Bupivacaine/Meloxicam

Brands

DEA Class; Rx

Common Brand Names; Zynrelef

NSAIDs Local Anesthetics, Parenteral

Bupivacaine: Local amide anesthetic; blocks generation and conduction of nerve impulses presumably by increasing the electrical excitation threshold in the nerve, by slowing nerve impulse propagation, and by reducing the rate of action potential rise

Meloxicam: Member of oxicam class; inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase (COX) isoenzymes, COX-1 and COX-2

Postoperative Analgesia

Known hypersensitivity (eg, anaphylactic reactions, serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; severe, sometimes fatal, anaphylactic reactions to NSAIDs reported

Patients undergoing obstetrical paracervical block anesthesia; use of bupivacaine in this technique has resulted in fetal bradycardia and death

Patients undergoing coronary artery bypass graft (CABG) surgery

>10%

Bunionectomy

  • Dizziness (22%)

  • Incision site edema (17%)

  • Headache (14%)

  • Incision site erythema (13%)

  • Herniorrhaphy H4

  • Headache (13%)

Total knee arthroplasty

  • Nausea (50%)

  • Vomiting (26%)

  • Constipation (24%)

  • Hypertension (19%)

  • Pyrexia (14%)

1-10%

Bunionectomy

  • Bradycardia (8%)

  • Impaired healing (6%)

  • Muscle twitching (6%)

  • Incision site cellulitis (4%)

  • Wound dehiscence (4%)

  • Incision site infection (3%)

Herniorrhaphy

  • Bradycardia (9%)

  • Dysgeusia (9%)

  • Skin odor abnormal (8%)

Total knee arthroplasty

  • Leukocytosis (7%)
  • Pruritus (7%)
  • Headache (7%)
  • Headache (7%)
  • Anemia (5%)
  • Hyperhidrosis (5%)
  • Hypotension (5%)

Bupivacaine

  • Prevent dose-related toxicity by assuring proper dose and correct technique

  • Limit exposure to articular cartilage due to the potential risk of chondrolysis

  • Chondrolysis reported with intra-articular infusion of local anesthetics; intra-articular infusions of local anesthetics, following arthroscopic and other surgical procedures is an unapproved use

Meloxicam

  • Anaphylaxis and aspirin-sensitive asthma

  • Cardiovascular events

  • Hypertension

  • GI bleeding, ulceration, and perforation

Pregnancy; Data are unavailable on use of bupivacaine/meloxicam in pregnant females to evaluate drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes; however, data are available on the individual components

Lactation: Data are unavailable on whether drug is present in human milk, or on the effects on breastfed infants, or on milk production

Adults

Foot and ankle surgical procedures (eg, bunionectomy)

Up to 2.3 mL (bupivacaine 60 mg/meloxicam 1.8 mg); apply to proximal and distal ends (ie, beyond the boney repair) of the wound

Small-to-medium open abdominal procedures (open inguinal herniorrhaphy)

Up to 10.5 mL (bupivacaine 300 mg/meloxicam 9 mg); apply above and below the fascial repair

Lower extremity total joint arthroplasty surgical procedures (eg, total knee arthroplasty)

Up to 14 mL (bupivacaine 400 mg/meloxicam 12 mg); apply directly to posterior capsule, the anteromedial tissues and periosteum, and the anterolateral tissues and periosteum after cementation of the components

Pediatric

Safety and efficacy not established

Extended-release solution for soft-tissue or periarticular instillation

  • 60mg/1.8mg as 2.3-mL single-dose vial
  • 200mg/6mg as 7-mL single-dose vial
  • 300mg/9mg as 10.5-mL single-dose vial
  • 400mg/12mg as 14-mL single-dose vial
  • Concentration: (29.25mg/0.88mg)/mL
  • Kit contains: 5 vented vial spikes, 10 Luer lock applicators, 10 sterile 3-mL Luer lock syringes, 8 sterile 12-mL Luer lock syringes
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