`
`FEE
`27EDITION
`
`
`
`
`
`fl
`
`3.y-
`
`ige of all the essential
`acts.
`
`rmation gives you the I
`ial data you need.
`
`)ur widespread net-
`
`ther, organize and
`
`1 a timely manner.
`
`Ire it is published.
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`xed for quick,
`
`ly for fast reference.
`
`Place
`Stamp
`Here
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`1999
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`
`
`PHVSICIANS'
`DESK
`PFEEENCE
`
`
`
`
`
`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
`
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`
`TEVA - EXHIBIT 1013
`
`TEVA - EXHIBIT 1013
`
`
`
`
`
`
`
`Section 1: Indices
`
`
`Page I
`
`1. Manufacturers’ Index ............................................................................................................ l
`2. Product Name Index ............................................................................................................ III
`
`3. Product Category Index ........................................................................................................ VI
`
`4. Active Ingredients Index ....................................................................................................... IX
`
`Section 2: Pharmaceuticals in Ophthalmology
`Page 1
`
`
`1. Mydriatics and Cycloplegics ............................................ . ..................................................... 2
`2. Antimicrobial Therapy ........................................................................................................... 2
`
`3. Ocular Anti-inflammatory Agents ............................................................................................ 7
`4. Anesthetic Agents ................................................................................................................ 9
`5. Agents for Treatment of Glaucoma ...................................................................................... 10
`6. Medications for Dry Eye ...................................................................................................... 13
`
`7. Ocular Decongestants ........................................................................................................ 14
`8. Ophthalmic Irrigating Solutions ............................................................................................ 15
`9. Hyperosmolar Agents ................................................................................. '. ....................... 15
`10. Diagnostic Agents ............................................................................................................ 16
`
`11. Viscoelastic Materials Used in Ophthalmology .................................................................... 17
`12. Off-Label Drug Applications in Ophthalmology .................................................................... 17
`
`13. Ocular Toxicology .............................................................................................................. 19
`
`Section 3: Suture Materials
`
`
`Page 23
`
`Section 4: Ophthalmic Lenses
`
`Page 25
`
`1. Soft Contact Lenses ........................................................................................................... 25
`
`2. Aphakic Lenses .................................................................................................................. 50
`
`3. Comparison and Conversion Tables ..................................................................................... 52
`
`
`Section 5: Vision Standards and Low Vision
`
`
`Page 56
`
`1. Vision Standards ................................................................................................................ 56
`2. Low'Vision Aids .................................................................................................................. 58
`
`
`Section 6: Evaluation of Permanent Visual Impairment
`
`
`59
`
`1- Criteria and Methods ......................................................................................................... 59
`2- Visual System Impairment Values ....................................................................................... 68
`3- COmbined ValuesChart .........'.'..' .............................. 71
`
`PIE
`'ing family of
`00-232-7379 or f,-
`
`'netics (FD&C) Act,
`a labeled, promote
`)r only those uses f}?
`ess have been esta'
`ations 201.100(d)(:
`In products require
`)esk Reference A
`;, dosages,
`route
`on of administratir;
`s, contraindicatiorir
`it be in the "san
`‘oved labeling for ti
`same language a
`se of the approva
`Furthermore,
`infi
`s emphasized by ti
`;, boldface, or italii
`in Physicians' Del
`
`FD&C Act does nc
`)hysician may user
`5 been approved 'l'
`)e it for uses or.
`
`Iations that are n'
`A also observes the
`des drug use that
`g. For products tit:
`s, the publisher hz
`bing such produc,
`have access tor
`Id informed decisic
`ar—the-counter dieta’
`ed that this inform
`he Food and DIt
`; are not intendedl
`fisease.
`
`Jmpilation, organir
`tion. Each produ.
`a manufacturer, a‘
`Jfacturer's media
`medical consultan
`
`in Physiciarf
`terial
`e publisher does It
`ducts describedq
`connection with a;
`herein. Physician
`es not assume. 8F
`I obtain and includ
`)vided to it by It
`i that by making iii
`advocating the 1:9.
`or
`is the publisili
`Iue to typographici"
`Iy product may l3,
`
`"T'TT‘lF'
`‘gw
`
`
`
`
`
`
`
`
`
`
`
`
`
`2. Full-Color Product Photographs .......................................................................................... 103
`
`
`sfigllgm
`INDICE
`
`Section 8: Pharmaceutical and Equipment Product Information
`
`
`Page 201
`
`
`
`Listed alphabetically by manufacturer
`‘—
`
`
`Section 9: lntraocular Product Information
`
`Page 315
`
`Key to Controlled Substances Categories
`
`
`Page 319
`
`Page 320
`Key to FDA Use—in—Pregnancy Ratings
`
`
`Amsler’s Grid
`
`Inside Front Cover
`
`
`
`
`ashram—""
`
`This section offers f
`mation you need:
`
`1. Manufacturers’
`participating manui
`two page numbers
`graphs in‘the Proc
`0nd to product
`i
`addresses and teIe
`headquarters and re
`
`2. Product Namel
`uct information alp
`mond symbol to the
`tograph
`of
`the
`Identification Guid:
`page number refer:
`
`PART I/MANUF.
`
`AKORN, INC. ......
`2500 Millbrook Driv
`Buffalo Grove, IL 6(
`Direct Inquiries to:
`Customer Service
`(800) 5357155
`
`ALGON LABORATOII
`and its 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 Managemi
`Systems)
`
`ALLERGAN .......
`2525 Dupont Drive
`PO. Box 19534
`Irvine, CA 92623-9
`For Medical lnfom
`Outside CA: (800)
`CA: (714) 24645C
`Sales and Ordering
`Outside CA: (800)
`CA: (714) 246-45C
`
`BAUSCH & LOMB .
`PHARMACEUTII
`8500 Hidden River
`Tampa, FL 33637
`
`
`
`
`
`PHARMACEUTICALS / 13
`
`6. MEDICATIONS FOR DRY EYE
`
`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.
`
`TABLE 20
`
`
`
`MAJOR COMPUNENT(S)
`
`Carboxymethyl cellulose
`
`CONCENTRATION (“/o)
`
`TRADE NAME
`
`ARTIFICIAL TEAR PREPARATIONS
`
`PRESERVATIVE/EDTN
`None
`Refresh Plus
`0.5%
`None
`Celluvisc
`1%
`None
`Theratears
`0.25%
`Dry Eye Therapy
`None
`TearGard
`
`“
`
`3%
`
`Glycerin
`Hydroxyethyl cellulose,
`
`polyvinyl alcohol
`Hydroxypropyl cellulose
`
`SET/DURATION
`ACTION
`
`nin/5—6 h
`
`60 min/6 h
`45 min/5—6 h
`
`D—NSTET URATION
`0F Ac l0N
`2 h/4—6 h
`
`5—10 min/2 h
`
`3—0 min/6 h
`
`2 h/4—6 h
`
`SIZE(S)(mL)
`5
`single use bottle
`5,10,15
`
`Chlorobutanol
`
`,None
`Lacrisert Ibiode-
`
`gradable insert)
`Benzalkonium chloride
`lsopto Plain
`Benzalkonium chloride
`lsopto Tears
`Tearisol
`Benzalkonium chloride, EDTA
`
`Benzalkonium chloride
`lsopto Alkaline
`Bion Tears
`Wone
`Ocucoat
`Benzalkonium chloride, EDTA
`None
`Ocucoat PF
`Tears Naturale ll
`Polyquad
`Tears Naturale Free
`7
`7
`None
`Benzalkonium chloride, EDTA
`Tears Renewed
`Murocel
`MethyI-, propylparabens
`Methylcellulose
`1%
`EDTA
`Polycarhophil, PEG-400, dextrah 70 “— AduaSite
`EDTA, Sorbic acid
`AquaSite multi-dose
`Viva Drops
`AKWA Tears
`1.4%
`Dry Eyes
`Liquifilm Tears
`HypoTears
`Benzalkonium chloride, EDTA—
`EDTA
`HypoTears PF
`Benzalkonium chloride, EDTA
`Puralube Tears,
`Murine Tears
`Refresh
`Tears Plus
`
`Sorbic acid, EDTA
`
`
`HydroIrypropyl methylcellulose
`
`Hydroxypropyl methylcellulose,_
`dextran 70
`
`Polysorbaie 80
`Polyvinyl alcohol
`
`3%
`
`Polyvinyl alcohol,
`PEG-400, dextrose
`
`
`1%
`
`Benzalkonium chloride, EDTA
`Chlorobutanol
`Chlorobutanol
`
`SlZE(S)(mL)
`_2.5
`
`_
`
`1.4%“ ‘ "
`Polyvinyl alcohol,
`0.6%
`povidone
`
`
`*EDTA = ethylenediaminetetraacetic acid.
`
`Benzalkonium chloride-EDTA
`None
`
`
`
` / 3
`
`14- / PDR FOR OPHTHALMOLOGY
`
`TABLE 21
`
`
`
`"
`OPHTHALMIC LUBRICANTS
`
`
`T—RADE NAME
`__ __ _ _coMPosmorI 0F STERILE OlNTMENT
`
`White petrolatum, liquid lanolin, and mineral _oi_|
`AKWA Tears Ointment
`
`White petrolatum, iiqu_idlanolin, and mineral oil
`_
`_
`Dry Eyes
`'7
`
`_
`7
`7 White petrolatum and mineral oil
`—‘
`buolube
`buratears Naturale
`White petrolatum, liquid lanolin, and mineral oil
`_
`
`White petrolatum and light mineral oil
`“—
`l-lypoTears_
`
`V
`42.5% mineral oil, 55%divhite_petr_olatum,
`Lac-ri-Lube S.OP Lubritears
`lanolin alcohol and chlorobutanol
`White petrolatum, liquid lanolin, and mineral oil —__
`
`Puralube
`
`
`Refresh PM, Dry Eyes Lubricant
`41.5% mineral oil, 55% white petrolatum, petrolatum, and lanolin alcohol
`
`_
`
`_
`
`
`
`7. OGULAR 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).
`
`. OPHTHA
`
`Listed in Table 23
`geeneral ophthalmic
`products. There ar
`tions available for
`//
`
`TABLE 23/
`
`oPHTHALMIc II
`//___
`
`TRADE NAME
`AK—Rinse
`
`”If!
`/_—_—
`Collyrium Fresh Eyes
`Dacriose
`fl
`
`Eye—Stream
`
`_‘___’_p_
`
`lrigate
`
`
`Lavoptik Eye Wash
`
`
`9. HYPER
`
`Hyperosmolar (hy
`They act through
`
`TABLE 24
`
`HYPEROSMOI
`
`GENERIC NAME
`
`A. Therapeutic prepa
`Sodium chloride
`
`B. Diagnostic prepa‘
`Glycerin
`
`
`
`TABLE 22
`
`OCULAR DEGONGESTANTS
`
`DRUG
`
`'
`
`Naphazoline hydrochloride
`
`TRADE NAME
`
`_
`
`,
`Tetrahydrozoline hydrochloride
`
`_A[TD_lT|0NAL COMPONENTS
`—
`Benzalkonium chloride, edetate disodium
`AK-Con*
`Albalon*
`Benzalkonium chloride, edetate disodium
`Benzalkonium chloride, edetate disodium
`Clear Eyes
`Benzalkonium chloride, edetate disodium
`Naphcon
`Vasoclear
`Benzalkonium chloride, edetate disodium
`Phenylmercuric acetate
`_
`Vasocon Regular*
`Oxymetazoline hydrochloride
`Visine L.R.
`Benzalkonium chloride, edetate disodium
`
`Benzalkonium chloride, edetate disodium
`_
`Vchclear
`Benzalkonium chloride, edetate disodium
`Phenylephrine hydrochloride
`AK-Nefrin
`Thimerosal, edetate disodium
`Eye Cool
`Benzalkonium chloride, edetate disodium
`Prefrin Liquifilm
`
`—
`Relief
`Benzalkonium chloride, edetate disodium
`Collyrium Fresh
`Murine Plus
`Benzalkonium chloride, edetate disodium
`Visine
`Benzalkonium chloride, edetate disodium
`
`
`
`
`_ _
`
`DECONGESTANT/ASTRINGE_NTCOMBINATIONS
`Naphazoline hydrochloride
`
`plus zinc sulfate
`Phenylephrlne hydrochloride
`plus zinc sulfate
`
`TetrahydIozo—line plus zinc sulfate
`*Prescription medication.
`
`Clear Eyes ACR
`(allergy/cold relief)
`
`Zincfrin
`
`
`
`
`VEIne Allergy Relief
`
`Benzalkonium chloride, edetate disodium
`
`Benzalkonium chloride
`
`Benzalkonium chloride, edetate disodium
`
`
`
`
`
`
`
`PHARMACEUTICALS / 15
`
`3,-OPHTHALMIC IRRIGATING SOLUTIONS
`
`Listed in Table 23 are sterile isotonic solutions for
`eneral ophthalmic use. They are all over-the- counter
`roducts- There are also intraocular irrigating solu-
`tionS available for use during surgical procedures.
`
`They include prescription medications such as
`Bausch & Lomb’s Balanced Salt Solution, Alcon's
`888 and 858 Plus, and lolab's locare Balanced
`
`Salt Solution.
`
`TABLE 28/
`
`
`OPHTHALMIC IRRIGATING SOLUTIONS
`
`_
`{FREE—I
`__ — '
`COMPONENTS _
`. — — '
`_
`.I’I" —
`,
`AK-Rinse
`Sodium, potassrum, calcrum, and
`magnesium chlorides,
`sodium acetate, and sodium citrate
`_
`_
`
`Wh Eyes
`Antipyrine, boric acid, and borax
`Benzalkonium chloride
`Dacriose
`Sodium and potassium
`Benzalkonium chloride,
`
`
`chlorides, and sodium phosphate
`edetate disodium
`
`_ _
`
`
`ADDITIONAL COMPONENTS
`.
`,
`_____
`Benzalkonium chloride
`
`'
`
`
`
`Eye-Stream
`
`Benzalkonium chloride
`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
`
`Benzalkonium chloride,
`
`edetate disodium _ _ _
`Benzalkonium chloride
`
`Irigate
`
`f L
`
`avoptik EerVash
`
`
`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
`
`
`TIT—ADE NAME
`
`__
`
`
`CONCENTRATION (_%)
`
`2% or 5% (solution)
`Adsorbonac Ophthalmic
`5% (solution and ointment)
`AK-NaCl
`2% or 5% (solution),
`Mum-128
`5% (ointment)
`
`GENERIC NAME
`A. Therapeutic preparations
`Sodium chloride
`
`B. Diagnostic preparation
`Glycerin
`
`Ophthalgan
`
`
`
`lICOhOI, and chlorobutanol
`
`m, and lanolin alcohol
`
`a. Three types are avail-
`Iith phenylephrine. Usual
`
`
`IfiNENTs
`
`ilorid-e, edetate disodium
`iloride. edetate disodium
`iloride, edetate disodium
`iloride, edetate disodium
`Iloride, edetate disodium
`
`Acetate
`
`Iloride, edetate disodium
`
`Iloride, edetate disodium
`
`iloride, edetate disodium
`ate disodium
`iloride, edetate disodium
`
`
`iloride. edetate disodium—
`iloride, edetate disodium
`Iloride, edetate disodium
`
`Eride, edetate disodium
`
`iloride
`
`Iloride, edetate—disod—ium
`
`
`
`
`
`
`
`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 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 Iacrimal 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 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 U 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.
`
`lntravascular 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 (IO—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
`(Homer’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%
`Epinephrine
`(Adrenalin) 1:1000
`
`Phenylephrine 1%
`
`NEURON m
`(POST-
`GANGLIONIC)
`—
`
`NEUBON ll_
`(PRE-
`GANGLIONIC)
`—
`
`_— _ _
`
`NEURON l7
`+/—
`7
`
`+++
`+++
`
`+
`+
`
`‘
`+/—
`
`
`
`
`
`__-._..._.._...——___.__.____._.___.__
`
`
`
`
`
`
`
`Pilocarpine may be use
`dilated pupil is due to
`ruption of the pupil’s p
`an atropine-like drug
`if
`react to pilocarpine.
`of the parasympatheti:
`aneurysm, Adie’s tor
`carpine will cause the
`
`11. VISCOEI
`
`Viscoelastic substam
`surgery to maintain the
`dissect tissues, act as
`ade, and prevent mecr
`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 chamberf
`
`AMVlSC (Chiron Vision
`of sodium hyaluronate
`viscosity is 40,000 0
`and molecular weigh
`shelf life is estimated
`
`AMVlSC PLUS (Chiror
`composed of sodium
`saline. The viscosity
`shear rate), and mo
`1,500,000 daltons. T
`by increasing total c
`hyaluronate of lower r
`estimated at 1 year.
`
`DUOVISC (Alcon) — l
`syringes. One syringe
`taining Viscoat. Plea
`below for details of e:
`
`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 Mucomj
`Though none of the
`are approved for use
`administered as frec
`and up to 4 times a
`
`
`
`
`
`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~ganglionic defects.Am J Ophthalmol. 1971;72:472.
`2. Hecht SD. Evaluation of the lacrimal drainage system.
`Ophthalmology. 1978;853:1250.
`3. Thompson HS, Newsome DA, Lowenfeld l E. The fixed dilated
`pupil. Sudden iridoplegia or mydriatic drops; a simple
`diagnostic test. Arch Ophthalmol. 1971;86:12.
`
`
`
`3 been used pri-
`3 posterior pole
`rescein angiog—
`sclera, and con-
`iical tool.
`
`prevented from
`‘etinal vascular
`:J the intact reti—
`ither the retinal
`ll allow leakage
`:udied by either
`3r good results,
`3ite the fluores‘
`gths. The peak
`185 and 500 nm
`530 nm.
`
`iagnostic agent.
`ng nausea and
`3 and vagal reac-
`gency equipment
`giography is per-
`ded that the dye
`rine; in the aver-
`a day.
`
`tn used in recent
`n, to obtain bet-
`tion.
`
`ry Responses
`nstilled into the
`1ic pupil
`(Adie’s
`a normal pupil
`)nse is seen fol
`oline in patients
`ysyndrome).
`
`'al drugs on mic-
`lpathetic system
`ds on the location
`in.
`
`N H
`
`IONIC)
`
`NEURONI
`+/-
`
`+/—
`
`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.
`
`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 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 755,000 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. lts 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 GV (Pharmacia — UpJohn) — Composed of
`sodium hyaluronate 1.4% in physiologic saline. The vis-
`cosity is 2,000,000 (@ O/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.
`
`OCCUCOAT (Storz — Bausch and Lomb) — Composed of
`hydroxypropylmethylcellulose 2% in balance salt solu-
`tion (888). 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 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
`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 shelf life 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 by inhibiting 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,
`trade-named Activase,
`used to treat
`fibrin formation in postvitrectomy
`patients. Though initial studies were based on
`intraocular injections of 25 pg, more recent work has
`shown the drug to be effective in doses of as little 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.
`
`
`
`
`
`
`
`18 / PDR FOR OPHTHALMOLOGY
`
`C. Antimetabolites
`
`
`
`13.00ULA
`
`The table on the fc
`the more recently F
`effects of drugs In 3
`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 partii
`an adequate sampl
`tal environment, it
`andeffect relations
`multitude of variab
`impossible.
`it was
`National Registry 0'
`was founded.
`
`Established by.
`Administration, Wit
`
`L l l l
`
`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.
`in: Tasman W, Jaeger E, eds.
`Ralph R. Chemical burns of the eye.
`Duane's Clinical Ophthalmology. Philadelphia, Pa: )8 Lippincott;
`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 postvitrectomy firbrin formations.
`Am J Optha/mol. 1990;109:606.
`Williams G, Lambrou F, et al. Treatment of postvitrectomy 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 C and
`5fluorouracil. Ophthalmology. 1992;99:1809.
`Falck F, Skuta G, Klein T. Mitomycin versus 5-fluorouracil
`antimetabolite therapy for glaucoma filtration surgery.
`Semin in Ophthalmol. 1992;7z97.
`Who should receive antimetabolites after filtering surgery?
`Arch Ophthalmol. 1992;110:1069. Editorial.
`Welsh R, Palmer 8. 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 8. Effect of apraclonidine on intraocular
`pressure in glaucoma patients receiving maximally tolerated
`medications. Glaucoma. 1992;1:19.
`Holland E, Chan C, et al. lmmunohistologic 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, Leonardi 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. 1988;20,No.2(suppl 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 Ophtha