ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TAB- aspirin and omeprazole tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)

Available from:

Innovida Phamaceutique Corporation

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

aspirin and omeprazole delayed-release tablets, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The aspirin component of aspirin and omeprazole delayed-release tablets is indicated for: - reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, - reducing the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, - reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris, - use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated. The omeprazole component of aspirin and

Product summary:

aspirin and omeprazole delayed-release tablets (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. aspirin and omeprazole delayed-release tablets tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as: Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature]. Store in the original container with desiccant and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.

Authorization status:

New Drug Application

Patient Information leaflet

Innovida Phamaceutique Corporation
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: September 2018 r1
MEDICATION GUIDE
aspirin and omeprazole delayed-release tablets™ (yo SPRA lah)
(aspirin and omeprazole)
delayed-release tablets
What is the most important information I should know about aspirin and
omeprazole delayed-release tablets?
You should take aspirin and omeprazole delayed-release tablets exactly
as prescribed, at the lowest dose
possible and for the shortest time needed.
aspirin and omeprazole delayed-release tablets may help reduce the
risk of stomach ulcers from aspirin use,
but you could still have bleeding and stomach or intestine ulcers, or
other serious stomach or intestine
problems. Talk with your doctor.
Tell your doctor if you have unexpected bleeding, if you bleed more
than usual, or if your bleeding lasts
longer than is normal for you, such as increased bruising or more
frequent nose bleeds.
aspirin and omeprazole delayed-release tablets contains aspirin, a
nonsteroidal anti-inflammatory drug
(NSAID) and omeprazole, a proton pump inhibitor (PPI) medicine. Before
taking aspirin and omeprazole
delayed-release tablets, tell your doctor if you take:
•
aspirin, or any prescription or over-the-counter medicines containing
aspirin or other NSAIDs.
•
clopidogrel bisulphate (PLAVIX ®). You should not take clopidogrel
bisulphate (PLAVIX ®) if you
take aspirin and omeprazole delayed-release tablets.
•
ticagrelor (BRILINTA ®).
Do not stop taking aspirin and omeprazole delayed-release tablets
without talking with your doctor.
Stopping aspirin and omeprazole delayed-release tablets suddenly could
increase your risk of having a heart
attack or stroke.
aspirin and omeprazole delayed-release tablets can cause serious side
effects, including:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including aspirin and omeprazole delayed-release
tablets, may develop a kidney
problem c

Summary of Product characteristics

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TAB- ASPIRIN AND
OMEPRAZOLE TABLET, FILM COATED
INNOVIDA PHAMACEUTIQUE CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASPIRIN AND OMEPRAZOLE
DELAYED-RELEASE TABLETS™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ASPIRIN
AND OMEPRAZOLE DELAYED-RELEASE TABLETS.
ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETS (ASPIRIN AND
OMEPRAZOLE) DELAYED-RELEASE
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2016
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps ( 5.19)
06/2018
INDICATIONS AND USAGE
aspirin and omeprazole delayed-release tablets is a combination of
aspirin, an anti-platelet agent, and
omeprazole, a proton pump inhibitor (PPI), indicated for patients who
require aspirin for secondary
prevention of cardiovascular and cerebrovascular events and who are at
risk of developing aspirin
associated gastric ulcers.
The aspirin component of aspirin and omeprazole delayed-release
tablets is indicated for:
reducing the combined risk of death and nonfatal stroke in patients
who have had ischemic stroke or
transient ischemia of the brain due to fibrin platelet emboli,
reducing the combined risk of death and nonfatal MI in patients with a
previous MI or unstable angina
pectoris,
reducing the combined risk of MI and sudden death in patients with
chronic stable angina pectoris,
use in patients who have undergone revascularization procedures
(Coronary Artery Bypass Graft
[CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when
there is a pre-existing
condition for which aspirin is already indicated.
The omeprazole component of aspirin and omeprazole delayed-release
tablets is indicated for decreasing
the risk of developing aspirin associated gastric ulcers in patients
at risk for developing aspirin-associated
gastric ulcers due to age (≥ 55) or documented history of gastric
ulcers. ( 1)
Limitations of Use:
Not for use as the initial dose of aspirin therapy during onset