LANSOPRAZOLE capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

INN (International Name):

LANSOPRAZOLE

Composition:

LANSOPRAZOLE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Lansoprazole Delayed-Release Capsules, USP 15 mg, are opaque purple cap and opaque white body capsules imprinted with “KU” and “415” in black ink. They are supplied as follows: Bottles of 30                 NDC 62175-415-32 Bottles of 90                 NDC 62175-415-46 Bottles of 100               NDC 62175-415-37 Bottles of 500               NDC 62175-415-41 Bottles of 1000             NDC 62175-415-43 Lansoprazole Delayed-Release Capsules, USP 30 mg, are opaque magenta cap and opaque white body capsules imprinted with “KU” and “430” in black ink. They are supplied as follows: Bottles of 30                 NDC 62175-430-32 Bottles of 90                 NDC 62175-430-46 Bottles of 100               NDC 62175-430-37 Bottles of 500               NDC 62175-430-41 Bottles of 1000             NDC 62175-430-43 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lannett Company, Inc.
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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 serious side effects.
Lansoprazole can have other serious side e

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
LANNETT COMPANY, INC.
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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,
Severe Cutaneous Adverse Reactions (5.5)
03/2022
Hypomagnesemia and Mineral Metabolism (5.8)
03/2022
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
Contraindicated in patients with known hypersensitivity to any
component of the Lansoprazole
formulation. (