Regional Parenteral Manual Usage Guidelines 1. Background and Objectives... 2 2. Off-Label Use of Drugs... 3 3. Abbreviations for Monographs and Definitions... 4 3.1 Abbreviations for Regional Parenteral Monographs ONLY... 4 3.2 Staff Abbreviations... 5 3.3 Y-Site Compatibility... 5 4. Parenteral Monograph Template Description... 6 FOR CAPITAL HEALTH/CARITAS USE ONLY. Unauthorized distribution, copying or disclosure prohibited. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 1 of 10
1. Background and Objectives The objective of the Capital Health (CH)/Caritas Regional Parenteral Manual this manual is to provide a convenient, accessible, and reliable reference for health professionals involved with parenteral drug administration. This manual is a compilation of existing site-specific parenteral monographs; current literature; and consultation with stakeholders, programs, and sites as needed. The Regional Parenteral Manual is maintained by Regional Pharmacy Services through the Regional Drug Information Center (RDIC), and is reviewed by the Medication Administration Policy Advisory Subcommittee (MAPAS) of the CH Drugs and Therapeutics Committee (DTC). Please note that this manual is NOT a comprehensive drug reference. The manual is to be consulted first for information on medication administration. If the information is not adequate, alternative sources should be consulted. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 2 of 10
2. Off-Label Use of Drugs Some of the monographs in the Regional Parenteral Manual may have indications, administration routes, or use in age groups that are not endorsed by the manufacturer, i.e. off-label use. Examples include the approved IV use of haloperidol and ketorolac in the parenteral manual, even though the manufacturers indicate that these drugs are for IM use only. The information in the regional parenteral monographs is obtained from several sources, including the manufacturer, the literature, and from current practice within Capital Health and/or across Canada. With off-label use, the information in the parenteral manual takes precedence over data from the manufacturer, as the parenteral manual monographs are a compilation of several references, and therefore are evidence-based or accepted practice. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 3 of 10
3. Abbreviations for Monographs and Definitions 3.1 Abbreviations for Regional Parenteral Monographs ONLY CrCl ClCr D5S D5-1/2S D5LR D5W D10W DSS g IM INR IV kg L LR m 2 mcg meq mg ml mmol (mmol) mosm (mosm) ng NS ½NS R RL Creatinine clearance Creatinine clearance Dextrose 5% and 0.9% sodium chloride Dextrose 5% and 0.45% sodium chloride Dextrose 5% and lactated Ringer s Dextrose 5% in water Dextrose 10% in water Dextrose-saline solutions Gram Intramuscular International normalization ratio Intravenous Kilogram Litre or liter Lactated Ringer s or Ringer s lactate or Ringer s injection, lactated Square metre Microgram Milliequivalent(s) Milligram Millilitre(s) Millimole(s) Milliosmole(s) Nanograms (= 1000 milligrams) Normal saline Half-strength normal saline (0.45% sodium chloride) Ringer s solution Ringers lactate SCC Specialized Clinical Competency SWI Sterile water for injection 2/3-1/3 Dextrose 3.3% and sodium chloride 0.3% q h Every hours. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 4 of 10
3.2 Staff Abbreviations NP DR RN RN-SCC RPN LPN ENS Nurse practitioner Physician/ resident Registered nurse RN with a Specialized Clinical Competency Registered psychiatric nurse Licensed practical nurse Employed nursing student. Note: ENS designation will not be included within the monographs. Each unit/patient care area will inform the ENS of their responsibilities regarding medication administration by any route. 3.3 Y-Site Compatibility Y-site compatibility means that two separate drug infusions are compatible when infused through the same line. For example, if the parenteral monograph indicates that ampicillin is compatible for 3 hours with furosemide in NS, it means that both infusions must be mixed in NS separately. The separate lines can then be connected, and both infusions run through the same line without risk of precipitation. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 5 of 10
4. Parenteral Monograph Template Description CLASSIFICATION: 8:12.16 Antibiotic - Antipseudomonal Penicillin OTHER NAMES: Piperacillin sodium, PIPRACIL PIPERACILLIN NAMES: Listed alphabetically by GENERIC name at the top right hand corner of each monograph. Other Names: Trade names, alternative generic names, and drug salts. Note: This is not a comprehensive listing and should not be considered as an endorsement of any product. CLASSIFICATION: Describes the group or class of medication. Route of Administration Who may give Special Training, Equipment, or Monitoring INTRAVENOUS SUBCUTANEOUS IM Direct IV Intermittent Continuous Injection Infusion YES YES NO NO NO YES RN/RPN- SCC 1 RN, RPN RN, RPN, LPN 2 1. RN or RPN with Specialized Clinical Competency in direct IV administration. 2. LPN with site and/or program requirements for IM administration. POLICY SECTION This is Capital Health/Caritas policy describing various routes of administration, who may administer the medication, special training, equipment or monitoring required. The numbers found under Route of administration and Who may give correspond with policy number in the Special training, Equipment and Monitoring section The Special Training, Equipment or Monitoring section implies that the available staff are knowledgeable in operating equipment and/or performing the monitoring. INDICATIONS Treatment of infections caused by susceptible aerobic and anaerobic bacteria. Treatment of infections caused by Pseudomonas aeruginosa. Combination antipseudomonal therapy is recommended for serious non-urinary infections. For further indications, refer to the current Capital Health Bugs & Drugs antimicrobial reference. CONTRAINDICATIONS Hypersensitivity to piperacillin or other penicillins. Cross-hypersensitivity with cephalosporins possible. INDICATIONS/CONTRAINDICATIONS General information included from the product monograph/cps. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 6 of 10
DOSAGE ADULTS Usual dose: 4 g every 6 hours. Dosage range: 16-24 g/24 hours in divided doses Maximum recommended dose: 24 g/24 hours NEONATES Age 7 days or less: Age more than 7 days: 150 mg/kg/day divided q8h. 200 mg/kg/day divided q6h. INFANTS/CHILDREN Usual Dose: 200-300 mg/kg/24 hours divided every 4-6 hours Maximum dose is the lesser of 500 mg/kg/24 hours or 24 g/24 hours. Cystic Fibrosis: 500 mg/kg/24 hours divided every 4-6 hours RENAL FAILURE Adult dosing recommendations based on creatinine clearance (CrCl): CrCl (ml/min) > 50 10 50 < 10 Dosage Interval q6h q6 8h q8h DOSAGE Adult: Reflects clinical practice in the CH region, and dosing information from the product monograph/cps. Antimicrobial/anti-infective doses are taken from the most current Capital Health Bugs and Drugs antimicrobial reference. Neonates/Infants/Children: Dosages for infants and children are taken from the current edition of the Pediatric Dosage Handbook, or the Neonatal/Pediatric Intravenous Medication Administration Guidelines, Stollery Children s Health Centre, Edmonton (the Child Health Subcommittee of the Drugs and Therapeutics Committee (DTC) endorsed use of this latter reference). Dosages for neonates are from the current edition of the Pediatric Dosage Handbook or Neofax. Renal or Hepatic Failure: This information will ONLY be included if dosage adjustments are required. Dosing regimens listed are derived from a variety of renal drug references including the product monograph/cps and/or the most current editions of: Capital Health Bugs and Drugs antimicrobial reference Drug Prescribing in Renal Failure American Hospital Formulary Service Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 7 of 10
ADMINISTRATION/DILUTION Confirm patency of vein and avoid extravasation. If thrombophlebitis occurs, decrease infusion rate and/or concentration. DIRECT IV Neonates/Infants/Children/Adults: Administer concentrations of 200 400 mg/ml over 3 5 minutes INTERMITTENT IV INFUSION Adults/Neonates/Infants/Children: Administer concentrations of 20-80 mg/ml, and infuse over 30 60 minutes. INTRAMUSCULAR Administer reconstituted solution (usual concentration 400 mg/ml). Injections should not exceed 2 g/site. Refer to Parenteral Medical Delivery Definitions for injection volumes see Corporate Administrative Directive 2.3.3 or the Regional Parenteral Manual Usage Guidelines. ADMINISTRATION/DILUTION Pediatrics: Recommendations for administration and dilution are taken from the most current edition of: Pediatric Dosage Handbook Neofax Neonatal/Pediatric Intravenous Medications Administration Guidelines, University of Alberta Hospital, Edmonton. Adults: Recommendations for administration and dilution are derived from a variety of sources including previous site-specific parenteral drug manuals, references/literature, and the product monograph/cps. ADVERSE EFFECTS Frequent: Diarrhea, nausea, vomiting, and headache. Less frequent: Rash, hives, pruritis, exfoliative dermatitis, hypersensitivity reactions including anaphylaxis, elevated liver function tests, oral or vaginal candidiasis, and serum sickness-like reactions. Rare: Leukopenia, neutropenia, thrombocytopenia or platelet dysfunction, C. difficile or pseudomembranous colitis, Stevens-Johnson syndrome, seizures with high doses, and interstitial nephritis. Parenteral: Thrombophlebitis, pain, erythema at injection site. ADVERSE EFFECTS Most common or serious side effects listed (may include frequency). This section does not necessarily contain all the side effects that may be encountered. Consult other references (CPS, AHFS) or pharmacy for more information. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 8 of 10
CLINICAL IMPLICATIONS Monitor for hypersensitivity reactions, blood dyscrasias, and for pseudomembranous colitis. Contains sodium, which may aggravate congestive heart failure. CLINICAL IMPLICATIONS Information regarding the most common administration, patient care, and patient assessment criteria associated with the drug. Recommendations from site specific monographs, various references, and product monograph/cps. STABILITY (Please note that stability information does not apply to parenteral products mixed by the pharmacy.) VIAL: Available as 2 g, 3 g, and 4 g vials. Store at room temperature. Once reconstituted (usual concentration 400 mg/ml), the vials are stable for 8 hours at room temperature. IV SOLUTION: Piperacillin is stable for 24 hours at room temperature and 72 hours refrigerated in D5W, NS, D5S, and LR. STABILITY The manufacturer s recommendations. These recommendations refer to the preparation of parenteral products on the patient care unit, and DO NOT include sterile products prepared in a pharmacy-based Centralized IV Additive (CIVA) service. COMPATIBILITY (If a medication is not listed, please contact pharmacy for information.) Y-SITE: Piperacillin is compatible with the following (usual administration concentrations for both drugs) for 3 hours in D5W, NS and D5-½S (unless indicated): alfentanil * amikacin aminophylline ampicillin mix in NS only ascorbic acid atracurium atropine aztreonam benztropine bretylium calcium chloride calcium gluconate cefazolin cefotaxime cefoxitin chlorpromazine mix in NS only cimetidine clindamycin cyclosporine dexamethasone digoxin diphenhydramine dopamine enalaprilat ephedrine epinephrine epoetin erythromycin lactobionate esmolol furosemide * gentamicin glycopyrrolate heparin hydralazine mix in NS only hydrocortisone imipenem/cilastatin indomethacin insulin, human regular isoproterenol ketorolac lidocaine magnesium sulfate mannitol meperidine metoprolol metronidazole midazolam morphine naloxone nitroglycerin norepinephrine ondansetron oxytocin penicillin G K penicillin G Na pentobarbital phenobarbital phentolamine mix in NS only phenylephrine * Stagger administration times with aminoglycosides, due to possible physical incompatibility leading to aminoglycoside inactivation. propranolol pyridoxine ranitidine sodium bicarbonate sodium nitroprusside streptokinase succinylcholine sufentanil theophylline in D5W thiamine ticarcillin ticarcillin/clavulanate * tobramycin vancomycin vasopressin verapamil Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 9 of 10
INCOMPATIBILITY amphotericin B ampicillin in D5W & D5 ½S azathioprine chlorpromazine in D5W & D5 ½S co-trimoxazole dantrolene diazepam dobutamine doxycycline famotidine ganciclovir haloperidol hydralazine in D5W & D5 ½S hydroxyzine labetalol papaverine pentamidine pentazocine phentolamine in D5W & D5 ½S phenytoin promethazine protamine quinidine gluconate COMPATIBILITY Y-Site Data is taken from the most current edition of Trissel s Tables when possible. The other references used include the most current editions of Trissel s Handbook on Injectable Drugs, or King Guide to Parenteral Admixtures. This is not a complete listing of all compatibility data but should be used as a guide for nurses, physicians and pharmacists when administering two intravenous drugs simultaneously via Y- site. The drugs are physically and/or chemically compatible in the solution(s) listed for 3 hours unless otherwise noted. Incompatibility: This is a documented physical interaction (precipitation, color change) or chemical interaction (drug degradation, drug interaction). These two drugs should NOT be infused through the same intravenous site. Where there are conflicting reports, factors such as concentration or additives, intravenous solutions used, ph of the solution, and percentage of drug degradation are considered, and a conclusion is made. Where no compatibility data is available, avoid infusing the drugs simultaneously. MISCELLANEOUS Half-life: Ranges from 36 72 minutes in healthy volunteers. REFERENCES 1-6,8,10A, 32, 47B FOR CAPITAL HEALTH/CARITAS USE ONLY. Unauthorized distribution, copying or disclosure prohibited. September 18, 2006 Piperacillin (version 3) cab/vc Page 4 of 4 MISCELLANEOUS: Information relating to the drug or drug therapy, that doesn t fit into the other sections. REFERENCES: References used in developing the monograph. The reference list (with the corresponding numbers), is located on the Regional Pharmacy Intranet site. FOOTER: Capital Health property disclaimer, date, drug name, initials of the primary author, and page number are listed at the bottom of each page. Regional Parenteral Manual Usage Guidelines Revised October 24, 2006 Page 10 of 10