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:

Lake Erie Medical DBA Quality Care Products LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Pantoprazole sodium delayed-release tablets, USP 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 delayed-release tablets are c

Descriptif du produit:

Pantoprazole Sodium Delayed-release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole. The 20 mg tablets are dark yellow film-coated, oval, unscored tablets imprinted with M P8 in black ink on one side of the tablet and blank on the other side. They are available as follows: The 40 mg tablets are dark yellow film-coated, oval unscored tablets imprinted with M P9 in black ink on one side of the tablet and blank on the other side. They are available as follows: 55700-318-30    30 55700-318-60    60 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP
(pan toe′ pra zole soe′dee um)
20 mg and 40 mg
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 tablets are a prescription
medicine called a proton pump inhibitor (PPI).
Pantoprazole sodium delayed-release tablets reduce the amount of acid
in

Résumé des caractéristiques du produit

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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:
•
•
•
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
See full prescribing information for
administration instructions.
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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)
Controlled studies did not extend beyond 12 months
*
Delayed-release Tablets, 20 mg and 40 mg (3)
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
PP