Association Between Serious Hypoglycemia and Calcium-Channel Blockers Used Concomitantly with Insulin Secretagogues
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Optum Essential Health Benefits Enhanced Formulary PDL January
PENICILLINS ketorolac tromethamineQL GENERIC mefenamic acid amoxicillin/clavulanate potassium nabumetone amoxicillin/clavulanate potassium ER naproxen January 2016 ampicillin naproxen sodium ampicillin sodium naproxen sodium CR ESSENTIAL HEALTH BENEFITS ampicillin-sulbactam naproxen sodium ER ENHANCED PREFERRED DRUG LIST nafcillin sodium naproxen DR The Optum Preferred Drug List is a guide identifying oxacillin sodium oxaprozin preferred brand-name medicines within select penicillin G potassium piroxicam therapeutic categories. The Preferred Drug List may piperacillin sodium/ tazobactam sulindac not include all drugs covered by your prescription sodium tolmetin sodium drug benefit. Generic medicines are available within many of the therapeutic categories listed, in addition piperacillin sodium/tazobactam Fenoprofen Calcium sodium to categories not listed, and should be considered Meclofenamate Sodium piperacillin/tazobactam as the first line of prescribing. Tolmetin Sodium Amoxicillin/Clavulanate Potassium LOW COST GENERIC PREFERRED For benefit coverage or restrictions please check indomethacin your benefit plan document(s). This listing is revised Augmentin meloxicam periodically as new drugs and new prescribing LOW COST GENERIC naproxen kit information becomes available. It is recommended amoxicillin that you bring this list of medications when you or a dicloxacillin sodium CARDIOVASCULAR covered family member sees a physician or other penicillin v potassium ACE-INHIBITORS healthcare provider. GENERIC QUINOLONES captopril ANTI-INFECTIVES -
Diabetes Medications: Oral Medications
Diabetes Medications: Oral Medications Medication Types 1. Biguanides 2. Sulfonylureas 3. Thiazolidinediones (TZDs) 4. Alpha-Glucosidase Inhibitors 5. D-Phenylalanine Meglitinides 6. SGLT-2 inhibitors 7. DPP-4 inhibitors 8. Combination Oral Medications 1. Biguanides This works by lowering blood glucose by reducing the amount of glucose produced by the liver and helping the body respond better to the insulin made in the pancreas Metformin can be used with diet and exercise or with other agents, diet, and exercise. Types of Biguanides: • Metformin (Glucophage) 500mg/1000mg • Metformin (Glucophage XR) 500mg/1000mg • Fortamet (extended release) 500mg/1000mg • Riomet (oral solution) 500mg/5ml Side Effects: • Cramping • Gas • Diarrhea • Taking the pill before meals may decrease stomach upset 2. Sulfonylureas Sulfonylureas stimulate the pancreas to produce insulin and cause the body to respond better to the insulin it does produce. Sulfonylureas can be used alone or in combination with other medications. Types of Sulfonylureas: • Glimepiride (Amaryl) • Glipizide (Glucotrol, Glucotrol XL) • Glyburide (Diabeta, Micronase) • Glyburide, micronized (Glynase) • Tolbutamide (Orinase) 1st generation • Tolazamide (Tolinase) 1st generation • Acetohexamide (Dymelor) 1st generation • Chlorpropamide (Diabinese) 1st generation Side Effects: • Hypoglycemia • Upset stomach • Weight gain • Skin rash 3. Thiazolidinediones (TZDs) TZDs primarily reduce insulin resistance by improving target cell response (sensitivity) to insulin. They also can decrease glucose output from the liver and increase glucose disposal in the skeletal muscles. Types of TZDs: • Pioglitazione (Actos) 15-45 mg Actos may be taken with or without food • Avandia—off the market Side Effects: • Jaundice • Nausea and vomiting • Stomach pain • Dark urine • Swelling • These medicines are generally safe and do not cause hypoglycemia when used alone. -
Orange Book Patent Listing Dispute List
Patent Listing Disputes Current through September 10, 2021 Established Drug Product Due Date for NDA Holder NDA Holder NDA Number NDA Holder Strength(s) Relevant U.S. Patent Number(s) Type of Patent Claim Original Use Code (if applicable) Revised Use Code (if applicable) Dispute Outcome Name Response Response Date Disputes Not Related to epinephrine 205029 Belcher 1mg/mL 10,004,700 and 10,039,728 N/A N/A 7/24/2021 Pending Pending Use Code 7 mg 14 mg 8,168,209, 8,173,708, 8,283,379, Disputes Not Related to memantine hydrochloride 22525 Allergan Sales LLC N/A N/A 5/28/2021 5/28/2021 Patent Listing Updated 21 mg 8,329,752, 8,362,085 and 8,598,233 Use Code 28 mg 0.1 mg Disputes Not Related to epinephrine 201739 Kaleo Inc 0.15 mg 10,824,938 N/A N/A 2/28/2021 2/3/2021 Patent Listing Updated Use Code 0.3 mg Disputes Not Related to netarsudil and latanoprost 208259 Aerie Pharms Inc 0.02%/0.005% 10,654,844 N/A N/A 11/18/2020 10/30/2020 Patent Listing Updated Use Code Disputes Not Related to netarsudil 208254 Aerie Pharms Inc 0.02% 10,654,844 N/A N/A 11/18/2020 10/30/2020 Patent Listing Updated Use Code U-2869: IV Administration of cangrelor before U-2979: Method comprising IV administration PCI and continuous infusion for at least 2 of cangrelor before PCI then continuous hours or the duration of the PCI and, during infusion for at least 2 hours or the duration of cangrelor 204958 Chiesi 50 mg/vial 8,680,052 Method of Use 11/8/2020 11/3/2020 Patent Listing Updated or after the continuous infusion, PCI and, during or after continuous infusion, -
Medication Choice Diabetes
Weight Change Low Blood Sugar Blood Sugar Considerations (Hypoglycemia) Blood(A1c Reduction) Sugar Weight Change Low Blood Sugar (A1c Reduction) Considerations (Hypoglycemia) Metformin Metformin Metformin 1 – 2% Metformin In the rst few weeks after starting Metformin, patients may have some nausea, indigestion or diarrhea. None No Severe Risk Minor = 0 – 1% Insulin There are no other side effects associated with Insulin. Insulin Insulin Insulin Unlimited % Pioglitazone 4 to 6 lb. gain Over time, 10 in 100 people may have fluid retention Severe = 1 – 3% Minor = 30 – 40% (edema) while taking the drug. For some it may be as little as ankle swelling. For others, fluid may build up Pioglitazone 1% in the lungs making it difficult to breathe. This may Pioglitazone Pioglitazone resolve after you stop taking the drug. 10 in 100 people at risk of bone fractures who use this drug will have More than 2 to 6 lb. gain a bone fracture in the next 10 years. There appears to No Severe Risk Minor = 1 – 2% be a slight increase in the risk of bladder cancer with Liraglutide/ 0.5 – 1% this drug. Liraglutide/Exenatide Liraglutide/Exenatide Exenatide Liraglutide/Exenatide Some patients may have nausea or diarrhea. In some 3 to 6 lb. loss cases, the nausea may be severe enough that a patient No Severe Risk Minor = 0 – 1% has to stop taking the drug. There are reports of pain in the abdomen that may be caused by inammation Sulfonylureas Sulfonylureas Sulfonylureas 1 – 2% of the pancreas with these agents. Glipizide, Glimepiride, Glyburide Glipizide, Glimepiride, Glyburide Glipizide, Glimepiride, Glyburide Sulfonylureas 2 to 3 lb. -
Sulfonylureas
Therapeutic Class Overview Sulfonylureas INTRODUCTION In the United States (US), diabetes mellitus affects more than 30 million people and is the 7th leading cause of death (Centers for Disease Control and Prevention [CDC] 2018). Type 2 diabetes mellitus (T2DM) is the most common form of diabetes and is characterized by elevated fasting and postprandial glucose concentrations (American Diabetes Association [ADA] 2019[a]). It is a chronic illness that requires continuing medical care and ongoing patient self-management education and support to prevent acute complications and to reduce the risk of long-term complications (ADA 2019[b]). ○ Complications of T2DM include hypertension, heart disease, stroke, vision loss, nephropathy, and neuropathy (ADA 2019[a]). In addition to dietary and lifestyle management, T2DM can be treated with insulin, one or more oral medications, or a combination of both. Many patients with T2DM will require combination therapy (Garber et al 2019). Classes of oral medications for the management of blood glucose levels in patients with T2DM focus on increasing insulin secretion, increasing insulin responsiveness, or both, decreasing the rate of carbohydrate absorption, decreasing the rate of hepatic glucose production, decreasing the rate of glucagon secretion, and blocking glucose reabsorption by the kidney (Garber et al 2019). Pharmacologic options for T2DM include sulfonylureas (SFUs), biguanides, thiazolidinediones (TZDs), meglitinides, alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogs, amylinomimetics, sodium-glucose cotransporter 2 (SGLT2) inhibitors, combination products, and insulin (Garber et al 2019). SFUs are the oldest of the oral antidiabetic medications, and all agents are available generically. The SFUs can be divided into 2 categories: first-generation and second-generation. -
Oregon Drug Use Review / Pharmacy & Therapeutics Committee
© Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program OHA Division of Medical Assistance Programs 500 Summer Street NE, E35; Salem, OR 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Oregon Drug Use Review / Pharmacy & Therapeutics Committee Thursday, July 26, 2018 1:00 - 5:00 PM HP Conference Room 4070 27th Ct. SE Salem, OR 97302 MEETING AGENDA NOTE: Any agenda items discussed by the DUR/P&T Committee may result in changes to utilization control recommendations to the OHA. Timing, sequence and inclusion of agenda items presented to the Committee may change at the discretion of the OHA, P&T Committee and staff. The DUR/P&T Committee functions as the Rules Advisory Committee to the Oregon Health Plan for adoption into Oregon Administrative Rules 410-121-0030 & 410-121-0040 as required by 414.325(9). I. CALL TO ORDER 1:00 PM A. Roll Call & Introductions R. Citron (OSU) B. Conflict of Interest Declaration R. Citron (OSU) C. Approval of Agenda and Minutes T. Klein (Chair) D. Department Update T. Douglass (OHA) E. Legislative Update T. Douglass (OHA) F. Mental Health Clinical Advisory Group Discussion K. Shirley (MHCAG) 1:40 PM II. CONSENT AGENDA TOPICS T. Klein (Chair) A. P&T Methods B. CMS and State Annual Reports C. Quarterly Utilization Reports 1. Public Comment III. DUR ACTIVITIES 1:45 PM A. ProDUR Report R. Holsapple (DXC) B. RetroDUR Report D. Engen (OSU) C. Oregon State Drug Reviews K. Sentena (OSU) 1. A Review of Implications of FDA Expedited Approval Pathways, Including the Breakthrough Therapy Designation IV. -
Download Product Insert (PDF)
PRODUCT INFORMATION Nateglinide Item No. 23320 CAS Registry No.: 105816-04-4 Formal Name: N-[[trans-4-(1-methylethyl)cyclohexyl] O OH carbonyl]-D-phenylalanine Synonyms: A-4166, SDZ-DJN 608 O MF: C H NO 19 27 3 N FW: 317.4 Purity: ≥98% H UV/Vis.: λmax: 207 nm Supplied as: A crystalline solid Storage: -20°C Stability: ≥2 years Information represents the product specifications. Batch specific analytical results are provided on each certificate of analysis. Laboratory Procedures Nateglinide is supplied as a crystalline solid. A stock solution may be made by dissolving the nateglinide in the solvent of choice. Nateglinide is soluble in organic solvents such as ethanol, DMSO, and dimethyl formamide, which should be purged with an inert gas. The solubility of nateglinide in these solvents is approximately 30 mg/ml. Description Nateglinide is a hypoglycemic agent.1-3 It induces insulin and somatostatin release from perfused rat pancreas when used at concentrations ranging from 0.03 to 3 μM.1 Nateglinide (3 µM) increases intracellular calcium levels in isolated rat pancreatic β cells, an effect that can be inhibited by the L-type calcium channel blocker nitrendipine (Item No. 17549). Nateglinide-induced secretion of insulin and somatostatin and calcium influx is also reversed by the potassium channel activator diazoxide (Item No. 14576). Oral administration of nateglinide (1.6 mg/kg) reduces blood glucose levels by 20% in fasted mice.2 It also decreases blood glucose levels in an oral glucose tolerance test in normal rats, genetically diabetic KK mice, and a rat model of diabetes induced by streptozotocin (STZ; Item No. -
New Therapeutic Agents Marketed in 2014: Part 1 Daniel A
CPE New therapeutic agents marketed in 2014: Part 1 Daniel A. Hussar Objective: To provide information regarding the most important properties of Daniel A. Hussar, PhD, is Remington Professor of Pharmacy, Philadelphia College new therapeutic agents that have been marketed in 2014. of Pharmacy, University of the Sciences in Data sources: Product labeling supplemented selectively with published studies Philadelphia. and drug information reference sources. Development: This home-study CPE activity Data synthesis: Seven new therapeutic agents that were marketed in the United was developed by the American Pharmacists States in early 2014 are considered in this first of a four-part series: umeclidinium Association. bromide/vilanterol trifenatate, perampanel, eslicarbazepine acetate, apremilast, dapagliflozin propanediol, avanafil, and bazedoxifene/conjugated estrogens. In- dications and information on dosage and administration for these agents are re- viewed, as are the most important pharmacokinetic properties, drug interactions, and other precautions. Practical considerations for use of these new agents are also discussed. When possible, properties of the new drugs are compared with those of older agents marketed for the same indications. Conclusion: Umeclidinium/vilanterol is the first combination formulation for oral inhalation to include both a long-acting muscarinic antagonist and a long-acting beta-2-adrenergic agonist for the maintenance treatment of patients with chronic ob- structive pulmonary disease. Both perampanel and eslicarbazepine have been ap- proved as adjunctive treatment for patients with partial-onset seizures. Perampanel has a unique mechanism of action whereas eslicarbazepine has properties that are most similar to those of oxcarbazepine. Apremilast is indicated for the treatment of patients with active psoriatic arthritis and is effective following oral administra- tion. -
Ambetter 90-Day-Maintenance Drug List- 2020
Ambetter 90-Day-Maintenance Drug List Guide to this list: What is Ambetter 90‐Day‐Maintenance Drug List? Ambetter 90‐Day‐Supply Maintenance Drug List is a list of maintenance medications that are available for 90 day supply through mail order or through our Extended Day Supply Network. How do I find a pharmacy that is participating in Extended Day Supply Network? To find a retail pharmacy that is participating in our Extended Day Supply Network please consult information available under Pharmacy Resources tab on our webpage. Alternatively, you can utilize our mail order pharmacy. Information on mail order pharmacy is available in Pharmacy Resources tab on our webpage. Are all formulary drugs covered for 90 day supply? No, certain specialty and non‐specialty drugs are excluded from 90 day supply. Please consult 90‐Day‐ Supply Maintenance Drug List for information if your drug is included. A Amitriptyline HCl Acamprosate Calcium Amlodipine Besylate Acarbose Amlodipine Besylate-Atorvastatin Calcium Acebutolol HCl Amlodipine Besylate-Benazepril HCl Acetazolamide Amlodipine Besylate-Olmesartan Medoxomil Albuterol Sulfate Amlodipine Besylate-Valsartan Alendronate Sodium Amlodipine-Valsartan-Hydrochlorothiazide Alendronate Sodium-Cholecalciferol Amoxapine Alfuzosin HCl Amphetamine-Dextroamphetamine Aliskiren Fumarate Anagrelide HCl Allopurinol Anastrozole Alogliptin Benzoate Apixaban Alosetron HCl Arformoterol Tartrate Amantadine HCl Aripiprazole Amiloride & Hydrochlorothiazide Armodafinil Amiloride HCl Asenapine Maleate Amiodarone HCl Aspirin-Dipyridamole -
Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG . -
Glucotrol XL (Glipizide) Tablets Label
® GLUCOTROL XL (glipizide) Extended Release Tablets For Oral Use DESCRIPTION Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5 methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below: N H C 3 CONHCH CH SO NHCONH 2 2 2 N Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. GLUCOTROL XL® is a registered trademark for glipizide GITS. Glipizide GITS (Gastrointestinal Therapeutic System) is formulated as a once-a-day controlled release tablet for oral use and is designed to deliver 2.5, 5, or 10 mg of glipizide. Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, red ferric oxide, cellulose acetate, polyethylene glycol, Opadry® blue (OY-LS-20921)(2.5 mg tablets), Opadry® white (YS-2-7063)(5 mg and 10 mg tablet) and black ink (S-1-8106). System Components and Performance GLUCOTROL XL Extended Release Tablet is similar in appearance to a conventional tablet. It consists, however, of an osmotically active drug core surrounded by a semipermeable membrane. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. The membrane surrounding the tablet is permeable to water but not to drug or osmotic excipients. -
Medications Used to Treat Type 2 Diabetes
Medications Used to Treat Type 2 Diabetes This handout shows the different medications that your healthcare provider may prescribe to treat your type 2 diabetes, and where and how these medications work in your body to lower blood glucose. Type 2 diabetes medications are taken orally (by mouth), by injection (inserted into the fat under your skin), or inhaled (breathed in). Oral Injectable Alpha-glucosidase inhibitors (acarbose, miglitol) Amylin mimetic (pramlintide) Help to slow down the breakdown of starches (such Helps to decrease the amount of glucose made by your liver. as bread and potatoes) and certain types of sugar (such as table sugar) from your food in your intestines: Helps to slow down the breakdown of foods in your stomach this slows down increases in blood glucose. and intestines: this slows down increases in blood glucose Biguanide (metformin) GLP-1 receptor agonists (albiglutide, dulaglutide, exenatide, liraglutide) Helps to decrease the amount of glucose made by your liver Help your pancreas to make more insulin: insulin helps to lower blood glucose Helps to improve the way that insulin works in your Help to decrease the amount of glucose made by your muscles: if your muscles are more sensitive to insulin, it liver is easier for insulin to bring glucose from your blood into Helps to slow down the breakdown of foods in your muscles where glucose can be used for energy your stomach and intestines: this slows down increases in blood glucose DPP-4 inhibitors (alogliptin, linagliptin, saxagliptin, sitagliptin) Fat Tissue