PANTOPRAZOLE SODIUM tablet, delayed release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

RedPharm Drug, Inc.

INN (আন্তর্জাতিক নাম):

PANTOPRAZOLE SODIUM

রচনা:

PANTOPRAZOLE 40 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole 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. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole 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 is 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. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole is indicated for the long-term treatment of pathological hypersec

পণ্য সারাংশ:

How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg white, oval biconvex delayed-release tablets debossed with "17" on one side and are available as follows: NDC 62175-617-46, bottles of 90 NDC 62175-617-43, bottles of 1000 Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white, oval biconvex delayed-release tablets imprinted in black ink with "KU" on one side and "180" on the other side and are available as follows: NDC 62175-180-46, bottles of 90 NDC 62175-180-43, bottles of 1000 Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP 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].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
RedPharm Drug, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP
CIA77568H Rev. 12/2016
Read this Medication Guide before you start taking Pantoprazole 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?
Pantoprazole may help your acid-related symptoms, but you could still
have serious stomach problems. Talk
with your doctor.
Pantoprazole 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, may develop a kidney problem called
acute interstitial nephritis that can
happen at any time during treatment with Pantoprazole. Call your
doctor if you have a decrease in the amount
that you urinate or if you have blood in your urine.
Diarrhea. Pantoprazole 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 PPI 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
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.
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,
may develop certain types of lupus erythematosus or have worsening of
the lupus t

পণ্য বৈশিষ্ট্য

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
REDPHARM DRUG, 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, Atrophic Gastric removed (5.2) 10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus
(5.5)
10/2016
INDICATIONS AND USAGE
Pantoprazole 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
Indication Dose Frequency
*
Controlled studies did not extend beyond 12 months
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
In adults, symptomatic response does not preclude presence of gastric
malignancy.
Consider additional follow-up and diagnostic testing. (5.1)
Acute interstitial nephritis has been observed in patients taking
PPIs. (5.2)
PPI therapy may be associated with increased risk of Clostridium
difficile-associated
diarrhea. (5.3)
Bone Fracture: L