LANSOPRAZOLE capsule, delayed release

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Xiromed LLC

INN (Միջազգային անվանումը):

LANSOPRAZOLE

Կազմը:

LANSOPRAZOLE 15 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Lansoprazole delayed-release capsules are indicated 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 delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated 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 delayed-release capsules in combination with amoxicillin as dual therapy is indicated 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 intoler

Ապրանքի ամփոփագիր:

Lansoprazole Delayed-Release Capsules, USP, 15 mg, are hard gelatin capsules No 3, opaque white body and green cap, with black printing “A262” over “15 mg” on the body and cap containing white or almost white spherical pellets. The 30 mg capsules are hard gelatin capsules No 1, opaque white body and light blue cap, with black printing “A263” over “30 mg” on the body and cap containing white or almost white spherical pellets. They are available as follows: 15 mg: Bottle of 30.......NDC# 70700-262-30 30 mg: Bottle of 30.......NDC# 70700-263-30 Bottle of 90.......NDC# 70700-263-90 Bottle of 500.....NDC# 70700-263-05 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

Xiromed LLC
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MEDICATION GUIDE
Lansoprazole (lan soe' pra zole) Delayed-Release Capsules, for oral
use
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. 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 stool, stomach pain,
and fever 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 doctor about your risk of these serious side ef

Ապրանքի հատկությունները

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
XIROMED 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
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 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
Contraindicated in patients with known severe hypersensitivity to any
compo