DR-DOT Provider Handbook_Bangaldesh - CAP-TB

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DR-DOT Provider
BOOK
(DRAFT)
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TB Basics and Introduction to Drug-Resistant Tuberculosis
What is tuberculosis (TB)?
TB is a dangerous disease that starts in the lungs. If it remains untreated,TB can spread to other
parts of the body. It can spread to bones and joints, the stomach, the throat, the heart, and the
brain. TB is very serious and can kill people if left untreated.
What is tuberculosis multidrug-resistant tuberculosis (MDR-TB)?
Multidrug-resistant TB (MDRTB) is defined as TB resistant to at least isoniazid and rifampicin,
the two most potent drugs against TB. MDR-TB is tuberculosis that cannot be treated with the
drugs to treat regular TB.
What is the difference between TB and MDR-TB?
TB and MDR-TB are the same disease. The only difference is that the main drugs to treat regular
TB (Isoniazid and Rifampicin) cannot treat MDR-TB. They do not work. MDR-TB needs other
medicines that have to be taken for 2 years.
Symptoms of TB including MDR-TB
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Cough
Fever
Chills
Weight loss
Chest pain
Loss of appetite
Fatigue
Night sweats
Who can get MDR-TB?
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Everybody can get MDR-TB.
Those who are more vulnerable to TB, including MDR-TB are children and adults who
cannot fight off illness, people who are already sick or people who do not eat enough
nutritious food.
Specially those who are not taking drugs regularly are getting MDR TB.
How MDR-TB transmitted?
MDR-TB, like TB is transmitted by droplets of water in the air. When a person who has MDR
TB , coughs, sneezes or talks, he can spray these droplets of water into the air. If someone else
breathes in the droplets, he can also get MDR-TB.
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Who are MDR TB suspects?
The followings are the MDR TB suspects. Sputum of all the below mentioned patients must
send for Culture and sensitivity test.
 Cat. 2 failures and relapses
 Cat.1 failures and relapses
 Cat. 1 & Cat 2 late converters
 Cat.1 & Cat. 2 defaults
 Close contacts of known MDR-TB cases.
How MDR TB diagnosed?
Diagnosis of MDR TB is done by culture and sensitivity of Sputum. The facilities in the country
where culture and sensitivity testing is available are:
National TB reference laboratory, NIDCH, Mohakhali, Dhaka
Regional TB reference laboratory, General Hospital, Chittagong
Regional TB reference laboratory, CDH, Rajshahi
Regional TB reference laboratory, CDH, Khulna
MDR-TB Treatment
MDR-TB medicines must be taken with care. The patients have to take multiple medicines every
day. The standard MDR-TB regimen is:
8(Km-Z-Lfx-Eto-Cs)/12(Lfx-Eto-Cs-Z)
(Km= Kanamycin, Lfx = Levofloxacin, Z=Pyrazinamide, Eto=Ethionamide, Cs=Cycloserine.
)
The numbers in front of the drug abbreviations represent the average number of months the
drugs are given. In the Intensive phase five drugs are used and in continuation phase 4 drugs are
used
Drug*
Average daily dosage
33-50 kg
51–70 kg
>70 kg (max dose)
Pyrazinamide (Z) (400 mg)
30–40 mg/kg daily
1000-1600
mg
1600 -1800
mg
2000-2500 mg
Kanamycin (Km) (1 g vial)
15–20 mg/kg daily
500-750
mg
1000 mg
1000 mg
Levofloxacin (Lfx) (250 mg,
500 mg)
Usual adult dose 1000
mg
750 mg
750-1000
mg
750-1000mg
Ethionamide (Eto) (250 mg)
15–20 mg/kg daily
500mg
750 mg
750–1000 mg
Cycloserine (Cs) (250 mg)
15–20 mg/kg daily
500mg
750 mg
750–1000 mg
For additional information on the DR-TB drugs, please reference Annex 1. In Annex 1, there are
drug sheets that provide brief descriptions, along with common side effects and directions on
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when to provide the medication, for each drug. Annex 2 provides information on how to give an
intramuscular (IM) injection.
Identifying Side-effects
MDR-TB medicines have more side effects than regular TB medications.
Urgent Side effects
Difficulty Breathing
Rash
Difficulty Swallowing
Swollen Eyes
Change in Vision
Urgent side effects
Difficulty breathing or chest pain
Rash
Vomiting
Difficulty swallowing
Jaundice
Swollen eyes
Swollen tongue
Change in vision
Hearing loss
Jaundice
Swollen Tongue
Hearing Loss
Stomach ache
Vomiting blood
Depression
Acting crazy
Chest Pain
Pains in the legs
Vomiting
Ask the patient
Are you having difficulty breathing?
Are you having chest pain?
Do you have a rash anywhere on your
body?
Have you been vomiting or felt nauseous?
Have you had trouble swallowing?
Has your skin changed color?
Have your eyes been swollen?
Has your tongue been swollen
Has your vision changed? Can you see as
well as always?
Can you hear as well as always?
 If your patient is having urgent side effects, he or she should go to the clinic immediately.
 If your patient needs help getting to the clinic, do you best to help him or her there.
Non-urgent side effects
Dizziness
Weakness
Muscle pain
Burning feet or tingling feet or hands
Non-urgent side effects
Non-urgent side effects
Loss of appetite
Ask the patient
Are you eating well
Dizziness
Do you feel dizzy?
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Weakness
Do you feel weak?
Muscle pain
Do you have muscle pain>
Burning or tingling in hands or feet
Do you feel burning or tingling in uour
hands or feet?
 If your patient is having a non-urgent side effect, he or she should go to the clinic within one
week
 For additional information on DT-TB side-effects, including detailed descriptions of each,
please reference Annex 3.
DR-DOT Provider: Roles and Responsibilities
Summary:
1. Directly Observed Therapy (DOT)
2. Educating patients, their families and the community.
3. Psychological and Social Support
4. Communication skills
5. Be a link between the community and the clinic
6. Noticing needs
7. The Clinical Team
Directly Observed Therapy (DOT)
 Collection of patient’s medicine each month from the pharmacist at the clinic.
 Storing of medicine in a safe place.
 Daily home visits to give the patient his/her medicine..
 Provide support and encouragement to the patient.
 Answer questions about medicines and their side effects.
 Reassure patients who are experiencing normal side effects that the side effects are
normal and that they do not need to be concerned.
 Every day, ask the patient how he or she is feeling.
 Watch for allergic reactions and urgent side effects to medicines. If those serious signs
and symptoms are present, help get the patient to the clinic immediately.
 Tell patients who are experiencing non-urgent side effects that they should visit the clinic
within one week.
 Fill in the DR-DOT Provider Form for each patient during every visit.
 Remind patient when she/he has an appointment at the clinic.
Educating patients, their families and community
 Provide accurate information about MDR-TB, including what MDR-TB is and how to
live with it, how it is spread, how to prevent it, and how to support patients with MDRTB.
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Correct people’s misunderstandings or myths about MDR-TB.
Encourage household contacts of the patient to get tested for MDR-TB.
Educate the community about MDR-TB and encourage those with MDR-TB symptoms
to go to the clinic to get tested.
Tell people in community that the spread of TB / MDR-TB can be prevented by sunlight,
fresh air, medicine, nutritious food, and by people covering theirmouths when they
cough.
Tips for Teaching DR-TB Information using the Patient Education Flipchart
Tips for educating the patient using the Patient Education Flipchart:
1. All material in the Flipchart must be reviewed with the DR-TB patient
2. Place the Flipchart in-between you (the Provider) and the patient, so that both people can
see the Flipchart material
3. Emphasis important information to the patient
4. Allow the patients to ask questions any time during the training
5. Clarify any confusing information for the patient while reviewing the information
6. Do not review the patient education material too quickly. Give the patient time to
understand what is being covered on each page.
Psychological and Social Support
 Provide patient not only medicine, but also support. Talk with patient each day about
his/her life, how s/he is feeling, and any concerns or problems that s/he may have. It can
be very helpful to talk about things that do not have anything to do with diseases or
medicine.
 Spend time with the patient and be a good listener. Encourage the patient to seek support
from spiritual and religious leaders.
 Help patients and their family members understand the different psychological and
emotional issues related to MDR-TB: shock, denial, fear, loss, grief, shame, guilt, anger,
anxiety, low self-esteem, depression, and suicidal thoughts.
 Recognize signs of depression and thoughts of suicide and know when to seek help from
a social worker or doctor.
 Recognize that children of different ages will respond differently to having MDR-TB.
Listen to them and make them feel recognized and special..
 Encourage patients to live positively by eating nutritious food, getting enough sleep,
exercising, limiting alcohol intake, and taking part in family and community life.
Communication skills
Remember to use good communication skills when speaking with patients, their family
members, or community members.
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Be respectful.
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Be empathetic.
Take time to listen and be patient.
Be caring and not judgmental.
Questions that need be full answered, not just “yes” or “no.”This will encourage people
to talk.
Keep information confidential.
Meet children at their level and communicate in a way that is appropriate to their age.
Be a link between the community and the clinic
 Refer patients to the clinic immediately if they have an allergic reaction or urgent side
effect from taking medicine.
 Communicate with the clinic about problems of patients .
 Let a doctor, nurse, or DR-DOT Provider Supervisor know if patient having problems
Things a DR-DOT Provider should never do
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Never discuss patient information with anyone except the doctor or nurse.
Never give other people medicine to give to the
Never ask the patient for money or gifts.
Never give patients medicine to take by themselves.
Never hide information from the doctor or nurse about the patient’s health, problems, or
concerns.
Home visit checklist
☐Make daily home visits to give the patient their medicine and watch them take it (every day, at
the same time, and the right amount).
☐Provide support and encouragement when a patient takes the medicine and explain the
importance of taking the medicine every day.
☐Reassure patients who are experiencing normal side effects.
☐Answer questions about medicines and their side effects. Let the patient know if you do not
know an answer and then contact the clinic for more information.
☐Everyday, ask patients how they are feeling.
☐Watch for allergic reactions and urgent side effects to HIV/AIDS and TB medicines. If there
are signs and symptoms of a bad reaction, help get the patient to the clinic immediately.
☐Recommend that patients who are experiencing non-urgent side effects visit the clinic within
one week.
☐Fill out the DR DOT Provider Form for each patient every day.
☐Remind patients when they have an appointment at the clinic.
☐Provide accurate information about MDR-TB as needed
☐Watch out for any signs of depression and thoughts of suicide
☐Spend time with other household members..
☐Encourage the patient to live positively by eating nutritious food, getting enough sleep,
exercising, and taking part in family and community life
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Annex 1: DR-TB Drug Sheets
These are some descriptions of the DR-TB drugs that can help remind you of which drugs to provide DR-TB
patients, when to give them, and how to give them (orally, via injection). Use this information as a reference
when learning about the different DR-TB drugs.
Name:
Abbreviation:
Dose/KG:
Usual Dose:
Maximum Dose:
When to give drug?
KANAMYACIN
Km
15 mg/kg/day IMI
Adult dosing ranges from 500 mg to 1 gram per day
1500 mg dly IMI
Once daily in the morning
Side-effects:
Cautions:
Heating loss; Dizziness or ringing in the ears;
Swelling in legs or lack of urination (kidney problems);
Pain/redness at injection site; rash
Do not use during pregnancy
Other:
Patients MUST be have blood tests each month to assess
creatinine and potassium levels;
This drug is given via IM injection
Name:
Abbreviation:
Dose/KG:
Usual Dose:
Maximum Dose:
When to give drug?
LEVOFLOXACIN
Lfx
N/A
Dosing varies, in adults doing is 750 to 1000 mg per day
750 mg dly
Once daily in the morning
Side-effects:
Cautions:
Other:
Pain, swelling or tearing a tendon (back of ankle or elbow);
Rash; Severe or bloody diarrhea; yellow eyes (hepatitis)
No laboratory monitoring required
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Name:
Abbreviation:
Dose/KG:
Usual Dose:
Maximum Dose:
When to give drug?
PYRAZINAMIDE
Z
20-30 mg/kg/day
Dosing varies, in adults dosing is 800 to 2500 mg per day
2 g dly
Once daily in the morning
Side-effects:
Cautions:
Yello eyes or skin (Hepatitis); Severe nausea or vomiting with
abdominal pain; Painfully inflamed joints (Gout)
Avoid in patients with severe liver disease or gout
Other:
This medicine should be taken with food;
Monthly blood tests will need to be condcuted to assess for side
effects associated with yellow eyes/skin or if nausea or
vomitting develops
Name:
Abbreviation:
Dose/KG:
Usual Dose:
Maximum Dose:
When to give drug?
ETHIOAMIDE
Eto
15-20
mg/kg/day
Dosing varies, in adults dosing is 500 to 1000 mg per day
1000 mg dly
Once daily in the morning OR twice daily if side effects develop
Side-effects:
Yellow eyes/skin (Hepatitis); Severe nausea/vomitting with
abdominal pain; Unusual tiredness or fatigue; Unusual loss of
appetite; Numbness, pain, or tingling in the hands or feet
Cautions:
Do not use during pregnancy;
Avoid in patients with severe liver disease
Other:
Monthly blood tests to assess for hepatitis will need to be
perfomred;
Every 3 to 6 months, blood tests to assess for hypothyroidism
needs to be performed
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Name:
Abbreviation:
Dose/KG:
Usual Dose:
Maximum Dose:
When to give
drug?
CYCLOSERINE
Cs
10-20 mg/kg/day
Dosing varies, in adults dosing is from 500 to 1000 mg per
day
1000 mg dly
Once daily in the morning OR twice daily if side effects
Side-effects:
Disoriented thinking, personality changes, or aggressive
behavior (Psychosis); Seizures; Shakiness or trouble talking;
Numbness, pain, or tingling in hands or feet
Cautions:
Avoid drinking alcohol while on this drug;
Avoid in patients with psychiatric problems
Other:
No laboratory monitoring requred;
Food can modestly decrease the absorption of this drug,
therefore, this drug should be taken on an empty stomach
Name:
Abbreviation:
Dose/KG:
Usual Dose:
Maximum Dose:
When to give
drug?
CAPREOMYCIN
Cm
N/A
Dosing varies, in adults dosing is 500 to 1000 mg/1 g per day
1000 mg dly
Once daily in the morning
Side-effects:
Cautions:
Hearing loss; Dizziness or ringing in the ears; Swelling in the
legs or lack of urination (kidney problems); Pain/reddness at
the injection site
Do not use in preganancy (unless absolutely necessary)
Other:
Patients MUST be have blood tests each month to assess
creatinine and potassium levels;
This drug is given via IM injection
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Name:
Abbreviation:
Dose/KG:
Usual Dose:
Maximum Dose:
When to give
drug?
PARA-AMINO
SALICYLIC ACID
PAS
150 mg/kg/day OR 10-12 g/day in 2 divided doses
Dosing varies, in adults dosing is 8 to 12 grams per day
12 g/day
Once daily in the morning OR twice daily if side effects
Side-effects:
Cautions:
Yellow eyes/skin (Hepatitis); Severe nausea/vomitting with
abdominal pain; Black or bloody stools; Unusual
tiredness/fatigue; Unusual loss of appetite
Avoid in patients with severe liver disease
Other:
Monthly blood tests to assess for hepatitis will need to be
perfomred;
Every 3 to 6 months, blood tests to assess for hypothyroidism
needs to be performed
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Annex 2: How to provide an Intramuscular (IM) Injection
The pictures below show how to inject into the buttock. Steps 2 through 6 are the same for injections into
the arm or thigh. IM injections can be given while the patient is lying on a bed or while standing upright.
However, before you can provide an IM injection to a patient, you must practice many times giving
an IM injection with the supervision of a nurse or other healthcare provider before you can do so
on your own.
1. The person should sit or lie down.
Pointing the toes together will relax the
muscle to be injected.
4. Before injecting the medicine,
gently pull back on the plunger a
little bit (do not pull until the
plunger falls out). If blood enters
the syringe, take the needle out
and put it back in somewhere else
close by in the area you have
cleaned.
2. Clean the skin with alcohol, or soap and
water (it will hurt less if you let the
alcohol dry before injecting).
5. Pull back on the plunger again. If no
blood enters, inject the medicine
slowly.
3. Put the needle straight in, all the way. If it
is done with one quick movement, it hurts
less.
6. Remove the needle and
clean the skin again
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Annex 3: DR-TB Side-effect Descriptions:
Burning or pain in the feet and legs (Neuropathy)
A number of anti-TB medications can cause abnormal sensations that can develop in
the hands and feet. These medications most commonly include: isoniazid and
cycloserine.
Abnormal sensations in the hands and feet are pain, burning, numbness, tingling, and
loss of temperature sensation. Patients with abnormal sensations can experience
difficulty walking or with balance. When severe, patients can develop abnormal
sensations in their hands and arms, as well as, their feet.
Abnormal sensations in the feet and hands can be permanent. Any patient with
complaints of abnormal sensations should receive medical attention within one week
of developing these symptoms.
Notes:
Cramping
Cramping occurs when a muscle in the body becomes tightened, and therefore, is painful
to the patient.
Cramping most often occurs in the arms and legs. Cramps often improve on their own.
Continued muscle cramping, however, may be a sign of a serious imbalance of essential
chemicals in the blood.
Cramping due to an imbalance of essential chemicals (electrolytes like potassium) can be
fatal if untreated. As a result, muscle cramping always requires immediate medical
attention.
Notes:
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Depression
Depression is a condition where the patient feels sad or has a low mood. Some anti-TB
medications can cause depression, including isoniazid, cycloserine, ethionamide and
clofazimine.
Patients with depression often develop symptoms that include: decreased interest in
things that they previously enjoyed, feelings of guilt, feelings of helplessness or
hopelessness, inability to concentrate, difficulty falling asleep or sleeping too much, and
decreased appetite or eating too much. Patients can develop thoughts of hurting or killing
themselves when depression is severe.
Any patient with signs of severe depression should receive immediate medical attention.
Any patients with thoughts of suicide need to receive immediate medical attention.
Notes:
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Nausea, Vomiting, and other Digestive Problems
Digestive problems are defined as symptoms related to the stomach and intestines,
which are organs in the abdomen that help to digest food. Digestive problems are
common in anti-TB therapy, with nausea and vomiting being the most common
adverse effect.
Digestive problems include burning in the stomach or esophagus, an acid taste in
your mouth, nausea and vomiting, loss in appetite, diarrhea and generalized
abdominal pain.
Excessive vomiting, vomiting blood, passing bloody or dark stool, or severe pain are
signs of a more severe digestive problem.
Digestive problems are usually mild and can be managed with a few helpful hints that
the patient should be aware of while taking anti-TB medications:
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Take a small amount of food (without a lot of fat) before taking the medicines
Lay down and rest after taking the medicines
Taking anti-nausea medicine, usually 30 to 40 minutes before taking the medicines
(the doctor will tell the patient the exact does and type) is very helpful

If there is a gastritis (pain in the stomach), the doctor may prescribe some
medication for this symptom
 Sometimes, although rarely necessary, decreasing the doses of anti-TB
 medications may be necessary. Never do this without instructions from the
 doctor.
 Encourage patients that usually with time the nausea and vomiting will get better.
The body has a way of adjusting to medications.
Remember: some severe digestive problems can be fatal. These include: blood in the stool
orvomit, really severe abdominal pain, or bad vomiting that causes the patient to become
dehydrated.
Patients with symptoms of severe digestive problems should receive immediate medical
attention. Patients who vomit up the medications or vomit shortly after taking the
medications should also be reported to the doctor.
Notes:
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Fatigue
Fatigue is a generalized lack of strength or energy. It is very common during therapy
for DR-TB. The specific cause for weakness due to anti-TB therapy, however,
sometimes it can be a side effect of the medicine.
Fatigue can be associated injury to the thyroid, a gland in the body (hypothyroidism).
Fatigue can also be due to anemia.
Fatigue is usually not a medical emergency, but the doctor will need to do some blood
test to see if the patient has hypothyroidism or anemia. Patients with severe fatigue and
symptoms associated with thyroid problems should receive immediate medical
attention.
Notes:
Headaches
A headache is an episode of pain or pressure in the head and neck. Headache is a common
occurrence during initial stages of therapy for DR-TB.
Headache can be associated with nausea and vomiting. Rarely, headache is a symptom of
serious infection of the brain. In this situation, it is usually accompanied by neck stiffness,
fever and decreased level of consciousness.
Headaches due to TB therapy can often be controlled by changes in dosages of anti-TB
medication or with medications that help to reduce pain.
Headaches that are concerning for brain infection, however, are serious. Patients with
these types of headaches should receive immediate medical attention.
Notes:
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Hearing Loss (and dizziness or ringing in the ears)
Hearing loss is a decrease in the ability to hear every day sounds. The injectable drugs, in
particular, can cause hearing loss.
Patients with hearing loss may complain they cannot hear common sounds (like
conversations or radio/television broadcasts) as well as they previous could hear these
things. Hearing loss is often associated with ringing or buzzing in the ears. The ringing or
buzzing can be very disabling for the patient, and this symptom should be taken very
serious when a patient complains of it. Patients with hearing loss also can experience
difficulties with balance resulting in dizziness (or vertigo).
Hearing loss, the ringing in the ears or the dizziness, can be permanent. Patients with
signs and symptoms of hearing loss, ringing in the ears, or dizziness should receive
immediate medical attention! Often the medications can be adjusted and prevent
permanent disability.
Patients should be asked every few days if they are having hearing problems, ringing,
buzzing in the ears, or dizziness. Remind the patients to report these problems right
away.
Notes:
Irrational Behavior (Psychosis)
Irrational behavior is characterized by a variety of thoughts or actions that are not
consistent with reality. Irrational behavior is most commonly caused by cycloserine.
Patients with irrational behavior (acting crazy) due to anti-TB medications can
experience sights and sounds that are not actually present. They can believe strongly
in ideas that are not real, including beliefs about their own perceptions and abilities.
They can also develop a belief that they are threatened when no threat exists in
reality--this is called “paranoia”. Patients can also demonstrate bizarre behaviors,
such as exaggerated dress or speech.
Severe forms of Irrational behavior can lead to behavior that is dangerous to the
patient and others. Patients with signs and symptoms of irrational behavior require
immediate medical attention.
Patients with psychosis are at risk for suicide and need immediate attention.
Notes:
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Kidney Injury
The kidneys are a pair of organs deep in the abdomen, near the upper back. They help
to remove wastes from the body by making urine. The injectable drugs, in particular,
can injure the kidneys.
Kidney injuries often do not have any symptoms until the injury is severe. Severe
kidney injury can be associated high blood pressure, swelling of feet and legs,
confusion and decrease in the frequency and volume of urination. Blood tests can be
used to detect mild kidney injury before it becomes severe.
Kidney injury can be irreversible if severe. Any patient with signs and symptoms of
kidney injury should receive immediate medical attention.
Remember: Rifampin causes the urine to become orange/red in color. This side effect
occurs in all people taking rifampin and does not require medical attention.
Notes:
Liver Injury
The liver is an organ in the abdomen that helps to remove wastes from the body. Some
anti-TB medications can injure the liver, including isoniazid, rifampin, pyrazinamide,
ethionamide and PAS. Patients who use alcohol are at higher risk for liver injury due
to anti-TB medications.
The signs and symptoms of liver injury include nausea, vomiting, loss of appetite, and
a general feeling of being unwell. Patients with liver injury due to anti-TB medications
can also experience abdominal pain, often on the right side below the ribs, where the
liver is located in the body. If the liver is severely damaged, the white area of the
patient’s eyes can appear yellow. The skin of patients with lighter skin tones may also
start to appear yellow. Blood tests can be used to detect mild liver injury before it
becomes severe.
Severe liver injury can be fatal. Any patient with signs and symptoms of liver injury
should receive immediate medical attention.
Notes:
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Rash
A rash is any change in the appearance of the patient’s skin. Many types of anti-TB
medications can cause a rash.
A rash may develop as patches, bumps, or blisters on the skin. Rashes can also appear
as a redness or darkening of skin. Rashes generally appear on the arms, legs, and
trunks of the body. The rash may or may not itch. In severe cases, patients with rash
may also experience swelling of the lips, tongue and throat, which can progress to
difficulty with breathing. A rash that has blistering or peeling of the skin is also more
severe.
Severe forms of rash can be fatal. Any patient with signs of a rash due to anti-TB
therapy should receive immediate medical attention.
Notes:
Seizures
A seizure is a sudden, abnormal activity of the brain. It often occurs in the form of
convulsions, which is uncontrolled shaking of the body. Anti-TB medications, such as
isoniazid, cycloserine, levofloxacin and moxifloxacin, can cause seizures.
A seizure can be associated with a loss of consciousness and involuntary loss of bowel
and bladder control. Patients are often in a confused state following a seizure. Seizures
can last for seconds to minutes and often cease on their own. Severe seizures, however,
may not stop unless medications are administered.
A severe seizure can result in permanent brain damage or cause death. Any patient with
signs and symptoms of a seizure requires immediate medical attention.
Notes:
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