YOSPRALA- 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:

Genus Lifesciences Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

YOSPRALA, 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 YOSPRALA 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 YOSPRALA is indicated for decreasing the risk of developing aspirin-associated gastric u

Product summary:

YOSPRALA (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. YOSPRALA 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

Genus Lifesciences Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised:
03/2022
MEDICATION GUIDE
YOSPRALA® (yo SPRA lah)
(aspirin and omeprazole)
delayed-release tablets
What is the most important information I should know about YOSPRALA?
You should take YOSPRALA exactly as prescribed, at the lowest dose
possible and for the shortest time
needed.
YOSPRALA 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.
YOSPRALA contains aspirin, a nonsteroidal anti-inflammatory drug
(NSAID) and omeprazole, a proton
pump inhibitor (PPI) medicine. Before taking YOSPRALA, 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 YOSPRALA.
•
ticagrelor (BRILINTA®).
Do not stop taking YOSPRALA without talking with your doctor. Stopping
YOSPRALA suddenly could
increase your risk of having a heart attack or stroke.
YOSPRALA can cause serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including YOSPRALA, may develop a kidney
problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with YOSPRALA. Call your
doctor right away if you have a decrease in the amount that you
urinate or if you have blood in your
urine.
•
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 fra

Summary of Product characteristics

YOSPRALA- ASPIRIN AND OMEPRAZOLE TABLET, FILM COATED
GENUS LIFESCIENCES INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YOSPRALA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YOSPRALA.
YOSPRALA (ASPIRIN AND OMEPRAZOLE) DELAYED-RELEASE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
YOSPRALA 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 YOSPRALA 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 YOSPRALA 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 of
acute coronary syndrome, acute
myocardial infarction or before percutaneous coronary intervention.
(1)
Has not been shown to reduce the risk of gastrointestinal bleeding due
to aspirin. (1)
Do not substitute YOSPRALA with the single-ingredient products of
aspirin and omeprazole. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage: One tablet daily at least