PANTOPRAZOLE SODIUM tablet, delayed release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Major Pharmaceuticals

INN (mednarodno ime):

PANTOPRAZOLE SODIUM

Sestava:

PANTOPRAZOLE 40 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Pantoprazole sodium delayed-release tablets are indicated for: 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. 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. Risk Summary Available data from published observational st

Povzetek izdelek:

How Supplied Pantoprazole sodium delayed-release tablets, USP are supplied as 40 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "97" printed with brown ink on the other side. They are available as follows: Carton of 80 tablets (10 tablets each blister pack x 8) NDC 0904-6474-45 Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6474-61 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Major Pharmaceuticals
----------
MEDICATION GUIDE
MEDICATION GUIDE
Pantoprazole sodium (pan TOE pra zole SO-dee-um) delayed-release
tablets, USP
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 tablets, may develop
certain types of lupus
erythematosus or have worsening of the lupus they already have. Call
your doctor right away if you
hav

Lastnosti izdelka

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
MAJOR PHARMACEUTICALS
----------
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 is a proton pump inhibitor indicated (PPI) for the
following:
•
•
•
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
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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)
*
Delayed-Release Tablets: 20 mg and 40 mg (3)
Patients with known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles (4)
Patients receiving rilpivirine-containing products (4,7)
Gastric Malignancy: In adults, symptomatic response does not preclude
presence of gastric
malignancy. Consider additional follow-up and diagnostic testing.
(5.1)
Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluat