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`1999
`
`EDITION
`
`PEYSCIANS
`DEK
`REFERENCE
`
`OPHTHALMOLOGY’
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`
`Drug Information Specialist: Maria Deutsch, MS, RPh, CDE -
`Editor, Special Projects: David W. Sifton
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`ige of all the essential
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`imation gives you'the
`Editorial Consultants and Contributors
`ial data you need.
`“Philadelphia, PA
`Clement A; Weisbecker, RPh, Director-of Pharmacy, Wills Eye Hospital,
`sur widespread net-
`Oregon Health Sciences University,
`ET. Fraunfelder, MD, Director, National Registry of Drug-Induced Ocular Side Effects,
`ther, organize and
`_>>Portland, OR
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`1a timely manner.
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`
`re itis published.
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`
`xed for quick,
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`Mukesh Mehta, RPh
`Senior Drug Information Specialist:
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`FAMY CARE- EXHIBIT 1013-0001
`
`FAMY CARE - EXHIBIT 1013-0001
`
`

`

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`00:232-7379 or
`
`CONTENTS
`ssccennenarnmnsnseeeenieeescenesteraintIEE
`
`‘ing family. of r
`fae
`
`netics (FD&C) Act,
`2 labeled, promote.
`dr only those uses |,
`
`
`lesk Reference
`
`i, dosages,
`route
`dn of administrat
`3,-contraindicati
`
`it-be-in-the “s
`
`
`oved labeling for
`Same language
`
`se-of-the-appr
`
`ing,
`Furthermore,
`§ emphasized by
`
`3, boldface, or it
`in Physicians’
`
`Section 1: Indices
`
`Page|
`
`1. MANUPACTULErS' INGOX se cceccscccocseccsneeecesupacnnueeaeensaeacsesscsesessesecessurssasssccesscuueceeterssnsteaeasseeseaterce |
`2. Product Name Index vcccicciiecics sineueouseusaeusepecoapunsuausteaeeasnaunsesssusctsenbansateussecscestsasssescuessnies itl
`3. Product Category INd@X o.oo ..ecciecseccceeseeeeccuerecceunvensesurnns jan eeaunnoenhenenna ssn ceeuurauaseetsvensssecccsneceaseeves Vi
`4. Active Ingredients ING@X ........ccceeccccpeececcesececeeceeeecneeererscsuunersevunesreesescees seeeentenieevesseenaeansaeeneanae IX
`
`
`Section 2: Pharmaceuticals in Ophthalmology
`
`
`Page 1
`
`4. Mydriatics and Cycloplegics ....0. 0... puaueveuwvnsessdsuadesauuersueetsuuaaecceesssessacecssssssccsseesstsecececcsececeecenes 2
`2. Antimicrobial THOraDy. ....cccecccceeccccsesessecereseecsneveesecenneses petuussnetuusaaisccasersuuseccsstussetsauseversecentesess 2
`3. Ocular Anti-inflammatory ABENtS .....o..cee ec ceceec sce censceeeeceeeeeeceeneusreereenenenee beoetetntoaenteeenenectacaess 7
`4. Anesthetic AZ@nts .........ccscsececceeccceressecercneeseteessseeceseteeeesceesucceeunenseenecteetavessvensssssseenenseqennneanes 9
`5. Agents for Treatment Of GlauCOMa eee ie ceieeccscceccesscaeceeseetensseenccescenerssectereetecserensses 10
`6. Medications for Dry Eye.ccc ics cs iasaseccecncctevenecustesvsveceecesenssevessensvessnssens 13
`7. OcUlar DECONBESTANIS Loic cles ccccceccccssesesccecceecsssssessuusveusuneucrstsssssstesvesseveurereversensess 14
`8: Ophthalmic Irrigating Solutions...c..0.. becenneescoenene subaususscacccaccaeceetsenecctasseecsseececescuesneveavereneaes 415
`9, Hyperosmolar ABENIS viiccs.ccscusiscecsrtssscscuusrsssceetensctsnssstsscstersscesscsssesteessissseesseee kien 15
`10. Diagnostic ASOnts .....cecccretsseceseeecreeneerscrrenensneenevsnssnennes cotentenns revrontaseeentennmeaenaseretnen lO
`11. Viscoelastic Materials Used in Ophthalmology... ....cccecccccscccccececcecccseccuseveveveveviesesrevsesieereees 17
`12, Off-Label Drug Applications in Ophthalmology ceccececccccsscecscccceensceseeseercceeeserenccceceesneueveseenenes 17
`13. Ocular TOXICOlORYooEi ses te taecscbecasses ti essssasisiacsssssssiscevassssisssivicesicistss es 19
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`FD&C Act does
`
`yhysician may us
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`
`
`
`lations that are
`A also observes
`des drug use th
`g. For products
`3, -the-publisher
`
`3.are not intende
`liséase.
`
`
`
`Section 3: Suture Materials
`
`Section 4: Ophthalmic Lenses
`
`
`Page 23
`
`Page 25
`
`4) Soft Contact LENSGS oso ceeceee 25
`2. Aphakic Lens@S....cseceeces (sedeeeethas sain sasedieuatekenbkasodsusiusiiuuiaeliuvsieuiebbiuuuustusbivieevussuugeesbayeniedl 50
`8, Comparison and Conversion TableS ...sc..ceecessesrreeee devuvesdetesetetsstsecsectatssticetssdestsitestsatacestiees 52
`
`
`Page 56
`
`
`Each: pro
`tions
`
`> manufacturer,
`
`afacturer's -méd
`médical consult
`
`Section 5: Vision Standards and Low Vision
`terial
`in Physicia
`
`
`€ publisher does.
`ducts described,
`i VISION StANG@rS.......cccccccccccsececsccesccccecssccssccoesusaccncscsssssssessecesesecssseseceseossseravssserseetsssteerssess56
`connection with
`herein. Physica
`2. LOW-VISION AICS .esscsscceccscssessssesesssssssssesnssssccsssuscssesessasessecnseneusveessescssssscseesvsessvsvssvevacvevsvereenes 58
`
`es not assume,
`
`“obtain. and_ inc!
`Section 6: Evaluation of Permanent Visual Impairment
`
`
`wided to it by.
`
`1 that by making|
`advocating the |
`
`
`Criteria and Methods .........
`is the publis
`or
`Visual System Impairment Values .....:ccccccccsccsssesesessssesesccsaceececsesesesssesseseecsssssevessvseserersesnsenes68
`jue to typograph
`
`ly product: may
`Combined Values Chart .....cccceccccceseecccceeececesecsecccesersecescecevsceseveccetersessvetserssecsecteevereseeswef
`
`
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`59
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`
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`FAMY CARE- EXHIBIT 1013-0002
`
`FAMY CARE - EXHIBIT 1013-0002
`
`

`

`
`
`SECTION1
`
`INDICE
`
`
`
`Section 9: Intraocular Product Information
`
`Key to Controlled Substances Categories
`
`
` Key to FDA Use-in-Pregnancy Ratings
`
`
`Page 31
`
`Page 31
`
`Page 32
`
`
`This section offers f
`mation you need:
`
`4, Manufacturers’
`participating manut
`two page numbers
`graphs in: the: Proc
`ond to. product
`i
`addresses. and tele
`Neeaquarters and re
`2 Product Name |
`uct information alp
`mond symbol to the
`tograph.
`of
`the
`Identification. Guide
`ce number refer:
`PARTI/MANUF
`AKORN, ING. cess
`2500 Millbrook Driv
`Buffalo Grove; 1k: 6¢
`Direct Inquiries to:
`Customer Service
`(800).535-7155
`
`ALCON LABORATOR
`and its Affiliates
`Corporate Headqua
`6201 South Freewe
`_ Fort Worth, TX 761
`_ Direct Inquities 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 Inforr:
`Outside: CA: (800)
`CAs (71.4) 246-45
`Sales and Ordering
`Outside-CA: (800)
`CA! (714) 246-450
`
`BAUSCH & LOMB.
`PHARMACEUTK(
`8500 Hidden Rivel
`Tampa, FL 33637
`
`
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`FAMY CARE- EXHIBIT 1013-0003
`
`FAMY CARE - EXHIBIT 1013-0003
`
`

`

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`oaaici
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`6. MEDICATIONS FOR DRY EYE
`
`PHARMACEUTICALS. 7.13
`
`Dry eyé is treated with artificial tear preparations
`Dry eye refers to a deficiencyin either the aqueous or
`(see Table 20) and ophthalmic lubricants (see Table 214).
`mucin components. of the precorneal tear film. The
`The lubricants form an occlusive film over the ocular
`most-commonly:-encountered:-aqueous-deficient: dry
`surface
`“and
`protect
`“the
`eye
`from.
`drying.
`eye in the United States is keratoconjunctivitis sicca,
`Administered.-as..a--nighttime:.medication,.they.-are
`while-mucin-deficient-dry-eyes-may:be-seen-in-cases
`:
`nin/5-6 h
`useful both for dry eye and in cases of recurrent
`of hypovitaminosis “A; Stevens-Johnson:syndrome,
`60 min/éh
`corneal erosion.
`ocular pemphigoid, extensive trachoma, and chemi-
`45min/5-6h
`cal burns.
`
`SET/DURATION
`ACTION
`
`|
`
`
`
`
`
`F ACTION
`2h/4-6h
`
`30-min/6-h
`
`2hid-6h
`
`
`~~SIZE(S)(mL)
`25
`
`
`
`1%
`
`1%
`
`TA%
`
`3%
`1%
`
`{Ae
`0.6%
`
`7 EDTA = ethylenediaminétetraacetic’ acid.
`
`
`
`
`
`TABLE 20
`| ARTIFICIAL TEAR PREPARATIONS
`_ MAJORCOMPONENT(S)
`CONCENTRATION (%)
`PRESERVATIVE/EDTA*
`TRADE NAME
`ONSETDURATION ;
`carboxymethyl cellulose
`0.5%
`None
`Refresh Plus
`None
`Gelluvisc
`:
`1%
`
`0.25%
`=
`TheatersINone
`
`Dry Eye Therapy nmatnnnnc Nonesssnonnonasnahnnemieiooodaate
`
`Glycerin
`3%
`TearGard
`Sorbic acid, EDTA
`Hydroxyethylcellulose,
`B-10min2h
`polyviny:alcohol
`: ‘Hydroxypropyl.cellulose
`
`
`_ Hydroxypropyl methylcellulose
`
`
`
`Hydroxypropyl methylcellulose,
`
`dextran: 70
`
`
`
`
`
`~~SiZE(S)(mL)Jo
`
`single usebottle
`
`
`ggIONcee
`
`
`
`
`Polyvinyl alcohol,
`
`__
`PEG-400; dextrose
`
`
`
`Polyviny!alcohol,
`povidone
`
`Lacrisert (biede-
`gradable insert)
`Isopto Plain
`lsopto Tears
`Tearisot
`Isopto Alkaline
`Bion Tears
`Ocucoat
`Ocucoat PF
`Teats Naturale Ii
`Tears Naturale Free
`Tears Renewed
`Murocel
`AquaSite
`AquaSite multi-dose
`Viva Drops
`AKWA Tears
`Dry Eyes
`
`Ligui
`Hyp
`HypoTears: PE
`Piiralibe Tears
`Murine Tears
`Refresh
`
`None
`
`Benzalkonium chloride
`Benzalkonium chloride
`Benzalkonium chloride, EDTA
`_Benzalkonium chloride
`None
`Benzalkonium:-chloride, EDTA
`None
`Polyquad
`oS
`None
`Benzalkonium chloride, EDTA
`Methyl+,prpropylparabens
`EDTA
`EDTA; Sorbic acidee
`
`EDTA
`Benzalkonium chloride, EDTA
`Chiorobutanol
`Chlorobutanal
`Benzalkonium chloride, EDTA
`EDTA
`Benzalkonium chloride, EDTA
`Benzalkonium chloride; EDTA
`None
`Chlorobulanol
`
`FAMY CARE- EXHIBIT 1013-0004
`
`FAMY CARE - EXHIBIT 1013-0004
`
`

`

`7-PDR FOR OPHTHALMOLOGY
`
`TABLE 21
`
`OPHTHALMIC LUBRICANTS
`TRANENAME..
`TRADE NAME
`AKWA TearsOinOintment
`Dry!Eyes
`Duolube
`Duratears Naturale
`
`a
`
`:
`
`:
`jisted in Table 23
`general ophthalmic
`oducts. There ar
`fons available. for
`
`HypoTears
`lanolin alcohol, and chlorabutanol
`5%mineral oil, 55% white petralatum,
`Pp. Lubritears
`Lacri-LubeS.
`Puralube
`
`petrolatum, liquid-lanolin,-and-mineral-oil
`41.5% mineral oll, 55% white petrolatum, petrolatum, and lanolin alcohol
`
`Refresh P.M., Dry Eyas Lubricant
`
`7. OCULAR DECONGESTANTS
`
`Thesetopically 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
`
`TRADE NAME
`AK-Con*
`Albalon*
`Clear Eyes
`Naphcon
`Vasoclear
`Vasocon Reguiar*
`Visine LR.
`Ocuclear
`AK-Nefrin
`Eye Cool
`Prefrin Liquifilm
`Relief
`
`Collyrium Fresh
`Murine Plus
`Visine
`
`“ADDITIONAL COMPONENTS
`Benzalkonium chi
`oridé, edetate disodium
`Benzalkonium ch
`oride, edetate disodium
`Benzalkonium ch
`oridé, édetate disodium
`Benzalkonium-chl
`oride,-edetate disodium
`Benzalkonium ch
`oride, edetate disodium
`Phenylmercuric acetate
`Benzalkonium ch
`oride, edetate disodium
`Benzalkonium ch
`oride, edetate disodium
`Benzalkonium ch
`oride, edetate disodium
`Thimerosal, edetate disodium
`Benzalkonium ch
`
`Benzalkonium ch
`Benzalkonium ch
`Benzalkonium ch
`
`oride, edetate disodium
`oride, edetate disodium
`oride, edetate disodium
`
`GENERIC NAME
`OA Therapeuticprepeprepa
`__
`Sodium chloride
`
`8. Diagnostic prepa’
`
`Glycerin
`
`‘Benzalkonium ch orids,; edetate disodium
`
`DECONGESTANT/ASTRINGENT COMBINATIONSeeeeatinSISSS
`
`Naphazoline hydrochloride
`plus zine sulfate
`Phenylephrine hydrochtoride
`plus: zinc: sulfate
`
`*Prescription: medication:
`
`Clear Eyes ACR
`_fallergy/eald relief)
`
`Zinetrin
`
`Visine Allergy Relief
`
`Benzalkonium ch
`
`oride: edetate disodium
`
`oride
`
`oride, edetate disodium
`
`FAMY CARE- EXHIBIT 1013-0005
`
`FAMY CARE - EXHIBIT 1013-0005
`
`

`

`ALMC RRGATNG SOLUTONS
`
`PHARMACEUTICALS
`
`15
`
`in Tabe 23 are sterile isotonic solutions
`for
`ophthalmic use They are all over1he counter
`irrigating solu
`ucts There
`are also intraocular
`available for use during surgical procedures
`
`prescription medications such
`as
`include
`They
`Lombs Balanced Salt Solution Alcons
`Bausch
`BSS and BSS Plus and blabs
`ocare Balanced
`Salt Solution
`
`23
`
`JHALMC RRGATNG SOLUTONS
`
`COMPONENTS
`
`Sodium potassium calcium and
`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
`
`ADDTWNAL
`
`COMPONENTS
`
`Benzalkonium chloride
`
`Benzalkonium chloride
`
`Benzalkonium chloride
`
`edetate disodium
`
`Benzalkonium chloride
`
`Benzalkonium chloride
`
`edetate disodium
`
`Benzalhonium chloride
`
`ium Fresh Eyes
`
`ose
`
`tik Eye Wash
`
`HYPEROSMOLAR AGENTS
`
`erosmobar hypertonic agents are used to reduce corneal edema therapeutically or for diagnostic purposes
`corneal epithelium
`through the semipermeable
`through osmotic attraction of water
`
`act
`
`LE 24
`
`PEROSMOLAR AGENTS
`
`RC NAME
`
`erapeutic preparations
`
`chloride
`
`TRADE NAME
`
`Adsorbonac Ophthalmic
`AKNaCl
`
`Muro-128
`
`Diagnostic preparation
`
`Glycerin
`
`Ophthalgan
`
`CONCENTRA11ON
`
`2% or 5% solution
`5% solution and ointment
`2% or 5% solution
`5% ointment
`
`bcohol and chlorobutanob
`
`and lanolin alcohol
`
`Three types are avai
`U5L
`ith phenylephrine
`
`MPONENTS
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`icetate
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`ate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride edetate disodium
`
`bride
`
`bride edetate disodium
`
`FAMY CARE - EXHIBIT 1013-0006
`
`

`

`16
`PDR FOR OPHTHALMOLOGY
`10 DAGNOSTC AGENTS
`
`Some of the more common diagnostic
`tests used in ophthalmologic
`practice
`below
`
`agents and
`are hsted
`
`Examination of the Conjunctiva Cornea
`and Lacrima Apparatus
`2% alkaline solu
`Fluorescein applied primarily as
`tion and with impregnated
`paper strips is used to
`examine
`the
`the
`and
`conjunctival
`integrity of
`corneal epithelia Defects in the corneal epithelium
`wifi appear bright green in ordinary light and bright
`is used in the light
`yellow when
`cobalt blue filter
`path Similar
`lesions of
`the conjunctiva
`appear
`bright orange-yellow in ordinary illumination
`
`Fluorescein has also come into wide use in the fit
`lenses though it cannot
`be
`rigid contact
`ting of
`used for soft
`lenses which absorb the dye Proper
`is determined by examining the pattern of fluo
`lens
`rescein beneath the contact
`
`fit
`
`In addition fluorescein is used in performing appla
`nation tonometry and one test of
`lacrimal appara
`drop of 1% fluo
`tus patency Jones test uses
`sac If the dye
`rescein instilled into the conjunctival
`in the nose drainage is normal.1
`
`appears
`
`1% solution is particularly use
`Rose bengal as
`for demonstrating abnormal
`conjunctival
`or
`ful
`corneal epithelium Devitalized
`cells stain
`bright
`red while normal cells show no change The abnor
`mal epithelial cells present
`in dry eye disorders are
`revealed by this stain
`
`effectively
`
`is
`
`valuable method of assess
`The Schirmertest
`ing tear production It employs prepared strips of
`by 30 mm in size The strips are
`filter paper
`inserted into the topically anesthetized conjunctival
`of the middle and outer
`sac at the junction
`third of
`lid with approximately 25 mm of paper
`the lower
`exposed After 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
`Schirmer II test
`can be performed by repeating the procedure while
`number of varia
`stimulating the nasal mucosa.2
`tions of
`the Schirmer test can
`be found in text
`books and journals
`
`Examination of Acquired Ptosis or
`Extraocular Musde Pasy
`gravis as the cause of pto
`To confirm myasthenia
`sis or muscle oalsv an intravenous
`inlection of
`mg of edrophonium chloride is administered fol
`mg if
`lowed 45 seconds
`later by an additional
`there is no response to the first dose In case of
`severe reaction to the edrophonium immediate
`ly give atropine sulfate 0.6 rng intravenously
`
`Examination of the Retina and Choroid
`Sodium tluorescein 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 sciera and con
`junctiva are studied is also
`useful clinical
`tool
`
`is normally prevented from
`Intravascular
`fluorescein
`vascular
`entering the retina by the intact
`retinal
`endotheliurn 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
`to excite the fluores
`appropriate filters are needed
`The peak
`cein and exclude unwanted wavelengths
`frequencies for excitation lie between 485 and 500 nm
`and for emission between 520 and 530 nm
`
`safe diagnostic agent
`Fluorescein has proved to be
`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
`temporarily stain their skin and urine in the aver
`this lasts no more than
`day
`age patient
`
`will
`
`Indocyanine green IC-Green has been used in recent
`years either alone or with fluorescein to obtain bet
`ter frames of choroid neovascularization
`
`conjunctival
`
`Examination of Abnorma Pupiflary Responses
`2.5% solution instilled into the
`as
`Methacholine
`cause the tonic pupil Adies
`sac will
`but will
`leave
`normal
`to contract
`pupil
`pupil
`unchanged
`similar pupillary response is seen fol
`lowing instillation of 2.5% methacholine
`in patients
`with familial dysautonomia Riley-Day syndrome
`Tabe 25 shows the effects of several drugs on mb
`sis due to interruption
`the sympathetic
`system
`of
`Homers syndrome The effect depends on the location
`of the lesion in the sympathetic chain
`
`TABLE 25
`
`HORNERS SYNDROME
`
`NEURON
`
`IN
`
`POST-
`GANGUONIC
`
`II
`
`NEURON
`PR
`GANGUONIC
`
`NEURON
`
`TOPICAL DROP
`CENTRAL
`Cocaine 2%10%
`
`Epinephrine
`Adrenalin 11 000
`
`Phenylephrine
`
`1%
`
`rpine may be use
`is due to
`hated pupil
`iption of the pupils
`atropine-like drug
`act to pilocarpine
`the parasympatheti
`neurysm Adies tor
`pine will cause the
`
`If
`
`VSCOE
`
`iscoelastic
`
`substam
`urgery to maintain th
`sect
`tissues act
`Ic and prevent mect
`endc
`the corneal
`
`ially
`eristics of the various
`esult of the chain Ien
`cular
`interactions of
`scoelastic substance
`to produc
`they an
`pressure if
`1he anterior chamber
`
`potential
`
`1VISC Chiron Vision
`sodium hyaluronate
`osity is 40000
`end molecular weigh
`life is estimatec
`3helf
`
`MVISC PLUS Chiror
`omposed of sodium
`The viscosity
`rate and mo
`hear
`1500000 daltons
`by increasing total
`aluronate of lower
`timated at
`
`year
`
`UOVISC Alcon
`yringes One syringe
`ining Viscoat PIe
`low for details of Ci
`
`HEALON Pharmacia
`ialuronate 1% in ph
`00000
`0/sec
`is approximatE
`
`OFFLAJ
`
`Acetylcysteine
`is used to
`This agent
`Ikali burns cornea
`icca It
`is thought tc
`tion of collagen ase
`aling The drug is
`name Mucom
`none of the
`oved for use
`ninistered as frec
`times
`up to
`
`FAMY CARE - EXHIBIT 1013-0007
`
`

`

`fixed
`
`pilocarpino may be used to determine whether
`is due to an atropine-like drug or inter
`dilated pupil
`rnnervation If
`ruptiOn of the pupils parasympathetic
`an atropine-like drug is involved the pupil will not
`If dilation is due to interruption
`react to pilocarpine
`innervation compression by
`of the parasympathetic
`aneurysm Adies tonic pupil
`instillation
`of pilo
`carpine will cause the pupil to constrict
`
`PHARMACEUTICALS
`
`17
`
`REFERENCES
`
`Thompson HS Mensher JH Adrenergk mydnsis in
`Homers syndrome hydroxyarnpheta mine test for diagno
`OphthamO 197172472
`defects.Am
`of postgariglionio
`Hecht SD Evaluation ofthe lacrimal drainage system
`
`ThompsonHsNewsomeDALowenfeld
`pupil Sudden iridoplegia or mydriatic drops
`
`diagnostic test Arch Ophthaimol 1971
`
`simple
`
`The fixed dilated
`
`11 VISCOELASTIC MATERIALS USED IN OPHTHALMALOGY
`
`Viscoelastic
`
`are used in ophthalmic
`substances
`surgery to maintain the anterior chamber hydraulically
`vitreous substitute/tampon-
`tissues act as
`dissect
`damage
`ade and prevent mechanical
`to tissue espe-
`endothelium The individual charac-
`cially the corneal
`teristics of the various viscoelastic materials are the
`result of the chain length and intra and interchain mol
`interactions of the compounds comprising the
`ecular
`viscoelastic substance All viscoelastic materials have
`large postoperative increase
`the potential to produce
`they are not adequately removed from
`in pressure if
`the anterior chamber following surgery
`
`AMVISC Chiron Vision Bausch and Lomb
`Composed
`of sodium hyaluronate 1.2% in physiologic saline The
`viscosity is 40000 cSt @25
`shear rate
`1/sec
`2000000 daltons Its
`and molecular weight
`is estimated at
`years
`shelf life
`
`is
`
`and Lomb
`AMVISC PLUS Chiron Vision
`Bausch
`composed of sodium hyaluronate 1.6% in physiologic
`saline The viscosity is 55000 cSt @25
`1/sec
`shear rate and molecular weight
`is approximately
`1500000 daltons The greater viscosity is obtained
`and using sodium
`by increasing total concentration
`hyaluronate of lower molecular weight
`Its shelf
`life
`is
`estimated at
`year
`
`DUOVISC Alcon
`two
`contains
`separate
`Package
`syringes One syringe containing Provisc the othercon
`taming Viscoat Please see individual descriptions
`below for details of each
`
`Composed of sodium
`HEALON Pharmacia
`Upjohn
`hyaluronate 1% in physiologic saline The viscosity is
`rate and the molecular
`200000
`shear
`0/sec
`is approximately 4000000 daltons
`weight
`
`Composed of
`UpJohn
`HEALON GV Pharmacia
`sodium hyaluronate 1.4% in physiologic saline The vis
`0/sec shear rate and the mol
`cosity is 2000000
`IS approximately 5000000 daltons In
`ecular weight
`the presence
`high positive vitreous pressure
`of
`Healon GV has three times more resistance to pres
`sure than does Healon
`
`Bausch and Lomb Composed of
`OCCUCOAT Storz
`hydroxypropylmethylcellulose 2% in balance salt solu
`ton BSS The viscosity is 4000 cSt
`mew
`37
`sured on Cannon-Fenske Viscometer and the molec
`ular weight is approximately 80000 daltons Occucoat
`is termed
`viscoadherent
`rather than
`viscoelastic
`its coating ability which
`because of
`is related to its
`contact angle and low surface tension
`
`Composed of sodium hyaluronate
`PROVISC Alcon
`1% in physiologic saline The viscosity is 39000 cps
`25
`2/sec shear rate and the molecular weight
`is approximately 1900000 daltons Clinical studies
`similar fashion
`demonstrate that ProViso functions in
`to Healon
`
`Composed of 13 mixture of chon
`VISCOAT Alcon
`droitin sulfate 4% CS and sodium hyaluronate 3%
`SH in physiologic saline The viscosity is 40000 cps
`25
`2/sec shear rate and the molecular weight
`is 22500 daltons for CS and 500000 daltons for SH
`
`Composed of sodium hyaluronate
`VITRAX Allergan
`salt solution BSS The viscosity is
`3% in balanced
`30000 cps
`2/sec shear rate and the molecular
`is 500000 daltons It
`is highly concentrated to
`weight
`significantly viscous material
`It does not
`produce
`life of 18 months
`require refrigeration and has
`shelf
`
`12 OFF-LABEL DRUG APPLICATIONS IN OPHTHALMOLOGY
`
`been used pri
`p01
`posterior
`rescein angiog
`sclera and con
`ical tool
`
`prevented from
`etinal vascula
`
`the intact
`
`ret
`
`ither
`
`the retina
`
`II allow leakag
`udied by eithe
`Dr good results
`cite the fluore
`gths The
`pea
`85 and 500
`530 nm
`
`iagnostic agent
`ng nausea an
`and vagal
`rea
`ency equipmen
`iography is pe
`ied that the dy
`rine in the ave
`day
`
`used in rece
`to obtain be
`
`tion
`
`ry Responses
`nstilled into th
`-lic pupil Adie
`normal
`pup
`nse is seen fol
`oline in patien
`syndrome
`
`al drugs on mi
`pathetic
`syste
`1s on the Iocatio
`in
`
`NIC NEURON
`
`Acetylcysteine
`is used to treat corneal conditions such as
`This agent
`aikali burns corneal melts and keratoconjunctivitis
`to improve healing by inhibiting the
`Sicca It
`is thought
`action of collagenase which may contribute to delay in
`healing The drug is available generically or under the
`in 10% and 20% solutions
`trade name Mucomyst
`Though none of the commercially available solutions
`for use in ophthalmology they have been
`are approved
`administered as frequently as hourly in acute cases
`and up to
`day in maintenance therapy
`times
`
`is
`
`patients
`
`initial
`
`Alteplase tissue plasminogen activator
`trade-named Activase
`thromboltic
`agent
`This
`used to treat
`fibrin formation in postvitrectomy
`studies were based
`Though
`on
`injections of 25 pg more recent work has
`intraocular
`shown the drug to be effective in doses of as little
`as
`Jg Because by products of alteplase activity
`to
`may mediate endothelial cell toxicity the lower doses
`are preferred This agent has also been used frr sub-
`macular hemhorrage but this use is controversial
`
`FAMY CARE - EXHIBIT 1013-0008
`
`

`

`18 / PDR FOR OPHTHALMOLOGY
`
`F. Edetate disodium
`This chelating agent plays a role in the treatmentof band
`keratopathy. After removal of the cornéal epithelium, itis
`used to remove calcium from Bowman's. membrane.
`
`Administration, wit
`
`C. Antimetabolites
`oFluorouractl: (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 dally.
`for
`7 days postoperatively and once daily for the sue-
`ceeding 7 days. However, many physicians today are
`achieving positive results with as little as 4 mg
`administered 4 to.6-times during a 40-day. period.
`Useof this drug is associated with a number of com-
`plications, including conjunctival wound leak, corneal
`epithelial defects, hypotony associated with permia-
`nently reduced vision acuity, serious cornéal
`infec.
`tions in” éyes with preexistent corneal epithelial
`edema, and increased susceptibility.
`to.
`late-onset
`bleb infections. The drug should be considered only
`when there is @ 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
`major side 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 immuncsuppressant 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 blood levels of up to 64 ng/mL have been
`observed after topical application. All patients receiv-
`ing thif medication should have blood work that
`includes cyclosporine levels, blood urea nitrogen, cre-
`atinine, lactate dehyrogenase, alkaline phosphatase,
`and total bilirubin.
`E. Doxycycline
`This derivative of tetracycline is used for the treatment of
`ocular rosaceaand tmelbomianitis: The Usual dose is 100
`mg PO daily for a 6 to 12 weekcourseof treatment. It has
`the same side effects, contraindications, and interactions
`as tetracycline.
`
`“the table..on.the fc
`he more recently
`effects of drugs in:
`effects of drugs cor
`itis not a catalog of
`would be too length
`The volume of ocul:
`ture is overwhelmi
`soft data, since,
`it
`patients on a parti
`an adequate sampl
`tal environment,it
`and-effect relations
`multitude of variak
`impossible. It was
`National Registry 0
`was founded.
`Established by
`
`REFERENCESee
`
`Nesburn-A: Trauma topics: smalt:corneal perforations. Audio: Digest:
`Ophthalmol: 1983;12:34;
`Ralph R. Chemical burns of the eye.
`In: Tasman W, JaégerE, éds,
`Duane’s Clinical Ophthaliology. Philadelphia, Pa: JB Lippincott:
`1989 vol. 4, chap 28:44.
`Jaffe: G, Abrams G, etal: Tissue plasminogen activator for post
`vitrectomy: fibrin formation: Opthalmology. 1990:97:189.
`MeDermott:M;:Edelhauser:H,ét al: Tissue plasminogen activator
`and corneal endothelium: Am J Ophthalmol. 1989:1.08:
`Williams D, Benett'S, et al- Low-dose intraocular tissue plasminogen
`activator for treatment of postvitrectomyfirbrin formations.
`Am J-Opthaimol: 4990:109-606:
`Williams G, Lambrow F, at al. Treatment of postvitrectomy: fibrin
`formation with intraocular tissue plasminogen‘activator:
`Arch Ophthalmol, 1988:106:1056.
`Ando H, Tadayoshi|, et al. Inhibition of corneal: epithelial
`wound healing. A comparative study of mitomycin Cand
`5-fluorouracil, Ophthalmology. 1992°99:1809,
`Falck F, Skuta G, Klein T. Mitomycin versus 5-fluorouracil
`antimetabolite therapy for glaucoma filtration surgery.
`Semin in: Ophthalmol, 1992:7:97:
`Who-should: receive antimetabolites after filtering surgery?
`Arch: Ophthalmol, 1992;110:4069. Editorial:
`Welsh 'R, Palmer S: Mitomycin in trabeculectoniy: alter you