Yosprala (aspirin/omeprazole) Pain & Antiplatelet Medication

What is Yosprala, and how does it work?

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.

The aspirin in Yosprala 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 Yosprala 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.
Yosprala 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
Yosprala 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.

What are the side effects of Yosprala?

Yosprala can cause serious side effects, including:

Stomach and intestine problems. Stop taking
Yosprala and call your doctor right away if you have symptoms of stomach and intestine problems, including 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 treatment with
Yosprala. Tell your doctor if you have symptoms of kidney failure, including changes in urination, swelling of the hands, ankles or feet, 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 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. Low vitamin B-12 levels in your body can happen in people who have taken
Yosprala 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 in the arms or legs.
Low magnesium levels. Low magnesium levels in your body can happen in people who have taken
Yosprala for at least 3 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.
Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

The most common side effects of
Yosprala include: indigestion or heartburn and stomach-area pain, nausea, diarrhea, and chest pain behind the breastbone, for example, with eating.

These are not all the possible side effects of
Yosprala. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What is the dosage for Yosprala?

Recommended Dosage

Take one tablet daily.
Yosprala is available in combinations that contain 81 mg or 325 mg of aspirin. Generally 81 mg of aspirin has been accepted as an effective dose for secondary cardiovascular prevention. Providers should consider the need for 325 mg and refer to current clinical practice guidelines.

Administration Instructions

Take
Yosprala once daily at least 60 minutes before a meal.
The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet.
Use the lowest effective dose of
Yosprala based on the individual patientâ€™s treatment goals and to avoid potential dose dependent adverse reactions including bleeding.
If a dose of
Yosprala is missed, advise patients to take it as soon as it is remembered. If it is almost time for the next dose, skip the missed dose. Take the next dose at the regular time. Patients should not take 2 doses at the same time unless advised by their doctor.
Do not stop taking
Yosprala suddenly as this could increase the risk of heart attack or stroke.

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What drugs interact with Yosprala?

Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with
Yosprala and instructions for preventing or managing them.

Consult the labeling of concomitantly used drugs to obtain further information about interactions with omeprazole or aspirin.

Table 2: Clinically Relevant Interactions Affecting Drugs Co-Administered with
Yosprala and Interaction with Diagnostics

AntiretroviralsClinical Impact:The effect of PPIs, such as omeprazole, on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.

Decreased exposure of some antiretroviral drugs (e.g., rilpivirine,
atazanavir and nelfinavir) when used concomitantly with omeprazole may
reduce antiviral effect and promote the development of drug resistance.
Increased exposure of other antiretroviral drugs (e.g., saquinavir) when
used concomitantly with omeprazole may increase toxicity.
There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole.

Intervention:Rilpivirine-containing products:
Concomitant use with Y OSPRALA is contraindicated.
Atazanavir: Avoid concomitant use with
Yosprala. See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with
Yosprala. See prescribing information for nelfinavir.
Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities.
Other antiretrovirals: See prescribing information for specific antiretroviral drugs.Heparin and WarfarinClinical Impact:Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
Aspirin can increase the anticoagulant activity of heparin and warfarin, increasing bleeding risk.Intervention:Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain target INR range. Monitor and adjust the dose of heparin and warfarin as needed.MethotrexateClinical Impact:Concomitant use of omeprazole with methotrexate (primarily at high dose) may
elevate and prolong serum concentrations of methotrexate and/or its
metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.
No formal drug interaction studies of high-dose methotrexate with PPIs, such
as omeprazole, have been conducted.Intervention:A temporary withdrawal of
Yosprala may be considered in some patients receiving high-dose methotrexate.CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, phenytoin,diazepam)ClopidogrelClinical Impact:
Concomitant use of omeprazole 80 mg results in reduced plasma concentrations
of the active metabolite of clopidogrel and a reduction in platelet
inhibition.
There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.Intervention:Avoid concomitant use with
Yosprala. Consider use of alternative antiplatelet therapy.CitalopramClinical Impact:
Concomitant use of omeprazole results in increased exposure of citalopram
leading to an increased risk of QT prolongation.Intervention:Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram.CilostazolClinical Impact:Concomitant use of omeprazole results in increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol).Intervention:Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol.PhenytoinClinical Impact:Potential for increased exposure of phenytoin with concomitant omeprazole. Aspirin can displace protein-bound phenytoin leading to a decrease in the total concentration of phenytoin.Intervention:Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for phenytoin.DiazepamClinical Impact:
Increased exposure of diazepam with concomitant omeprazole.Intervention:Monitor patients for increased sedation and reduce the dose of diazepam as needed.TicagrelorClinical Impact:Maintenance doses of aspirin above 100 mg reduce the effectiveness of ticagrelor.Intervention:Avoid concomitant use of ticagrelor with the 325 mg/40 mg tablet strength of
Yosprala.DigoxinClinical Impact:
Potential for increased exposure of digoxin with concomitant omeprazole.Intervention:Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information.Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole)Clinical Impact:Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.Intervention:Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving omeprazole and MMF. Use
Yosprala with caution in transplant patients receiving MMF.
See the prescribing information for other drugs dependent on gastric pH for absorption.TacrolimusClinical Impact:Potential for increased exposure of tacrolimus with concomitant omeprazole, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.Intervention:Monitor tacrolimus whole blood concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.ACE-InhibitorsClinical Impact:Aspirin may diminish the antihypertensive effect of ACE-inhibitors.Intervention:Monitor blood pressure as needed.Beta BlockersClinical Impact:The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin.Intervention:Monitor blood pressure as needed in patients taking
Yosprala concomitantly with beta blockers for hypertension.DiureticsClinical Impact:The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of aspirin.Intervention:Monitor blood pressure as needed.NSAIDsClinical Impact:The concurrent use of NSAIDs and aspirin may increase the risk of serious adverse events, including increased bleeding or decreased renal function.Intervention:Monitor for signs and symptoms of bleeding or decreased renal function.Oral HypoglycemicsClinical Impact:Moderate doses of aspirin may increase the effectiveness of oral hypoglycemic drugs, leading to hypoglycemia.Intervention:Monitor blood sugar as needed.AcetazolamideClinical Impact:Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity).Intervention:Adjust the dose of acetazolamide if signs of toxicity occur.Uricosuric Agents (Probenecid)Clinical Impact:Aspirin antagonizes the uricosuric action of uricosuric agents.Intervention:Monitor serum uric acid levels as needed.Valproic AcidClinical Impact:Concomitant use of aspirin can displace protein-bound valproic acid, leading to an increase in serum concentrations of valproic acid.Intervention:Monitor valproic acid serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for valproic acid.Interactions with Investigations of Neuroendocrine TumorsClinical Impact:
Serum chromogranin A (CgA) levels increase secondary to omeprazole-induced
decreases in gastric acidity. The increased CgA level may cause false
positive results in diagnostic investigations for neuroendocrine tumors.Intervention:Temporarily stop
Yosprala treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.Interaction with Secretin Stimulation TestClinical Impact:Omeprazole can cause a hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.Intervention:Temporarily stop
Yosprala treatment at least 14 days before assessing to allow gastrin levels
to return to baseline.False Positive Urine Tests for THCClinical Impact:There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs such as omeprazole.Intervention:An alternative confirmatory method should be considered to verify positive results.OtherClinical Impact:There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (e.g., cyclosporine, disulfiram) with omeprazole.Intervention:Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with
Yosprala.

Table 3: Clinically Relevant Interactions Affecting
Yosprala When Co-Administered with Other Drugs

CYP2C19 or CYP3A4 InducersClinical Impact:
Decreased exposure of omeprazole when used concomitantly with strong
inducers.Intervention:St. John’s Wort, rifampin: Avoid concomitant use with
Yosprala. Ritonavir-containing products: See prescribing information for specific drugs.CYP2C19 or CYP3A4 InhibitorsClinical Impact:Increased exposure of omeprazole.Intervention:Voriconazole: Avoid concomitant use with
Yosprala.

Is Yosprala safe to use while pregnant or breastfeeding?

Use of NSAIDs, including Yosprala, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
Avoid use of NSAIDs, including 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.
Pregnant women should avoid use of Yosprala and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus.
Breastfeeding is not recommended during treatment with Yosprala.