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) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Medarbor Llc

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole and sodium bicarbonate capsules 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) ] Omeprazole and sodium bicarbonate capsules 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 capsules 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 capsules 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 capsules 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. I

Product summary:

Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg are hard gelatin capsules with a light blue opaque cap and white opaque body, imprinted in black ink with 'U' on the cap, '88' on the body and filled with white to off-white powder.                   Bottles of 30                   NDC 69665-215-30 Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg are hard gelatin capsules with a dark blue opaque cap and white opaque body, imprinted in black ink with 'U' on the cap, '89' on the body and filled with white to off-white powder.                   Bottles of 30                   NDC 69665-216-30 Storage Store at 20° to 25°C (68° to 77°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 AND SODIUM BICARBONATE- OMEPRAZOLE AND SODIUM BICARBONATE
CAPSULE
Medarbor Llc
----------
MEDICATION GUIDE
Omeprazole and Sodium Bicarbonate Capsules
(oh mep' ra zole and soe' dee um bye kar' bo 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 “Wha

Summary of Product characteristics

OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE AND SODIUM BICARBONATE
CAPSULE
MEDARBOR LLC
----------
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
RX ONLY
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014
Warnings and Precautions, Cyanocobalamin
(Vitamin B-12) Deficiency (5.4) 12/2014
INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate capsules 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 (2)
• Maintenance of Healing of Erosive Esophagitis: 20 mg once daily*
(2)
*studied for 12 months (2)
DOSAGE FORMS AND STRENGTHS
Omeprazole and sodium bicarbonate is available as a capsule in 20 mg
and 40 mg strengths (3)
CONTRAINDICATIONS
Known hypersensitivity to any components of the formulation (4)
WARNINGS AND PRECAUTIONS
Concomitant Gastric Malignancy: Symptomatic response to therapy with
omeprazole and sodium bicarbonate does
not preclude the presence of gastric malignancy (5.1)
Atrophic Gastritis: Has been observed in gastric