PANTOPRAZOLE SODIUM DR- pantoprazole sodium tablet, delayed release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Advanced Rx Pharmacy of Tennessee, LLC

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Pantoprazole sodium delayed-release tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) 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 (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 may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-release tablets 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. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Vörulýsing:

How Supplied: Pantoprazole Sodium Delayed-Release Tablets, USP are available containing USP equivalent to 20 mg, respectively. 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: Bottles of 60 Tablets NDC: 80425-0179-02 Bottles of 90 Tablets NDC: 80425-0179-03 Storage: 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.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE
Pantoprazole Sodium Delayed-Release Tablets, USP
(pan toe′ pra zole soe′dee um)
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 tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including pantoprazole sodium
delayed-release tablets, may develop a
kidney problem called acute tubulointerstitial 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 p

Vara einkenni

PANTOPRAZOLE SODIUM DR- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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PANTOPRAZOLE SODIUM DR 20MG
1. INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated with
Gastroesophageal
Reflux Disease (GERD)
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 (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 may be considered. Safety
of treatment
beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets 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.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the
long-term treatment
of pathological hypersecretory conditions, including Zollinger-Ellison
(ZE) Syndrome.
2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The
recommended dosages
are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium
Delayed-Release
Tablets
Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated with GERD
Adults
40 mg
Once daily for up to 8 weeks *
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily†
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Adults
40 mg
Twice daily‡
* For adult p