LANSOPRAZOLE capsule, delayed release pellets

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

A-S Medication Solutions

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Lansoprazole is indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1)] . Triple Therapy: Lansoprazole/amoxicillin/clarithromycin Lansoprazole 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 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 resistanc

Produkto santrauka:

Product: 50090-4596 NDC: 50090-4596-0 30 CAPSULE, DELAYED RELEASE PELLETS in a BOTTLE

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
A-S Medication Solutions
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.lannett.com/med-guide/lansoprazole
Lansoprazole (lan soe' pra zole) Delayed-Release Capsules, USP
What is the most important information that I should know about
Lansoprazole?
You should take Lansoprazole exactly as prescribed, at the lowest dose
possible and for the shortest time needed.
Lansoprazole may help your acid-related symptoms, but you could still
have serious stomach problems. Talk with
your doctor.
Lansoprazole 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, may develop a kidney problem
called acute tubulointerstitial
nephritis that can happen at any time during treatment with PPI
medicines including Lansoprazole. 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,
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.
Talk to your doctor about your risk of these s

Prekės savybės

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
A-S MEDICATION SOLUTIONS
----------
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, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions,
Acute Tubulointerstitial Nephritis (5.2)
11/2020
Risk of Heart Valve Thickening in Pediatric Patients
Less than One Years of Age (5.12)
9/2020
INDICATIONS AND USAGE
Lansoprazole is a proton pump inhibitor (PPI) indicated for the:
Treatment of active duodenal ulcer in adults. (1.1)
Eradication of _H. pylori_ to reduce the risk of duodenal ulcer
recurrence in adults. (1.2)
Maintenance of healed duodenal ulcers in adults. (1.3)
Treatment of active benign gastric ulcer in adults. (1.4)
Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated
gastric ulcer in adults. (1.5)
Risk reduction of NSAID-associated gastric ulcer in adults. (1.6)
Treatment of symptomatic gastroesophageal reflux disease (GERD) in
adults and pediatric patients 1
year of age and older. (1.7)
Treatment of erosive esophagitis (EE) in adults and pediatric patients
1 year of age and older. (1.8)
Maintenance of healing of EE in adults. (1.9)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome (ZES) in adults. (1.10)
DOSAGE AND ADMINISTRATION
Recommended Dosage:
See full prescribing information for complete dosing information for
Lansoprazole by indication and age
group and dosage adjustment in patients with severe hepatic
impairment. (2.1, 2.2, 2.3)
Administration Instructions (2.4)
_Lansoprazole capsules_
Should be swallowed whole.
See full prescribing information for alternative administration
options.
DOSAGE FORMS AND STRENGTHS
Delayed-release capsules: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
Patients receiving rilpivirine-containing products. (4, 7)
Con