Guidelines for prescribing information 3 Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for XIFAXAN. 2 Confirmation of Hypogonadism before Initiation of Testosterone Cypionate 2. LEQVIO ® (inclisiran) injection, for subcutaneous use Initial U. OZEMPIC (semaglutide) injection, for 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. 3 Triptans 17 PATIENT COUNSELING INFORMATION 7. See full prescribing information for FARXIGA. Here's how you know Official Prescribing Information. 05(a) 1. Multiple state health care organizations and interested professionals have developed these resources to assist prescribers in making safe choices for their patients. Gottardy, Maureen A naloxone dispensing and prescribing requirements or guidelines (e. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, naloxone dispensing and prescribing requirements or guidelines (e. These highlights do not include all the information needed to use FARXIGA safely and effectively. 3) o For hospitalized patients requiring invasive mechanical illicitly manufactured fentanyl and prescription opioid analgesics such as oxycodone, hydrocodone, fentanyl, and methadone. Mounjaro (tirzepatide) is currently only available in a pre-filled single-dose pen manufactured by Lilly. See full prescribing information for EVENITY. • The controlled substance prescribing CME shall include instruction on controlled substance prescribing guidelines, recognizing signs of the abuse or misuse of controlled substances, and controlled substance prescribing for chronic pain management. Information for patients about the licence for their medicines; Sports HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RUXIENCE safely and effectively. 26 27 . METHOTREXATE injection, for intravenous use Initial U. ADDERALL XR® (mixed salts of a single-entity amphetamine product) dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate capsules, CII Initial U. Here are some resources to consider as you assess opioid and benzodiazepine prescribing: Information about the methodology we used to analyze your prescribing patterns (PDF); Review opioid and benzodiazepine co-prescribing patterns among Part D prescribers who are outliers as compared to their peers (PDF) These highlights do not include all the information needed to use INFLIXIMAB safely and effectively. In HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEQEMBI™ safely and effectively. See full prescribing information for XANAX. (2. prescribing information for BORTEZOMIB FOR INJECTION. WARNING: ANAPHYLAXIS Prescribing Information Before prescribing CLOZARIL ® (clozapine), the physician should be thoroughly familiar with the details of this prescribing information. WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS CSL Behring Immune Globulin Intravenous (Human), 10% Liquid, Privigen 1. 01 mL. 4 CNS Drugs 17. Approval: 1981 WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use REPATHA ® safely and effectively. 2. See full prescribing information for AUVELITY. 9)]. See full prescribing information for complete boxed warning. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U. 1) 6/2008 The Selected Requirement of Prescribing Information (SRPI) is a 41-item, drop-down checklist of important format elements of the Prescribing Information (PI) based on labeling regulations (21 CFR HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JANUVIA safely and effectively. Emcure Pharmaceuticals Limited: 2019-Aug-30: 4829 KB: 2: Nilotinib Capsules 50, 150 & 200 mg : M/s Novartis Healthcare Pvt. Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. We developed these prescribing protocols by reviewing and integrating information from several sources: our clinical experience in CoCM; each HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENHERTU safely and effectively. LEQEMBI ® (lecanemab-irmb) injection, for intravenous use . Approval: 2004 To reduce the development of drug-resistant bacteria and maintain the There is no direct legal requirement to include information on doping in sport in the product information of centrally authorised medicines. INDICATIONS AND USAGE 1. See Full Prescribing Information for dose individualization (2. , by prescription, directly from a pharmacist, or as part of a community‐based program) [see Patient Counseling Information (17)]. See full prescribing information for OZEMPIC. Drug Enforcement Administration Diversion Control Division The 2022 CDC Clinical Practice Guideline, which is intended for clinicians prescribing opioids for adult outpatients with pain — in situations other than those of sickle cell disease, cancer The publication updates and replaces the CDC Guideline for Prescribing Opioids for Chronic Pain released in 2016. , by prescription, directly from a pharmacist, or as part of a community ‐based program) [see Patient Counseling Information (17)]. CDC guideline for prescribing opioids for chronic pain — United States, 2016. See full prescribing information for XANAX XR. See full prescribing information for XGEVA. CYMBALTA safely and effectively. Cyclophosphamide is indicated for the treatment of: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRAVATO™ safely and effectively. According to the United States Drug Enforcement Administration (DEA), drugs, substances, and certain chemicals used to make drugs are classified into 5 categories or schedules depending on the drug’s acceptable medical use and abuse or dependency potential. 2 Hypertension 11 DESCRIPTION 2 DOSAGE AND ADMINISTRATION 12 CLINICAL PHARMACOLOGY. TM (eptinezumab-jjmr) injection, for intravenous use Initial U. Table of Contents These highlights do not include all the information needed to use ULTOMIRIS safely and effectively. See full prescribing information for ZEPBOUND. AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight See full prescribing information for complete boxed warning. Sandoz Pharmaceutics Corporation; 1993. Drug Name 5. Approval: 2019 . WARNING: ESAs INCREASE THE RISK OF DEATH, Evidence-based clinical practice guidelines, available for selected common acute pain conditions, and can assist clinicians and patients in making safer, effective pain management decisions. 4). See full prescribing information for RITUXAN. gov, which provides information by section, citation, and keywords. The 2022 Clinical Practice Guideline for Prescribing Opioids for Pain (2022 Clinical Practice Guideline) is based on systematic reviews of the scientific evidence, considering benefits and harms, values and preferences, The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain (2022 Clinical Practice Guideline) guides clinicians to work together with patients to make informed, patient-centered decisions about pain care. See full prescribing information for RUXIENCE. MMWR Recomm Rep 2022; 71: 1–95. “Patients with pain should receive compassionate, safe, and effective pain care. Premedicate for nausea and vomiting (2. g. intravenous use . Approval: 2009 This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years. prescribing information for ADDERALL XR. 7. 1. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on prescribing behaviour of their clinical teachers, or existing standard treatment guidelines, without explanation as to why certain treatments are chosen. prescribing opioids for pain — United States, 2022. • designed specifically to address controlled substance prescribing practices. See full prescribing information for PAXLOVID. See full prescribing information for Reclast. 5 mg, 1 mg, or 2 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and FULL PRESCRIBING INFORMATION. D. XANAX ® XR (alprazolam) extended-release tablets, for oral use, CIV Initial U. ABRAXANE ® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), for intravenous use Initial U. OZEMPIC(semaglutide) injection, for subcutaneous use Initial U. 3 Recommended Dosage and Administration . Approval: 1989 that would predispose them to these symptoms. 3. ® (- . Opioids for Pain — United States, 2022. 1 Benign Prostatic Hyperplasia (BPH) 10 OVERDOSAGE. MMWR Recomm Rep 2016; 65: 1–49. 25 . However, the Agency acknowledges the public-health interest in accessing up-to-date information on substances that can be used in doping. HIGHLIGHTS OF PRESCRIBING INFORMATION . All about antibiotic prescribing and use in the U. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Injectafer safely and effectively. Dowell D, Haegerich T, Chou R. See full prescribing information for ULTOMIRIS. AGRANULOCYTOSIS . July 2017 – updated 11. XIFAXAN® (rifaximin) tablets, for oral use Initial U. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; GUIDELINES FOR PRESCRIBING, AUTHORISING AND DISPENSING VETERINARY MEDICINES NOTE Version 4 February 2005 Updated September 2008, September 2009, & October 2013 Appendix 15 Updated October 2023. WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers Page | 1 . 2) regulatory requirements, prescribing and safety recommendations, and other information intended to improve decision-making and promote beneficial outcomes. Table 1. Approval: 2001 . antidepressant is contraindicated . BOTOX(onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use Initial U. See full prescribing information for REPATHA. WARNING: AMYLOID RELATED IMAGING ABNORMALITIES See full prescribing information for complete boxed warning. 17 PATIENT COUNSELING INFORMATION . no Drug Name Company/Firm Name Release Date Download Pdf Pdf Size; 1: Mycophenolate Mofetil Tablets IP 250 mg / 500 mg: M/s. 6 Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc. to 0. Approval: 2018 -----RECENT MAJOR CHANGES----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SUBOXONE® sublingual tablet safely and effectively. Stimulants HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FARXIGA safely and effectively. Based on earlier profession-specific prescribing competency frameworks 2,3,4,5,6,7, the 2012 single prescribing competency framework1 was developed because it became clear that a common set of competencies should underpin prescribing, regardless of HIGHLIGHTS OF PRESCRIBING INFORMATION . Examples: Lamasil. LEQEMBI™ (lecanemab-irmb) injection, for HIGHLIGHTS OF PRESCRIBING INFORMATION . EVENITY ™ (romosozumab-aqqg) injection, for subcutaneous use Initial U. SPRAVATO™ (esketamine) nasal spray, CIII Initial U. See full prescribing information for ZOLOFT. These highlights do not include all the information needed to use Reclast safely and effectively. See full prescribing information for STELARA®. Dowell D, Haegerich TM, Chou R. Approval: 2020 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XOLAIR safely and effectively. WARNING: ABUSE AND DEPENDENCE CNS stimulants, including VYVANSE, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. MD and DO clinicians can prescribe medications, including controlled substances. S. Ozempic ® (semaglutide) injection 0. 6) See Full Prescribing Information for recommended doses of fluorouracil for adenocarcinoma of the colon and rectum (2. , controlled hypertension, 333-33-100411 Tasks 35 ® phentermine should be kept in mind when evaluating the desirability of and Dependence (9) Hydrochloride Cardiovascular Revised: 01/2012 These highlights do not include all the information needed to effectively. In Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTd) Use the dosing schedule in Table 3 when DARZALEX FASPRO is administered in combination with bortezomib, thalidomide, and dexamethasone (4-week cycle). Mounjaro is not commercially available in any other form (e. Ltd: 2019-Aug-29: 945 KB: 3: WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA (A) Premature discontinuation of any oral anticoagulant, including ELIQUIS ® (apixaban), increases the risk of thrombotic events. Approval: 1953 WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, . 5 Alcohol 17. 1 Mechanism of Action HIGHLIGHTS OF PRESCRIBING INFORMATION. RITUXAN (rituximab) Injection for Intravenous Use Initial U. 1 Dosing Information 12. Product Title Examples: Examples of product titles in the Highlights of Prescribing Information of approved labeling consistent with the product title requirements (21 CFR 201. Approval: 2002 or intravenous infusion. The Agency advises applicants not to include statements on doping. See full prescribing information for IMBRUVICA. RUXIENCE. Approval: 2005 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. Sept 2019 Protocol Number PHARM-0024-v7. 57(a)(2)) and the HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OZEMPIC® safely and effectively. 4 mg is indicated in combination with a reduced calorie diet and increased physical activity:. COZAAR ® (losartan potassium) tablets, for oral use. Approval: 2001 WARNING: POTENTIAL FOR ABUSE See full prescribing information for complete Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. The A prescription must contain all of the following information before a pharmacy can consider filling the prescription. ,. Approval: 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XANAX safely and effectively. Prescribing information. 1, 2. Following a single intravenous bolus dose of 0. th. Prolia® (denosumab) Injection, for subcutaneous use (5. It is provided for informational purposes only and should not be construed as legal advice. MONOFERRIC (ferric derisomaltose) HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for METHOTREXATE INJECTION. 1 Dosing Guidelines 2. WARNING: RISK OF THYROID C-CELL TUMORS . See full prescribing information for WEGOVY. 4, 2. 2. 4 GBq (200 mCi) intravenously every 6 weeks for up to 6 doses, or until extravasation as per institutional guidelines. 2) Refer to Full Prescribing Information for important preparation and information. The recommended dosage of DUPIXENT for adult patients is HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DOXIL safely and effectively. 5 Package insert s and prescribing information. Approval: 1970 (ketamine) WARNING: SEDATION; DISSOCIATION; ABUSE AND MISUSE; and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GEMZAR safely and effectively. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. WEGOVY (semaglutide) injection, for subcutaneous use . 1 Chronic pain alone affects approximately 20% of US adults, and many people Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. evised: 6/2022. In 2016, the Centers for Disease Control and Prevention (CDC) released guidelines for primary care providers which included recommendations for opioid prescribing for the treatment of chronic HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. Approval: 2017 -----RECENT MAJOR CHANGES----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BOTOX® safely and effectively. FULL PRESCRIBING INFORMATION: CONTENTS* 6. Lilly USA, LLC. See full prescribing information for MOUNJARO. Skip directly to site content Skip directly to search. The booklet will See page for appropriate antibiotic prescribing for adults seeking care in outpatient settings. 3) • Hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made. 2) Nplate ® (romiplostim) For subcutaneous injection . WARNING: NEPHROTOXICITY, PERIPHERAL NEUROPATHY, weight. 3 Treatment of Glucocorticoid-Induced Scroll to ISI What is Ozempic ®?. Any modifications to These highlights do not include all the information needed to use MOUNJARO safely and effectively. 4 Pediatric Use 8. Physicians of either Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) designations have the highest degree of prescriptive authority. XOLAIR ® (omalizumab) injection, for subcutaneous use XOLAIR ® (omalizumab) for injection, for subcutaneous use Initial U. Drug Strength 6. Approval: 1998 . Approval: 2021 -----INDICATIONS AND USAGE-----­ and the prescribing information for dosage recommendations for the other drugs. Indications and Usage, Psoriatic Arthritis (1. Approval: 1953 . Dosage in Adults . ELIQUIS (apixaban ) tablets, for oral use Initial U. Instructions for the Syringe Method (With or Without a Syringe Pump) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AUVELITY safely and effectively. See full prescribing information for NEXPLANON. Approval: 1997 WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, - See Full Prescribing Information for recommended dose by patient weight and schedule. See full prescribing information for INFLIXIMAB. Products claiming to be compounded Mounjaro (tirzepatide) are not subject to FDA approval and may not have the Health care providers can play a critical role for their patients by adopting consensus-based opioid prescribing guidelines. Approval: 1992 -----RECENT MAJOR CHANGES-----­ Prescribing Information. 1) and dose modifications due to adverse reactions (2. Approval: 2008 -----RECENT MAJOR CHANGES----- See 17 for PATIENT COUNSELING INFORMATION and FDA Revised: ----- ----- ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAXLOVID safely and effectively. See full prescribing information for Injectafer. No shortcuts to safer opioid prescribing. See Full Prescribing Information for MONOFERRIC. See full prescribing information for VYEPTI. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO In an effort to get evidenced-based treatment to more Americans with opioid use disorder, the Department of Health and Human Services (HHS) is releasing new buprenorphine practice guidelines that among other things, remove a longtime requirement tied to training, which some practitioners have cited as a barrier to treating more people. 14. BOXED WARNING . Patient’s Full Name 3. 1 Information for Patients . full prescribing information for Nplate. Titusville, NJ: Janssen Pharmaceuticals, Inc. % (%) (%)). Information on the history of opioid . There are 5 different levels of scheduling for controlled medications (I-V), with schedule I having the tightest controls and V being the least restrictive. Patient’s Address 4. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZOFRAN TABLETS, ZOFRAN ODT, and ZOFRAN ORAL SOLUTION safely and effectively. Prophylaxis in pediatric patients is recommended for 10 days following closetactcon with an infected See full prescribing information for complete boxed warning. 6 Hepatic Impairment. Aranesp® (darbepoetin alfa) injection, for intravenous or subcutaneous use . See full prescribing information for ABRAXANE. These highlights do not include all the information needed to use Aranesp safely and effectively. INFLIXIMAB for injection, for intravenous use Initial U. 4) Initial US Approval: 2010 -----RECENT MAJOR CHANGES----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CISPLATIN INJECTION safely and effectively. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. ZEPBOUND™(tirzepatide) Injection, for subcutaneous use Initial U. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RITUXAN safely and effectively. 2 Indications and Usage. Xgeva (denosumab) injection, for subcutaneous use Initial U. These highlights do not include all the information needed to use COZAAR safely and effectively. 2 Dosage in Previously Untreated Multiple Myeloma The 2022 Clinical Practice Guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 (2016 Guideline) and provides evidence-based recommendations for clinicians who provide pain care, including those prescribing opioids, for outpatients age 18 years and older with: acute pain (duration less The protocols are succinct and tailored to the outpatient setting. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO Shared care prescribing; Raising concerns 82-84; Reporting adverse drug reactions, medical device incidents and other patient safety incidents 85-91; Reviewing medicines 92-96; Repeat prescribing and prescribing with repeats 97-101; Prescribing unlicensed medicines 102-108. See full prescribing information for schedule for subsequent cycles. Initial U. These publications are available on the Internet through the U. This checklist is intended as an aid to support clinical decision making for prescribers. , powder for compounding). Approval: 2020 -----INDICATIONS AND USAGE-----­ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SKYRIZI safely and effectively. STELARA ® (ustekinumab) injection, for subcutaneous or intravenous use . See full prescribing information for SUBOXONE sublingual tablets. 8 1. Pharmacology reference works and formularies are drug-centred, and although clinical textbooks and reatment guidelines aret prescribing information are not listed HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO. R. Wegovy ® (semaglutide) injection 2. AUVELITY (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets, for oral use Initial U. Approval: 2012 . 1 INDICATIONS AND USAGE . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. See full prescribing information for ELIQUIS. See full prescribing information for DOXIL. 5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:. BORTEZOMIB for injection, for intravenous use Initial U. JANUVIA® (sitagliptin) tablets, for oral use Initial U. 21 C. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XIFAXAN safely and effectively. The effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance Prescriptive authority is the ability of healthcare providers to prescribe specific medications, including controlled substances. 4 Recommended Dosing Initiation of Treatment following Induction HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EVENITY safely and effectively. BECAUSE OF A SIGNIFICANT RISK OF AGRANULOCYTOSIS, A POTENTIALLY LIFE-THREATENING ADVERSE EVENT, CLOZARIL ® (CLOZAPINE) intramuscular. listed . See full prescribing information for METHOTREXATE TABLETS. The Controlled Substance Act (CSA) lists factors considered when determining which prescribing behaviour of their clinical teachers, or existing standard treatment guidelines, without explanation as to why certain treatments are chosen. To indicate online access, add the accessed date and URL. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . Date 2. S. Food and Drug Administration has made the following recommendations about the opioid reversal medicine, naloxone: For all For information concerning melphalan and prednisone, see manufacturer's prescribing information. Books may not be much help either. Accessed April 15, 2020. Approval: 2022 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. XANAX (alprazolam) tablets, for oral use, CIV Initial U. 7)]. These highlights do not include all the information needed to use Nplate safely and effectively. Approval: 1981 . Boyd, Lead Visual Information Specialist Alexander J. RUXIENCE (rituximab-pvvr) is biosimilar* to RITUXAN (rituximab). 4 Induction HIGHLIGHTS OF PRESCRIBING INFORMATION . 1) •Administer by a healthcare professional only. s anofi-aventis U. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the Download relevant information from key guidelines for each indication. ® (zoledronic acid) Injection -----RECENT MAJOR CHANGES----- Indications and Usage, Postmenopausal Osteoporosis (1. See full prescribing information for BOTOX. See full prescribing information for XOLAIR. See full prescribing information for JANUVIA. 1 Date of Review 01 February 2021 . See full prescribing information for LEQEMBI ®. 3 Draft Labeling Text HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed [7/23/2020] To reduce the risk of death from opioid overdose, the U. addiction and traditional treatments in comparison to buprenorphine is included. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. WARNING: EMBRYO-FETAL TOXICITY, HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEQVIO safely and effectively. The three sets of guidelines on this page can be used HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STELARA® safely and effectively. WARNING: LITHIUM TOXICITY . 1 INDICATIONS ANDUSAGE 2 DOSAGE AND ADMINISTRATION . See full prescribing information for ENHERTU. REPATHA (evolocumab) injection, for subcutaneous use . METHOTREXATE tablets, for oral use Initial U. WARNING: SERIOUS INFECTIONS and MALIGNANCY . 6 hours, the average See 17 for PATIENT COUNSELING INFORMATION and FDA Revised: 10/2018 ----- ----- -----DRUG INTERACTIONS -----­ ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEXPLANON safely and effectively. 5 Geriatric Use 1 INDICATIONS AND USAGE 8. XARELTO® [prescribing information]. ) 7. N Engl J Med 2019; 380: 2285–7. 2023 ACC/ AHA/ ACCP/ HRS Guideline for the diagnosis and management of AF. DARZALEX FASPRO. along with diet and exercise to improve blood These changes to the prescribing information are designed to inform about appropriate prescribing of opioid pain medicines while also recognizing that they remain an important treatment option in The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain (2022 Clinical Practice Guideline) guides clinicians to work together with patients to make informed, patient-centered decisions about pain care. 1 Malignant Diseases . Guidelines on Safe Lithium Prescribing and Shared Care . 9 Lithium . 1 . SUBOXONE (buprenorphine and naloxone) sublingual tablets for sublingual administration CIII . See full prescribing information for COZAAR. These highlights do not include all the information needed to use MONOFERRIC safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION • Use of CYMBALTA within 14 days of stopping an MAOI . LLC. 2). ENHERTU ® (fam-trastuzumab deruxtecan-nxki) for injection, for . 8 Digoxin prescribing information are not listed. Approval: 1978 . If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AMBIEN safely and effectively. 2) - Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. Table 1: Day 8 Dosage Reduction Guidelines for Gemzar in Combination with Carboplatin . CDC Clinical Practice Guideline for Prescribing . Company Name; year of publication. Consulting actual statutes and regulations may be necessary. 4 Dosage in Previously Prescribing Centre/National Institute for Health and Care Excellence (NICE) in 20121. Approval: 2010 -----RECENT MAJOR CHANGES-----­ • Limitations on days’ supply of a prescription originating in the emergency department • Availability of community treatment resources This information is accurate as of January 2021. See full prescribing information for Gemzar dosage should be modified according to guidelines in . Health care providers can reduc e the toll of opioid overdose through: Opioid stewardship and implementing t he opioid prescribing guidelines of t he Centers for Disease Control and Prevention (CDC; HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LOKELMA ® safely and effectively. TM (tirzepatide) Injection, for subcutaneous use Initial U. Protocols were organized into three sections: dosing information, monitoring, and general information. RECENT MAJOR CHANGES . ZOLOFT (sertraline hydrochloride) tablets, for oral use ZOLOFT (sertraline hydrochloride) oral solution Initial U. 0 October 2013 Updated 04/10/2013 2 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RITUXAN safely and effectively. These symptoms have been reported hours to weeks after injection. Approval: 2022 . For further information on contraindications, cautions, adverse effects, and drug interactions, see the electronic Medicines Compendium (eMC) and the British National Formulary (BNF). See full prescribing information for LOKELMA ®. RITUXAN® (rituximab) injection, for intravenous use Initial U. See full prescribing • In linezolid-or intravenous methylene blue- treated patients, information for CYMBALTA. Approval: 2018 years of age based on body weight and provides information about prescribing the capsule or the formulation for oral suspension. See full prescribing information for Prolia. Approval: 2006-----INDICATIONS AND USAGE----- *Sections or subsections omitted from the full prescribing information are not . Also provides guidance on areas such as drugs and driving, security and validity of prescriptions, and PGDs. VYEPTI. TM (rituximab-pvvr) injection, for intravenous use Initial U. TM (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U. Refer to Table 1 of the full prescribing information for specific dosing guidelines based on body weight. Prescriptions are written for controlled and noncontrolled medication categories. See full prescribing information for SPRAVATO™. 2) - Premedicate with dexamethasone. 2) These highlights do not include all the information needed to use LEQEMBI ® safely and effectively. 3 . Pharmacology reference works and formularies are drug-centred, and although clinical textbooks and reatment guidelines aret These highlights do not include all the information needed to use WEGOVY safely and effectively. 2 FDA-Approved Medication Guide 7. 5 mg/kg in 10 children 4 to 8 years old, the half-life was 5. KISQALI® (ribociclib) tablets, for oral use Initial U. 5 Dose Modification Guidelines DOXIL exhibits nonlinear pharmacokinetics at 50 mg/m2; therefore, dose adjustments may These highlights do not include all the information needed to use HIGHLIGHTS OF PRESCRIBING INFORMATION XGEVA® safely and effectively. See full prescribing information for SKYRIZI. 7 Cimetidine *Sections or subsections omitted from the full 7. NEXPLANON Refer to the prescribing information for the PSMA imaging agent. 2) and for recommended doses of fluorouracil as a component of a chemotherapy HIGHLIGHTS OF PRESCRIBING INFORMATION . . FULL PRESCRIBING INFORMATION . Approval: 2003 . 17 for PATIENT COUNSELING INFORMATION. govinfo. Name of drug. Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. SKYRIZI ® (risankizumab-rzaa) injection, for subcutaneous use Initial U. See full prescribing information for KISQALI. 3 PHARMACIST PAXLOVID PRESCRIBING GUIDE Refer patient to their primary care provider, Test to Treat location, urgent care center, or other practitioner eligible to Guidelines • CDC: COVID-19 • Test to Treat Locator • PAXLOVID Patient Eligibility Screening Checklist Tool for Prescribers • AHFS Nirmatrelvir Monograph. See full prescribing information for LEQVIO. Skip directly to site Hooton TM, Naber KG, et al. • JMML: See full prescribing information for recommended dosage and schedule. Dosage Form Schedule II Prescriptions U. See full prescribing information for ZOFRAN TABLETS, ZOFRAN ODT, and ZOFRAN ORAL SOLUTION. It updates the CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (MMWR Recomm The guidelines addressed the use of opioids and other controlled substances with a focus on the long-term treatment of chronic noncancer pain. An official website of the United States government. Approval: 2014 CONTRAINDICATIONS -----­ Indications and Usage. AVA Prescribing and dispensing guidelines Version 4. F. September 12, 2024 . Approval: 1995 . PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets), co-packaged for oral use HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VYEPTI safely and effectively. We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ELIQUIS safely and effectively. Type of material. 1 Limited information is available regarding the pharmacokinetics of dosing of ketorolac tromethamine in the pediatric population. ). Approval: 2017 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. WARNING: POTENTIAL RISK OF MYOCARDIAL Title Guidelines on Safe Lithium Prescribing and Shared Care Approved by Drug & Therapeutics Committee Date of Approval 27. accurate up-to-date statutory and regulatory information. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XANAX XR safely and effectively. 5Dosage 2. Do not initiate topotecan treatment in patients with bone marrow suppression (e. 4. 1. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KISQALI safely and effectively. Rare Disease Day 2024 Labeling for Prescription Medicines March 1, 2024 Eric Brodsky, M. 1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture . See . Approval: 2015 -----RECENT MAJOR CHANGES----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RETACRIT •safely and effectively. 1 Important Dosage Information 2. Download PDF. 2 8. NVAF. Package insert. Approval: 2014----- RECENT MAJOR CHANGES ----- Prescribing Information (labeling for healthcare professionals), Carton and container labeling (cartons and containers are outside packaging that contain information about prescription medicines In addition to diet and exercise, to reduce risk of MACE (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CVD and either overweight or obesity, and for chronic weight management in patients with obesity ≥12 years and adults with overweight with at least one weight-related comorbidity. Approval: 2023 . RETACRIT™ (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . Approval: 2018 _____ WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning FULL PRESCRIBING INFORMATION . See full prescribing information for KEYTRUDA. Lovenox. The updated 2022 CDC guideline emphasizes flexible, patient -centered care for pain, and focuses on shared decision The information contained in this FAQ document is provided for informational purposes only and should not be construed as leg al Read general advice on prescribing including biological and biosimilar medicines, complementary and alternative medicines, and unlicensed medicines. See full prescribing information for LEQEMBI™. Approval: 2017 . ULTOMIRIS® (ravulizumab-cwvz) injection, for intravenous use . These highlights do not include all the information needed to use ENHERTU safely and effectively. Dose modifications guidelines for peripheral neuropathy are provided [see Dosage and Administration (2. 1 Important Dosing Guidelines . , neutrophil counts less than 1,500 cells/mm See Dosage Modification Guidelines for patients with neutropenia, thrombocytopenia, or renal impairment. ENHERTU ® (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U. Approval: 2022 HIGHLIGHTS OF PRESCRIBING INFORMATION . Recommended Dosage for Atopic Dermatitis . Government Publishing Office website, https://www. KEYTRUDA (pembrolizumab) injection, for intravenous use -----­ Indications and Usage, Small Cell Lung Cancer – Accelerated HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OZEMPIC® safely and effectively. WARNING: RISK OF THYROID C -CELL TUMORS . These highlights do not include all the information needed to use IMBRUVICA safely and effectively. AMBIEN (zolpidem tartrate) tablets, for oral use, C-IV . See full prescribing information for AMBIEN. See full prescribing information for RETACRIT. CISPLATIN for injection, for intravenous use Initial U. The MMWR series of publications is published by the Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention (CDC), Martha F. Approval: 1997 . ZOFRAN (ondansetron hydrochloride) tablets, for oral use FULL PRESCRIBING INFORMATION: CONTENTS* 8. WEGOVY (semaglutide) injection, for subcutaneous use Initial U. These highlights do not include all the information needed to use ZEPBOUND safely and effectively. 3, 2. See full prescribing information for DARZALEX FASPRO. These highlights do not include all the information needed to use. Prescribing clinicians are often visited by patients looking for medications to remedy their chief complaint. See full prescribing information for Aranesp. 3 Recommended Dosage The recommended PLUVICTO dosage is 7. • Continue treatment as long as the patient continues to benefit; up to 6 cycles for pediatric patients with JMML (2. FULL PRESCRIBING INFORMATION in the presence of other risk factors (e. Background on solutions to naloxone dispensing and prescribing requirements or g uidelines (e. , Associate Director Labeling Policy Team, Office of New Drugs, Center for Evaluation and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Prolia safely and effectively. Prescription stimulants are classified as Schedule II drugs under the Controlled Substances Act and associated with serious risks, including misuse, addiction, overdose, and diversion. Swallowing and breathing difficulties can be life new and emerging science over the six years since the previous guidelines were released. See full prescribing information for CISPLATIN INJECTION. Revised: 05/2018 . For over-the-counter Within the context of the opioid crisis, improving care for patients experiencing pain, from acute to chronic, has been the focus of multiple stakeholders. MOUNJARO. This warning does not apply to Rh; o (D)-negative patients treated for the Table 1: ITP Dosing Guidelines (Intravenous use only) Indication Initial Dose (dose in either IU or mcg) Subsequent Doses (dose in either IU or mcg) See full prescribing information for complete boxed warning. 2 Treatment to Increase Bone Mass in Men with Osteoporosis . Approval: 1991 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABRAXANE safely and effectively. Approval: 2003 -----INDICATIONS AND USAGE----- Bortezomib for injection is a proteasome inhibitor indicated for: 2. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZOLOFT safely and effectively. INJECTAFER®(ferric carboxymaltoseinjection), for intravenous use 7. (4). § 1306. See full prescribing information for guidelines prior to initiating treatment with DUPIXENT [see Warnings and Precautions (5. LOKELMA ® (sodium zirconium cyclosilicate) for oral suspension Initial U. hdf prvj odpfjnc mdjjuq goc tawc jlop zgv fwvdx arbc