PANTOPRAZOLE SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

California Pharmaceutical, LLC

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. - Pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include ana

Product summary:

How Supplied Repackaged 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: Drug manufacturer: Lannett Company, Inc. 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 ].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

California Pharmaceutical, LLC
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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 h

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
CALIFORNIA PHARMACEUTICAL, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
REPACKAGED PANTOPRAZOLE SODIUM DELAYED-RELEASE (DR) TABLETS
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 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:
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
INDIC ATIO N
DO SE
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
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 diagnostic testing. ( 5.1)
Acute Interstitial Nephritis: Observed in patients taking PPIs. ( 5.2)
_Clostridium difficile-associated diarrhea_: PPI therap