PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

PANTOPRAZOLE SODIUM

구성:

PANTOPRAZOLE 40 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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-r

제품 요약:

How Supplied Pantoprazole sodium delayed-release tablets, USP, 20 mg , are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A6” with black ink on one side and plain on the other side. They are available as follows: Bottles of 30:               NDC 65162-636-03 Bottles of 90:               NDC 65162-636-09 Pantoprazole sodium delayed-release tablets, USP, 40 mg , are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A37” with black ink on one side and plain on the other side. They are available as follows: Bottles of 30:               NDC 65162-637-03 Bottles of 90:               NDC 65162-637-09 Bottles of 500:             NDC 65162-637-50 Bottles of 1000:           NDC 65162-637-11 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].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Pantoprazole (pan-TOE-pra-zole) Sodium Delayed-release Tablets
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 tabletsmay help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Pantoprazole sodium delayed-release tabletscan 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 sodiumdelayed-release tablets?
Pantoprazole sodium delayed-release tablets are a prescription
medicine called a proton pump inhibitor
(PPI).
Pantoprazole sodium delayed-release tablets reduce the amount of acid
in your stomach.
Pantoprazole sodium delayed-release tab

제품 특성 요약

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosing Schedule (2.1) 12/2014
Contraindications (4) 12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets, USP are 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
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 (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)
Acute interstitial nephritis has been observed in patients taking
PPIs. (5.3)
Cyanocobalamin (vitamin B-12) Deficiency: Dai