OMEPRAZOLE/BICARBONATE- omeprazole and sodium bicarbonate capsule, gelatin coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Предлага се от:

AvKARE

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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).] 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 h

Каталог на резюме:

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. 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. NDC: 42291-585-30 Bottles of 30s Storage Store at 25°C (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.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

OMEPRAZOLE/BICARBONATE- omeprazole and sodium bicarbonate capsule,
gelatin coated
AvKARE
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MEDICATION GUIDE
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:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including omeprazole and sodium bicarbonate capsules,
may develop a kidney
problem called acute interstitial nephritis that can happen at any
time during treatment with
omeprazole and sodium bicarbonate capsules. Call your doctor if you
have a decrease in the amount
that you urinate or if you have blood in your urine.
•
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 PPI medicines
for a long period of time (a
year or longer) may have an incre

Данни за продукта

OMEPRAZOLE/BICARBONATE- OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE,
GELATIN COATED
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES
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
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps ( 5.13)
06/2018
INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate is a proton pump inhibitor (PPI)
indicated for:
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)
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
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
Gastric Malignancy: In adults, symptomatic response does not preclude
the presence of gastric
malignancy. Consider additional follow-up and diagnostic testing. (
5.1)
Acute interstitial nephritis has been observed in patients taking
PPIs. ( 5.2)
Buffer Content: contains sodium