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:

Cardinal Health 107, LLC

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 is

Product summary:

Lansoprazole Delayed-Release Orally Disintegrating Tablets are available as follows: 30 mg – white to off-white, flat, beveled round, unscored tablet with off-white to grayish speckles, debossed with "30" on one side of the tablet and plain on the other side. Available: Overbagged with 10 tablets per bag, NDC 55154-4848-0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Cardinal Health 107, LLC
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MEDICATION GUIDE
Lansoprazole (lan-SOE-pra-zole) Delayed-Release Orally Disintegrating
Tablets
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 interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including lansoprazole delayed-release
orally disintegrating tablets, may
develop a kidney problem called acute interstitial 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 already

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED
RELEASE
CARDINAL HEALTH 107, 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
RECENT MAJOR CHANGES
Dosage and Administration
Recommended Pediatric Dosage (2.2)
06/2018
Contraindications (4)
07/2017
Warnings and Precautions
Interactions with Investigations for Neuroendocrine Tumors (5.8)
07/2017
Patients with Phenylketonuria (5.10)
07/2017
Fundic Gland Polyps (5.11)
06/2018
INDICATIONS AND USAGE
Lansoprazole delayed-release orally disintegrating tablets are a
proton pump inhibitor (PPI) indicated for
the:
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DOSAGE AND ADMINISTRATION
Recommended Dosage:
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Administration Instructions (2.4)
_Lansoprazole delayed-release orally disintegrating tablets_
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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 non-steroidal 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)
See full prescribing information for complete dosing information for
lan