PANTOPRAZOLE SODIUM tablet, delayed release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Clinical Solutions Wholesale, LLC

DCI (Dénomination commune internationale):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 40 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. 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 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 are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole sodium is contraindicated in patients w

Descriptif du produit:

How Supplied Pantoprazole sodium delayed-release tablets, USP are supplied as 20 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "96" printed with brown ink on the other side. They are available as follows: Bottles of 30 NDC 13668-096-30 Bottles of 90 NDC 13668-096-90 Bottles of 500 NDC 13668-096-05 100 Unit Dose Tablets NDC 13668-096-74 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: Bottles of 30 NDC 13668-429-30 Bottles of 90 NDC 13668-429-90 Bottles of 500 NDC 13668-429-05 80 Unit Dose Tablets NDC 13668-429-77 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].

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Clinical Solutions Wholesale, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Pantoprazole sodium (pan TOE pra zole SO-dee-um) 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:
• 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 if you have a decrease in
the amount that you urinate or if you
have blood in your urine.
• 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 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 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.
•

Résumé des caractéristiques du produit

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
CLINICAL SOLUTIONS WHOLESALE, 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Atrophic Gastritis 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
(2)
DOSE
(2)
FREQUENCY
(2)
SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1)
(2)
Adults
(2)
40 mg
(2)
Once Daily for up to 8 wks
(2)
Children (5 years and older)
(2)
≥ 15 kg to < 40 kg
(2)
20 mg
(2)
Once Daily for up to 8 wks
(2)
≥ 40 kg
(2)
40 mg
(2)
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1)
(2)
Adults
40 mg
Once Daily*
(2)
(2)
(2)
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME (2.1)
(2)
Adults
(2)
40 mg
(2)
Twice Daily
(2)
Controlled studies did not extend beyond 12 months (2)
See full prescribing information for administration instructions (2)
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 the