LANSOPRAZOLE- lansoprazole capsule, delayed release pellets

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Lake Erie Medical DBA Quality Care Products LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Lansoprazole delayed-release capsules 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/amoxicillin/clarithromycin Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated I 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/amoxicillin Lansoprazole in combination with amoxicillin as dual 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) who are either allergic or intolerant to clarithrom

Produktsammanfattning:

Lansoprazole Delayed-release Capsules USP, 15 mg are enteric-coated pellets filled in size '3' hard gelatin capsules with standard pink opaque colored cap printed with "ZA -50" in black ink and white opaque body printed with "15mg" in black ink and are supplied as follows: Lansoprazole Delayed-release Capsules USP, 30 mg are enteric-coated pellets filled in size '1' hard gelatin capsules with standard pink opaque colored cap  printed with "ZA -51" in black ink and white opaque body printed with "30 mg" in black ink and are supplied as follows: 55700-616-30 Storage Store at 20ο to 25ο C (68ο to 77ο F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
Lansoprazole
(lan-SO-pruh-zole)
Delayed-release Capsules, USP
What is the most important information that I should know about
lansoprazole delayed-release capsules?
You should take lansoprazole delayed-release capsules exactly as
prescribed, at the lowest dose possible
and for the shortest time needed.
Lansoprazole delayed-release capsules may help your acid-related
symptoms, but you could still have
serious stomach problems. Talk with your doctor.
Lansoprazole delayed-release capsules 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
capsules, may develop a kidney
problem called acute interstitial nephritis, that can happen at any
time during treatment with PPI
medicines including lansoprazole delayed-release capsules. 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 capsules, 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 your cheeks or arms
that gets worse in the sun.
Talk t

Produktens egenskaper

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANSOPRAZOLE DELAYED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LANSOPRAZOLE DELAYED-RELEASE
CAPSULES.
LANSOPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Contraindications (4) 07/2017
Warnings and Precautions
Interactions with Investigations for Neuroendocrine Tumors (5.8)
07/2017
INDICATIONS AND USAGE
Lansoprazole delayed-release capsules 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 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)
DOSAGE AND ADMINISTRATION
Recommended Dosage:
See full prescribing information for complete dosing information for
lansoprazole delayed-release capsules 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 capsules_
Should be swallowed whole.
See full prescribing information for alternative administration
options.
DOSAGE FORMS AND STRENGTHS
Capsules: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
Contraindicated in patients with