PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)

Available from:

DIRECT RX

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pantoprazole Sodium Delayed-Release Tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole Sodium Delayed-Release Tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pa

Product summary:

How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H125” on one side with black ink and plain on the other side. They are supplied as follows: Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H126” on one side with black ink and plain on the other side. They are supplied as follows: Storage Store pantoprazole sodium delayed-release tablets, USP at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIRECT RX
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MEDICATION GUIDE
Pantoprazole Sodium Delayed-Release Tablets USP
(pan toe’ pra zole soe’dee um)
What is the most important information I should know about
pantoprazole sodium delayed-release
tablets?
You should take pantoprazole sodium delayed-release tablets exactly as
prescribed, at the lowest dose
possible and for the shortest time needed.
Pantoprazole sodium delayed-release tablets may help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Pantoprazole sodium delayed-release tablets can cause serious side
effects, including:
• A type of kidney problem (acute interstitial nephritis). Some
people who take proton pump inhibitor
(PPI) medicines, including pantoprazole sodium delayed-release
tablets, may develop a kidney problem
called acute interstitial nephritis that can happen at any time during
treatment with pantoprazole sodium
delayed-release tablets. Call your doctor right away if you have a
decrease in the amount that you urinate
or if you have blood in your urine.
• Diarrhea caused by an infection (Clostridium difficile) in your
intestines. Call your doctor right away if
you have watery stools or stomach pain that does not go away. You may
or may not have a fever.
• Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in people who
take multiple daily doses of PPI medicines and for a long period of
time (a year or longer). Tell your
doctor if you have a bone fracture, especially in the hip, wrist, or
spine.
• Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body’s
immune cells attack other cells or organs in the body). Some people
who take PPI medicines, including
pantoprazole sodium delayed-release tablet, may develop certain types
of lupus erythematosus or have
worsening of the lupus they already have. Call your doctor right away
if you have new or worsening joint
pain or a rash on your cheeks or arms that gets worse in the sun.
Talk to yo

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
DIRECT RX
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PANTOPRAZOLE
BOXED WARNING
Pantoprazole Sodium Delayed-Release Tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With
Gastroesophageal
Reflux Disease (GERD)
Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and
pediatric patients
five years of age and older for the short-term treatment (up to 8
weeks) in the healing
and symptomatic relief of erosive esophagitis (EE). For those adult
patients who have
not healed after 8 weeks of treatment, an additional 8-week course of
pantoprazole
sodium delayed-release tablets may be considered. Safety of treatment
beyond 8 weeks
in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole Sodium Delayed-Release Tablets are indicated for
maintenance of healing
of EE and reduction in relapse rates of daytime and nighttime
heartburn symptoms in
adult patients with GERD. Controlled studies did not extend beyond 12
months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Pantoprazole Sodium Delayed-Release Tablets are indicated for the
long-term treatment
of pathological hypersecretory conditions, including Zollinger-Ellison
(ZE) syndrome.
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The
recommended dosages
are outlined in Table 1.
Table 1: Recommended Dosing Schedule for
Pantoprazole Sodium Delayed-Release Tablets
Indication Dose Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg Once daily for up to 8 weeks*
Children (5 years and older)
≥ 15 kg to < 40 kg
≥ 40 kg
20 mg Once daily for up to 8 weeks
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults 40 mg Once daily***
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Adults 40 mg Twice daily **
* For adult patients who have not healed after 8 weeks of treatment,
an additional 8-
week course of pantopraz