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:

Akron Pharma Inc

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole and sodium bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)] Gastric Ulcer Omeprazole and sodium bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2)] Symptomatic GERD Omeprazole and sodium bicarbonate is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. [See Clinical Studies (14.3)] Erosive Esophagitis Omeprazole and sodium bicarbonate is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. The efficacy of Omeprazole and sodium bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive e

Product summary:

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: 71399-2420-3   Bottles of 30s 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: 71399-2440-3  Bottles of 30s Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OMEPRAZOLE SODIUM BICARBONATE - OMEPRAZOLE SODIUM BICARBONATE CAPSULE
Akron Pharma Inc
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SPL MEDGUIDE
Omeprazole and Sodium Bicarbonate Capsules
oh-ME-pray-zol/SO-dee-um by-KAR-boe-nate
Read this Medication Guide before you start taking omeprazole and
sodium bicarbonate capsules and
each time you get a refill. There may be new information. This
information does not take the place of
talking to your doctor about your medical condition or treatment.
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:
•
Omeprazole and sodium bicarbonate capsules contains sodium
bicarbonate. Tell your doctor if
you are on a sodium restricted 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. Omeprazole and sodium bicarbonate capsules may increase your
risk of getting severe
diarrhea. This diarrhea may be caused by an infection (Clostridium
difficile ) in your intestines.
•
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go
away.
•
Bone fractures. People who take multiple daily doses of proton pump
inhibitor medicines for a
long period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist or
spine. You should take omeprazole and sodium bicarbonate capsules
exactly as prescribed, at the
lowest dose possible for your treatment and for the shortest time
needed. Talk to your doctor about
your risk of bone fracture if you take omeprazole and sodium
bicarbonate capsules.
Omeprazole and sodium bicarbonate capsules can have other serious side
effects. See "What are the

Summary of Product characteristics

OMEPRAZOLE SODIUM BICARBONATE - OMEPRAZOLE SODIUM BICARBONATE CAPSULE
AKRON PHARMA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE [ ]
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR[ ] INITIAL U.S. APPROVAL:[ ]
INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate is a proton pump inhibitor indicated
for: (1)
Short-term treatment of active duodenal ulcer (1.1)
Short-term treatment of active benign gastric ulcer (1.2)
Treatment of gastroesophageal reflux disease (GERD) (1.3)
Maintenance of healing of erosive esophagitis (1.4)
The safety and effectiveness of omeprazole and sodium bicarbonate
capsules in pediatric patients (<18 years of age) have
not been established. (8.4) (1)
DOSAGE AND ADMINISTRATION
Short-Term Treatment of Active Duodenal Ulcer: 20 mg once daily for 4
weeks (some patients may require an
additional 4 weeks of therapy (14.1)) (2)
Gastric Ulcer: 40 mg once daily for 4-8 weeks (2)
Gastroesophageal Reflux Disease (GERD) (2)
Symptomatic GERD (with no esophageal erosions): 20 mg once daily for
up to 4 weeks
Erosive Esophagitis: 20 mg once daily for 4-8 weeks
Maintenance of Healing of Erosive Esophagitis: 20 mg once daily* (2)
*Studied for 12 months
Omeprazole and sodium bicarbonate is available as a capsule in 20 mg
and 40 mg strengths of omeprazole for adult use.
Directions for use for each indication are summarized in Table 1. All
recommended doses throughout the labeling are
based upon omeprazole. (2)
Since both the 20 mg and 40 mg CAPSULES contain the same amount of
sodium bicarbonate (1100 mg), two capsules of 20
mg are NOT equivalent to one capsule of omeprazole and sodium
bicarbonate 40 mg; therefore, two 20 mg capsules of
omeprazole and sodium bicarbonate should not be substituted for one
capsule of omeprazole and sodium bicarbonate 40
mg. (2)
Omeprazole and sodium bicarbonate capsules should be taken on an empty
stomach at least one hour before a meal. (2)
TABLE 1: RECOMMENDED DOSES OF OMEPRAZOLE AND SODIUM