LANSOPRAZOLE capsule, delayed release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 d

Podsumowanie produktu:

Lansoprazole delayed-release capsules 30 mg, contain white to off white coloured spherical shaped pellets filled in size "1" capsules with dark blue colour body and pink colour cap, printed NATCO on cap and 30 on body with white ink. They are available as follows: NDC-70934-369-30 Bottle of 30-30 mg capsules Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Denton Pharma, Inc. dba Northwind Pharmaceuticals
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MEDICATION GUIDE
LANSOPRAZOLE delayed-release capsules, for oral use
(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:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including lansoprazole delayed-release
capsules, may develop a kidney
problem called acute interstitial 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

Charakterystyka produktu

LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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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
Dosage and Administration
Recommended Pediatric Dosage ( 2.2)
06/2018
Contraindications ( 4)
07/2017
Warnings and Precautions
Interactions with Investigations for Neuroendocrine Tumors ( 5.8)
07/2017
Fundic Gland Polyps ( 5.11)
06/2018
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 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
opti