Generic drug: meloxicam
Brand name: Vivlodex
What is Vivlodex (meloxicam), and how does it work?
What are the side effects of Vivlodex?
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal 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.
- Vivlodex is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration, and Perforation
- 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.
Common side effects of Vivlodex include:
- abdominal discomfort,
- joint pain,
- urinary tract infection,
- high blood pressure,
- upper respiratory tract infection,
- back pain,
- runny or stuffy nose,
- sinus infection,
- nausea, and
- pain and swelling in the extremities.
What is the dosage for Vivlodex?
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
- For management of osteoarthritis pain, the recommended starting dosage is 5 mg orally once daily. Dose may be increased to 10 mg in patients who require additional analgesia. The maximum recommended daily oral dose of Vivlodex is 10 mg.
- In patients on hemodialysis, the maximum daily dosage is 5 mg
Non-Interchangeability With Other Formulations Of Meloxicam
- Vivlodex capsules have not shown equivalent systemic exposure to other formulations of oral meloxicam. Therefore, Vivlodex capsules are not interchangeable with other formulations of oral meloxicam even if the total milligram strength is the same.
- Do not substitute similar dose strengths of other meloxicam products.
What drugs interact with Vivlodex?
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 Vivlodex 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 Vivlodex and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding.|
|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.|
|Intervention:||During concomitant use of Vivlodex with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects|
|Clinical Impact:||The concomitant use of meloxicam with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of Vivlodex and digoxin, monitor serum digoxin levels.|
|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 Vivlodex 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 Vivlodex and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of Vivlodex and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of Vivlodex 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 Vivlodex and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of Vivlodex and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.|
Is Vivlodex safe to use while pregnant or breastfeeding?
- Use of NSAIDs, including Vivlodex, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
- Avoid use of NSAIDs, including Vivlodex, in pregnant women starting at 30 weeks of gestation (third trimester).
- There are no adequate and well-controlled studies of Vivlodex in pregnant women.
- Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.
- 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 Vivlodex and any potential adverse effects on the breastfed infant from the Vivlodex or from the underlying maternal condition.
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Vivlodex (meloxicam) is a non-steroidal anti-inflammatory drug indicated for management of osteoarthritis (OA) pain. Serious side effects of Vivlodex include increased risk of serious cardiovascular thrombotic events (heart attack and stroke, which can be fatal) and increased risk of serious gastrointestinal (GI) adverse events (bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal).
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