PANTOPRAZOLE SODIUM tablet, delayed release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Macleods Pharmaceuticals Limited

INN（国际名称）:

PANTOPRAZOLE SODIUM

组成:

PANTOPRAZOLE 20 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablets are  indicated in adults 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 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 contraindicated in patients with known hypersensitivity to any component of the for

產品總結:

Pantoprazole sodium delayed-release tablets USP are supplied as yellow, oval, biconvex enteric – coated tablets imprinted with ‘CL 25’ on one side and plain on other side containing 40 mg of pantoprazole and are available as follows: • NDC 33342-020-10, bottles of 90 • NDC 33342-020-44, bottles of 1000 Pantoprazole sodium delayed-release tablets USP are supplied as yellow , oval, biconvex enteric – coated tablets imprinted with ‘CL 24’ on one side and plain on other side containing 20 mg of pantoprazole and are available as follows: • NDC 33342-019-10, bottles of 90 • NDC 33342-019-44, bottles of 1000 Storage Store pantoprazole sodium delayed-release tablets 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 .]

授权状态:

Abbreviated New Drug Application

资料单张

Macleods Pharmaceuticals Limited
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SPL MEDGUIDE SECTION
Pantoprazole Sodium Delayed-Release Tablets
(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 tabletsmay 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 dealyed-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
or worsening joint pain or a rash on
your cheeks or arms that gets worse in th

产品特点

PANTOPRAZOLE SODIUM - PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
MACLEODS PHARMACEUTICALS LIMITED
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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 DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps (5.9) 06/2018
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are 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
theformulation 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 diagnostic testing. (5.1)
• Acute Interstitial Nephritis: Observed in patients taking PPIs.
(5.2)
• Clostridium difficile-associat