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`BLACKWELL sanosns MATHENY
`WEARY & L0?r!:E§\RDi
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`SiC|/ANS’
`PH
`DESK
`l2EEEl2ENCE®
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`-
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`_ Product Manager
`DAN|EL 3- ZUHFCH -
`
`Director of Production
`MAFtJOFiiE A. DUFFY
`
`Sales Managm
`CHARLIE J. MEJTNER
`Account Managers
`CHAD E. ALCORN
`JAMES R PANTN-E0
`MICHAEL S. SAHAJIAN
`
`Commercial Sales Manager
`ROBIN B. BARTLETT
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`M
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`Direct Marketing Manager
`ROBERT W. CHAPMAN
`‘P f
`I
`In "
`“lr‘3?<"ésH’ErEfFr2TE. pi.“
`index-Editor
`ADELE L.. DOWD
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`'
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`_
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`' Assistant Director of Production
`CARR”; WILLIAMS
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`Production Manager
`' KIMBERLY V. HILLER
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`-
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`I M"-DEED M‘ SCHUMACHER.
`Production Coordinator
`ELIZABETH A_ KARST
`-
`'
`—
`Art Associate
`JOAN K. AKERLIND
`Medical Consultant
`LOUIS V. NAPOLITANO. MD
`
`i Copyright © 1993 and published by Medical Economics Data. a division oi Medical Econcrnics Company |nc., at Montveie. N.J. I'.i?E45. All rights reserved. None oi the
`.. content of this publication may be reproduced. stored in a retrieval system. or transmitted in any form or by any means {eiectronic. mechanical. photocopying. or other-
`Mtlsai without the prior written permission oi the publisher. PHYSICIANS‘ DESK REFEHENCEQ. POEM. PDFI For Ophthalmoiogytiit. PDFi For Nonprescription Drugs®. PDF.
`Drug interactions and Side Eflects® are trademarks of Medical Economics Company Inc.. registered in the Uniled States Patent and Tradernaiit Oilice.
`_ Otlicers of Medical Economics Data. a division at Medical Economics Company Inc: President and Chief Executive Otiicer. Norman Ft. Snesii: Executive Vice President.
`Mark L. Welnstein: Senior Vice President and Chief Financial Dtticer, J. Crisp-in Ashworih‘. Senior Vice President at Business Development. Stephen J. Sorkenn: Vice
`President of Product Management. Curtis E. Allen: Vice President of sales and Marketing. Thomas F. Ftice; Vice President of Operations. -John R, Ware; Vice
`Presldenloi Information Systems and Services. Edward J. Zacchini
`
`_
`
`ISBN ‘i-55363-U15 K
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`Amerigen Ex. 1050, p. 1
`Amerigen Ex. 1050, p. 1
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`190?
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`In patients with severe interstitial cystitis with very sensi-
`tive bladders, the initial treatment, and possibly the second
`and third {depending on patient response) should be done
`under anesthesia. lfisddls block has been suggested].
`HOW SUPPLIED
`of sterile and pyrogen-frce
`Bottles contain 50 ml
`RlMSO®-50
`(50% wiw dimethy]
`sulfoxidc
`aqueous
`solution}.
`Dimethyi sulfoxide is clear and colorless
`Protect from strong light
`Store at room temperature I59’ to 86'}?! (15° to 30'Cl
`Do not autoclave
`NDC #0433-0433-05
`For additional information concerning RIMSO CPD-50, contact
`the Pharmaceutical Division, Research Industries Corpora-
`tion. Salt Lake City, Utah
`RlMSO®-50 is manufactured by Tera Pharmaceuticals,
`Inc., Buena Park. California. for the Pharmaceutical Divi-
`sion, Research Industries Corp, Salt Lake City, Utah.
`
`
`
`Rexar Pharmacal Corp.
`ass ROCKAWAY AVENUE
`VALLEY STREAM, NY 11531
`
`DEETHOLIM Tablets
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`G
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`'
`DESCRIPTION
`A single entity amphetamine product comb ining the neutral
`sulfate salts ofdeittroamphoiamine and amphetamine, with
`the dextro isomer of amphetamine saccharste and d,l aro-
`phetsmine aspartste.
`EACH TQBLET CONTAINS:
`Dextroamphetamine Saccharate
`Amphetamine Aspartate
`Dextroampheimnine Sulfate
`Amphetamine Sulfate
`Inactive ingredients: Sucrose,
`and Magnesium Steam-ate.
`Colors: Dbetrol 10 contains FD&C Blue #1
`Colors: Dbetrol 20 contains FD&C Yellow #6 as a color
`additive
`'
`
`
`
`..
`
`HOW SUPPLIED
`Obetrol 10 mg Blue scored tablet IMPRENTEI} OP-32
`NBC ti4"."i'-5432-01
`for 100's
`NDC D477-5432-05
`for 5l}EJ’s
`NDC OIl'i"i'-5-13240
`for 1000's
`Obetrol 20 mg Orange scored tablet IMPRINTED OP-33
`NDC 04??-5433-01
`for 100's
`NDC 04??-5433-U5
`for 50El’s
`NDC 047'?-5433-1D
`for 1000's
`Disp-cnse in a tight container as defined in the LISP.
`Store at controlled room Temperature 15-3(}'C (59'—B6“F').
`" Shown in Pmduci I'clenllflcotI'ori Section, page 424
`
`DEXTHOAMPHETAMINE SULFATE. USP
`5 mg and 10 mg Tablets
`
`Shown in Product Identification Section, page 424
`
`.
`DBY-TRIM Capsules
`Phentermlne Hydrochloride, USP‘, 30 mg
`[equivalent to 24 mg phenterrnine base}
`
`nsxarm. Tablets
`Phenobarbital. USP, (‘la gr} 16.2 rag
`Hyoscyemlne Sulfate. USP, 0.103? mg
`Atropine Sulfate. USP, 0.0134 mg
`Soopolamlne Hydrobromlde, USP. 0.0035 mg
`
`'
`x-fnozlius Tablets
`X-TBDZINE Capsules
`Phendimalrazlne Tartrete, USP. 35 mg
`
`X-TRDZINE LA. Extended Release capsules
`Phendlmetrazioo Tartrate. USP. 105 mg
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`E
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`R
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`3
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`R
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`Physicia ns' Desk Referoncero
`Following topical application, dimethyl sulfoxlde is absorbed
`and generally distributed in the tissues and body fluids.
`INDICATI ONE AND USAGE
`RI1\<lS0®v50 idirnethyl sulfoxidei is indicated for the symp
`tomatic relief of patients with interstitial cystitis. RlMSU®-
`50 has not been spproveclas being safe and effective for any
`other indication. There is no clinical evidence of effective-
`ness of dimethyl aulfoxide in the treatment of bacterial infec-
`tions of the urinary tract.
`CON.TRAINDlCA'I'IONS
`None lLnow'n.
`WARNINGS
`Dimcthyl sulfoxide can initiate the liberation of histamine
`and there has been an occasional hypersensitivity reactidn
`with topical administration of dimethyl sulfoxide. This hy-
`persensitivity has been reported in one patient receiving
`intraveaical RIMSDGD-50, The physician should be cognizant
`of this possibility in prmcribing RIMSO®-50. If emphy-
`lactoid symtaoms develop, appropriate therapy should be
`instituted.
`'ERECAU'I'IONS
`Changes in the refractive index and lens opacitics have been
`seen in monkeys, dogs and rabbits given high doses of di-
`methyl aulioxide chronically. Since lane changes were noted
`in animals, full eye evaluations, including slit lamp exami-
`nations are recommended prior to and periodicslly_ during
`treatment.
`Approximately every six months patients receiving di-
`methyl sullbxido should have a biochemical screening, par-
`ticularly liver and renal function tests. and complete blood
`count Inti-avesica] instillation ofRIMSO®-ED may be harm-
`ful to patients with urinary tract malignancy because of di-
`methyl sullbxideinduced vasodflation.
`Some data indicate that dirnsth yi sulfoxide potentiates other
`concomitantly administered medications.
`Pregnancy Category C. Dimethyl sulfoxide caused terato-
`genie responses in hamsters, rats and mice when adminis-
`tered intraperitoncally at high doses (2.5-12 gm! kg). Oral or
`topical doses ofdimethyl sulfoxide did not cause problems of
`reproduction in rats,_mice and hanisters. Topical doses (5
`gmikg first two days, thcn 2.5 grnlkg-last eight days) pro-
`duced teratn in rabbits, but in another study, topical doses of
`1.1 gmflig days 3 through 16 of gestation failed to produce
`any abnormalities There are no adequate and well con-
`trolled studies in pregnant women. Dimathyl sulfoxide
`should be used during pregnancy only ifthe potential benefit
`justifies. the potential risk to the fetus. It is "not known
`Whether this drug is excreted in human milk. Because many
`drugs are excreted in human milk, caution should be exer-
`cised when dimethyl sulfoxids is administered to a nursing
`woman.
`and
`Safety
`established.
`Information available to be given to the patient is reprinted
`at the end of this text.
`ADVERSE REACTIONS
`Agarlic-like team may be noted by the patient within a few
`minutes after instillation of RiMSO®-50 {dimethyl sulfa):-
`idc). This taste may last several hours and because of the
`presence of mstabolitm an odor on the breath andskin may
`remain for 72 hours.
`Transient chemical cystitis has been noted following instilla-
`tion of dimethyl sulfoxide.
`"Elm patient may experience moderately severe discomfort
`on administration. Usually this becomes less prominent with
`repeated administration.
`DRUG ABUSE AND DEPENDENCE
`None known.
`CIVERDOSAGE
`' The oral 1.1350 of dimethyl suifoxide in the dog is greater than
`10 g-mfltg. It is improbable that this dosage level could be
`obtained with intravesical instillation ol'Ri’MSO@)-50 in the
`patient.
`In case of accidental oral ingestion, specific measures should
`be taken to induce emesia. Additional measures which may
`be considered are gastric lavage. activated charcoal and
`forced diuresis.
`.
`DOSAGE AND ADMINISTRATION
`Instiliation of so ml of Rl.MSO®-5|) (dimethyl sulfoxide)
`directly into the bladder may be accomplished by catheter or
`asepto syringe and allowed to remain for 15 minutes. Appo-
`cation of an analgesic lubricant gel such as lidocaine jelly to
`the urethra is suggested prior to insertion of the catheter bo
`avoid spasm. The medication is expelled by spontaneous
`voiding. It is recommended that the treatment be repeated
`every two weeks until maximum symptomatic relief is ob-
`tained. Thereafter, time intervals between therapy may be
`increased appropriately.
`'
`Ad ministration of oral analgesic medication or suppositories
`containing belladonna and opium prior to the instillation of
`RIMSO®-50 can reduce bladder spasm.
`
`effecIn'veness_
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`in
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`children
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`has
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`beef:
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`Amerigen Ex. 1050, p. 2
`Amerigen Ex. 1050, p. 2
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`-
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`supplefflflnls for revisions
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`t WLATIONS AND COPIIFOSITION
`mg and ‘F2 trace minerals in adliltichild
`
`,; with lysine and biollavonoids
`-—
`' -'"‘
`ed B-complex vitamins in a herbal
`.
`=
`on
`d
`51, of US_R
`Pei’
`053
`-mgnwntration 25,000 LU.‘ per spray
`-.
`the nutrient needs during syndrome
`wmbinstion with Ascorbic Acid and D-At
`upplement nutrient needs, aid smoking
`
`ariack replacements wiI:h_ a combination
`B-12 and Chromium Polynicotinate
`
`Am.flN1STRATI0N
`(except Vit. A formula, 1 spray = 1 dose).
`“E, 1'1-youth 2 sprays 4 times per day.
`LED
`hints] Sprays are supplied in a 13.3 ml vial
`.
`.
`':i_n1ately 240 metered sprays from a non-
`_
`_-...—————e
`_
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`EDUCATIONAL MATERIAL
`
`lions] literature on oral absorption will be
`mquest to Regency Medical Research.
`
`arch industries Corporation
`Eauticel Division
`‘ours coo wssr
`'
`,' UTAH econ
`
`'
`
`yl Itllfoitldel
`
`opponent oI‘Rimso®-E0 is sterile and progen-
`Iulioxide.
`-
`
`been proved to be clinically effective for the
`gelicf of patients with iriterstifial cystitis.
`ORELATION
`insti.lletion of Rin'I.so®-50 may be harmful to
`tract malignancy because of dimethyl
`tread vasodilation.
`side can initiate the liberation of histamine
`been occasional hypersensitivity reactions
`'
`bdmmistratioo.
`1°" __ ndo should be used during pregnancy only if
`- benefit justifies the potential risk to the fetus.
`
`'
`traad of dimethyl sulfoxide (romeo;
`i-POW Solution for intravesical instillation.
`.54 gm dimet hyl sulfoxide STERILE AND
`
`ation for the treatmclnt of interstitial
`
`1 DR LV. INJECTION
`
`.
`
`-
`l"ll3ll5 dispensing without a prescription.
`i3'°|'i9_l'l_l: ol'Rl'MSO@-50 is dimethyl sulfoxide
`fflplncel formula C2H30S'.
`is a clear, colorless and essentially odor-
`h is miscible with water and most organic
`lilfsical characteristics include: molecular
`_ hilt point 18.<l'C, and a specific gravity of
`
`l’H-fiRMac0L0GY
`We is metabolized in man by oxidation to
`N .‘.''1° or by reduction to dimethyl sulfide. Di-
`- .9 find dimethyl sulfons are excreted in the
`Dlnicthyl sulfide is eliminated through the
`and is responsible for the characteristic odor
`' °-I.‘ ‘llmethyl sulfoxide medication. Dimethyl
`who serum for longer than two weeks after
`mlfilcal instillation. No residual accumulation
`‘lids has occurred in man or lower animals
`“ed treatment for protracted periods of time.
`
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