PANTOPRAZOLE SODIUM for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ajanta Pharma USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

How Supplied Pantoprazole sodium for delayed-release oral suspension is supplied as yellow to brownish yellow color enteric coated granules containing 40 mg pantoprazole filled and sealed in a unit-dose packet and are available as follows:  Storage Store pantoprazole sodium for delayed-release oral suspension at 20°C to 25°C (68°F to77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ajanta Pharma USA Inc.
----------
MEDICATION GUIDE
Pantoprazole sodium (pan toe’ pra zole soe’ dee um)
for delayed-release oral suspension
What is the most important information I should know about
pantoprazole sodium for delayed-release
oral
suspension?
You should take pantoprazole sodium for delayed-release oral
suspension exactly as prescribed,
at the lowest dose
possible and for the shortest time needed.
Pantoprazole
sodium
for
delayed-release
oral
suspension may help your acid-
related symptoms, but you could still have serious stomach
problems. Talk
with your doctor.
Pantoprazole sodium for delayed-release oral suspension can cause
serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including pantoprazole sodium for
delayed-release oral suspension, may
develop a kidney problem called acute tubulointerstitial nephritis
that can happen at any time
during treatment with pantoprazole sodium for delayed-release oral
suspension. 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 for delayed-release oral suspension, may
develop certain types of
lupus erythematosus or have worsening of the lupus they already have.
Call your doctor ri

Summary of Product characteristics

PANTOPRAZOLE SODIUM - PANTOPRAZOLE SODIUM FOR SUSPENSION
AJANTA PHARMA USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM
FOR DELAYED-RELEASE ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR PANTOPRAZOLE SODIUM FOR DELAYED-RELEASE ORAL
SUSPENSION.
PANTOPRAZOLE SODIUM FOR DELAYED-RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Pantoprazole sodium for delayed-release oral suspension 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
(ZE) 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
For Delayed-Release Oral Suspension: 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 Tubulointerstitial Nephritis: Discontinue treatment and evaluate
patients. (5.2)
Clostridium difficile-Associated Diarrhea: PPI therapy may be
associated with increased risk of
Clostri