Therapeutic Class Overview Ophthalmic Agents, Intraocular Pressure (IOP)-Modifying
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Intraocular Pressure Rise After Phacoemulsification Prophylactic
British Journal of Ophthalmology 1995; 79: 809-813 809 Intraocular pressure rise after phacoemulsification Br J Ophthalmol: first published as 10.1136/bjo.79.9.809 on 1 September 1995. Downloaded from with posterior chamber lens implantation: effect of prophylactic medication, wound closure, and surgeon's experience Thomas G Bomer, Wolf-Dietrich A Lagreze, Jens Funk Abstract pressure rises usually occur between 6 and 8 Aims-A prospective clinical trial was hours after surgery.6 carried out to evaluate the effect of Various antiglaucomatous agents have been prophylactic medication, the technique of used to prevent the intraocular pressure rise wound closure, and the surgeon's experi- after cataract extraction. Oral acetazolamide15 16 ence on the intraocular pressure rise after and topical timolol'6-19 lowered the pressure cataract extraction. rise in the early period after intracapsular and Methods-In 100 eyes, the intraocular extracapsular cataract extraction. Levobunolol pressure was measured before as well as proved to be superior to timolol 4-7 hours 2-4, 5-7, and 22-24 hours after phaco- after extracapsular cataract extraction.20 Apra- emulsification and posterior chamber lens clonidine lowered the intraocular pressure rise implantation. Each of 25 patients received after uncomplicated phacoemulsification21 and either 1% topical apraclonidine, 0.5%/o extracapsular cataract extraction22 23 when topical levobunolol, 500 mg oral acetazo- given 30 minutes to 1 hour before surgery, lamide, or placebo. Forty four eyes were whereas immediate postoperative treatment operated with sclerocorneal sutureless with apraclonidine was ineffective.22 24 Miotics tunnel and 56 eyes with corneoscleral are frequently used to promote miosis and incision and suture. -
Brimonidine Tartrate; Brinzolamide
Contains Nonbinding Recommendations Draft Guidance on Brimonidine Tartrate ; Brinzolamide This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Brimonidine tartrate; Brinzolamide Dosage Form; Route: Suspension/drops; ophthalmic Strength: 0.2%; 1% Recommended Studies: One study Type of study: Bioequivalence (BE) study with clinical endpoint Design: Randomized (1:1), double-masked, parallel, two-arm, in vivo Strength: 0.2%; 1% Subjects: Males and females with chronic open angle glaucoma or ocular hypertension in both eyes. Additional comments: Specific recommendations are provided below. ______________________________________________________________________________ Analytes to measure (in appropriate biological fluid): Not applicable Bioequivalence based on (95% CI): Clinical endpoint Additional comments regarding the BE study with clinical endpoint: 1. The Office of Generic Drugs (OGD) recommends conducting a BE study with a clinical endpoint in the treatment of open angle glaucoma and ocular hypertension comparing the test product to the reference listed drug (RLD), each applied as one drop in both eyes three times daily at approximately 8:00 a.m., 4:00 p.m., and 10:00 p.m. for 42 days (6 weeks). 2. Inclusion criteria (the sponsor may add additional criteria): a. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes b. -
Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients with Elevated Intraocular
Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2) JANET B. SERLE, L. JAY KATZ, EUGENE MCLAURIN, THERESA HEAH, NANCY RAMIREZ-DAVIS, DALE W. USNER, GARY D. NOVACK, AND CASEY C. KOPCZYNSKI, FOR THE ROCKET-1 AND ROCKET-2 STUDY GROUPS PURPOSE: To evaluate the efficacy and ocular and sys- ROCKET-2) for timolol (P < .0001 for netarsudil vs temic safety of netarsudil 0.02% ophthalmic solution, a timolol). rho-kinase inhibitor and norepinephrine transporter in- CONCLUSIONS: In 2 large, randomized, double-masked hibitor, in patients with open-angle glaucoma and ocular trials reported here, once-daily dosing of netarsudil hypertension. 0.02% was found to be effective and well tolerated for DESIGN: Double-masked, randomized noninferiority the treatment of patients with ocular hypertension and clinical trials: Rho Kinase Elevated IOP Treatment Trial open-angle glaucoma. The novel pharmacology and 1 and 2 (ROCKET-1 and ROCKET-2). aqueous humor dynamic effects of this molecule suggest METHODS: After a washout of all pre-study ocular hy- it may be a useful addition to the armamentarium of potensive medications, eligible patients were randomized ocular hypotensive medications. (Am J Ophthalmol to receive netarsudil 0.02% once daily (q.d.), timolol 2018;186:116–127. Ó 2017 The Authors. Published 0.5% twice a day (b.i.d.), and (ROCKET-2 only) netar- by Elsevier Inc. This is an open access article under the sudil 0.02% b.i.d. -
Table 1. Glaucoma Medications: Mechanisms, Dosing and Precautions Brand Generic Mechanism of Action Dosage/Avg
OPTOMETRIC STUDY CENTER Table 1. Glaucoma Medications: Mechanisms, Dosing and Precautions Brand Generic Mechanism of Action Dosage/Avg. % Product Sizes Side Effects Warnings Reduction CHOLINERGIC AGENTS Direct Pilocarpine (generic) Pilocarpine 1%, 2%, 4% Increases trabecular outflow BID-QID/15-25% 15ml Headache, blurred vision, myopia, retinal detachment, bronchiole constriction, Angle closure, shortness of breath, retinal narrowing of angle detachment Indirect Phospholine Iodide (Pfizer) Echothiophate iodide 0.125% Increases trabecular outflow QD-BID/15-25% 5ml Same as above plus cataractogenic iris cysts in children, pupillary block, Same as above, plus avoid prior to any increased paralysis with succinylcholine general anesthetic procedure ALPHA-2 AGONISTS Alphagan P (Allergan) Brimonidine tartrate 0.1%, 0.15% with Purite Decreases aqueous production, increases BID-TID/up to 26% 5ml, 10ml, 15ml Dry mouth, hypotension, bradycardia, follicular conjunctivitis, ocular irritation, Monitor for shortness of breath, dizziness, preservative uveoscleral outflow pruritus, dermatitis, conjunctival blanching, eyelid retraction, mydriasis, drug ocular redness and itching, fatigue allergy Brimonidine tartrate Brimonidine tartrate 0.15%, 0.2% Same as above Same as above 5ml, 10ml Same as above Same as above (generic) Iopidine (Novartis) Apraclonidine 0.5% Decreases aqueous production BID-TID/up to 25% 5ml, 10ml Same as above but higher drug allergy (40%) Same as above BETA-BLOCKERS Non-selective Betagan (Allergan) Levobunolol 0.25%, 0.5% Decreases -
Rhopressa™ Netarsudil Ophthalmic Solution 0.02%
Rhopressa™ Netarsudil ophthalmic solution 0.02% CDER Dermatologic and Ophthalmic Drugs Advisory Committee October 13, 2017 Aerie Pharmaceuticals, Inc. 1 Introduction Marvin Garrett Vice President, Regulatory Affairs and Quality Assurance Aerie Pharmaceuticals, Inc. 2 Aerie Pharmaceuticals • 2005: Aerie founded as a spin-out from Duke University: – Dr. Eric Toone – Dr. Casey Kopczynski – Dr. David Epstein – Dr. Epstein’s goal from the beginning: Develop a therapy that targeted the diseased tissue in glaucoma, the trabecular outflow pathway • 2006: Aerie discovered its first Rho kinase inhibitor • 2009: Aerie invented netarsudil • 2012: Netarsudil 1st clinical study • 2017: NDA filed 3 Netarsudil: A New Drug Class for Lowering IOP We are requesting a recommendation for approval of netarsudil ophthalmic solution 0.02% for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension given one drop QD 4 Agenda Unmet Medical Needs Richard A. Lewis, MD Chief Medical Officer Aerie Pharmaceuticals, Inc. Past President, American Glaucoma Society Program Design and Efficacy Casey Kopczynski, PhD Chief Scientific Officer Aerie Pharmaceuticals, Inc. Safety Theresa Heah, MD, MBA VP Clinical Research and Medical Affairs Aerie Pharmaceuticals, Inc. Benefits and Risks Janet Serle, MD Professor of Ophthalmology Glaucoma Fellowship Director Icahn School of Medicine at Mount Sinai 5 List of Expert Responders • Cynthia Mattox, MD – Associate Professor of Ophthalmology, Tufts University School of Medicine – Current President, American Glaucoma Society • Mark Reasor, PhD – Professor of Physiology & Pharmacology, Robert C. Byrd Health Sciences Center, West Virginia University • Bennie H. Jeng, MD – Professor and Chair, Department of Ophthalmology & Visual Sciences, University of Maryland School of Medicine • Dale Usner, PhD – Biostatistics Consultant to Aerie Pharmaceuticals, Inc. -
Looking for New Classes of Bronchodilators
REVIEW BRONCHODILATORS The future of bronchodilation: looking for new classes of bronchodilators Mario Cazzola1, Paola Rogliani 1 and Maria Gabriella Matera2 Affiliations: 1Dept of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy. 2Dept of Experimental Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy. Correspondence: Mario Cazzola, Dept of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, Rome, 00133, Italy. E-mail: [email protected] @ERSpublications There is a real interest among researchers and the pharmaceutical industry in developing novel bronchodilators. There are several new opportunities; however, they are mostly in a preclinical phase. They could better optimise bronchodilation. http://bit.ly/2lW1q39 Cite this article as: Cazzola M, Rogliani P, Matera MG. The future of bronchodilation: looking for new classes of bronchodilators. Eur Respir Rev 2019; 28: 190095 [https://doi.org/10.1183/16000617.0095-2019]. ABSTRACT Available bronchodilators can satisfy many of the needs of patients suffering from airway disorders, but they often do not relieve symptoms and their long-term use raises safety concerns. Therefore, there is interest in developing new classes that could help to overcome the limits that characterise the existing classes. At least nine potential new classes of bronchodilators have been identified: 1) selective phosphodiesterase inhibitors; 2) bitter-taste receptor agonists; 3) E-prostanoid receptor 4 agonists; 4) Rho kinase inhibitors; 5) calcilytics; 6) agonists of peroxisome proliferator-activated receptor-γ; 7) agonists of relaxin receptor 1; 8) soluble guanylyl cyclase activators; and 9) pepducins. They are under consideration, but they are mostly in a preclinical phase and, consequently, we still do not know which classes will actually be developed for clinical use and whether it will be proven that a possible clinical benefit outweighs the impact of any adverse effect. -
Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object. -
NEW ZEALAND DATA SHEET 1. PRODUCT NAME IOPIDINE® (Apraclonidine Hydrochloride) Eye Drops 0.5%
NEW ZEALAND DATA SHEET 1. PRODUCT NAME IOPIDINE® (apraclonidine hydrochloride) Eye Drops 0.5%. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Iopidine Eye Drops 0.5% contains apraclonidine hydrochloride 5.75 mg, equivalent to apraclonidine base 5 mg. Excipient with known effect Benzalkonium chloride 0.1 mg per 1 mL as a preservative. For the full list of excipients, see section 6.1. 2. PHARMACEUTICAL FORM Eye drops, solution, sterile, isotonic. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Iopidine Eye Drops 0.5% are indicated for short-term adjunctive therapy in patients on maximally tolerated medical therapy who require additional IOP reduction. Patients on maximally tolerated medical therapy who are treated with Iopidine Eye Drops 0.5% to delay surgery should have frequent follow up examinations and treatment should be discontinued if the intraocular pressure rises significantly. The addition of Iopidine Eye Drops 0.5% to patients already using two aqueous suppressing drugs (i.e. beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because apraclonidine is an aqueous-suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP-lowering efficacy of Iopidine Eye Drops 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month. 4.2. Dose and method of administration Dose One drop of Iopidine Eye Drops 0.5% should be instilled into the affected eye(s) three times per day. -
Levobetaxolol Hydrochloride
1882 Miotics Mydriatics and Antiglaucoma Drugs if necessary 5 to 10 minutes later. In the treatment of uveitis Herpes simplex dendritic keratitis developed in 2 patients during Levobetaxolol Hydrochloride (USAN, rINNM) ⊗ (p.1515), the eye drops should be instilled two or three times dai- latanoprost therapy.3 The author suggested that the biochemical ly, or up to every 3 to 4 hours if required. changes in the cornea caused by latanoprost may predispose to AL-1577A (levobetaxolol or levobetaxolol hydrochloride); Hid- herpes keratitis. rocloruro de levobetaxolol; Lévobétaxolol, Chlorhydrate de; The BNFC recommends that eye drops containing 0.5% homat- Levobetaxololi Hydrochloridum. (−)-(S)-1-{p-[2-(Cyclopropyl- ropine hydrobromide are used once daily or on alternate days for 1. Wardrop DRA, Wishart PK. Latanoprost and cystoid macular methoxy)ethyl]phenoxy}-3-isopropylaminopropan-2-ol hydro- uveitis in children aged 3 months to 2 years; older children may oedema in a pseudophake. Br J Ophthalmol 1998; 82: 843–4. be given 1 or 2% eye drops twice daily. 2. Stewart O, et al. Bilateral optic disc oedema associated with chloride. latanoprost. Br J Ophthalmol 1999; 83: 1092–3. Левобетаксолола Гидрохлорид Homatropine has also been used as the quaternary ammonium 3. Ekatomatis P. Herpes simplex dendritic keratitis after treatment methobromide derivative in the treatment of gastrointestinal with latanoprost for primary open angle glaucoma. Br J Ophthal- C18H29NO3,HCl = 343.9. spasm and as an adjunct in peptic ulcer disease; homatropine mol 2001; 85: 1008–9. CAS — 93221-48-8 (levobetaxolol); 116209-55-3 (levo- betaxolol hydrochloride). methobromide has also been included in preparations used for Systemic effects. -
Drug List (SORTED by TRADE with GENERIC EQUIVALENT)
NBEO Drug List (SORTED BY TRADE WITH GENERIC EQUIVALENT) Trade Generic Trade Generic Abilify aripiprazole Avandia rosiglitazone Accolate zafirlukast Avastin bevacizumab Accupril quinapril Azasan azathioprine Achromycin tetracycline AzaSite azithromycin Aciphex rabeprazole Avodart dutasteride Actos pioglitazone Azopt brinzolamide Acular ketorolac Bactrim trimethoprim-sulfamethoxazole Acuvail ketorolac Bactrim DS trimethoprim-sulfamethoxazole Advair fluticasone propionate Baquacil polyhexamethylene biguanide Advil ibuprofen Beconase AQ beclomethasone AeroBid flunisolide Benadryl diphenhydramine Afrin oxymetazoline Bepreve Bepotastine besilate Aggrenox aspirin and dipyridamole Besivance besifloxacin Alamast pemirolast Betadine povidone-iodine Alaway ketotifen Betagan levobunolol Aldactone spironolactone Betasept chlorhexidine topical Aleve naproxen sodium Betaseron interferon beta-1b Allegra fexofenadine Betimol timolol Allegra-D fexofenadine-pseudoephedrine Betoptic S betaxolol Alluvia lopinavir Biopatch chlorhexidine topical Alocril nedocromil Blephamide sulfacetamide-prednisolone Alomide lodoxamide Botox onabotulinum toxinA Alphagan P brimonidine Brolene propamidine isethionate Alrex loteprednol 0.2% Bromday bromfenac Ambien zolpidem Calamine zinc oxide and iron oxide Amicar aminocaproic acid Calan verapamil Amoxil amoxicillin Calgon Vesta chlorhexidine topical Amphocin amphotericin B Capoten captopril Anectine succinylcholine Carafate sucralfate Ansaid flurbiprofen Carbocaine mepivacaine HCl injection Antivert meclizine Cardizem diltiazem -
IOPIDINE® 0.5% (Apraclonidine Ophthalmic Solution) 0.5% As Base
IOPIDINE® 0.5% (apraclonidine ophthalmic solution) 0.5% As Base DESCRIPTION: IOPIDINE® 0.5% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off-white powder and is highly soluble in water. Its chemical name is 2-[(4-amino-2,6 dichlorophenyl) imino]imidazolidine monohydrochloride with an empirical formula of C9H11Cl3N4 and a molecular weight of 281.57. The chemical structure of apraclonidine hydrochloride is: Each mL of IOPIDINE 0.5% Ophthalmic Solution contains: Active: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg; . Inactives: sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4-7.8), purified water and benzalkonium chloride 0.01% (preservative) CLINICAL PHARMACOLOGY: Apraclonidine hydrochloride is a relatively selective alpha- 2-adrenergic agonist. When instilled in the eye, IOPIDINE 0.5% Ophthalmic Solution, has the action of reducing elevated, as well as normal, intraocular pressure (IOP), whether or not accompanied by glaucoma. Ophthalmic apraclonidine has minimal effect on cardiovascular parameters. Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. IOPIDINE 0.5% Ophthalmic Solution has the action of reducing IOP. The onset of action of apraclonidine can usually be noted within one hour, and maximum IOP reduction occurs about three hours after instillation. Aqueous fluorophotometry studies demonstrate that apraclonidine's predominant mechanism of action is reduction of aqueous flow via stimulation of the alpha-adrenergic system. -
Hyperlinked Region IX SOP for MWLCEMS
2 Region IX 2 0 0 STANDARD OPERATING PROCEDURES/ 1 1 STANDING MEDICAL ORDERS 9 9 McHenry Western Lake County EMS System Healthcare delivery requires structure (people, equipment, education) and process (policies, protocols, procedures) that, when integrated, produce a system (programs, organizations, cultures) that leads to optimal outcomes (patient survival and safety, quality, satisfaction). An effective system of care comprises all of these elements—structure, process, system, and patient outcomes—in a framework of continuous quality improvement (AHA, 2015). These protocols have been developed and approved through a collaborative process involving the Advocate Lutheran General; Greater Elgin Area, McHenry Western Lake County, Northwest Community, Amita Saint Joseph Hospital, and Southern Fox Valley EMS Systems to reduce variation in practice and establish a Region-wide System of care. They shall be used: as the written practice guidelines/pathways of care approved by the EMS Medical Directors (EMS MDs) to be initiated by System EMS personnel for off-line medical control. as the standing medical orders to be used by Emergency Communications Registered Nurses (ECRNs) when providing on-line medical control (OLMC). in medium to large scale multiple patient incidents, given that the usual and customary forms of communication are contraindicated as specified in the Region IX disaster plan. System members are authorized to implement these orders to their scope of practice. OLMC communication shall be established without endangering the patient. Under no circumstances shall emergency prehospital care be delayed while attempting to establish contact with a hospital. In the event that communications cannot be established, EMS personnel shall continue to provide care to the degree authorized by their license, these protocols, drugs/equipment available, and their scope of practice granted by the EMS MD in that System.