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:

Lifestar Pharma LLC.

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 /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 /amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of

Product summary:

Lansoprazole delayed-release capsules, USP are available as: • 15 mg capsules are white to off white, spherical to oval pellets filled in hard gelatin capsule shells of size 3 with " " imprinted in grey ink on green opaque colored cap and "806" imprinted in black ink on white opaque colored body. Bottles of 30: NDC 70756-806- 30 • 30 mg capsules are white to off white spherical to oval pellets filled in hard gelatin capsule shells of size 1 with " " imprinted in white ink on black opaque colored cap and "807" imprinted in black ink on white opaque colored body. Bottles of 30: NDC 70756-807- 30 Bottles of 90: NDC 70756-807- 90 Bottles of 500: NDC 70756-807-51 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LANSOPRAZOLE- lansoprazole capsule, delayed release
Lifestar Pharma LLC.
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MEDICATION GUIDE
Lansoprazole
(lan-SO-pruh-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 joint pain or a rash on your c

Summary of Product characteristics

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
LIFESTAR PHARMA LLC.
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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 proton pump inhibitors
(PPIs) 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 non-steroidal 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 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 delayed-
release capsules formulation. ( 4)
•Patients receiving rilpivirine-containing products. ( 4, 7)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response with lansoprazole
delayed-release capsule does
not preclude the presence of gastric malignancy. Consider additional
follow-up and diagnostic testing . (
5.1)
Acute Tubulointerstitial Nephritis: Discontinue tr