IEHP Dualchoice Cal Mediconnect Formulary Maintenance Drug List
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2020 Prior Authorization Criteria
2020 PRIOR AUTHORIZATION CRITERIA TABLE OF CONTENTS abiraterone tablet ...................................................................................................................... 217 ABRAXANE .............................................................................................................................. 131 ACTIMMUNE .............................................................................................................................. 14 ADASUVE ................................................................................................................................... 27 ADEMPAS ................................................................................................................................ 197 AFINITOR ................................................................................................................................. 217 AFINITOR DISPERZ ................................................................................................................. 217 AIMOVIG ..................................................................................................................................... 15 ALECENSA ............................................................................................................................... 217 ALIMTA ..................................................................................................................................... 131 ALIQOPA ................................................................................................................................. -
Valturna Label
HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------WARNINGS AND PRECAUTIONS---------------- These highlights do not include all the information needed to use • Avoid fetal or neonatal exposure. (5.1) Valturna safely and effectively. See full prescribing information for • Head and neck angioedema: Discontinue Valturna and monitor until Valturna. signs and symptoms resolve. (5.2) • Hypotension in volume- or salt-depleted Patients: Correct imbalances Valturna (aliskiren and valsartan, USP) Tablets before initiating therapy with Valturna. (5.3) Initial U.S. Approval: 2009 • Patients with renal impairment: Decreases in renal function may be anticipated in susceptible individuals. (5.4) WARNING: AVOID USE IN PREGNANCY • Patients with hepatic impairment: Slower clearance may occur. (5.5) See full prescribing information for complete boxed warning. • Hyperkalemia: Consider periodic determinations of serum electrolytes to When pregnancy is detected, discontinue Valturna as soon as possible. detect possible electrolyte imbalances, particularly in patients at risk. When used in pregnancy during the second and third trimester, drugs (5.7) that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) --------------------------------ADVERSE REACTIONS----------------------- The most common adverse events (incidence ≥1.5% and more common than ---------------------------INDICATIONS AND USAGE----------------------- with placebo) are: fatigue and nasopharyngitis. (6.1) Valturna is a combination of aliskiren, a direct renin inhibitor, and valsartan, an angiotensin II receptor blocker (ARB), indicated for the treatment of To report SUSPECTED ADVERSE REACTIONS, contact Novartis hypertension: Pharmaceuticals Corporation at 1-888-669-6682 or FDA at • In patients not adequately controlled with monotherapy. (1) 1-800-FDA-1088 or www.fda.gov/medwatch • May be substituted for titrated components. -
An Approach to the Patient with a Dry Mouth
MedicineToday 2014; 15(4): 30-37 PEER REVIEWED FEATURE 2 CPD POINTS An approach to the patient with a dry mouth Key points • The subjective complaint of ELHAM AFLAKI MD; TAHEREH ERFANI MD; NICHOLAS MANOLIOS MB BS(Hons), PhD, MD, FRACP, FRCPA; xerostomia needs to be MARK SCHIFTER FFD, RCSI(Oral Med), FRACDS(Oral Med) differentiated from true salivary hypofunction. Dry mouth is a common and disabling problem. After exclusion of treatable • Salivary hypofunction can significantly reduce quality causes, treatment is symptomatic to prevent the consequences of salivary of life through its adverse hypofunction, such as tooth decay and infection of the oral mucosa. effects on taste, mastication, swallowing, cleansing of the erostomia, or the subjective feeling of neuropathic-induced orofacial dysaesthesia) mouth, killing of microbes a dry mouth, is a common complaint. and psychological and psychiatric disorders, and speech. It is often a consequence of salivary such as anxiety and depression. • Salivary hypofunction is a hypofunction (hyposalivation), in substantive risk factor for X which there is objective evidence of reduced NORMAL SALIVA PRODUCTION dental caries, oral mucosal salivary output or qualitative changes in saliva. Under normal physiological conditions, the disease and infection, Typically, patients complain of oral dryness salivary glands produce 1000 to 1500 mL of particularly oral candidiasis. only when salivary secretion is reduced by more saliva daily as an ultrafiltrate from the circu- • Patients should be than half.1 As saliva has a crucial role in taste lating plasma. Therefore, simple dehydration investigated for contributory perception, mastication, swallowing, cleansing reduces saliva production. The parotid glands and underlying causes, of the mouth, killing of microbes and speech, are the major source of serous saliva (60 to 65% which include drugs and abnormalities in saliva production can signif- of total saliva volume), producing the stimu- rheumatological diseases. -
New Zealand Data Sheet
NEW ZEALAND DATA SHEET 1. PRODUCT NAME INCRUSE ELLIPTA Umeclidinium (as bromide), 62.5 micrograms, powder for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece of the inhaler) contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). This corresponds to a pre-dispensed dose of 62.5 micrograms of umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide). Excipient with known effect: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for Inhalation White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Incruse Ellipta is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 Dose and method of administration Dose Adults Incruse Ellipta (umeclidinium 62.5 micrograms) should be taken as one inhalation once daily by the orally inhaled route. Incruse Ellipta should be taken at the same time every day. Do not use Incruse Ellipta more than once every 24 hours. Special populations Elderly population No dosage adjustment is required in patients over 65 years (see 5.2 Pharmacokinetics properties– Special patient populations). 1 Renal impairment No dosage adjustment is required in patients with renal impairment (see 5.2 Pharmacokinetics properties – Special patient populations). Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment. Incruse Ellipta has not been studied in patients with severe hepatic impairment (see 5.2 Pharmacokinetics properties– Special patient populations). -
Acebutolol Hydrochloride Eq 200 Mg Base, Capsule, Oral, 100 0.4612 B Eq 400 Mg Base, Capsule, Oral, 100 0.6713 B
TRANSMITTAL NO. 37 - FEDERAL UPPER LIMIT DRUG LIST NOVEMBER 20, 2001 The following list of multiple source drugs meets the criteria set forth in 42 CFR 447.332 and Section 1927(e) of the Social Security Act, as amended by OBRA 1993. Payment for multiple source drugs identified and listed below must not exceed, in the aggregate, payment levels determined by applying to each drug entity a reasonable dispensing fee (established by the State and specified in the State plan), plus an amount based on the limit per unit which CMS has determined to be equal to 150 percent applied to the lowest price listed (in package sizes of 100 units, unless otherwise noted) in any of the published compendia of cost information of drugs. The listing is based on data current as of April 2001 from First Data Bank (Blue Book), Medi- Span, and the Red Book. This list does not reference the commonly known brand names. However, the brand names are included in the electronic FUL listing provided to the state agencies. The FUL price list and electronic listing are available at http://www.cms.hhs.gov/Reimbursement/05_FederalUpperLimits.asp. In accordance with current policy, Federal financial participation will not be provided for any drug on the FUL listing for which the FDA has issued a notice of an opportunity for a hearing as a result of the Drug Efficacy Study and Implementation (DESI) program, and which has been found to be a less than effective or is identical, related or similar (IRS) to the DESI drug. The DESI drug is identified by the Food and Drug Administration or reported by the drug manufacturer for purposes of the Medicaid drug rebate program. -
Topically Applied Minoxidil in Baldness
Review Topically Applied Minoxidil in Baldness ERVIN NOVAK,M.D., THOMASJ. FRANZ, M.D., JOHN T. HEADINGTON,M.D., AND RONALD C. WESTER,PH.D. From the Upjohn Company, Kalamazoo, Michigan, School idil and its metabolites can be removed by hemodi- of Medicine, University of Washington, Seattle, alysis. Washington, Medical School, University of Michigan, Ann Fluid retention and hypertrichosis are the most Arbor, Michigan, and School of Medicine and School of Pharmacy, University of California, San Francisco, California commonly occurring side effects of minoxidil. Hair regrowth in a patient with male pattern baldness was described in a case report of a hypertensive patient treated twice daily with 20 mg oral minoxidil.6 The Minoxidil, an orally administered, peripheral va- extensive hair regrowth continued after 10 months sodilator used to treat hypertension, causes hypertri- of therapy. New and increased hair growth as a side chosis in more than 80% of users. The drug reduces effect was also detected in an early clinical study elevated blood pressure by decreasing peripheral involving five of eight patients on oral minoxidil vascular resistance. Chemically, minoxidil is 2,4-di- therapy for 2 month^.^ Zappacosta' reported reversal amino-6-piperidinopyrimidine-3-oxide; it is soluble in of baldness in a patient on minoxidil for the treatment water to the extent of approximately 2 mg/ml, is of hypertension. more readily soluble in propylene glycol or ethanol, After the third week of therapy with oral minoxidil, and is nearly insoluble in acetone, chloroform, or hypertrichosis usually appears between the eyebrows ethyl acetate. Following oral administration of minox- and the hair line, in the malar and temporal areas, idil and in association with the reduction in peripheral on the backs of the arms, on the shoulders, and on vascular resistance, cardiac output is augmented, salt the legs. -
M2021: Pharmacogenetic Testing
Pharmacogenetic Testing Policy Number: AHS – M2021 – Pharmacogenetic Prior Policy Name and Number, as applicable: Testing • M2021 – Cytochrome P450 Initial Presentation Date: 06/16/2021 Revision Date: N/A I. Policy Description Pharmacogenetics is defined as the study of variability in drug response due to heredity (Nebert, 1999). Cytochrome (CYP) P450 enzymes are a class of enzymes essential in the synthesis and breakdown metabolism of various molecules and chemicals. Found primarily in the liver, these enzymes are also essential for the metabolism of many medications. CYP P450 are essential to produce many biochemical building blocks, such as cholesterol, fatty acids, and bile acids. Additional cytochrome P450 are involved in the metabolism of drugs, carcinogens, and internal substances, such as toxins formed within cells. Mutations in CYP P450 genes can result in the inability to properly metabolize medications and other substances, leading to increased levels of toxic substances in the body. Approximately 58 CYP genes are in humans (Bains, 2013; Tantisira & Weiss, 2019). Thiopurine methyltransferase (TPMT) is an enzyme that methylates azathioprine, mercaptopurine and thioguanine into active thioguanine nucleotide metabolites. Azathioprine and mercaptopurine are used for treatment of nonmalignant immunologic disorders; mercaptopurine is used for treatment of lymphoid malignancies; and thioguanine is used for treatment of myeloid leukemias (Relling et al., 2011). Dihydropyrimidine dehydrogenase (DPD), encoded by the gene DPYD, is a rate-limiting enzyme responsible for fluoropyrimidine catabolism. The fluoropyrimidines (5-fluorouracil and capecitabine) are drugs used in the treatment of solid tumors, such as colorectal, breast, and aerodigestive tract tumors (Amstutz et al., 2018). A variety of cell surface proteins, such as antigen-presenting molecules and other proteins, are encoded by the human leukocyte antigen genes (HLAs). -
Pilocarpine (Systemic) | Memorial Sloan Kettering Cancer Center
PATIENT & CAREGIVER EDUCATION Pilocarpine (Systemic) This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. Brand Names: US Salagen Brand Names: Canada JAMP Pilocarpine; M-Pilocarpine; Salagen What is this drug used for? It is used to treat dry mouth. What do I need to tell my doctor BEFORE I take this drug? If you have an allergy to pilocarpine or any other part of this drug. If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have any of these health problems: Asthma, glaucoma, liver disease, or swelling in parts of the eye. If you are breast-feeding or plan to breast-feed. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure Pilocarpine (Systemic) 1/6 that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take this drug? Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. -
TAYSIDE PRESCRIBER Issue No
TAYSIDE PRESCRIBER Issue No. 122 – May 2012 Produced by the NS Tayside Medicines Governance Unit in conjunction with Mental Health Citalopram & escitalopram:QT interval prolongation New maximum daily dose restrictions, contraindications, and warnings Information has been issued via Drug Safety Update, Volume 5, Issue 5, December 2011 and ‘Dear Healthcare Professional Letters’ for both citalopram and escitalopram regarding new restrictions on the maximum daily doses, contraindications, and warnings. This is as a result of an assessment of a QT study that revealed dose-dependent increase in the QT interval observed with ECG monitoring for both citalopram and escitalopram. Maximum licensed daily doses for citalopram and escitalopram Adults Adults > 65 years Adults with hepatic impairment Citalopram 40 mg 20 mg 20 mg Escitalopram (non-formulary) 20 mg 10 mg 10mg The guidance in NHS Tayside is: ⇒ to review all patients on high dose* citalopram or escitalopram with aim of reducing to new maximum licensed doses ( * above new maximum licensed daily doses as stated in the table above) ⇒ not to prescribe citalopram or escitalopram with other medication known to prolong the QT interval ⇒ not to prescribe citalopram and escitalopram in patients with known QT prolongation or congenital long QT syndrome ⇒ to consider alternative antidepressant in patients with cardiac disease ( e.g. patients with significant bradycardia; recent myocardial infarction or decompensated heart failure) See flow diagram on page 3 for further guidance and table below on medicines known to prolong the QT interval. Medicines known to increase plasma levels of citalopram or escitalopram, e.g. omeprazole & some antivirals may require dose reduction of citalopram or escitalopram and should be used with caution. -
Different Beta-Blocking Effects of Carvedilol and Bisoprolol in Humans
Journal of Clinical and Basic Cardiology An Independent International Scientific Journal Journal of Clinical and Basic Cardiology 2001; 4 (1), 53-56 Different beta-blocking effects of carvedilol and bisoprolol in humans Koshucharova G, Klein W, Lercher P, Maier R, Stepan V Stoschitzky K, Zweiker R Homepage: www.kup.at/jcbc Online Data Base Search for Authors and Keywords Indexed in Chemical Abstracts EMBASE/Excerpta Medica Krause & Pachernegg GmbH · VERLAG für MEDIZIN und WIRTSCHAFT · A-3003 Gablitz/Austria ORIGINAL PAPERS, CLINICAL CARDIOLOGY Different Beta-Blocking Effects of Carvedilol and Bisoprolol J Clin Basic Cardiol 2001; 4: 53 Different Beta-Blocking Effects of Carvedilol and Bisoprolol in Humans G. Koshucharova, R. Zweiker, R. Maier, P. Lercher, V. Stepan, W. Klein, K. Stoschitzky Bisoprolol is a beta1-selective beta-adrenergic antagonist while carvedilol is a non-selective beta-blocker with additional blockade of alpha1-adrenoceptors. Administration of bisoprolol has been shown to cause up-regulation of β-adrenoceptor density and to decrease nocturnal melatonin release, whereas carvedilol lacks these typical effects of beta-blocking drugs. The objective of the present study was to investigate beta-blocking effects of bisoprolol and carvedilol in healthy subjects. We compared the effects of single oral doses of clinically recommended amounts of bisoprolol (2.5, 5 and 10 mg) and carvedilol (25, 50 and 100 mg) to those of placebo in a randomised, double-blind, cross-over study in 12 healthy male volun- teers. Three hours after oral administration of the drugs heart rate and blood pressure were measured at rest, after 10 min. of exercise, and after 15 min. -
PRODUCT MONOGRAPH ELAVIL® Amitriptyline Hydrochloride Tablets
PRODUCT MONOGRAPH ELAVIL® amitriptyline hydrochloride tablets USP 10, 25, 50 and 75 mg Antidepressant AA PHARMA INC. DATE OF PREPARATION: 1165 Creditstone Road Unit #1 August 29, 2018 Vaughan, ON L4K 4N7 Control No.: 217626 1 PRODUCT MONOGRAPH ELAVIL® amitriptyline hydrochloride tablets USP 10, 25, 50, 75 mg THERAPEUTIC CLASSIFICATION Antidepressant ACTIONS AND CLINICAL PHARMACOLOGY Amitriptyline hydrochloride is a tricyclic antidepressant with sedative properties. Its mechanism of action in man is not known. Amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. Amitriptyline has pronounced anticholinergic properties and produces EKG changes and quinidine-like effects on the heart (See ADVERSE REACTIONS). It also lowers the convulsive threshold and causes alterations in EEG and sleep patterns. Orally administered amitriptyline is readily absorbed and rapidly metabolized. Steady-state plasma concentrations vary widely and this variation may be genetically determined. Amitriptyline is primarily excreted in the urine, mostly in the form of metabolites, with some excretion also occurring in the feces. INDICATIONS AND CLINICAL USE ELAVIL® (amitriptyline hydrochloride) is indicated in the drug management of depressive illness. ELAVIL® may be used in depressive illness of psychotic or endogenous nature and in selected patients with neurotic depression. Endogenous depression is more likely to be alleviated than are other depressive states. ELAVIL® ®, because of its sedative action, is also of value in alleviating the anxiety component of depression. As with other tricyclic antidepressants, ELAVIL® may precipitate hypomanic episodes in patients with bipolar depression. These drugs are not indicated in mild depressive states and depressive reactions. -
Therapeutic Class Overview Beta-Adrenergic Blocking Agents
Therapeutic Class Overview Beta-adrenergic Blocking Agents INTRODUCTION Approximately 92.1 million American adults have at least 1 type of cardiovascular disease according to the American Heart Association (AHA) Heart Disease and Stroke Statistics 2018 update. From 2003 to 2015, mortality associated with cardiovascular disease declined 25.5% (Benjamin et al 2018). Beta-adrenergic blocking agents (beta-blockers) are a group of drugs that block the sympathomimetic effects of catecholamines on beta receptors. This results in negative inotropic and chronotropic effects and relaxation of smooth muscle. Beta-blockers have varied pharmacologic properties. ○ Cardioselective beta-blockers preferentially interact with beta1-receptors, which are predominantly found in the heart. Non-cardioselective beta-blockers also interact with beta2-receptors found on smooth muscle in the lungs, blood vessels, and other tissues. The cardioselectivity of beta-blockers is dose dependent; therefore, beta2 blockade can occur at higher doses with certain cardioselective agents. ○ Some beta-blockers (acebutolol and pindolol) have intrinsic sympathomimetic activity (ISA), which may result in a lower incidence of bradycardia and bronchoconstriction (Facts and Comparisons 2018). In addition, some beta- blockers (nebivolol and propranolol) have higher lipophilicity, which may increase the risk for central nervous system- related adverse events (Facts and Comparisons 2018). ○ Carvedilol and labetalol also block alpha-adrenergic receptors and may reduce peripheral resistance more than other beta-blockers (Clinical Pharmacology 2018). Specific indications for the beta-blockers vary by product. Most beta-blockers (all except sotalol) are approved to treat hypertension (HTN). The 2017 American College of Cardiology (ACC)/AHA clinical practice guideline defines HTN as blood pressure (BP) ≥ 130/80 mm Hg (Whelton et al 2017).