4Q——
`
`The
`l\/lERCK
`l Manual
`
`.
`
`'
`
`Of Diagnosis and Therapy
`
`
`
`_ Robert 5. Porter, MD, Edimr—in-Chief
`Justin L Kaplan, MD, Senior Axsistaril lidimr
`
`.
`
`.
`i
`
`i
`
`g
`I
`
`‘
`l
`
`Editorial Board
`Richard K. Alhcn. .VlD
`Matthew E. Levison, MD
`Marjorie A. Bowman. MD. MPA
`James Jeffrey Malalack. MD
`Glenn D. Braunstein. MD
`Brian F. Mandcll, MD. PhD .
`Sidney Cohen. MD
`'
`'
`Gerald L.‘ Mandell. MD
`Linda Emanuel, PhD
`Judith S. Palfrey, MD
`‘
`Jan Fawceu. MD
`Albert A. Rundio. Jr., PhD
`Eugene P. Frenkel. MD
`David A. Spain. MD
`Susan L. Hendrix, DO
`Paul II. Tanser. MD
`Michael Jacewicz. MD
`Michael R. \Vaswrman. MD -
`
`‘
`
`‘
`
`-
`
`.
`
`mi‘
`J
`Published by
`- MERCK SHARP 8: DOHME CORP., A SUBSIDIARY OF MERCK 8- CO” INC.
`' Whilehouse Stalion, NI '
`
`- S
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`ENJU EXHIBIT 2067
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`PAGE 1 OF 7
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`LUPIN v SENJU
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`IPR2015—01l05
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`PAGE 2 OF 7
`
`‘
`
`

`
`Contents
`
`TAB‘ V
`
`NO.
`
`noco~:_mi.n.r>o4ro--
`
`5
`
`:0:-—Iium’-
`Ii5;5,3
`N...»OKDCO
`
`N _.
`
`MNLAN
`
`usmg1"xgzc92-*msee.
`
`GD
`
`E3
`
`51‘Q'50Z
`
`U1‘U
`
`.lJ1
`
`l
`
`"
`
`SECTION"
`Guide for Readers »
`Abbreviations
`
`Editors and Editorial Board ,
`Consultants
`Contributors
`
`Nutritional Disorders
`
`Gastrointestinal Disorders
`
`.
`Hepatic and Biliary Disorders
`Musculoskeletal and Connective Tissue "Disorders
`‘Ear, Nose, Throat, and Dental Disorders
`Eye Disorders
`4
`Dermatologic Disorders -
`Endocrine and Metabolic Disorders
`
`.~
`Hematology and Oncology
`‘ Immunology; Allergic‘Disorders l
`Infectious Diseases 0
`A
`A
`
`.
`
`'
`
`V
`
`. Psychiatric Disorders
`Neurologic Disorders
`_PuImonary Disorders
`Cardiovascular Disorders
`' Critical Care Medicine
`
`Genitourinary Disorders
`‘ Gynecology and Obstetrics
`Pediatrics.
`.
`I
`»
`
`I
`
`V
`y
`'
`‘Geriatrics I
`Clinical Pharmacology
`Injuries; Poisoning‘
`-Special Subjects ‘
`.
`Appendixes
`"
`Ready Reference Guides
`Z
`_
`I
`.
`,
`A
`_
`1
`’ Norrnal_Laboratory Values
`Trade Names of Solrneicommonly Used Drugs ‘
`Index
`
`-
`
`PAGE OF
`
`

`
`3562
`
`Index
`
`=
`
`‘
`
`..
`'
`
`.
`
`-
`
`g
`
`-
`
`‘
`
`_
`
`:
`
`'
`
`1
`
`.
`
`_
`
`3
`
`i
`
`'
`
`.
`
`-‘
`
`.
`
`I
`
`v
`
`‘-
`
`‘M 1
`
`.
`
`.51.
`
`Casa1’s necklace 31
`Cascara 87
`in elderly 3101
`Caspofungin 1320. 1323'
`Cast 3203
`1.
`.
`'
`.
`-
`Castleman disease 1394
`Castor bean poisoning 3337. ‘
`'
`'
`Castor oil 87
`-
`Casts, urinary 2309. 2311, 2375 ,
`Cataplexy 1704, 1712 .
`-
`»
`'
`‘
`Cataracts 606-607
`congenital 2920 '
`.
`-
`Catatonia 1541, 1560 --'
`Catecholamines 791 (see also Epinephrine; '
`Norepinephrine)
`1
`-
`-
`-
`in MEN 2A syndrome 912 .
`pheochromocytoma secretion of 801-803,
`912
`=
`"
`—
`-
`.
`'5
`’
`"urinary 802, 3500
`Catechol 0-methyltransferase inhibitors -
`1768,1769
`" 3*‘
`Catheterization , m .
`arterial 2249-2250
`bladder 2316-2317 ..
`'
`"
`-
`in children 2845
`for incontinence 2359. 2362..23'64- .4
`in-dwelling 2362
`.
`.
`infection and 2378'
`A
`.
`oliguria with.2252—2253, 2252
`in trauma 3192
`V
`'
`'
`cardiac 2048-2052, 2050, 2051
`complications of 2051-2052 '
`I
`left-heart 2048
`A
`.» v
`2
`right-heart 2048, 2105, 220 ~
`2
`central venous 2247-2249, 2249 =
`1.
`in cardiopulmonary resuscitation 2259
`for dialysis 2449.»:
`.»
`‘
`.
`..
`%
`infection and 1166 -
`1
`' " pleural effusion and 1998'
`intra-abdominal abscess drainage with .
`119 ~
`-
`intmcranial 2246
`peripheral vein 2247
`peritoneal 2451
`"
`pleural 2001, 2003
`pulmonary artery 1986, 2240-2246, 22115,’
`2246
`v.
`~
`in shocl(2299.12301 .7:
`, . -
`urinary (see Catheterization, _bladder)= :1
`CAT scan (see Computed tomography)‘ '
`-
`Cat-scratch disease 469, I158, 12/14-1245,
`I244=:‘
`> ;.
`~.
`,_
`Cauda equina 1804 ' “ "
`"
`
`"
`
`F
`
`’
`
`*
`
`PAGE 4 OF 7
`
`Cauda equina syndrome 1806, 3228, 3228,
`.-3229’
`--- m
`.
`.
`’
`Cauliflower ear 3231
`Causalgia (complex regional pain syndrome)
`1633-1634
`7.
`Caustic ingestion 3335-3336
`gastritis with 133'
`"
`Cavernous hemangioma 976
`Cavernous lyrnphangioma 748. .
`Cavernous sinus thrombosis 554, 560,-
`624-625
`-.
`~
`CEA (see Carcinoembryonic antigen)
`Cecum
`.
`-
`‘
`ameboma of 1368
`volvulus of 117 =
`Cefaclor 1187
`in otitis media 449 ”
`I
`-
`Cefadroxil 1186
`'
`'
`in endocarditis prophylaxis 2200
`Cefazolin 1186
`-.
`in endocarditis prophylaxis 2200
`in infective endocarditis 2198
`-
`1
`.
`-
`neonatal dosage of 2812 -
`‘t
`as preoperative prophylaxis 33494350
`Cefepime1188,1202 « ‘~
`'
`-
`»'
`in infective endocarditis 2198 -
`in meningitis 1739,1740, 17.41 .
`neonatal dosage of 2813 .-
`Cefoperazone 1187
`-
`Cefotaxime 1187, 1203
`in meningitis 1739, 1740, 1741 ‘
`neonatal dosage of 2813 '.
`I
`'
`Cefotetan I187
`'
`'
`’
`'
`Cefoxitin~1187
`1
`Cefpodoxime 1188. 1203 ""
`Cefprozil I187
`‘
`.
`.
`.
`Ceftazidime 1188, 1203
`,» in’ infective endocarditis 2198‘ 1-
`in meningitis 1740. 1741 “
`»
`<
`neonatal dosage of 2813
`'
`Ceftibuten 1188
`3
`‘
`’
`Ceftizoxime 1188
`1
`-~'
`'-
`Ceftobiprole 1202
`Ceftriaxone 1'1 84, 1188, 120
`.
`in children 2761
`-
`- ~ s
`in infective endocarditis 2197-2198 w
`in Lyme disease 1271, 1271 9-
`'
`'
`in meningitis 1739, 1740, 1741
`1-
`'- neonatal dosage of 2813 N '
`'
`in oritis media 449
`.
`Cefuroxime 1187
`.in Lyme disease 1271
`in otitis media 449 " .
`
`.
`
`‘V
`
`*
`
`-
`
`'
`
`~
`
`.» -_
`-"
`
`'
`
`1
`
`-
`
`I
`
`'
`
`~‘
`
`"
`
`'
`
`.
`
`

`
`606
`
`SECHON 6 ; Eye Disorders
`
`block. It is done as soon as the cornea Is Clear
`and inflammation has subsided. In some cases
`the cornea clears within hours of lowering the
`IOP; in othercascs, it can take 1 to 2 days. Be-
`cause the chance of having an acute attack 111
`the other eye is 80%, LPI IS done on both_eyes.
`The risk of complications with LPI IS ex-
`tnemely low compared with its benefits. Glare.
`which can be bothersome, may occur ifthe iri-
`dotomy is not placed superiorly enough for the
`upper lid to cover it. '
`i
`..
`'
`
`Chronic angle-closure glaucoma: Patients
`with chronic, subacute, or intennittcnt angle-
`closure glaucoma should also have LPI. Ad-
`ditionally, paticnts with a narrow angle, even in
`the absence of symptoms. should undergo
`prompt LP! to prevent angle—closure glaucoma.
`The drug and surgical treatments are the
`same as with open-angle glaucoma. Laser tra-
`beculoplasty is relatively contraindicated ifthe
`angle is so narrow that additional PAS may
`fonn after the laser procedure.
`V
`
`l";cararacr
`
`
`
`(For developmental or congenital cataracts,
`secp.2920.)_
`_ ..
`_
`,'
`V ""_:'
`A catarad is a congenital or degenerative opac-
`ity of the lens. The main symptom is gradual,
`palnless vision blurring. Diagnosis is by oph-
`thalmoscopy and slit-lamp examination. Treat-
`ment is surgical removal and placement of an
`intraocular lens.
`'
`” "
`‘
`
`‘ Lens opacity can develop in several locations:
`-- Central lens nucleus (nuclear cataract)"
`- Beneath the posterior lens capsule (poste-
`- rior subcapsular cataract)
`‘
`
`.
`
`_
`
`K
`Etiology
`Cataracts occur with aging. Other risk tac-
`tors may include the following: «
`" "
`' Trauma _(S9metimes causing cataracts years
`later)
`i
`_
`--
`0 Smoking _
`I
`_,
`.f_Alcohol use
`: - Exposure to x-rays_':
`_.
`_- Heat from infrared exposure
`' S)'stemic‘dise_ase (eg, diabetes)‘ .
`' Uveitis_.
`y,__
`_
`- Systemic drugs (cg, Corticosteroids)
`'
`‘
`7- Undemutrrtion
`.
`‘
`,
`'
`.. -.'
`’
`..°Dark'e)'€s'..
`.\- Possibly chronic ultraviolet "exposure; ,_‘,
`~ Many people have no risk factors other than
`age. Some cataracts are congenital, associated
`with numerous syndromes and diseases,
`Symptoms and Signs I
`Cataracts generally develop slowly over
`years. Early symptoms may be loss ofcontrast,
`glare (halos and starbursts around lights),
`“°°d"18 more light to see well,‘and probléms
`
`A
`
`,
`"j
`
`'
`
`_
`i
`
`distinguishing dark blue from black. Painless
`blurring eventually occurs. The degree of blur-
`ring depends on the location and extent of the
`opacity. Double vision occurs rarely."
`‘
`' With‘ a nuclear cataract (see Plate 4). dis-
`tance vision worsens. Near vision may’im-
`prove _in theiearly stages because of changes
`in the refractive index of the lens; presbyopic
`patientsmay be temporarily able to read with-'
`out glasses (second sight).
`-
`'
`‘
`'
`'
`~
`'
`' A posterior subcapsular cataract dispropor-
`tionately affects vision because the opacity is
`‘located at the crossing point of incoming light
`rays. Such cataracts reduce visual acuity more
`when the pupil constricts (cg, in bright light,
`during reading). They are also the type most
`likely to cause loss of contrast as well as glare,
`especially from bright lights or from car head-
`lights while driving at night. ‘j
`y
`" ‘
`' Rarely;Ihe'cataract swells, occluding the tra-
`becular drainage meshwork and causing sec-
`ondary closed-angle glaucoma and pain.
`
`Diagnosis
`
`-
`
`_
`
`__
`
`I Ophthalmosoopy followed by slit-lamp_ex-
`,““‘“"*""°“-...
`- Diagnosis is bestmade with the pupil di-
`lated. Well-developed cataracts appear as
`878)’. White. or yellow-brown opacitics in the
`lens. Examination of the red reflex through the
`drlated pupil with:the ophthalmoscope held
`about 30 cm away usually discloses subtle
`opacities. Small cataracts stand out as dark de-
`fects’ in the red reflex.'A large cataract may
`obliterate the red ret'lex.,Slit-lamp examina-
`tion provides more details about the character,
`locanon. and extent of the opacity; 2:-.
`treatment ¢_
`_
`V‘ Surgical removal of the cataract
`' Placement of an mtraocular lens -
`
`V"
`
`'
`
`'
`
`
`
`_._...._........._.._.—A-..a....a—-u-cg-n:n._a-:-"amass:-9
`
`" P5
`
`

`
`_
`
`'
`
`Frequent refractions and corrective lens '
`prescription changes may help maintain useful
`vision during cataract development. Occa-
`sionally, long-term pupillary dilation (with
`phenyleplirine 2.5% q 4 to 8 h) is helpful for
`small centrally located cataracts. lndirectlight—
`ing while reading minimizes pupillary con-
`striction and may optimize vision for close
`tasks. Polarized lenses reduce glare.
`'
`Usual indications forpsurgery include the
`following:
`'
`'
`'
`'
`’
`'
`»
`-Best vision obtained with glasses is worse
`than 20/40 (< 6/12), or visio_n is signifi-
`cantly decreased under glare conditions
`(eg, oblique fighting while trying to read a
`chan) in a patient with bothersome halos or
`stzirbursts.
`.
`.
`, -; -
`‘Patients sense that vision is limiting (eg,
`by preventing activities of daily living
`such as driving,
`reading, hobbies, and
`occupational activities). '
`-‘Vision could potentially be meaningfully
`|l'flpl’0Ved if the cataract is removed (ie, a
`significant portion of the vision loss must be
`caused by the cataract). "
`-
`Far less common indications include cata-
`racts that cause glaucoma or that obscure the
`fllndlls in_ patients who need periodic fundus
`examinations for manageineiit ofdiseases such
`35d‘|3bE_ltc rctlnopathy and glaucoma. There is
`madvantage to removing a cataract early.
`Cataract extraction is usually done using a
`topical or local anesthetic and IV sedation;
`were are 3 extraction techniques. In intra-
`Pflpsular cataract extraction, the cataract
`3'ld1§ns capsule are removed in one piece; this
`'°°h”"lU¢ is rarely used.'Iri extracapsularcata-
`:9‘ 9Xl|’_1ictlon,_the hard central nucleus is
`is’:e°V°d' In one piece and then the soft cortex
`c0Ei;l“°l\§tq In multiplcpsmall pieces. ‘In pha-
`M II Isl ication, the hard central nucleus
`umsi‘? ‘ml by ultr_asot_ind‘and then the soft
`Phamels F:i_I_n0ve_d in multiple small pieces.
`‘Non E" 5"-1Ci1f_l0n requires the smallest ll'l_-
`um". mus enabling
`fastest healing, and is
`at ex}:
`9 Plfiferned procedure. In extracapsu—
`Faction and phacoemulsilication, the
`-°5°3P5|l1e Is not removed.
`.
`'
`‘
`‘
`. A Plastic or silicone lens is almosfalways
`glP]f’(‘)“l¢<1_intraocularly to replace the opti-
`uystalcfifiénlg POWBI‘ lost by removalof the
`phcedono 0113. The lens implant is usually
`r leggllhln the lens capsule (posterior
`fmmo“he_ .- The lens can also be placed in
`inched ‘O [hills (anterior chamber lens) or at-
`° 1'15’ and within the pupil (iris
`
`‘ “CHAPTER 66 . Cataract
`
`607
`
`plane lens). Iris plane lenses are rarely used in
`the US because many designs led to a high
`frequency of postoperative complications.
`Multifocal intraocula'r'lenses'are newer and
`havediffcrent focusing zones that may re-
`duce dependence on glasses after surgery. Pa-
`tientsoccasionally experience glare or halos
`with these lenses. especially under low-light
`conditions.
`i
`'
`'
`In most cases, a tapering schedule of topical
`antibiotics (eg, moxifloxacin 0.5% 1 drop qid)
`and topical corticosteroids (cg. prednisolone
`acetate l% 1 drop qid) is used for tip to 4 wk
`postsurgery. Patients often wear an eye shield
`while sleeping and should avoid the Valsalva
`maneuver, heavy lifting, excessive forward
`bending. and eye rubbing for several weeks.
`Major complications of cataract surgery are
`rare. Complications include the following: '
`
`'
`
`'. Intraoperative: Bleeding‘ beneath the ret-
`ina, causing the intraocular contents to
`'extnide through the incision (choroidal
`_ hemorrhage), vitreous prolapsing out of
`the incision (vitreous loss), fragments of
`the cataract dislocating into the vitreous,
`incisional burn, and detachment of corneal
`endothelium and its basement membrane
`(Desceinefls membrane)
`.
`Within thefirst week: Endophthalmitis
`(infection within the eye) and glaucoma
`Within thefirst month: Cystoid macular
`edema
`‘
`-'
`’
`'
`" '
`'
`Months later: Bullous keratopathy (ie, swell-
`ing of the comea due todamage to the cor-
`neal pump cells during cataract surgery).
`_ retinal detachment, and posterior capsular
`opacification (common, but treatable with
`laser)
`‘
`*'
`-‘
`‘
`'
`‘
`
`After surgery, vision returns to 20/40 (6/12)
`or better in 95% of eyes if there are no preex-
`isting disorders such as amblyopia, retinopa—
`thy, macular degeneration, and glaucoma. If
`an intraocular lens is not implanted, contact
`lenses or thick glasses are needed to correct the
`resulting hyperopia. _
`y
`_
`_
`'
`i
`‘
`
`Prevention
`Many ophthalmologists recommend ultra-
`violet-coated eyeglasses or sunglasses as a
`preventive measure. Reducing risk factors such
`as alcohol. tobacco, and corticosteroids and
`controlling blood glucose in diabetes delay
`onset. A diet high in vitamin C, vitamin A, and
`carotenoids (contained _in vegetables such as
`spinach aridrkale) may protect against cataracts.
`
`‘PAGE 6 or 7
`
`

`
`
`
`2920
`
`SECTION 19
`
`Pediatrits
`
`Treatment should be directed byan oph-‘ '
`thalmologist. Any underlying causes must be
`treated (eg, eyeglasses or contact lenses to
`correct refractive error, removal of a cataract).
`Use of the amblyopic eye is then encouraged
`by patching the better eye or by administering
`atropine drops into the better eye to provide a
`visual advantage to the amblyopic eye. Ad-
`herence to treatment is better with drop ther-
`apy._Maintena'nce treatment for prevention of
`recurrences may be recommended after im-
`provement-‘has stabilized, until a child is
`about8tol0.‘
`"
`"
`V
`
`CONIGEVNITAL CATARAC_T'
`(Infantile Cataract)
`H
`Corigenitdatatactisalerisopadtythatispresent
`atbirth orshortlyatterbirfli.‘
`‘N
`V.
`
`Congenital cataracts may be sporadic. or they
`may be caused by chromosomal anomalies,
`metabolic'disease (eg, galactosemia), or in-_
`trauterine infection (eg, rubella) or other ma-
`ternal disease during pregnancy. Cataracts
`may be located in_the center of the lens (nu-
`clear), or they ‘may involve the lensmaterial
`undenieath the anterior of posterior lens cap-'
`sule (subcapsular or conical). They may be
`unilateral or bilateral. They may not be no-
`ticed unless the red reflex is checked or unless
`ophthalmoscopy is done at birth. :As with other
`cataracts.'the lerisopacity obscures vision..Cat-‘
`aracts may obscure the view of the‘_optic disk
`and vessels and should" always be evaluated
`by an ophthalmologist: ‘
`-~' ;~ -»
`1-
`q
`f‘ -Removal of a cataracfwitliin 17 wk after
`birth permits the 'de'v‘el’opme‘n't'of vision and
`cortical visual pathways. Cataracts are removed
`by aspirating them through a small incision.
`In many children, an intraocular lens’ may be
`implantedl"Postoperative visualacorrection
`with eyeglasses, contact lenses, ‘o'r"both is usu-
`ally required to achieve the best outcome._. .=.;
`After a unilateral cataract is removed, the
`quality of the image in the treated eye is infe-
`rior to mat of the other eye (asstirning the‘ other
`eye is normal). Because the better eye‘ is pre-
`ferred, the brain suppresses the poorer-quality
`image. and amblyopia (see p.-2919) develops.
`Thus, effective amblyopia therapy is neces-‘
`sary for the treated eye to develop normal sight.
`Some children are unable to attain good visual
`acuity because of accompanying structural de-
`fects: In contrast, children with bilateral cata-
`ract removal in_which image" quality is similar
`in both eyesmote frequently develop equal vi-
`sion inboth-eyes. (:1-'2« .= 3 .
`A y if ,-/E"
`._«_-E: -:
`Some cataracts are partial .(posten'or lenti-
`conus) and opacify during the 1st decade of
`
`life. Eyes with partial ‘cataracts have a better
`visual outcome.
`_
`'
`V
`g
`I
`.
`PRAIMARY AINVFANTILE“
`-GLAUCOMA:-»—-'
`A
`(Infantile Glaucoma; Congenital
`Glaucoma; Buphthalmos)
`Primary infantile glaucoma is a rare develop-
`mental defect in the lrldooorneal filtration angle
`of the anterior dianiber that prevents aqueous
`fluid from properly chaining from the eye. This
`obstruction can cause increases in the intra-
`ocular pressure. which If untreated can damage
`the optic nerve.
`.
`
`5:
`"
`
`The disorder occurs in infants and young
`children and may be unilateral (40%) orbilateral
`(60%). lntraocular pressure increases above the
`normal range (10 to 22 mm Hg). Glaucoma
`can also occur in infants after trauma or in-
`traocular surgery.(eg, cataract extraction).
`Glaucoma associated with aniridia or Lowe
`syndrome or Sturge-Weber syndrome is called
`secondary glaucomaz;---.
`-
`;
`- »..~
`;
`.2 .- 5
`The eye becomes enlarged because the col-
`lagen of the sclera and cornea can stretch from
`the increased intraocular pressure; The large-
`diameter (> 12 mm) cornea is thinned and
`sometimes cloudy. The infant may have
`and photophobia. If untreated, comeal clouding
`progresses, the optic nerve is damaged (as ev-
`idenced clinically by optic nerve cupping), and
`blindness may occur. Early surgical interven-
`tion (eg,»goniotomy, trabeculotomy, trabec-
`ulectomy) is the mainstay of treatment: ~ ‘
`
`
`__ ;
`~~ '- STRABISMUS
`Strabismus is misalignment of the eyes. MI“?
`causa deviation from the parallelism of n_om|i
`‘gaze. Diagnosis iscfiiid. induding observation of
`the ‘corneal light reflex and use of a covu
`'lh;atmuit'may hdude corredion of viaial irnP"'
`
`. Strabismus occurs in about 3% of children
`.
`Although most strabismus is caused by re-
`fractive errors or muscle ~imba.lance,’rare CaU5¢3
`include retinoblastoma or .othcr serious
`defects and netuologic disease. Left unneawd.
`about 50% of children with strabismus have
`some visual lossdue to amblyopia (see p. 2919)-
`:: ‘Several varieties of strabismus have been
`described, based on‘ direction of deviation;
`specific conditions under. which deviation
`occurs, and whether deviation is»oonstant_0T
`intermittent. Description of thesevarietics
`0
`requires the definition of several terms-
`
`_
`
`PAGE 7 OF 7