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 Therapeutique Corporation

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, 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 TABLETSA 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 AN

Product summary:

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA (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 TABLETSA 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 Therapeutique 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 TABLETSA™ (yo SPRA lah)
(aspirin and omeprazole)
delayed-release tablets
What is the most important information I should know about ASPIRIN AND
OMEPRAZOLE
DELAYED-RELEASE TABLETSA?
You should take ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA
exactly as
prescribed, at the lowest dose possible and for the shortest time
needed.
ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA 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 TABLETSA contains aspirin, a
nonsteroidal
anti-inflammatory drug (NSAID) and omeprazole, a proton pump inhibitor
(PPI) medicine. Before taking
ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA, 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 TABLETSA.
•
ticagrelor (BRILINTA®).
Do not stop taking ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA
without
talking with your doctor. Stopping ASPIRIN AND OMEPRAZOLE
DELAYED-RELEASE
TABLETSA suddenly could increase your risk of having a heart attack or
stroke.
ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA 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
TABLETSA, may develop a kidney p

Summary of Product characteristics

ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TAB- ASPIRIN AND OMEPRAZOLE
TABLET,
FILM COATED
INNOVIDA THERAPEUTIQUE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASPIRIN AND OMEPRAZOLE DELAYED-
RELEASE TABLETSA™ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ASPIRIN AND
OMEPRAZOLE DELAYED-RELEASE TABLETSA.
ASPIRIN AND OMEPRAZOLE DELAYED-RELEASE TABLETSA (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 TABLETSA 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
TABLETSA 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
TABLETSA 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