LANSOPRAZOLE capsule, delayed release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

DIRECT RX

INN (Jina la Kimataifa):

LANSOPRAZOLE

Tungo:

LANSOPRAZOLE 15 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

- 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 capsul

Bidhaa muhtasari:

Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green colored body, imprinted ‘RDY’ on cap and ‘LAN’ 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). Bottles of 30 NDC 55111-398-30 Bottles of 60 NDC 55111-398-60 Bottles of 90 NDC 55111-398-90 Bottles of 100 NDC 55111-398-01 Bottles of 500 NDC 55111-398-05 Unit Dosage Package of 10 (1x10) NDC 55111-398-79 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). Bottles of 30 NDC 55111-399-30 Bottles of 60 NDC 55111-399-60 Bottles of 90 NDC 55111-399-90 Bottles of 100 NDC 55111-399-01 Bottles of 500 NDC 55111-399-05 Unit Dosage Package of 10 (1x10) NDC 55111-399-79 Store at 20°–25° C (68°–77° F); [See USP Controlled Room Temperature].

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
DIRECT RX
----------
SPL MEDGUIDE SECTION
•
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
duod

Tabia za bidhaa

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
DIRECT RX
----------
LANSOPRAZOLE
INDICATIONS & USAGE SECTION
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