QAMZOVA

AbsorptionFollowing intravenous administration of meloxicam injection to healthy volunteers, plasma concentrations of 30 mg meloxicam injection exceed that of 15 mg oral meloxicam for the first 24 hours. The single-dose pharmacokinetics of meloxicam following intravenous administration of QAMZOVA are presented in Table 4 .

Table 4Single-Dose Pharmacokinetics of QAMZOVA Injection QAMZOVA 30 mg IV Parameter C max (ng/mL) 6667.2±984.0 T max (h) 0.10±0.04 AUC inf (ng*hr/mL) 102301.5±31999.9 T ½ (...

The efficacy and safety of meloxicam injection in the treatment of moderate to severe pain was evaluated in two Phase 3 randomized, double-blind, placebo-controlled, multiple-dose clinical trials in patients with postoperative pain. In both trials, oral oxycodone 5 mg was permitted as rescue medication for pain management. Study 1 (Bunionectomy Surgery) In the first controlled, multiple-dose trial (NCT02675907) of adult patients with postoperative pain who underwent bunionectomy surgery, 201 patients were treated with meloxicam injection 30 mg or placebo administered once daily for two days st...

The following adverse reactions are discussed in greater detail in the other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.3 ) ] Hypertension [see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5...

QAMZOVA is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions ( 5.7 ) ]. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal anaphylactic-like reactions to NSAIDs have been...

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue QAMZOVA immediately if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking QAMZOVA. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of QAMZOVA in patients with severe heart failure unless benefits are exp...

7 DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with meloxicam.

Table 3Clinically Significant Drug Interactions with Meloxicam Drugs That Interfere with Hemostasis Clinical Impact: Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared...