation		 • Gloves: Double
• Gown: Yes
• Ventilated Engineering controls: Yes, Class II bio-safety cabinet or compounding aseptic containment isolator
• Closed System Transfer Device: Yes
Nursing:
Administration		 • Gloves: Double
• Gown: Yes
• Eye/face protection: ---
• Closed System Transfer Device: Yes
USP <800> Hazardous Drugs 
Per Policy, these drugs have special handling requirements (any drug with an "AOR" is exempt from these requirements under normal circumstances).
generic (Brand) Route Relative Risk Level AOR? NIOSH 2024 Table MSHI?↑ Warnings
 ziv-aflibercept (Zaltrap) IV Low N/A 2B↑    
NIOSH Supplemental information (2016): Embryotoxic and teratogenic in rabbits at exposure levels lower than human exposures at the recommended dose, with increased incidences of external, visceral, and skeletal fetal malformations FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks;
USP <800> Hazardous Drug Assessment of Risk (AOR)
Per policy, these drugs are exempt from USP <800> handling requirements under normal circumstances.
The following outlines must be followed.
generic (Brand) Route
[Packaging: Manufacturer ⇒ Dispense]
abacavir (Ziagen) PO
[UD ⇒ UD]		  300 mg tablet Stock @ IDBH? N
NIOSH Table 2↑
Activity Details
Pharmacy:
Receiving / Storage / Preparation

Exposure Risk: minimal
 • Handling/preparation PPE Requirements: n/a
• Receiving from Distributor: Standard
• Pharmacy Storage Area: Carousel
• Packaging/Reconstitution Location: n/a
• Compounding (Non-Sterile/Sterile) Location: n/a
• Omnicell Load: No
Transport • Transport (dose is placed inside a plastic sealable bag): Standard
Nursing:
Storage / Administration

Exposure Risk: low
 • Handling/administration PPE Requirements: Single pair of CX approved gloves. Wash hands after handling
• Storage of Finished dose in Nursing Area/Procedural Area: Patient Med Drawer
• Signage on Patient Door Required: No
• Manipulation of Dosage Form: n/a
• Special Manipulation for Administration: do not crush tablet
Disposal / Spills • Disposal of Drug Waste: Full-  blue bin , Trace/packaging- trash
• Disposol of Used PPE: trash bin (inside plastic bag)
• Spill ma nagement: n/a
NIOSH Supplemental Information: malignant tumors observed in male/female mice/rats; genotoxic in in vivo micronucleus tests
Reason for exemption of USP<800> Containment Requirements: Purchased in final dosage form; packaged as unit dose. Does not require additional manipulation for dispensing.
Anticoagulant / Antiplatelet Stoppage For Procedures
generic (Brand) Dept. Procedure Type
(hover over entry for examples)		 Stop Medication Prior To Procedure
abciximab
(ReoPro)
(not stocked at IHS)		 Anesthesia High-risk 2-5 days
Intermediate-risk 2-5 days
Low-risk 2-5 days
Patients with high risk of bleeding (eg, old age, history of bleeding tendency, concurrent uses of other anticoagulants/antiplatelets, liver cirrhosis or advanced liver disease, and advanced renal disease) undergoing low- or intermediate-risk procedures should be treated as intermediate or high risk, respectively.
Radiology
 Invasive Procedures No data
Paracentesis/Thoracentesis No data
Adult Extravasation Management
Generic (Brand) Vesicant / irritant Local Care
Comments / Treatment links
 calcium salts Vesicant Cold compress
Enteral Drug Administration notes.
Generic
(Brand)		 Comments and Considerations Recommendations for Administration with Enteral Nutrition
benzonatate
(Tessalon Perles)		 Do NOT alter integrity of dosage form. Mucosal irritant Do NOT administer through feeding tube. Use therapeutic alternative.
2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults.
Medication: acetaminophen-codeine (Tylenol #3)
Criteria 2: Potentially inappropriate medication use in older adults due to drug–disease or drug–syndrome interactions that may exacerbate the disease or syndrome. (Table 3)
Drug(s) ⇆ disease or syndrome opioids ⇄ Delirium
Rationale Avoid in older adults with or at high risk of delirium because of the potential of inducing or worsening delirium.
Opioids: emerging data highlights an association between opioid administration and delirium. For older adults with pain, use a balanced approach, including the use of validated pain assessment tools and multimodal strategies that include nondrug approaches to minimize opioid use.
Recommendation Avoid, except in situations listed under the rationale statement.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Drug(s) ⇆ disease or syndrome opioids ⇄ History of falls or fractures
Rationale May cause ataxia, impaired psychomotor function, syncope, or additional falls
If one of the drugs must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures. (i.e., anticholinergics, selected antidepressants, antiepileptics, antipsychotics, sedative/hypnotics including benzodiazepines and, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids) and implement other strategies to reduce fall risk.
Recommendation Avoid except for pain management in the setting if severe acute pain.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Criteria 4: Potentially clinically important drug-drug interactions that should be avoided in older adults. (Table 5)
Interacting drug(s) or class(es) opioids ⇄ benzodiazepines
Risk Rationale Increased risk of overdose and adverse events.
Recommendation Avoid
 Quality of evidence: Moderate, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ CNS-active agents
Risk Rationale Increased risk of falls and of fracture with the concurrent use of ≥3 CNS-active agents (antiepileptics including gabapentinoids, antidepressants, antipsychotics, benzodiazepines, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids, and skeletal muscle relaxants).
Recommendation Avoid concurrent use of ≥3 CNS-active drugs Click for list; minimize the number of CNS-active drugs.
 Quality of evidence: High, Strength of Recommendation: Strong
 
Interacting drug(s) or class(es) opioids ⇄ gabapentin, pregabalin
Risk Rationale Increased risk of severe sedation-related adverse events, including respiratory depression and death.
Recommendation Avoid; exceptions are when transitioning from opioid therapy to gabapentin or pregabalin, or when using gabapentinoids to reduce opioid dose, although caution should be used in all circumstances.
 Quality of evidence: Moderate, Strength of Recommendation: Strong
Per policy, these hazardous drugs have special handling and/or waste requirements.
generic (Brand) Handling Risk Level Warnings
(hover over entry for details)
Waste Requirements
 arsenic trioxide (Trisenox) High  IARC-1 NTP-1 FDA-D
If > 3% by weight of drug remains ⇒  BLACK BUCKET 
Trace amounts/uncontaminated PPE ⇒  YELLOW BUCKET 
Per policy, these hazardous drugs have special handling and/or waste requirements.
Generic (Brand) Waste Requirements
aclidinium (Tudorza Pressair) Inhaler canister ⇒  BLACK BUCKET 
Per policy, these hazardous drugs have special handling and/or waste requirements.
generic (Brand) Handling Risk Level Warnings
(hover over entry for details)
 clonazePAM (KlonoPIN) Low  Notes FDA-D
Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics Reference
Medication: ARIPiprazole (Abilify)
Key Potentially Inappropriate Drugs in Pediatrics (KIDs) List: Second Edition (Table 1)
Drug DOPamine antagonists: 2nd generation antipsychotics
Risk/Rationale Withdrawal emergent dystonia/dyskinesia
Recommendation Avoid rapid discontinuation in 18 yr of age and younger
 Quality of evidence: High, Strength of Recommendation: Strong
 
Drug DOPamine antagonists: 2nd generation antipsychotics
Risk/Rationale Type 2 diabetes, weight gain, dyslipidemia, and/or metabolic syndrome (risk greater for cloZAPine ≥ OLANZapine > QUEtiapine > risperiDONE, paliperidone, iloperidone > asenapine > ARIPiprazole, brexpiprazole > lurasidone, cariprazine > ziprasidone, lumateperone)
Recommendation Avoid use of OLANZapine for a duration of >12 wk in 18 yr of age and younger
Caution in 18 yr of age and younger
 Quality of evidence: High, Strength of Recommendation: Strong
 
Drug DOPamine antagonists: 2nd generation antipsychotics
Risk/Rationale Hyperprolactinemia (risk greater for paliperidone > risperiDONE > OLANZapine)
Recommendation Caution in 18 yr of age and younger
 Quality of evidence: High, Strength of Recommendation: Strong
Last updated: Sep. 29, 2025
  • Renal Adjustment Policy DemoDrug is subject to adjustments by pharmacy.
  • Therapeutic Interchange Policy albuterol (Ventolin)
  • Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug / Assessment of Risk
  • Hazardous Waste BLACK BUCKET
  • IV to PO Conversion Policy Policy
  • Black Box Warnings Cardiovascular; gastrointestinal risk
  • Look-Alike/Sound-Alike HYDROmorphone confused with morphine
UpToDate Lexidrug

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556



This site is intended for the staff of Iredell Health System. While others may view accessible pages, Iredell Health System makes no warranty, express or implied, as to the use of this information outside of Iredell Health System. The content of this policy and procedure document serves as guidance to the delivery of quality patient care. Care providers are expected to exercise critical thinking and situational awareness skills, and in specific situations to take such action as is necessary for the delivery of quality patient care.
Copyright © 2025 Rpharmy, LLC ­ All Rights Reserved