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:PANTOPRAZOLE:
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~

:Name- devaraj Che


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: Yadav
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:Group -
INTRODUCTION :
Proton pump inhibitors (PPls) are a group of drugs wl
action is a pronounced and long-lasting reduction of g,
~
production
H
• Omeprazole N 0

• Lansoprazole
F
F~ o
1 r s'
N
N

• Dexlansoprazole
~
- o o-
• Esomeprazole
• Pantoprazole
• Rabeprazole
• llaprazole
INTRODUCTION
Pantoprazole is a substituted benzimidazole and proton pum
that inhibits gastric acid secretion. It is used to treat gastroe
disease (GERO), a condition that causes gastric juices to flo"
your stomach and into the oesophagus. It also treats conditi
stomach makes excess acid, such as Zollinger-Ellison syndrc
shut off the acid-pumping cells in your stomach . It reduces t
stomach acid and helps to reduce painful symptoms related
gastroesophageal reflu x disease (GERO).
MECHANISM OF ACTION :
Pantoprazole is a proton pump inhibitor (PPI) that suppre
final step in gastric acid production by covalen1tly binding
(rt, ~-ATPase enzyme system at the secretory surface of
gastric parietal cell. This effect leads to inhibition of both
stimulated gastric acid secretion, irrespective of the stim
binding of pantoprazole to H+/K+-ATPase is irreversible ·
and effectively inhibits acid secretion until new enzyme
synthesized.

MOA
PHARMACOKINETICS .
Rapidly absorbed after oral administration. On set of acti1
2-,4 hours, duration of action is about 24 hours . Peak cor
(Cmax) i~/mL; the time to reach the peak concentratior
(tmax) is 2.5 h. The drug is subject to low first pass, hep
excretion, the oral bioavailability is 77 o/o . approximately j

dose was excreted in the urine, with 18% excreted in thj


;through biliary excretion . There was no renal excretion o
unchan,g ed pantoprazole. ...-1:• ~
■ ,~--.i
zc.r
...
~
Geriatric

Only slight to moderate increases in pantoprazole AUC (4


Cmax (26°/o) were found in elderly volunteers (64 to 76 y1
age) after repeated oral administration, compared with y
subjects. No dosage adjustment is recommended base
Children and Adolescents 6 through 16 Years ofAge

6-11 Y 2-16 RS
_ N=12)~~--,-(N=11)j - J

t
1-i
~ - 8'-P-9/_m_L-)a- ] 1.8 1 I 1.8
I - r - I r - -1
1f.nJh)b 1
2.0 1 1
2.0 1
I t I
:~U~•h/mL)a 6.9 5.5
' r r<
' I I
1 6.6 1
:CL/F (L/h)b I .J
1

I
6.8 1 J

_ , . ,____.r

~~--..." '-1

,i
DOSE ADJUSTMENTS 1

Gender
There is a modest increase in pantoprazole AUC and Cm,
compared to men. However, weight-normalized clearanc1
similar in women and men. No dosage adjustment is recc
based on gender.
Renal Impairment
In patients with severe renal impairment, pharmacokinet
for pantoprazole were similar to those of healthy subject~
adjustment is necessary in patients with renal impairmer
patients undergoing hemodialysis.
Hepatic Impairment
No dosage adjustment is needed in patients with mild to
hepatic impairment.

-
INDICATIONS
• To treat ulcers in the stomach and the part of the gut cc
duodenum.
• To reduce acid reflux which may cause heartburn or infi
the gullet (oesophagitis). These conditions are sometim
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oesophageal reflux disease (GORD).
• As one part of treatment to get rid of Helicobacter pylor
(bacterium) found in the stomach, which can cause ulcE
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• To help prevent and treat ulcers associated with anti-in·
medicines called non-steroidal anti-inflammatory drugs
I

1 • In a rare condition called Zollinger-Ellison syndrome. 1

1
In other conditions where it is helpful to reduce acid int

4---
RECOMMENDED D,OSING
SCH-ED-ULE: I I
I ,-. - - - .. - ... - ·- · •

INDICATION' DOSE FREQUENCY l


Short-Tenn Treatment of Eroalve Eaopha91tla At sociated with
Adult• 40 mg Once daily for up to 8 weeks
Chlldren (I years and older)
40
!!:::=-=...,,.......,.,---:-,-=-,--~-

~ 19 kg to c kg 20 mg Once daily for up to 8 weeks ;


~~kB ==;_- 40 mg _ , _ _ _ _ _ __
~====•=a=lnte_n ance of Heallna of Eroalve Eaop~agitis :
::--
Adult• 40 mg ~ Once daily
" --
Patholo9lcal Hyperaecretory Condition• lncludl~ollinger-Elli
Adult• 40 mg " Twice daily 1
:NOT TO PRESCRIBE OR TAKE
CAREi
Pregnancy:
Pregnancy Category B, this drug should be used during p
only if clearly needed
1
Nursing Mothers
Pantoprazole excretion in human milk has been detected
of a single nursing mother after a single 40 mg oral dose
clinical relevance of this finding is not known. Many dru
are excreted in human milk have a potential for serious
reactions in nursing infants.
r
Tumorigenicity
In long-term rodent studies, pantoprazole was carcinoger
caused rare types of gastrointestinal tumors. The relevar
findings to tumor development in humans is unknown
Bone Fracture
Several published observational studies suggest that pro1
inhibitor (PPI) therapy may be associated with an increa
for osteoporosis-related fractures of the hip, wrist, or s
f - - - I

:POSSIBLE SIDE EFFECTS:


L

I
Common
J

• Gastrointestinal: abdominal pain (6o/o), diarrhea (9%},


(7°/o), vomiting (4°/o)
• Neurologic: headache (12°/o}, dizziness (3o/o)
I
Rare
t • Gastroi~testinal: constipation, dry mouth, hepatitis

r-• Blood problems: low white blood cell count, thrornboc·


- .
' • lmmu~ologic: Stevens-Johnson syndrome, toxic epider
necrolys1s
- - - - - ---- ----
• Metabolic: elevated creatine kinase, elevated choleste
elevated Iiver enzymes (AST/ALT), swel Ii ng
• Musculoskeletal: Muscle disorders, bone fracture a
Clostridium difficile infection, osteoporosis-related hip
rhabdomyolysis
1POSSIBLE SIDE EFFECTS.
I I
Common ,
[ J

• Gastrointestinal: abdominal pain (6o/o), diarrhea (9o/o),


(7o/o), vomiting (4%)
• Neurologic: headache (12o/o), dizziness (3o/o)
I
Rare
~ • Ga~trointestinal: constipation, dry mouth, hepatitis
1
• Blood problems: low white blood cell count, thromboc·
lmmu~ologic: Stevens-Johnson syndrome, toxic epider
1

necrolys1s
1
• Metabolic: elevated creatine kinase, elevated choleste
elevated liver enzymes (AST/ALT), swelling
1
• Musculoskeletal: Muscle disorders, bone fracture a
Clostridium difficile infection, osteoporosis-related hip
1
rhabdomyolysis ~ ~•~--J
--~"'~-
.L ~
~ •
r - - --- -,
r Long-term ~ _ __ _ _ _ ___ __ _ __ __
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• Osteoporosis and bone fracture have been observed in
high-dose and/or long term (over 1 year) prescription pro
inhibitors
~ • Hypomagnesia has been observed in patients on -medic
1
pantoprazole when taken for longer periods of time (genE
year or more, although cases have been reported with re
short as 3 months)

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