Bupivacaine and Meloxicam

Important warning:

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as the combination of bupivacaine and meloxicam may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, angina (chest pain), irregular heartbeats, a stroke, diabetes, if you smoke, and if you have or have ever had high cholesterol or high blood pressure. Get emergency medical help right away if you experience any of the following symptoms: pain inthe chest, arms, back, neck, jaw, or stomach; breaking out in cold sweat; lightheadedness; shortness of breath; nausea or vomiting; weaknessin one part or side of the body; slurred speech; sudden severe headache; problems walking; dizziness; loss of balance or coordination; or changes in vision.

NSAIDs such as meloxicam may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. Therisk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, if you smoke, drink large amounts of alcohol, or have liver disease. Tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking meloxicam and rizatriptan and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Why is this medicine prescribed?

Bupivacaine and meloxicam is used to manage pain after certain types of surgery. Bupivacaine is in a class of medications called local anesthetics.It works by blocking nerves from sending pain signals. Meloxicam is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain and inflammation.

Are there other uses for this medicine?

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

How should this medicine be used?

Bupivacaine and meloxicam comes as a solution (liquid) to be instilled (placed) into a surgical wound site by a doctor or nurse. It is instilled as a single dose during surgery to provide pain relief for up to 72 hours after surgery.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What special precautions should I follow?

Before receiving bupivacaine and meloxicam,

  • tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving bupivacaine and meloxicam. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

  • the following nonprescription or herbal products may interact with bupivacaine and meloxicam: aspirin; nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofenand naproxen. Be sure to let your doctor and pharmacist know that you are taking these medications before you receive bupivacaine and meloxicam. Do not start any of these medications after receiving bupivacaine and meloxicam without discussing with your healthcare provider.

  • tell your doctor if you have or have ever had glucose-6-phosphate dehydrogenase deficiency (an inherited disease that affects red blood cells); methemoglobinemia (a condition that affect how the redblood cells work to carry oxygen);asthma, especially if you have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); heart failure; swelling of the hands, feet, ankles, or lower legs; high blood pressure; high level of potassium in your blood; or liver or kidney disease.

  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Meloxicam may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. If you become pregnant after receiving bupivacaine and meloxicam, call your doctor.

  • if you are having another surgery within 96 hours, including dental surgery, tell the doctor or dentist that you recently received bupivacaine and meloxicam.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medicine cause?

Bupivacaine and meloxicam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • numbness or loss of feeling near the surgical wound site
  • swelling, redness, or infection at the surgical wound site
  • dizziness
  • headache
  • nausea
  • vomiting
  • constipation
  • change in taste
  • sweating
  • muscle twitching

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • rash; hives; swelling of the eyes, face, lips, tongue, or throat; hoarseness; difficulty breathing or swallowing
  • fever, blistering or peeling skin, rash, or swollen glands
  • pale, gray, or blue colored skin; headache; rapid heartrate; shortness of breath; lightheadedness; or fatigue
  • unusual bleeding or bruising
  • nausea, excessive tiredness, lack of energy, yellowing of the skin or eyes, pain in the right upper part of the stomach, and flu-like symptoms
  • restlessness,anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth andlips, metallic taste, ringing in the ears, dizziness, blurred vision, tremors, twitching, drowsiness,or seizures

Bupivacaine and meloxicam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What other information should I know?

Keep all appointments with your doctor.

Keepa written list of all of the prescription and nonprescription(over-the-counter) medicines, vitamins, minerals, and dietary supplements youare taking. Bring this list with you each time you visit a doctor or if you areadmitted to the hospital. You should carry the list with you in case ofemergencies.

Brand name(s)

  • Zynrelef®
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