LANSOPRAZOLE DR- lansoprazole capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Treatment of Active Duodenal Ulcer 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]. 1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole /amoxicillin /clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple 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) 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 in adults for the treatment

Product summary:

Lansoprazole delayed-release capsules, USP are available as: • 30 mg capsules are white to off white spherical to oval pellets filled in hard gelatin capsule shells of size 1 with " " imprinted in white ink on black opaque colored cap and "807" imprinted in black ink on white opaque colored body Bottles of 30 Capsules: NDC 80425-0174-01 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANSOPRAZOLE DR- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Lansoprazole
(lan-SO-pruh-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 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
wo

Summary of Product characteristics

LANSOPRAZOLE DR- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
LANSOPRAZOLE DR 30MG CAPSULES
INDICATIONS AND USAGE
1.1 Treatment of Active Duodenal Ulcer
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].
1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer
Recurrence
Triple Therapy: Lansoprazole /amoxicillin /clarithromycin
Lansoprazole delayed-release capsules in combination with amoxicillin
plus
clarithromycin as triple 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) 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 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 clarithromycin or in whom resistance to clarithromycin
is known or
suspected (see the clarithromycin prescribing information,
Microbiology section).
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.
1.3 Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated in adults to
maintain healing of
duodenal ulcers. Controlled studies do not extend beyond 12 months
[see Clinical
Studies ( 14.3)].
1.4 Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for
short-term treatment
(up to eight weeks)