ZEGERID- omeprazole and sodium bicarbonate powder, for suspension ZEGERID- omeprazole and sodium bicarbonate capsule

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Disponibbli minn:

Santarus, Inc..

INN (Isem Internazzjonali):

OMEPRAZOLE

Kompożizzjoni:

OMEPRAZOLE 20 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for the : ZEGERID for oral suspension is indicated in adults for the : ZEGERID is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)] . Proton pump inhibitors (PPIs), including ZEGERID, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions (7)] . Risk Summary There are no adequate and well-controlled studies with ZEGERID in pregnant women. ZEGERID contains omeprazole and sodium bicarbonate. Omeprazole There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcom

Sommarju tal-prodott:

Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Fuljett ta 'informazzjoni

ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE POWDER, FOR SUSPENSION
ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE
Santarus, Inc..
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MEDICATION GUIDE
ZEGERID® (ze-ger-id)
(omeprazole and sodium bicarbonate)
for oral suspension and capsules, for oral use
What is the most important information I should know about ZEGERID?
ZEGERID may help your acid-related symptoms, but you could still have
serious stomach problems. Talk
with your doctor.
ZEGERID can cause serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including ZEGERID, may develop a kidney
problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with ZEGERID. Call your
doctor right away if you have a decrease in the amount that you
urinate or if you have blood in your
urine.
•
ZEGERID contains sodium bicarbonate. Long-term use of bicarbonate with
calcium or milk can cause
a condition called “milk-alkali syndrome”. Long-term use of sodium
bicarbonate can cause a condition
called “systemic alkalosis”. Talk to your doctor about any
questions you may have. Too much sodium
can cause swelling and weight gain. Tell your doctor if you are on a
low-sodium diet or if you have
Bartter’s Syndrome (a rare kidney disorder). Tell your doctor right
away if you have confusion,
shaking hands, dizziness, muscle twitching, nausea, vomiting, and
numbness or tingling in the face,
arms, or legs.
•
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 bone fracture, especially in the hip, wrist,
or spine. Certain types of lupus
erythematosu

Karatteristiċi tal-prodott

ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE POWDER, FOR SUSPENSION
ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE
SANTARUS, INC..
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZEGERID SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZEGERID.
ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) FOR ORAL SUSPENSION
ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
ZEGERID is a proton pump inhibitor (PPI).
ZEGERID for oral suspension and ZEGERID capsules are indicated in
adults for:
•
•
•
•
ZEGERID for oral suspension is indicated in adults for:
•
DOSAGE AND ADMINISTRATION
INDICATION (2)
RECOMMENDED ADULT DOSAGE (2)
ZEGERID FOR ORAL SUSPENSION OR ZEGERID CAPSULES (2)
Active Duodenal Ulcer (2)
20 mg once daily for 4 weeks; some patients may
require an additional
4 weeks (2)
Active Benign Gastric Ulcer (2)
40 mg once daily for 4 to 8 weeks (2)
Treatment of Symptomatic GERD (2)
20 mg once daily for up to 4 weeks (2)
Treatment of EE due to Acid-Mediated GERD (2)
20 mg once daily for 4 to 8 weeks* (2)
Maintenance of Healing of EE due to Acid-
Mediated GERD (2)
20 mg once daily** (2)
40 MG ZEGERID FOR ORAL SUSPENSION (2)
Reduction of Risk of Upper
GI Bleeding in Critically Ill Patients (2)
40 mg initially followed by
40 mg 6 to 8 hours later and
40 mg once daily thereafter
for 14 days (2)
* an additional 4 weeks of treatment may be given if no response; if
recurrence, additional 4 to 8-week
courses may be considered. (2)
** studied for 12 months. (2)
DOSAGE FORMS AND STRENGTHS
For Capsules (3):
•
•
For Oral Suspension (3):
•
•
CONTRAINDICATIONS
®
®
Treatment of active duodenal ulcer (1)
Treatment of active benign gastric ulcer (1)
Treatment of erosive esophagitis (EE) due to acid-mediated
gastroesophageal reflux disease (GERD)
(1)
Maintenance of healing of EE (1)
Reduction of risk of upper gastrointestinal (GI) bleeding in
critically ill patients (1)
20 mg omepra