PDI
`
`
`
`27
`1999
`
`PHYSICIANS
`_ DEK
`REFEREINOE
`
`OPHTHALMOLOGY"
`
`
`
`Y
`
`tl
`
`ae
`
`' 1 t t 1 ' 1 t 1 1 1 1 ' 1 I '
`
`
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`Place
`Stamp
`Here
`
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`
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`ige of all the essential
`acts.
`
`rmation gives you the .
`d
`a:
`|
`ial datayou need.
`Editorial Consultantsan Contributors -
`
`yur widespread net-
`Clement A. Weisbecker, RPh, Director of Pharmacy, Wills Eye Hospital, Philadelphia, PA
`ther, organize and
`F.T.ei Director, National Registry of Drug-Induced Ocular Side Effects, Oregon Health Sciences University,
`1a timely manner.
`Michael Naidoff, MD, Cornea Service, Wills Eye Hospital, Philadelphia, PA
`re
`iti
`:
`Douglas Rhee, MD, Wills Eye Hospital, Philadelphia, PA
`re itis published.
`Richard Tippermann, MD,Wills Eye Hospital, Philadelphia, PA
`
`xed for quick,
`Vice President of Directory Services: Stephen B. Greenberg
`
`Drug Information Specialist: Maria Deutsch, MS, RPh, CDE
`ly for fast reference.
`Director of Product Management: David P. Reiss
`Editor, Special Projects: David W. Sifton
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`Inc. at Montvale, NJ 07645-1742. All rights reserved. None of the
`mea Copyright © 1998 and published by Medical Economics Company,
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`ae content of this publication may be reproduced,stored in a retrieval system, resold, re
`means(electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of the publisher. PHYSICIANS’
`DESK REFERENCE?, PDR®, PDR For Nonprescription Drugs®, POR For Ophthalmology®, Pocket PDR®, and The PDR? Family Guide to Prescription
`Drugs? are registered trademarks used herein under ticense. PDR Companion Guide™, PDR? for Herbal Medicines™, PDR® Medical Dictionary™,
`Family Guide Encyclopedia of Medical Care™, PDR®
`PDR? Nurse's Handbook", PDR® Nurse's Dictionary™, PDR® Atlas of Anatomy™, The PDR®
`System™are trademarks used herein underlicense.
`Electronic Library™, and PDR® Drug Interactions, Side Effects, Indications, Contraindications
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`cere of Medical Economics Company: President and ChiefExecutive Officer: Curtis B. Allen;
`iad President, Corporate Human Resources: Pamela M. Bilash; Vice President and ChiefInformation Officer: Steven M. Bressler; Senior Vice
`Services: Stephen B. Greenberg; Vice President,
`Mecent, Finance, and Chief Financial Officer: Thomas W. Ehardt; Vice President, Directory
`Communications: Thomas J. Kelly; Executive Vice
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`k; Vice President, Production: David
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`A. Pitler; Vice President, Group Publisher: ThomasC.Pizor; Vice Président, MagazineBusinessManagement:Eric Sehtett, Senior Vice President,
`Operations: John R. Ware
`ISBN: 1.56363-290-X
`
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`TEVA - EXHIBIT 1013
`
`TEVA - EXHIBIT 1013
`
`

`

`
`
`‘ing family of PC
`00-232-7379 or fj
`
`CONTENTS
`
`
`
`netics (FD&C) Act,
`2 labeled, promote
`or only those uses f,
`ess have been esta
`ations 201.100(d)(
`iN products require
`Jesk Reference fF,
`3, dosages,
`route
`on of administratic.
`3, contraindication:
`3t be in the “san
`oved labeling forti
`same language a
`se of the appro
`Furthermore,
`inf
`Ss emphasizedbyti
`3, boldface, or italk
`in Physicians' De
`
`FD&C Act does nt
`»hysician may use;
`3 been approved f
`ve
`it for uses or)
`lations that are fj
`A also observesth
`des drug use that
`g. For products th
`5, the publisher hi
`bing such produc
`have access to:
`1d informed decisi
`+r-the-counter dieta
`3d that this inform
`he Food and Dna
`3 are not intended!
`lisease.
`;
`
`dmpilation, organi
`tion. Each produ”
`3 manufacturer, @
`dfacturer's medi¢
`medical consultat
`terial
`in Physician
`e publisher does fi
`ducts described, !
`connection with @
`herein. Physiciat
`es not assume, 4!
`» obtain and inclu
`wided to it by tf
`i that by making th
`advocating the ut
`or
`is the publish
`jue to typographi¢”
`W product may b
`
`PIT
`=="
`
`Section 1: Indices
`
`
`Page I
`
`1. MAnufacturers’ INCOX.....cccssesesseececeanccesnasenersseeeeeaeucnssesssseceecsecssncessoesessesecuueveususssusneaagesseeeteerss I
`2. Product NAME INGOX ...sesececesevecesessesseeeceseeecseneeeeessoussecsesoaseessssuanscescesanseeesseneceeesessauuessuceeegersss IT
`3. Product Category INGOX........cccccccseccssecesccceccoueeeseresecuesuauceuaecususuueauseeussecesaseueesensuuescuseuvecaueeanes Vi
`4A, Active Ingredients INGOX 2.0.0... cececcceceeseeeseseeecaneesaueeesececeesonsessstousseneuveuseauevenesseecussununeseceeeennes IX
`
`
`Section 2: Pharmaceuticals in Ophthalmology
`Page 1
`
`
`4. Mydriatics and Cycloplegics ........ cc ceesesssenesesceeeseaseneneaas Seeee 2
`2. Antimicrobial Therapy .........cccccceccssccsscccecccececsscusevenscussnauscussnsuensceseuseseseceseceneseseeutseeacsaecaereauas 2
`3. Ocular Anti-inflammatory AQents ..............ceescecccssceesseccseveceurseneererseousseeauseeeececansueseusenevenseneeens 7
`A, Anesthetic ASents .......:ccccceccececsececseeeneseeeceusessuessensessessenegssseeuserssaceseuvsccenseesranaeeseceseneeesuesees 9
`5. Agents for Treatment Of GlAUCOMA ....... cecceseeeeeseseececeensceseesessaecssuscaaceseesssaueeserecagacccenecsensesses 10
`6. Medications for Dry Ey@.........ccssccsscccssceeccescecsscoveceuscaeesesceuesneuuseuuecutesuevssueeencceeecenesecsesacesenees 13
`7. Ocular DECONGESTANS ......ccccceecessacsseesseceeeanccesssnaassseseeeeecuceuseeasessueserersesususeucuuseuseaeaereteutessens 14
`8. Ophthalmic Irrigating SOIUtIONS.........ecccseescecessseteecsusssccccssssceucnseeecesenseuuaecesesuucuseeensugeceesees 15
`Q. Hyperosmolar Agent.......ceccecececseseneeneesaeeeesenaesesesseunessuseeesseeegsseeevecsseuucennes eavercuerceerauerevens 15
`10. Diagnostic ASONts ........cececcseceeeeeneeeeenseeecaeseeceseecuerssansesuecensoueceeousenenessssenepseeuecenesesaueeeeness 16
`11. Viscoelastic Materials Used in OphthalMology.............ccccecccsceecccsscencccceceeveceeeseensneeeueneeenenss 17
`12. Off-Label Drug Applications in Ophthalmology ............ccccsescessessccuceccuscccsenssassuecceseneesacseeuensss 17
`13. Ocular TOXxiCOlOgy........ ce eeeceeeeeeceeenceseceuneesnessecuenssesceseausecerscenecesensesenuceceeesseceueneesauusaauaeusennes 19
`
`
`Section 3: Suture Materials
`
`
`Page 23
`
`Section 4: Ophthalmic Lenses
`
`Page 25
`
`1. Soft Contact LENS@S..........ccesscssssceccessssssnsescesecessucssscaueeesoueusracceseoseususccaueceueenauueuseenseneaanasess 25
`2. APNAKIC LENSES........cccccccesssesncescucusesseasseeeseueuveceusenseveveesessavenssausesusesusensevsusenecserteneusnsatentess 50
`3. Comparison and Conversion Tables .........cccsccssssssesssecccccecssanssencsesecseseeeesesseenstessecerecsseersrecsans 52
`
`
`Section 5: Vision Standards and Low Vision
`
`
`Page 56
`
`1. Vision Standards...c..ccccccccssssscesssesscessssscsescsecescssesssenucseessevaceeaessevenessesateeatesssnaseaeteassneeeateass 56
`2. LOW-VISION AIS ....cccesccescccsccressscsaccscessecseccsevsessssscascssscaeceaeesassnscacsenevsesessnateaevnecsssnieenevenevaes 58
`
`
`Section 6: Evaluation of Permanent Visual Impairment
`
`
`59
`
`1. Criteria and Methods ...ccccccsecsscscscsscsssscscscscsssssesescevscsceceusecavavavesauececaceseesasatavaceceecesacecaveces 59
`2. Visual System Impairment ValUeS .....c.ccccssessececcecscsscseececcacescavaceecacacssassvssessacaeusacsuvevavaeeasas68
`3. Combined Values CHALE.ssssesssseessssersssensnsessssensnsossseessneesnnrennnrernarersetessapeenrerettensrennennuennuenss71
`
`
`
`
`
`

`

`
`
`
`
`Section 7: Product Identification Guide
`
`SECTION4
`INGOX 0... cecsceeecenercccseescdauseseescenseussansceceusuanunscauseeecuusesnaeeenaseneueseccauseseccegensearstcnusneneessnes102
`1.
`2. Full-Color Product PRHotographss ...........ccccccsuvesnuvsccssccaucssnececceueuseaenseususesensessuuccuseuacecuseeeanenens 103
`INDICE
`
`
`Page 101.
`
`Section 8: Pharmaceutical and Equipment Product Information
`
`
`Page 201
`
`
`
`_
`Listed alphabetically by manufacturer
`
`
`Section 9: Intraocular Product Information
`
`Key to Controlled Substances Categories
`
`
`Page 315
`
`Page 319
`
`Page 320
`Key to FDA Use-in-Pregnancy Ratings
`
`
`Amsler’s Grid
`
`Inside Front Cover
`
`
`ieee
`
`This section offersf
`mation you need:
`
`41, Manufacturers’
`participating manut
`two page numbers
`graphs in the Proc
`ond to product
`i
`addresses and tele
`headquarters and re
`
`2. Product Name|
`uct information alp
`mond symbol to the
`tograph
`of
`the
`Identification Guide
`page number refer:
`
`PART I/MANUF
`
`AKORN,INC. ......
`2500 Millbrook Driv
`Buffalo Grove, IL 6¢
`Direct Inquiries to:
`Customer Service
`(800) 535-7155
`
`ALCON LABORATOR
`andits Affiliates
`Corporate Headqua
`6201 South Freewe
`Fort Worth, TX 761
`Direct inquiries to:
`Ophthalmic/VisionC
`(Pharmaceuticals/L
`Surgical: (800) 862
`(instrumentation/S
`Systems: (800) 28:
`(Medical Managem
`Systems)
`
`ALLERGAN .......
`2525 Dupont Drive
`P.O. Box 19534
`Irvine, CA 92623-9
`For Medical Infor
`Outside CA: (800)
`CA: (714) 246-45C
`Sales and Ordering
`Outside CA: (800)
`CA: (714) 246-45C
`
`BAUSCH & LOMB.
`PHARMACEUTI(
`8500 Hidden Rive!
`Tampa, FL 33637
`
`
`
`

`

`—_——
`
`ee
`
`PHARMACEUTICALS / 13
`
`6. MEDICATIONS FOR DRY EYE
`
`3ET/DURATION
`ACTION
`
`;
`
`nin/5-6 h
`60 min/é 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, StevensJohnson 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.
`
`TABLE 20
`
`
`
`ARTIFICIAL TEAR PREPARATIONS
`
`PRESERVATIVE/EDTA*
`TRADE NAME
`CONCENTRATION (%)
`None
`Refresh Plus
`0.5%
`None
`Celluvisc
`1%
`None
`Theratears
`0.25%
`None
`Dry Eye Therapy
`TearGard
`
`Glycerin
`Hydroxyethyl cellulose,
`
`polyvinyl alcohol
`Hydroxypropy| cellulose
`
`3%
`
`Chlorobutanol
`
`Sorbic acid, EDTA
`
`Lacrisert (biode-
`None
`
`gradable insert)
`Benzalkonium chloride
`Isopto Plain
`Benzalkonium chloride
`Isopto Tears
`Tearisol
`Benzalkonium chloride, EDTA
`
`Benzalkonium chloride
`Isopto Alkaline
`None
`Bion Tears
`Ocucoat
`Benzalkonium chloride, EDTA
`None
`Ocucoat PF
`Tears Naturale I!
`Polyquad
`Tears Naturale Free
`7
`None
`Tears Renewed
`Benzalkonium chloride, EDTA
`Methyl-, propylparabens
`Murocel
`1%
`EDTA
`- AquaSite
`EDTA, Sorbic acid
`AquaSite multi-dose
`Viva Drops
`AKWATears
`Benzalkonium chloride, EDTA
`Chlorobutanol
`Dry Eyes
`Chlorobutanol
`Liguifilm Tears
`Benzalkonium chloride, EDTA
`HypoTears
`EDTA
`HypoTears PF
`Benzalkonium chloride, EDTA
`Puralube Tears _
`Benzalkonium chloride, EDTA.
`Murine Tears
`None
`Refresh
`Tears Plus
`
`ONSET/DURATION: 7
`OF ACTION
`J
`2 h/4-Gh
`
`5-10 min/2 h
`
`30 min/6 h
`
`2h/4-6 h
`
`SIZE(S)(mL) 4
`5
`single use bottle_
`5, 10, 15
`
`SIZE(S)(mL)
`25
`
`MAJOR COMPONENT(S)
`Carboxymethyl cellulose
`
`Hydroxypropy| methylcellulose
`
`Hydroxypropyl methylcellulose, .
`dextran 70
`
`Methylcellulose
`Polycarbophil, PEG-400,dextran 70
`
`
`Polysorbate 80
`Polyvinyl alcohol
`
`-
`1.4%
`
`3%
`1%
`Polyvinyl alcohol, =
`PEG-400, dextrose
`
`Polyvinyl alcohol,
`1.4%
`povidone
`0.6%
`
`
`*EDTA = ethylenediaminetetraacetic acid.
`
`

`

` a g
`
`, OPHTHA
`
`a T
`
`
`
`TABLE 21
`OPHTHALMIC LUBRICANTS—
`Listed in Table 23
`4
`TRADE NAME
`_ COMPOSITION OF STERILE OINTMENT
`
`eneral ophthalmic
`4
`AKWATears Ointment
`:
`White petrolatum, liquid lanolin, and mineral oil
`products. There ar
`
`
`tions available for
`
`
`
`
`Dry Eyes White petrolatum, liquid|lanolin, and mineral oilOe - ‘
`Duolube
`-
`-
`White petrolatum and mineral oil
`od
`
`Duratears Naturale
`White petrolatum, liquidlarlanolin, and mineraloil
`-
`9
`ABLE 23
`—i =
`White petrolatum andlight mineraloil
`_
`HypoTears
`
`OPHTHALMIC il
`
`
`Lacri-Lube S.0.P., Lubritears 42.5% mineraloil, 55% white:petrolatum, lanolin alcohol, and chlorobutanol
`
`TRADE NAME
`Puralube
`White petrolatum, liquid lanolin, and mineraloil ma
`
`AK-Rinse
`41.5%mineraloil, 55% white petrolatum, petrolatum, and lanolin alcohol
`Refresh PM., Dry Eyes Lubricant
`
`14 / PDR FOR OPHTHALMOLOGY
`
`a C
`
`Eye-Stream
`
`ollyrium Fresh Eyes
`pelaa
`Dacriose
`mami
`
`7. OCULAR DECONGESTANTS
`
`a i
`
`rigate
`
`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).
`LavoptikEyeWash
`
`
`
`
`TABLE 22
`
`OCULAR DECONGESTANTS
`
`DRUG
`Naphazoline hydrochloride
`
`ADDITIONAL COMPONENTS
`TRADE NAME
`
`Benzalkonium chloride, edetate disodium
`AK-Con*
`Benzalkonium chloride, edetate disodium
`Albalon*
`Benzalkonium chloride, edetate disodium
`Clear Eyes
`Benzalkonium chloride, edetate disodium
`Naphcon
`Vasoclear
`Benzalkonium chloride, edetate disodium
`HYPEROSMO!)
`
`
`Vasocon Regular*
`Phenylmercuric acetate
`GENERICNAME
`Oxymetazoline hydrochloride
`Visine L.R.
`Benzalkonium chloride, edetate disodium
`
`
`A.Therapeuticprepe
`_Ocuclear
`Benzalkonium chloride, edetate disodium
`-
`Sodium chloride
`Ak-Nefrin
`Benzalkonium chloride, edetate disodium
`Phenylephrine hydrochloride
`Eye Cool
`Thimerosal, edetate disodium
`Prefrin Liquifilm
`Benzalkonium chloride, edetate disodium
`Relief
`—_
`
`
`9. HYPER
`
`Hyperosmolar(hy
`They act through
`
`TABLE 24
`
`B. Diagnostic prepa’
`Glycerin
`
`Tetrahydrozoline hydrochloride
`
`Benzalkonium chloride, edetate disodium
`Collyrium Fresh
`Murine Plus
`Benzalkonium chloride, edetate disodium
`Visine
`Benzalkonium chloride, edetate disodium
`
`
`DECONGESTANT/ASTRINGENTCOMBINATIONS
`-
`-
`
`
`
`Naphazoline hydrochloride
`Benzalkonium chloride, edetate disodium
`Clear Eyes ACR
`plus zine sulfate
`(allergy/cold relief)
`Phenylephrine hydrochloride
`plus zinc sulfate
`
`Tetrahydrozolineplus zinc sulfate
`*Prescription medication.
`
`Zincfrin
`Visine Allergy Relief
`
`Benzalkonium chloride
`‘Benzalkonium chloride, edetate disodium
`
`
`
`

`

`
`
`PHARMACEUTICALS / 15
`
`g, OPHTHALMIC IRRIGATING SOLUTIONS
`= Listed in Table 23 are sterile isotonic solutions for
`They include prescription medications such as
`_ eneral ophthalmic use. Theyare all over-the- counter
`Bausch & Lomb’s Balanced Salt Solution, Alcon’s
`roducts. There are also intraocular irrigating solu-
`BSS and BSS Plus, and lolab’s jocare Balanced
`| tions available for use during surgical procedures.
`Salt Solution.
`
`
`_
`
`
`
`TABLE 23
`__
`= a Moe
`ff
`OPHTHALMIC IRRIGATING SOLUTIONS
`
`cohol, and chlorobutanol
`__ a
`
`
`-TRADENAME COMPONENTS — ADDITIONAL COMPONENTS
`
`
`
`
`aeaereTea~ ACRinse —_ Sodium, potassium calcium,and ne:Benzalkonium chloride :
`
`
`
`i
`AK-
`1
`'
`;
`m, and lanolin alcohol =_
`magnesium chlorides,
`
`sodium acetate, and sodium citrate
`—
`/
`CollyriumFresh Eyes
`Antipyrine, boric acid, and borax
`Benzalkonium chloride
`
`Dacriose
`Sodium and potassium
`Benzalkonium chloride,
`
`chlorides, and sodium phosphate
`edetate disodium
`
`Eye-Stream
`Sodium, potassium, magnesium
`Benzalkonium chloride
`and calcium chlorides, sodium
`
`acetate, and sodium citrate
`Boric acid, potassium chloride, and
`Benzalkonium chloride,
`sodium carbonate
`_ edetate disodium
`Sodium chloride, sodium biphosphate,
`Benzalkonium chloride
`and sodium phosphate
`
`2. Three types are avail-
`‘ith phenylephrine. Usual
`
`frigate
`
`LavoptikEye Wash
`
`
`;
`
`=
`
`
`MPONENTS
`iloride, edetate disodium
`iloride, edetate disodium
`iloride, edetate disodium
`
`loride, edetate disodium TABLE24
`tt edetate disodium
`HYPEROSMOLAR AGENTS
`
`acetate
`lloride, edetate disodium
`GENERIC NAME
`TRADE NAME
`lloride, edetate disodium
`A. Therapeutic preparations
`2% or 5%(solution)
`Adsorbonac Ophthalmic
`lloride, edetate disodium
`Sodium chloride
`5%(solution and ointment)
`AK-NaCl
`ate disodium
`,
`2%or 5% (solution),
`Muro-128
`|
`iloride, edetate disodium
`5% (ointment)
`loride, edetate disodium
`B. Diagnostic preparation
`Glycerin
`iloride, edetate disodium en —_—_—_—
`loride, edetate disodium
`
`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.
`
`CONCENTRATION (%)
`
`Ophthalgan
`—$——_—_—_—— <= —
`
`loride, edetatedisodium
`
`iloride
`
`\loride, edetatedisodium
`
`
`
`

`

`
`
`
`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 epithelia. Defects in the corneal epithelium
`will appear bright green in ordinary light and bright
`yellow when a cobalt blue filter is used in the Sight
`path. Similar Jesions 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.*
`
`Rose bengal, as a 1% solution, is particularly use-
`ful
`for demonstrating abnormal conjunctival or
`cornea! 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 Schirmer test 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 Il test
`can be performedby repeating the procedure while
`stimulating the nasal mucosa.? 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 ofthe 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 intactreti-
`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 commonside 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 showsthe 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
`
`TOPICAL DROP
`(CENTRAL)
`Cocaine 2%-10%
`
` NEURONI =NEURONI
`(POST-
`(PRE-
`GANGLIONIC)
`GANGLIONIC)
`-
`-
`
`NEURON 1
`+/~
`
`Epinephrine
`(Adrenalin) 1:1000
`
`Phenylephrine 1%
`
`HH
`+44
`
`+
`+
`
`~
`+/~
`
`
`
`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 parasympatheti:
`aneurysm, Adie’s tor
`carpine will cause the
`
`11. VISCOEI
`
`Viscoelastic substanc
`surgery to maintain the
`dissect tissues, act as
`ade, and prevent mect
`cially 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 are
`the anterior chamber f
`
`AMVISC (Chiron Vision
`of sodium hyaluronate
`viscosity is 40,000 c
`and molecular weigh
`shelf life is estimatec
`
`AMVISC PLUS (Chiror
`composed of sodium
`saline. The viscosity
`shear rate), and mo
`1,500,000 daltons. T
`by increasing total c
`hyaluronate of lower 1
`estimated at 1 year.
`
`DUOVISC (Alcon) — I
`syringes. One syringe
`taining Viscoat. Plez
`below for details of ei
`
`HEALON (Pharmacia -
`hyaluronate 1% in ph
`200,000 (@ O/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 frec
`and up to 4 times a
`
`—————w=
`
`|
`
`

`

`
`
`PHARMACEUTICALS / 17
`
`Pilocarpine may be used to determine whethera fixed
`dilated pupil is due to an atropine-like drug or inter-
`ruption of the pupil’s parasympathetic innervation.’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
`
`4. Thompson HS, Mensher JH. Adrenergic mydrisis in
`Homer's syndrome: hydroxyampheta mine test for diagnosis
`of post-ganglionic defects.Am J Ophthalmol. 1971;72:472.
`2. Hecht SD. Evaluation of the lacrimal drainage system.
`Ophthalmology. 1978;85:1250.
`3. Thompson HS, NewsomeDA, Lowenfeld | E. The fixed dilated
`pupil. Suddeniridoplegia or mydriatic drops; a simple
`diagnostic test. Arch Ophthalmol. 1971;86:12.
`
`11. VISCOELASTIC MATERIALS USED IN OPHTHALMALOGY
`
`
`
`3 been used pri-
`2 posterior pole
`rescein angiog-
`sclera, and con-
`lical tool.
`
`prevented from
`‘etinal vascular
`J the intact reti-
`ither the retinal
`il allow leakage
`cudied by either
`yr good results,
`site the fluores-
`gths. The peak
`485 and 500 nm
`530 nm.
`
`iagnostic agent,
`ng nausea and
`> and vagal reac-
`‘ency equipment
`siography is per-
`red that the dye
`rine; in the aver-
`a day.
`
`in used in recent
`n, to obtain bet-
`tion.
`
`ty Responses
`nstilled into the
`jic pupil
`(Adie’s
`a normal pupil
`ynse is seen fol-
`oline in patients
`y syndrome).
`
`‘al drugs on mio-
`ipathetic system
`ds on the location
`in.
`
`Nil
`
`IONIC)
`
`NEURON|
`+-
`
`+f-
`
`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 chamberfollowing surgery.
`
`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 shearrate),
`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 Provisc; the other con-
`taining Viscoat. Please see individual descriptions
`below for details of each.
`
`HEALON GV (Pharmacia — UpJohn) - Composed of
`sodium hyaluronate 1.4% in physiologic saline. The vis-
`cosity is 2,000,000 (@ O/sec shearrate), 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.
`
`OCCUCOAT(Storz ~ Bausch and Lomb) ~ Composed of
`hydroxypropylmethyicellulose 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 ProVisc functions in a similar fashion
`to Heaton.
`
`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
`HEALON(Pharmacia — UpJohn) — Composed of sodium
`weight is 500,000 daltons.It is highly concentrated to
`hyaluronate 1% in physiologic saline. The viscosity is
`produce a significantly viscous material.
`It does not
`200,000 (@ O/sec shear rate), and the molecular
`require refrigeration and has a shelflife of 18 months.
`weight is approximately 4,000,000 daltons.
`
`
`12. OFF-LABEL DRUG APPLICATIONS IN OPHTHALMOLOGY
`
`B. Acetylcysteine
`This agent is used to treat corneal conditions such as
`alkali burns, corneal melts, and keratoconjunctivitis
`sicca. It is thought to improve healing byinhibiting the
`action of collagenase, which may contribute to delay in
`healing. The drug is available generically or under the
`trade name Mucomyst
`in 10% and 20% solutions.
`Though none of the commercially available solutions
`are approved for use in ophthalmology, they have been
`administered as frequently as hourly in acute cases,
`and up to 4 times a day in maintenance therapy.
`
`B. Alteplase (tissue plasminogen activator)
`is
`This thrombolytic agent,
`tradenamed Activase,
`used to treat
`fibrin formation in postvitrectomy
`patients. Though initial studies were based on
`intraocular injections of 25 ug, more recent work has
`shownthe drug to be effective in dosesofaslittle as
`3 to 6 Ug. Because by-products of alteplase activity
`may mediate endothelial cell toxicity, the lower doses
`are preferred..This agenthas also been used for sub-
`macular hemhorrage, but this use is controversial.
`
`
`
`

`

`
`
`
`
`43. OCULA
`
`The table on the fc
`the more recently f
`effects of drugsin ;
`effects of drugs con
`itis not a catalog of
`would be too length
`The volume of oculi
`ture is overwhelmi
`soft data, since,
`ir
`patients on a parti:
`an adequate sampl
`tal environment,it
`and-effect relation:
`multitude of variak
`impossible. It was
`National Registry o
`was founded.
`by —
`Established
`Administration, wit
`
`F. Edetate disodium
`This chelating agent playsa role in the treatment of band
`keratopathy. After removal of the corneal epithelium,it is
`used to remove calcium from Bowman’s membrane.
`
`
`REFERENCES
`
`18 / PDR FOR OPHTHALMOLOGY
`
`C. Antimetabolites
`5-Fluorouracil
`(5-FU). This drug inhibitsfibroblasts
`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.
`Useof this drug is associated with a numberof 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
`whenthere is a high risk of surgicalfailure.
`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 Weck Cell in a concen-
`tration of 0.2 to 0.4 mg/mL. Reported side effects
`are similar to those of 5-FU. However, some serious
`side effects may go unreported, since there is a pos-
`sibility of delayed reactions 6 to 24 months after
`surgery. Mitomycin has also been administered in a
`0.02% to 0.04% solution 2 to 4 times a day to pre-
`vent recurrence after pterygium surgery. Serious side
`effects associated with this therapy include corneal
`melts and scleral ulceration and calcification.
`Physicians should bear in mind the possibility of
`majorside effects from all antineoplastic agents and
`carefully weigh the risks and benefits of the use.
`Remember, too, that these agents should always be
`handled and discarded in accordance with OSHA,
`AMA, ASHP, and/or hospital policies regarding the
`safe use of antineoplastics.
`D. Cyclosporine
`This potent immunosuppressant has a high degree of
`selectivity for T lymphocytes. Available under the
`trade name Sandimmune, it has been used in a 2%
`topical solution as prophylaxis against rejection in
`high-risk, penetrating keratoplasty and for treatment
`of severe vernal conjunctivitis resistant to more con-
`ventional
`therapy,
`ligneous conjunctivitis unrespon-
`sive to other
`topical
`therapy, and noninfectious
`peripheral ulcerative keratitis associated with sys-
`temic autoimmunedisorders. All contraindications for
`systemic use also apply to topical administration,
`since