Applies to the following strength(s): 100 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Tuberculosis - Resistant
-Week 1 and Week 2: 400 mg orally once a day.
-Week 3 to Week 24: 200 mg orally 3 times per week, with at least 48 hours between doses.
-Duration of therapy: 24 weeks
-Required testing prior to treatment: Susceptibility information for the background regimen against Mycobacterium tuberculosis isolate if possible; ECG; serum potassium, calcium, and magnesium concentrations; and liver enzymes.
-Use this drug only in combination with 3 other antimycobacterial drugs to which the patient's multi-drug resistant tuberculosis (MDR-TB) isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, treatment may be initiated in combination with at least 4 other drugs to which the patient's MDR-TB isolate is likely to be susceptible.
-Administer by directly observed therapy (DOT).
-This drug should be reserved for use when an effective treatment regimen cannot otherwise be provided.
Use: Part of combination therapy in the treatment of adults 18 years and older with pulmonary multi-drug resistant tuberculosis (MDR-TB).
Renal Dose Adjustments
-Mild or moderate renal impairment: No adjustment recommended.
-Severe renal impairment: Use with caution.
Liver Dose Adjustments
-Mild or moderate hepatic impairment: No adjustment recommended.
-Severe hepatic impairment: Data not available; Use with caution only when benefits outweigh risks.
US BOXED WARNING:
-INCREASED MORTALITY: An increased risk of death was seen in the treatment group for this drug compared to the placebo treatment group in one clinical trial. Only use this drug when an effective treatment regimen cannot otherwise be provided.
-QT PROLONGATION: QT prolongation can occur with this drug. Concomitant use with drugs that prolong the QT interval may cause additive QT prolongation. Monitor ECGs. Discontinue this drug if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
End-stage renal disease requiring hemodialysis or peritoneal dialysis: Use with caution.
-Take with food.
-Swallow drug tablets whole with water.
-Missed dose during Weeks 1 and 2: The missed dose should not be made up; the usual dosing schedule should be continued.
-Missed Dose during Weeks 3 to 24: The missed dose should be taken as soon as possible and then the regular 3 times a week dosing regimen should be resumed.
-Protect from light.
-DRUG RESISTANCE: Modification of the atpE target gene and/or upregulation of the MmpS5-MmpL5 efflux pump have been associated with increased MIC values for this drug in isolates of M. tuberculosis.
-CROSS RESISTANCE: M. tuberculosis isolates in patients with MDR-TB that developed at least 4-fold increase in MIC values for this drug were associated with upregulation of the MmpS5-MmpL5 efflux pump and were found to be cross-resistant to clofazimine.
-SUSCEPTIBILITY TEST METHODS: Consult the manufacturer product information.
-OVERDOSAGE: Removal of unabsorbed drug may be achieved with activated charcoal.
-This drug has been shown to be active in vitro and in clinical infections against most isolates of M. tuberculosis.
-This drug is approved under accelerated approval based on time to sputum culture conversion. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
-The safety and efficacy of this drug in HIV patients with MDR-TB have not been established due to limited clinical data.
-Skipping doses or not completing the full course of therapy may decrease the treatment effectiveness and increase the likelihood of drug resistance.
-Drug should be dispensed in its original container.
-Cardiovascular: ECG (before treatment, and 2, 12, and 24 weeks after starting treatment)
-Hepatic: Hepatotoxicity symptoms (e.g., fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly); laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin at baseline, monthly during treatment, and as needed); viral hepatitis
-Metabolism: Electrolytes (serum potassium, calcium, and magnesium at baseline and correct if abnormal)
-Other: Susceptibility testing, minimum inhibitory concentration (MIC) values
-Do not drink alcohol during treatment.
-Take the full course of this drug treatment and do not skip doses, even if you feel well. Not completing the total 24 weeks of treatment may result in this drug not working as well and your TB being harder to treat.
-If you miss a dose during Week 1 or Week 2, do not take a double dose to make up for the missed dose; take the next dose as usual. During Week 3 to Week 24, take the missed dose as soon as possible and then resume the regular 3 times a week dosing schedule.
-Do not take this drug alone; it must be taken in combination with other medications to treat TB that are prescribed by your healthcare provider.
-Avoid taking herbal products and medications that may cause liver damage during treatment with this drug.
-This drug may cause side effects such as dizziness that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.
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