LANSOPRAZOLE capsule, delayed release

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:

H.J. Harkins Co., 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 contraindicated in patients with known severe hypersensitivity to any component of the formulation of lansoprazole delayed-release capsules. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see Adverse Reactions (6)].

製品概要:

Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of 30’s, 60’s, 90's, 100’s, 500’s and unit dose package of 10 (1 x 10). Store at 20°–25° C (68°–77° F); [See USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

H.J. Harkins Co., Inc
----------
MEDICATION GUIDE
MEDICATION GUIDE
Lansoprazole Delayed-Release Capsules, USP
Read this Medication Guide before you start taking lansoprazole
delayed-release capsules and each time
you get a refill. There may be new information. This information does
not take the place of talking to
your doctor about your medical condition or your treatment.
What is the most important information that I should know about
lansoprazole delayed-release capsules?
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:
Diarrhea. Lansoprazole delayed-release capsules may increase your risk
of getting severe diarrhea. This
diarrhea may be 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.
Bone fractures. People who take multiple daily doses of proton pump
inhibitor medicines for a long
period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist or spine. You
should take lansoprazole delayed-release capsules exactly as
prescribed, at the lowest dose possible for
your treatment and for the shortest time needed. Talk to your doctor
about your risk of bone fracture if
you take lansoprazole delayed-release capsules.
Lansoprazole delayed-release capsules can have other serious side
effects. See “What are the possible
side effects of lansoprazole delayed-release capsules?”
What are lansoprazole delayed-release capsules?
Lansoprazole delayed-release capsules are prescription medicine called
a proton pump inhibitor (PPI).
Lansoprazole delayed-release capsules reduces the amount of acid in
your stomach.
Lansoprazole delayed-release capsules are used in adults:
for 4 weeks for the healing and symptom relief of duodenal ulcers. The
duodenal area is the area where
food passes when it leaves the st

製品の特徴

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
H.J. HARKINS CO., INC
----------
INDICTAIONS & USAGE
1.1 Short-Term Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release capsules are indicated for short-term
treatment (for 4 weeks) for healing
and symptom relief of active duodenal ulcer. [See CLINICAL STUDIES
(14)]
1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
Triple Therapy: Lansoprazole delayed-release capsules /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)]
Please refer to the full prescribing information for amoxicillin and
clarithromycin.
Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin
Dual Therapy: Lansoprazole delayed-release capsules
/amoxicillinLansoprazole 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 intolerant to clarithromycin or in whom resistance
to clarithromycin is known or
suspected (see the clarithromycin package insert, MICROBIOLOGY
section). Eradication of H. pylori
has been shown to reduce the risk of duodenal ulcer recurrence. [See
CLINICAL STUDIES (14)]
Please refer to the full prescribing information for amoxicillin.
1.3 Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated to maintain
healing of duodenal ulcers. Controlled
studies do not extend beyond 12 months. [See CLINICAL STUDIES (14)]
1.4 Short-Term Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated for short-term
treatment (up to 8 week