OMEPRAZOLE AND SODIUM BICARBONATE- omeprazole, sodium bicarbonate powder, for suspension OMEPRAZOLE AND SODIUM BICARBONATE- ome

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:

Oceanside Pharmaceuticals

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole and Sodium Bicarbonate for oral suspension and 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 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 may be considered. - maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not

Product summary:

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:

New Drug Application Authorized Generic

Patient Information leaflet

OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE
CAPSULE
Oceanside Pharmaceuticals
----------
MEDICATION GUIDE
Omeprazole and Sodium Bicarbonate
for oral suspension and capsules, for oral use
What is the most important information I should know about Omeprazole
and Sodium Bicarbonate?
Omeprazole and Sodium Bicarbonate may help your acid-related symptoms,
but you could still have
serious stomach problems. Talk with your doctor.
Omeprazole and Sodium Bicarbonate 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, may develop a kidney
problem called acute tubulointerstitial nephritis that can happen at
any time during treatment with
Omeprazole and Sodium Bicarbonate. 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 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).
Tell your doctor if yo

Summary of Product characteristics

OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE
POWDER, FOR
SUSPENSION
OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE
CAPSULE
OCEANSIDE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE AND SODIUM BICARBONATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE AND
SODIUM BICARBONATE.
OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION
OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Omeprazole and Sodium Bicarbonate is a proton pump inhibitor (PPI).
Omeprazole and Sodium Bicarbonate for oral suspension and 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)
Omeprazole and Sodium Bicarbonate for oral suspension is indicated in
adults for:
Reduction of risk of upper gastrointestinal (GI) bleeding in
critically ill patients ( 1)
DOSAGE AND ADMINISTRATION
INDICATION (2)
RECOMMENDED ADULT DOSAGE (2)
OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION OR OMEPRAZOLE
AND SODIUM BICARBONATE CAPSULES (2)
Active Duodenal Ulcer (2)
20 mg once daily for 4 weeks; some patients may require an
additional
4 weeks (2)
Active Benign Gastric Ulcer (2)
40 mg once daily for 4 to 8 weeks (2)
Treatment of Symptomatic GERD (2)
20 mg once daily for up to 4 weeks (2)
Treatment of EE due to Acid-Mediated GERD
20 mg once daily for 4 to 8 weeks* (2)
Maintenance of Healing of EE due to Acid-Mediated GERD
(2)
20 mg once daily** (2)
40 MG OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION (2)
Reduction of Risk of Upper
GI Bleeding in Critically Ill Patients (2)
40 mg initially followed by
40 mg 6 to 8 hours later and
40 mg once daily thereafter
for 14 days (2)
* an additional 4 weeks of treatment