PANTOPRAZOLE SODIUM D/R tablet, delayed release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Direct_Rx

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

PANTOPRAZOLE SODIUM D/R- PANTOPRAZOLE SODIUM D/R TABLET, DELAYED
RELEASE
Direct_Rx
----------
Trademarks are the property of their respective owners.
Keep pantoprazole sodium delayed-release tablets and all medicines out
of the reach of children.
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
This product's label may have been updated. For current full
prescribing information, please visit
www.torrentpharma.com.
[Torrent Logo]
Manufactured by:
TORRENT PHARMACEUTICALS LTD., INDIA.
Manufactured For:
TORRENT PHARMA INC., Basking Ridge, NJ 07920.
8075355 Revised May 2019
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 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).

Ciri produk

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
(ZE) 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 dai