OMEPRAZOLE AND SODIUM BICARBONATE for suspension

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:

Ajanta Pharma USA Inc.

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole and Sodium Bicarbonate for oral suspension is 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 for oral suspension 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 for oral suspension may be considered. - The efficacy of Omeprazole and Sodium Bicarbonate for oral suspension used for longer than 8

Product summary:

Omeprazole and Sodium Bicarbonate for Oral Suspension is supplied as: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F 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
FOR
SUSPENSION
Ajanta Pharma USA Inc.
----------
MEDICATION GUIDE
Omeprazole and Sodium Bicarbonate
(oh mep’ ra zole and soe’ dee um bye kar’ bo nate)
for Oral Suspension, for oral use
What is the most important information I should know about Omeprazole
and Sodium Bicarbonate for oral
suspension?
Omeprazole and Sodium Bicarbonate for oral suspension may help your
acid-related symptoms, but you
could still have serious stomach problems. Talk with your doctor.
Omeprazole and Sodium Bicarbonate for oral suspension 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
for oral suspension, may
develop a kidney problem called acute tubulointerstitial nephritis
that can happen at any time during
treatment with Omeprazole and Sodium Bicarbonate for oral suspension.
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 for oral suspension 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 fra

Summary of Product characteristics

OMEPRAZOLE AND SODIUM BICARBONATE - OMEPRAZOLE AND SODIUM
BICARBONATE FOR SUSPENSION
AJANTA PHARMA USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE AND
SODIUM BICARBONATE FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION.
OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Omeprazole and Sodium Bicarbonate for oral suspension is a proton pump
inhibitor (PPI).
Omeprazole and Sodium Bicarbonate for oral suspension is 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
* an additional 4 weeks of treatment may be given if no response; if
recurrence, additional 4 to 8-week
courses may be considered.
** studied for 12 months.
INDICATION (2)
RECOMMENDED ADULT DOSAGE (2)
OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION
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**
40 MG OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION
Reduction of Risk of Upper GI Bleeding in Critically Ill
Patients
40 mg initially followed by 40 mg 6 to 8 hours later
and
40 mg once daily thereafter for 14 days
DOSAGE FORMS AND STRENGTHS
For Oral Suspension (3):
20 mg omeprazole and 1,680 mg sodium bicarbonate in unit-