PhysicianS
`·Desk
`Reference.
`
`Publisher: CHARLES E. BAKER, Jr.
`General Manager: JACK E. ANGEL
`Production Manager: GEORGE E. QUIST, Jr.
`Compilation Editor: BARBARA B. HUFF
`Medical Consultant: AUSTIN JOYNER, M.D.
`Ass't To Production Manager: ELIZABETH H. CARUSO
`Compilation Editor/PDR Supplement: JANICE M. CLARK
`t:ditorial Assistants: EMILY B. BROGELER, GWYNNED L.
`OAKLEY, F. EDYTHE PATERNITI
`Circulation Director: JOSEPH L. KENNA
`Circulation Manager: ETHEL F. McGILLIGAN
`Ass't To Circulation Manager: ALICE SCHRAMM
`Fulfillment Manager: WILLIAM R. BOBBINK
`
`[8 Copyright reo 1974 bY Medical Economics
`
`company, Oradell, N.J. 07649. All ri~hts
`.
`reserved. None of the content of this
`Lttton publication tnay be re)lroctucecl, stored in a
`retrieval system, or transmitted in any form
`or by any means (electronic, mechanical,
`Photocopyin~, recording, or otherwise) without
`the prior wntten permission of the publisher.
`
`--p[)R- ---·
`
`I
`
`I
`
`I
`
`I
`
`I
`I
`
`1974
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1051
`
`I
`
`Exh. 1051
`
`

`
`TABLE OF CONTENTS
`
`• • t'
`
`t
`
`*'
`
`'f
`
`I
`
`1111
`
`A few minutes spent familiarizing yourself with the
`contents and organization of PDR's five color-coded sections will
`be mnply repaid in time saved locating needed drug
`inforrnation du,ring the year ahead.
`101
`SEC1,ION 1 (PINI<)
`IJ. tt • . t
`• 4o.
`Alphabetical Index. (I. by brand na1ne; 2. by company name) Brand name
`pharmaceutical products are listed alphabetically with the manufacturer's name fol-
`lowing. Manufacturers are also listed alphalJetically with a complete list of their
`products. In both parts of this section, the nurober following the product name
`refers to the page in Section 5 (White) where the product is described.
`" ........................ . 201
`SECTION 2 (YELLOW)
`Drug, Chem.ical and Pharnulcological Index. Products are listed according
`to the major ingredients of the product formula. The number following the product
`name refers to the page in Section 5 (White) where the product is described.
`
`t
`
`W
`
`t • • 9 • • • • IJ
`
`SECTION 3 (BL'UE) .... .................. " ..... . 301
`Therapeutic lndications Index. Producfs are Iisted under the conditions for
`which they are indicated, according to the manufacturer, and are further subdivided
`into categories of pharmacological andjor therapeutic usefulness. (For more details,
`see the introduction to this section.) The num1er following the product name refers to
`the page in Section 5 (White) where the product is described.
`
`. ... I-XXVIII
`SECTION 4
`Product Identification Section. Over 800 capsules and tablets are shown in color
`and actual size as an aid in identification, Products are shown under company
`headings, and are not necessarily in alphabetical order since some manufacturers
`prefer to show their products in certain grou:ps.
`SECTION 5 (WHITE) . . . . . . . . . . . . . . . . . . . . . . . . . . . 501
`Product Inform,ation Section. This sectiml is an alphabetical arrangement by
`name of manufacturer of over 2,600 pharmaceutical specialties, biologieals and anti-
`biotics which are fully described as to: cornposition, action and uses, administration
`and dosage, contraindications, precautions, side effects, the form in which supplied
`and other information concerning their use, lncluding their common names, generic
`compositions or chemical names.
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . 1253
`SECTION 6 (WHITE)
`Manufacturers' Ser·vice Material. Various publications, motion picture films,
`recordings, charts, etc., available from mannfacturers are described in this section. ·
`Items are grouped by category and by manufacturers.
`
`Exh. 1051
`
`

`
`942
`Pfizer-Cont.
`
`for as long as eight hours. Bedtime instilla~
`tion usually assures sleep undisturbed by
`the neecl for remedication bcfore morning or
`by insomnia from centrat stimulation.
`Children 2 to 6 years of age: It is recom~
`mendecl that 2 to 3 drops of Tyzine (tetra-
`hydrozoline HCl) 0.05% Pediatric Nasal
`Drops be instilletl in each nostril, as needed,
`nevcr mote often than every three hours. Re-
`lief usually Iasts for several hours so that
`instillations are usually needed only evcty
`four to six hours.
`Instillation of nose drops can be most con-
`veniently accomplished with the patient in
`the lateral head-low position.
`SUPPLY: Tyzine (tetrahydrozoline HCl):
`Nasal Solution (0.1%)-1 H. oz. (30 cc.)
`and 1 pint bottlcs; 0 11. oz. (1 5 cc.) plastic
`squeeze bottles.
`Petliatric Nasal Drops (0.05%)-0 fl. oz.
`( 15 cc.) bottlcs.
`LITERATURE AVAILABLIJ: Yes.
`J1.
`UROBJOTIC®
`COMPOSITION: Bach cap.w/e conta{11s:
`Tcr1'amycin@ ( oxytetracycline H Cl equiva-
`lent to 125 mg. oxytetracycline); 250 mg.
`Sttlfamethizole; 50 mg. phenazopyridine HCI;
`with glucosnmine H Cl.
`ACTJONS: Urobiotic is designed specifi-
`in urinary traet infections.
`cally for use
`Terramycin
`(oxytetracycline)
`is
`active
`against gram-positive and gram-negative
`bacteria, rickettsiae, spirochctes,
`large vi-
`ruses anti certain protozoa. Terramycin (oxy-
`tetracyclinc HCl) b; well tolerated and well
`absorbed aftet· oral administration. I t diffuses
`readily through the placenta and is present
`iu the fetal circulation. It diffuses into thc
`pleural fluid, and undcr some circumstances
`into the cerebraspinal Huid. Oxytetracyclin~
`appears to be concentrated in
`the hepatic
`system and is excrctetl in thc hile. lt is ex-
`creted in the urine and in the feccs, in high
`concentrations, in a hiologicnlly active form.
`Sulfnmethizole is a chemotherapeutic agent
`active against a numbcr of important gram-
`positive and gram~negntive bacteria, is weil
`absorbcd, has a low degrce of acetylation
`and is extrcmely soluble.
`Phcnazopyridine is an orally absorbcd agent
`which produces prompt nnd cffective local
`analgesia ancl
`relief of symptoms
`in
`the
`urinary tract. This action is confined to the
`urinary system and is not aceompanied by
`generalized scdation or narcosis.
`INDJCATIONS: Urobiotic is indicated in
`the therapy of a numbcr of genitourinary
`infcctions caused by susccptible organisms.
`These infections include the following: pye-
`lonephdtis, pyeliti~ •. uretcl'itis, cystitis, pros-
`tatitis and urethntts.
`Since 1both Terramycin (oxytetri\Cyclinc HCI)
`and sulfamethizole provide effective levels in
`tissue, and urine, U robiotic provides
`blood
`a multiple antimicrobial approach at the site
`of infcction. Both antibncterial components
`are active against the most common urinary
`pathogens, including Bscherichict coli, P sett-
`Streptococcus fa~ca ts, .) trcfJlococcus llemo-
`lyticfl.s, and. Mlcrococ~·lls pyogc11es. Uro~
`biotic is parttcularly uscful 111. the treatmer:t
`of infections cau~ed ,hY bactel'la 11?01'e senst-
`tive to the con~l~nHittOn t~an. to e.tther com-
`poncnt alone. 1 he con.llHnat!on
`1~ als? of
`value in those. cascs wtth nuxed tnfectlo~1s,
`and in thosc lllstances wher~ the causattvc
`organiBm
`is unknown petHhng
`laboratory
`isolation.
`"
`"
`.
`, CONTRAINDICAT IONS:
`is
`lhts drug
`~~: . individuals wl~o havc
`contraindicated
`shown bypcrsensttlvtty to any of tts com-
`ponents.
`This drtlß', becausc of the st!lfonatJ1idc co!n-
`ponent, should not be u~ed m p~t~e~1~s Wt~h
`a history of sulfonatmde . senslttvttles, . m
`prcgnant females at term, m premature tn·
`
`domonas actu{fi1!osa1. Aerobactar aerogenes,
`
`Product Information
`fants, or in newbon1 infants during thc first
`week of life.
`WARNJNGS: If renal impainnent exists,
`cven usual oral or parenteral doses may
`lcad to exccssivc systcmic accumulation of
`the drug and possiblc liver toxicity. Under
`such conditions, lowcr than wmal doses arc
`intlicatcd and if therapy is prolonged, tetra-
`cycline scrum Ievel detcrminntions may be
`advisable.
`Oxytctracyclinc HCl, which is one of thc in-
`gredients of Urohiotic, may form n stable
`calcittnl complex in any bonc-forming tissue
`with no serious hannful effects rcported
`thus far in humans. Howcvcr, use of oxy~
`tetracycline during tooth tlevclopment (last
`trimestet' of pregnancy, neonatal period und
`early childhood) may cause discoloration of
`thc teeth (yellow-gray-hrownish). This effcct
`occm·s mostly during long-term use of the
`drttg but it has also bcen obl:icrved in t.tsual
`short-treatment courses.
`Because of its sulfonamitle contcnt, this drug
`should be used only after critical appraisal
`in paticnts with livcr damage, renal damage,
`urinary obstruction, or blood dyscrasias,
`Deaths have becn reported from hypersensi-
`tivity reactions, agrunulocytosis, aplastic ane-
`mia, and other blood dyscrasius associated
`with sulfonamide ndministration. vVhen used
`intermittently, or for a. prolonged period,
`blood counts und liver anti kidney f unction
`tests should bc performed.
`Certain hypersensitive individuals may de-
`velop a photodynamic reactiotl precipitatcd
`by exposure to tlirect sunlight during the
`w;c of this clrug. This reaction is ust1ally of
`the photoallergic type which may also be
`produced by other tetracycline derivatives.
`lndividuals with a history of photosensitiv-
`ity reactions shoulcl be instructed to avoid
`expo!ltli'C to tlirect sunlight whilc under treat-
`mcnt with thi$ or other tetracycline drugs,
`and treatment should be discontintted at ßrst
`evitlence of skin cliscomfort.
`NOTE: Rcactions of a photoallergic nature
`arc exceedingly rare with Terramycin ( oxy-
`tetracyclinc HCI). Phototaxie rcactions are
`not believcd to occur with Terramycin (oxy-
`tctracyclinc HC!).
`PRECAVTIONS: As with all antibiotic
`preparations, use of this drug may resnlt in
`ovcrgrowth of nonsusceptible organisms in-
`clucling fungi. If st1pcrinfection ocCtlrs,' the
`antibiotic shottld be discontinued and appro-
`priate specitic therapy should be instituted.
`lncrcased intrncranial pressttre with hutging
`fontanelles has been observed oecasionally
`in
`infants rcceiving
`therapeutic · doses of
`oxytetracycline. Although
`the mechanism
`for this phenomenon is unknown, the signs
`nnd
`symptoms have disappeared
`rapidly
`upon cessation of trentment with no sequelac.
`This dn1g sho\1ld be used with caution in
`pcrsons having histories of significant aller·
`gics and/or asthma.
`ADVERSE RBAC1'JONS: Glossitis,
`sto~
`matitis, proctitis, nansea, diarrhea, vaginitis
`and dermatilis, as weil as rcactions of an
`allcrgic nature, may occur during oxytetra-
`cycline therapy, but are rare. If advcrse
`reactions, individual icliosyncrasy, or allergy
`occur, discontinue tncclication.
`As in all sulfonamide therapy, thc following
`reactions may occnr: nausea, vomiting, dinr-
`rhcn, hepatiti~. pancrcatitis, blood clyscras-
`ias, neuropalhy, drug fever, sldn rash, in-
`jection of the conjunctiva and sclera, pete~
`chiac, purpura, hematuria and crystalluria.
`The dosage should be decreased or
`the
`cln1g withdrawn, depending upon thc sever-
`ity of the reaction.
`DOSAGE: In adults a close of 1~2 capsules
`is suggested, depending
`four
`times daily
`upon the severity and responsc of the infec-
`tion. In children unclet· 100 lbs.
`the sug-
`gestetl average dose is 1 capsule fot1r times
`daily ; in children undcr 60 lbs., 1 capsule
`three times daily, Therapy should be con-
`tintlcd for a minimum of seven days or
`until bacteriologic eure
`in acute urinary
`tract infections.
`To aid ahsorption of the drug, it should be
`1riven at least onc hour before or two hours
`
`Always consult Supplement
`
`after cating. Aluminum hydroxide gel given
`wit~ antibio~ics has .been sh<;>wn to decrease
`the1r ahsorpbon and ts contratndicated.
`SUPPLY: Urobiotic Capsnles: bottles of
`50's.
`LITERATURE AVAILABLE: Yes.
`[SlwwH in Product Idcntification Sectioll]
`:a
`VIBRAMYCIN@ Hyc:late
`(doxyeycllne hyclate)
`CAPSULES
`VIBRAMYCIN@ Monohydrate
`(doxycydine monohydrate)
`FOR ORAL SUSPENSION
`DESCRJP1'ION: Vibramycin
`(dox~cy·
`is a new broad~spectnuu antibtotic
`cline)
`synthetically derived
`from methacyclin.e
`availablc as Vibramycin Monohydrate (clo:x~
`ycyclinc monohydratc) and Vibramycin Hy~
`clate ( doxycycline hydrochloride hemietha·
`n.olate hen~ihy~lrnte). 'l'he chemical designa·
`~ton of tlns hght-yellow cr.ystalline powder
`ts a.-6-deoxy·5"oxytetracyclme. Vibramycin
`(doxycycline) possesses the following useful
`propertics not o~servesl with previously
`lts greater absorp·
`avatlable tetmcychncs:
`tion from thc gastrointestinal tract and i ts
`capability for once~a-day maintenance dqsage
`ACTIONS: VibramY,cin (doxycycline)
`ls .~
`~nttb~otic . and has been
`broad-spcctrum
`tC! • be actt ve m Vlf ro against botll
`shown
`gram~posttlv.e and gram-.negative organisn1.s.
`In VI~'O anunal protectwn studies (PD
`)
`in micc ancl extensive clinical us~ in · m~n
`have veritiecl that Vibrnmycin (doxycycline)
`is a potent anti effective nntihiotic,
`fron1
`Vibramycin
`(doxycycline)
`diffcrs
`other tetracyclines by virtue of its greater
`nbsorption after oral administration alld prc·
`i11 vivo antibacterial
`Jonged duration of
`activity. Bccause of
`these factors
`tbera•
`peutic effectivcness can he achiev~d by a
`onee-a-day maintenance dosage, Vibram.ycin
`therapeutic doses
`(doxycycline)
`in
`g1Vet1
`'activi ty
`once daily, will prod uce serum
`to 36 hours ·after
`u~ually. pers,isting for 24-
`tltscontmuabon of therapy,
`·
`Vibramycin (doxycycline) has been admin-
`isteretl to 60 normal vohmte~rs for 70 ·days
`at a dose of 200 mg./day wtthout evidence
`of increased toxicity.
`·.
`Studics reported to date ind!cate that. the
`is
`absorption of Vibramycin ( doxycycline)
`not notably influenccd by the ingestion cf
`food or milk, which do impair the absorptioll
`of certain othcr tctracyclines.
`ANIMAL PHARMACOLOGY: As witJ1
`other
`tetracyclines. at doses grcater
`tha.n
`those recommended for human usage
`\Tj.
`bramycin ( doxycycline) prodttces disc~lor-a­
`tioi_l of animal. thyroid glauds. Careful mon.i·
`tonng of anunals nnd humans has dis•
`clost;cl no abnorma~itics of thyroid function
`stuchcs. Also, as w1th other tetracvclines at
`relatively high oral doses, evidence of h~Pa•
`totoxicity has becn noted in clogs and sig:ns
`of gastrointcstinal intolerance has beeu seeo
`in both dogs and monkeys.
`:
`TNDJCATIONS: Vibramycin (doxycycline)
`has been found elinically effective ·.·in.· tbe
`treatment of a variety of infections . caused
`by susceptible strains of gram~positive · a:nd
`gram-negative bacteriu.
`'
`Pneumonla: Single and multilobe pnetm1onia
`and bronchopneumonia due
`to stlsceptible
`strains of Pnetmlococctls, Streptococcus1
`Staphylococcus, H. ill/lHCI!/Jae, and Klcbsh•J111
`tmcmmoniae,.
`Other Respiratory Tract lnfec:tlonst Phar}'":n•
`gitis, tonsillitis, otitis media, bronchitis nn(l
`sinusitis eauscd by susceptible strnins 0 !
`ß-hemolytic Streptococcus, Staphylococcus1
`Pneumococctts and I-I. i11/lttell/1ae.
`Genitourinary Tract lnfections: Pyclonephrl·
`tis, cystitis, tll'ethritis, cmtsed by susceptiblt:
`strah1s of the Klebsiella-Aerobacter grot::i;p1
`E. coli, Entcrococctls, Staphylocoecus, Stre:p•
`toeoccus, an.d 1'( ar'ssen'a gouort"/rca, Gon.occ~­
`cal urethrihs, tn the male, has beet1 elf~·
`tivcly trented by Vibramycin (doxycycJin.e)
`at a dose of 100 mg. t.i.d. for a single da,•,
`but highest eure rates were achieved b)"
`'ß
`do:::e of 50 to 100 mg. b.i.d. for two. to fo\.lf
`
`1
`
`Exh. 1051
`
`

`
`for posslble revislons
`
`days. Adult femalcs with acttte gonot'rheal
`infections may
`rcquire more
`extended
`therapy.
`Soft Tissue lnfec:tlons: Impetigo, fttrunculosis
`cellulitis, abscess,
`infccted
`traumatic an;J
`postoperative wotmds, paronychia, caused by
`susceptible strains of Slaphylococcus aureus
`al1d albus, Streptococcus, E. coU, and the
`Klebsiella~Aerobacter group. In the treat-
`ment of soft tissue infections, intlicated sur-
`gical procedures should be carried out in
`conjunction with Vibramycin (doxycycline)
`treatment.
`Since Vibramycin ( doxycycline) is a mem-
`ber of the tetracycline series of antibiotics,
`it may be expected to be useful in the trcat-
`ment of infections which respond to other
`tetracyclincs. These inclucle infcctions caused
`by susceptible organisms, such as:
`lnfections: Due
`to susccptible
`Ophthalmie
`~trains of Gonococci, Staphylococci, and H.
`m/l11111tZae.
`lnfec:tlons1 Dtte to suscep~
`Gcutrointestlnal
`tible strains of such organhaus as E. his-
`tolytica, pathogenic E. coli, und spccics of
`Shigella and Salmonella.
`Mlscellaneous: Other infcctions due to stts-
`ceptible strains of Bacteroides, Pasteurella,
`Brucella (in combination with streptomycin) 1
`Psitta.cosis, Listeria, Rickettsia, 1vl ;/t:OfJ/asma
`lmettmoniae (Eaton agent, PPLO), H. jJer-
`tus.sis, B. cmthracis, C. 'ltJe!chii, N. meningi-
`lidis, spirochctes
`(Treponema), Donovania
`[Jranulomatis, and prostatitis and trigonitis
`dtte to Proteus ot Pseudomonas.
`Vibramyci\t ( doxycycline) may be useful in
`the treatment of acna v:tlgaris and aclla
`c01zglobata.
`CONTRAINDICATIONS: This dn1g
`is
`in
`individuals who have
`contraindicatecl
`shown hypersensitivity to it.
`W ARNINGS: If renal impairment exists,
`even usual doses may Iead to excessivc sys-
`temic accumulation of the drug and possible
`hepatic
`toxicity, Under
`such conditions,
`lower than usual doscs are indicated and if
`treatment is prolonged, Vibramycin (doxy-
`cycline) serum Ievel determinations may be
`advisable.
`tetracyclincs, Vibramycin
`As with other
`(doxycycline) may form a stable calcimn
`~omP.lex !n ~ny bone-forming tissue, though
`m vltro It bmds calcium less strongly than
`other tetracyclines.
`Though not obscrvcd in clinical studics to
`d'ate and until evidence
`to
`the contrary
`develops, it should be anticipated that, like
`other tetracyclines, thc use of Vibramycin
`(doxycycline)
`during
`tooth development
`(last trimester of pregnancy, neonatal pe-
`dod, and early childhood) may cause dis-
`coloration of teeth (yellow-gray-brownish).
`This tetracycline cffcct is more commonly
`associated with long-term use of the drug,
`but has been known to occur with treat-
`ment of short cluration.
`lncreasecl intracrnnial pressttre with bulging
`fontanelles has been obscrved
`in
`infants
`receiving therapetJtic doses of tetracyclines.
`Although the mechnnism of this phenome-
`non is unknown, the signs and symptoms
`have disappeared rapidly upon cessation of
`treatment with no seqttclae.
`Certain hypersensitive individuals may ele-
`vetop a photodynamic reaction precipitated
`by exposure to direct sunlight during the
`use of this drug, This reaction may also be
`produced hy other tetracycline derivatives
`and is usually of the photoallergic
`type.
`Individuals with a history of photosensitiv-
`ity reactions should be instructed to avoid
`exposure
`to cHrect sunlight while under
`treatment with tetracycline drugs, and trcat-
`mcnt should be discontinucd at first evidence
`of sldn discomfort.
`PRECAUTIONS: The use of antibiotics
`may occasionally rcsult
`in overgrowth of
`nonsusceptible organisms. Constant observa-
`tion of the patient is essential. If n resistant
`infection appears, the antibiotic should be
`discontinued and appropriate therapy insti-
`tuted.
`When treating gonorrhea in which lcsions
`of pritnary or secondary syphilis are sus-
`
`Product Information
`943
`pected, proper diagt~osti,c procedures, inchtd-
`cortical depressant, but its action may be
`mg darkfield exanunatlons shottld be uti~
`litte to a suppression of activity in cerhdn
`lizcd. ln all cases
`in wl1ich concomitant
`key regions of the subcortical area of the
`syphilis
`is suspectcd, monthly serological
`centrat nervous system.
`tests should be made for at
`least four
`Primary skeletal mttscle
`relaxation, anti-
`months.
`spasmoclic properties (apparently medicated
`ADVERSE REACTIONS: Nausea vomit-
`through
`interference with
`the mechanism
`ing, diarrhea, Vaginitis and derm~titis as
`that responcls .to spasmogenic agents such as
`well as reactions of an' allergic nature ;uay
`serotonin, acetylcholine, and histamine), and
`occur .. but are rare. Glossitis, stomatitis
`antihistaminic etfects have beett demon,..
`proctltts, onycholysis and discolorntion of
`strnted experimentally and the latter con~
`th.e nails may rarely occur dudng tetmcy-
`finned clinically. An antiemetic effect, both
`clme therapy as with other antibiotics. lf
`by the apomorphine nnd the veriloid test,
`severe ndverse
`teactions,
`individual
`idio-
`hns been demonstrated Pharmacologic and
`syncrasy, or allcrgy occur discontinue medi~
`clinical studies indicate' timt hydroxyzine in
`cation.
`'
`therapeutic dosage does not increase gastric
`secretion or acidity and in most cases pro;. .
`As with other
`tetracyclines
`elevation of
`SGOT or SGPT valttes a;1emia neutro~
`vitlcs mild antisccrctory benefits.
`pcnia, eosinophilia or el~vatcd BUN have
`Hydroxyzine panwate is rapidly absorbed in
`bcen rcported, the significance of which is
`the gastrointcstinal tract and the effects of
`not known at this time
`Vistnril (hydroxyzine pamoate) are ttsually
`DOSAGE.: Th~ t;sual ~lose of Vibramycin
`noted withtn 15 to 30 minutcs aftet' oral
`( doxycychnc) 1s 200 mg. on the first day
`administration.
`INDICATIONS: The total management o~
`of treatmcnt (administercd 100 mg. every
`12 hours) followed by a maintenance dose
`anxiety, tension, and psychomotor agitation
`of 100 mg./clay. The maintenance dose may
`in conditions of emotional stt·css requit·es in
`be administered as a singlc dose, or as 50
`most instatlCcs a combined approach of psy:-
`mg. every 12 hours. In the management of
`chothcrapy and chemotherapy. I-Iydroxyzine
`more severe infcctions (particularly chronic
`hns been found to be particttlal'ly useful for
`this h\tter phase of therapy in its ability to
`infcctions of the urinary tract) 100 mg.
`every 12 hottrs is reconnnendcd.' The rec-
`render the disturbed patient more amenable
`to psychotherapy in long-term treatment of
`ommended dosage
`schedule
`for chilclren
`weighing 100 pouncls or less is 2 mg./lb. of
`the psychoneurotic and
`the psychotic, · al-
`though it shoulcl not be used ns the sole
`bocly weight divided into two doses on the
`first day of treatment, followed by 1 mg./lb.
`treatment of psychosis or of clearly dem-
`of body weight given as a single claily dose
`onstratcd cases of depression.
`Hydroxyzine is also useful in alleviating
`or divided into two doses, on subsequcnt
`the manifestatiotls of anxiety and tension
`days. For more sevcre infections tlP to 2
`as in the preparation for dental procedures
`mg./lb. of body weight may be used. For
`and in acute emotional problems. lt has also
`children over 100 lbs. the usual adult dose
`been recommended for the management of
`should be uscd.
`anxiety associated with organic disturbance.s
`Therapy should be continued beyond
`the
`ancl as adjtmctive therapy in alcoholism and
`time tltat symptoms and fever have sub-
`sidcd. It should be noted, howcver,
`allergic conditions with strong emotional
`that
`overlay, sttch ns
`in asthma, ehronic urti~
`effective antibacterial
`Ievels are
`ttsttally
`caria, nnd pruritus.
`prese'nt 24 to 36 hours following discontinu-
`Vistaril
`(hydroxyzine hydrochloride) Par~
`ation of Vibramycin (doxycycline). When
`enteral Solution is ttseful in trenting the
`used
`in streptococcal
`infections
`therapy
`following types of patients when parenteral
`should be continued for 10 days to prcvent
`administration is indicated.
`the development of rhettmatic fever or glo~
`1. The actttely disturbed or hystedcal pa-
`mernlonephritis.
`Studies reported to date indicate that the
`tient.
`2. The acute or chronic alcoholic with anx-
`( cloxycycline),
`nbsorption of Vibramycin
`iety withdrawnl
`symptmns, or delirittm
`unlike certain other
`tetracyclines,
`is not
`tremens.
`markedly inflttenced by simultaneotts inges-
`3. As pre- and postoperative and pre- and
`tion of food or milk.
`postpartum adjunctive medication to permit
`Simultaneous administration of aluminum
`hydroxide gel given with tetracycline nnti-
`reduction in narcotic dosage, allay anxiety
`and eontrol emesis.
`htotics including Vihrnmycin ( doxycycline)
`Vistaril
`(hydroxyzine hydrochloride) has
`has heen shown to dccrease nbsorption.
`also demonstrated effectiveness in control-
`SUPPLY: Vibrnmycin Hyclate
`(doxycy-
`ling nausea nncl vomiting, excluding nauseil
`cline hyclate) is available as capsules con-
`ancl vomiting of pregnancy. (See CONTRA-
`taining doxycycline hyclate equivalent to 50
`INDICATIONS).
`mg, of doxycycline: bottles of 50. Vibrn-
`Clinical use of hydroxyzine hydrochlodde as
`mycin Monohydrate
`( doxycycline monohy-
`an adjunct to the management of Iabor has
`drate) is available as a dry powder for oral
`been extensively reported in the Iiterature
`suspcnsion containing, when
`reconstituted,
`withottt evidence of harm
`to
`the mother
`doxycycline monohyclrate equivalent to 25
`or neonate.
`·
`mg. of doxycyclinc/5 cc. (each teaspoonful),
`Hydroxyzine benefits the cardiac patieut by
`with a pleasant tasting, raspberry flavor:
`its ability to allay the associated anxicty
`2 oz. bottlcs.
`and apprehension attendant to certain types
`LITERATURE AVAILABLB: Yes.
`of henrt disease. Hydroxyzine is not known
`[Shown- tn Ptoduct ldelltificntlon Sact(on]
`to interfere with the action of digitalis .io.
`ll any way and may be uscd concurrently wi,th
`VISTARIL®
`(hydroxy.zlno pamoate)
`this agent.
`.
`Its effectivencss ancl safcty make
`tt an
`CAPSULES and ORAL SUSPENSION
`outstanding drug for long-term use.
`. ·
`VISTARIL®
`CONTRAINDICATJONS:
`IJydro;cyztp~
`(hydroxydne l'!ydrochlorlde)
`hydrochloride pa~enteral soluttou • ts m·
`PARENTERAL SOLUTION
`tcnded only for mtranntscular or tntrave~
`ACTIONS: Hydroxyzine
`unrelated
`is
`nous administration und shottld not, under
`chemically to phenothiazinc, reserpine, and
`any cit·cumstances, be
`injectcd sttbctttane-
`meprobamatc. Hydroxyzinc
`has
`demon-
`ously or intra-arterinlly.
`.
`.
`strated its clinical effcctiveness in the chem-
`I-Iydroxyzine is contraindicatcd for p~t~et}ts
`othcrapeutic aspect of the total mnnagement
`who have shown a previous hypersenstttvtty
`of neuroses and emotional disturbances man-
`to it.
`ifested by anxiety, tension, agitation, apprc-
`the
`to
`Hydroxyzine, when administered
`hension or confusion.
`induced
`prcgnant mouse, rat, and rabbit,
`H ydroxyzine has been shown clinicnlly to
`fetal abnormalitics in thc rat at doses sul:·
`be a rapid-acting, tn1e ataraxic with a wide
`stnntially abovc
`the human th~rapeuttc
`margin of safety. It induces a calming effect
`range, Clinicnl data in human bemgs are
`in anxious, tense, psychonenrotic adults ancl
`inadequate to estnhlish snfcty in early preg-
`also in anxious, hyperlcinetic ehildren with-
`continued on noxt page
`out impairing mental nlertness. It is not n
`
`Exh. 1051