PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

XLCare Pharmaceuticals Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Pantoprazole Sodium Delayed-Release Tablets are indicated for: 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. 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. Pantoprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome. • Pantoprazole sodium delayed-release tablets are contraindicat

Sommarju tal-prodott:

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 90 tablets   NDC 72865-229-90 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: Bottles of 90 tablets   NDC 72865-230-90 Bottles of 1000 tablets  NDC 72865-230-10 Storage Store pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

XLCare Pharmaceuticals Inc.
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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 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 get

Karatteristiċi tal-prodott

PANTOPRAZOLE SODIUM - PANTOPRAZOLE TABLET, DELAYED RELEASE
XLCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM
DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions ( 5.5) 03/2022
Hypomagnesemia and Mineral Metabolism ( 5.8) 03/2022
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablet is a proton pump inhibitor
(PPI) indicated for the following:
• Short-Term Treatment of Erosive Esophagitis Associated with
Gastroesophageal Reflux Disease
(GERD) (1.1)
• Maintenance of Healing of Erosive Esophagitis ( 1.2)
• Pathological Hypersecretory Conditions Including Zollinger-Ellison
(ZE) Syndrome (1.3)
DOSAGE AND ADMINISTRATION
Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD (
2.1)
Adults 40 mg � Once Daily for up to 8 wks
Children (5 years and
older)
≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks
≥ 40 kg 40 mg
Maintenance of Healing of Erosive Esophagitis ( 2.1)
Adults 40 mg Once Daily*
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME ( 2.1)
Adults 40 mg Twice Daily
*Controlled studies did not extend beyond 12 months
See full prescribing information for administration instructions
DOSAGE FORMS AND STRENGTHS
• Delayed-Release Tablets: 20 mg and 40 mg pantoprazole ( 3)
CONTRAINDICATIONS
• Patients with known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles ( 4)
• Patients receiving rilpivirine-containing products ( 4, 7)
WARNINGS AND PRECAUTIONS
• Gastric Malignancy: In adults, symptomatic response does not
preclude presence of gastric
malignancy. Consider additional follow-up and diagonostic testing. (
5.1)
• Acute Tubulointerstitia