Patient Encounter 3 Creating a Care Plan

Based on the information provided, what are the goals of therapy for this patient? Select and recommend a therapeutic plan for treatment of this patient's TB infection. What drugs, dose, schedule, and duration of therapy are best for this patient? How should any contacts infected by this patient be evaluated and treated? What drugs, dose, and schedule of therapy are best for his close contacts?

Table 75-3 Drug Regimens for Culture-Positive Pulmonary Tuberculosis Caused by Drug-Susceptible Organisms

Initial Phflit

ConmnmtLgn Pluw

Bgjlrwn Dnji

InurvalAnd Ddui' minimal Pu-ration I

Begimgn Drugs

InltrvdL and Dam" I Minimal Du ration I

Rajigr df Minimal Odsci M_

ISOfiiälÜJ Rifampin Pyraiinaroide EtlWiCumt isoniaiid Rifampin Pyrafinamide t;fii)iriiiul(jl

IsorJaild Rifampin

Pyïaflnamidi Fthambulol konlaiid Rifampin Fihambntol

7dJyS/weeMc« SfidCSft Bwee*s)Of SdtyV «fefc iof iO doses


! iiys/wkta i4(*küs vnskTyfaf Udmei (Ü vwt'kit cx 5 dJuViitn.-k fix lOdowsdweeW. then 1wke weekly (of 12 dOMS iG wCOks) 3x weekly fof >1 doses

Begimgn Drugs

7dJyS/weeMc« SfidCSft Bwee*s)Of SdtyV «fefc iof iO doses




7days/WeeM(ü 1»


dtws weeks] cm 5

days/week tor 90 doses

(|0 weeftsi



Twiût weekly lot 36


(J05« (IS Wieks)



Ortii weekly (or 16


(KHeSilS weeks)



Twice weekly for 36


dös« (is w*eks)



Oixtwtikiyfior ie


dôsesdâ weeks)

Ii? 130(26wMli)

92-76 Qb wCekV Wieks)

7 daysAwefcfa ütdoses to 0 weets) w S days/ week füf MI doses 0 wert s)1

I5«fca7ld/ ï* weekly tor 54 doses Rifampin (19 werts)

Isomajky 7 daysAwet fof 217 Rifampin cfoses(3l wetk^f

-, djyy^eek tor hi doses (II WEek^ Ism« rid/ Twice weekly ft» 62 Rifampin ck>ses(il ivfftil

Ii? 130(26wMli)

92-76 Qb wCekV Wieks)


7fi Ob weeks!

118 liM1 {59 weeks]

"Mien OOf ¡sus<?d, drugs may be given J days/Wet* and the neccssary numbc-i ofdtKi's jdjuslcd actcjfdingfy. Althougt» HIM nosnriies hue rompais five wlhtmr rtiiiy (tsiev enensfce eJdieiiHXC indtaies HiK be an effttUit prKtict,

■Paiieris with catiiiaiion on inirial civil ladiograph and pofitive Lulruics a! compleiionof 7 months of TlYtapy ihouKJ leieive a 7-rnonrh (Jî-week; either 21 / doses (dallyl oi iîckKies (1wire weeklyDconhnualion phase rFivp day a-week administration is always given by DOT. Rating tot S day/week regimens is Mill).

'hlot recommended iof HIV-infected pullenls with CD4I-cell courts less 1han 100 celkrtnL

'Options k and 2b should be used orïty In HlV-negaHw? patients who have neg.vive sputum smears at the time of completion of 2 months oil (horjpy and who (fc not haw? cdivitjlicn on (he indul chest radiograph for patient* started on (his ictj men and found to haw a positive culture from the 2-morth specimen Heatmem should be extended an emia 3 months

Human Immunodeficiency Virus

Patients with AIDS and other immunocompromised hosts may be managed with chemotherapeutic regimens similar to those used in immunocompetent individuals, although treatment is often extended to 9 months2'12'34 (Table 75-3). The precise duration to recommend remains a matter of debate. Highly intermittent regimens (twice or once weekly) are not recommended for HIV-positive TB patients.34 Prognosis has been particularly poor for HIV-infected patients infected with MDR-TB. Some patients with AIDS malabsorb their oral medications, and drug interactions are com-

mon.2'34'41'42 It is advisable that such patients are managed by TB-HIV experts because the challenges are many.

Renal Failure

Because they are primarily hepatically cleared, isoniazid and rifampin usually do not require dose modification in renal failure.41'44'45 Pyrazinamide and ethambutol typically are reduced to three times weekly to avoid accumulation of the parent drug (ethambutol) or metabolites (pyrazinamide).34'45 Renally cleared TB drugs include the aminoglycosides (e.g.' amikacin' kanamycin' and streptomycin)' capreomycin' ethambutol' cycloserine' and levofloxacin.34' 5'44'45 Dosing intervals need to be extended for these drugs. Serum concentration monitoring must be performed for cycloserine to

37 41 42

avoid dose-related toxicities in renal failure patients. ' ' Table 75-4 Antituberculosis Drugs for Adults and Children"

Adver» Elftctf

Aiitoi i rng/kg <300 mg) CïiikJiïTT 10-li nxyhg (JÛ0 mgl

Asymptomatic efevatlon afamlnolrdrrsraaseSr dlntal hepjiflii. fjui hcpaririv peiiptvfdi neuifflourily, ÇN% lysifm effetls, lupuvllke iyndrofTK?, iiypei«?nsiliviLy, monckwrifKi iXirv.ïfiir'h f. ilxvi

LFT monlNy m fullcntï whotooe pMKilliriÇ llvtr iftiJSC c* whs diYik>f> afinormal I vw func tkm 1haf don not require dkocffiinuation oi tJiug

Doii^^JuiTinintii maytw net««fy In pallents receiving anticonvulsants or Mffeftn l?i*.vnpm Adu&f-. M mg/kg

Curaneous reacilont.GI reaflom (natiiea, jnCeiiid, JbdornirUl pdir^t Nulikr iyrtdiomi. bepMCKtufciy, wvere immunologic PHdctlorc, orange discoloNailion at bodily fluiJi (sputum. urine, tswî}, druii inn?ractions owing ro Inihmion ni h^paric nwerosorna1e<vymes HçnvtnlOi?< ^ympiomsi, pieueksjiurvJice (siiri Oiscoioiiiisn with normal t: (jinn), rah, f In-like syndrome, orange dtscotaaton of bodily fluids tputwn, urine, iwWMB^ig

Rifampin cwsh many drug inlpurlent fa j ioflpkui lilt Of drug interjtrkjfli effetw liif to CIX wçtjîire mm*. ctk.gav/nchs)pAb/tb ij600rng> CM?.'1fn: 10-JO nkj/ïig (600 mgi

AfrHr?: s nvyte; [Jgo nv)h ChftÉn ADfrtjlMt

Drug migrai; [ijnj are lew prot^fna'IC (han rifampin







AmikacW kanamycin


Adults: 10 mg/kg (continuation phase) {600 mg> Dosed weekly. ChSdterr. The drug is not approved for use in children Adults: Based on IBW 40-55 kg: 1.000 mg; 56-75 kg: 1.500 mg; 76-90 kq:2jOOOmg ChMtert 15-30 mg/kg AdUfrs: Based on I^V. 40-55 kg:800mg; 56-75 kg: 1,200 mg; 76-90 kg: 1.600 mq ChUdrerf: 15-20 mg/kg daily

Adutts': 10-15 mg/kq/day. usually 500-750 mq/day in2doses Children: 10-15 mg/kg/day

Mulrf: 15-20 mg/l<g/day. usuaSy 500-750 mg/day in a single daily dose or 2 divided doses Children: 15-20 mq/kg/day Mulls'

Children: 20-40 mg/kg/day


Children. 15-30 mg/kgAJay Ivor intramuscular as a single daily dose Mulls'

ChMren. 15-30 rng/kg/day as a single daily dose

^-Aminosalicylic Muiiy 8-12 gfday 2 or acid (PAS) 3 doses

Children. 200-300 mg/kg/ day in 2-4 Avided doses

Levofloxacin Moxifloxacin Gatifloxacin

Adulls: 500-1.000 mg daily Chidrcft

Muln. 400 mg daily Children?

Adults: 400 mg daily Chidren

Similar to those associated with rifampin

Hepatotoxicity.GI symptoms (nausea, vomiting). nongouty polyarthralgia. asymptomatic hyperuricemia. acute gouty arthritis, transient morbilliform rash, dermatitis Retrobutoar neuritis, peripheral neuritis, cutaneous reactions

CNS effects

Gl effects, hepatotoxicity. neurotoxicity, endocrine effects

Ototoxicity, neurotoxicity, nephrotoxicity

Ototoxicity, nephrotoxicity

Nephrotoxicity, ototoxicity

Hepatotoxicity, Gl distress, malabsorption syndrome, hypothyroidism, coagulopathy

Gl disturbance, neurologic effects, cutaneous reactions

Drug interactions are being investigated and are likcty similar to RIFAMPIN

Serum uric acid can serve as a surrogate marker for compliance LF Is in patients with underlying liver disease

Baseline visual acuity testing and testing

01 color discrimination

Monthly testing of visual acuity and color discrimination in patients taking greater than 15-20 mg/Vg. renal insufficiency.or receiving the drug for greater than

2 months

Monthly assessments oi neuropsychiatry status

Serum concentration may be necessary until appropriate dose is established

Baseline IFTs

Monthly LFTs if underlying liver disease is present

TSH at baseline and monthly intervals

Baseline audiogram, vestibular testing,

Romber testing and SO Monthly assessments of renal function arvd auditory or vestibular symptoms Baseline audiogram, vestibular testing.

Romberg testing and SO Monthly assessments of renal function and auditoiy or vestibular symptoms Baseline audiogram, vestibular testing,

Romber testing and SO Monthly assessments of renal function and auditoiy or vestibular symptoms Baseline and monthly serum K' and Mg '• Baseline LFTs and TS»i TSH every 3 months

No specific monitoring recommended

IFT. liver function test; SO. serum creatinine; TSH, thyroid-stimulating hormone, •for purposes of this document, adult dosing begins at age 15 years

•Dose per weight K based on ideal body weigh!. Children weighing more than 40 Ig should be dosed as adultv

Dose may need to be adjusted when there is concomitant use of protease inhibitors or nonnucleoside reverse transcriptase inhibitors.

The drug likely can be used safely in older children but should be used with caution in children younger than 5 years of age. in whom visual acuity cannot be monitored. In younger children, ethambutol at the dose of IS mg/kg/<iay can be used if there is suspected or proven resistance to isoniirtd or rifampin

1 sivxiU bt-iKucd imji jnirtugh ihri ¡4Hie dow rtawinnctyini gtnerafly. itwst timieiini with capctience u<iny<>tioiiTihe indicate nut n ft ynirtuii tor patietn* 10 be *ik? (0 ((ftfiie (hi; amount. contCTitriiiori it<? often in Uiwimcning (tic opfimal dose

Hnp line** daily dme can be given at bedtime or with Ihemain me.*

"Ooiff li iTKj/lit) Aiiy [I gi W310 mg/krt In [ii™ oldet lhan 50 yew it ifje [750 mgfc Usmsl ckjjf: riO-UOOO mq admins tened InlFjmLrti ularly or IV, ijii/en its j ilngla dose i-7 ddysAvK'tand i<?duc<!d to j-j* per wivk aHlcr Ihellrsl 7-A months or afler culture

"The long-lerm faioie than several weeki use (rf levoiloxacm In chikfren and adolescents has not be appoved because of concerns about iftiK ti on bone jnd Cdnitj<ie (^Ci/ifM. HOwCvti, efXftl Agree ttm Tlw Jruq SlkXild 1)0 C0«5ic|c(iM) fof (hildiert wilHi 11! i JuiCO t* Oicpnhnis fpnt.ini 10 twill honijjd nt.mifyn Theopclmjl dow r. not kro*n.

T he long-DCfm (moif I Iwn iiNtfjl uie of nvjitilVKjCin In (hidicn and MfcileKenH lw iK) roved Of [tWflii alxifl effects on tune and carriage giowlh. The optimal doio Is not knotf/n.

Hepatic Failure

Elevations of serum transaminase concentrations generally are not correlated with the residual capacity of the liver to metabolize drugs, so these markers cannot be used directly as guides for residual metabolic capacity. Hepatically cleared TB drugs include isoniazid, rifampin, pyrazinamide, ethionamide, and p-aminosalicylic acid.44 Ciprofloxacin and moxifloxacin are about 50% cleared by the liver. Further, isoniazid, ri-fampin, pyrazinamide, and to a lesser degree ethionamide, p-aminosalicylic acid, and rarely ethambutol may cause hepatotoxicity.34,41,44 These patients require close monitoring, and serum concentration monitoring may be the most accurate way to dose them.

The TB Drugs

The interested reader is referred to several other publications for more detailed information regarding these drugs.2,11,34,39-42,44-47 A summary of daily doses, adverse effects, and monitoring parameters of first- and second-line antituberculosis drugs is provided in Table 75-4. 4 Isoniazid and rifampin are considered the two key drugs for the treatment of active TB, followed by pyrazinamide, which has a special role in the first 2 months of treatment. Other drugs are used to suppress the emergence of drug resistance in conjunction with the first-line drugs or for pre-existing drug-resistant TB. In general, the most important toxicity with first-line drugs is hepatotoxicity, whereas various organs may be affected by each of the second-line drugs. Recent research is placing emphasis on the potential role of quinolones such as moxifloxacin in the treatment of TB. The role of these agents in the first 2-month intensive phase of therapy is currently being evaluated. It is possible that future regimens may consider

these agents part of the first-line drugs. Other new therapies include investigational vaccines, and investigational drugs such as PA-824, OPC67683, TMC207, and SQ109 which are in clinical trials.49,50

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