Yosprala

Yosprala is a prescription medication used to help prevent a cardiovascular event and stroke in those that are at risk for aspirin-associated stomach ulcers.

Yosprala is a single product containing 2 medications: aspirin and omeprazole.

Aspirin belongs to a group of drugs called salicylates. Aspirin has anti-inflammatory and anti-platelet affects. Aspirin helps to prevent cardiovascular and cerebrovascular events, including heart attacks, strokes, and transient ischemic attacks, by reducing the ability for blood to form clots. 

Omeprazole belongs to a group of drugs called proton-pump inhibitors, which work by reducing the amount of acid made in the stomach. Omeprazole can be used in the treatment of stomach ulcers, but it is not known whether it can help to prevent the development of aspirin-associated stomach ulcers.

This medication comes in a delayed-release tablet and is taken once daily, at least 60 minutes before a meal. Do not split, chew, crush or dissolve the tablet. Swallow the tablet whole.

Common side effects include stomach inflammation (gastritis), nausea, and diarrhea.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following: 

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication 

The recommended dose range of Yosprala is one delayed-release tablet daily. Yosprala is available in the following dosage forms and strengths:

• 81 mg delayed-release aspirin/40 mg immediate-release omeprazole
• 325 mg delayed-release aspirin/40 mg immediate-release omeprazole 

Bleeding abnormalities. Contact your healthcare provider if you observe any signs of increased bleeding such as bose bleeds, excessive bruising, or blood in urine. 

Stomach ulcers and bleeding. Contact your healthcare provider if you observe any signs or symptoms of a stomach ulcer or stomach bleed such as stomach pain, vomiting, heartburn, indegestion.

Acute kidney injury. Contact your healthcare provider if you have some or all of the following symptoms of acute kidney injury:

• decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• unusual tiredness or weakness.

Diarrhea. Contact your healthcare provider if you have frequent, watery stools that does not resolve. Yosprala may increase the risk of a serious form of diarrhea known as Clostridium difficile (C. difficile) associated diarrhea (CDAD).

Bone fractures. Long-term daily dose of a proton-pump inhibitor like omeprazole may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.

Vitamin B-12 deficiency. Long-term daily dose of a proton-pump inhibitor like omeprazole may be associated with a malabsorption or deficiency in certain vitamins and minerals. 

Low magnesium levels. Long-term daily dose of a proton-pump inhibitor like omeprazole may be associated with a malabsorption or deficiency in certain vitamins and minerals. 

Premature closure of the ductus arteriosus. Avoid use in pregnant women starting at 30 weeks gestation. 

Serious side effects have been reported with Yosprala. See the “Yosprala Precautions” section. 

Common side effects of Yosprala include the following: 

• gastritis
• nausea
• diarrhea
• gastric polyps
• non-cardiac chest pain 

This is not a complete list of Yosprala side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: 

• Clopidogrel
• Ticagrelor
• Anticoagulant (blood thinner) medications such as warfarin (Coumadin,), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis) 
• Methotrexate: omeprazole may elevate methotrexate levels, which may lead to bone marrow toxicity
• Antiretroviral drugs used for HIV such as rilpivirine, atazanavir, nelfinavir and saquinavir
• Citalopram
• Cilostazol
• Phenytoin
• Diazepam
• Digoxin
• Medications that require acidic pH in stomach for absorption such as: iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole 
• St. John's Wort
• Rifampin
• Tacrolimus
• ACE-inhibitors such as benazepril (Lotensin, Lotensin HCT), captopril (Capoten, Capozide), enalapril (Vasotec, Vaseretic), lisinopril (Prinivil, Prinzide, Zestril, Zestoretic), quinapril (Accupril, Accuretic, Quinaretic)
• Diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), triamterene (Dyrenium, Dyazide, Maxzide)
• Beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• Valproic acid
• Cyclosporine
• Disulfiram
• Voriconazole

This is not a complete list of Yosprala drug interactions. Ask your doctor or pharmacist for more information. 

Tell your doctor if you are pregnant or plan to become pregnant.

Avoid use in pregnant women starting at 30 weeks gestation due to risk of premature closure of the ductus arteriosus. Avoid use of Yosprala in pregnant women starting at 30 weeks of gestation (third trimester). There are no available data with Yosprala use in pregnant women to inform a drug-associate risk for major birth defects and miscarriage; however, there are published studies with each individual component of Yosprala. 

Tell your doctor if you are breastfeeding or plan to breastfeed. 

There is no information about the presence of Yosprala in human milk; however, the individual components of Yosprala, aspirin and omeprazole, are present in human milk. Because of the possibility for adverse reactions in nursing infants from Yosprala, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.