LANSOPRAZOLE tablet, orally disintegrating, delayed release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

lansoprazole (UNII: 0K5C5T2QPG) (lansoprazole - UNII:0K5C5T2QPG)

Dostupno od:

NorthStar Rx LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1) ]. Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.2) ]. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin  Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual thera

Proizvod sažetak:

Lansoprazole delayed-release orally disintegrating tablets, 15 mg are white to off white, round, flat faced beveled edge, uncoated tablets with orange to dark brown colored speckles, debossed with '' on one side and ‘15’ on the other side. The 30 mg are white to off white, round, flat faced beveled edge, uncoated tablets with orange to dark brown colored speckles, debossed with '' on one side and ‘30’ on the other side. The tablets are available as follows:   15 mg tablets: Unit dose packages of 100 (10 x 10) NDC 16714-185-02 30 mg tablets: Unit dose packages of 100 (10 x 10) NDC 16714-186-02  Store at 20° to 25° C (68° to 77° F); [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

NorthStar Rx LLC
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MEDICATION GUIDE
Lansoprazole Delayed-Release Orally Disintegrating Tablets
(lan soe' pra zole)
What is the most important information that I should know about
lansoprazole delayed-
release orally disintegrating tablets?
You should take lansoprazole delayed-release orally disintegrating
tablets exactly as
prescribed, at the lowest dose possible and for the shortest time
needed.
Lansoprazole delayed-release orally disintegrating tablets may help
your acid-related
symptoms, but you could still have serious stomach problems. Talk with
your doctor.
Lansoprazole delayed-release orally disintegrating 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 lansoprazole
delayed-
release orally disintegrating tablets, may develop a kidney problem
called acute
tubulointerstitial nephritis that can happen at any time during
treatment with PPI
medicines including lansoprazole delayed-release orally disintegrating
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 lansoprazole delayed-release
orally
disintegrating tablets, may develop certain types of lupus
erythematosus or have
worsening of the lupus they al

Svojstava lijeka

LANSOPRAZOLE- LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED
RELEASE
NORTHSTAR RX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANSOPRAZOLE
DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR LANSOPRAZOLE DELAYED-RELEASE ORALLY
DISINTEGRATING
TABLETS.
LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Lansoprazole delayed-release orally disintegrating tablet is a proton
pump inhibitor (PPI) indicated for the:
Treatment of active duodenal ulcer in adults. (1.1)
Eradication of H. pylori to reduce the risk of duodenal ulcer
recurrence in adults. (1.2)
Maintenance of healed duodenal ulcers in adults. (1.3)
Treatment of active benign gastric ulcer in adults. (1.4)
Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated
gastric ulcer in adults. (1.5)
Risk reduction of NSAID-associated gastric ulcer in adults. (1.6)
Treatment of symptomatic gastroesophageal reflux disease (GERD) in
adults and pediatric patients 1
year of age and older. (1.7)
Treatment of erosive esophagitis (EE) in adults and pediatric patients
1 year of age and older. (1.8)
Maintenance of healing of EE in adults. (1.9)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome (ZES) in adults. (1.10)
DOSAGE AND ADMINISTRATION
Recommended Dosage:
See full prescribing information for complete dosing information for
lansoprazole delayed-release orally
disintegrating tablets by indication and age group and dosage
adjustment in patients with severe
hepatic impairment. (2.1, 2.2, 2.3)
Administration Instructions (2.4)
Lansoprazole delayed-release orally disintegrating tablets
• Should not be broken or cut.
• Should not be chewed.
• Place the tablet on the tongue and allow it to disintegrate, with
or without water, until the particles can
be swallowed.
• See full prescribing information for alternative administration
opt