PANTOPRAZOLE SODIUM tablet, delayed release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Proficient Rx LP

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: 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 (EE). 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. Pantoprazole is indicated for maintenance of healing of 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 is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pregnancy Category C Reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area)

Přehled produktů:

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: 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 ].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Proficient Rx LP
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MEDICATION GUIDE
Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP
CIA77568J Rev. 07/2017
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 they already have. Call your doctor right away if you have new
or worsening joint pain

Charakteristika produktu

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
PROFICIENT RX LP
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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 (PPI) 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
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)
Patients with known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles (4)
Patients receiving rilpivirine-containing products (4)
Gastric Malignancy: In adults, symptomatic response does not preclude
presence of gastric
malignancy. Consider additional follow-up and diagnostic testing.
(5.1)
Acute Interstitial Nephritis: Observed in patients taking PPIs. (5.2)
_Clostridium di