RABEPRAZOLE SODIUM tablet, delayed release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Asclemed USA, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. 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. 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. 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. Rabeprazole

Přehled produktů:

Rabeprazole Sodium Delayed-Release Tablets 20 mg are light yellow to yellow, round, biconvex, enteric coated tablets with imprinting ‘Y70’ on one side and plain on other side.             Bottles of 30        NDC 76420-107-30 (relabeled from NDC 65862-721-30)             Bottles of 60        NDC 76420-107-60 (repackaged from NDC 65862-721-90)             Bottles of 90        NDC 76420-107-90 (relabeled from NDC 65862-721-90) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
Asclemed USA, Inc.
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MEDICATION GUIDE
Rabeprazole Sodium Delayed-Release Tablets
(ra-BEP-ra-zole SOE-dee-um)
What is the most important information I should know about rabeprazole
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 yo

Charakteristika produktu

RABEPRAZOLE SODIUM- RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
ASCLEMED USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RABEPRAZOLE SODIUM DELAYED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR RABEPRAZOLE SODIUM
DELAYED-RELEASE TABLETS.
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps (5.10) 06/2018
INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are a proton pump inhibitor
(PPI) indicated in adults for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease
(GERD) ( 1.1).
Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2).
Treatment of Symptomatic GERD ( 1.3).
Healing of Duodenal Ulcers ( 1.4).
_Helicobacter pylori_ Eradication to Reduce Risk of Duodenal Ulcer
Recurrence ( 1.5).
Treatment of Pathological Hypersecretory Conditions, Including
Zollinger-Ellison Syndrome ( 1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD ( 1.7).
DOSAGE AND ADMINISTRATION
INDICATION
RECOMMENDED DOSAGE ( 2)
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease
(GERD)
20 mg once daily for 4 to 8 weeks
Maintenance of Healing of Erosive or Ulcerative GERD* studied for 12
months
20 mg once daily*
Symptomatic GERD in Adults
20 mg once daily for 4 weeks
Healing of Duodenal Ulcers
20 mg once daily after morning meal for up to
4 weeks
_Helicobacter pylori _Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
Three Drug Regimen:
Rabeprazole Sodium Delayed-Release Tablets 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
_All three medications_
_should be taken twice_
_daily with morning and evening meals for 7_
_days_
Pathological Hypersecretory Conditions, Including Zollinger-Ellison
Syndrome
Starting dose 60 mg once daily then adjust to
patient needs
Symptomatic GERD in Adolescents 12 Years of Age and Older
20 mg once daily for up