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Unit 8: Complications and Special Situations Botswana National Tuberculosis Programme Manual Training for Medical Officers Objectives At the end of this unit, participants will be able to: • Manage Category I, II, and second-line therapy in special situations: • • • • • Pregnancy Breastfeeding Rash Liver disease Kidney Disease Unit 8: Complications and Special Situations • Peripheral neuropathy • Psychiatric illness and MDR • Paradoxical reactions Slide 8-2 Pregnancy • Every woman of child bearing age should be asked if she is pregnant prior to starting anti-TB treatment • Successful outcome of pregnancy largely depends on successful completion of anti-TB treatment • Category I- drugs are safe in pregnancy • Category II- Streptomycin should be avoided if possible as it can cause ototoxicity of the foetus Unit 8: Complications and Special Situations Slide 8-3 Pregnancy: Category IV If a woman is pregnant, if possible: • Avoid the first trimester and start treatment during the 2nd or 3rd trimester • Avoid amikacin (and streptomycin) until after delivery (fetal ototoxicity possible) • Avoid ethionamide (teratogenic in animals) Unit 8: Complications and Special Situations Slide 8-4 Breastfeeding • Women on Category I and II Regimens should continue breastfeeding • If mother has smear+ TB and baby does not have active TB, give baby INH, as appropriate for weight, for 6 months followed by BCG vaccination Unit 8: Complications and Special Situations Courtesy of: Jeanne Raisler Slide 8-5 Rash in TB Treatment (1) • Before attributing a skin symptom or rash to TB medications, assess • Was it present before TB therapy began? • Is it a condition unrelated to TB treatment? • Many persons on TB treatment also have HIV • Many people with HIV have skin conditions • ARVs can also cause skin conditions, especially NVP Unit 8: Complications and Special Situations Slide 8-6 Rash in TB Treatment (2) • Mild to Moderate rashes • Skin rash with mild itching • No blisters or mucous membrane involvement • Management • • • • • Consider other causes (scabies, etc.) Aqueous cream, Calamine skin lotion May need to stop TB medications Chlorpheniramine 4 mg tds, or Promethazine 25-50 mg nocte Unit 8: Complications and Special Situations Slide 8-7 Mild to Moderate Rash Mild Rash Unit 8: Complications and Special Situations Source: I-TECH, 2006. Slide 8-8 Severe Rash Rash with: • Persistent itchiness • Mucous membrane involvement and/or • Blistering • Urticaria (hives) Unit 8: Complications and Special Situations Slide 8-9 Severe Rash Unit 8: Complications and Special Situations Source: I-TECH, 2006. Slide 8-10 Severe Rash Management (1) • • • • Stop all TB drugs together Hospitalise the patient Give IV fluids as required Consider antibiotics for severe desquamation/exfoliation • Treat like a burn • Consider the use of steroids Unit 8: Complications and Special Situations Slide 8-11 Severe Rash Management (2) • Most patients can wait for the rash to resolve before resuming TB treatment • If the patient has life-threatening TB as well as life-threatening rash, may provide at least 2 TB drugs (3 drugs preferred) the patient has not taken before until the rash subsides Unit 8: Complications and Special Situations Slide 8-12 Treatment After Rash (1) If it is not obvious which caused the reaction, which is often the case, re-introduce TB medications in a step-wise fashion • Gradually increase the dose of each medication • If no reaction, continue the medication and gradually increase the dose of the next medication • Use in reverse order of likelihood of cause of rash Unit 8: Complications and Special Situations Slide 8-13 Schedule for Reintroduction of Anti-TB Drugs Day Drug and dose 1 INH 25 mg 2 INH 50 mg 3 INH 100 mg 4 INH 200 mg 5 INH 300 mg* 6 INH 300 mg + R 150 mg 7 INH 300 mg + R 300 mg 8 INH 300 mg + R 450 mg 9 INH 300 mg + R 600 mg* 10 INH 300 mg + R 600 mg + E 400 mg 11 INH 300 mg + R 600 mg + E 800 mg 12 INH 300 mg + R 600 mg + E 1200 mg* 13 INH 300 mg + R 600 mg + E 1200 mg + Z 500 mg 14 INH 300 mg + R 600 mg + E 1200 mg + Z 1000 mg 15 INH 300 mg + R 600 mg + E 1200 mg + Z 1500 mg 16 INH 300 mg + R 600 mg + E 1200 mg + Z 2000 mg* Unit 8: Complications and Special Situations Slide 8-14 Treatment After Rash (2) • If gradual reintroduction succeeds without a recurrence of rash, can continue treatment • If the offending drug causes a reaction, suspend it and replace the offending drug with another agent • May leave out pyrazinamide, ethambutol or streptomycin • Get expert advice; substitutions may require longer duration of therapy Unit 8: Complications and Special Situations Slide 8-15 Liver Disease • Three important issues complicate therapy: • Hepatotoxicity of anti-TB drugs • Acute liver disease with concurrent TB • Chronic liver disease with concurrent TB • Provided there is no clinical evidence of chronic liver disease, ATT is safe in patients with hepatitis virus carriage, history of acute hepatitis or excessive alcohol consumption Unit 8: Complications and Special Situations Slide 8-16 Acute Hepatitis Prior to TB Treatment • Evaluate the cause: • • • • • Viral (Hepatitis A, Hepatitis B) Alcohol ARVs Traditional medicines Other toxins • If possible, await resolution of acute hepatitis before starting TB treatment Unit 8: Complications and Special Situations Slide 8-17 Acute Hepatitis Prior to TB Treatment (2) • Consult TB expert • Initial phase: SE for 3 months • Continuation phase: • RH for 6 months OR • SE for 9 additional months • Avoid Z, H, R and Eth (ethionamide) during acute hepatitis Unit 8: Complications and Special Situations Slide 8-18 Established Chronic Liver Disease Prior to TB Treatment • Evaluate the cause • Viral: Hepatitis B, Hepatitis C • Alcohol • Disseminated TB • Avoid PZA • Requires close monitoring • Liver function tests • Sputum samples • Experienced TB doctor Unit 8: Complications and Special Situations Slide 8-19 TB Treatment with Chronic Liver Disease • Preferred option • Initial: 2 months RHES • Continuation: 6 months RH • Second option • Initial: 2 months RES • 10 months RE • Third option • Initial: 2 months HES • Continuation: 10 months HE Unit 8: Complications and Special Situations Slide 8-20 Hepatotoxicity • Symptoms: Fever, malaise, right upper quadrant abdominal pain, nausea, vomiting, loss of appetite • Signs: • ALT or AST more than 3x increased if symptoms of hepatitis are present, or more than 5x increased without symptoms • Bilirubin or alkaline phosphatase more than 2x increased • Jaundice Unit 8: Complications and Special Situations Slide 8-21 TB Drugs & Hepatotoxicity Hepatotoxic NOT Hepatotoxic • Pyrazinamide and isoniazid are the most common causes • Pyrazinamide causes the most severe • Rifampicin hepatotoxicity is less common and less severe • Ethionamide • Ethambutol • Streptomycin Unit 8: Complications and Special Situations Slide 8-22 Hepatotoxicity • Try to rule out other causes of acute liver disease before attributing it to the TB treatment • In hepatotoxicity, stop all TB drugs until the patient improves • In case of severe TB, consider using “liver sparing regimen” (Ethambutol, streptomycin, and Ciprofloxacin) • Admit patients to the hospital if unable to maintain hydration or if hepatic failure develops Unit 8: Complications and Special Situations Slide 8-23 Acute Hepatitis: During TB Treatment • Rare • Decision whether to stop or continue anti-TB treatment requires good clinical judgment • Safest option in acute hepatitis not due to TB is to give streptomycin and ethambutol until the hepatitis has resolved (for a maximum of 3 months) followed by a continuation phase of INH and rifampicin for 6 months Unit 8: Complications and Special Situations Slide 8-24 Treatment After Hepatotoxicity (1) • When hepatitis has resolved, reintroduce therapy • If lab tests are not available, wait until 2 weeks after the jaundice ends • If lab tests are available wait until AST/ALT < 2x normal • Stepwise fashion, starting with safest drugs • Try to create a safe combination regimen Unit 8: Complications and Special Situations Slide 8-25 Reintroduction of Drugs After Hepatoxicity • Continue EMB, streptomycin, +/- ciprofloxacin • INH 300 mg daily x 4 days • If no symptoms, add • Rifampicin 600 mg daily x 4 days • If no symptoms, 2 options: • Do not try PZA • Try PZA • D/C streptomycin and ciprofloxacin when back on E, H, R Unit 8: Complications and Special Situations Slide 8-26 Treatment After Hepatotoxicity (2) • Pyrazinamide toxicity • 2 months RHES then 6 months RH • Check sputum at 2, 5, and 7 months • Pyrazinamide and isoniazid toxicity • 2 months RES then 10 months RE • Check sputum at 2, 5, 8, and 11 months • Pyrazinamide and rifampicin toxicity • 2 months HES then 10 months HE • Check sputum at 2, 5, 8, and 11 months Unit 8: Complications and Special Situations Slide 8-27 Renal Disease • Some patients with active TB will have renal disease due to either TB in the urinary tract or another condition • Adjust dose of ethambutol based on creatinine clearance if renal disease is suspected • Avoid streptomycin unless specialist care is available • Safest regimen: 2HRZ/4HR Unit 8: Complications and Special Situations Slide 8-28 Key Points • Careful assessment is needed to distinguish drug reactions from other conditions • Successful management of adverse drug reactions is necessary for patient health and integrity of the TB control program • Treatment of patients with chronic liver or kidney disease may require changes in regimen or dosing • Issues with category II regimen and second-line treatment are more complex Unit 8: Complications and Special Situations Slide 8-29