C
`
`RDR®
`55
`2001
`
`EDITION
`
`PHYS CANS'
`DESK
`REFERENCE®
`
`Senior Vice President, Directory Services: Paul Walsh
`
`Vice President, Sales and Marketing: Dikran N. Barsamian
`National Sales Manager, Custom Sales: Anthony Sorce
`Senior Account Manager: Frank Karkowsky
`·Account Managers:
`Marion Gray, RPh
`Lawrence· C. Keary
`Suzanne E. Yarrow, RN
`National Sales Manager, Medical Economics Trade Sales:
`Bill Gaffney
`Senior Business Manager: Mark S. Ritchin
`Financial Analyst: Wayne M. Soltis
`Vice President, Clinical Communications and
`New Business Devel9pment: Mukesh Mehta, RPh
`New Business Development Manager: Jeffrey D. Dubin
`Manager, Drug Information Services: Thomas Fleming, RPh
`Drug Information Specialists: Maria Deutsch, MS, PharmD, COE;
`Christine Wyble, PharmD
`Editor, Directory Services: David W. Sitton
`Project Manager:. Edward P. Connor
`
`Senior Associate Editor: Lori Murray
`Assistant Editor: Gwynned L. Kelly
`Director of Direct Marketing: Michael Bennett
`Direct Mail Manager: Lorraine M. Loening
`Senior Marketing Analyst: Dina A. Maeder
`Director of Production: Carrie Williams
`Data Manager: Jeffrey D. Schaefer
`Production Manager: Amy Brooks
`Production Coordinators: Gianna Caradonna, Dee Ann DeRuvo,
`Melissa Katz·
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`
`------------~ the content of this publication may be reproduced, stored in. a.retrieval system, resold, redistributed, or transmitted in any form or
`MEDICAL ECONOMICS Copyright© 2001 and published by Medical Economics Company, Inc. at Monh(ale, NJ 07645-1742. All rights reserved. None of
`by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of the publisher.
`THOMSON HEALTHCARE
`PHYSICIANS' DESK REFERENCE®, PDR®, Pocket PDR", The PDR® Family Guide to Prescription Drugs", The PDR® Family
`Guide to Women's Health and Prescription Drugse, and The PDR" Family Guide to Nutrition and Healthe are registered trademarks used herein und.er license. PDR for
`Ophthalmic Medicines™, PDR for Nonprescription Drugs and Dietary Supplements™, PDR Companion Guide™, PDR Pharmacopoeia™ Pocket Edition, PDR"for Herbal
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`Encyclopedia of Medical Care™, The PDR® Family Guide to Natural Medicines and Healing Therapies™, The PDR" Family Guide to Common Ailments™, The POW Family
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`Officers of Medical Economics Company: President and Chief Executive Officer: Curtis B. Allen; Vice President, New Media: L. Suzanne BeDe/1; Vice President, Corporate.Human
`Resources: Pamela M. Bilash; Chief Financial Officer: Christopher Caridi; Vice President and Controller: Barry Gray; Vice President, Finance: Donna Santarpia; Senior Vice President,
`Directory Services: Paul Walsh; Senior Vice President, Operations: John R. Ware
`
`ISBN: i-56363-330-2
`
`

`

`CONTENTS
`
`Manufacturers' Index (White Pages)
`Section 1 .
`Lists all pharmaceutical manufacturers participating in PHYSICIANS' DESK REFERENCE.
`Includes addresses, phone numbers, and emergency contacts. Shows each manufacturer's
`products and the page number of those described in PDR.
`
`Brand and Generic Name Index (Pink Pages)
`Section 2
`Gives the page number of each product by brand and generic name.
`
`,...
`
`,
`
`,
`
`-
`
`101
`
`201
`
`301
`
`401
`
`3497
`
`Product Category Index (Blue Pages)
`Section 3
`Lists all fully described products by prescribing category. An overview of the headings
`appears on pages 201 and 202.
`
`. Product Identification Guide (Gray Pages)
`Section 4
`Presents full-color, actual-size photos of tablets and capsules, plus pictures of a variety of other
`dosage forms and packages. Arranged alphabetically by manufacturer.
`
`Product Information (White Pages)
`Section 5
`The main section of the book. Includes entries for over 3,200 pharmaceuticals. Listings are
`arranged alphabetically by manufacturer.
`
`Diagnostic Product Information
`Section 6
`Gives usage guidelines for a variety of diagnostic agents. Arranged alphabetically by manufacturer.
`
`Key to Contolled Substances Categories .............................................. .................................................... 344
`Gives the definition of each category and the prescribing limitiations that apply.
`Key to FDA Use-In-Pregnancy Ratings ......... ............................................................................................. 344
`Provides the exact interpretation of each risk/benefit rating.
`Poison Control Centers ............................................................................................................................ 345
`A national directoryarranged alphabetically by state and city.
`U.S. Food and Drug Administration Telephone Directory ........................................................................... 3507
`Gives numbers of key reporting programs and information services.
`Drug Information Centers: ........................ : ......................................................... , ................................... 3509
`A national directory of drug information services, organized alphabetically by state and city.
`Look-Alike, Sound-Alike Drug Names .................. , .......................................................................... , ........ 3515
`Lists names that cause confusion, and shows the other brands and generics that might be it1tended.
`Adverse Event Report Forms .............................. , .................................................................................... 3519
`Contains master copies and instructions for completion.
`
`

`

`PRODUCT INFORMATION
`
`OVER 30 MINUTES, AND DOSES Of 125 MG OF ELEMEN(cid:173)
`TAL IRON WERE ADMINISTERED OVER ONE HOUR. THIS
`RATE OF ADMINISTRATION 12.1 MG/MIN) SHOULD NOT
`_BE EXCEEDED. See ADVER SE REACTIONS.
`PRECAUTIONS
`General:
`Iron is 'not easily eliminated from the body and
`accumulation can be toxic. Unnecessary therapy with par(cid:173)
`enteral iron will cause excess storage of iron with conse(cid:173)
`quent possibility of iatrogenic hemosiderosis. Iron overload
`is particula~ly-:ap~ to occur in patients with h_expoglobinop(cid:173)
`athies and other refractory anemias. Ferrlecit® should not
`be administered to patients with iron overload. See OVER-
`f'i 'DOSAGE.
`.
`Carcinogenesis, 'Mutagenesis, Impairment of Fertility: Long(cid:173)
`t.erm carcinogenicity studies in animals were not performed.
`Studies to asseSS .. the effects of Ferrlecit® on fertility were
`not conducted. ·Ferrlecit® was not mutag~ni~• in· the Ames.
`test and the rat micronucleus test. ~t ~r<J.d.uc~ ic;l~stogeµir
`effect in an in uitro chromosomal aberratfon 3.ssay iri Chin(cid:173)
`ese hainster Ovary ceus.
`Category B: Fetrlecit® \vas not fera_toge'niC
`of elementa~ . iron up
`to TOO mg/kg/d_ay
`. mice and 20 mg/kg/day (i20 mg/m2/day)
`surface area IJasis, these doses were 1.3
`t~e recommended human ?ose (125 mg/day
`/day) for a person of 50 kg body weight, aver(cid:173)
`d body surface area of 1.46 m2. There were no
`d ·well-contrq.J.l0d studie~ in pregnant . v,,omen.
`ould be used during pregnancy only if the po(cid:173)
`t justifies the potential risk to the fetus.
`hers: It is not known whether this drug is ex(cid:173)
`man milk. Because many drugs are excreted in
`ution should be exercised When Ferrlecit® i~
`. a nursing woman.
`Safety and effectiveness of Ferrlecit® in pe-
`s has not bee11 established. Ferrlecit®. con(cid:173)
`ohol and therefore should not be used in neo-
`
`Clinical studies of Ferrlecit® did not in(cid:173)
`ers of sribjects aged 65 and over to de(cid:173)
`nd differently from younger sub(cid:173)
`clinical experience has not identified
`ses between the elderly and younger
`lar, 51/159 hemodialysis patients .in
`cal studies were aged, 65 years or older.
`, no differences in s3.fety or efficacy as
`were identified. In general, dose selection for
`· ent should be cautious, usually starting at
`the dosing range, reflecting the greater fre(cid:173)
`ecreased hepatic, renal, or card.iac function, and
`tant disease or other drug therapy.
`
`to Ferdecit® has been documented in 385 pa(cid:173)
`ialysis. Of these, 159 were patients in North
`ies and.,226 were European -patients de(cid:173)
`edical literature.
`ypotension: See WARNINGS.
`ypotension have been reported following ad(cid:173)
`Ferrlecit® in EurQpean ease reports .. Ofthe
`sis patients exposed to Ferrlecit® ~nd re(cid:173)
`, 3 (1.3%) pa~ents experienced serf·
`wp.ich were a:ccompaniedby f;lushing
`reversed after one hour without se-
`
`nical studies the incidence of any hy(cid:173)
`vho received Ferrlecit®,B.2.5 mg of el(cid:173)
`inutes WP.S similar to the incidence of
`ts who received Ferrlecit® 125 mg of
`inutes (34% vs. 36%).
`to be aW!1inistered during dial)'siS
`ients m.iy e:\.-perience transierit hy(cid:173)
`f Ferrlecit® may augment hypo-
`
`aluated in North American clin(cid:173)
`. enced a transient decreased
`hypotension. Another patient
`aturely because of ·dizziness,
`ma1aise, and weakness without
`n a 3-4 hour hospitalization for
`administr8:tion. The syndrome
`
`ity reactioris: have not occurred
`Fe.rrleci~, insufficient nwn(cid:173)
`ave been exposed to observe this
`lecit®-associated hypersensitivity
`Type· III reactions that occurred in
`(3.4%) Ferrlecit®~treated patients
`premature study discontinuation.
`rew after the development of pruri~
`wing the test dose ofFerrlecit®. The
`· h-dose,group, experienced· nausea,
`e . and r.ash following the
`t, in the low-dose
`allowing the first
`patiemts exposed to Ferrlecit®
`hypersensitivity reactions. Hy(cid:173)
`e not reported in 33 additional
`ith maintenance Ferrlecit®• in North
`·s group includes five chronic hemo.di(cid:173)
`·th a.history of anaphylaxis to iron dextran
`up to 1000-mg of Ferrlecit® without an aller-
`
`Of the 226 renal dialy?is patients exposed to .Ferrlecit® and
`reported in the literature, 2 (0.9%) patients experienced ad(cid:173)
`verse events that recurred on drug rechallenge and P.rohib·
`ited further drug .U~, These were: (1) malaise, heat, vomit(cid:173)
`ing, and loin pain ·and -(2) intense epigastric pain,lasting
`3-4 hours.
`From a total of 387 Ferrlecit®-treated patients in medical
`reports and North American trials, six patients (1.6%) expe(cid:173)
`rienced serious reactions which precluded .further therapy
`with Ferrlecit®.
`Adverse Laboratory Changes: No differences in laboratory
`findings associated with Ferrlecit® were reported in North
`American clinical' trials when normalized· against a Na(cid:173)
`tional Institute•\}f Health database on laboratory findings in
`1,100 hemodialysis patients.
`Other -Aduerse,• Euents Obserued During- Clinical Trials:
`.Ferrlecit® has been administered to 159 patients in North
`American clinical trials. During these trials, all adverse
`events•were recorded by clinical investigators using termi(cid:173)
`nology of their own choosing. Adverse events, whether or
`;nQt related-to Ferrlecit® administration, reported in >1% of
`Ferrlecit@..treated patients from trials A and B are catego(cid:173)
`rized below by body system using modified COSTART ter(cid:173)
`minology and ranked in order of decreasing frequency
`within each system. Hemodialysis patients· mii.y have simi(cid:173)
`lar symptoms related to dialysis itself or to chl:'oilic rel.}al
`failure.
`Body as a Whole:
`injection site reaction, pain, chest pain,
`asthenia, headache, abdominal pain, fatigue, fever, malaise,
`infection, back pain, rigors, chills, arm pain, flu-like syn-
`drome, sepsis, carcinoma.
`·
`Neruous System: cramps, dizziness, leg cramps, paresthe(cid:173)
`sias, agitation, insomnia, somnolence.
`Respiratory: dyspnea, coug~ing, upper respiratory infec(cid:173)
`tions, rhinitis, pneumonia.
`Cardiovascular System: hypotcnsion, hypertension, syn(cid:173)
`cope, tachycardia, bradycardia, angina pectoris, myocardial
`infarction, pulmonary edema.
`Gastrointestinal System: nausea, vomiting, diarrhea, rec(cid:173)
`tal disorder, dyspepsia, eructation, flatulence, melena.
`Musculoskeletal System: myalgi.a, arthralgia.
`Skin and Appendages: pruritus, increased sweating, rash,
`Genitourinary System: urinary tract infection.
`Special Senses: conjunctivitis, abnormal vision.
`Metabolic and Nutritional Disorders: hyp€rkalemia,-gen(cid:173)
`eralized edema, leg edema, hypoglycemia, hypokalemi~,
`edema, hypervolenria.
`Hematologic System: abnormal erythrOCytes, anemia, lym(cid:173)
`phadenopathy.
`OVERDOSAGE
`Dosages in excess of iron needs may lead to accumulation.of
`iron-in iron storage sites and hemosiderosis. Periodic mon(cid:173)
`itoring of laboratory parameters of iron levels storage may
`assist in recognition of iron accumulation. Ferrlecit® should
`~9_t_'be admin~stered i!l. patients w:_ith iron overloa9,. _
`Serum._iron.levels greater than 390.µg/dL {combined with
`transferrin overs8:turation) may indicate iron poisoning
`which is chai:acterized by abdominal pain, diarrhea, or vom(cid:173)
`iting which progresses to pallor or cyanos.is, lassitude, drow(cid:173)
`siness, hyperventilation due .to acidosis, and cardiovascular
`collapse. Symptoms attributed to oversaturation oftransfer(cid:173)
`rin following tapid IV infusions of Ferrlecit® have been re(cid:173)
`ported in two patients.
`. . . , ,
`The Ferrlecit® iron complex is not dialyzable.
`Ferrlecit® at elemen.tal .irori doses ofl25 mg/kg, ·18.B mg/kg,
`62.5 mg/kg and 250 mg/kg caused deaths to mice, rats, rab(cid:173)
`bits, and dogs, respectively. The major symptoms of ac~~
`toxicity were decreased activi.ty, staggering, ataxia, .in(cid:173)
`creases in the respiratory rate, .tremor~ and convulsions.
`DOSAGE AND ADMINISTRATION
`The dosage of Ferrlecit® is expressed in terms of mg of ele(cid:173)
`mental iron. Each.5 mL ampule contains 62.5 mg of elemen-
`tal iron (12.5 mg/mL}.
`'
`Before initiating therapeutic doses',of Ferrlecit®, adminis(cid:173)
`tration of an
`int ravenous
`test dose of 2 · mL
`Ferrlecit<ll) (25 mg of elemental iron) is recommended. This
`test dose shOuld be dihit€d in 50 mL of 0.9% sodfom chloride
`for injection and administered over sixty minutes.
`'
`The reco·mmended dosage of Ferrlecit® for · the repletion
`treatment of ii::on deficiency ln hemodialysis p·atients is
`10 mL of Ferrlecit® (125 mg of elemental iroil.) diluted in
`100 ruL of 0.9% ·sodium chloride for iiljection, administered
`by inti-avenOus infusion ·over 1 hour. Most patients" will re•
`quire a mitiimum cuffiulati.ve dose Of 1.0 gram of elemental
`iron, administered 'over· eight sessioils at sequential dialysis
`treatment, to achieve a favorable hemoglobin or hematocrit
`response. Patients may cOil.tinue to require therapy with
`Ferrlecit® or other intravenous iron preparations at the
`lowest dose necessary to maintain the target levels of hemo(cid:173)
`globin, hematocrit, and laboiatory pa·rameteis of iron stor(cid:173)
`age within ae<;eptable limits.
`Ferrlecit® has been adminhtered at sequential dialY'sis ses(cid:173)
`sions by infusiori during the dialysis session itself.
`Note: Do not mix Ferrlecit® with other medications, or
`add to parenteral nutrition ~lutions for iiitravenous infu(cid:173)
`sion. The compatibility of Ferl'iecit® with intravenous infu(cid:173)
`sion vehicles other than 0.9% .sodium chlOride for inje_ctioll
`has not been evaluated. Parenteral drug prcid ucts should be
`inspected visually for particulate matter 'and discolor ation
`before administration, whenever the solution and ·container
`_permit.
`Use immediately after_ dilution in saline ..
`
`HOW SUPPL IED
`Ferrlecit® is supplied in colorless glass' ~mpul;s .. ,
`a viscous dark red solution with no visible partic~
`ter. Each aiµpule contains 62.5 mg of elemental iron.~-
`for intravenous use, packaged in cartons of 10 ampules,~,
`Store at' 20°C-25°C (68°F-77°F); excursions permitted-~, ;
`15°C-30°C ·(5!)..86°FJ. See USP Controlled Room Tempera(cid:173)
`ture.
`Caution: Rx Only
`© Schein Pharmaceutical, lnc. ·and R&D Laboratories, Inc.
`1998.
`Shown ,in Product Identification Gui.de, page 334
`
`INFeD"
`(IRON DEXTRAN INJECTION, USP)
`
`WARNING
`THE PARENTERAL USE OF COMPLEXES OF IRON AND
`CARBOHYDRATES HAS RESULTED IN ANAPHYLACTIC(cid:173)
`TYPE REACTIONS. DEATHS ASSOCIATED WITH SUCH
`ADMINISTRATION HAVE BEEN REPORTED. THERE- ·
`FORE, INFeD SHOULD BE USED ONLY IN THOSE PA(cid:173)
`TIENTS IN WHOM THE INDICATIONS HAVE BEEN
`CLEARLY ESTABLISHED AND LABORATORY INVESTI(cid:173)
`GATION$ CONFIRM AN IRON DEFICIENT STATE NOT
`AMENABLE TO ORAL IRON. THERAPY.
`
`I
`
`DESCRIPTION
`INFeD (iron dextran injection.USP) ·is a dark brown,
`slightly viscous sterile liquid complex of ferric hydroxide
`and dextran for intravenous or intramuscular use .
`Each mL contains the equivalent of 50 mg of elemental iron
`(as ·an iron ·dextran complex), approximately 0.9% sodium
`chloride, in water for injection: Sodium hydroxide and/or hy(cid:173)
`drochloric acid may -have been used to adjust pH. The pH of
`the solution is between 5.2 and 6.5.
`The iron dextran complex has ari. average appiirent molecu(cid:173)
`lar weight of 165,000 g/mole with a ra:nge of approximately
`+/- 10%.
`Therapeutic Class: Hematinic
`CLINICAL PHARMACOLOGY.
`Genera l: · After intramuscular injecti~n, iron dextr:an,is._ab(cid:173)
`sorbed fi:o,m the injection· site into the capillaries and the
`lyrilphatic system. Circulating -iron .dextran is removed fro~
`the plasma by cells of th,e reti.culoendothelial system, which
`split the complex into its components of iron and dextran.
`The iron is immediately bound to the available protein mo.i(cid:173)
`eties to form hemosiderin or ferritin, the physiological forms
`.of iron, or to a lesse_r extent to transferrin. This iron which is
`subject to physiological control replenishes hemoglobin and
`depleted iron stores.
`Dextran, a polyglucose, is either metabolize<.f or excreted.
`Negligible amounts: of ir.on are lost via the .urinary or ali(cid:173)
`mentary pathways after administration of iron dextran.
`The major portion of intrainuscular injections of Jron, dex(cid:173)
`tran is absorbedMithin 72 hoµrs; most of the remaining iron
`is absorbed over the ensuing 3 to 4 weeks.
`Various studies involving intravenously administered 59Fe
`iron dextran to iron deficient subjects, some of whom had
`coexisting diseases, have yielded half-life values ranging
`from 5. hours to more than 20 hours. The 5:hpur value was
`determined for 59Fe iron dextran from a study that used lab(cid:173)
`oratory methods to separate the circulating 59Fe iron dex(cid:173)
`tran from the transferrin-bound 59Fe. The 20-hour value re(cid:173)
`flects a half-life determined by measuring total 59Fe, both
`circulating and bound. It should be understood that these
`half-life values do not represent clearance of iron from the
`body. lr on is not easily eliminated from the body and ~ccu(cid:173)
`mulation of iron can be toxic.
`In vitro studies ha~e shown that removal of iron dextran by
`dialysis is negligi.ble.1•.2 Six different dialyzer membranes
`were investigated (pp1ysulfone, cuprophane, cellulose, ace_(cid:173)
`tate, cellulose triace4tte, polymethylmethacrylate and poly(cid:173)
`acrylonitrile), including those considered high efficiency and
`high flux.
`INDI CATIONS AND U SAGE
`Intravenous or intramµscular injections of iron dextran are
`indicated for treatmerit of patients with documented iron
`deficiency in whom oral administration is unsatisfactory or
`impossible·.
`·-
`·
`·
`·
`
`CONTRAINDICATION S
`Hypersensitivity to the product. All anemias not associated
`with iron deficiency.
`·
`·
`WARNINGS
`See BOXED WARNING.
`A risk of carcinogenesis may attend the intramuscular in(cid:173)
`jection of iron-carbohydrate complexes. Such complexes
`have been .fou® under experimental conditions to produce
`sarcoma when large doses or small doses_. injected repeat(cid:173)
`edly at the same,site were given to rats, mice, and rabbits,
`and possibly in hamsters.
`The-long latent period between the injection of a potential
`carcinogen and the appearance of a tumor makes it impos(cid:173)
`sible to measure accurately the risk in man. There have,
`however, been several reports in th~ Jiterature describing
`tumors at the injectiQn site in humans who had previously
`
`Continued on next page
`
`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`Consult 2 0 O 1 PDR8 supplements and future editio.ns for revisions
`
`

`

`2880/SCHEIN
`
`INFeD-Cont.
`
`PHYSICIANS!DESK REFE
`
`-'• mLblood
`lb body weig
`65mL/kg
`weight
`b) Normal hemoglobin (males ··and females)
`14.8 g/dl
`over 15 kg (33 lbs)
`12.0 g/
`15 kg (33 lbs) or less , ..... : .. :.:.
`0.34%
`c) Iron content•ofhemoglobin . ...
`d) Hemoglobin•deficit
`,
`, •·• .
`., , ,.
`.
`e) Weight
`Based ohthe above factors, individuals with nornlahhemoglobin' levels y;ilJ'have appro
`·
`_•
`. ,
`,
`·•
`:. .
`kilogram of body weight (15,mgllb).•, .,
`Note: The table and accompanying formula are applicable for dosage detenn.inations
`·
`·
`·
`·
`deficiency anemia;.they are
`loss.
`
`kg
`
`lb
`
`(g/dl)
`
`15,
`18
`21
`23
`26
`28
`31
`34
`36
`39
`41
`
`'
`
`,.
`
`: , , ,
`
`,
`
`_,
`
`:
`
`;-:
`
`_ "'"
`
`__ ·:
`
`__
`
`__
`
`received intramuscularjnjectioris of iron-carbohydrate com-
`• ••
`·
`· ·.•
`·
`plexes.
`Large intravenous doses, such as·used with total dose infu(cid:173)
`sions (TDI), have been associated with an increased inci(cid:173)
`dence of adverse effects. The adverse effects frequently:-are
`delayed (1-2 days) reactions typified by one or more of the
`following Symptoms; arthralgia, backache, chills, dizziness ,
`moderate to high fever, headache, malaise, myalgia, nausea,
`and vomiting. The onset is usually 24-48 hours after ad(cid:173)
`ministration and symptoms generally subside within '3-4
`days. These symptoms have also been reported following in(cid:173)
`tramuscular injection and generally subside within 3-:-7
`days. The etiology of these reactions is not known. The po(cid:173)
`tential for a delayed reaction must be considered wheit'· es'
`timating the risk/benefit of treatment.
`The maximum daily dose should not exceed 2 mL undiluted
`.
`iron dextran.
`Tiris preparation should be used with extreme care in pa(cid:173)
`tients with serious i'mpain'nent of liver . function .. . · - ·' .
`It should·not be used during the acute .. phase of infectious
`· ·
`·
`·
`kidney disease.
`Adverse reactions l!xperienced following ·administration of
`INFeD may exacerbate cardiovascu!ar ·.complications in pa(cid:173)
`tients y;ith pre-existing cardiovascular. disease,
`PRECAUTIONS
`General: Unwarranted therapy with pai:enteral · irori ,viii
`cause excess storage of iron with"the consequent possibility
`of exogenous hemosiderosis. Such iron overload is particu(cid:173)
`larly apt to occur in patients with hemoglobinopathie,i"'and
`other refractory anemias that might be erroneously diag-
`. .
`-nosed as iron deficiency anemias.
`INFeD should be used with caution in individua ls with his(cid:173)
`tories of significant allergies and/or asthma.
`Anaphylaxis and other hypersensitivity reactions have been
`reported after uneventful test. doses as well as therapeutic
`doses of iron dextran injection. Therefore, administration of
`subsequent test doses during therapy should be considered.
`(See DOSAGE AND ADMINISTRAT!ON: Administratiorr:)
`Epinephrine should be immediately _available in the event
`of acute hypersensitivity reactions. (Usual adult dose·: 0.5
`mL of a 1:1000 solution, by subcutaneous or intramuscular
`injection.)
`Note: Patients using beta'.biocking agents may not re(cid:173)
`spond adequately to epinephrine. Isoproterenol or similar
`beta-agonist agents may be required in these patients.
`Patients with rheumatoid arthritis may have an acu_te ex(cid:173)
`acerbation of joint pairr and swelling following the adminis0
`·•
`•·
`tration of INFeD.
`Reports in the literature from countries outside the United
`States (in particular,New Zealand)have suggested that the
`use of intramuscular iron dextiah in neonates has been as(cid:173)
`sociated with an increased incidence of gram-negative sep'
`sis, primarily due to E. Coli.
`Information . For Patients: Patients should be advised of
`the potential adverse reactions associated with the use of
`INFeD.
`Drug/laboratory Test' l11teractioris: Large doses of iron
`dextrarr (5 mL or more) have been reported' to give a brown
`color to serum from a blood· sample drawn 4 hours after ad(cid:173)
`;:'/
`__
`'· :-_
`_.-
`-:..
`'-:. ;'
`_-
`.
`-~inistration.
`The drug may cause falsely elevated· valu'es of serum bilii'ii'
`biri and falsely decreased values of Serum calcium,
`Serum iron determinations (especiany by colohfoetric as(cid:173)
`says) may not be meaningful for 3 weeks following the ad(cid:173)
`ministration ofiron dextran.
`Serum ferritin· peaks approximately 7 to 9 days after an in(cid:173)
`travenous dose ofINFeD and slowly returns to baseline af-
`•,
`·. '
`· ·
`·· . ·:.
`·.
`•
`ter about 3 weeks.
`Examination of the bone marrow for iron stores' may· not be
`meaningful for proloriged periods followirig iron ·abtrah
`therapy because residual iron-dextran ·may remain in the
`· "
`·
`·
`reticuloendotheliai'cells. ·
`Bone scans involving 99m.-Tc'.diphosphonate have been ·re(cid:173)
`ported to show a· dense, crescentic area of activity in the but(cid:173)
`tocks; following the contour of the•iliac crest, l to · 6 days
`after intramuscular injections of iron deid:ran. -
`Bone scans with 99m Tc-labeled bone seeking agerits, in' the
`presence of high serum ferritinlevels oi: following _ir~n dex-
`tran jnfusions, h ave been reporte<l to . 5ho:-v, reductio11 of
`bony uptake , marked renal activity, a11d. excessive blood po~!
`. .'
`· . .. •··• .,.:
`.
`. . ·,,
`. ,
`and ~oft. fosue accumulation. ,
`Carcinogenesis, Mutagenesis, Impairment Of Fertility: See
`WARNINGS.
`Pregnancy:., Pregnancy Catego'ry · C: .: •Iron · dextran -has
`been shown to be teratogenic.and embryocidal in mice, rats,
`rabbits, dogs, and monkeys when given -in doses .. of about.3
`times the maximum human dose .
`No consistent adverse fetal effects were observed in mice,
`rats, rabbits, dogs and monkeys at doses of 50 mg iron/kg or
`less. Fetal and maternal toxicity has been reported-irr mon·
`keys at a-totalintravenous dose·of 90 mg iron/kg over-a 14
`day period. Similar effects were observed in mice and rats
`on administration of a single dose of 125 mg iron/kg. •Fetal
`abnormalities in rats and-dogs were observed at doses · of '
`250 mg iron/kg and higher. The animals used in these tests
`were not -iron deficient. There ·are no adequate and:well(cid:173)
`controlled studies •in pregnatrt -women. INFeD should ·be
`used during pregnancy only if the potential·benefitjustifies
`the potential risk to the fetus,·
`Placental Transfer: Various animal-studies and studies in
`pregnant humans have demonstrated inconclusive results
`with respect to the placental transfer of iron dextran as iron
`Information will be superseded by supplements arid subsequent editions
`
`2
`2
`3
`3
`lL
`5
`4
`5
`5
`7
`22
`10
`7
`7
`8
`10
`33
`15
`11
`13 '
`12
`16
`44
`20
`14
`15
`16
`20
`.55 .
`· 25
`17
`18
`19
`23
`66
`30
`23 ,
`20
`21
`27
`77
`35
`22
`24
`26
`31
`88
`40
`25
`27
`29
`35
`99
`45
`28
`30
`32
`39
`110
`50
`31
`33
`36
`, 43 .
`121
`55
`34
`36
`39
`47
`132
`60 ..
`36
`39 .
`. 42
`51
`143
`65
`39
`42
`45
`55
`154
`70
`42
`45
`49
`59
`165
`75
`45
`. 52
`48
`63
`176
`80
`48
`51
`55
`66
`187
`85
`50
`54
`58
`His
`70
`90
`53
`57
`62
`74
`209 .
`95
`56
`60
`65
`78
`220
`100
`59
`63
`68
`82
`231
`105
`62
`67
`71
`86
`242
`110
`64
`70
`75
`80
`90
`253
`115
`67
`73 _
`78
`83
`94
`264
`120
`;' Taj)le values ,yere calcµlated based on, 'l normal adult hemoglobiri of ~4,3'g/dlfor weights ~eat~r thaii 15 ~g (33 lb~)
`·
`·
`·
`·
`' •
`a hemoglobin of 12.0 g/dl for weights Jess than or equal to 15 kg (33 lbs).
`excess of the requirements for ,restoration of,hemog
`dextran. It appei'rs tilat some iron ~oes ?'each the _f~tus, but
`::r!?~: ~oit:;~ itJ~ri~i;~ ~t~~/a'c:~i:x~i~~!J1!'if~n IN-
`and replenishine'ilt ofiron stores may lead to hemoside
`Peri?dic 'monitoring ~fserum fert itfn'. J'ev~ls may
`in- recognizing a ,deleterious progressive accum
`iron 'resulting !TOlll impafred uptake of iron fro,n th,fr
`,.;10~1).dotheHal ~ys~e;n . in c?ncr1rr,ent r,ned_ical. cor1di
`such .as chronic renal failure , Hodgkin's d,se~ e, and r
`matoid a rthritis. Tbe LD 50 o'r iron dext;an is\ iot ·1es~
`.,
`500 mg/kg in. the mouse.
`DOSAGE AND ADMINISTRATION
`'oral ii'o'n should be disconti'nued prior to admi'nihrati;
`'•
`.
`._
`'
`.,
`...
`'
`·' _ .. ,
`. - '
`lNFeD.
`[)o~_agt!': ,'> : ~ .. . .-.. _ _ :,.:-i. --~• :,;:,_,1
`,1_ ·;
`I. fro,:, Deficiency Anemia: Periodic hematologic. determi'.
`nation (hemoglobin .. and hematocrit) is, a, ,si,npJe: ~nd accu(cid:173)
`rate technique for monitoring hematological response,.and
`should be used as a guide in therapy. It should be recognized
`that,iron. storage .may lag. behind the appearance of normal
`blood-morphology. ,Serum iron, total i;'on binding capacity
`(TIBC). and,percent saturation of trarrsferrin are other im(cid:173)
`portant tests,for detecting and monitorirrg the iroh·deficieril
`'
`.. ,,_
`state. ,,,
`After admiriistfati611 offrori 'dextr'an -cbmplex, evidence
`therapeutic respons7 -.?~'\ be seen in ·a 'few ctays as an
`Although ser\nµ 'fegitin, 'is usually" go<ld guide to body ir~n
`~rease in t~e ~eticr1]0.cyte · count.
`stores, ~h'J'corre]a~ono~b~f,-;irin .stor~s _arid serWIJ ferri~
`may _IlOt be v~lidjn p'atie'nts Oll ~h.rm,,if r_ew,1 di~lysis who
`are also receiv1ng iron de; tran complex. i ,
`Altho11gh there _are significant yariatio11s in b~dy build ang
`. weight ,distribution-among m,tles and females, the accompa
`nying table. and.formula -represent i i convenient means.for
`estimating-the total iron required·.,.This total iron require(cid:173)
`ment reflects the amount•ofiron needed to restore hemoglo(cid:173)
`bin concentration to ·normal,or near. normal levels plus an
`additional allowance to provide a dequate replenishment of
`iron stores in. most irrdividuals with moderately or se~erely
`reduced levels ofh-emoglobin. It should.be remembered that
`iron deficiency anemia. will not appear until•.essentially
`irori-stores have been depleted; Therapy,thus, should·aim
`not only replenishinent·ofhemoglobin iron but iron stores
`•,
`. well.'
`Factors contributing ,to the Tormula are shown below.
`[See first table above]
`[See second table above]
`
`·
`
`FeD is administered to a nursing womarr-. Traces of unme(cid:173)
`tabolized iron dextran are- excreted, in human milk.
`Peiliatric Use:'· Not-recommended for use in infants under 4
`months of age. (See DOSAGE AND ADMINISTRATION.)
`ADVERSE REACTIONS
`Sevexe/Fatal: Ani'phylactic r litc~ions 11,.JE1 been reported
`with the use of iron dextran injection; on · occasi6rrs these
`reactions have beeri fatal. Such' reiictio,rs_, which occur most
`'ofteri within the first several· minutes of administration ,
`have beet- generally- characterized •by sudden onset of respi(cid:173)
`ratory difficulty and/or:c,ardiovascular collapse\ (See: boxed
`WARNING and PRECAU,TJ,ONS: General, pertaining to i,n-
`' ·
`· ·
`'
`mediate availability of epihephririe.)
`Cardiovascular: • · Chest pain, chesttightnes·s, shock, cardiac
`arrest,•hypoterision, . hypertension; tacfiycardia,, bradycar(cid:173)
`dia, flushing, arrhythmias. (Flushing and .hypotension may
`occur from too rapid ii_,.jections by the:intravenous route.)
`Dermatologic: Urticaria, pJuritus,, purpura, r'lsh,,cyano-
`. ,.,
`.-•.
`. , .. , .. . , "°'' ., , :, . , . -:::-
`.
`. . . _
`,
`"
`sis.
`gll~tr<>in1tistinal: Abdomin11l pain, nausea, yo,niting, _diar-
`.·,
`, .· _;· ,;,,, ·: ·
`:-
`,.,
`:
`.. , . . ,·.•:·•
`·
`:.·..
`rhea.
`Hematologic/l'(mphatic:. • .- Jceucocytqsis, :• ly,nphad~119pa}hy.
`Musrulo.skeletal_/soft tissue: ; Arthr!'lgia;. arthritis (may
`represent. reactivation in patients withe qu,escent rheuma-
`19i( arth;fihs---,~~e, l'RE,CA{JTIO,NS: , G-eiiera]), . m~"!lgia;
`backache; sterile abscefS, atrophy/fibrosis (intramuscular
`injection site); prow,n; s!pn _al).d/or Ul).Mrlying tiss,ll~ .dissolor,
`~tion '(stainiIJ.g), s oreness o~ Pa.Ul ,at or}i~~rjntra,nusc1:1lar
`injection sites; cellulitis; _ swelling; _inflammation; _ local phle-
`,-'- " ,
`bitis at, or nea! fatray~nous injectioIJ. site. , ,