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:

Wockhardt USA LLC.

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pantoprazole sodium delayed-release tablets, USP are indicated for: Pantoprazole sodium delayed-release tablets, USP 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 (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, USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole sodium delayed-release tablets, USP are 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 sodium delayed-release tablets, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome. -   Pantoprazole sodium delayed-rele

Product summary:

How Supplied Pantoprazole sodium   delayed-release tablets, USP are supplied as yellow colored, biconvex oval shaped tablets plain on one side and imprinted with "W433" (brown ink) on other side containing 20 mg and are available as follows: HDPE bottle of 30 tablets                  NDC 64679-433-01 HDPE bottle of 90 tablets                  NDC 64679-433-04 HDPE bottle of 1000 tablets              NDC 64679-433-02 Unit dose packages of 100 tablets      NDC 64679-433-03 HDPE bottle of 100 tablets                NDC 64679-433-05 Pantoprazole sodium   delayed-release tablets, USP are supplied as yellow colored, biconvex oval shaped tablets plain on one side and imprinted with "W434" (brown ink) on other side  containing 40 mg and are available as follows: HDPE bottle of 30 tablets                  NDC 64679-434-01 HDPE bottle of 90 tablets                  NDC 64679-434-04 HDPE bottle of 1000 tablets              NDC 64679-434-02 Unit dose packages of 100 tablets      NDC 64679-434-03 HDPE bottle of 100 tablets                NDC 64679-434-05 Storage Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Wockhardt USA LLC.
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MEDICATION GUIDE
Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um)
Delayed-Release Tablets, USP
What is the most important information I should know about
pantoprazole sodium delayed-release
tablets?
You should take pantoprazole sodium delayed-release tablets exactly as
prescribed, at the lowest dose
possible and for the shortest time needed.
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 right away if you have a
decrease in the amount that you urinate
or if you have blood in your urine.
● Diarrhea caused by an infection ( Clostridium difficile) in your
intestines. Call your doctor right away
if you have watery stools or stomach pain that does not go away. You
may or may not have a fever.
● Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in people
who take multiple daily doses of PPI medicines and for a long period
of time (a year or longer). Tell your
doctor if you have a bone fracture, especially in the hip, wrist, or
spine.
● 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 sodium delayed-release tablets, 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 o

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
WOCKHARDT USA 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,
Fundic Gland Polyps ( 5.9) 06/2018
Warnings and Precautions,
Interference with Investigations for Neuroendocrine
Tumors ( 5.10) 12/2017
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets, USP are 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
(ZE) Syndrome ( 1.3)
DOSAGE AND ADMINISTRATION
* Controlled studies did not extend beyond 12 months (2)
INDICATION
DOSE
FREQUENCY
SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1)
Adults
40mg
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
40mg
Twice Daily
See full prescribing information for administration instructions (2)
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 20 mg and 40 mg pantoprazole ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to any component of the
formulation or to substituted benzimidazoles ( 4)
Patients receiving rilpivirine-containing products ( 4, 7)
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 Interstiti