PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals,Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Pantoprazole Sodium Delayed-Release Tablets are indicated for: Pantoprazole Sodium Delayed-Release Tablet 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 (EE). 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 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 syndrome. •Pantoprazole Sodium Delayed-Release Tablets are contraindicated in pat

Dettagli prodotto:

Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted H126 on one side with black ink and plain on the other side. They are supplied as follows: NDC 68071-4864-9 BOTTLES OF 90 Storage Store pantoprazole sodium delayed-release tablets, USP at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Pantoprazole Sodium Delayed-Release Tablets
pan toe’ pra zole soe’ dee um
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 sodiumdelayed-release tablets may help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Pantoprazole sodiumdelayed-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 offractures 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 tablet.
• Certain types of lupus erythematos

Scheda tecnica

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
NUCARE PHARMACEUTICALS,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 Gastritis removed (5.2)
10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus
(5.5) 10/2016
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablet is 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
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
• Patients with known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles ( 4)
• Patients receiving rilpivirine-containing products (4)
WARNINGS AND PRECAUTIONS
• Gastric Malignancy: In adults, Symptomatic response does not
preclude presence of gastric
malignancy. Consider additional follow-up and diagonostic testing. (
5.1)
• Acute interstitial nephritis