ZYNRELEF 400 mg/14mL
BUPIVACAINE and MELOXICAM · SOLUTION · Heron Therapeutics, Inc.
ZYNRELEF is a solution containing bupivacaine and meloxicam at 400 mg/14mL, taken infiltration. Manufactured by Heron Therapeutics, Inc..
Key Facts
- Brand Name
- ZYNRELEF
- Generic Name
- BUPIVACAINE and MELOXICAM
- NDC Code (Product)
47426-501- Manufacturer
- Heron Therapeutics, Inc.
- Strength
- 400 mg/14mL
- Dosage Form
- SOLUTION
- Route
- INFILTRATION
- Marketing Status
- Application #
- NDA211988
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]; Amide Local Anesthetic [EPC]
- Marketing Start
- 12/01/2024
Recall History
HERON THERAPEUTICS, INC.
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures orthopedic surgical procedures – foot and ankle procedures – other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10) ] ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures orthopedic surgical procedures – foot and ankle procedures – other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10) ] Limitations of Use Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large 4 or more level spinal, and head and neck procedures ( 1 ). Limitations of Use Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large 4 or more level spinal, and head and neck procedures.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION ZYNRELEF is intended for single-dose administration only ( 2.1 ). Administer ZYNRELEF via instillation only. The toxic effects of local anesthetics are additive. Avoid additional use of local anesthetics within 96 hours following administration of ZYNRELEF ( 2.1 ). ZYNRELEF should only be prepared and administered with the components provided in the ZYNRELEF kit ( 2.1 ). ZYNRELEF is applied without a needle into the surgical site following final irrigation and suction and prior to suturing ( 2.1 ). – The recommended dose of ZYNRELEF is up to a maximum dose of 400 mg/12 mg (14 mL) ( 2.4 ). See Full Prescribing Information for important preparation and administration instructions, dose selection, and compatibility considerations ( 2.2 , 2.3 , 2.4 , 2.5 ). 2.1 Important Dosage and Administration Information ADMINISTER ZYNRELEF VIA INSTILLATION ONLY. ZYNRELEF should not be administered via the following routes. – Epidural – Intrathecal – Intravascular – Intra-articular [see Warnings and Precautions (5.10) , Nonclinical Toxicology (13.2) ] – Regional nerve blocks – Pre-incisional or pre-procedural locoregional anesthetic techniques. ZYNRELEF is intended for s…
Contraindications
4 CONTRAINDICATIONS ZYNRELEF is contraindicated in: Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF [see Warnings and Precautions (5.9 , 5.14) ] . Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.9) ] . Patients undergoing obstetrical paracervical block anesthesia. The use of bupivacaine in this technique has resulted in fetal bradycardia and death [see Use in Specific Populations (8.1) ] . Patients undergoing coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] . ZYNRELEF is contraindicated for: Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF ( 4 ) Patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.…
Drug Interactions
7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs) : Monitor patients for bleeding who are concomitantly taking ZYNRELEF with drugs that interfere with hemostasis ( 7.2 ). ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers : Concomitant use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure ( 7.2 ). ACE Inhibitors and ARBs : Concomitant use with ZYNRELEF in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function ( 7.2 ). Diuretics : NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effect ( 7.2 ). 7.1 Bupivacaine Drug Interactions In clinical studies, other local anesthetics (including ropivacaine and lidocaine) have been administered before, during, or after application of ZYNRELEF without evidence of local anesthetic systemic toxicity. Administration of ZYNRELEF with other formulations of local anesthetics, including bupivacaine liposome injectable suspension…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions have been associated with bupivacaine HCl or meloxicam and are discussed in greater detail in other sections of the labeling: Cardiovascular System Reactions [see Warnings and Precautions (5.1 , 5.4) ] Gastrointestinal Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2) ] Dose-Related Toxicity [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Hypertension [see Warnings and Precautions (5.6) ] Heart Failure and Edema [see Warnings and Precautions (5.7) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.8) ] Anaphylactic Reactions [see Warnings and Precautions (5.9) ] Chondrolysis [see Warnings and Precautions (5.11) ] Methemoglobinemia [see Warnings and Precautions (5.12) ] Exacerbation of Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.13) ] Serious Skin Reactions [see Warnings and Precautions (5.14) ] Drug Reaction with Eosinophilia and Systemic Toxicity (DRESS) [see Warnings and Precautions (5.15) ] Fetal Toxicity [see Warnings and Precautions (5.16) ] Hematologic Toxicity [see Warnings and Precautions (5.17) ] Most comm…
Frequently Asked Questions
What is ZYNRELEF used for?
ZYNRELEF contains BUPIVACAINE and MELOXICAM. It is a solution taken infiltration. Consult your doctor for specific uses.
Is ZYNRELEF a controlled substance?
ZYNRELEF is not classified as a controlled substance by the DEA.
What is the generic name for ZYNRELEF?
The generic name for ZYNRELEF is BUPIVACAINE and MELOXICAM. There are no other listed brand versions of BUPIVACAINE and MELOXICAM.
What is the NDC code for ZYNRELEF 400 mg/14mL?
The NDC (National Drug Code) for ZYNRELEF 400 mg/14mL is 47426-501, listed by Heron Therapeutics, Inc..
Other ZYNRELEF Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)