Anjeso (meloxicam): NSAID Side Effects, Dosage, Warnings

Generic drug: meloxicam

Brand name: Anjeso

What is Anjeso (meloxicam), and how does it work?

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.

What are the side effects of Anjeso?

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

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.

Gastrointestinal Risk

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:

constipation,
GGT increased, and
anemia

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.

QUESTION

Medically speaking, the term “myalgia” refers to what type of pain?
See Answer

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 HemostasisClinical 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
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.AspirinClinical 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-BlockersClinical Impact:

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Intervention:

During concomitant use of
Anjeso and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
During concomitant use of Anjeso and ACE-inhibitors or ARBs in patients who
are elderly, volume-depleted, or have impaired renal function, monitor for
signs of worsening renal function.
When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.

DiureticsClinical 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.LithiumClinical 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.MethotrexateClinical 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.CyclosporineClinical 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 SalicylatesClinical 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.PemetrexedClinical 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.CYP2C9 InhibitorsClinical 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.