OMEPRAZOLE AND SODIUM BICARBONATE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Zydus Pharmaceuticals USA Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 capsules 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 capsules may be considered. - The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with EE has not been est

Prehľad produktov:

Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg are white to off white fine powder filled in hard gelatin capsule shells of size '00' having a opaque white cap and a opaque white body printed with 501 on body in black ink and are supplied as follows: NDC 68382-501-67 in bottle of 14 capsules with child-resistant closure. NDC 68382-501-06 in bottle of 30 capsules with child-resistant closure. NDC 68382-501-16 in bottle of 90 capsules with child-resistant closure. NDC 68382-501-01 in bottle of 100 capsules NDC 68382-501-05 in bottle of 500 capsules NDC 68382-501-10 in bottle of 1000 capsules NDC 68382-501-77 in unit-dose blister carton of 100 (10 x 10) unit-dose capsules Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg are white to off white fine powder filled in hard gelatin capsule shells of size '00' having a opaque white cap and a opaque white body printed with 502 on body in black ink and are supplied as follows: NDC 68382-502-06 in bottle of 30 capsules with child-resistant closure. NDC 68382-502-16 in bottle of 90 capsules with child-resistant closure. NDC 68382-502-01 in bottle of 100 capsules NDC 68382-502-05 in bottle of 500 capsules NDC 68382-502-10 in bottle of 1000 capsules NDC 68382-502-77 in unit-dose blister carton of 100 (10 x 10) unit-dose capsules Storage Store at 20  to 25 C (68   to 77 F) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep container tightly closed.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Zydus Pharmaceuticals USA Inc.
----------
MEDICATION GUIDE
Omeprazole (oh mep' ra zole) and
Sodium Bicarbonate (soe' dee um bye kar' bo nate), Capsules, for oral
use
What is the most important information I should know about omeprazole
and sodium bicarbonate
capsules?
Omeprazole and sodium bicarbonate capsules may help 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 tubulointerstitial nephritis). Some
people who take
proton pump inhibitor (PPI) medicines, including omeprazole and sodium
bicarbonate
capsules, may develop a kidney problem called acute tubulointerstitial
nephritis that can
happen at any time during treatment with omeprazole and sodium
bicarbonate capsules.
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 capsules contain 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 i

Súhrn charakteristických

OMEPRAZOLE AND SODIUM BICARBONATE - OMEPRAZOLE AND SODIUM
BICARBONATE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.6)
03/2022
Hypomagnesemia and Mineral Metabolism (5.10)03/2022
INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate capsules are a proton pump inhibitor
(PPI).
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)
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. (2)
** studied for 12 months. (2)
INDICATION
RECOMMENDED ADULT DOSAGE
OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES
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**
DOSAGE FORMS AND STRENGTHS
Omeprazole and sodium bicarbonate is available as a capsule in 20
mg/1100 mg and 40 mg/1100 mg
strengths (3)
CONTRAINDICATIONS
Known hypersensitivity to any components of the formulation (4)
Patients receiving rilpivirine-containing products (4,7)
WARNINGS AND PRECAUTIONS
GASTRIC MALIGNANCY:In adults, symptomatic response does not preclude
the presence of gastric
malignancy.