Generic drug: meloxicam
Brand name: Anjeso
What is Anjeso (meloxicam), and how does it work?
What are the side effects of Anjeso?
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
- Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- Anjeso is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Side effects of Anjeso include:
What is the dosage for Anjeso?
- Use for the shortest duration consistent with individual patient treatment goals.
- For intravenous administration only.
- The recommended dose of Anjeso is 30 mg once daily, administered by intravenous bolus injection over 15 seconds.
- When initiating Anjeso, monitor patient analgesic response. Because the median time to meaningful pain relief was 2 and 3 hours after Anjeso 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.
- 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.
- To reduce the risk of renal toxicity, patients must be well hydrated prior to administration of Anjeso.
- 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.
What drugs interact with Anjeso?
See Table 3 for clinically significant drug interactions with meloxicam.
Table 3: Clinically Significant Drug Interactions with Meloxicam
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of Anjeso 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.|
|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.|
|Intervention:||Concomitant use of Anjeso and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding.|
|In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.|
|Anjeso is not a substitute for low dose aspirin for cardiovascular protection.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. However, studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam.|
|Intervention:||During concomitant use of Anjeso with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Anjeso and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).|
|Intervention:||During concomitant use of Anjeso and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of Anjeso and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of Anjeso and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.|
|Intervention:||The concomitant use of meloxicam with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of Anjeso and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of Anjeso and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.|
|Patients taking meloxicam should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.|
|In patients with creatinine clearance below 45 mL/min, the concomitant administration of meloxicam with pemetrexed is not recommended.|
|Clinical Impact:||In vitro studies indicate that CYP2C9 (cytochrome P450 metabolizing enzyme) plays an important role in this metabolic pathway with a minor contribution of the CYP3A4 isozyme. Thus concomitant usage of CYP2C9 inhibitors (such as amiodarone, fluconazole, and sulphaphenazole) may lead to abnormally high plasma levels of meloxicam due to reduced metabolic clearance.|
|Intervention:||Consider dose reduction in patients undergoing treatment with CYP2C9 inhibitors, and monitor patients for adverse effects.|
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Is Anjeso safe to use while pregnant or breastfeeding?
- Use of NSAIDs, including Anjeso, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Anjeso, in pregnant women starting at 30 weeks of gestation (third trimester).
- There are no adequate and well-controlled studies of meloxicam in pregnant women.
- There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Anjeso and any potential adverse effects on the breastfed infant from the Anjeso or from the underlying maternal condition.
Anjeso (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID) used in adults to manage moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Serious side effects of Anjeso include potentially fatal heart attack, stroke, or gastrointestinal (GI) adverse events (bleeding, ulceration, and perforation of the stomach or intestines).
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