LANSOPRAZOLE capsule, delayed release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

lansoprazole (UNII: 0K5C5T2QPG) (lansoprazole - UNII:0K5C5T2QPG)

Διαθέσιμο από:

Major Pharmaceuticals

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 dise

Περίληψη προϊόντος:

Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied:  Cartons of 80 capsules (10 capsules each blister pack x 8), NDC 0904-6662-45  Store at 20°–25° C (68°–77° F); [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
Major Pharmaceuticals
----------
MEDICATION GUIDE
Lansoprazole Delayed-Release Capsules, USP
(lan soe' pra zole)
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:
1.
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.
2.
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.
3.
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.
4.
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 cheeks or arm

Αρχείο Π.Χ.Π.

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
MAJOR PHARMACEUTICALS
----------
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
FOR ORAL ADMINISTRATION
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 capsule is a proton pump inhibitor (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 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
capsule 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)
CO