PANTOPRAZOLE SODIUM D/R tablet, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

DIRECT RX

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 (ZE) Synd

Dettagli prodotto:

How Supplied Pantoprazole sodium delayed-release tablets, USP are supplied as 20 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "96" printed with brown ink on the other side. They are available as follows: Bottles of 30 Bottles of 90 Bottles of 500 100 Unit Dose Tablets Pantoprazole sodium delayed-release tablets, USP are supplied as 40 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "97" printed with brown ink on the other side. They are available as follows: Bottles of 30 Bottles of 90 Bottles of 500 80 Unit Dose Tablets Storage Store 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

PANTOPRAZOLE SODIUM D/R- PANTOPRAZOLE SODIUM D/R TABLET, DELAYED
RELEASE
DIRECT RX
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MEDICATION GUIDE
Pantoprazole sodium (pan TOE pra zole SO-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 stool, 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 or a rash on your cheek

Scheda tecnica

PANTOPRAZOLE SODIUM D/R- PANTOPRAZOLE SODIUM D/R TABLET, DELAYED
RELEASE
DIRECT RX
----------
PANTOPRAZOLE SODIUM D/R
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
(ZE) Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the
long-term treatment of pathological
hypersecretory conditions, including Zollinger-Ellison syndrome.
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
* For 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.
** Dosage regimens should be adjusted to individual patient needs and
should continue for as long as
clinically indicated. Doses up to 240 mg daily have been administered.
*** Controlled studies did not extend beyond 12 months
Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for