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Indian Journal of Pharmacy Practice
Presented by:
N.BENAZEER BEGUM


This is a case report focusing on a 32 years male
patient who experienced hepatotoxicity after
administration of anti tubercular drugs.



Isoniazid,Rifampacin, Pyrazinamide, Ethambutol are
the first line agents in the treatment of Tuberculosis.



The first line anti-TB drugs are potentially
hepatotoxic.



The incidence rate of anti-TB induced hepatotoxicity
is found to be 2% to 28%.



The goal of this study was to evaluate the risk factor,
alteration in liver enzymes,approach and outcome of
anti-TB drugs induced hepatotoxicity in Esra hospital
patient.
A

32 year old male patient was brought to
the hospital in unconscious state associated
with frothing from mouth and sweating.

 The

patient consumed alcohol at night
before sleeping and did not get up in the
morning. Shortness of breath was observed
but was not associated with seizures.

 Patient

was diagnosed as pulmonary Koch's 3
months back and he was on regular
medications.
 On

the 1st day, patient was brought to the
hospital with pulse rate 135/min, BP was found
to be 100/60 mm Hg with SPO 2 95% with high
flow oxygen and General random blood sugar
was dropped to 23 mg/dL.

 The

patient was evaluated for hypoglycaemia
and received following medications:



Injection thiamine – 100 mg

 Nebulization

salbutamol (100 mcg), ipratropium
bromide(20 mcg) and budesonide (100mcg)



Injection ceftriaxone - 1gm


Injection tramadol - 1 ampoule



Tablet chlordiazepoxide - 25mg



25% dextrose intravenously immediately



Multivitamin tablet.



The physician advised the following
investigations:
Arterial blood gases, Liver function test, Blood
urea, Serum creatinine, Complete blood , Chest
X-ray, Complete urinary examination, Serum
electrolytes and monitor general random blood
sugar 4th hourly.


On the same day, pulmonologist prescribed the
following drugs to the patient after examination:



Tablet Theophylline - 50 mg



Tablet Montelukast - 10 mg



Tablet Levocetirizine - 5 mg



Tablet Methyl Prednisolone -16 mg



Tablet Ursodeoxycholic acid - 150 mg



Injection Pantoprazole - 40 mg



normal saline intravenously - 100ml/hour


Injection Dexrabeprazole - 10 mg



Injection Metoclopramide -10 mg



Injection L-orthinine,L-aspartate - 1 ampoule



Syrup Sucralfate - 20 ml



Injection Butyl Scopolamine 1 ampoule
intramuscular immediately was given to the
patient by pulmonogist at 9.00 p.m and Methyl
Prednisolone was stopped.
Parameter
LFT
SGPT
SGOT
Total Bilirubin
Direct Bilirubin
ABGPO2
BIOCHEMISTRY
Ammonia
Serum Amylase
Serum Lipase
CBP
Lymphocytes
Platelets
URINE ANALYSIS
Albumin
Sugar
Acetone
Calcium Oxalates
USG
Abdomen

Test Values
Day 1 Day 2
150 U/L, 412 U/L
124 U/L, 482 U/L
1.6mg%
0.7mg%
140.3
-

130μmol/L 95 U/L
28 U/L
0.282×103/mm3
1182×103/mm3
++
++++
++
1-2

Grade IV fatty
infiltration of liver

Normal Range
17-63
Up to 35
0.2-1
0-0.2
75-100

10.47
28
38
150-500
 The

results of investigations are given below:

 On

the 3rd day, alcoholic syndrome
withdrawal symptoms
such as contractile delirium were seen in
the patient.

 On

the 4th day patient was shouting and
agitated with irritability and restlessness, to
reduce the anxiety he was prescribed with
tablet Lonazepam 0.25mg for 5days.
 On

the 5th day nutritional assessment was
done.

 On

6th day no fresh complaints were seen.

 On

7th day, patient was considered to be the
case of ALD with acute hepatitis.

 On

8th day, the patient was diagnosed as the
case of anti-TB drug – induced hepatitis.
 Anti-TB

drugs induced hepatotoxiciy is a
serious problem and it was reported that 228% of TB patients experience drug related
hepatotoxicity (DIH) during the course of the
treatment.

 The

incidence rate of drug induced
hepatotoxicity in India is 8-36%.

 According

to a study, overall incidence of
serious adverse effects was three times
higher with pyrazinamide than with
isoniazide, or rifampicin.
 In

this case, the patient is chronic alcoholic
and consumed large amounts of alcohol
which may lead to following liver conditions –
fatty liver,hepatitis and cirrhosis.

 In

this case, hepatitis was seen in the
patient.

 Taking

all the information under
consideration, a causality assessment of
the entitled medical conditions was done by
using Naranjo Causality Assessment Algorithm
 Upon

discharge, patient was counselled
regarding the medications and course of the
treatment.
 The discharge medication includes:
 Tablet multivitamin - 1 week
 Tablet Ursodeoxycholic acid - 1 week
 Tablet montelukast/levocetirizine - 1 week
 Syrup sucralfate
 Syrup lactulose
 Patient

developed hepatotoxicity and severe
alcohol induced hepatitis following the
administration of 1st line anti-TB drugs,
which were administered for the treatment .

 pulmonary

koch's. Following the withdrawal
of alcohol,standard treatment and standard
care, we were able to achieve a favourable
outcome. Clinicians need to be made aware
of these potentially fatal adverse effects
associated with anti-TB drugs.












1. Brewer TF, Heymann SJ To control and beyond:
moving towards
eliminating the global tuberculosis threat. J
Epidemiol Community
Health, 2004; 58:822-5.
2. Hussain Z, Kar P, Hussain SA. Antituberculosis druginduced
hepatitis: risk factors, prevention and management.
Indian J Exp Biol,
2003; 41:1226-32.
3. Frieden TR, Sterling TR, Munsiff SS, Watt CJ, Dye
C. Tuberculosis.
Lancet, 2003; 362: 887-99.
Indian Journal of Pharmacy Practice Volume 6 Issue 2
Apr - Jun, 2013
Anti tuberculosis drug - induced hepatitis – A Case Study

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Anti tuberculosis drug - induced hepatitis – A Case Study

  • 1. Indian Journal of Pharmacy Practice Presented by: N.BENAZEER BEGUM
  • 2.  This is a case report focusing on a 32 years male patient who experienced hepatotoxicity after administration of anti tubercular drugs.  Isoniazid,Rifampacin, Pyrazinamide, Ethambutol are the first line agents in the treatment of Tuberculosis.  The first line anti-TB drugs are potentially hepatotoxic.  The incidence rate of anti-TB induced hepatotoxicity is found to be 2% to 28%.  The goal of this study was to evaluate the risk factor, alteration in liver enzymes,approach and outcome of anti-TB drugs induced hepatotoxicity in Esra hospital patient.
  • 3. A 32 year old male patient was brought to the hospital in unconscious state associated with frothing from mouth and sweating.  The patient consumed alcohol at night before sleeping and did not get up in the morning. Shortness of breath was observed but was not associated with seizures.  Patient was diagnosed as pulmonary Koch's 3 months back and he was on regular medications.
  • 4.  On the 1st day, patient was brought to the hospital with pulse rate 135/min, BP was found to be 100/60 mm Hg with SPO 2 95% with high flow oxygen and General random blood sugar was dropped to 23 mg/dL.  The patient was evaluated for hypoglycaemia and received following medications:  Injection thiamine – 100 mg  Nebulization salbutamol (100 mcg), ipratropium bromide(20 mcg) and budesonide (100mcg)  Injection ceftriaxone - 1gm
  • 5.  Injection tramadol - 1 ampoule  Tablet chlordiazepoxide - 25mg  25% dextrose intravenously immediately  Multivitamin tablet.  The physician advised the following investigations: Arterial blood gases, Liver function test, Blood urea, Serum creatinine, Complete blood , Chest X-ray, Complete urinary examination, Serum electrolytes and monitor general random blood sugar 4th hourly.
  • 6.  On the same day, pulmonologist prescribed the following drugs to the patient after examination:  Tablet Theophylline - 50 mg  Tablet Montelukast - 10 mg  Tablet Levocetirizine - 5 mg  Tablet Methyl Prednisolone -16 mg  Tablet Ursodeoxycholic acid - 150 mg  Injection Pantoprazole - 40 mg  normal saline intravenously - 100ml/hour
  • 7.  Injection Dexrabeprazole - 10 mg  Injection Metoclopramide -10 mg  Injection L-orthinine,L-aspartate - 1 ampoule  Syrup Sucralfate - 20 ml  Injection Butyl Scopolamine 1 ampoule intramuscular immediately was given to the patient by pulmonogist at 9.00 p.m and Methyl Prednisolone was stopped.
  • 8. Parameter LFT SGPT SGOT Total Bilirubin Direct Bilirubin ABGPO2 BIOCHEMISTRY Ammonia Serum Amylase Serum Lipase CBP Lymphocytes Platelets URINE ANALYSIS Albumin Sugar Acetone Calcium Oxalates USG Abdomen Test Values Day 1 Day 2 150 U/L, 412 U/L 124 U/L, 482 U/L 1.6mg% 0.7mg% 140.3 - 130μmol/L 95 U/L 28 U/L 0.282×103/mm3 1182×103/mm3 ++ ++++ ++ 1-2 Grade IV fatty infiltration of liver Normal Range 17-63 Up to 35 0.2-1 0-0.2 75-100 10.47 28 38 150-500
  • 9.  The results of investigations are given below:  On the 3rd day, alcoholic syndrome withdrawal symptoms such as contractile delirium were seen in the patient.  On the 4th day patient was shouting and agitated with irritability and restlessness, to reduce the anxiety he was prescribed with tablet Lonazepam 0.25mg for 5days.
  • 10.  On the 5th day nutritional assessment was done.  On 6th day no fresh complaints were seen.  On 7th day, patient was considered to be the case of ALD with acute hepatitis.  On 8th day, the patient was diagnosed as the case of anti-TB drug – induced hepatitis.
  • 11.  Anti-TB drugs induced hepatotoxiciy is a serious problem and it was reported that 228% of TB patients experience drug related hepatotoxicity (DIH) during the course of the treatment.  The incidence rate of drug induced hepatotoxicity in India is 8-36%.  According to a study, overall incidence of serious adverse effects was three times higher with pyrazinamide than with isoniazide, or rifampicin.
  • 12.  In this case, the patient is chronic alcoholic and consumed large amounts of alcohol which may lead to following liver conditions – fatty liver,hepatitis and cirrhosis.  In this case, hepatitis was seen in the patient.  Taking all the information under consideration, a causality assessment of the entitled medical conditions was done by using Naranjo Causality Assessment Algorithm
  • 13.
  • 14.  Upon discharge, patient was counselled regarding the medications and course of the treatment.  The discharge medication includes:  Tablet multivitamin - 1 week  Tablet Ursodeoxycholic acid - 1 week  Tablet montelukast/levocetirizine - 1 week  Syrup sucralfate  Syrup lactulose
  • 15.  Patient developed hepatotoxicity and severe alcohol induced hepatitis following the administration of 1st line anti-TB drugs, which were administered for the treatment .  pulmonary koch's. Following the withdrawal of alcohol,standard treatment and standard care, we were able to achieve a favourable outcome. Clinicians need to be made aware of these potentially fatal adverse effects associated with anti-TB drugs.
  • 16.          1. Brewer TF, Heymann SJ To control and beyond: moving towards eliminating the global tuberculosis threat. J Epidemiol Community Health, 2004; 58:822-5. 2. Hussain Z, Kar P, Hussain SA. Antituberculosis druginduced hepatitis: risk factors, prevention and management. Indian J Exp Biol, 2003; 41:1226-32. 3. Frieden TR, Sterling TR, Munsiff SS, Watt CJ, Dye C. Tuberculosis. Lancet, 2003; 362: 887-99. Indian Journal of Pharmacy Practice Volume 6 Issue 2 Apr - Jun, 2013