Generic Name: aspirin and omeprazole
Date of Approval: September 14, 2016
Company: Aralez Pharmaceuticals Inc.
Treatment for: Prevention of Cardiovascular Disease in Patients at Risk for Aspirin-Associated Gastric Ulcers
FDA Approves Yosprala
The U.S. Food and Drug Administration (FDA) has approved Yosprala (aspirin and omeprazole) a once-daily anti-platelet agent and proton pump inhibitor fixed-dose combination indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
Take this medicine 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.
Tell your doctor if you have stomach problems during or after treatment.
Yosprala contains aspirin. Before you start treatment, tell your doctor if you take:
- aspirin, or any prescription or over-the-counter medicines containing aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)
- clopidogrel bisulphate (Plavix). You should not take clopidogrel bisulphate (Plavix) if you take Yosprala.
- ticagrelor (Brilinta). You should not take the 325 mg/40 mg strength dose of Yosprala.
Do not stop taking this medicine without talking with your doctor. Stopping treatment suddenly could increase your risk of having a heart attack or stroke.
Yosprala can cause serious side effects, including:
- Kidney problems (acute interstitial nephritis) may happen at any time during treatment. Call your doctor 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 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) in people who take multiple daily doses of proton pump inhibitor (PPI) medicines and for a long period of time (a year or longer).
- Certain types of lupus erythematosus may happen or get worse in people who already have lupus and who take PPI medicines, including Yosprala. Call your doctor right away if you have joint pain or a rash on your cheeks or arms that gets worse in the sun.
Talk to your doctor about your risk of these serious side effects.
Yosprala can have other serious side effects. See Yosprala side effects.
What is Yosprala?
Yosprala is a prescription medicine used:
- in people who have had heart problems or strokes caused by blood clots, to help reduce their risk of further heart problems or strokes, and
- who are at risk of developing stomach ulcers with aspirin
Yosprala contains the medicines aspirin and omeprazole (a proton pump inhibitor medicine).
The aspirin in this medicine is used:
- to help reduce the risk of strokes and death in people who have previously had certain types of “mini strokes” (transient ischemic attacks or TIAs) or strokes
- to help reduce the risk of heart attack and death in people who have previously had a heart attack or a type of chest pain called unstable angina pectoris
- to help reduce the risk of heart attack and sudden death in people with a type of ongoing chest pain called chronic stable angina pectoris
- in people who have had surgery or a procedure to improve blood flow to their heart, such as coronary artery bypass grafting (CABG), or percutaneous transluminal coronary angioplasty (PTCA), and who already have another condition that is being treated with aspirin
The omeprazole in this medicine is used:
- to help decrease the risk of developing stomach ulcers due to aspirin in people who are 55 years of age or older, or who have a history of stomach ulcers
Yosprala should not be used to treat sudden signs and symptoms of a heart attack or stroke. It should only be used as directed by your doctor to help reduce the risk of further heart problems or strokes.
It is not known if this medicine is safe and effective in children.
Yosprala has not been shown to reduce the risk of bleeding in the stomach or intestines that is caused by aspirin.
You should not take an aspirin tablet and an omeprazole tablet together instead of taking Yosprala, because they will not work the same way.
Who should not take Yosprala?
Do not take Yosprala if you:
- are allergic to aspirin, omeprazole, or any of the other ingredients. See the end of this page for a complete list of ingredients.
- are allergic to any non-steroidal anti-inflammatory drug (NSAID)
- have a medical condition with severe shortness of breath, chest tightness or pain, coughing or wheezing (asthma), sneezing, runny nose or itchy nose (rhinitis), and growths inside of your nose or sinuses (nasal polyps)
- are taking a medicine that contains rilpivirine (Edurant, Complera, Odefsey) used to treat HIV-1 (Human Immunodeficiency Virus)
- Do not give this medicine to a child who has a suspected viral infection, even if they do not have a fever. There is a risk of Reye’s syndrome because this medicine contains aspirin.
Before taking Yosprala
See Important information.
Before you start treatment, tell your doctor about all of your medical conditions, including if you:
- drink three or more drinks that contain alcohol every day
- have any bleeding problems
- have been told that you have low magnesium levels in your blood
- have liver or kidney problems
- are of Asian descent and have been told that your body’s ability to break down (metabolize) omeprazole is poor or if your genotype called CYP2C19 is not known
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby if taken before 30 weeks of pregnancy. Yosprala can harm your unborn baby if taken at 30 weeks of pregnancy or after. You should avoid taking Yosprala starting at 30 weeks of pregnancy. Talk to your doctor for advice.
- are breastfeeding or plan to breastfeed. The aspirin and omeprazole in this medicine can pass into your breast milk and may harm your baby. Breastfeeding is not recommended during treatment with Yosprala. Talk to your doctor about the best way to feed your baby during treatment.
- are a female who can become pregnant. NSAIDSs, including Yosprala, may be related to infertility in some women that is reversible when treatment is stopped.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, anti-cancer medicines, vitamins and herbal supplements.
Yosprala may affect how other medicines work, and vice versa.
See Important information.
Especially tell your doctor before you take:
- a medicine that contains rilpivirine (Edurant, Complera, Odefsey)
- clopidogrel bisulphate (Plavix)
- ticagrelor (Brilinta)
- St. John’s Wort (Hypericum perforatum)
- rifampin (Rimactane, Rifater, Rifamate Rifadin)
- methotrexate (Otrexup, Rasuvo, Trexall)
Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take Yosprala?
- Take this medicine exactly as prescribed by your doctor.
- Do not change your dose or stop treatment without talking to your doctor.
- Take Yosprala one time each day at least one hour before a meal.
- Swallow the tablets whole with liquid. Do not split, chew, crush, or dissolve the tablets.
- If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses at the same time unless your doctor tells you to.
- If you take too much or overdose, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.
What should I avoid while taking Yosprala?
Avoid heavy alcohol use during treatment. People who drink three or more drinks that contain alcohol every day have a higher risk of bleeding during treatment with Yosprala, because it contains aspirin.
Yosprala side effects
Yosprala can cause serious side effects, including:
- See Important information.
- Stomach and intestine problems. Stop treatment and call your doctor right away if you have any of the following signs or symptoms: black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds, or severe nausea, vomiting, or stomach pain.
- Kidney failure. Long-lasting (chronic) kidney failure can happen with regular use of aspirin, a medicine in Yosprala. This is more likely to happen in people who already have kidney problems before they start treatment. Tell your doctor if you have signs or symptoms of kidney failure, including: changes in urination, swelling, skin rash or itching, or your breath smells like ammonia.
- Liver problems. Long-term use of Yosprala at certain doses may cause liver problems. Tell your doctor if you have signs or symptoms of liver problems, including: yellowing of your skin or your eyes, stomach-area (abdominal) pain and swelling, itchy skin, and dark (tea-colored) urine.
- Low vitamin B-12 levels in your body can happen in people who have taken a PPI medicine, such as omeprazole, for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including: shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness.
- Low magnesium levels in your body can happen in people who have taken Yosprala for at least three months. Tell your doctor if you have symptoms of low magnesium levels, including: seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
The most common side effects include: indigestion or heartburn and stomach-area pain, nausea, diarrhea, growths (polyps) in your stomach, and chest pain behind the breastbone, for example, with eating.
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Yosprala?
- Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Store the medicine in the original container.
- Keep the container tightly closed to protect from moisture.
- The container may contain a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the container. Do not throw away the desiccant packet.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Yosprala
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information that is written for health professionals.
What are the ingredients in Yosprala?
Active ingredients: aspirin and omeprazole
Inactive ingredients: microcrystalline cellulose, corn starch, pre-gelatinized starch, colloidal silicon dioxide, stearic acid, methacrylic acid copolymer dispersion, triethyl citrate, glyceryl monostearate, polysorbate 80, titanium dioxide, hydroxypropyl methycellulose, polyethylene glycol, polydextrose, triacetin, yellow iron oxide, FD&C Blue #2, talc, sodium phosphate dibasic anhydrous, carnauba wax and povidone.