ZYNRELEF Rx

Should be administered where trained personnel and resuscitative equipment are readily available. Avoid epidural, intrathecal, intravascular, intra-articular, regional nerve blocks, pre-incisional or pre-procedural locoregional anesthetic techniques. Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Cardiovascular dysfunction (eg, hypotension, heart block); monitor closely for BP, HR, and ECG changes. Monitor cardiovascular and respiratory vital signs, and patient’s state of consciousness after administration. Evaluate if signs/symptoms of liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, others). Hypertension; monitor BP. Dehydration. Hypovolemia. Advanced renal disease: not recommended; if needed, monitor. Hyperkalemia. Limit exposure to articular cartilage due to potential risk of chondrolysis. Risk of methemoglobinemia (esp. in G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants <6 months of age, concurrent exposure to oxidizing agents or metabolites); monitor closely and discontinue any oxidizing agents if occurs. Pre-existing asthma. Coagulation disorders. May mask signs of infection or fever. Renal impairment (mild to moderate): consider dose reduction; (severe): not recommended; (on hemodialysis): do not exceed max dose or use with other meloxicam-containing products. Hepatic impairment (moderate to severe): monitor for toxicity; (severe): only use if benefits outweigh risks. Poor CYP2C9 metabolizers: monitor and consider dose reduction. Debilitated. Elderly. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.