Bupivacaine; Meloxicam Extended-Release Solution for Instillation

What is this medication?

BUPIVACAINE; MELOXICAM (bue PIV a kane; mel OX i cam) relieves pain after procedures. It numbs the area where it is applied, which blocks your nerves from sending pain signals to your brain. It also works by decreasing inflammation. It is a combination of a local anesthetic and an NSAID.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZYNRELEF

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Asthma
• Bleeding problems
• Dehydration
• Frequently drink alcohol
• G6PD deficiency
• Have had a heart attack, stroke, or mini-stroke
• Heart bypass surgery, or CABG, within the past 2 weeks
• Heart or blood vessel conditions
• Heart failure
• High blood pressure
• Kidney disease
• Liver disease
• Low blood pressure
• Stomach bleeding
• Stomach ulcers, other stomach or intestine problems
• Tobacco use
• An unusual or allergic reaction to bupivacaine, meloxicam, aspirin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for insertion into a surgery site. This medication is given in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

Do not take this medication with any of the following:

• Cidofovir
• Ketorolac

This medication may interact with the following:

• Acetaminophen
• Alcohol
• Aspirin and aspirin-like medications
• Blood thinners
• Chloroquine
• Cyclosporine
• Digoxin
• Diuretics
• Lithium
• Medications for blood pressure
• Methotrexate
• Metoclopramide
• Nitrates, such as nitric oxide, nitroglycerin, nitroprusside, nitrous oxide
• Other local anesthetics, such as lidocaine, pramoxine, tetracaine
• Other NSAIDs, medications for pain and inflammation, such as ibuprofen and naproxen
• Primaquine
• Quinine
• Some antibiotics, such as dapsone, nitrofurantoin, sulfonamides
• Some medications for cancer, such as cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase
• Some medications for depression
• Some medications for seizures, such as phenobarbital, phenytoin, valproic acid
• Steroid medications, such as prednisone or cortisone
• Sulfasalazine
• Supplements, such as garlic, ginger, ginkgo, methylsulfonylmethane (MSM)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

Use care to avoid injury while the area is numb, and you are not aware of pain.

If you have a procedure in the next 4 days, tell your care team you have had this medication.

Do not take aspirin or other NSAIDs, such as ibuprofen or naproxen, while you are taking this medication. Side effects, such as upset stomach, nausea, and ulcers, may be more likely to occur. Many over-the-counter medications contain aspirin, ibuprofen, or naproxen. It is important to read labels carefully. Talk to your care team about all the medications you take. They can tell you what is safe to take together.

This medication can cause serious bleeding, ulcers, or tears in the stomach. These problems can occur at any time and with no warning signs. They are more common with long-term use. Talk to your care team right away if you have stomach pain, bloody or black, tar-like stools, or vomit blood that is red or looks like coffee grounds.

This medication increases the risk of blood clots, heart attack, and stroke. These events can occur at any time. They are more common with long-term use and in those who have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your care team. They can help you find an option that works for you.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you may be pregnant. Taking this medication after 20 weeks of pregnancy may cause serious birth defects. Use of this medication after 30 weeks of pregnancy is not recommended.

This medication may cause infertility. It is usually temporary. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Headache, unusual weakness or fatigue, shortness of breath, nausea, vomiting, rapid heartbeat, blue skin or lips, which may be signs of methemoglobinemia
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Increase in blood pressure
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Round red or dark patches on the skin that may itch, burn, and blister
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Headache
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.