Durlaza

What is Durlaza used for?

• Durlaza is used to lower the chance of heart attack, stroke, and death in some people.
• Durlaza may be given to you for other reasons. Talk to your doctor.

Before taking Durlaza, tell your doctor:

For all patients taking Durlaza:

• If you are allergic to Durlaza; 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 have any of these health problems: GI (gastrointestinal) bleeding or ulcer disease.
• If you are taking another drug that has the same drug in it.
• If you are taking any other NSAID.
• If you are pregnant or may be pregnant. Do not take Durlaza if you are in the third trimester of pregnancy. You may also need to avoid Durlaza at other times during pregnancy. Talk with your doctor to see when you need to avoid taking Durlaza during pregnancy.
• If you are breast-feeding or plan to breast-feed.

Children:

• If the patient is a child. This medicine is not approved for use in 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 Durlaza 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 Durlaza 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 Durlaza?

• Tell all of your health care providers that you take Durlaza. This includes your doctors, nurses, pharmacists, and dentists.
• Have your blood work checked if you are on Durlaza for a long time. Talk with your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Durlaza for longer than you were told by your doctor.
• Do not stop taking Durlaza without calling the doctor who ordered it for you.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• 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.
• If you are over the age of 60, use Durlaza with care. You could have more side effects.
• This medicine is not for use if you have chest pain and need to take aspirin quickly. Take a fast-acting form of aspirin. If you are not sure which form of aspirin is fast-acting, talk with the doctor.
• Do not take Durlaza within 2 hours before or 1 hour after drinking alcohol.
• 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 Durlaza, call your doctor right away.

How is Durlaza best taken?

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

• Take with or without food. Take with food if it causes an upset stomach.
• Take with a full glass of water.
• Swallow whole. Do not chew, open, or crush.
• Take Durlaza at the same time of day.

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.

What are the side effects of Durlaza 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 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 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 high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad dizziness or passing out.
• Very bad headache.
• Ringing in the ears, hearing loss, or any other changes in hearing.
• Feeling agitated.
• Seizures.

What are some other side effects of Durlaza?

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 Durlaza?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• 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.

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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Durlaza, please talk with your doctor, nurse, 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 Durlaza 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 Durlaza. 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.