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:

Aralez Pharmaceuticals Us Inc.

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 81 mg

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: NDC 70347-081-30       Bottles of 30 tablets       YOSPRALA 81/40 NDC 70347-081-90       Bottles of 90 tablets       YOSPRALA 81/40 NDC 70347-325-30       Bottles of 30 tablets       YOSPRALA 325/40 NDC 70347-325-90       Bottles of 90 tablets       YOSPRALA 325/40 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

Aralez Pharmaceuticals Us Inc.
----------
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 interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including YOSPRALA, may develop a kidney
problem called
acute interstitial 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 fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in
people who take

Summary of Product characteristics

YOSPRALA- ASPIRIN AND OMEPRAZOLE TABLET, FILM COATED
ARALEZ PHARMACEUTICALS US 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
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps (5.20) 06/2018
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