Meloxicam — uses, dosing, side effects & the brands that sell it · pharmaranks
Meloxicam: uses, dosing, side effects & brands
Meloxicam is a nonsteroidal anti-inflammatory drug sold in the U.S. under 7 brand and generic names, for rheumatoid arthritis and osteoarthritis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
From the FDA label for Xifyrm (application NDA218395). Other meloxicam products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. For intravenous administration only. The recommended dosage of XIFYRM is 30 mg once daily, administered by intravenous bolus injection over 15 seconds. When initiating XIFYRM, monitor patient analgesic response. Because the median time to meaningful pain relief was 2 and 3 hours after XIFYRM administration in two clinical studies, a non-NSAID analgesic with a rapid onset of effect may be needed, for example, upon anesthetic emergence or resolution of local or regional anesthetic blocks [ see Clinical Studies ( 14 ) ]. Some patients may not experience adequate analgesia for the entire 24-hour dosing interval and may require administration of a short-acting, non-NSAID, immediate-release analgesic [ see Clinical Studies ( 14 ) ]. To reduce the risk of renal toxicity, patients must be well hydrated prior to administration of XIFYRM. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. Should the contents appear discolored or contain particulate matter, discard the vial [ see Dosage Forms and Strengths ( 3 ) ]. • Use for the shortest duration consistent with individual patient treatment goals. ( 2 ) • Recommended dosage: 30 mg once daily, administered by intravenous bolus injection over 15 seconds. ( 2 ) •…
Meloxicam side effects
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 ( 5.6 ) ] • Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] • Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] • Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] The most common adverse reactions (≥ 2% and greater than placebo) in controlled clinical trials include constipation, GGT increased, and anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical development, 1426 patients were exposed to meloxicam injection in controlled…
Every meloxicam product we track (7)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
The elimination half-life of meloxicam is about 15 to 20 hours. Meloxicam follows linear kinetics (half-life is constant across doses) and its four metabolites are all pharmacologically inactive, so no active metabolite prolongs its effect. The half-life runs somewhat longer in older adults (roughly 21 to 24 hours in the label's elderly subjects) and is modestly longer in men than women.
Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Frequently asked questions
What is meloxicam?
XIFYRM (meloxicam injection) is a nonsteroidal anti-inflammatory drug (NSAID). It is a sterile clear, pale-yellow to yellow color solution, containing the active pharmaceutical ingredient meloxicam for intravenous administration. Each mL of aqueous solution contains 30 mg of meloxicam, 150 mg of hydroxypropyl betadex, 20 mg of meglumine, 60 mg of povidone and water for injection. The pH of the meloxicam injection is 8.0 to 9.5. The meloxicam drug substance is polymorph I. It is pale yellow powder. It is soluble in dimethylformamide, slightly soluble in acetone, very slightly soluble in ethanol 96% and in methanol, and practically insoluble in water. Meloxicam is designated chemically as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2- benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its molecular formula is C 14 H 13 N 3 O 4 S 2 and the structural formula of meloxicam is: Figure-1 Structure
What kind of drug is meloxicam?
The FDA classifies meloxicam as a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does meloxicam stay in your system?
The elimination half-life of meloxicam is about 15 to 20 hours — that is how long the body takes to clear half of a dose. Meloxicam follows linear kinetics (half-life is constant across doses) and its four metabolites are all pharmacologically inactive, so no active metabolite prolongs its effect. The half-life runs somewhat longer in older adults (roughly 21 to 24 hours in the label's elderly subjects) and is modestly longer in men than women. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take meloxicam with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run meloxicam against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take meloxicam
XIFYRM 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 reported in such patients [ see Warnings and Precautions ( 5.8 ) ]. • In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ]. • Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion [ see Warnings and Precautions ( 5.6 )]. • Known hypersensitivity to meloxicam or any components of the drug product. ( 4 ) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ( 4 ) • In the setting of coronary artery bypass graft (CABG) surgery. ( 4 ) • Moderate to severe renal insufficiency patients who are at risk for renal failure due to volume depletion. ( 4 )
Meloxicam drug interactions
See Table 3 for clinically significant drug interactions with meloxicam. Table 3: Clinically 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 to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case- control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of XIFYRM with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [se e Warnings and Precautions ( 5.12 ) ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Warnings and…
We track 7 meloxicam-containing products in the U.S.: Xifyrm, Mobic, Anjeso, Meloxicam, Qamzova, Qmiiz ODT and Vivlodex. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does meloxicam come in?
Across the brands we track, meloxicam is currently marketed as injectable, tablet, solution, capsule, suspension and tablet, orally disintegrating, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic meloxicam?
Yes. Our catalog lists 1 generic meloxicam product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.