Fallon Community Health Plan

Total Page:16

File Type:pdf, Size:1020Kb

Fallon Community Health Plan Prior Authorization Approval Criteria Inspra (eplerenone) Generic Name: eplerenone Brand Name: Inspra Medication Class: Selective aldosterone receptor antagonist FDA Approved Uses: mild to moderate hypertension (HTN) & congestive heart failure (CHF)post-myocardial infarction Criteria for Approval (HTN): (bullet points below are all inclusive unless otherwise noted Failed/intolerant to therapy with at least 2 alternative formulary medications including; diuretics, beta blockers, calcium channel blockers, ACE inhibitors, ARBs, spironolactone. Documented mild-moderate hypertension Document of recent potassium and serum creatinine levels. o Serum potassium must be <5.5 mEq/L at initiation. o Serum creatinine must be <2.0 mg/dl in males and <1.8 mg/dl in females. o Creatinine clearance must be >50 ml/min at initiation. Criteria for Approval (CHF): (bullet points below are all inclusive unless otherwise noted) Clinically documented CHF post MI Currently receiving standard care with ACE inhibitors and beta blockers. Failed/intolerant to spironolactone and at least 1 other formulary alternative medication of the following classes/drug: diuretics, digoxin, ARBs. Left ventricular ejection fraction (LVEF) < 40%. Documentation of recent potassium and serum creatinine levels. o Serum potassium must be <5.5 mEq/L at initiation. o Creatinine clearance must be >30 ml/min at initiation. Contraindications: Patients with clinically significant hyperkalemia or conditions associated with hyperkalemia Serum potassium > 5 mEq/L at initiation. Moderate to severe renal impairment (Creatinine clearance <50 ml/min) Concomitant use with ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir, or any drug that is a potent CYP3A4 inhibitor. Concomitant use of potassium supplements or potassium-sparing diuretics (amiloride, spironolactone, or triamterene). The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB) with eplerenone. Page 1 of 2 11/16/06 Approval Duration: Indefinite Benefit Type: Pharmacy FCHP Pharmacy and Therapeutics Committee approval: __________________________________________ Date: ______________________ Adopted: 12/14/16 Revised: 12/14/16 Page 2 of 2 11/16/06 .
Recommended publications
  • "Macrolides"? Classify Each Drug in This Chapter As a Macrolide Or Azalide, and As an Antibiotic Or Semi-Synthetic Derivative
    STUDY GUIDE THE MACROLIDE/AZALIDE ANTIMICROBIAL AGENTS 1. Why are these antibiotics derivatives called "macrolides"? Classify each drug in this chapter as a macrolide or azalide, and as an antibiotic or semi-synthetic derivative. 2. What are the key structural differences between erythromycin, clarithromycin, azithromycin and dirithromycin? 3. Generally how does spiramycin and josamycin differ in structure from the commercial macrolides/azalides (2 reasons)? 4. What are the “ketolides and how do they differ in structure from the commercial macrolides? 5. What is the biosynthetic source of erythromycin? What is the lactone moiety of erythromycin called? What sugar moieties are present and what are their properties? 6. What hydrolysis product forms from erythromycin in aqueous acid or base? What is the significance of this reaction? Can it occur with other macrolides? 7. When does the “intramolecular cyclization” reaction occur with erythromycin? What is it's significance (two reasons) and how does it occur? Which functional groups are important for this reaction? 8. What salt forms of erythromycin are available? Which are water soluble? Which are water-insoluble? How is each salt form formulated and used (oral or parenteral)? 9. What ester and ester salt derivatives of erythromycin are available? What is the estolate? How is each salt form formulated and used (oral or parenteral)? What are the advantages of these esters dosage forms? 10. How does clarithromycin differ in structure from erythromycin? Why was this macrolide developed (the role of the 6-methoxy)? 11. How does azithromycin differ in structure from erythromycin? Why was this macrolide developed? 12. How does dirithromycin differ in structure from erythromycin? Why was this macrolide developed? What is the active form of this prodrug? 13.
    [Show full text]
  • 35 Cyproterone Acetate and Ethinyl Estradiol Tablets 2 Mg/0
    PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCYESTRA®-35 cyproterone acetate and ethinyl estradiol tablets 2 mg/0.035 mg THERAPEUTIC CLASSIFICATION Acne Therapy Paladin Labs Inc. Date of Preparation: 100 Alexis Nihon Blvd, Suite 600 January 17, 2019 St-Laurent, Quebec H4M 2P2 Version: 6.0 Control # 223341 _____________________________________________________________________________________________ CYESTRA-35 Product Monograph Page 1 of 48 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................. 3 INDICATION AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................ 3 WARNINGS AND PRECAUTIONS ....................................................................................................... 4 ADVERSE REACTIONS ....................................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................................... 16 DOSAGE AND ADMINISTRATION ................................................................................................ 20 OVERDOSAGE ....................................................................................................................................
    [Show full text]
  • Portia®(Levonorgestrel and Ethinyl Estradiol Tablets USP)
    PORTIA- levonorgestrel and ethinyl estradiol Teva Pharmaceuticals USA, Inc. ---------- Portia® (levonorgestrel and ethinyl estradiol tablets USP) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION Portia® (levonorgestrel and ethinyl estradiol tablets USP) consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel, USP, (18, 19-Dinorpregn-4-en-20-yn- 3-one, 13-ethyl-17-hydroxy-, (17α)-(−)-), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 white inert tablets. The inactive ingredients in the pink active tablets include anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The ingredients in the film-coating include FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. Each white inert tablet contains anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows: Levonorgestrel, USP C21H28O2 M.W. 312.45 Ethinyl Estradiol, USP C20H24O2 M.W. 296.40 CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective.
    [Show full text]
  • FDA Approved Medications Part 3: Review of Individual Medications Part 4: Additional Board-Pertinent Information
    Dr. Jack’s MedQuik Guide A Psychotropic Medication Guide for Board Exam Preparation Free Additional Board Exam Preparation Resources www.BeatTheBoards.com • 877-225-8384 Dr. Jack’s MedQuik Guide Table of Contents Part 1: Medications FDA Approved In 2009-2010 Part 2: List of Psychiatric Disorders With Their FDA Approved Medications Part 3: Review of Individual Medications Part 4: Additional Board-Pertinent Information Copyright Notice Copyright © 2007-2010 American Physician Institute for Advanced Professional Studies, LLC. All rights reserved. This manuscript may not be transmitted, copied, reprinted, in whole or in part, without the express written permission of the copyright holder. Requests for permission or further information should be addressed to Jack Krasuski at: DrJack@AmericanPhysician.com or American Physician Institute for Advanced Professional Studies, LLC, 125 Windsor Dr., Suite 111, Oak Brook, IL 60523 Disclaimer Notice This publication is designed to provide general educational advice. It is provided to the reader with the understanding that Jack Krasuski and American Physician Institute for Advanced Professional Studies LLC are not rendering medical services. This guide is designed to aid physicians in exam preparation and is not to be considered medical advice for guiding medical care of patients. If medical or other expert assistance is required, the services of a medical or other consultant should be obtained. The author and publisher disclaim any liability arising directly or indirectly from the use of this book.
    [Show full text]
  • Divestra Leaflet
    • Known or suspected estrogen-dependent neoplasia Drugs which may decrease the therapeutic effect of Cyproterone acetate+Ethinyl Pregnancy and Breastfeeding • Undiagnosed abnormal vaginal bleeding Combination of Cyproterone acetate and Ethinyl estradiol is contraindicated during estradiol and increase the incidence of breakthrough bleeding • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete pregnancy and breastfeeding. loss of vision or defect in visual fields Effects on ability to drive and use machines • Concomitant use with other Estrogen+Progestogen combinations or estrogens or Unknown progestogens alone • When pregnancy is suspected or diagnosed Adverse Reactions • Severe diabetes with vascular changes Common adverse reactions includes headaches, nausea, abdominal pain, weight gain, • A history of otosclerosis with deterioration during pregnancy depressed or altered mood and breast pain or tenderness. • Hypersensitivity to this drug or to any ingredient in the formulation or component of the Uncommon adverse reactions include vomiting, diarrhea, fluid retention and migraine. container. Overdose (Cyproterone acetate + Warnings and Precautions There is no antidote and treatment should be symptomatic. Ethinyl estradiol) Discontinue Cyproterone acetate+Ethinyl estradiol tablets at the earliest manifestation of the following: PHARMACOLOGICAL PROPERTIES • Thromboembolic and Cardiovascular Disorders such as thrombophlebitis, pulmonary Pharmacotherapeutic group: Sex hormones and modulators of the genital system, QUALITATIVE AND QUANTITATIVE COMPOSITION embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, and anti-androgens and estrogens. ATC code: G03HB01 Each film-coated tablet contains: retinal thrombosis. Cyproterone acetate (Ph.Eur.)………...2 mg • Conditions that predispose to Venous Stasis and to Vascular Thrombosis (eg. Mechanism of action Ethinyl estradiol (USP)……………...0.035 mg immobilization after accidents or confinement to bed during long-term illness).
    [Show full text]
  • Drugs Interfering with the Metabolism of Tacrolimus (FK506)
    BLOOD SCIENCES DEPARTMENT OF CLINICAL BIOCHEMISTRY Title of Document: Drugs Interfering with the metabolism of tacrolimus (FK506) Q Pulse Reference No: BS/CB/DCB/TOX/4 Version NO: 6 Authoriser: P Beresford Page 1 of 3 Drugs Interfering with the Metabolism of Tacrolimus (FK506) Introduction Tacrolimus (FK506) is an immunosuppressant drug. The purpose of this protocol is to highlight drug interactions in the metabolism of tacrolimus (FK506) Systemically available tacrolimus is metabolised by hepatic CYP3A4. There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall. Concomitant use of medicinal products or herbal remedies known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels. It is therefore recommended to monitor tacrolimus blood levels whenever substances which have the potential to alter CYP3A metabolism are used concomitantly and to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure Inhibitors of metabolism Clinically the following substances have been shown to increase tacrolimus blood levels: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole and voriconazole, the macrolide antibiotic erythromycin or HIV protease inhibitors (e.g. ritonavir). Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients. Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole and nefazodone. In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethisterone, quinidine, tamoxifen, troleandomycin. Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.
    [Show full text]
  • The Role of Highly Selective Androgen Receptor (AR) Targeted
    P h a s e I I S t u d y o f I t r a c o n a z o l e i n B i o c h e m i c a l R e l a p s e Version 4.0: October 8, 2014 CC# 125513 CC# 125513: Hedgehog Inhibition as a Non-Castrating Approach to Hormone Sensitive Prostate Cancer: A Phase II Study of Itraconazole in Biochemical Relapse Investigational Agent: Itraconazole IND: IND Exempt (IND 116597) Protocol Version: 4.0 Version Date: October 8, 2014 Principal Investigator: Rahul Aggarwal, M.D., HS Assistant Clinical Professor Division of Hematology/Oncology, Department of Medicine University of California San Francisco 1600 Divisadero St. San Francisco, CA94115 rahul.aggarwal@ucsf.edu UCSF Co-Investigators: Charles J. Ryan, M.D., Eric Small, M.D., Professor of Medicine Professor of Medicine and Urology Lawrence Fong, M.D., Terence Friedlander, M.D., Professor in Residence Assistant Clinical Professor Amy Lin, M.D., Associate Clinical Professor Won Kim, M.D., Assistant Clinical Professor Statistician: Li Zhang, Ph.D, Biostatistics Core RevisionHistory October 8, 2014 Version 4.0 November 18, 2013 Version 3.0 January 28, 2013 Version 2.0 July 16, 2012 Version 1.0 Phase II - Itraconazole Page 1 of 79 P h a s e I I S t u d y o f I t r a c o n a z o l e i n B i o c h e m i c a l R e l a p s e Version 4.0: October 8, 2014 CC# 125513 Protocol Signature Page Protocol No.: 122513 Version # and Date: 4.0 - October 8, 2014 1.
    [Show full text]
  • Phase II Trial of VELCADE® (Bortezomib)
    Phase II Trial of VELCADE® (Bortezomib) in Combination with Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients with Newly-diagnosed Glioblastoma Multiforme. Protocol Version: Date of Protocol: Original January 22, 2009 Amendment 1 February 14, 2011 Amendment 2 May 31, 2012 Amendment 3 August 1, 2012 Amendment 4 January 09, 2013 Amendment 5 March 13, 2013 Amendment 6 November 19, 2013 Amendment 7 February 11, 2014 Principal Investigator Dr. Albert Lai University of California at Los Angeles VELCADE (bortezomib) for Injection UCLA STUDY PROTOCOL Protocol Number X05303 Phase II Trial of VELCADE® (Bortezomib) in Combination with Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients with Newly-diagnosed Glioblastoma Multiforme. Protocol Version: Date of Protocol: Original January 22, 2009 Amendment 1 February 14, 2011 Amendment 2 May 31, 2012 Amendment 3 August 1, 2012 Amendment 4 January 09, 2013 Amendment 5 March 13, 2013 Amendment 6 November 19, 2013 Amendment 7 February 11, 2014 Investigator &Study Center: Principal Investigator Co-Principal Investigator Sub-Investigators Sub-Site: *VELCADE is the exclusive trademark of Millennium Pharmaceuticals, Inc., registered in the United States and internationally. CONFIDENTIAL Page 1 of 86 Amendment 7 version dated February 11, 2014 VELCADE (bortezomib) for Injection UCLA Neuro-Oncology Program PROTOCOL SUMMARY Title: Phase II Trial of VELCADE* (Bortezomib) in Combination with Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients with Newly-diagnosed Glioblastoma Multiforme. Objectives: This phase II study will examine the safety and efficacy of bortezomib in combination with temozolomide/radiation followed by bortezomib and temozolomide for 2 years (24 28-day cycles) in newly-diagnosed patients with glioblastoma.
    [Show full text]
  • Pharmacokinetics, Pharmacodynamics
    Supplementary Pharmacokinetics, Pharmacodynamics and Drug-Drug Interactions of New Anti-Migraine Drugs–Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies Danuta Szkutnik-Fiedler Table S1. Possible drug-drug interactions of lasmiditan [14,28,31,35–38,40,42,45–47]. The risk or severity of Serum concentration of the Serum concentration of Lasmiditan may serotonin syndrome can following drugs (P-gp lasmiditan (P-gp substrate) increase the be potentially increased and/or BCRP substrates) may potentially increase bradycardic when lasmiditan is may potentially increase when it is combined with effects of the combined with the when combined with the following drugs3,. following drugs. following drugs1,. lasmiditan2,. 5-hydroxytryptophan* afatinib acebutolol alfentanil* alpelisib amlodipine almotriptan* ambrisentan atenolol amitriptiline* apixaban betaxolol amoxapine* belinostat carteolol buspirone* bisoprolol carvedilol citalopram* brentuximab vedotin diltiazem clomipramine* cabazitaxel esmolol cyclobenzaprine* ceritinib felodipine desipramine* cladribine isradipine desvenlavaxine* cobimetinib clobazam ivabradine dexfenfluramine* colchicine* daclatasvir labetalol dextromethorphan* cyclosporine erythromycin levobetaxolol dihydroergotamine* daunorubicin fexofenadine levobunolol dolasetron* delafloxacin lapatinib methyldopa doxepin* digitoxin ritonavir metipranolol doxepin topical* digoxin metoprolol duloxetine* donepezil nadolol eletriptan* doxorubicin nebivolol ergotamine* edoxaban* nicardipine escitalopram*
    [Show full text]
  • Antibiotics and Antibiotic Resistance
    This is a free sample of content from Antibiotics and Antibiotic Resistance. Click here for more information on how to buy the book. Index A Antifolates. See also specific drugs AAC(60)-Ib-cr, 185 novel compounds, 378–379 ACHN-975 overview, 373–374 clinical studies, 163–164 resistance mechanisms medicinal chemistry, 166 sulfamethoxazole, 378 structure, 162 trimethoprim, 374–378 AcrAB-TolC, 180 Apramycin, structure, 230 AcrD, 236 Arbekacin, 237–238 AdeRS, 257 Avibactam, structure, 38 AFN-1252 Azithromycin mechanism of action, 148, 153 resistance, 291, 295 resistance, 153 structure, 272 structure, 149 Aztreonam, structure, 36 AIM-1, 74 Amicoumacin A, 222 Amikacin B indications, 240 BaeSR, 257 structure, 230 BAL30072, 36 synthesis, 4 BB-78495, 162 Aminoglycosides. See also specific drugs BC-3205, 341, 344 historical perspective, 229–230 BC-7013, 341, 344 indications, 239–241 b-Lactamase. See also specific enzymes mechanism of action, 232 classification novel drugs, 237 class A, 67–71 pharmacodynamics, 238–239 class B, 69–74 pharmacokinetics, 238–239 class C, 69, 74 resistance mechanisms class D, 70, 74–77 aminoglycoside-modifying enzymes evolution of antibiotic resistance, 4 acetyltransferases, 233–235 historical perspective, 67 nucleotidyltransferases, 235 inhibitors phosphotransferases, 235 overview, 37–39 efflux-mediated resistance, 236 structures, 38 molecular epidemiology, 236–237 nomenclature, 67 overview, 17, 233 b-Lactams. See also specific classes and antibiotics ribosomal RNA modifications, 235–236 Enterococcus faecium–resistancemechanisms,
    [Show full text]
  • Simultaneous Physiologically-Based Pharmacokinetic (PBPK) Modeling of Parent and Active Metabolites to Investigate Complex CYP3A
    DMD Fast Forward. Published on November 8, 2017 as DOI: 10.1124/dmd.117.078006 This article has not been copyedited and formatted. The final version may differ from this version. DMD # 078006 Simultaneous physiologically based pharmacokinetic (PBPK) modeling of parent and active metabolites to investigate complex CYP3A4 drug-drug interaction potential: a case example of midostaurin Helen Gu, Catherine Dutreix, Sam Rebello, Taoufik Ouatas, Lai Wang, Dung Yu Chun, Heidi J. Einolf, Handan He Downloaded from Primary affiliations of all authors: HG, SR, LW, DYC, HJE, and HH: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. CD and TO: Basel, Switzerland. DYC: Insmed dmd.aspetjournals.org Inc., Bridgewater, New Jersey, USA. Laboratory of origin: same as affiliations at ASPET Journals on September 30, 2021 DMD Fast Forward. Published on November 8, 2017 as DOI: 10.1124/dmd.117.078006 This article has not been copyedited and formatted. The final version may differ from this version. RUNNING TITLE PAGE Running title: PBPK modeling for midostaurin-CYP3A4 interaction Corresponding author: Helen Gu, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936 telephone: 1-862-778-5722 fax: 1-973-781-7579 Downloaded from e-mail: helen.gu@novartis.com dmd.aspetjournals.org Text pages: 23 Tables: 5 Figures: 7 at ASPET Journals on September 30, 2021 References: 38 Word count: Abstract: 249 Introduction: 748 Discussion: 1500 2 DMD Fast Forward. Published on November 8, 2017 as DOI: 10.1124/dmd.117.078006 This article
    [Show full text]
  • PART III: CONSUMER INFORMATION Pr SELECT 1/35
    IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION control. The reported rates represent the number of women out of 100 who would become pregnant in one Pr SELECT 1/35 * (Norethindrone and Ethinyl year. Estradiol tablets) Reported Pregnancies per 100 Women per Year This leaflet is part III of a three-part "Product Combination pill less than 1 to 2 Monograph" published when SELECT 1/35 was Intrauterine system (IUS) less than 1 to 6 approved for sale in Canada and is designed Condom with spermicidal 1 to 6 specifically for Consumers. This leaflet is a foam or gel summary and will not tell you everything about Mini-pill (progesterone-only 3 to 6 SELECT 1/35. Contact your doctor or pharmacist pill) if you have any questions about the drug. Condom 2 to 12 Diaphragm with spermicidal 3 to 18 ABOUT THIS MEDICATION foam or gel What the medication is used for: Spermicide 3 to 21 SELECT 1/35 is used for the prevention of pregnancy. 3 to 28 Sponge with spermicide What it does: 5 to 18 SELECT 1/35 is a birth control pill (oral contraceptive) Cervical cap with spermicide that contains two female sex hormones (ethinyl 2 to 20 estradiol and norethindrone). SELECT 1/35 has been Periodic abstinence (rhythm), shown to be highly effective in preventing pregnancy all types when taken as prescribed by your doctor. Pregnancy is 60 to 85 always more risky than taking birth control pills, except No birth control in smokers over 35. The chance of becoming pregnant increases with incorrect use.
    [Show full text]