LANSOPRAZOLE tablet, orally disintegrating, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)

Available from:

Aurobindo Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 therapy

Product summary:

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg are white to yellowish white uncoated tablets with orange to dark brown speckles, debossed with ‘J’ on one side and ‘71’ on the other side of the tablet. 10 x 10 Unit-dose Tablets                     NDC 65862-895-78 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg are white to yellowish white uncoated tablets with orange to dark brown speckles, debossed with ‘J’ on one side and ‘72’ on the other side of the tablet. 10 x 10 Unit-dose Tablets                   NDC 65862-896-78 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANSOPRAZOLE - LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED
RELEASE
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Lansoprazole Delayed-Release Orally Disintegrating Tablets
(lan-SO-pruh-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 de

Summary of Product characteristics

LANSOPRAZOLE - LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED
RELEASE
AUROBINDO PHARMA LIMITED
----------
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
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.5) 03/2022
Hypomagnesemia and Mineral Metabolism (5.8) 03/2022
INDICATIONS AND USAGE
Lansoprazole delayed-release orally disintegrating tablets are proton
pump inhibitors (PPIs) 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 disintegr