LANSOPRAZOLE- lansoprazole capsule, delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Preferred Pharmaceuticals, Inc.

ІПН (Міжнародна Ім'я):

LANSOPRAZOLE

Склад:

LANSOPRAZOLE 15 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Lansoprazole delayed-release capsules, USP are indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)]. 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 cl

Огляд продуктів:

●   15 mg capsules are opaque dark pink cap and opaque dark green body, size ‘3’ empty hard gelatin capsules imprinted with  W  on cap with black ink.   Bottle of 14 - 68788-8999-1 Bottle of 30 - 68788-8999-3 Store at 20°-25°C (68°-77°F), [see USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Lansoprazole (lan-SO-pruh-zole)
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:
•
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.
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. 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 PPI 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.
•
Certain types of lupus erythematosus . Lupus erythematosus is an
autoimmune disorder (the body's
immune cells

Характеристики продукта

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
PREFERRED PHARMACEUTICALS, INC.
----------
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, Cutaneous and Systemic
Lupus Erythematosus (5.5) 10/2016
INDICATIONS AND USAGE
Lansoprazole is a proton pump inhibitor (PPI) indicated for:
● Short-Term Treatment of Active Duodenal Ulcer (1.1)
● _H. pylori_ Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence (1.2)
● Maintenance of Healed Duodenal Ulcers (1.3)
● Short-Term Treatment of Active Benign Gastric Ulcer (1.4)
● Healing of nonsteroidal anti-inflammatory drugs (NSAID)-Associated
Gastric Ulcer (1.5)
● Risk Reduction of NSAID-Associated Gastric Ulcer (1.6)
● Gastroesophageal Reflux Disease (GERD) (1.7)
● Maintenance of Healing of Erosive Esophagitis (EE) (1.8)
● Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome (ZES) (1.9)
DOSAGE AND ADMINISTRATION
*Studied for 12 months
INDICATION
DOSE
FREQUENCY
Duodenal Ulcers (1.1, 1.3)
Short-Term Treatment
15 mg
Once daily for 4 wks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce Recurrence of Duodenal Ulcer (1.2)
Triple Therapy: Lansoprazole
30 mg
Amoxicillin
1 gram
Twice daily for 10 or 14 days
Clarithromycin
500 mg
Dual Therapy: Lansoprazole
30 mg
Three times daily for 14 days
Amoxicillin
1 gram
Benign Gastric Ulcer (1.4)
Short-Term Treatment
30 mg
Once daily up to 8 wks
NSAID-associated Gastric Ulcer (1.6)
Healing
30 mg
Once daily for 8 wks
Risk Reduction
15 mg
Once daily up to 12 wks
GERD (1.7)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily up to 8 wks
Short-Term Treatment of EE
30 mg
Once daily up to 8 wks
Pediatric (8.4)
(1 to 11 years of age) Short-Term Treatment of Sympto