PANTOPRAZOLE SODIUM DR- pantoprazole sodium 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:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1 INDICATIONS AND USAGE 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 tablets are 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 Zol

Product summary:

Pantoprazole sodium delayed-release tablets USP, 20 mg, are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A6” with black ink on one side and plain on the other side. Bottles of 90 Tablets NDC 80425-0085-03 Storage Store pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM DR- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Pantoprazole Sodium (pan toe’ pra zole soe’ dee um)
Delayed-Release Tablets
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 tablets 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
o

Summary of Product characteristics

PANTOPRAZOLE SODIUM DR- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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PANTOPRAZOLE SODIUM DR 20MG TABLETS
1. INDICATIONS AND USAGE SECTION
1 INDICATIONS AND USAGE
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 tablets are 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
(ZE) Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the
long-term treatment
of pathological hypersecretory conditions, including Zollinger-Ellison
(ZE) Syndrome.
2. DOSAGE AND ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing Schedule
Pantoprazole sodium delayed-release tablets are 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
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily***
Pathological