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Home , Erythromycin

Volume 24, Number 10 November/December 2010 Drugs & Therapy B N U N L N L N E N T N I N N

PRESCRIBING FORMULARY UPDATE The Pharmacy and Therapeutics Oral erythromycin for : Committee met October 19, 2010. 1 product was added in the Formulary, The more stable choice? and 1 product was deleted. 2 prod- rythromycin is a anti- requested that the bottle with the pow- ucts were designated nonformulary biotic that has been available since der for suspension and the measured and not available. 1 interchange and E the 1950s. It is rarely used as an anti- amount of water be sent home with 1 restriction were approved. biotic today and is primarily used for patients so they could reconstitute the its “prokinetic” effect on the gastro- mixture themselves and avoid 2 trips ◆ ADDED intestinal (GI) tract. It has been used to the pharmacy. It is not clear that this Acetaminophen 80-mg successfully off-label for the treatment is legal in the State of Florida since a Suppositories of gastroparesis and other GI hypo- pharmacist is responsible for the final (Generic by Actavis) motility disorders. preparation. Erythromycin ethylsuc- When erythromycin was used as an cinate oral suspension (EryPed®) is ◆ DELETED , patients often complained stable for 35 days after reconstitution, about it causing . Re- which avoids this issue. Urokinase searchers eventually determined that Another concern with the long-term (Kinlytic®)* erythromycin stimulates recep- use of is the contribu- *Nonformulary and Not Available tors in the GI tract. Motilin receptors tion to the development of resistance. stimulate GI contractions and results in Unlike erythromycin, azithromycin is ◆ NONFORMULARY AND increased GI motility. still commonly used for its antibacterial NOT AVAILABLE effects and chronic use may contribute ◆ - (Tekamlo®) to resistance. Erythromycin does have Erythromycin does have more sig- ◆ INTERCHANGES nificant drug interactions than azithro- more significant drug mycin. Erythromycin is an inhibitor of Oral for Phenytoin IV† interactions than CYP3A isoforms, which can lead †Same dose if meets criteria for inter- to increased exposure to some drugs change azithromycin. (eg, cyclosporine, , dihy- droergotamine, methadone, , ◆ CRITERIA-FOR-USE CHANGES Both oral and intravenous (IV) eryth- , , , Nitric Oxide (INOmax®)‡ romycin have been used for its proki- , and vinblastine). Erythromy- ‡Restricted to Nitric Oxide Order Form netic effect. The IV form is generally cin also causes QT-prolongation, which for Adults reserved for acute conditions. The oral can be problematic when used with form is usually given in lower dosages drugs that also prolong the QT-interval Acetaminophen 80-mg sup- than required for antibiotic effects (ie, (eg, , disopyramide, dro- positories were previously deleted 150-250 mg PO 3 to 4 times a day given peridol, haloperidol, and ziprasidone). from the Formulary and designated 30 minutes before a meal). The oral There is better evidence supporting nonformulary and not available. form has been shown to work rapidly the use of erythromycin rather than This was done only because they and can be substituted when the IV azithromycin for prokinetic effects. were no longer available from a form is unavailable. Erythromycin 35-day stability makes manufacturer. Since a new vendor There have been some prescribers it the obvious choice in the outpatient has marketed this dosage form, who use azithromycin instead of eryth- setting so patients can obtain a 30-day acetaminophen 80-mg suppositories romycin. There is much less published supply at a time. were re-added in the Formulary. evidence to support the prokinetic effects of azithromycin compared with Acetaminophen is used for pain ◆ and fever control and is given erythromycin. Azithromycin suspen- rectally when patients cannot take sion also has the disadvantage of being INSIDE THIS ISSUE medications by mouth. Low dosages stable for only 10 days after reconstitu- ◆ Do not substitute used in small children are difficult to tion. The 10-day stability presents a problem for patients who take the drug ◆ Desvenlafaxine interchange give without the 80-mg suppository correction option. longer than 10 days. They need to re- ◆ (continued on next page) turn to the pharmacy to obtain a fresh Annual index bottle 3 times a month. Some have Formulary update, from page 1 unfamiliarity with optimal administra- phenytoin: 1) ICU patients, 2) patients Urokinase is a thrombolytic en- tion practices for this medication. receiving continuous enteral nutrition, zyme produced by kidney cells. There The approval of a policy that allows 3) patients with a history of seizure have been several parenteral uroki- automatic interchange from IV to oral activity within the last 72 hours, nase products produced using recom- (PO) phenytoin was approved by the 4) patients on continuous EEG moni- binant DNA technology and tissue P&T Committee to potentially avoid toring, 5) patients receiving intra- cultures of kidney cells. Urokinase adverse effects of IV phenytoin (ie, venous doses of 400 mg or more (or has had a history of quality problems. cardiac toxicity and extravasation reac- 10 mg/kg or more for children) will In 1999 it was removed from the mar- tions) when oral phenytoin is a viable not be automatically converted to PO, ket because of a viral contamination option. and 6) loading doses. of the kidney cell tissue cultures used Intravenous phenytoin sodium Nitric oxide is an inhaled gas that in production. injection must be administered at a dilates the pulmonary blood ves- Urokinase (Abbokinase®) was maximum rate of 50 mg/min for adults sels. It has a labeled indication for remarketed in 2002. Abbott discon- and 1 mg/kg/min (up to 50 mg/min) for the treatment of hypoxic respiratory tinued manufacturing Abbokinase® in pediatric patients. If given too quickly, failure [in conjunction with ventila- 2004. ImaRx purchased Abbokinase® it can cause cardiac and tory support and other agents] for in 2006 and renamed it Kinlytic®, hypotension. For a typical adult load- term and near-term (greater than 34 which became available in April ing dose of 1 gram, this dose should weeks) neonates. It has been used 2007. Microbix purchased Kinlytic® be administered over no less than 20 extensively for off-labeled uses where in September 2008. Microbix was minutes. In addition to concerns about patients, including adults, have in- unable to use the available inventory creased pulmonary arterial pressures. of Kinlytic®. It is unclear when new ◆ In November 2008, the P&T Com- product will be available. Therefore, mittee required the use of inhaled urokinase was deleted from the For- The following are exclusion epoprostenol (Flolan®), a prostaglan- mulary and designated nonformulary criteria for automatic IV to PO din analogue that also dilates the pul- and not available because it cannot conversion of phenytoin: monary vasculature, prior to nitric ox- be acquired for use. ide except in the following situations: Alteplase is an alternative to uro- 1) ICU patients, 1) pre-ECMO, PPHN, and CDH in the kinase listed in the Formulary. 2) patients receiving continuous NICU; 2) rapid deterioration (PaO2/FIO2 Tekamlo® is a combination anti- enteral nutrition, less than or equal to 60); 3) pediatric hypertensive containing the direct 3) patients with a history of post-operative cardiac surgery (per renin inhibitor, aliskiren, and the seizure activity within the last the Pediatric Cardiac Surgeons); 4) calcium-channel-blocker, amlodipine. 72 hours, pulmonary hypertension (primary or There have been many combination 4) patients on continuous EEG secondary) with MPAP of 30 mm Hg or greater in the SICU-NSICU-CICU or 40 antihypertensive agents approved by monitoring, FDA over the last year or so. Combi- mm HG or greater in MICU; 5) patients 5) patients receiving intravenous nation products may decrease “pill placed on a ventricular assist device burden” since many hypertensive doses of 400 mg or more (VAD); and, 6) patients “who do not patients require multiple medica- (or 10 mg/kg or more for respond” to inhaled epoprostenol. tions to control their blood pressure. children) will not be auto- The use of nitric oxide in adult pa- Tekamlo®’s labeled indication is for matically converted to PO, and tients is now restricted to use with the add-on or initial therapy for hyperten- 6) loading doses. Shands at UF Adult ICUs and Operat- sion. ing Room Nitric Oxide Order Form, Tekamlo® was designated nonfor- which requires the use of inhaled mulary and not available; however, infusion rates, phenytoin injection is a epoprostenol as the first therapeutic patients may continue to use their venous and soft tissue irritant. Phenyt- consideration [to lower pulmonary supply from home. It is not possible to oin sodium injection has a pH between arterial pressures] except in the fol- stock the various combination drugs 11 and 12, and an osmolality of 9740 lowing circumstances: pulmonary that are marketed. Shands at UF will mOsm/kg. Due to its high pH and os- hypertension defined as a MPAP 30 not acquire this combination product molality, repeated injections through a mm Hg or greater (MPAP 40 mm Hg for inpatient use. If needed, patients peripheral IV site frequently results in or greater in the MICU); MPAP 20 may be prescribed the individual phlebitis and the need to find alternate mm Hg or greater in lung transplant, ingredients. IV sites. Additionally, if IV phenytoin ventricular assistant device initial Phenytoin is an anticonvulsant does extravasate, tissue necrosis can insertion, no response to inhaled that has been on the market for many occur. epoprostenol as defined by less than years. Parenteral phenytoin was re- Since oral of phenytoin 10% decrease in MPAP or less than moved from the Formulary and desig- is 90 to 100%, IV dosages of phenytoin 5% increase in SpO2/SaO2, or P/F Ratio nated nonformulary and not available sodium can be changed to oral doses less than 80 (lung transplant P/F ratio several years ago. IV fosphenytoin, of phenytoin sodium in a 1:1 ratio. All less than 120). A positive response to which has a much better safety patients receiving IV phenytoin sodium nitric oxide is defined as an increase profile and is easier to administer, maintenance doses will be automati- in SpO2 by 5%, an increase in PaO2 by was used instead. This decision likely cally converted by a pharmacist to an 10 mm Hg, or a decrease in MPAP by prevented phenytoin-related adverse equivalent oral dose of phenytoin if the 15%. drug events. patient is able to take PO medications The value of this order form will be Unfortunately, a fosphenytoin and is receiving other PO medications. the assessment of “response” and shortage required that phenytoin This process is similar to other medica- discontinuing the use of nitric oxide be re-added in the Formulary. It is tions already on the automatic IV to PO when there is no response. Also, pa- anticipated that this shortage will conversion list, such as ciprofloxacin, tients will be weaned off nitric oxide not end soon. The increased risk of fluconazole, and proton pump inhibi- as soon as possible. The form should adverse events with IV phenytoin tors. The following are exclusion crite- result in less use of nitric oxide. 2 can be partially attributed to clinician ria for automatic IV to PO conversion of

POLICIES AND PROCEDURES Do not "Do Not Substitute" here are 3 main types of drug inter- is an attempt to maintain a revenue best solution, however, is to write an T changes that occur in the inpa- source in the face of a shrinking market order that will allow their patient to use tient setting. The medical staff, via share. Continued use of more expen- their own supply of drug from home. the P&T Committee, approves these sive brand name drugs would be irre- If a physician has a problem with interchanges. By policy, the Depart- sponsible when less expensive alterna- a substitution policy at Shands at UF, ment of Pharmacy Services is given the tives have become available. Evidence they should petition the P&T Commit- authority to interchange a drug to an has consistently shown that generics tee to reconsider the existing policy. A-rated generic product (ie, generic are equal to brand name products. In addition to a letter requesting this interchange). In individual cases, the Therapeutic interchange substitutes re-evaluation (sent to Secretary, P&T P&T Committee may approve specific a similar drug in the same category to Committee PO Box 100316), evidence instances when a similar but thera- avoid stocking multiple drugs in the should be submitted that refutes the peutically equivalent product may be same category. A complete lista of the current policy along with a Disclosure substituted for the ordered drug (ie, current drugs that are therapeutically Form. The requester will be invited to therapeutic interchange). Therapeu- interchanged at Shands at UF is avail- the P&T Committee meeting when this tic interchange includes substituting able on the Portal. issue will be discussed. An indepen- a different salt (ie, pharmaceutical A listb of current IV to PO conver- dent review of the available evidence alternatives) for a drug. An example of sions at Shands at UF is also available will be presented to the P&T Commit- a pharmaceutical alternative would be on the Portal. There are minimum tee along with the evidence provided substituting hydroxyzine hydrochlo- criteria that a patient must meet before by the requester. ride for hydroxyzine pamoate using an the interchange will be considered. The P&T Committee-approved equivalent dose. An automatic route However, the most important criterion interchange polices are critical for change, usually converting the patient is that patients are receiving other cost-containment. They enable us from a parenteral (ie, intravenous or IV) drugs by the oral route. Some drugs to be good stewards of our limited to oral (ie, PO) route of administration (eg, phenytoin) may have additional resources. However, no interchange is the third most common automatic criteria. would be done if there is evidence that interchange approved by the P&T Com- Some prescribers may be familiar this would result in patient harm. The mittee (ie, IV to PO interchange). with the ability to prevent generic complete policies on interchanges are Usually these interchanges are interchange in the outpatient setting. available on the Portal.c,d intended to decrease the number of un- Florida law prevents a pharmacist from LINKS necessary choices in the Formulary (ie, substituting a generic for a brand name generic and therapeutic interchange) drug if the prescriber writes “Medically ahttps://my.portal.shands.ufl.edu/portal/ and promote safety (ie, IV to PO in- Necessary” on the face of the prescrip- page/portal/DEPT_CONTENT/Pharmacy/ terchange). These interchanges also tion. It is important to note that this UF/Formulary/TherapeuticInterchange/TIs/ decrease acquisition and storage costs. law applies ONLY to prescriptions. IVtoPO/IV-to-PO.pdf Generic drugs usually cost a frac- Inpatient orders are NOT prescriptions, bhttps://my.portal.shands.ufl.edu/portal/ tion of the cost of brand name drugs. thus writing “Medically Necessary” or page/portal/DEPT_CONTENT/Pharmacy/ Sometimes, when a product becomes other terms like “Do Not Substitute” UF/Formulary/TherapeuticInterchange available as a generic, brand name with the order will not prevent an inter- c manufacturers will match the cost of change from occurring. https://my.portal.shands.ufl.edu/portal/ generics in the inpatient setting to en- If a physician has a concern with page/portal/DEPT_CONTENT/Policies/ courage the continued use of the brand an interchange for a specific patient SUF/DEPT/Pharmacy/SatelliteOpera- tions/06-05-42.pdf name product. However, this pricing because of unusual circumstances (eg, policy could end at any time. Some- the patient is allergic to an “inert” dhttps://my.portal.shands.ufl.edu/portal/ times, brand name companies actually ingredient in a generic or specific brand page/portal/DEPT_CONTENT/Policies/ increase the costs of brand name drugs named product), they should consult SUF/DEPT/Pharmacy/SatelliteOpera- when generics become available. This with the pharmacist in their area. The tions/06-05-39.pdf

POLICIES AND PROCEDURES Desvenlafaxine-Venlafaxine interchange (correction) n the October 2010 issue of the Bul- will occur when a patient cannot pro- In last month’s issue of the Bulletin, I letin, the interchange from desven- vide their own supply of desvenlafax- the “XR” was inadvertently left off the lafaxine (Pristiq®) to venlafaxine was ine: Venlafaxine XR 225 interchange. announced. The following interchanges

ORDERED [DAILY DOSE] INTERCHANGED [DAILY DOSE] Desvenlafaxine 50 mg Venlafaxine XR 75 mg Desvenlafaxine 100 mg Venlafaxine XR 75 mg Desvenlafaxine 150 mg Venlafaxine XR 150 mg Desvenlafaxine ≥ 200 mg Venlafaxine XR 225 mg

3 Drugs & Therapy SHANDS NON-PROFIT ORG. B N U N L N L N E N T N I N N Shands at the University of Florida U.S. POSTAGE DRUG INFORMATION SERVICE PAID GAINESVILLE, FL Volume 24, No. 10 Nov./Dec. 2010 PO Box 100316 PERMIT NO. 94 This publication is produced by the Gainesville, FL 32610-0316 Drug Information and Pharmacy Re- source Center under the direction of the Department of Pharmacy Services and the Pharmacy and Therapeutics Committee. EDITOR, DRUGS & THERAPY BULLETIN Randy C. Hatton, PharmD DIRECTOR, PHARMACY SERVICES Alan Knudsen, MS, RPh CHAIRMAN, PHARMACY & THERAPEUTICS COMMITTEE Ricardo Gonzalez-Rothi, MD EDITING, DESIGN, & PRODUCTION Shands HealthCare’s Publication Svcs. © Copyright 2010. All rights reserved. No portion of the Drugs & Therapy Bulletin may be reproduced without the written consent of its editor. FOR MORE INFORMATION, VISIT US ONLINE http://shands.org/professionals/ druginfo/bulletin.asp

2010 Annual index TOPIC...... ISSUE/PAGE(S) TOPIC...... ISSUE/PAGE(S) TOPIC...... ISSUE/PAGE(S) AADA Eye Drops...... July-August/2,5 Epirubicin...... July-August/1-3 Pantoprazole...... March/1-2 AbobotulinumtoxinA...... February/1-3 Epoetin...... October/1,6 Papillomavirus Vaccine...... January/1,3 Acetaminophen Suppositories...... June/1-2 Epoprostenol Inj, Room-temperature Stable...... Oct./1-2 Pazopanib...... January/2,4 ...... Nov-Dec/1 Ergocalciferol...... May/1-2 PCA Order Form, Adult...... March/3 Alaris Pump Guardrails...... March/3 Erythromycin...... Nov-Dec/1 Pentosan...... October/1,3 Albumin...... February/2,4 Erythropoiesis-stimulating Agents...... October/1,6 Peramivir...... January/2,5 Alglucosidase alfa...... October/1,3 Ethiodized Oil...... May/1,3 Phenol...... March/1-2 Alteplase...... June/2-3 Etodolac...... February/1-2 Phenytoin...... April/1,3 Amphotericin B...... January/2-3 Etravirine...... July-August/1,3 ...... Nov-Dec/1-2 Apraclonidine...... February/1-2 Ferrous sulfate...... May.2,4 Pilocarpine...... May/2-3 Arginine...... July-August/2,5 Finasteride...... October/2,4 Pitavastatin...... May/2,4 Ascorbic Acid Drops...... March/1-2 Flunisolide Nasal Spray...... July-August/1,3 Pioglitazone...... May/2-3 Atripla...... July-August/1-2 Fosphenytoin...... April/1,3 Pneumococcal Vaccine...... June/1-2 Auralgan...... June/1,3 Gadobenate...... April/1-2 Pork Insulin...... October/1-2 Aztreonam Inhaled...... October/2,4 ...... June/2-3 Povidone Iodine Ophth...... February/1-2 Beclomethasone Nasal Spray...... July-August/1,3 Ganciclovir...... May/1,3 Pralatrexate...... January/2,4 Bendamustine...... April/1-2 Gemtuzumab...... September/1-2 Pramipexole...... June/1-3 Gel...... May/1,3 Glucose Chews...... October/1-2 Pravastatin...... May/2,4 Benzocaine Lozenges...... April/1-2 Glycerol Injection, Sterile...... January/1,3 Prescription Assistance Programs...... January/1,6 Benzocaine Spray...... April/1-2 Hyaluronidase...... June/1-2 ...... February/2,4 Budesonide Capsules...... June/1-2 Hydromorphone ER...... May/2-3 RimabotulinumtoxinB...... February/1,3 Budesonide Nasal Spray...... July-August/1,3 Hydroxyprogesterone Caproate...... January/2,4 Risperidone...... March/1-2 Bupropion...... July-August/1-3 Hyoscyamine...... February/1,3 Tablets...... September/1-2 Brand Name Drug Prices...... February/6 Immune Globulins, Subcutaneous...... May/2,4 Romidepsin...... February/2,4 Brimonidine...... March/1-2 IncobotulinumtoxinA...... October/1,3 Ropivacaine...... March/1-2 Cabazitaxel...... September/2-3 ...... June/1-2 Rosiglitazone...... May/2-3 Calcium Carbonate...... February/2-4 Influenza A [H1N1] Vaccine...... January/1-2 Rubella Virus Vaccine...... February/1-2 Case Reporting...... June/1 ...... October/1-2 Simethicone...... June/1,3 Cefoxitin...... September/1-2 Iron Dextran...... April/1,3 Sipuleucel-T...... July-August/2,5 Cholecalciferol...... May/1-2 Jalyn...... September/1-2 Sodium Bicarbonate Injection...... October/1,3 Ciclesonide...... July-August/2-3 Kayexalate...... September/1,4 Sodium Polystyrene Sulfonate...... September/1,4 Cidofovir...... October/2,4 Ketorolac Nasal Spray...... July-August/2,4 Stalevo...... September/1,3 ...... May/1,3 ER...... April/1,3 Sulfisoxazole Suspension...... May/2-3 Collagenase Clostridium Histolyticum...... April/1-3 Lansoprazole...... January/1-2 Sumatriptan Injection...... September/1,3 Controlled Substances...... March/1,4 Leflunomide...... May/1-2 Tekamlo...... Nov-Dec/1-2 Coral Snake Antivenin...... February/2,4 Liothyronine...... October/1-2 Terazosin...... June/1-3 Criteria for Use...... March/3 Medication Reconciliation...... June/3-4 Terbutaline Injection...... July-August/2,5 Cyclosporine Ophth...... January /1,3 Meloxicam...... February/1-2 Therapeutic Interchange...... June/3-4 Darbepoetin...... October/1,6 Memantine...... September/1,3 Top Drugs in 2009...... July-August/1,3 Daclizumab...... October/1-2 Meningococcal Vaccine...... September/1,3 Torsemide...... March/1-2 Dalteparin...... October/1-2 Metformin ER...... July-August/2,4 Tramadol ER...... July-August/2,5 Deferasirox...... September/1-2 Mometasone Nasal Spray...... July-August/2-3 ER...... April/1,3 Denosumab...... September/1-2 Naloxone...... April/3-4 Treprostinil...... January/1-3 Desvenlafaxine...... October/1,3 Natazia...... July-August/2,4 ...... October/1,3 Dexmedetomidine...... September/2-3 ...... September/1,3 Triamcinolone MDI...... March/1-2 ...... October/2,5 New Drugs 2009...... February/1,6 Triamcinolone Nasal Spray...... July-August/2-3 Dipivefrin...... May/1,3 Nitric Oxide...... Nov-Dec/1-2 Tribenzor...... October/1,3 Do Not Substitute...... Nov-Dec/3 Ofatumumab...... January/2,4 Triptorelin Pamoate...... May/2,4 Doxazosin...... June/2-3 Olanzapine ER Injection...... March/1-2 Urokinase...... Nov-Dec/1-2 Doripenem...... July-August/1-2 ...... January/1-2 Ustekinumab...... February/1,3 ...... May/2-3 OnabotulinumtoxinA...... February/1,3 Velaglucerase...... May/2,4 Dronedarone...... February/1-2 Ondansetron Soluble Film...... September/1,3 Veltin Gel...... October/1,3 Dutasteride...... October/2,4 Paliperidone Palmitate...... July-August/2,5 Venlafaxine...... October/2-3 4 Eculizumab...... January/2,4 Pancrelipase...... July-August/1,3 Vigabatrin...... January/2,5 Entacapone...... September/1-2 Pancrelipase Powder...... May/1,3 Vimovo...... July-August/2,4 ...... April/1