RABERPRAZOLE SODIUM D/R tablet, delayed release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

RABEPRAZOLE SODIUM (UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL)

Dostupné z:

Direct_Rx

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

1.1 Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered. 1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months. 1.3 Treatment of Symptomatic GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks. 1.4 Healing of Duodenal Ulcers in Adults Rabep

Prehľad produktov:

Rabeprazole sodium 20 mg is supplied as yellow colored, round, biconvex delayed-release tablets imprinted with '107' on one side in black ink and plain on other side. Bottles of 30 Bottles of 90 Bottles of 500 Bottles of 4000 100 Unit dose Tablets 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]. Protect from moisture.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Direct_Rx
----------
MEDICATION GUIDE
Rabeprazole sodium (ra-BEP-ra-zole SOE-dee-um) delayed-release tablets
What is the most important information I should know about r
abeprazole sodium delayed-release tablets?
You should take rabeprazole sodium delayed-release tablets exactly as
prescribed, at the lowest dose
possible and for the shortest time needed.
Rabeprazole sodium delayed-release tablets may help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Rabeprazole 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 rabeprazole sodium delayed-release tablets,
may develop a kidney problem
called acute interstitial nephritis that can happen at any time during
treatment with rabeprazole 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
rabeprazole 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 cheeks or arms that gets worse in the sun.
Talk to your doctor about you

Súhrn charakteristických

RABERPRAZOLE SODIUM D/R- RABERPRAZOLE SODIUM D/R TABLET, DELAYED
RELEASE
DIRECT_RX
----------
RABERPRAZOLE SODIUM D/R 20MG
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for
short-term (4 to 8 weeks)
treatment in the healing and symptomatic relief of erosive or
ulcerative
gastroesophageal reflux disease (GERD). For those patients who have
not healed after 8
weeks of treatment, an additional 8-week course of rabeprazole sodium
delayed-release
tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for
maintaining healing and
reduction in relapse rates of heartburn symptoms in patients with
erosive or ulcerative
gastroesophageal reflux disease (GERD Maintenance). Controlled studies
do not extend
beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the
treatment of daytime
and nighttime heartburn and other symptoms associated with GERD in
adults for up to
4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for
short-term (up to four
weeks) treatment in the healing and symptomatic relief of duodenal
ulcers. Most patients
heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal
Ulcer Recurrence in
Adults
Rabeprazole sodium delayed-release tablets, in combination with
amoxicillin and
clarithromycin as a three drug regimen, are indicated for the
treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history
within the past 5 years)
to eradicate H. pylori. Eradication of H. pylori has been shown to
reduce the risk of
duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done.
If resistance to
clarithromycin is demonstrated or susceptibility testing is not
possible, alternative
antimicrobial therapy should be instituted [see Clinical Pharmacology