OMEPRAZOLE AND SODIUM BICARBONATE capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

ScieGen Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

OMEPRAZOLE

रचना:

OMEPRAZOLE 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Omeprazole and sodium bicarbonate capsules are indicated in adults for the: - short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. - short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of omeprazole and sodium bicarbonate may be considered. - The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patie

उत्पाद समीक्षा:

Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: White to off white powder filled in size “00” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted “SG” on cap and “363” on body with black ink. They are supplied as: NDC: 50228-363-30 Bottles of 30s NDC: 50228-363-05 Bottles of 500s Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: White to off white powder filled in size “00” hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted “SG” on cap and “364” on body with black ink. They are supplied as: NDC: 50228-364-30 Bottles of 30s NDC: 50228-364-05 Bottles of 500s Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE AND SODIUM BICARBONATE
CAPSULE
ScieGen Pharmaceuticals, Inc.
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MEDICATION GUIDE
Omeprazole and Sodium Bicarbonate Capsules, for oral use
oh-mep-ra-zole / soedee-um bye-kar-bo-nate
What is the most important information I should know about Omeprazole
and Sodium Bicarbonate
Capsules?
Omeprazole and sodium bicarbonate capsules may help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Omeprazole and sodium bicarbonate 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 omeprazole and sodium bicarbonate
capsules, may develop a
kidney problem called acute tubulointerstitial nephritis that can
happen at any time during
treatment with omeprazole and sodium bicarbonate 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.
•
Omeprazole and sodium bicarbonate capsules 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 me

उत्पाद विशेषताएं

OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE AND SODIUM
BICARBONATE CAPSULE
SCIEGEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE AND
SODIUM BICARBONATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES.
OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate is a proton pump inhibitor (PPI).
Omeprazole and sodium bicarbonate capsules are indicated in adults
for:
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)
DOSAGE AND ADMINISTRATION
Indication
Recommended Adult Dosage
Omeprazole and sodium bicarbonate capsules
Active Duodenal Ulcer
20 mg once daily for 4 weeks; some patients may
require an additional 4 weeks
Active Benign Gastric Ulcer
40 mg once daily for 4 to 8 weeks
Treatment of Symptomatic GERD
20 mg once daily for up to 4 weeks
Treatment of EE due to Acid-Mediated GERD
20 mg once daily for 4 to 8 weeks*
Maintenance of Healing of EE due to Acid-Mediated
GERD
20 mg once daily**
* an additional 4 weeks of treatment may be given if no response; if
recurrence additional 4 to 8-week
courses may be considered.
** studied for 12 months.
DOSAGE FORMS AND STRENGTHS
Capsules ( 3):
20 mg omeprazole and 1,100 mg sodium bicarbonate
40 mg omeprazole and 1,100 mg sodium bicarbonate
CONTRAINDICATIONS
Known hypersensitivity to any components of the formulation ( 4)
Patients receiving rilpivirine-containing products ( 4, 7)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response does not preclude
the presence of gastric
malignancy. Consider additional follow-up and diagnostic testing. (
5.1)
Acute Tubulointerstitial Nephritis:Discontinue treatment and evaluate
patients. ( 5.2)
Sodium B