57
`2003
`
`EDITION
`
`PHYSCANS'
`DESK
`REFERENCE"
`
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`TH 0 M S 0 N
`
`Copyright© 2003 and published by Thomson PDR at Montvale, NJ 07645-17 42. All rights reserved. None of the content of this publication
`may be repro<;,luced, stored in a retrieval system, resold, redistributed, or transmitted in any form or by any means (electronic, mechanical,
`photocopying, recording, or otherwise) without the prior written permission of the publisher. PHYSICIANS' DESK REFERENCE®, PDR"',
`PDR
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`Officers of Thomson Healthcare: President and Chief Executive Officer: Richard Noble; Chief Financial Officer and Executive Vice President, Finance: Paul J. Hilger;
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`
`ISBN: 1-56363-445-7
`
`

`
`Tranxene-Cont.
`Tra nxene-_——Cont.
`
`Eightccn rhesus monkeys were given oral doses of cloraze-
`Eighteen rhesus monkeys were given oral doses of cloraze(cid:173)
`pate dipotassium from 3 to 36 mg/kg daily for 52 weeks. All
`pate dipotassium from 3 to 36 mg/kg daily for 52 weeks. All
`treated animals remained similar to control animals. Al-
`treated animals remained similar to control animals. Al(cid:173)
`though total leucocyte count remained within normal limits
`though total leucocyte count remained within normal limits
`it tended to fall in the female animals on the highest doses.
`it tended to fall in the female animals on the highest doses.
`Examination ofall organs revealed no alterations attribut-
`Examination of all organs revealed no alterations attribut(cid:173)
`able to clorazepate dipotassium, There was no damage to
`able to clorazepate dipotassium. There was· no damage to
`liver function or structure.
`liver function or structure.
`Reproduction Studies: Standard fertility, reproduction,
`Reproduction Studies: Standard fertility, reproduction,
`, and teratology studies were conducted in rats and rabbits.
`and teratology studies were conducted. in rats and rabbits.
`Oral doses in rats up‘ to 150 mg/kg and in rabbits up to
`Oral doses in rats up to 150 mg!kg and in rabbits up to
`15 mg/kg produced no abnormalities in the fetuses.
`15 mg/kg produced no abnormalities in the fetuses.
`TRANXENE did not alter the fertility indices or reproduc-
`TRANXENE did not alter the fertility indices or reproduc(cid:173)
`tive capacity of adult animals. As expected, the sedative ef-
`tive capacity of adult animals. As expected, the sedative ef(cid:173)
`fect of high doses interfered with care of the young by their
`fect oflrigh doses interfered with care of the young by their
`mothers (see Usage in Pregnancy).-
`mothers (see Usage in Pregnancy).
`HOW SUPPLDED
`HOW SUPPLIED
`TRANXENE® 3.75 mg, scored T-TAB® tablets are supplied
`TRANXENE® 3.75 D;lg, scored T-TAB® tablets are supplied
`as blue-colored tablets. bearing the Abbott logo, the distinc-
`tive 'l‘ shape and a two-letter Abbo-Code designation, -’l‘L:
`as blue-colored tablets bearing the Abbott logo, the distinc(cid:173)
`Bottles of 100 ...........<........
`(NDC 0074-4389-13).
`tive T shape and a twa-letter-Abbo-Code designation, TL:
`Bottles of 100 ......... , ............. : ........ : .. (NDC 0074-4389-13).
`ABBO-PAC® unit dose packages:
`100 .................................... : ............. (NDC 0074-4389-11).
`
`7.5 mg scored T-TAB_® tablets are supplied as peach-colored
`tablets bearing the Abbott logo, the distinctive '1‘ shape and
`7.5 mg scored T-TAB(\j) tablets are supplied as peach-colored
`a two-letter Abbo-Code designation, TM:
`‘
`'
`'
`tablets bearing the Abbott logo, the distinctive T shape and
`Bottles of I00 .
`'
`.. (NDC 0074-4390-13).
`a two-letter Abbo-Code designation, TM:
`·
`Bottles of 500 .
`.. (NDC 0074-4390-53).
`Bottles of 100 · ... : ............................. (NDC 0074-4390-13).
`ABBO-PAC® unit dose packages
`‘
`-
`Bottles of 500 ..... : .... .-.... : ... : ............. (NDC 0074-4390-53).
`100 .
`.. (NDC 0074-4390-I1).
`ABBO-PAC® unit dose packages:
`100
`.............. :· .......... , ............ : ......... (NDC 0074-4390-11).
`
`506/ABBOTI
`506/ABBOTT
`PHYSICIANS' DESK REFERENCE®
`PHYSICIANS’ DESK REFERENCE®
`----------------------------,--------------~------------,-----------------------------
`CLINICAL PHARMACOLOGY
`CLINICAL PHARMACOLOGY
`A variety of clinical studies have demonstrated that ele-
`A variety of clinical studies have demonstrated that ele(cid:173)
`vated levels of total cholesterol (total-C), low density lipo-
`vated levels of total cholesterol (total-C), low density lipo(cid:173)
`protein cholesterol (LDL-C), and apolipoprotein B (apo B),
`protein cholesterol (LDL-C), and apolipoprotein B (apo B),
`an LDL membrane complex, are associated with human _
`an LDL membrane complex, are associated with human
`atherosclerosis. Similarly, decreased levels of high density
`atherosclerosis. Similarly, decreased levels of high density ·
`lipoprotein cholesterol (HDL-C) and its transport complex,
`lipoprotein cholesterol (HDL-C) and its transport complex,
`apolipoprotein A (apo AI and apo All) are associated with
`apolipoprotain A (apo AI and apo AI!) are associated with
`the development of atherosclerosis. Epidemiologic investi-
`the development of atherosclerosis. Epidemiologic investi(cid:173)
`gations have established that cardiovascular morbidity and
`gations have established that cardiovascular morbidity and
`mortality vary directly with the level of total-C, LDL-C, and
`mortality vary directly with the level oftotal-C, LDL-C, and
`triglycerides, and inversely with the level ofHDL-C. The in-
`triglycerides, and inversely with the level ofHDL-C. The in(cid:173)
`dependent eifect of raising HDL-C or lowering triglycerides
`dependent effect of raising HDL-C or lowering triglycerides
`(TG) on the risk of cardiovascular morbidity and mortality
`has not been determined.
`(TG) on the risk of cardiovascular morbidity and mortality
`has not been determined.
`·
`Fenofibric acid, the active metabolite of fenofibrate, pro-
`Fenofibric acid, "the active metabolite of fenofibrate, pro(cid:173)
`duces reductions in total cholesterol, LDL cholesterol, apo-
`duces reductions in total cholesterol, LDL cholesterol, apo~
`lipoprotein B, total triglyoerides‘aud triglyceride rich lipo-
`lipoprotein B, total trigl'ycerides and triglyceride rich lipo(cid:173)
`protein (VLDL) in treated patients. In addition, treatment
`protein (VLDL) in treated patients. In addition, treatment
`- with fenofibrate results in increases in high density lipopro-
`tein (HDL) and apoproteins apoAl and apoAII.
`with fenofibrate results in increases in high density lipopro(cid:173)
`The effects of fenofibric acid seen in clinical practice have
`tein (HDL) and apoproteins apoAI and apoAII.
`been explained in vivo in transgenic mice and in oitro in
`The effects of fenofibric acid seen in clinical practice have
`human hepatocyte cultures ‘by the activation of peroxisome
`been explained in vivo -in transgenic mice and in vitro in
`proliferator activated receptor 01 (PPARa). Through this
`hum8.ri hepatocyte cultures 'by the activation of peroxisome
`mechanism, fenofibrate increases lipolysis and elimination
`proliferator activated receptor a (PPARa). Through this
`of triglyceride-rich particles from plasma by activating lipo-
`mechanism, fenofibrate increases lipolysis and elimination
`proteinlipase and reducing production of apoprotein C-Ill
`of triglyceride-rich particles from plasma by activating lipo(cid:173)
`(an inhibitor of lipnprotein lipase activity). The resulting
`protein ·lipase and reducing production of apoprotein C-III
`fall in.triglyccrides' produces an alteration in the size and
`(an inhibitor of lipoprotein lipase activity). The resulting
`composition of LDL from small, dense particles (which are
`fall in. triglycerides produces an alteration in the size and
`thought‘-to-be atherogenic due to their susceptibility to oxi-
`composition of LDL from small, dense particles (which are
`- dation), to large buoyantpanides. These larger particles
`thoughfto be atherogenic due to their susceptibility to oxi(cid:173)
`have a greater aflinity for cholesterol receptors and are ca-
`dation), to· large buoyant_particles. These larger particles
`tabolized rapidly Activation of PPARu also ihduces an in-
`have a greater ·affinity for Cholesterol r"ecept;Rrs and are ca(cid:173)
`‘ crease in the synthesis of apoproteins A-I, A-II and HDL-
`cholesterol.
`tabolized rapidly. ACtivation of PPARo: also ihduces an in(cid:173)
`crease in the synthesis of apoproteins A-I, A-II and HDL(cid:173)
`' Fenoflhrate also reduces serum uric acid levels in hyperuri—
`cholesterol.
`cemic and normal individuals by increasing the urinary ex-
`Fenofibrate· also reduces serum uric acid levels in hyperuri(cid:173)
`, cretion of uric acid?
`cemic and normal individuals by increasing the urinary ex(cid:173)
`Phairmatiokinétics/‘Metabollsm
`_
`V
`_
`cretion Of uric aCid~··
`Blasma concentrations’ of feuoiibric acid after administra-
`Plulrmariokin8ticstMetab61ism
`tion of 54 mgrand 160 mg tablets are equivalent under fed
`Plasma conceD.tra'tions: of fenofibriC acid after aciministra·
`conditions to 67 and 200 mg" capsules,‘respectively.
`tiori of 54 mg and 160 mg tablets are equivalent under fed
`Absorption
`V
`'
`'
`.
`'
`The absolute bioavailability of fenoflbrate cannot be deter-
`conditions to 67 and 200 mg capsules,' respectively.
`mined as the compound is virtuallyfinsoluble in aqueous
`Absorption
`media suitable for injection. However, fenojfibrate is well ab-
`The absolq.te bioavailability of feriofibrate ~annot be deter(cid:173)
`sorbéid from the gastrointestinal tract: Eollowing oral ad-
`miried as .the compound is virtually )p.s.oluble in aqueouS
`ministration in héhlthy voluntccrs,,approxi'
`'tely 60% of_a
`mt;~~li.a sUi~ble f<?r injectioh. HOwever, fenQfibrate is Wt?]l ab(cid:173)
`single dose of radiolabelled fenofibrate ap earedin urine,
`sorbiid from the ·ga~trointestirial tract: lfoliowing oral ad(cid:173)
`primarily as fenofibric acid and its glucuronate conjugate,
`ministration in healtliy volunteers, approxiD,!ately 60% of a
`and 25% was excretedm _tlie’fecesI Peak plasma levels of
`single dose of r.adi\>l;~belled fenofibrate appeared. in urine,
`, fenofibric acid occur Within
`to 8 hours iafier administra-
`px:imarily. ~s fello.fibric ·. ~cid · ~d its glucui-onate ·conjl:lgate,
`tion.
`‘
`.
`_
`and 25% was excreted, in .the feces: Peak plasma levels of
`The absorption of fenofibrate is increased when adminis-
`fenofibrii: acid occur within 6 to 8 hours. after admini~tra-
`tered with food. With fenofibrate tablets, the extent_of ab-
`tion.
`,
`.
`.
`sorption is increased,byapproinrnately 35% under fed as
`The absorptiOn of fenofibrate is increased Wh~n adminls·
`compared to fasting" conditions. "
`'
`tered with food,. With fenofibrate tablets, t))e extent of ab:
`Dlstiiliution "
`_
`7
`7
`.
`.
`sorption is incr~ased by-approximately 35% under fed as
`In. healthy volunteers, steady-state plasma levels of
`cOmParec,i to fasting· ~9llditlop."s. · ·
`fenofibric acid were shown to be achieved within 5 days of
`Dlstiibution .. ·
`·
`dosing and did not demonstrate accumulation across time
`In. healthy. volu!lteet~, steady-state plasma ·levels of
`following njiultiple close administration. Serum.protein bind-
`fenofibric' acid were shown to be aclrieved within 5 days of
`ing was app‘-oximately 99% in normal and hyperlipidemic
`subjects.
`‘
`'
`.
`'
`dosing and did not demonstrate ac~umulation ac_roSs time
`Metabolism
`‘
`following nwltiple dose administration. Serum. protein bind(cid:173)
`ing was approximately 99% in normal and hyperlipidemic
`Following oral administration, Ieiiofibrate is ré1pidly'hydro--
`subjecte.
`''
`lyzed by esterases to the active metabolite, fenofibric: acid;
`·
`. no unclianged_fe_nofibra'l;e is detected in plasma.
`Metabolism
`Fenofibric acid is piiinarily conjugated with glucuronic acid
`Following oral administration, feiiofibrate is rapidly. hydro- ..
`and then excreted in urine. A small amount of fenofibric acid
`lyzed by esterases to the active metabolite, fenofibrie acid;
`is reduced at the carbonyl moiety to a benzhydrol metabo-
`no unchanged_fenofibrate is \letected in plasma.
`lite which is, in turn, conjugated with glucuronic acidan
`Fenofibric acid is prilnarily conjugated with glucuronic acid
`. excreted in urine. -
`-
`_
`-
`and then excreted in urine. A small amount of fenofibric acid
`' In uioo metabolism data indicate that neither fenofibrate
`is reduced at the carbonyl moiety to a benzhydrol metabo(cid:173)
`nor fenaiibric acid undergo oxidative metabqlisrn (e.-g., cyto-
`lite ·wlrich is, in turn, conjugated with glucuronic acid and
`chrome P450) to a significant extent.
`-
`excreted in urine.
`Excretion
`‘
`'
`'
`In vivo metabolism data indicate that neither fenofibrate
`' After absorption, fenofibrate is mainly excreted in the urine
`nor fenofibric acid undergo oxidative metabolism (e,g., cyto(cid:173)
`in the form of metabolites, primarily fenofibric acid and
`chrome P450) to a significant extent.
`fenofibric acid glucuronide. After administration of radio-
`Excretion
`labelled fenofibrate, approximately 60% of the dose ap-
`After ~bso~#cm, fep.ofibrate is mainly excreted in the urine
`peared in the urine and 25% was excreted in the feces’.
`in the form ·of metabolites, primarily fenofibric acid and
`Fenofibric acid is eliminated with a half-life of 20 hours, al-
`fenofibric acid glucuronide. After admiriistration of radio(cid:173)
`lowing once daily administration in a clinical setting.
`labelled fenofibrate, approximately 60% of the dose ap(cid:173)
`Speclal Populations
`'
`'
`Geriatrics
`peared in the urine and 25% was excreted in the feceS ..
`Fenofibric acid is eliminated with a half-life of 20 hours, ·ai(cid:173)
`In elderly volunteers 77-87 years of age, the oral clearance
`of fenofibric acid following a single oral dose of fenofibrate
`I~Wing once dai~y adml~stration in a clinical setti:fig.
`was 1.2 L/h, which compares to 1.1 L/h in young adults. This
`Sp8cial Populations
`·
`indicates that a similar dosage regimen can be used in the
`Geriatrics
`elderly, without increasing accumulation of the drug or me-
`In elderly volunteers 77-87 years of age, the oral clearance
`tabolites.
`of fenofibric acid following a single oral dose of fenofibrate
`Pediatrics
`was 1.2 Llh, wlrich compares to 1.1 Llh in young adults. Tlris
`TRICOR has not been investigated in adequate and well-
`indicates that a similar dosage regimen can be used in the
`controlled trials in pediatric patients.
`elderly, without increasing accumulation of the drug or me~
`Gander
`-
`v
`tabolites.
`No pharmacokiuetic difierence between males and females
`Pediatrics
`has been observed for fenoflbrate.
`TRICOR has not been investigated in adequate and well(cid:173)
`Haas
`'
`controlled trials in pediatric patients.
`The influence of race on the pharmacokinetics of fenolibrate
`Gender
`has not beerrstudied, however fenofibrate is not metabo-
`No pharmacokinetic difference between males and females
`has been observed for fenofibrate .
`Race
`The influence of race on the pharmacokinetics offenofibrate
`has not been: studied; however fenofibrate is not metabo-
`
`Thereafter, gradually reduce the daily dose to 7.5 to 15 mg.
`Thereafter, gradually reduce the daily dose to 7.5 to 15 mg.
`Discontinue drug therapy as soon as patient’s condition is
`DiscontinUe drug therapy as soon as patient's condition is
`stable.
`stable.
`The maximum recommended total daily dose is 90 mg.
`Th,e maximum recommended total daily dose is 90 mg.
`Avoid excessive reductions in the total amount of drug ad-
`Avoid excessive reductions in the total amount of drug ad·
`ministered on successive, days.
`_
`ministered on successive days.
`-
`As an Adjlinct to Antiepileptic Drugs:
`'
`As an Adjunct to Antiepileptic Drugs:
`In order to minimize drowsiness, the recommended initial
`In order to minimize drowsiness, the recommended initial
`dosages and dosage increments should not be exceeded.
`dosages and dosage increments should not be exceeded.
`Adults: The maximum recommended initial dose ‘in pa-
`Adults: The maximum recommended ~nitial dose 'in pa·
`tients over 12 years old is 7.5 mg three times a day. Dosage
`tierits over 12 yean; old is 7.5 mg three tiines a day. Dosage
`should be increased by no more than 7.5 mg every week and
`should be increased by no more than 7.5 mg every week and
`should not exceed 90 mg/day,
`’
`'
`'
`‘
`.
`_‘
`·
`'
`.
`.
`should not exceed 90 mg/day._
`Children (9-12_years): The maximum recommended initial
`Clrildren (9-12 years): The maximum recommended initiaf
`dose is .7.5,mg two times a day. Dosage should be increased
`dose is .7.5 _mg two times a day. D'?sage should be increa~e~
`by no more than 7.5 mg every week and should not exceed
`60 mg/day.
`by no more than 7.5 mg every week and should not exceed
`60 mg/day.
`DRUG INTERACTIONS
`DRUG INTERACTIONS
`If TRANXENE is to be combined with other drugs acting on
`the central nervous system, careful consideration should be
`IfTRANXENE is to be combined with other drugs acting on
`given to the pharmacology ofthe agents to be employed. An-
`the central nervous syste~. careful consideration should be
`imal experience indicates that clorazepate dipotassium pro-
`given to the pharmacology of the agents to be employed. An(cid:173)
`longs the sleeping time after hexobarbital or after ethyl al-
`imal experience indicates that clorazepate dipotassium pro(cid:173)
`cohol, increases the inhibitory effects ofchlorpromazine, but
`longs the sleeping time after hexobarbital or after ethyl al(cid:173)
`does not exhibit monoamine oxidase inhibition. Clinical
`cohol, increases the inhibitory effects of chlorprf.?mazine, but
`studies have shown increased sedation with concurrent
`-does not exhibit monoamine oxidaSe inhibition. Clinical
`hypnotic medications. The actions of the benzodiazepines
`studies have shown incre~sed sedation with cOncurrent
`may be potentiated by barbiturates, narcotics, phenothia-
`hypnotic medications. The. actions of the benzodiazepines
`zines, monoamine oxidase inhibitors or other antidepres-
`sants.
`'
`may _be potentiated by barbiturates, narcotics, phenotlria(cid:173)
`zines," monQamine oxidase inhibitors or other antidepres·
`If TRANXENE tablets are used to treat anxiety associated
`sants. ·
`with somatic disease states, careful attention must be paid
`If TRANXENE tablets are used to treat anxiety associated
`to possible drug interaction with concomitant medication.
`with somatic disease states, careful attention must be paid
`In bioavailability studies with normal subjects, the concur-
`to pOssible drug interaction with concomitant medication.
`rent administration of antacids at therapeutic levels did not
`In bioavailability studies with normal subjects, the concur(cid:173)
`tab ets.
`‘
`rent administr'!tion of antacids at therapeutic levels did not
`sigI1iificantly.influence‘tl1e bioavailabllity of TRANXENE
`signifjcantly. influence ·the bioavailability of TRANXENE
`QVERDOSAGE
`tablets ..
`Overdosage is_usua.lly manifested by varying degrees of
`OVERDOSAGE
`CNS depression raifging from slight sedation to co1na..—-As in
`Overdosage is. usually manifested by varying degrees of
`the management of overidosage with any drug, it_shouId be
`borne in mind that multiple agents may have been taken.
`CNS depression rrutgjng from slight sedation to coma. As in
`The treatment of overdosage should consist of the general
`the management of overdosage with any <!rug, it should be
`measures employed in the management of overdosage of
`borne in mind that multiple agents may have been taken.
`any CNS depressant. Gastric evacuation either by ‘theirs-
`The treatment of overdosage should consist of the general
`duction of emesis, lavage, or both, should be performed im-
`measures employed in the management of overdos:age of
`mediately. General supportive care, including frequent
`any CNS depressant. Gastric evacuation either by the in(cid:173)
`monitoring of the vital signs and close observation of the
`du~tion of emesis, lavage, or both, should be perforined im(cid:173)
`patient, is indicated. Hypoten‘sio'n,' though rarely reported,
`mediately. General supportiVe care, includi~g frequent
`TRANXENE®-SD_'”‘f'22.5 mg-single dose-tablets are sup-
`may occur with large overdoses. In such cases the use of
`plied. as tan-colored tablets bearing the Abbott logo and a
`moriitoring of the vital signs and close observation of the
`agents such as Levophed® Bitartrate (norepinephrine bite):-
`two-letter Abbo-Code designation,
`.
`patient, is indicated. Hypotension;' though rareiy reported,
`TRANxENE®-SD~ 22.5. mg single dosO:-tablets are sup(cid:173)
`trate injection, USP) or Aramine® Injection (metaraminol
`Bottles of 100 ........
`..................... (NDC 0074-2997-13).‘
`may occur With large overdoses. In such cases the use of
`bitartrate injection, USP) should beconsidered.
`.
`.
`plied. as tan-colored tablets bearing the Abbott !0go and a
`TRANX.ENE®-SDTM HALESTRENGTH 11.25 mg single
`agents such as Levophed® Bitartrate (norepinephrine bitar(cid:173)
`While reports indicate that individuals have survived over-
`two-letter Abbo-Code designation, TY:
`dose tablets-are supplied asblue-colored tablets bearing the
`trate injection, USP) or Aramine® Injection (metaraminol
`doses of clorazepate dipotassium as high as 450 to 675 mg,
`Bottles of 100 ........... : ..................... (NDC 0074-2997-13).
`Abbott logo and a two-letterAbbo-Code designation,
`bitartrate injection, USP) should be considered.
`these doses are not necessarily an accurate indication of the
`. TRANXENE®-SD™ HALF .STRENGTH 11.25 mg single
`Bottles of 1oo_
`(NDC 0074-2699-13),
`While reporte indicate that individuals have survived. over(cid:173)
`amount of drug absorbed since the time interval between
`T-TAB, tablet appearance and shape are trademarks of
`dose tablets-are supplied, as_.blue_-colored tablets bearing the
`doses of clorazepate dipotassium as high as 450 to 675 mg,
`ingestion and the institution of treatment was not always
`Abbott logo and a two-letter Abbo-Code designation, TX:
`Abbott Laboratories.
`‘
`'
`'
`known. Sedation in varying degrees wasthe most common
`these doses are not necessarily an accurate indication of the
`Bottles of 100 ...... , ................... , ... ,,, (NDC 0074-2699-13).
`physiological manifestation of clorazepate dipotassium
`. Recommended storage: ‘Store below 77_“F‘ (25°C)
`amount of drug absorbed since· the time interval be.tween
`' U.S. Design Pat. No. D—300,879
`T-TAB, tablet appearance and shape are tradema-rks of
`overdosage. Deep coma -when it occurred was usually asso-
`ingestion and the institution of treatment was not always
`Rail 03-50,51-R15,
`Abbott Laboratories.
`ciated with the ingestion of other drugs in addition to clo-
`known. Sedation in varying' degrees was. the most coJ)lmon
`Abbott Laboratories
`.
`.
`Recommended storage: Store below 77"F (25"C)
`razepate dipotassium.
`:-
`.»
`-
`physiological manifestation of clora~epate dipotassium
`North Chicago, IL 60064, U.S.A.
`._
`X
`U.S. Design Pat. No. D-300,879
`Flumazenil,‘a specific benzudiazepine receptor antagonist,
`overdosage. Deep coma when it occUlTed was usually asso~
`“
`"
`-
`'
`'
`»
`Revised: April, 2001
`‘
`Ref. 03-5Q51-R15
`is indicated for the complete or partial reversal of the seda-
`cia ted with the ingestion of other drugs in addition to clo(cid:173)
`Shown in.Product Identification‘ Guide, pages 303,304
`Abbott Laboratories
`tive efl"ects'of benzodiazepines and maybe used in situa-
`razepate dipotassium.
`North Clricago, IL 60064, U.S.A.
`tions when an overdose with a henzodiazepine is known or
`Flw;nazenil, ·a specific benzodiazepine re-ceptor antagonist,
`Revised: April, 2001
`suspected. Prior to the administration of flumazenil, neces-
`is indicated for the complete or partial reversal of the seda(cid:173)
`Shown in-Product Identification· Guide, pages 303, 304
`sa.ry'me'asures'should be instituted to secureairway, venti-
`tive effects of benzodiazepines and may· be used in situa(cid:173)
`' rnlcono
`.
`B2
`'
`lation, and. intravenous access. Flumazenil is intended as
`[tri cérl
`‘
`'
`‘
`.
`_-
`tions when an overdose with a benzodiazepine is known or
`an adjunctto, not as a substitute for, proper management of
`'
`lfencfibrate tablets)
`suspooted. Prior to the administration- of fiumazeriil, neces(cid:173)
`benzodiazepine overdose. Patients treated with flumazenil
`sary meaSures-should be instituted to secure--airway, venti(cid:173)
`TRICOR®
`should be monitored for resedation, respiratory depression,
`lation, and. intravenous access. Flumazenil is intended as
`[tri cor]
`and other residual benzodiazepine effects.for an appropriate
`,
`.
`_
`V
`D_ESCRlPI‘I_ON
`TRICOR (fenofibrate tablets), is -a lipid regulating agent
`an adjunct tO, not as a substitute for, proper management of
`period after treatment. The prescribe: should be aware of a»
`(fenofibrate tablets)
`V available as tablets for oral administration. Each tablet con-
`risk of seizure in association wlth llumazenir treatment,
`benzodiazepine overdose. Patients t•eated with flumilzeilil
`tains,54- mg or 160 mg offenofibrate. The chemical name for
`should be nionitored for resedation, respiratory depression,
`particularly in long-term‘ benzodiazepine users andin cyclic‘
`DESCRIPI'ION .. '
`and other residual berizodiazepirie effecte. for an appropriate
`fenofibrateis 2-[4-(4-chlorobenzoyl}pheuoxyl-2-rnethyl-pro
`antidepressant overdose. The complete flumazenil package
`TRICOR (fenofibrate table~), is a lipid regulating agent
`ponoic acid, 1-mothylethyl ester with the following struc-
`period after treatment. The prescriber should be aware of a
`insertincluding CONTRAINDICATIONS, WARNINGS, and
`available as tablets for oral administration. Each tablet con(cid:173)
`j tural formula:
`risk of seizure in association with flumazenil· treatment,
`PRECAUTIONS should be consulted prior to use.
`.-
`f:l!ins.54 mg or 160 mg offeno:fibrate. The chemical name for
`particularly in long·term· benzodiazepine Users and· in cyclic·
`ANIMAL PHARMACOLOGY AND TbxIcoLooY-
`fenofibrate-is 2-[4-(4-chlorobenzoyl)-phenoxy]-2-methyl-pro(cid:173)
`antidepressant overdose. The complete fiumazenil package
`(IZH3
`CH3
`panoic acid, 1-methylethyl ester with the following. struc(cid:173)
`Studies in rats and monkeys have shown a substantial‘ dif-
`insert including CONTRAINDICATIONS, WARNINGS, and
`.
`II
`I
`ll
`I
`Cl C O—C—C—O—C—H
`ference between doses producing tranquilizing, sedative
`tural formula:
`PRECAUTIONS should be consulted prior to use.
`v
`CH;
`.
`.l
`o
`0
`and toxic eifccts: In rats, conditioned avoidance response
`CH3
`CH3
`.
`ANIMAL PHARMACOLOGY AND 'TOXICOLOGY·
`was inhibitediat an oral dose of 10 mg/kg; sedationwas in-
`The empirical formula is CZoH21O4C1 and the molecular
`I
`-o- -~ I
`Cl
`duced at 32 mglkg; the LD5o was 1320 mg/kg. In monkeys
`weight is 360.83; fenofibrate-is insoluble in water. The melt-
`Studies in rats and monkeys have shown a substantial dif(cid:173)
`fi~O-y-fi-0-y-H
`aggressive behavior was reduced at an oral dose of 0.25 mg/
`ing point is 79—82"C. Fenofibrate is a white solid which is
`ference betWeen doses producing tranquilizing, sedative
`~.,
`0
`_
`CH3
`CH3 0
`stable under ordinary conditions.
`.
`kg; sedation (ataxia) was induced at 7.5 mg/kg; the LD50
`and toxic effects; In rats, conditioned avoidance response
`could not be determined because of the emetic effect of large
`lnactivelngredients: Each tablet contains colloidal silicon
`was inlribited .. at an oral dose of 10 mg!kg; sedation was in(cid:173)
`The empirical formula .is C20H 210 4C1 and the molecular
`doses, but the LDEO exceeds 1600 mg/kg.
`_
`d.ioxide,.crospovidone, lactose monohydrate, lecithin, micro-
`duced at 32 mg!kg; the LD50 was 1320 mg!kg. In monkeys
`weight is 360.83; fenofibrate-is insoluble in water. The melt(cid:173)
`crystalline‘ cellulose, polyvinyl alcohol, povidone, sodium
`Twenty-four dogs were given clorazepate dipotassium orally
`aggressive behavior was reduced at an oral dose of 0.25 mgl
`ing point .is 79-82"C. Fenofibrate is a white solid wlrich is
`in a 22-month toxicity studjr, doses up to 75 mg/kg were
`lauryl sulfate, sodium stearyl fumarate, talc, titanium diox-
`kg; sedation (ataxia) was induced at 7.5 mg!kg; the LD50
`stable· nnder ordinary conditions.
`ide, and xanthan gum. -In addition, individual tablets con-.
`given. ‘Drug-related changes occurred in the liver; weight
`could not be determined because of the emetic effect oflarge
`lnactive·lngredients: Each tablet contains colloidal silicon
`tain:
`.
`:-
`was increased and cholestasis with minimal hepatocellular
`doses, but the LD50 exceeds 1600 mg!kg.
`dioxide,.c.rospovidone, lactose monohydrate, h~cithin, micro~
`damage was found, but lobular architecture remained well
`54mg tablets: D&C Yellow No. 10, FD&C'Yellow No. 6,
`FD&C Blue No.*2.
`'
`.
`.
`.
`crystalline· cellulose, polyvinyl alcohol, povidone, sodium
`Twenty~ four dogs were given clorazepate dipotassium orally
`preserved.
`laucyl sulfate, sodium stearyl fumarate, talc, titanium diox(cid:173)
`in a 22-month toxicity study; doses up to 75 mg!kg were
`. ide, and ·xanthan gum. ·In addition, individual tablets con(cid:173)
`given. Drug-related changes occurred in the liver; weight
`Information will be superseded by supplamenlshnd subsequent editions
`tain:
`waS increased and cholestasis with minimal hepatocellular
`54·mg tablets: D&C Yellow No. 10, FD&C·Yellow No.6,
`damage was found, but lobular architecture remained well
`FD&C Blue No.-2.
`preserved.
`
`ij .~.-
`
`15 mg scored; T-'I¥\B(® tablets are supplied‘ as lavender-
`colored tablets bearing the Abbott logo, the distinctive T
`shape and a two-letter Ahbo-Codedesignation, T_N:'
`‘
`15 mg scored, T-TAB(j!) tablets are iiupplled' as lavender(cid:173)
`Bottles of 100 .............................:.—..L (NBC 0074-4‘391-13).
`colored tablets bearing the Abbott ·Jogo, the distinctive T
`shape and a two-letter Abbo-Code designation, TN:
`.
`AVBBOV-PAC®
`dose packages:
`Bottles of 100 ...... , .................. , ... ;. .... (NDC 0074-4..391~13).
`‘ 100
`.............