OMEPRAZOLE, SODIUM BICARBONATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsules used for longer than 8 weeks in patient 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 capsules may be considered. - The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patient with EE has not been

Product summary:

Omeprazole and Sodium Bicarbonate capsules are supplied as: NDC 63629-2491-1: 40 mg omeprazole, USP and 1,100 mg of sodium bicarbonate, USP, Bottles of 30 capsules, white opaque body printed with G40 in blue ink and blue cap hard gelatin capsule 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bryant Ranch Prepack
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Omeprazole and Sodium Bicarbonate (oh mep’ ra zole and soe’ dee um
bye kar’ bo nate) capsules, for oral use
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 interstitial 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 medicines and for a long period of time (a year or
longer

Summary of Product characteristics

OMEPRAZOLE, SODIUM BICARBONATE- OMEPRAZOLE, SODIUM
BICARBONATE CAPSULE
BRYANT RANCH PREPACK
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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
RECENT MAJOR CHANGES
Warnings and Precautions,
Acute Tubulointerstitial Nephritis (5.2) 11/2020
INDICATIONS AND USAGE
Omeprazole and Sodium Bicarbonate capsules are 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. (2)
**studied for 12 months. (2)
DOSAGE FORMS AND STRENGTHS
Capsules: (3)
20 mg omeprazole, USP and 1100 mg sodium bicarbonate, USP
40 mg omeprazole, USP and 1100 mg sodium bicarbonate, USP
CONTRAINDICATIONS
Known hypersensitivity to any components of 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 te