OMEPRAZOLE/SODIUM BICARBONATE- 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:

Prasco Laboratories

INN (International Name):

omeprazole

Composition:

omeprazole 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole/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)] Omeprazole/Sodium Bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2)] Symptomatic GERD Omeprazole/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/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/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 esophagitis or GERD symptoms (e.g.,

Product summary:

Omeprazole/Sodium Bicarbonate 20-mg Capsules: Each opaque, hard gelatin, white capsule, imprinted with the Santarus logo and “20”, contains 20 mg omeprazole and 1100 mg sodium bicarbonate. NDC 66993-412-30 Bottles of 30 capsules Omeprazole/Sodium Bicarbonate 40-mg Capsules: Each opaque, hard gelatin, colored dark blue and white capsule, imprinted with the Santarus logo and “40”, contains 40 mg omeprazole and 1100 mg sodium bicarbonate. NDC 66993-413-30 Bottles of 30 capsules Omeprazole/Sodium Bicarbonate Powder for Oral Suspension is a white, flavored powder packaged in unit-dose packets. Each packet contains either 20 mg or 40 mg omeprazole and 1680 mg sodium bicarbonate. NDC 66993-414-30 Cartons of 30: 20-mg unit-dose packets NDC 66993-415-30 Cartons of 30: 40-mg unit-dose packets Storage Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 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:

New Drug Application Authorized Generic

Patient Information leaflet

OMEPRAZOLE/SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE CAPSULE
Prasco Laboratories
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MEDICATION GUIDE
Omeprazole / Sodium Bicarbonate
Powder for Oral Suspension and Capsules
Read this Medication Guide before you start taking Omeprazole/Sodium
Bicarbonate 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/Sodium Bicarbonate?
Omeprazole/Sodium Bicarbonate may help with your acid-related
symptoms, but you could still have
serious stomach problems. Talk with your doctor.
Omeprazole/Sodium Bicarbonate can cause serious side effects,
including:
•
Omeprazole/Sodium Bicarbonate 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/Sodium Bicarbonate 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/Sodium Bicarbonate 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/Sodium Bicarbonate.
Omeprazole/Sodium Bicarbonate can have other serious side effects. See
“What are the possible side
effects of Omeprazole/Sodium Bicarbonate?”
What is Omeprazole/Sodium Bicarbonate?
Omeprazole/Sodium Bicarbonate i

Summary of Product characteristics

OMEPRAZOLE/SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE CAPSULE
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE/SODIUM BICARBONATE POWDER
FOR ORAL SUSPENSION AND CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
OMEPRAZOLE/SODIUM BICARBONATE POWDER FOR ORAL SUSPENSION AND CAPSULES.
INITIAL U.S. APPROVAL: 2004
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/Sodium Bicarbonate Powder for Oral Suspension and Capsules
is a proton pump inhibitor indicated for:
•
•
•
•
•
The safety and effectiveness of Omeprazole/Sodium Bicarbonate Powder
for Oral Suspension and Capsules in pediatric
patients (<18 years of age) have not been established. (8.4)
DOSAGE AND ADMINISTRATION
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•
•
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*Studied for 12 months
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
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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)
Reduction of risk of upper GI bleeding in critically ill patients
(1.5)
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)
Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill
Patients: (40mg oral suspension only) 40 mg
initially followed by 40 mg 6-8 hours later and 40 mg daily thereafter
for 14