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:

Zydus Pharmaceuticals USA Inc.

INN (Tarptautinis Pavadinimas):

LANSOPRAZOLE

Sudėtis:

LANSOPRAZOLE 15 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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 clarithro

Produkto santrauka:

Lansoprazole Delayed-release Capsules USP, 15 mg are enteric-coated pellets filled in size '3' hard gelatin capsules with standard pink opaque colored cap printed with "ZA -50" in black ink and white opaque body printed with "15mg" in black ink and are supplied as follows: NDC 68382-543-06 in bottle of 30 capsules NDC 68382-543-10 in bottle of 1000 capsules NDC 68382-543-77 in cartons of 100 capsules (10 x 10 unit-dose) Lansoprazole Delayed-release Capsules USP, 30 mg are enteric-coated pellets filled in size '1' hard gelatin capsules with standard pink opaque colored cap  printed with "ZA -51" in black ink and white opaque body printed with "30 mg" in black ink and are supplied as follows: NDC 68382-544-06 in bottle of 30 capsules NDC 68382-544-16 in bottle of 90 capsules NDC 68382-544-01 in bottle of 100 capsules NDC 68382-544-10 in bottle of 1000 capsules NDC 68382-544-77 in cartons of 100 capsules (10 x 10 unit-dose) Storage Store at 20ο to 25ο C (68ο to 77ο F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Zydus Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Lansoprazole (lan soe' pra zole) Delayed-release Capsules, USP
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 cheeks or arms that gets worse in the sun.
Talk to y

Prekės savybės

LANSOPRAZOLE - LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
ZYDUS PHARMACEUTICALS USA INC.
----------
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,
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 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 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
Capsules: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
Patients r