Yosprala

Generic name: aspirin and omeprazole (AS pir in and oh MEP ra zole)
Brand name: Yosprala
Drug class: Platelet aggregation inhibitors

Yosprala contains a combination of aspirin and omeprazole. Aspirin is as platelet aggregation inhibitor. It also reduces substances in the body that cause pain, fever, and inflammation. Omeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Yosprala is used to help lower the risk of heart problems, strokes, or death in people who have had certain conditions related to blood clots, including angina (chest pain), a past heart attack, or a stroke or a "mini stroke."

Yosprala is also used in people who have had surgery to improve blood flow to the heart and also have another condition that is already being treated with aspirin.

Omeprazole helps reduce the risk of stomach ulcers that may be caused by aspirin, especially in people who are 55 or older, or those who have had stomach ulcers in the past.

Warnings

You should not use Yosprala if you take medicine that contains rilpivirine, or if you've ever had an asthma attack or severe allergic reaction after taking aspirin or another NSAID (nonsteroidal anti-inflammatory drug).

Aspirin can make you bleed more easily. Call your doctor if you have any unusual bleeding or bruising, or if you cough up blood or have bloody or tarry stools.

Omeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Omeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking Yosprala long term or more than once per day.

Do not stop using Yosprala suddenly, even if you feel fine.

Before taking this medicine

You should not use Yosprala if you are allergic to aspirin or omeprazole, or if:

• you are also allergic to medicines like esomeprazole, lansoprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Protonix, and others;
• you take medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey);
• you have had an asthma attack or severe allergic reaction (sneezing, runny or stuffy nose, wheezing, chest pain, shortness of breath) after taking aspirin or another NSAID; or
• if you had breathing problems, kidney problems, or a severe allergic reaction after taking this medicine in the past.

Yosprala should not be used to treat a sudden onset of heart attack or stroke symptoms (chest pain, sudden numbness or weakness, slurred speech).

Yosprala is not approved for use by anyone younger than 18 years old. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Tell your doctor if you have ever had:

• a bleeding disorder or vitamin K deficiency;
• low levels of magnesium in your blood;
• a habit of drinking more than 3 alcoholic beverages per day;
• liver or kidney disease;
• lupus; or
• if you are of Asian descent.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking Yosprala long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant.

Yosprala may temporarily affect your ability to get pregnant. Talk with your doctor if this concerns you.

You should not breastfeed while using Yosprala.

How should I take Yosprala?

Take Yosprala exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest dose that is effective in treating your condition.

Take Yosprala with a full glass of water. The usual dose is once daily, 1 hour before a meal.

Swallow the tablet whole and do not crush, chew, or break a tablet.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Yosprala.

Omeprazole may affect a drug-screening urine test and you could have false results. Tell the laboratory staff that you use Yosprala.

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

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.

Dosing information

Usual Adult Dose of Yosprala 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.

Usual Adult Dose of Yosprala 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.

Usual Adult Dose of Yosprala 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.

Usual Adult Dose of Yosprala 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.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time unless your doctor tells you to.

What happens if I overdose?

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.

What to avoid

Ask a doctor or pharmacist before using over-the-counter medicines. They may contain ingredients similar to aspirin or omeprazole.

Taking regular aspirin together with omeprazole (Prilosec) will not work the same way as taking combination aspirin and omeprazole (Yosprala). Do not substitute this medicine with over-the-counter products.

Drinking alcohol can increase your risk of stomach bleeding.

Yosprala side effects

Get emergency medical help if you have signs of an allergic reaction to Yosprala: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; 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;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• 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;
• kidney problems - fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
• liver problems - stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);
• low magnesium - dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
• new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking Yosprala long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

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.

Common Yosprala 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.

What other drugs will affect Yosprala?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with aspirin and omeprazole, especially:

• clopidogrel;
• digoxin;
• methotrexate;
• rifampin;
• St. John's wort;
• ticagrelor;
• a diuretic or "water pill"; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may interact with aspirin and omeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

How does Yosprala work?

Yosprala (aspirin and omeprazole) helps to protect the stomach by first delivering immediate-release omeprazole (40 mg) followed by a delayed-release, enteric-coated aspirin core in either 81 mg or 325 mg dose strengths.

The enteric-coated aspirin dissolves after the stomach pH reaches 5.5 or greater, which reduces ulcer risk and possible bleeding in the stomach.

Omeprazole, as part of Yosprala, is a proton-pump inhibitor that is used to help lower the risk of stomach ulcers in patients 55 years and older and people with a history of ulcers.

Aspirin may be recommended by your doctor to help protect your heart if you have a history of certain high risk conditions like a heart attack or stroke.