OMEPRAZOLE AND 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:

Northstar Rx LLC

INN (International Name):

omeprazole

Composition:

omeprazole 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omprazole 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 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 capsules may be considered. - The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with EE has not been esta

Product summary:

Omeprazole and sodium bicarbonate capsules are supplied as Storage Store at 25°C (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

OMEPRAZOLE AND SODIUM BICARBONATE - OMEPRAZOLE AND SODIUM BICARBONATE
CAPSULE
Northstar Rx LLC
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MEDICATION GUIDE
Omeprazole and Sodium Bicarbonate
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 with 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 interstitial 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). Te

Summary of Product characteristics

OMEPRAZOLE AND SODIUM BICARBONATE - OMEPRAZOLE AND SODIUM
BICARBONATE CAPSULE
NORTHSTAR RX LLC
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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
Contraindications (4) 09/2019
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
* an additional 4 weeks of treatment may be given if no response; if
recurrence additional 4 to 8-week courses may be
conside re d.
** studied for 12 months.
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**
DOSAGE FORMS AND STRENGTHS
Capsules (3):
20 mg omeprazole and 1100 mg sodium bicarbonate
40 mg omeprazole and 1100 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 Interstitial Nephritis: Observed in patients tak