Aspirin and omeprazole

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• ringing in the ears
• fever
• confusion
• drowsiness
• blurred vision
• rapid heartbeat
• nausea
• vomiting
• sweating
• flushing
• headache
• dry mouth

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Aspirin and omeprazole is usually taken once per day, at least 60 minutes before a meal.

Take this medicine with a full glass of water.

Do not crush, chew, break, or dissolve the delayed-release tablet. Swallow it whole.

This medicine can cause unusual results with certain medical tests, and you may need to stop using the medicine for a short time before a test. Tell any doctor who treats you that you are using omeprazole.

Medicines similar to omeprazole have caused false-positive results on drug screening tests. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking aspirin and omeprazole.

Do not stop using aspirin and omeprazole suddenly, even if you feel fine. Stopping suddenly may increase your risk of having a heart attack or stroke. Follow your doctor's instructions about tapering your dose.

If you use this medicine for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include ringing in your ears, increased thirst, muscle pain or weakness, trouble breathing, or feeling cold.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe nausea, vomiting, stomach pain, or diarrhea that is watery or bloody;

• easy bruising, unusual bleeding (such as a nosebleed), or any bleeding that will not stop;

• sudden pain or trouble moving your hip, wrist, or back;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• kidney problems--urinating less than usual, blood in your urine, swelling, skin rash, unusual breath odor;

• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• lupus-like syndrome--joint pain or swelling, butterfly-shaped skin rash on your cheeks and nose (worsens in sunlight);

• symptoms of low vitamin B-12 levels--pale skin, tingling or numbness, muscle weakness, feeling light-headed or short of breath, tiredness, mood changes; or

• symptoms of low magnesium--dizziness, irregular heartbeats, tremors or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling, or a seizure (convulsions).

Common side effects may include:

• heartburn, stomach pain, indigestion;

• nausea, diarrhea; or

• chest pain (may happen when you eat).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• cilostazol or clopidogrel;

• citalopram;

• diazepam;

• digoxin;

• a diuretic or "water pill";

• methotrexate;

• phenytoin;

• rifampin;

• St. John's wort;

• ticagrelor;

• voriconazole;

• warfarin (Coumadin, Jantoven); or

• HIV or AIDS medicine--atazanavir, nelfinavir, ritonavir, saquinavir.

Other drugs may interact with aspirin and omeprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

In the U.S.

• Yosprala

Available Dosage Forms:

• Tablet, Delayed Release

Therapeutic Class: Platelet Aggregation Inhibitor

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Aspirin

Aspirin: Irreversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, via acetylation, which results in decreased formation of prostaglandin precursors; irreversibly inhibits formation of prostaglandin derivative, thromboxane A2, via acetylation of platelet cyclooxygenase, thus inhibiting platelet aggregation; has antipyretic, analgesic, and anti-inflammatory properties.

Omeprazole: Suppresses gastric basal and stimulated acid secretion by inhibiting the parietal cell H+/K+ ATP pump

Avoid use in patients with hepatic impairment.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original container. Protect from moisture.

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

Data not available

Limited data from clinical lactation studies describe the presence of aspirin in human milk at relative infant doses of 2.5% to 10.8% of the maternal weight-adjusted dose. Case reports of breastfed infants whose mothers were exposed to aspirin during lactation revealed evidence of adverse reactions including metabolic acidosis, thrombocytopenia, and hemolysis. Limited data from a separate case report describes the presence of omeprazole in human milk at a relative infant dose of 0.9% of the maternal weight-adjusted dose.

Use is not recommended. Excreted into human milk: Yes (aspirin, omeprazole) Comments: -The direct use of aspirin in infants and children is associated with Reye's syndrome, even at low plasma levels. -Use of this drug during breastfeeding is not recommended due to the potential for adverse reactions in nursing infants including metabolic acidosis, thrombocytopenia, hemolysis, or Reye's syndrome.