FIELD OF APPLICATIONDETAILS
Generic Name
Bupivacaine and meloxicam extended-release solution
Active Ingredient
Bupivacaine and meloxicam
US Brand Names
ZYNRELEF, ZYNRELEF KIT
Drug Category
Perioperative Medicine, Orthopedic Surgery, Pain Management
Drug Class
Fixed-Dose Combination, Amide Local Anesthetic and NSAID
Route of Administration
Soft Tissue Surgical Instillation
FDA Approval Status
Originally approved (May 2021)
Approved

Bupivacaine and Meloxicam Extended-Release Solution Overview

Bupivacaine and meloxicam extended-release solution is a dual-acting combination of a local numbing agent and a nonsteroidal anti-inflammatory drug. It is an FDA-approved prescription medication used in orthopedic and general surgery. Surgical and pain management teams apply this needle-free liquid into surgical sites to provide pain relief lasting up to 72 hours in adults.

What Is Bupivacaine and Meloxicam Extended-Release Solution and How Does It Work

This solution is a targeted pain-relief combination designed to manage two main causes of pain after surgery: nerve signals and tissue swelling.

The medication works through two different pathways mixed into a slow-release gel:

  • Bupivacaine Nerve Blockade: Bupivacaine is a local anesthetic. It blocks sodium channels along nerve fibers, which stops pain signals from traveling from the surgical wound to the brain.
  • Meloxicam Inflammation Blockade: Meloxicam is an NSAID. Surgery causes the body to release enzymes that create swelling and pain. Meloxicam blocks these enzymes right at the wound. This reduces swelling and keeps the tissue environment stable so the bupivacaine can work better.
  • Extended-Release Gel: The gel slowly releases both drugs directly into the surgical site over 3 days. This provides long-lasting pain relief without needing high doses of opioid pills.

Is Bupivacaine and Meloxicam Extended-Release Solution FDA Approved

Yes, this extended-release solution is officially approved by the United States Food and Drug Administration. It received FDA approval on May 12, 2021, under the brand name ZYNRELEF. It is the first needle-free extended-release local anesthetic and NSAID combination approved for surgical pain management.

What Is Bupivacaine and Meloxicam Extended-Release Solution Used For

  • It is FDA-approved to be applied inside a surgical wound to relieve pain for up to 72 hours in adults.
  • It is indicated for use after surgeries like total knee replacement, groin hernia repair, shoulder decompression, and foot or ankle procedures.
  • It is used by surgical teams to lower the amount of narcotic opioid medications a patient needs during their recovery.

Before Taking Bupivacaine and Meloxicam Extended-Release Solution Contraindications and Precautions

Surgical teams conduct careful safety checks before using this medication during an operation. Checking heart health, kidney function, and allergy history ensures patient safety.

Who Should Not Take Bupivacaine and Meloxicam Extended-Release Solution

  • Anyone with a severe allergy to bupivacaine, other local anesthetics, meloxicam, or any part of the gel.
  • Anyone who has had asthma, hives, or severe allergic reactions after taking aspirin or other NSAIDs.
  • Patients having coronary artery bypass graft heart surgery.
  • Patients with severe kidney disease or sudden kidney failure.

Bupivacaine and Meloxicam Extended-Release Solution Pregnancy and Fertility

  • Pregnancy: Avoid use in pregnant women starting at 30 weeks of pregnancy. Meloxicam can cause heart and kidney problems in unborn babies during the third trimester. It should only be used earlier in pregnancy if the benefits clearly outweigh the risks.
  • Breastfeeding: Both drugs can pass into breast milk in very small amounts. Talk to your doctor to weigh the benefits of breastfeeding against any potential risks to the infant.

Tell Your Doctor Before Taking Bupivacaine and Meloxicam Extended-Release Solution

  • Tell your surgeon if you have a history of heart disease, heart failure, high blood pressure, or a recent heart attack.
  • Share any history of stomach ulcers, stomach bleeding, liver disease, or kidney problems.
  • Provide a full list of your daily medications, especially blood thinners, blood pressure drugs, or other pain relievers.

Bupivacaine and Meloxicam Extended-Release Solution Dosage and Administration

This medication is prepared and applied entirely by a qualified surgeon directly into the surgical wound before the incision is stitched closed.

Standard Bupivacaine and Meloxicam Extended-Release Solution Dosing

  • Large Surgical Sites: Up to 400 mg bupivacaine and 12 mg meloxicam for major surgeries like knee replacements.
  • Medium Surgical Sites: Up to 300 mg bupivacaine and 9 mg meloxicam for surgeries like hernia repairs.
  • Small Surgical Sites: Up to 200 mg bupivacaine and 6 mg meloxicam for smaller foot and ankle surgeries.
  • Maximum Dose: The total dose across all surgical areas must never exceed 400 mg bupivacaine and 12 mg meloxicam.
  • Pediatric Dosing: Safety has not been proven for children under 18 years old.

How Bupivacaine and Meloxicam Extended-Release Solution Is Administered

  • The thick liquid is drawn into a syringe and applied without a needle using a special applicator tip.
  • The surgeon coats the deep muscle and tissue layers evenly before closing the wound.
  • Important Safety Rule: This medication must only be coated onto open tissues. It must never be injected into blood vessels, the spine, or with a needle.

Bupivacaine and Meloxicam Extended-Release Solution Clinical Efficacy and Research

Clinical trials show that this extended-release solution provides better pain reduction for up to 72 hours compared to standard numbing medicine alone. Studies highlight that patients receiving this dual-acting treatment required significantly fewer opioid pain pills during their first three days of recovery. Many patients remained completely opioid-free during their hospital stay.

Bupivacaine and Meloxicam Extended-Release Solution Side Effects and Safety Profile

BLACK BOX WARNING

This medication carries an FDA Black Box Warning for serious NSAID risks, including potentially fatal heart attacks and strokes, as well as severe stomach bleeding, ulcers, and intestinal tears. These risks may occur early and increase with long-term use, with older adults at greater risk. It is also contraindicated during heart bypass surgery.

This medication is generally well-tolerated. Most side effects relate to normal surgery recovery or standard reactions to NSAIDs and local anesthetics.

Bupivacaine and Meloxicam Extended-Release Solution Common Side Effects

  • Nausea or vomiting after surgery.
  • Mild dizziness or headaches.
  • Constipation or gas.
  • Mild redness or minor drainage at the surgical wound.
  • Temporary increase in blood pressure.

Serious Bupivacaine and Meloxicam Extended-Release Solution Adverse Events

  • Local Anesthetic Toxicity: If too much drug absorbs into the blood, it can cause severe nervous system issues like ringing ears, mouth numbness, seizures, and dangerous heart rhythm changes.
  • Kidney Injury: High risk in patients who are dehydrated or have existing kidney damage.
  • Wound Healing Issues: Applying too much gel in one spot could potentially slow wound healing.

Managing Bupivacaine and Meloxicam Extended-Release Solution Side Effects

Hospital staff will closely monitor your heart rate, breathing, and blood pressure in the recovery room. Doctors keep emergency treatments on hand in case of a severe reaction. Tell your nurse immediately if you feel dizzy, taste metal, or have ringing in your ears. After going home, seek emergency care if you have chest pain, trouble breathing, or black, tarry stools.

Bupivacaine and Meloxicam Extended-Release Solution Interactions and What to Avoid

Other medications can interact with this extended-release treatment during your recovery.

Bupivacaine and Meloxicam Extended-Release Solution Interactions

  • Other Numbing Medicines: Doctors avoid giving extra local anesthetics like lidocaine for 96 hours after surgery to prevent an overdose.
  • Oral NSAIDs: Do not take extra NSAIDs like ibuprofen, naproxen, or aspirin for at least 72 hours after surgery. Combining them increases your risk of stomach bleeding and kidney damage.
  • Blood Thinners: Using blood thinners alongside meloxicam raises the risk of severe bleeding at the surgical wound.
  • Blood Pressure Medicines: Meloxicam can make certain blood pressure drugs and diuretics work less effectively.

Bupivacaine and Meloxicam Extended-Release Solution Food and Alcohol

  • Follow your surgeon’s diet instructions after surgery. Avoid drinking alcohol while recovering, as it greatly increases the risk of stomach bleeding when combined with meloxicam.

Bupivacaine and Meloxicam Extended-Release Solution Missed Dose Overdose and Storage

Because this is a one-time treatment applied by a surgeon, you do not have to worry about missing a dose or storing the medication at home.

Missed Dose of Bupivacaine and Meloxicam Extended-Release Solution

Not applicable. The drug is applied one time only in the operating room during your surgery.

Bupivacaine and Meloxicam Extended-Release Solution Overdose and Emergency

An overdose happens if the drug absorbs too quickly into the bloodstream. Symptoms include sudden dizziness, seizures, or heart problems. Hospital staff manage this emergency immediately using breathing support and an intravenous lipid treatment that binds the excess drug.

How to Store Bupivacaine and Meloxicam Extended-Release Solution

  • Medical facilities store unopened kits at room temperature between 20°C and 25°C.
  • The medication is kept in its original carton to protect it from light until the surgery begins.

Bupivacaine and Meloxicam Extended-Release Solution Patient Management and Monitoring

Clinical teams perform careful screening before surgery and closely monitor you afterward to ensure a safe recovery.

Tests Before Starting Bupivacaine and Meloxicam Extended-Release Solution

  • Blood tests to check kidney and liver function.
  • Blood count tests to check for bleeding risks.
  • A thorough allergy review for local anesthetics and NSAIDs.
  • Pregnancy tests for women of childbearing age.

Monitoring During Bupivacaine and Meloxicam Extended-Release Solution Treatment

  • Constant tracking of your heart rhythm, oxygen levels, and blood pressure during and right after surgery.
  • Routine checks of your pain levels to see if you need extra non-NSAID pain relievers.
  • Regular checks of your surgical bandage and wound healing.

Bupivacaine and Meloxicam Extended-Release Solution Dos and Donts

  • Do tell your doctor if you have ever had an allergic reaction or asthma attack after taking aspirin or ibuprofen.
  • Do take the non-NSAID pain pills prescribed by your doctor if you feel breakthrough pain.
  • Don’t take over-the-counter NSAIDs like ibuprofen or naproxen for at least 72 hours after surgery.
  • Don’t ignore severe stomach pain, dark stools, or chest pain after you go home. Call your doctor immediately.

Frequently Asked Questions

How is Zynrelef different from a normal nerve block?

A normal nerve block is injected through the skin with a needle. Zynrelef is a thick liquid coated directly onto your open surgical tissues by the surgeon before they stitch the wound closed.

Why are there two different medicines in the gel?

Bupivacaine is a numbing medicine that stops nerve pain. Meloxicam is an anti-inflammatory drug that stops swelling. The two drugs work together to provide better pain relief than either drug could provide on its own.

Can I take ibuprofen when I get home?

No. You should not take ibuprofen, naproxen, or any other NSAID for at least 72 hours (3 days) after your surgery. The gel is already slowly releasing meloxicam into your body, and taking more NSAIDs can cause dangerous stomach bleeding.

Will I still have pain after my surgery?

While this medication greatly reduces pain, it may not remove it completely. Your surgical team will provide a safe backup pain medicine, like acetaminophen, in case you need extra relief.

Are there major risks with this medication?

Yes. Because it contains meloxicam, there is an FDA Black Box Warning regarding an increased risk of heart attacks, strokes, and severe stomach bleeding. Your doctor will make sure it is safe for you before using it.

How long will the pain relief last?

The special gel is designed to slowly dissolve, releasing the numbing and anti-swelling medicines into your wound for up to 72 hours.

What should I do if I feel dizzy or my mouth goes numb?

If you experience mouth numbness, a metallic taste, ringing in your ears, or severe dizziness while in the hospital, tell your nurse right away. These can be signs that the numbing medicine is entering your bloodstream too quickly.

References

  • U.S. FDA – Zynrelef Prescribing Information: 
  • U.S. FDA Drugs@FDA – Zynrelef Approval Details: 

The information provided is for educational and informational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider at your local hospital or clinic before starting or stopping any medication.