Usual Adult Dose for Thromboembolic Stroke Prophylaxis

One tablet (aspirin 81 mg-omeprazole 40 mg or aspirin 325 mg-omeprazole 40 mg) orally once a day at least 60 minutes before a meal

Comments:

• Generally, 81 mg of aspirin has been accepted as an effective dose for secondary cardiovascular prevention; the current clinical practice guidelines should be referenced when considering the need for 325 mg of aspirin.

Use: For patients requiring secondary prevention of cardiovascular and cerebrovascular events who are at risk of developing aspirin associated gastric ulcers

• The aspirin component 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 myocardial infarction (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; and use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a preexisting condition for which aspirin is already indicated

• The omeprazole component is indicated to decrease the risk of developing aspirin-associated gastric ulcers in patients 55 years or older or with a documented history of gastric ulcers

Usual Adult Dose for Ischemic Stroke - Prophylaxis

One tablet (aspirin 81 mg-omeprazole 40 mg or aspirin 325 mg-omeprazole 40 mg) orally once a day at least 60 minutes before a meal

Comments:

• Generally, 81 mg of aspirin has been accepted as an effective dose for secondary cardiovascular prevention; the current clinical practice guidelines should be referenced when considering the need for 325 mg of aspirin.

Use: For patients requiring secondary prevention of cardiovascular and cerebrovascular events who are at risk of developing aspirin associated gastric ulcers

• The aspirin component 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 myocardial infarction (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; and use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a preexisting condition for which aspirin is already indicated

• The omeprazole component is indicated to decrease the risk of developing aspirin-associated gastric ulcers in patients 55 years or older or with a documented history of gastric ulcers

Usual Adult Dose for Cardiovascular Risk Reduction

One tablet (aspirin 81 mg-omeprazole 40 mg or aspirin 325 mg-omeprazole 40 mg) orally once a day at least 60 minutes before a meal

Comments:

• Generally, 81 mg of aspirin has been accepted as an effective dose for secondary cardiovascular prevention; the current clinical practice guidelines should be referenced when considering the need for 325 mg of aspirin.

Use: For patients requiring secondary prevention of cardiovascular and cerebrovascular events who are at risk of developing aspirin associated gastric ulcers

• The aspirin component 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 myocardial infarction (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; and use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a preexisting condition for which aspirin is already indicated

• The omeprazole component is indicated to decrease the risk of developing aspirin-associated gastric ulcers in patients 55 years or older or with a documented history of gastric ulcers

Usual Adult Dose for Gastric Ulcer Prophylaxis

One tablet (aspirin 81 mg-omeprazole 40 mg or aspirin 325 mg-omeprazole 40 mg) orally once a day at least 60 minutes before a meal

Comments:

• Generally, 81 mg of aspirin has been accepted as an effective dose for secondary cardiovascular prevention; the current clinical practice guidelines should be referenced when considering the need for 325 mg of aspirin.

Use: For patients requiring secondary prevention of cardiovascular and cerebrovascular events who are at risk of developing aspirin associated gastric ulcers

• The aspirin component 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 myocardial infarction (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; and use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a preexisting condition for which aspirin is already indicated

• The omeprazole component is indicated to decrease the risk of developing aspirin-associated gastric ulcers in patients 55 years or older or with a documented history of gastric ulcers

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction (GFR less than 10 mL/min): Avoid use.

Liver Dose Adjustments

Avoid use in patients with any degree of hepatic dysfunction

Dose Adjustments

Asian Population:

• In a study of healthy subjects, Asian patients had about a 4-fold higher exposure to omeprazole than Caucasians.
• About 15% to 20% of Asians are CYP450 2C19 poor metabolizers.

Recommendation:

• Avoid use in Asian patients with unknown CYP450 2C19 genotype or those known to be poor metabolizers.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take at least 60 minutes before a meal
• Swallow whole with liquid; do not split, chew, crush, or dissolve the tablet
• If a dose is missed, it may be taken as soon as it is remembered; if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time.
• This drug should not be abruptly stopped as it could increase the risk of heart attack or stroke.

Storage requirements:

• Store in original container with desiccant; keep tightly closed to protect from moisture.
• Dispense in tight container if package is subdivided.

General:

• Use the lowest effective dose based on individual patient treatment goals and to avoid potential dose dependent adverse reactions including bleeding.
• This drug contains a delayed-release formulation of aspirin and is not for use as the initial dose of aspirin therapy during acute coronary syndrome, acute myocardial infarction, or before percutaneous coronary intervention (PCI) for which immediate-release therapy is appropriate.
• This drug has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin.
• This drug is not interchangeable with the individual components of aspirin and omeprazole.

Monitoring:

• Hematologic: Monitor for signs/symptoms of increased bleeding.
• Metabolic: Monitor magnesium levels prior to initiation and periodically throughout treatment in patients receiving long term treatment or concomitant use with medications that may cause hypomagnesemia (e.g., digoxin, diuretics).

Patient advice:

• Consult the patient medication guide for further information