LANSOPRAZOLE tablet, orally disintegrating, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Teva Pharmaceuticals USA, Inc.

Designació comuna internacional (DCI):

LANSOPRAZOLE

Composición:

LANSOPRAZOLE 15 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Lansoprazole Delayed-Release Orally Disintegrating Tablets are available as follows: 15 mg – white to off-white, flat, beveled round, unscored tablet with off-white to grayish speckles, debossed with "15" on one side of the tablet and plain on the other side. Packaged in unit dose cartons of 100 tablets (10 blister cards x 10 tablets), NDC 0093-3008-93. 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. Packaged in unit dose cartons of 100 tablets (10 blister cards x 10 tablets), NDC 0093-3009-93. 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.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Teva Pharmaceuticals USA, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
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 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

Fitxa tècnica

LANSOPRAZOLE- LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED
RELEASE
TEVA PHARMACEUTICALS USA, INC.
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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
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.5) 3/2022
Hypomagnesemia and Mineral Metabolism (5.8) 3/2022
INDICATIONS AND USAGE
Lansoprazole delayed-release orally disintegrating tablets are 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 disint