PANTOPRAZOLE SODIUM DR- pantoprazole sodium tablet, delayed release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Advanced Rx Pharmacy of Tennessee, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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: Bottles of 30 Tablets NDC: 80425-0278-01 Bottles of 60 Tablets NDC: 80425-0278-02 Bottles of 90 Tablets NDC: 80425-0278-03 Storage Store pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Advanced Rx Pharmacy of Tennessee, LLC
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MEDGUIDE
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 tubulointerstitial nephritis).
Some people who take proton pump
inhibitor (PPI) medicines, including pantoprazole sodium
delayed-release tablets, may develop a kidney
problem called acute tubulointerstitial 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

Características técnicas

PANTOPRAZOLE SODIUM DR- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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PANTOPRAZOLE SODIUM 20MG TABLETS DR
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 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. DOSAGE & ADMINISTRATION
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 adul