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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

LANSOPRAZOLE

Composition:

LANSOPRAZOLE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . Triple Therapy: Lansoprazole delayed-release capsules/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 delayed-release capsules/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 (

Product summary:

Lansoprazole Delayed-Release Capsules, USP are available as follows: 15 mg - hard gelatin capsules, with a light-blue opaque cap and flesh-colored opaque body, imprinted with “93” and “7350”, filled with off-white to beige pellets, in bottles of 30 (NDC 0093-7350-56). 30 mg - hard gelatin capsules, with a light-gray opaque cap and flesh-colored opaque body, imprinted with “93” and “7351”, filled with off-white to beige pellets, in bottles of 30 (NDC 0093-7351-56). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Lansoprazole (lan soe’ pra 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 worsening

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
TEVA PHARMACEUTICALS USA, 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, 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 delayed-release capsules are 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 delayed-release
capsules 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 delayed-release 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
Con