throbber
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`ige of all the essential
`acts.
`nnation gives you the
`ial data you need.
`)ur widespread net-
`tlier, organize and
`i a timely manner.
`•re it is published,
`xed for quick,
`ly for fast reference.
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`
`Director of Product Management: David P. Reiss
`Senior Product Manager: Mark A. Friedman
`Associate Product Manager; Bill Shaughnessy
`National Sales Manager: Dikran N. Barsamian
`National Account Manager, Customized Projects:
`Anthony Sorce
`Senior Account Manager: Don Bruccoleri
`Account Managers: Marion Gray, RPh, Lawrence C. Keary,
`Jeffrey F. Pfohl, Christopher N. Schmidt,
`Stephen M. Silverberg, Suzanne E. Yarrow, RN
`National Sales Manager, Trade Group: Bill Gaffney
`B Director of Direct Marketing: Michael Bennett
`|
`Direct Marketing Manager: Lorraine M, Loening
`1
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`I
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`Senior Drug Information Specialist:
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`
`E D I T I O N
`
`PDR"
`27
`1999
`PHYSICIANS'
`R
`
`FOR
`OPHTHALMOLOGY
`
`Editorial Consultants and Contributors
`Clement A. Weisbecker, RPh, Director of Pharmacy, Wills Eye Hospital, Philadelphia, PA
`F.T. Fraunfelder, MD, Director, National Registry of Drug-Induced Ocular Side Effects, Oregon Health Sciences University,
`Portland, OR
`Michael Naidoff, MD, Cornea Service, Wills Eye Hospital, Philadelphia, PA
`Douglas Rhee, MD, Wills Eye Hospital, Philadelphia, PA
`Richard Tippermann, MD, Wills Eye Hospital, Philadelphia, PA
`
`Vice President of Directory Services: Stephen B. Greenberg
`
`Drug Information Specialist: Maria Deutsch, MS, RPh, CDE
`Editor, Special Projects: David W. Sifton
`Vice President of Production: David A, Pitier
`Director of Print Purchasing: Marjorie A. Duffy
`Director of Operations: Carrie Williams
`Manager of Production: Kimberly H. Vivas
`Senior Production Coordinators: Amy B. Brooks,
`Dawn B. McCall
`Production Coordinator: Mary Ellen R. Breun
`Index/Format Manager; Jeffrey D. Schaefer
`Senior Format Editor: Gregory J. Westley
`Index Editors: Johanna M. Mazur, Robert N. Woerner
`Art Associate; Joan K. Akerlind
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`Electronic Publishing Designer: Robert K. Grossman
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`
`Copyright © 1998 and published by Medical Economics Company, Inc. at Montvale, NJ 07645-1742. All rights reserved. None of the
`^^5 content of this publication may be reproduced, stored in a retrieval system, resold, redistributed, or transmitted in any form or by any
`• • means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of the publisher. PHYSICIANS'
`DESK REFERENCE®, PDR®, PDR For Nonprescription Drugs*, PDR For Ophthalmology*, Pocket PDR', and The PDR* Family Guide to Prescription
`Drugs' are registered trademarks used herein under license. PDR Companion Guide™, PDR* for Herbal Medicines™, PDR® Medical Dictionary™,
`pDR* Nurse's Handbook™, PDR® Nurse's Dictionary™, PDR* Atlas of Anatomy™, The PDR* Family Guide Encyclopedia of Medical Care™, PDR®
`Electronic Library™, and PDR® Drug Interactions, Side Effects, Indications, Contraindications System™ are trademarks used herein under license.
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` EXHIBIT 1013
`
`

`
`i
`
`ing family of PL
`
`00-232-7379 or . CONTENTS
`
`netics (FD&C) Act,
`? labeled, promote Section 1: Indices
`)r only those uses fij
`ess have been esta
`Jtions 201.100(d)(:
`m products require
`)esk Reference f
`dosages, route
`Dn of administratk
`s, contraindication i
`it be in the "san
`oved labeling for tl
`same language a
`se of the approv;
`Furthermore, infi
`s emphasized by ti
`boldface, or italf
`in Physicians' Da
`
`1. Manufacturers' Index....
`2. Product Name index
`3. Product Category Index.
`4. Active Ingredients index
`
`Section 2: Pharmaceuticals in Ophthalmology
`
`1. Mydriatics and Cyclopiegics
`2. Antimicrobial Therapy
`3. Ocular Anti-inflammatory Agents
`4. Anesthetic Agents
`5. Agents for Treatment of Glaucoma
`6. Medications for Dry Eye
`7. Ocular Decongestants
`8. Ophthalmic Irrigating Solutions
`9. Hyperosmolar Agents
`10. Diagnostic Agents
`11. Viscoelastic Materials Used in Ophthalmology,
`12. Off-Label Drug Applications in Ophthalmology
`13. Ocular Toxicology
`
`FD&C Act does nc
`)hysician may use;
`; been approved f
`)e it for uses or;
`lations that are i}
`A also observes
`des drug use that
`g. For products th
`3, the publisher hi
`bing such produc
`have access to i
`id informed decisic
`;r-the-counter dietj
`3d that this inform
`he Food and Dn
`; are not intended!
`lisease.
`
`jmpilation, orgamz
`tion. Each prodK
`3 manufacturer, a"
`jfacturer's medio
`medical consultar
`terial in Physiciai
`e publisher does ft
`ducts described, (
`connection with 3
`herein. Physician
`es not assume, af
`obtain and incii®
`)vided to it by If
`I that by making ttftj
`advocating the us'
`jr is the publis®
`iue to typography
`ly product may t
`
`Section 3: Suture Materials
`
`Section 4: Ophthalmic Lenses
`
`1. Soft Contact Lenses
`2. Aphakic Lenses
`3. Comparison and Conversion Tables
`
`Section 5: Vision Standards and Low Vision
`
`1. Vision Standards
`2. Low-Vision Aids..
`
`Section 6: Evaluation of Permanent Visual Impairment
`
`1- Criteria and Methods
`2. Visual System Impairment Values
`3. Combined Values Chart
`
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`Page I
`
`I
`
`,VI
`IX
`
`Page 1
`
`2
`2
`7
`,9
`10
`13
`14
`15
`15
`16
`17
`17
`19
`
`Page 23
`
`Page 25
`
`25
`50
`52
`
`Page 56
`
`56
`58
`
`59
`
`I
`
`68
`71
`
`59 I V
`
`•u
`
`PB:
`
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`Hi
`
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`
`

`
`Amsler's Grid
`
`Inside Front Cover
`
`1. Index
`2. Full-Color Product Photographs
`
`Section 8: Pharmaceutical and Equipment Product Information
`
`Listed alphabetically by manufacturer
`
`Section 9: Intraocular Product Information
`
`Key to Controlled Substances Categories
`
`Key to FDA Use-in-Pregnancy Ratings
`
`• ^
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`Section 7: Product Identification Guide
`
`Page 101
`
`102
`
`SECTION 1
`103 INDICE
`
`Page 201
`
`Page 315
`
`Page 319
`
`Page 320
`
`This section offers f
`mation you need:
`
`1. Manufacturers'
`participating manui
`two page numbers
`graphs in-the Proc
`ond to product i
`addresses and tele
`headquarters and rt
`
`2. Product Name I
`act information alp
`mond symbol to the
`tograph of
`the
`identification Guidi
`page number refer:
`
`PART l/MANUF
`AKORN, INC
`2500 Millbrook Driv
`Buffalo Grove, IL 6C
`Direct Inquiries to:
`Customer Service
`(800) 535-7155
`
`ALCON LABORATOR
`and its Affiliates
`Corporate Headqua
`6201 South Freewc
`Fort Worth, TX 761
`Direct inquiries to:
`Ophthalmic/VisionC
`(Pharmaceuticals/L
`Surgical: (800) 86:
`(Instrumentation/S
`Systems: (800) 28
`(Medical Managem
`Systems)
`
`ALLERGAN
`2525 Dupont Drive
`P.O. Box 19534
`Irvine, CA 92623-9
`For Medicai Infornr
`Outside CA: (800)
`CA: (714) 246-45C
`Saies and Orderin]
`Outside CA: (800)
`CA: (714) 246 45C
`
`BAUSCH & LOMB.
`PHARMACEUTK
`8500 Hidden Rivei
`Tampa, FL 33637
`
`I
`
`

`
`.
`
`6. MEDICATIONS FOR DRY EYE
`
`PHARMACEUTICALS / 13
`
`5ET/DURATI0N
`ACTION
`
`•nin/5-6 h
`•60 min/6 h
`•45 min/5-6 h
`
`Dry eye refers to a deficiency in either the aqueous or
`mucin components of the precorneal tear film. The
`most commonly encountered aqueous-deficient dry
`eye in the United States is keratoconjunctivitis sicca,
`while mucin-deficient dry eyes may be seen in cases
`of hypovitaminosis A, Stevens-Johnson syndrome,
`ocular pemphigoid, extensive trachoma, and chemi­
`cal burns.
`
`Dry eye is treated with artificial tear preparations
`(see Table 20) and ophthalmic lubricants (see Table 21).
`The lubricants form an occlusive film over the ocular
`surface and protect
`the eye
`from drying.
`Administered as a nighttime medication, they are
`useful both for dry eye and in cases of recurrent
`corneal erosion.
`
`ONSET/DURATION
`OF ACTION
`2 h/4-6 h
`
`5-10 min/2 h
`
`30 min/6 h
`
`2 h/4-6 h
`
`SIZE(S)(mL)
`5
`single use bottle
`5,10,15
`
`SIZE(S)(mL)
`2.5
`
`TABLE 20
`ARTIFICIAL TEAR PREPARATIONS
`CONCENTRATION (%)
`MAJOR COMPONENT(S)
`0.5%
`Carboxymefhyl cellulose
`1%
`0.25%
`3%
`
`Glycerin
`Hydroxyethyl cellulose,
`polyvinyl alcohol
`Hydroxypropyl cellulose
`
`Hydroxypropyl methylcellulose
`
`0.5%
`
`Hydroxypropyl methylcellulose,
`dextran 70
`
`1%
`
`Methylcellulose
`Polycarbophil, PEG-400, dextran 70
`
`1%
`
`Polysorbate 80
`Polyvinyl alcohol
`
`Polyvinyl alcohol,
`PEG-400, dextrose
`
`Polyvinyl alcohol,
`povidone
`
`1.4%
`
`3%
`1%
`
`1.4%
`0.6%
`
`*EDTA = ethylenediaminetetraacetic acid.
`
`TRADE NAME
`Refresh Plus
`Celliivisc
`Theratears
`Dry Eye Therapy
`TearGard
`
`Lacrisert (biode­
`gradable insert)
`Isopto Plain
`Isopto Tears
`Tearisol
`Isopto Alkaline
`Bion Tears
`Ocucoat
`Ocucoat PF
`Tears Naturale II
`Tears Naturale Free
`Tears Renewed
`Murocel
`AquaSite
`AquaSite multi-dose
`Viva Drops
`AKWA Tears
`Dry Eyes
`Llquifilm Tears
`HypoTears
`HypoTears PF
`Puralube Tears
`Murine Tears
`Refresh
`Tears Plus
`
`PRESERVATIVE/EDTA*
`None
`None
`None
`None
`Sorbic acid, EDTA
`
`None
`
`Benzalkonium chloride
`Benzalkonium chloride
`Benzalkonium chloride, EDTA
`Benzalkonium chloride
`None
`Benzalkonium chloride, EDTA
`None
`Polyquad
`None
`Benzalkonium chloride, EDTA
`Methyl-, propylparabens
`EDTA
`EDTA, Sorbic acid
`EDTA
`Benzalkonium chloride, EDTA
`Chlorobutanol
`Chlorobutanol
`Benzalkonium chloride, EDTA
`EDTA
`Benzalkonium chloride, EDTA
`Benzalkonium chloride, EDTA
`None
`Chlorobutanol
`
`

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`14 / PDR FOR OPHTHALMOLOGY
`
`TABLE 21
`OPHTHALMIC LUBRICANTS
`TRADE NAME
`AKWA Tears Ointment
`Dry Eyes
`Duolube
`Duratears Naturals
`HypoTears
`Lacri-Lube S.O.P., Lubritears
`Puralube
`Refresh P.M., Dry Eyes Lubricant
`
`COMPOSITION OF STERILE OINTMENT
`White petrolatum, liquid lanolin, and mineral oil
`White petrolatum, liquid lanolin, and mineral oil
`White petrolatum and mineral oil
`White petrolatum, liquid lanolin, and mineral oil
`White petrolatum and light mineral oil
`42.5% mineral oil, 55% white petrolatum, lanolin alcohol, and chlorobutanol
`White petrolatum, liquid lanolin, and mineral oil
`41.5% mineral oil, 55% white petrolatum, petrolatum, and lanolin alcohol
`
`7. OCULAR DECONGESTANTS
`These topically applied adrenergic medications are commonly used to whiten the eye. Three types are avail­
`able. Those containing naphazoline and tetrahydrozoline are more stable than those with phenylephrine. Usual
`dosage is 1 or 2 drops no more than 4 times a day (see Table 22).
`
`TABLE 22
`OCULAR DECONGESTANTS
`DRUG
`Naphazoline hydrochloride
`
`Oxymetazoline hydrochloride
`
`Phenylephrine hydrochloride
`
`Tetrahydrozoline hydrochloride
`
`DECONGESTANT/ASTRINGENT COMBINATIONS
`Naphazoline hydrochloride
`plus zinc sulfate
`Phenylephrine hydrochloride
`plus zinc sulfate
`Tetrahydrozoline plus zinc sulfate
`•Prescription medication.
`
`TRADE NAME
`AK-Con*
`Albalon*
`Clear Eyes
`Naphcon
`Vasoclear
`Vasocon Regular*
`Visine LR.
`Ocuclear
`AK-Nefrir
`Eye Cool
`Prefrin Liquifilm
`Relief
`Collyrium Fresh
`Murine Plus
`Visine
`
`Clear Eyes ACR
`(allergy/cold relief)
`
`Zincfrin
`Visine Allergy Relief
`
`ADDITIONAL COMPONENTS
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Phenylmercuric acetate
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Thimerosal, edetate disodium
`Benzalkonium chloride, edetate disodium
`
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`
`Benzalkonium chloride, edetate disodium
`
`Benzalkonium chloride
`Benzalkonium chloride, edetate disodium
`
`f
`
`8. OPHTHA
`Listed in Table 23
`general ophthalmic
`products. There ar
`tions available for
`
`TABLE 23
`OPHTHALMIC II
`TRADE NAME
`AK-Rinse
`
`Collyrium Fresh Eyes
`Dacriose
`
`Eye-Stream
`
`Irigate
`
`Lavoptik Eye Wash
`
`9. HYPER
`Hyperosmolar (h>
`They act through
`
`TABLE 24
`
`HYPEROSMOI
`
`GENERIC NAME
`A. Therapeutic preps
`Sodium chloride
`
`B. Diagnostic prepa
`Glycerin
`
`

`
`8. OPHTHALMIC IRRIGATING SOLUTIONS
`
`Listed in Table 23 are sterile Isotonic solutions for
`general ophthalmic use. They are all over-the- counter
`products. There are also intraocular Irrigating solu­
`tions available for use during surgical procedures.
`
`include prescription medications such as
`They
`Bausch & Lomb's Balanced Salt Solution, Alcon's
`BSS and BSS Plus, and lolab's locare Balanced
`Salt Solution.
`
`PHARMACEUTICALS / 15
`
`ADDITIONAL COMPONENTS
`Benzalkonium chloride
`
`Benzalkonium chloride
`Benzalkonium chloride,
`edetate dlsodium
`Benzalkonium chloride
`
`Benzalkonium chloride,
`edetate dlsodium
`Benzalkonium chloride
`
`TABLE 23
`OPHTHALMIC IRRIGATING SOLUTIONS
`COMPONENTS
`TRADE NAME
`Sodium, potassium, calcium, and
`AK-Rinse
`magnesium chlorides,
`sodium acetate, and sodium citrate
`Antipyrine, boric acid, and borax
`Sodium and potassium
`chlorides, and sodium phosphate
`Sodium, potassium, magnesium
`and calcium chlorides, sodium
`acetate, and sodium citrate
`Boric acid, potassium chloride, and
`sodium carbonate
`Sodium chloride, sodium biphosphate,
`and sodium phosphate
`
`Lavoptik Eye Wash
`
`9. HYPEROSMOLAR AGENTS
`Hyperosmolar (hypertonic) agents are used to reduce corneal edema therapeutically or for diagnostic purposes.
`They act through osmotic attraction of water through the semipermeable corneal epithelium.
`
`TABLE 24
`HYPEROSMOLAR AGENTS
`GENERIC NAME
`A. Therapeutic preparations
`Sodium chloride
`
`TRADE NAME
`
`Adsorbonac Ophthalmic
`AK-NaCI
`Muro-128
`
`B. Diagnostic preparation
`Glycerin
`
`Ophthalgan
`
`CONCENTRATION (%)
`
`2% or 5% (solution)
`5% (solution and ointment)
`2% or 5% (solution),
`5% (ointment)
`
`Collyrium Fresh Eyes
`Dacrlose
`
`Eye-Stream
`
`Irigate
`
`ilcchol, and chlorobutanol
`
`m, and lanolin alcohol
`
`3. Three types are avail-
`'ith phenylephrine. Usual
`
`MPONENTS
`iloride, edetate dlsodium
`iloride, edetate disodium
`iloride, edetate disodium
`iloride, edetate disodium
`iloride, edetate disodium
`icetate
`iloride, edetate disodium
`iloride, edetate disodium
`iloride, edetate disodium
`ate disodium
`iloride, edetate dlsodium
`
`iloride, edetate disodium
`iloride, edetate disodium
`iloride, edetate disodium
`
`iloride, edetate disodium
`
`Joride
`iloride, edetate disodium
`
`•
`
`

`
`16 / PDR FOR OPHTHALMOLOGY
`10. DIAGNOSTIC AGENTS
`
`Some of the more common diagnostic agents and
`tests used in ophthalmologic practice are listed
`below.
`
`A. Examination of the Conjunctiva, Cornea,
`and Lacrimal Apparatus
`Fluorescein, applied primarily as a 2% alkaline solu­
`tion, and with impregnated paper strips, is used to
`examine the integrity of the conjunctival and
`corneal eplthelia. Defects in the corneal epithelium
`will appear bright green in ordinary light and bright
`yellow when a cobalt blue filter Is used In the light
`path. Similar lesions of the conjunctiva appear
`bright orange-yellow in ordinary illumination.
`
`Fluorescein has also come into wide use in the fit­
`ting of rigid contact lenses, though it cannot be
`used for soft lenses, which absorb the dye. Proper
`fit is determined by examining the pattern of fluo­
`rescein beneath the contact lens.
`
`In addition, fluorescein is used in performing appla­
`nation tonometry and one test of lacrimal appara­
`tus patency (Jones test) uses 1 drop of 1% fluo­
`rescein instilled Into the conjunctival sac. If the dye
`appears In the nose, drainage is normal.1
`
`Rose bengal, as a 1% solution, is particularly use­
`ful for demonstrating abnormal conjunctival or
`corneal epithelium. Devitalized cells stain bright
`red, while normal cells show no change. The abnor­
`mal epithelial cells present in dry eye disorders are
`effectively revealed by this stain.
`
`The Schirmertest is a valuable method of assess­
`ing tear production. It employs prepared strips of
`filter paper 5 by 30 mm in size. The strips are
`inserted into the topically anesthetized conjunctival
`sac at the junction of the middle and outer third of
`the lower lid, with approximately 25 mm of paper
`exposed. After 5 minutes, the strip Is removed and
`the amount of moistening measured. The normal
`range Is 10 to 25 mm. If inadequate production of
`tears Is found on the initial test, a Schirmer II test
`can be performed by repeating the procedure while
`stimulating the nasal mucosa.2 A number of varia­
`tions of the Schirmer test can be found in text­
`books and journals.
`B. Examination of Acquired Ptosis or
`Extraocular Muscle Palsy
`To confirm myasthenia gravis as the cause of pto­
`sis or muscle palsy, an intravenous injection of
`2 mg of edrophonium chloride is administered, fol­
`lowed 45 seconds later by an additional 8 mg if
`there is no response to the first dose. (In case of
`a severe reaction to the edrophonium, immediate­
`ly give atropine sulfate, 0.6 mg intravenously.)
`
`C. Examination of the Retina and Choroid
`Sodium fluorescein solution, in concentrations of 5%,
`10%, and 25%, is injected intravenously to study the
`
`retinal and choroidal circulation. It has been used pri­
`marily in examination of lesions at the posterior pole
`of the eye, but anterior segment fluorescein angiog­
`raphy (wherein the vessels of the iris, sclera, and con­
`junctiva are studied) is also a useful clinical tool.
`Intravascular fluorescein is normally prevented from
`entering the retina by the intact retinal vascular
`endothelium (blood-retinal barrier) and the intact reti­
`nal pigment epithelium. Defects in either the retinal
`vessels or the pigment epithelium will allow leakage
`of fluorescein, which can then be studied by either
`direct observation or photography. For good results,
`appropriate filters are needed to excite the fluores­
`cein and exclude unwanted wavelengths. The peak
`frequencies for excitation lie between 485 and 500 nm
`and, for emission, between 520 and 530 nm.
`
`Fluorescein has proved to be a safe diagnostic agent,
`the most common side effects being nausea and
`vomiting. However, occasional allergic and vagal reac­
`tions do occur, so oxygen and emergency equipment
`should be readily available when angiography Is per­
`formed. Patients should also be warned that the dye
`will temporarily stain their skin and urine; in the aver­
`age patient this lasts no more than a day.
`
`Indocyanine green (IC-Green) has been used in recent
`years, either alone or with fluorescein, to obtain bet­
`ter frames of choroid neovascularization.
`
`D. Examination of Abnormal Pupillary Responses
`Methacholine, as a 2.5% solution Instilled Into the
`conjunctival sac, will cause the tonic pupil (Adie's
`pupil) to contract, but will leave a normal pupil
`unchanged. A similar pupillary response Is seen fol­
`lowing instillation of 2.5% methacholine in patients
`with familial dysautonomia (Riley-Day syndrome).
`Table 25 shows the effects of several drugs on mio­
`sis due to Interruption of the sympathetic system
`(Horner's syndrome). The effect depends on the location
`of the lesion in the sympathetic chain.
`
`TABLE 25
`HORNER'S SYNDROME
`NEURON II
`NEURON III
`(PRE­
`(POST-
`GANGLIONIC) GANGLIONIC)
`
`TOPICAL DROP
`(CENTRAL)
`Cocaine 2%-10%
`Epinephrine
`(Adrenalin) 1:1000
`Phenylephrine 1%
`
`+++
`
`+++
`
`+
`
`+
`
`NEURON I
`+/-
`
`+/-
`
`pilocarpine may be use
`dilated pupil is due to
`ruption of the pupil's p
`an atropine-like drug
`react to pilocarpine. If
`of the parasympathetii
`aneurysm, Adie's tor
`carpine will cause the
`
`11. VISCOEI
`Viscoelastic substanc
`surgery to maintain thf
`dissect tissues, act a:
`ade, and prevent mecl"
`daily the corneal endc
`teristics of the various
`result of the chain leng
`ecular interactions of
`viscoelastic substance
`the potential to produc
`in pressure If they an
`the anterior chamber f
`
`AMVISC (Chiron Vision
`of sodium hyaluronate
`viscosity Is 40,000 c
`and molecular weigh
`shelf life Is estimated
`
`AMVISC PLUS (Chlror
`composed of sodium
`saline. The viscosity
`shear rate), and mo
`1,500,000 daltons. 1
`by increasing total c
`hyaluronate of lower t
`estimated at 1 year.
`
`DUOVISC (Alcon) - (
`syringes. One syringe
`taining Viscoat. Plee
`below for details of ei
`
`HEALON (Pharmacia -
`hyaluronate 1% in ph
`200,000 (@ 0/sec
`weight is approximate
`
`12. OFF-LAI
`B. Acetylcysteine
`This agent is used to
`alkali burns, cornea
`sicca. It is thought tc
`action of collagenase
`healing. The drug is
`trade name Mucom;
`Though none of the
`are approved for use
`administered as free
`and up to 4 times a
`
`

`
`TUf
`
`PHARMACEUTICALS / 17
`
`Pilocarpine may be used to determine whether a fixed
`dilated pupil is due to an atropine-like drug or inter­
`ruption of the pupil's parasympathetic innervation.3 If
`an atropine-like drug is involved, the pupil will not
`react to pilocarpine. If dilation is due to interruption
`of the parasympathetic innervation (compression by
`aneurysm, Adie's tonic pupil) instillation of pilo­
`carpine will cause the pupil to constrict.
`
`REFERENCES
`
`1. Thompson HS, Mensher JH. Adrenergic mydrisis in
`Homer's syndrome: hydroxyampheta mine test for diagnosis
`of post-gangllonlc defects./lm J Ophthalmol. 1971;72:472.
`2. Hecht SD. Evaluation of the lacrimal drainage system.
`Ophthalmology. 1978:85:1250.
`3. Thompson HS, Newsome DA, Lowenfeld I E. The fixed dilated
`pupil. Sudden iridoplegia or mydriatic drops; a simple
`diagnostic test. Arch Ophthalmol. 1971:86:12.
`
`11. VISCOELASTIC MATERIALS USED IN OPHTHALMALOGY
`Viscoelastic substances are used in ophthalmic
`surgery to maintain the anterior chamber, hydraulically
`dissect tissues, act as a vitreous substitute/tampon-
`ade, and prevent mechanical damage to tissue, espe­
`cially the corneal endothelium. The individual charac­
`teristics of the various viscoelastic materials are the
`result of the chain length and intra- and interchain mol­
`ecular interactions of the compounds comprising the
`viscoelastic substance. All viscoelastic materials have
`the potential to produce a large postoperative increase
`in pressure if they are not adequately removed from
`the anterior chamber following surgery.
`
`HEALON GV (Pharmacia - UpJohn) - Composed of
`sodium hyaluronate 1.4% in physiologic saline. The vis­
`cosity is 2,000,000 (@ 0/sec shear rate), and the mol­
`ecular weight is approximately 5,000,000 daltons. In
`the presence of high positive vitreous pressure,
`Healon GV has three times more resistance to pres­
`sure than does Healon.
`
`AMVISC (Chiron Vision - Bausch and Lomb) - Composed
`of sodium hyaluronate 1.2% in physiologic saline. The
`viscosity is 40,000 cSt (@25 C, 1/sec shear rate),
`and molecular weight is > 2,000,000 daltons. Its
`shelf life is estimated at 2 years.
`
`AMVISC PLUS (Chiron Vision - Bausch and Lomb) -
`composed of sodium hyaluronate 1.6% in physiologic
`saline. The viscosity is 55,000 cSt (@25 C, 1/sec
`shear rate), and molecular weight is approximately
`1,500,000 daltons. The greater viscosity is obtained
`by increasing total concentration and using sodium
`hyaluronate of lower molecular weight. Its shelf life is
`estimated at 1 year.
`
`DUOVISC (Alcon) - Package contains two separate
`syringes. One syringe containing Proviso; the other con­
`taining Viscoat. Please see individual descriptions
`below for details of each.
`
`HEALON (Pharmacia - UpJohn) - Composed of sodium
`hyaluronate 1% in physiologic saline. The viscosity is
`200,000 (@ 0/sec shear rate), and the molecular
`weight is approximately 4,000,000 daltons.
`
`OCCUCOAT (Storz - Bausch and Lomb) - Composed of
`hydroxypropylmethylcellulose 2% in balance salt solu­
`tion (BSS). The viscosity is 4,000 cSt (@ 37 C mea­
`sured on Cannon-Fenske Viscometer), and the molec­
`ular weight is approximately 80,000 daltons. Occucoat
`is termed a viscoadherent rather than a viscoelastic
`because of its coating ability, which is related to its
`contact angle and low surface tension.
`
`PROVISC (Alcon) - Composed of sodium hyaluronate
`1% in physiologic saline. The viscosity is 39,000 cps
`(® 25 C, 2/sec shear rate) and the molecular weight
`is approximately 1,900,000 daltons. Clinical studies
`demonstrate that Pro Vise functions in a similar fashion
`to Healon.
`
`VISCOAT (Alcon) - Composed of a 1:3 mixture of chon-
`droitin sulfate 4% (CS) and sodium hyaluronate 3%
`(SH) in physiologic saline. The viscosity is 40,000 cps
`(@ 25 C, 2/sec shear rate), and the molecular weight
`is 22,500 daltons for CS and 500,000 daltons for SH.
`
`VITRAX (Allergan) - Composed of sodium hyaluronate
`3% in balanced salt solution (BSS). The viscosity is
`30,000 cps (@ 2/sec shear rate) and the molecular
`weight is 500,000 daltons. It is highly concentrated to
`produce a significantly viscous material. It does not
`require refrigeration and has a shelf life of 18 months.
`
`12. OFF-LABEL DRUG APPLICATIONS IN OPHTHALMOLOGY
`B. Alteplase (tissue plasminogen activator)
`B. Acetylcysteine
`This thrombolytic agent, trade-named Activase, is
`This agent is used to treat corneal conditions such as
`used to treat fibrin formation in postvitrectomy
`alkali burns, corneal melts, and keratoconjunctivitis
`patients. Though initial studies were based on
`sicca. It is thought to improve healing by inhibiting the
`intraocular injections of 25 pg, more recent work has
`action of collagenase, which may contribute to delay in
`shown the drug to be effective in doses of as little as
`healing. The drug is available generically or under the
`3 to 6 pg. Because by-products of alteplase activity
`trade name Mucomyst in 10% and 20% solutions.
`may mediate endothelial cell toxicity, the lower doses
`Though none of the commercially available solutions
`are preferred.-This agent has also been used for sub-
`are approved for use in ophthalmology, they have been
`macular hemhorrage, but this use is controversial.
`administered as frequently as hourly In acute cases,
`and up to 4 times a day in maintenance therapy.
`
`; been used pri-
`3 posterior pole
`rescein angiog-
`sclera, and con-
`lical tool.
`prevented from
`•etinal vascular
`d the intact reti-
`ither the retinal
`II allow leakage
`;udied by either
`Dr good results,
`:ite the fluores-
`gths. The peak
`185 and 500 nm
`530 nm.
`
`iagnostic agent,
`ng nausea and
`; and vagal reac-
`;ency equipment
`biography is per-
`ned that the dye
`rine; in the aver-
`a day.
`
`m used in recent
`n, to obtain bet-
`tion.
`
`ry Responses
`nstilled into the
`lie pupil (Adie's
`a normal pupil
`Dnse is seen fol-
`oline in patients
`/ syndrome).
`
`•ai drugs on mio-
`ipathetic system
`ds on the location
`in.
`
`Nil
`
`IONIC)
`
`NEURON I
`+/-
`
`+/-
`
`

`
`13. OCULA
`
`The table on the fc
`the more recently p
`effects of drugs in ;
`effects of drugs con
`It is not a catalog of
`would be too length
`The volume of ocul;
`ture is overwhelmi
`soft data, since, it
`patients on a parth
`an adequate sampl
`tal environment, it
`and-effect relation;
`multitude of variab
`impossible. It was
`National Registry c
`was founded.
`Established by
`Administration, wit
`
`F. Edetate disodium
`This chelating agent plays a role in the treatment of band
`keratopathy. After removal of the corneal epithelium, it is
`used to remove calcium from Bowman's membrane.
`
`REFERENCES
`
`Nesburn A. Trauma topics: small corneal perforations. Audio Digest:
`Ophthalmol. 1983;12;21.
`Ralph R. Chemical burns of the eye. In; Tasman W, Jaeger E, eds.
`Duane's Clinical Ophthalmology. Philadelphia, Pa; JB Llppincott;
`1989 vol. 4, chap 28:14.
`Jaffe G, Abrams G, et al. Tissue plasminogen activator for post
`vitrectomy fibrin formation. Opthalmology. 1990;97;189.
`McDermott M, Edelhauser H, et al. Tissue plasminogen activator
`and corneal endothelium. Am J Ophthalmol. 1989;108.
`Williams D, Benett S, et al. Low-dose intraocular tissue plasminogen
`activator for treatment of postvltrectomy firbrin formations.
`Am J Opthalmol. 1990;109:606.
`Williams G, Lambrou F, et al. Treatment of postvltrectomy fibrin
`formation with intraocular tissue plasminogen activator.
`Arch Ophthalmol. 1988;106:1055.
`Ando H, Tadayoshi I, et al. Inhibition of corneal epithelial
`wound healing. A comparative study of mitomycin 0 and
`5-fluorouracil. Ophthalmology. 1992;99;1809.
`Falck F, Skuta G, Klein T. Mitomycin versus 5-fluorouracll
`antimetabolite therapy for glaucoma filtration surgery.
`Semin in Ophthalmol. 1992;7:97.
`Who should receive antimetabolites after filtering surgery?
`Arch Ophthalmol. 1992;110;1069. Editorial.
`Welsh R, Palmer S. Mitomycin in trabeculectomy; alter your
`technique. Ocular Surgery News. May 1, 1992;67.
`Dunn J, Seamone S, Ostler H. Development of scleral ulceration and
`calcification after pterygium excision and mitomycin therapy.
`Am J Ophthalmol. 1991;112;343.
`Rubinfeld R, Pfister R, et al. Serious complications of topical
`mitomycin-C after pterygium surgery. Ophthalmology.
`1992;99:1647.
`Bonomi L Medical treatment of glaucoma. Current Science.
`1992',1040:70.
`Lish A, Camras C, Podos S. Effect of apraclonldine on intraocular
`pressure in glaucoma patients receiving maximally tolerated
`medications. Glaucoma. 1992;1:19.
`Holland E, Chan C, et al. Immunohistologlo findings and results of
`treatment with cyclosporine in ligneous conjunctivitis.
`Am J Ophthalmol. 1989;107;160.
`Bouchard C, Belin M, Letter to Editor concerning above article, with
`reply by author. Am J Ophthalmol. 1989;108;210.
`Secchi A, Tognan M, Leonard! A. Topical use of cyclosporine in the
`treatment of vernal conjunctivitis. Am J Ophthalmol.
`1990;110;641.
`BenEzra D, Matamoros N, Cohen E. Treatment of severe vernal
`keratoconjunctivitis with cyclosporine A eyedrops.
`Transplant Proc. igsS^O.No^fsuppI 2);644.
`Zierhut H, Thiel E, et al. Topical treatment of severe corneal ulcers
`with cyclosporine A. Graefe 's Arch Clin Exp Opthalmol.
`1989:227:30.
`Hill J. The use of cyclosporin in high-risk keratoplasty.
`' Am J Ophthalmol. 1989;107;506.
`Belin M, Bouchard C, Frantz S, et al. Topical cyclosporine in high-risk
`corneal transplants. Ophthalmology. 1989;96;1144.
`Quarterman MJ, et al. Signs, symptoms, and tear studies before
`and after treatment with doxycycline. Arch Dermatol. 1997;
`133:89.
`Frucht-Perry J, et al. The effect of doxycycline on ocular rosacea.
`Am J Ophthalmol. 1989;170(4):434.
`
`18 / PDR FOR OPHTHALMOLOGY
`
`C. Antimetabolites
`5-Fluorouracil (5-FU). This drug inhibits- fibroblasts
`and therefore diminishes scarring after glaucoma fil­
`tering surgery, initial recommendations called for
`subconjunctival injection of 5 mg twice daily for
`7 days postoperatively and once daily for the suc­
`ceeding 7 days. However, many physicians today are
`achieving positive results with as little as 4 mg
`administered 4 to 6 times during a 10-day period.
`Use of this drug is associated with a number of com­
`plications, including conjunctival wound leak, corneal
`epithelial defects, hypotony associated with perma­
`nently reduced vision acuity, serious corneal infec­
`tions in eyes with preexistent corneal epithelial
`edema, and increased susceptibility to late-onset
`bleb infections. The drug should be considered only
`when there is a high risk of surgical failure.
`Mitomycin. This potent chemotherapeutic agent,
`trade-named Mutamycin, is being used in filtering
`surgery for the same purpose and on the same type
`of patients as 5-FU. It is applied once during surgery
`on a small piece of Gelfilm or Week Cell in a concen­
`tration of 0.2 to 0.4 mg/

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