LANSOPRAZOLE capsule, delayed release pellets

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Direct RX

INN (Միջազգային անվանումը):

LANSOPRAZOLE

Կազմը:

LANSOPRAZOLE 15 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

1.1 Short-Term Treatment of Active Duodenal Ulcer Lansoprazole is 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/amoxicillin/clarithromycin Lansoprazole 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/amoxicillin Lansoprazole 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

Ապրանքի ամփոփագիր:

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: NDC 68382-543-06 in bottle of 30 capsules NDC 68382-543-10 in bottle of 1000 capsules NDC 68382-543-30 in unit-dose blister pack of 100 capsules 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: NDC 68382-544-06 in bottle of 30 capsules NDC 68382-544-16 in bottle of 90 capsules NDC 68382-544-01 in bottle of 100 capsules NDC 68382-544-10 in bottle of 1000 capsules NDC 68382-544-30 in unit-dose blister pack of 100 capsules Storage Store at 20ο to 25οC (68ο to 77οF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
Direct RX
----------
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.

Ապրանքի հատկությունները

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
DIRECT RX
----------
LANSOPRAZOLE
INDICATIONS & USAGE SECTION
1.1 Short-Term Treatment of Active Duodenal Ulcer
Lansoprazole is 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/amoxicillin/clarithromycin
Lansoprazole 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/amoxicillin
Lansoprazole 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 is 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 is indicated for short-term treatment (up to 8 weeks) for
healing and symptom relief of
active benign gastric ulcer [see CLINICAL STUDIES ( 14)].
1.5 Healing of NSAID-Associated Gastric Ulcer
Lansoprazole is indicated for the treatment of NSAID-associated
gastric ulcer in pa