PANTOPRAZOLE 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:

State of Florida DOH Central Pharmacy

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 USP are indicated for: Pantoprazole sodium delayed-release tablets USP 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. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.  Pantoprazole sodium delayed-release tablets USP are indicated for maintenance of healing of erosive esophagitis 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 USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole sodium delayed-relea

產品總結:

How Supplied Pantoprazole sodium delayed-release tablets USP 20 mg are yellow, round, biconvex coated tablets printed with “R332” on one side with black ink and plain on the other side. Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store pantoprazole sodium delayed-release tablets at 20°–25°C (68°–77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

资料单张

State of Florida DOH Central Pharmacy
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MEDICATION GUIDE
Pantoprazole Sodium Delayed-Release Tablets, USP
Read this Medication Guide before you start taking pantoprazole sodium
delayed-release tablets and each
time you get a refill. There may be new information. This information
does not take the place of talking
with your doctor about your medical condition or your treatment.
What is the most important information I should know about
pantoprazole sodium delayed-release
tablets?
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:
• Diarrhea. Pantoprazole sodium delayed-release tablets may increase
your risk of getting severe diarrhea.
This diarrhea may be caused by an infection (Clostridium difficile) in
your intestines.
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go away.
• Bone fractures. People who take multiple daily doses of proton
pump inhibitor medicines for a long
period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist or spine. You
should take pantoprazole sodium delayed-release tablets exactly as
prescribed, at the lowest dose possible
for your treatment and for the shortest time needed. Talk to your
doctor about your risk of bone fracture if
you take pantoprazole sodium delayed-release tablets.
Pantoprazole sodium delayed-release tablets can have other serious
side effects. See “What are the
possible side effects of pantoprazole sodium delayed-release
tablets?”
What are pantoprazole sodium delayed-release tablets?
Pantoprazole sodium delayed-release tablet is a prescription medicine
called a proton pump inhibitor
(PPI).
Pantoprazole sodium delayed-release tablets reduces the amount of acid
in your stomach.
Pantoprazole sodium delayed-release tablets are used in adults:
• for up to 8 weeks to heal acid-related damag

产品特点

PANTOPRAZOLE - PANTOPRAZOLE TABLET, DELAYED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM DELAYED-RELEASE
TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PANTOPRAZOLE SODIUM DELAYED-RELEASE
TABLETS USP.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Pantoprazole sodium is a proton pump inhibitor 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
Syndrome (1.3)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
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
See Full Prescribing Information for administration instructions
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets, 20 mg and 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles (4)
WARNINGS AND PRECAUTIONS
Symptomatic response does not preclude presence of gastric malignancy
(5.1)
Atrophic gastritis has been noted with long-term therapy (5.2)
PPI therapy may be associated with increased risk of _Clostridium
difficile_ associated diarrhea. (5.4)
Bone Fracture: Long-term and multiple daily dose PPI therapy may be
associated with an increased risk for
osteoporosis-related fractures of the hip, wrist or spine. (5.5)
Hypomagnesemia has been reported rarely with prolonged treatment with
PPIs (5.6)
ADVERSE REACTIONS
The most frequently oc