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St. Joseph College of Cavite Inc.

Institute of Health Sciences



DRUG STUDY
DRUG STUDY
NAME: Juan Miguel AGE: 15 years old SEX: Male RELIGION: Catholic ROOM NO: MTW
ADDRESS: Gilid Brgy Mayamot Summerville Antipolo City DATE OF ADMISSION: May 21, 2014
CHIEF COMPLAINT: Neck pain DIAGNOSIS: Compression Fracture C4-C5 Secondary to Pott's Disease

Medication Mechanism of Action Specific Indication Contra-indication& Side effects Nursing Responsibilities

Generic Name:
Rifampicin + Isoniazid +
Pyrazinamide +
Ethambutol HCl

Brand Name:


Classification:
Anti-infectives (systemic);
Antituberculosis

Route:
Per Orem

Dosage:
150 mg/ 75 mg/ 400 mg/
275 mg

Frequency:
OD

Form:


Color:


Rifampicin
Rifampicin, a semisynthetic antibiotic
derivative of Rifamycin, suppresses
bacterial RNA synthesis by binding to
the b subunit of DNA-dependent RNA
polymerase, thus inhibiting the
attachment of the enzyme to DNA,
blocking RNA transcription, elongation,
and subsequent translation to protein.
It does not inhibit the counterpart
mammalian enzyme.

Rifampicin has bactericidal action and
potent sterilizing effect against both
intracellular and extracellular tubercle
bacilli. Cross resistance has been
shown only with other rifamycin
derivatives.

Isoniazid
Isoniazid kills actively growing tubercle
bacilli by inhibiting the biosynthesis of
mycolic acid which is the major
component of the cell wall of
Mycobacterium tuberculosis. It is active
against susceptible bacteria only when
they are undergoing cell division.

Pyrazinamide
Pyrazinamide is the pyrazine analog of
nicotinamide. The precise mechanism
of action of pyrazinamide is unknown.
Its metabolite, pyrazinoic acid, which is
less active in vitro, may possibly be

For the initial phase
treatment of all forms of
pulmonary and
extrapulmonary
tuberculosis.

Contraindications:

Hypersensitivity to any ingredient in the product
Jaundice or severe liver disease
Acute gout
Pre-existing optic neuritis from any cause

Rifampicin

High doses of rifampicin (>600 mg) given once or
twice weekly have resulted in a high incidence of
adverse reactions including: the flu-like syndrome
(i.e., fever, chills, sometimes with headache,
dizziness, and bone pain); hematopoietic reactions
(i.e., leukopenia, thrombocytopenia, and acute
hemolytic anemia); cutaneous; gastrointestinal and
hepatic reactions; dyspnea, wheezing; shock; and
acute renal failure.

Hepatic: Elevations in serum concentrations of ALT,
AST, bilirubin, and alkaline phosphatase,
asymptomatic jaundice, and hepatitis. Rarely,
hepatitis or shock-like syndrome with liver involvement
and abnormal liver function test results.

Dermatologic: Rash, pruritus, urticaria, acneiform
eruptions, pemphigoid reaction, erythema multiforme
including Stevens-Johnson syndrome, toxic epidermal
necrolysis, vasculitis, exfoliative dermatitis, flushing,
and rarely, anaphylaxis.

Nervous system:Headache, drowsiness, fatigue,
dizziness, inability to concentrate, mental confusion,
behavioral changes, psychosis, and generalized


May cause reddish-orange
discoloration of urine, saliva, tears,
sweat and sputum. Instruct the patient
that this is to be expected and not
harmful.

Monitor patients visual acuity, visual
fields, and red-green discrimination
regularly as reversible optic neuritis
may be caused by Ethambutol.

Instruct patients in proper oral
hygiene, including caution in the use
of regular toothbrushes, dental floss,
and toothpicks. The leukopenic and
thrombocytopenic effects of Rifampin
may result in an increased incidence
of certain microbial infections,
delayed healing, and gingival
bleeding. If leukopenia or
thrombocytopenia occurs, dental work
should be defined until blood counts
have returned to normal. Rifampin
may cause a hypersensitivity
reaction of sores in mouth or tongue


Patient monitoring:

Hepatic function determinations (ALT
[SGPT], AST [SGOT], alkaline
phosphatase, and
serum bilirubin determinations may be
involved in pyrazinamides in vivo
activity.

Pyrazinamide is an effective
bactericidal antituberculosis drug, and
has a specific sterilizing action against
Mycobacterium tuberculosis in the
intracellular environment of
macrophages. The acid environment
presumably in some way makes
Mycobacterium tuberculosis more
susceptible to pyrazinamide, but this
does not occur with Mycobacterium
bovis which is resistant to the drug. As
with other antituberculous drugs,
resistance to pyrazinamide develops
rapidly if it is used alone to treat human
tuberculosis.

Ethambutol HCl
Ethambutol HCl diffuses into actively
growing Mycobacteria cells such as
tubercle bacilli. It inhibits the synthesis
of one or more metabolites resulting in
impaired cellular metabolism, arrested
cell multiplication and cell death. It is
active against susceptible bacteria only
when they are undergoing cell division.
No cross-resistance with other agents
has been demonstrated.
numbness.

GI: Heartburn, epigastric distress, nausea, vomiting,
anorexia, abdominal cramps, flatulence, diarrhea,
sore mouth and tongue, pseudomembranous colitis,
and pancreatic insufficiency.

Musculoskeletal: Ataxia, muscular weakness,
myopathy, and pain in muscles, joints and extremities.

Hematologic: Eosinophilia, leukopenia, purpura,
hemolytic anemia, decreased hemoglobin
concentrations, hemolysis, thrombocytopenia,
disseminated intravascular dissemination, and
agranulocytosis.

Renal: Increased BUN and serum uric acid
concentrations, hemoglubinuria, light chain
proteinuria, hematuria, renal insufficiency, interstitial
nephritis, acute tubular necrosis, and acute renal
failure.

Endocrine: Precipitation of adrenocortical insufficiency
and menstrual disturbances.

Opthalmologic: Visual disturbances and exudative
conjunctivitis.

Others: Fever, edema of face and extremities,
dyspnea, wheezing, hypotension, and shock.

Isoniazid

Hepatic: Mild liver dysfunction, as evidenced by mild
and transient elevations in serum concentrations of
ALT, AST, and bilirubin concentrations. Rarely,
progressive liver dysfunction, bilirubinuria, jaundice,
and severe and sometimes fatal hepatitis.

Dermatologic: Hypersensitivity reactions, including
fever, skin eruptions (morbilliform, maculopapular,
purpuric, or exfoliative), lymphadenopathy, vasculitis,
and, rarely, hypotension.

Nervous system: Seizures, convulsions, toxic
encephalopathy, stupor, euphoria, memory
indicated prior to and monthly or more
frequently during
treatment; however, elevated serum
enzyme values may not be predictive
of clinical hepatitis
and may return to normal despite
continued treatment; patients with
impaired hepatic function
should not receive rifampin, isoniazid,
pyrazinamide, and ethambutol
combination unless it is crucial to
therapy )

Ophthalmologic examinations
(symptoms of optic neuritis may occur
either in adults or
children during treatment due to
adverse effects of isoniazid and/or
ethambutol

Uric acid concentration
(may be required during treatment,
since elevated serum uric acid
concentration frequently occur due
ethambutol and/or pyrazinamide,
possibly resulting
in precipitation of acute gout

impairment, separation of ideas and reality, loss of
self-control, dizziness, vertigo, and toxic psychosis.

Gastrointestinal: Nausea, vomiting, and epigastric
distress.

Musculoskeletal: Ataxia and muscle twitching.

Hematologic: Agranulocytosis, eosinophilia,
thrombocytopenia, methemoglobinemia, and
hemolytic, sideroblastic, or aplastic anemia.

Endocrine: Hyperglycemia and metabolic acidosis.

Opthalmologic: Optic neuritis and atrophy

Others: Tinnitus, peripheral neuritis usually preceded
by paresthesia of the feet and hands, dryness of the
mouth, pyridoxine deficiency, pellagra, hyperreflexia,
urinary retention, gynecomastia, systemic lupus
erythematosus-like syndrome, and rheumatic
syndrome with arthralgia.

Pyrazinamide

Hepatic: Hepatotoxicity appears to be dose-related,
and may appear at any time during therapy. Transient
increases in serum aminotransferase concentrations,
jaundice, hepatitis, liver tenderness, and
hepatomegaly have been reported.

Dermatologic: Hypersensitivity reactions, including
rash, urticaria and pruritus have been reported.
Rarely, maculopapular rash, acne, and
photosensitivity with reddish-brown discoloration of
exposed skin.

GI: Nausea, vomiting, and anorexia.

Hematologic: Rarely, porphyria, thrombocytopenia
and sideroblastic anemia with erythroid hyperplasia,
vacuolation of erythrocytes, increased serum iron
concentration, and adverse effects on blood clotting
mechanisms.

Renal: Dysuria and interstitial nephritis.

Reference:
http://www.unilab.com.ph/consumers/products/quadtab

Others: Fever, splenomegaly, malaise, and frequently
mild arthralgia and myalgia. Hyperuricaemia
commonly occurs and may lead to attacks of gout.

Ethambutol HCl

Hepatic: Hepatotoxicity appears to be dose-related,
and may appear at any time during therapy.
Cholestatic jaundice, which appeared to be caused by
ethambutol, has been reported in at least one patient
who received the drug both alone and in combination
with streptomycin. Transient impairment of liver
function, as indicated by abnormal liver function tests,
and jaundice have been observed.

Dermatologic: Dermatitis and hypersensitivity
reactions, including rash, pruritus, and leukopenia
have been reported. Rarely, anaphylactoid reactions.

Nervous system:Headache, dizziness, mental
confusion, disorientation, possible hallucinations.

GI: Gastrointestinal upset, abdominal pain, nausea,
vomiting, and anorexia have occurred occasionally.

Hematologic: Thrombocytopenia and eosinophilia.

Others: Fever, joint pain, malaise, pulmonary
infiltrates, elevated serum uric acid levels,
precipitation of acute gout, and rarely, numbness and
tingling of the extremities due to peripheral neuritis.
Ethambutol may produce decreased visual acuity due
to optic neuritis. This effect appears to be related to
dose and duration of treatment.