NEW ZEALAND DATA SHEET 1. PRODUCT NAME IOPIDINE® (Apraclonidine Hydrochloride) Eye Drops 0.5%
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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Contains Nonbinding Recommendations Draft Guidance on Brimonidine Tartrate ; Brinzolamide This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic.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. -
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 -
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. -
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. -
0Bcore Safety Profile
Core Safety Profile Active substance: Levobunolol Pharmaceutical form(s)/strength: Eye drops solution/ 0,1%; 0,25%; 0,5%; 0,5% UD P-RMS: CZ/H/PSUR/0006/001 Date of FAR: 26.05.2009 4.2 Posology and method of administration Adults (including the elderly) Country specific posology and method of administration to be included. Children /.../ is not recommended for use in children due to lack of safety and efficacy data. If required, /.../ may be used with other agents to lower intra-ocular pressure. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.4). Intraocular pressure should be measured approximately four weeks after starting treatment with /.../ as a return to normal ocular pressure can take a few weeks. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac is compressed at the medial canthus (punctual occlusion) for one minute. This should be performed immediately following the instillation of each drop. Transfer from other beta-blocking treatment When another beta blocking agent is being used treatment must be discontinued after a full day of therapy. Start treatment with /.../ the next day with X drop of /.../ topically applied into the conjunctival sac in the affected eye(s). If /.../ is to replace a combination of anti-glaucoma products, only a single product should be removed at a time. Use in renal and hepatic impairment Levobunolol hydrochloride has not been studied in patients with hepatic or renal impairment. Therefore, caution should be used in treating such patients (see section 4.4). -
BETA RECEPTOR BLOCKERS MC Objective
Jack DeRuiter, Principles of Drug Action 2, Fall 2000 ADRENERGIC RECEPTOR ANTAGONISTS: BETA RECEPTOR BLOCKERS MC Objective: Describe the development of beta antagonists ("beta blockers") from the agonist norepinephrine (NE): HO H NH2 NE Alpha- and Beta-receptor agonist HO OH H H HO CH N 3 H Isoproterenol CH3 Selective beta-receptor agonist HO OH H H HO CH N 3 H Dichloroisoproterenol CH3 Partial beta-receptor agonist/antagonist Cl Cl H H HO CH N 3 Pronethalol H Beta-receptor antagonist, CH 3 low activity and toxic CH3 O N H Propranolol CH3 OH H Potent beta-antagonist No beta-receptor subtype selectivity CH3 CH3 O N H O N H CH CH OH H 3 OH H 3 Metoprolol N Beta-1-receptor H Pindolol O subtype selectivity Partial beta-agonist CH3 No beta-receptor subtype selectivity HO H H N H CH3 HO Labetolol O NH2 Dual alpha- and beta-antagonst 1 Jack DeRuiter, Principles of Drug Action 2, Fall 2000 MC Objective: Based on their structures, would the beta-blockers be expected to be relatively receptor selective? YES. They do not produce significant blockade of alpha- adrenergic receptors (alpha-1 or alpha-2), histamine receptors, muscarinic receptors or dopamine receptors. MC/PC Objective: Identify which beta blockers are classified as "non-selective": · The “non-selective" classification refers to those beta-blockers capable of blocking BOTH beta-1 and beta-2 receptors with equivalent efficacy. These drugs DO NOT have clinically significant affinity for other neurotransmitter receptors (alpha, dopamine, histamine, acetylcholine, etc.). · ALL of these beta-blockers (except satolol) consist of an aryloxypropanolamine side chain linked to an aromatic or “heteroaromatic” ring which is “ortho” substituted. -
Pharmacology of Ophthalmologically Important Drugs James L
Henry Ford Hospital Medical Journal Volume 13 | Number 2 Article 8 6-1965 Pharmacology Of Ophthalmologically Important Drugs James L. Tucker Follow this and additional works at: https://scholarlycommons.henryford.com/hfhmedjournal Part of the Chemicals and Drugs Commons, Life Sciences Commons, Medical Specialties Commons, and the Public Health Commons Recommended Citation Tucker, James L. (1965) "Pharmacology Of Ophthalmologically Important Drugs," Henry Ford Hospital Medical Bulletin : Vol. 13 : No. 2 , 191-222. Available at: https://scholarlycommons.henryford.com/hfhmedjournal/vol13/iss2/8 This Article is brought to you for free and open access by Henry Ford Health System Scholarly Commons. It has been accepted for inclusion in Henry Ford Hospital Medical Journal by an authorized editor of Henry Ford Health System Scholarly Commons. For more information, please contact [email protected]. Henry Ford Hosp. Med. Bull. Vol. 13, June, 1965 PHARMACOLOGY OF OPHTHALMOLOGICALLY IMPORTANT DRUGS JAMES L. TUCKER, JR., M.D. DRUG THERAPY IN ophthalmology, like many specialties in medicine, encompasses the entire spectrum of pharmacology. This is true for any specialty that routinely involves the care of young and old patients, surgical and non-surgical problems, local eye disease (topical or subconjunctival drug administration), and systemic disease which must be treated in order to "cure" the "local" manifestations which frequently present in the eyes (uveitis, optic neurhis, etc.). Few authors (see bibliography) have attempted an introduction to drug therapy oriented specifically for the ophthalmologist. The new resident in ophthalmology often has a vague concept of the importance of this subject, and with that in mind this paper was prepared. -
Antiglaucoma Compositions Containing Combinations of Alpha-2 Agonists and Beta-Blockers
~" ' MM II II II MM II II II Ml II II I II J European Patent Office _ _ _ © Publication number: 0 365 662 B1 Office europeen* des.. brevets , © EUROPEAN PATENT SPECIFICATION © Date of publication of patent specification: 09.03.94 © Int. CI.5: A61 K 31/47 © Application number: 89905874.7 @ Date of filing: 26.04.89 © International application number: PCT/US89/01994 © International publication number: WO 89/10126 (02.11.89 89/26) (54) ANTIGLAUCOMA COMPOSITIONS CONTAINING COMBINATIONS OF ALPHA-2 AGONISTS AND BETA-BLOCKERS. ® Priority: 26.04.88 US 186504 1075-1078 @ Date of publication of application: J. of Cardiovascular Pharmacology, vol. 2, 02.05.90 Bulletin 90/18 suppl. 1, 1980, S. 21-28 © Publication of the grant of the patent: © Proprietor: ALCON LABORATORIES INC 09.03.94 Bulletin 94/10 6201 South Freeway Ft. Worth, TX 76134(US) © Designated Contracting States: AT BE CH DE FR GB IT LI LU NL SE @ Inventor: DE SANTIS, Louis, M. 2316 Wlnton Terrace West © References cited: Fort Worth, TX 761 09(US) US-A- 4 455 317 US-A- 4 515 800 © Representative: Jump, Timothy John Simon et AM A DRUG EVALUATION, 2nd ed., 1973; al "Agent used to treat Glaucoma", pp. 675-686. Venner Shipley & Co. 20 Little Britain GLAUCOMA, vol. 1, no. 1, February 1979; London EC1A 7DH (GB) 00 S.SUGAR, pp. 9-15. CM CO Ophthalmology, vol. 96, no. 1, 1989, p. 3-7 CO m Ophthalmology, vol. 98, no. 7, 1991, p. CO 00 Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. -
Glaucoma Pharmacology A-Z Selecting Therapy Prostaglandin
1/6/2014 PGAs • QHS dosing • Long duration of action Glaucoma Pharmacology A-Z • Flatten diurnal curve • Effective on trough and peak IOP Eric E. Schmidt, O.D. • No systemic side effects Omni Eye Specialists Wilmington, NC • Little tachyphylaxis [email protected] Selecting Therapy PGAs 2008 • Goals of primary therapy • Bimatoprost (Lumigan) – Achieve lowest IOP on monotherapy – High response rate—few to no nonresponders • Latanoprost (Xalatan) – Maintain consistent IOP lowering – Obtain patient compliance and adherence by meeting their goals and expectations • Travaprost, Travaprost Z (Travatan, Travatan Z) • Building-block approach to medical therapy – Establish the strongest foundation prior to resorting to adjunctive therapy Prostaglandin analogs Prostaglandin Side Effects • Lower IOP by enhancing uveoscleral • Conjunctival hyperemia: Severe outflow hyperemia • They also reduce episcleral venous – Lumigan 3.5% – Travatan 1.5% pressure – Xalatan <1% – Rescula 1% • PGAs work by causing up to a 26% • Is this a transient phenomenon? reduction in resistance to outflow • Is it an allergic conjunctivitis? • Breaks down collagen in the uveoscleral • Is it worth stopping the drop? meshwork • Create new channels for outflow 1 1/6/2014 Conjunctival hyperemia Prostaglandins • PGAs have an effect on EP receptors • Oh sure, we know they are good, but just which are vasodilators how good are they? – Average IOP drop of 34% • The stronger the drug binds to that – Improved compliance receptor the more pronounced the – Excellent safety profiles