Heartland National TB Center
Web Address: www.HeartlandNTBC.org
1-800-TEX-LUNG
Tuberculosis Treatment Guidelines-2003
For additional information, refer to the printed guidelines.

TABLE 2. DRUG REGIMENS FOR CULTURE-POSITIVE PULMONARY TUBERCULOSIS CAUSED BY DRUG-SUSCEPTIBLE ORGANISMS

Initial Phase

Drugs
INH, RIF, PZA, EMB

Interval and DosesWhen DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.)
Seven days per week for 56 doses (8 weeks)
OR five days per week for 40 doses (8 weeks)Rating for 5 day a week regimens is perferred expert opinion.

Continuation Phase

Drugs
INH, RIF

Interval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.) Patients with cavitation on initial chest radiograph and positive cultures at completion of 2 months of therapy should receive
Seven days per week for 126 doses (18
weeks) OR five days per week for 90 doses
(18 weeks)Rating for 5 day a week regimens is perferred expert opinion.. Range of total Doses (minimal duration) 182 to 130 (26 weeks). Rating* (evidence), HIV- preferred(randomized clinical trial), HIV+ preferred(data from clinical trials that were not randomized or were conducted in other populations).

or

Drugs
INH, RIF

Interval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.)Patients with cavitation on initial chest radiograph and positive cultures at completion of 2 months of therapy should receive
Twice-weekly for 36 doses (18 weeks) Range of total doses (minimal duration) 92 to 76 (26 weeks). Rating (evidence), HIV- preferred(randomized clinical trial), HIV+ preferred(data from clinical trials that were not randomized or were conducted in other populations)(Not recommended for HIV-infected patients with CD4 cell counts < 100 cells/ml. Five-day-a-week administration is always given

Initial Phase

Drugs
INH, RIF, PZA, EMB

Interval and Doses
Seven days per week for 14 doses (2 weeks) then
twice-weekly for 12 doses (6 weeks) OR five days
per week for 10 doses (2 weeks)Rating for 5 day a week regimens is perferred expert opinion. then twice-weekly
for 12 doses (6 weeks)

Continuation Phase

Drugs
INH/RIF

Interval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.)Patients with cavitation on initial chest radiograph and positive cultures at completion of 2 months of therapy should receive
Twice-weekly for 36 doses (18 weeks), Range of Total Doses 62 to 58 (26 weeks), Rating (evidence), HIV- preferred(data from clinical trials that were not randomized or were conducted in other populations), HIV+ acceptable alternative(data from clinical trials that were not randomized or were conducted in other populations)(Not recommended for HIV-infected patients with CD4 cell counts < 100 cells/ml. Five-day-a-week administration is always given

Initial Phase

Drugs
INH, RIF, PZA, EMB

Interval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.)
Thrice-weekly for 24 doses (8 weeks)

Continuation Phase

Drugs
INH, RIF

Interval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.)Patients with cavitation on initial chest radiograph and positive cultures at completion of 2 months of therapy should receive
Thrice-weekly for 54 doses (18 weeks), Range of Total Doses 78 (26 weeks), Rating* (evidence), HIV- acceptable alternative(randomized clinical trial), HIV+ acceptable alternative(data from clinical trials that were not randomized or were conducted in other populations).

Initial PHase

Drugs
INH, RIF, EMB

Interval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.)
Seven days per week for 56 doses (8 weeks) OR
five days per week for 40 doses (8 weeks)Rating for 5 day a week regimens is perferred expert opinion.

Continuation PHase

Drugs
INH, RIF

Inteval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis.)Patients with cavitation on initial chest radiograph and positive cultures at completion of 2 months of therapy should receive
Seven days per week for 217 doses
(31 weeks) OR five days per week for
155 doses (31 weeks)Rating for 5 day a week regimens is perferred expert opinion.. Range of Total Doses 273 to 95 (39 weeks), Rating* (evidence), HIV- offer when preferred and acceptable alternative cannot be given(randomized clinical trial), HIV+ (CII)

or

Drugs
INH, RIF

Interval and Doses(When DOT is used drugs may be given 5 days per week and the necessary number of doses adjusted accordingly. Although there are not studies that compare 5 with 7 daily doses, extensive experience indicates this would be an effective
practice for drug susceptible tuberculosis)Patients with cavitation on initial chest radiograph and positive cultures at completion of 2 months of therapy should receive
Twice-weekly for 62 doses (31 weeks). Rante of Total Doses 118-102 (39 weeks), Rating* (evidence) HIV- offer when preferred and acceptable alternative cannot be given(randomized clinical trial), HIV+ offer when preferred and acceptable alternative cannot be given(data from clinical trials that were not randomized or were conducted in other populations)

TABLE 4. SUGGESTED PYRAZINAMIDE DOSES, USING WHOLE TABLETS,
FOR ADULTS WEIGHING 40-90 Kg

WEIGHT (Kg) Based on estimated lean body weight

Daily

40 to 55
1000mg (18.2 to 25.0)

Thrice Weekly

40 to 55
1500mg (27.3 to 37.5)

Twice weekly

40 to 55
2000 mg (36.4 to 50.0)

Daily

56-75, 1500mg (20.0 to 26.8)

Thrice weekly
56 to 75, 2500mg (33.3 to 44.6)

Twice weekly
56 to 75, 3000mg (40.0 to 53.6)

Daily
76 to 90, 2000mg Maximum dose regardless of weight. (22.2 to 26.3)

Thrice weekly
76 to 90, 3000mg Maximum dose regardless of weight. (33.3 to 39.5)

Twice weekly
76 to 90, 4000mg Maximum dose regardless of weight. (44.4 to 52.6)

TABLE 5. SUGGESTED ETHAMBUTOL DOSAGES, USING WHOLE
TABLETS, FOR ADULTS WEIGHING 40-90 Kg

WEIGHT (Kg) Based on estimated lean body weight

Daily

40 to 55
800mg (14.5 to 20.0)

Thrice Weekly

40 to 55
1200mg (21.8 to 30.0)

Twice weekly

40 to 55
2000 mg (36.4 to 50.0)

Daily

56-75, 1200mg (16.0 to 21.4)

Thrice weekly
56 to 75, 2000mg (26.7 to 35.7)

Twice weekly
56 to 75, 2800mg (37.3 to 50.0)

Daily
76 to 90, 1600mg Maximum dose regardless of weight. (17.8 to 21.1)

Thrice weekly
76 to 90, 2400mg Maximum dose regardless of weight. (26.7 to 31.6)

Twice weekly
76 to 90, 4000mg Maximum dose regardless of weight. (44.4 to 52.6)

Table 13. Evidence-Based Guidelines for the Treatment of Adults with Drug-Susceptible Extrapulmonary Tuberculosis and Adjunctive Use of Corticosteroids

Site
Lymph Node (Although guidelines do not recommend steroids, some case series suggest benefit.)

Length of Therapy
6 months

Rating (Duration)
AI

Corticosteroids
Not Recommended

Rating (Corticosteroids)
DIII

Site
Bone and Joint

Length of Therapy
6 to 9 months

Rating (Duration)
AI

Corticosteroids
Not Recommended

Rating (Corticosteroids)
DIII

Site
Pleural Disease

Length of Therapy
6 months

Rating (Duration)
AII

Corticosteroids
Not Recommended

Rating (Corticosteroids)
DI

Site
Pericarditis

Length of Therapy
6 months

Rating (Duration)
AII

Corticosteroids
Strongly Recommended

Rating (Corticosteroids)
AI

Site
CNS Tuberculosis including Meningitis

Length of Therapy
9 to 12 months

Rating (Duration)
BII

Corticosteroids
Strongly Recommended

Rating (Corticosteroids)
AI

Site
Disseminated Disease

Length of Therapy
6 to 9 months

Rating (Duration)
AII

Corticosteroids
Not Recommended

Rating (Corticosteroids)
DIII

Site
Genitourinary (Although guidelines do not recommend steroids, some case series suggest benefit)

Length of Therapy
6 to 9 month

Rating (Duration)
AII

Corticosteroids
Not Recommended

Rating (Corticosteroids)
DIII

Site
Peritoneal (Although guidelines do not recommend steroids, some case series suggest benefit)

Length of Therapy
6 to 9 months

Rating (Duration)
AII

Corticosteroids
Not Recommended

Rating (Corticosteroids)
DIII

Table 15. Dosing Recommendations for Adult Patients with Reduced Renal Function and For Adult
Patients Receiving Hemodialysis

Drug
Isoniazid

Change in Frequency
No change

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
300 mg once daily, or 900 mg three times/week

Drug
Rifampin

Change in Frequency
No change

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
600 mg once daily, or 600 mg three times/week

Drug
Pyrazinamide

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
25-35 mg/kg/dose three times/week (not daily)

Drug
Ethambutol

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
15-25 mg/kg/dose three times/week (not daily)

Drug
Levofloxacin

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
750-1000 mg/dose three times/week (not daily)

Drug
Cycloserine

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
250 mg once daily, or 500 mg/dose three times/week (The medications should be given after hemodiaylsis on the day of hemodialysis. *The appropriateness of 250 mg daily Cycloserine dose
has not been established. There should be careful monitoring or evidence of neurotoxicity. Monitoring of serum drug concentrations
should be considered)

Drug
Ethionamide

Change in Frequency
No Change

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
500 mg/dose daily

Drug
PAS

Change in Frequency
No Change

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
4 gm/dose twice daily

Drug
Streptomycin

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis

Drug
Capreomycin

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
12-15 mg/kg/dose two-three times/week (not daily)

Drug
Kanamycin

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
12-15 mg/kg/dose two-three times/week (not daily)

Drug
Amikacin

Change in Frequency
Yes

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
12-15 mg/kg/dose two-three times/week (not daily)

Drug
Moxifloxacin

Change in Frequency
No change

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
400 mg daily

Drug
Linezolid

Change in Frequency
No change

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
600 mg daily

Drug
Rifabutin

Change in Frequency
No change

Recommended Dose and Frequency for Patients with Creatinine Clearance less than 30 ml per minute or patients receiving Hemodialysis
Dose varies due to drug to drug interactions.

HOW TO MONITOR
HCV, HBV - If risk factors exist
* HIV, foreign birth in Asia or Africa, IVDU
Baseline labs on all: CBC's, Platelets, LFT's, Bilirubin, Alkaline Phosphatase, HIV, Creatinine
Monthly liver enzymes if baseline abnormal, chronic medical conditions or increased risk of hepatitis.
For pulmonary TB - Monthly sputum until 2 consecutive cultures are negative
* -2 months sputum is crucial
* 80% should convert by 2 mo, 95% by 3 mo
Assessment of visual acuity and red-green color vision if receiving EMB.
Clinical evaluations monthly to assess for adherence and adverse drug reactions