Yosprala

Generic name: aspirin and omeprazole
Drug class: Platelet aggregation inhibitors

Medically reviewed by  A Ras MD. Last updated on june 03,2022.

What is Yosprala used for?

• Yosprala is used to lower the chance of heart attack, stroke, and death in some people.

Description

• The active ingredients of YOSPRALA are aspirin which is an antiplatelet agent and omeprazole which is a PPI.
• YOSPRALA (aspirin and omeprazole) is an oval, blue-green, multi-layer film-coated, delayed-release tablet consists of an enteric coated delayed-release aspirin core surrounded by an immediate-release omeprazole layer for oral administration. Each delayed-release tablet contains either 81 mg aspirin and 40 mg omeprazole printed with 81/40, or 325 mg aspirin and 40 mg omeprazole printed with 325/40.
• The excipients used in the formulation of YOSPRALA are all inactive and United States Pharmacopeia/National Formulary (USP/NF) defined. The inactive ingredients in YOSPRALA include: carnauba wax, colloidal silicon dioxide, corn starch, FD&C Blue #2, glyceryl monostearate, hydroxypropyl methycellulose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, pre-gelatinized starch , sodium phosphate dibasic anhydrous, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, yellow iron oxide.
• Aspirin is acetylsalicylic acid and is chemically known as benzoic acid, 2-(acetyloxy). Aspirin is an odorless white needle-like crystalline or powdery substance. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids and gives off a vinegary odor. It is highly lipid soluble and slightly soluble in water. Aspirin irreversibly inhibits platelet COX-1.
• Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155 °C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
• Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H- benzimidazole, a compound that inhibits gastric acid secretion.

Structural Formula

Aspirin

      Omeprazole

Molecular Formula

The empirical formula of aspirin is C9H8O4 .
The empirical formula of omeprazole is C17H19N3O3S .

Molecular Weight

The molecular weight of aspirin is 180.16.
The molecular weight of omeprazole is 345.4.

Mechanism of Action

Aspirin (acetylsalicylic acid) is an inhibitor of both prostaglandin synthesis and platelet aggregation. The differences in activity between aspirin and salicylic acid are thought to be due to the acetyl group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase via acetylation.

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the [H+/K+]-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

Before taking Yosprala, tell your doctor:

For all patients taking Yosprala:

• If you are allergic to Yosprala; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Asthma, bleeding problems, nose polyps, or nose irritation.
• If you have any of these health problems: Kidney disease or liver disease.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you are pregnant or may be pregnant. Do not take Yosprala if you are in the third trimester of pregnancy. You may also need to avoid Yosprala at other times during pregnancy. Talk with your doctor to see when you need to avoid taking Yosprala during pregnancy.
• If you are breast-feeding. Do not breast-feed while you take Yosprala.
• If you are taking any of these drugs: Atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, St. John’s wort, ticagrelor, or voriconazole.
• If you are taking another drug that has the same drug in it.
• If you are taking any other NSAID.

Children:

• If your child or teenager has or is getting better from flu signs, chickenpox, or other viral infections. The risk of a very bad problem called Reye’s syndrome may be raised. Do not give Yosprala to a child or teenager who has or is getting better from a viral infection.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Yosprala with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Yosprala?

• Tell all of your health care providers that you take Yosprala. This includes your doctors, nurses, pharmacists, and dentists.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• This medicine may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Yosprala.
• This medicine may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take Yosprala in high doses or for longer than a year, or if you are older than 50 years old.
• Rarely, low magnesium levels have happened in people taking drugs like this one for at least 3 months. Most of the time, this happened after 1 year of treatment. You will need to have blood work if you take Yosprala for a long time or with certain other drugs.
• Rarely, long-term treatment (for instance longer than 3 years) with drugs like this one has caused low vitamin B-12 levels. Call your doctor right away if you have signs of low vitamin B-12 levels like shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs.
• Lupus has happened with Yosprala, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Very bad pancreas, liver, and white blood cell problems have happened in people who were taking Yosprala. Rarely, these have been fatal. Talk with the doctor if you have questions.
• This medicine may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
• If you are of Asian descent, use Yosprala with care. You could have more side effects.
• NSAIDs like Yosprala may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when Yosprala is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Yosprala, call your doctor right away.

How is Yosprala best taken?

Use Yosprala as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Yosprala at least 60 minutes before a meal.
• Swallow whole with a full glass of water.
• Do not chew, break, or crush.
• Keep taking Yosprala as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take Yosprala for longer than you were told by your doctor.
• Do not stop taking Yosprala all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Yosprala, you will want to slowly stop it as ordered by your doctor.
• Do not use Yosprala for sudden signs of a heart attack or stroke. Talk with your doctor about what to do if these signs happen to you.
• Talk with your doctor before you drink alcohol.
• Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses unless told to do so by your doctor.

What are the side effects of Yosprala that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Bone pain.
• Swelling.
• Very bad dizziness or passing out.
• Ringing in ears.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Yosprala?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain or heartburn.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Yosprala?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

• BOTTLES OF 30 TABLETS YOSPRALA 81;40

   

  

• NDC 70347-081-90 BOTTLES OF 90 TABLETS YOSPRALA 81/40

   

  

• BOTTLES OF 30 TABLETS YOSPRALA 325/40

   

  

• BOTTLES OF 90 TABLETS YOSPRALA 325/40

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Yosprala is refilled. If you have any questions about Yosprala, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Yosprala or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Yosprala. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.