PREVACID- lansoprazole capsule, delayed release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

REMEDYREPACK INC.

INN (Isem Internazzjonali):

LANSOPRAZOLE

Kompożizzjoni:

LANSOPRAZOLE 30 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

PREVACID and PREVACID SoluTab 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: PREVACID or PREVACID SoluTab/amoxicillin/clarithromycin PREVACID or PREVACID SoluTab 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: PREVACID or PREVACID SoluTab/amoxicillin PREVACID or PREVACID SoluTab 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

Sommarju tal-prodott:

PREVACID delayed-release capsules, 15 mg, are opaque, pink and green with "TAP" and "PREVACID 15" imprinted on the capsules. The 30 mg delayed-release capsules are opaque, pink and black with "TAP" and "PREVACID 30" imprinted on the capsules. They are available as follows: PREVACID SoluTab delayed-release orally disintegrating tablets, 15 mg, are white to yellowish white, round uncoated tablets containing orange to dark brown speckles, with "15" debossed on one side of the tablet. The 30 mg are white to yellowish white, round uncoated tablets containing orange to dark brown speckles, with "30" debossed on one side of the tablet. The tablets are available as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Fuljett ta 'informazzjoni

REMEDYREPACK INC.
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MEDICATION GUIDE
PREVACID (PREV-A-SID)
(LANSOPRAZOLE) DELAYED-RELEASE CAPSULES, FOR ORAL USE
AND
PREVACID SOLUTAB (PREV-A-SID SOL-U-TAB)
(LANSOPRAZOLE) DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: June 2018
What is the most important information that I should know about
PREVACID and PREVACID
SoluTab?
You should take PREVACID and PREVACID SoluTab exactly as prescribed,
at the lowest dose possible
and for the shortest time needed.
PREVACID and PREVACID SoluTab may help your acid-related symptoms, but
you could still have
serious stomach problems. Talk with your doctor.
PREVACID and PREVACID SoluTab can cause serious side effects,
including:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including PREVACID and PREVACID SoluTab,
may develop a
kidney problem called acute interstitial nephritis that can happen at
any time during treatment
with PPI medicines including PREVACID and PREVACID SoluTab. 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 PREVACID and PREVACID SoluTab, may develop
certain types of lupus
erythematosus or have worsening of the lupus they already have.

Karatteristiċi tal-prodott

PREVACID- LANSOPRAZOLE CAPSULE, DELAYED RELEASE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREVACID AND PREVACID SOLUTAB SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PREVACID AND
PREVACID SOLUTAB.
PREVACID (LANSOPRAZOLE) DELAYED-RELEASE CAPSULES, FOR ORAL USE
PREVACID SOLUTAB (LANSOPRAZOLE) DELAYED-RELEASE ORALLY DISINTEGRATING
TABLETS
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
Patients with Phenylketonuria ( 5.10)
07/2017
Fundic Gland Polyps ( 5.11)
06/2018
INDICATIONS AND USAGE
PREVACID and PREVACID SoluTab 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
PREVACID and PREVACID SoluTab by indication
and age group and dosage adjustment in patients with severe hepatic
impairment. ( 2.1, 2.2, 2.3)
Administration Instructions ( 2.4)
_PREVACID capsules_
Should be swallowed whole.
See full prescribing