LANSOPRAZOLE capsule, delayed release pellets

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Mylan Institutional Inc.

INN（国際名）:

LANSOPRAZOLE

構図:

LANSOPRAZOLE 30 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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)] . Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy are 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. Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy are indicated in adults for the treatment of patients with H. pylor

製品概要:

Lansoprazole Delayed-Release Capsules, USP are available containing 30 mg of lansoprazole, USP. The 30 mg capsules are hard gelatin capsules with a pink opaque cap and pink opaque body filled with white to off-white pellets. The capsules are axially printed with MYLAN over 8030 in black ink on both the cap and the body. They are available as follows: NDC 51079-121-08 – Unit dose blister packages of 80 (8 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Mylan Institutional Inc.
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MEDICATION GUIDE
Lansoprazole Delayed-Release Capsules, USP
(lan soe′ pra zole)
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 tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including lansoprazole delayed-release
capsules, may develop a kidney
problem called acute tubulointerstitial 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 to your

製品の特徴

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
MYLAN INSTITUTIONAL INC.
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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
Warnings and Precautions,
1. Acute Tubulointerstitial Nephritis ( 5.2) 11/2020
INDICATIONS AND USAGE
Lansoprazole delayed-release capsules 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
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
Delayed-release capsules: 15 mg and 30 mg. ( 3)
CONTRAINDICATIONS
Patients receiving rilpivirine-containing products. ( 4, 7)
Contraindicated i