Melcam15 mg

Melcam is a non-steroidal anti-inflammatory drug (NSAID) used for relief of the signs and symptoms of certain inflammatory joint conditions.

Established/FDA-approved uses

• Osteoarthritis (OA): Relief of pain and inflammation associated with osteoarthritis in adults.
• Rheumatoid arthritis (RA): Relief of pain and inflammation associated with rheumatoid arthritis in adults.
• Juvenile idiopathic arthritis (JIA): Relief of signs and symptoms of pauciarticular or polyarticular course JIA in children 2 years of age and older, using the oral suspension formulation.

Off-label uses (not FDA-approved)

Melcam is sometimes used off-label, based on clinical experience, for other painful musculoskeletal conditions such as ankylosing spondylitis, acute gout flares, dysmenorrhea, or postoperative/dental pain; such use should be individualized by a physician.

Each dosage unit of Meloxicam contains Meloxicam as the active pharmaceutical ingredient, commonly available as tablets/capsules of 7.5 mg and 15 mg strength, and as an oral suspension (7.5 mg/5 mL) for pediatric or dysphagic patients. Inactive excipients vary by manufacturer.

Melcam is an enolic-acid derivative non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. It has analgesic, anti-inflammatory, and antipyretic properties and is used to relieve pain, stiffness, and swelling associated with certain forms of arthritis.

Melcam belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, specifically the oxicam group, and acts as a preferential (not fully selective) COX-2 inhibitor at low-to-moderate doses.

Meloxicam works by inhibiting the cyclooxygenase (COX) enzyme, which converts arachidonic acid into prostaglandins - chemical mediators of pain, inflammation, and fever.

At therapeutic doses, Meloxicam preferentially inhibits the inducible COX-2 isoenzyme over the constitutive COX-1 isoenzyme, which may partly explain its comparatively lower incidence of gastrointestinal toxicity relative to older non-selective NSAIDs, although this selectivity is not absolute and diminishes at higher doses. Meloxicam is well absorbed orally, is extensively bound to plasma proteins, is metabolized in the liver (mainly via CYP2C9, with a minor contribution from CYP3A4), and has a long elimination half-life of approximately 15-20 hours, allowing once-daily dosing.

Melcam may be taken with or without food. Tablets/capsules should be swallowed whole with a glass of water; the oral suspension should be shaken well before each use and measured with an accurate dosing device. Taking Melcam with food or milk may help reduce stomach upset. Do not exceed the dose or duration prescribed by your physician.

Melcam has the following clinically significant interactions:

• Aspirin/other NSAIDs: Concurrent use increases the risk of gastrointestinal bleeding and ulceration without added therapeutic benefit; combination should be avoided.
• Anticoagulants (e.g., warfarin) and antiplatelet agents: Increased risk of serious bleeding due to additive effects; requires close monitoring if co-administration with Melcam is unavoidable.
• ACE inhibitors, ARBs, and diuretics: Melcam may reduce the antihypertensive and natriuretic effect of these agents and increase the risk of acute kidney injury, particularly in volume-depleted patients.
• Lithium: Melcam can raise plasma lithium levels, risking lithium toxicity; monitor lithium levels closely.
• Methotrexate: Melcam may reduce methotrexate clearance and increase its toxicity, particularly at higher methotrexate doses.
• Cyclosporine: Increased risk of nephrotoxicity when used together with Melcam.
• Corticosteroids and SSRIs: Additive increase in the risk of gastrointestinal ulceration/bleeding when combined with Melcam.

Common side effects of Melcam include:

• Gastrointestinal: dyspepsia, abdominal pain, nausea, diarrhea, constipation
• Headache and dizziness
• Edema/fluid retention
• Upper respiratory tract symptoms

Less common but serious side effects requiring prompt medical attention include gastrointestinal bleeding, ulceration or perforation; cardiovascular thrombotic events (heart attack, stroke); significant elevation of liver enzymes; renal impairment; severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis); and anaphylactoid/hypersensitivity reactions (see Precautions and Contraindications).

Pregnancy: Melcam should be avoided starting at 20 weeks of pregnancy because NSAIDs at this stage can cause fetal renal dysfunction leading to oligohydramnios, and in some cases neonatal renal impairment. If use between 20 and 30 weeks of pregnancy is deemed necessary, Melcam should be limited to the lowest effective dose for the shortest possible duration. Melcam is contraindicated from 30 weeks of gestation onward (third trimester) due to the risk of premature closure of the fetal ductus arteriosus. Use earlier in pregnancy should occur only if clearly needed, after a physician weighs potential benefit against potential risk to the fetus.

Lactation: Limited data suggest Melcam passes into breast milk in small amounts. Because of the potential for adverse effects in a nursing infant, a decision should be made whether to discontinue breastfeeding or discontinue Melcam, considering the importance of the drug to the mother, in consultation with a physician.

Cardiovascular Risk

Melcam, like other NSAIDs, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use and is higher in patients with existing cardiovascular disease or risk factors. Melcam is contraindicated for perioperative pain in the setting of CABG surgery (see Contraindications).

Gastrointestinal Risk

Melcam can cause serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time and without warning symptoms. Elderly patients and those with a prior history of peptic ulcer disease or GI bleeding are at greater risk.

Renal Effects

Long-term use of Melcam may cause renal papillary necrosis or other renal injury; caution is advised in patients with pre-existing renal impairment, heart failure, liver dysfunction, those on diuretics/ACE inhibitors, and the elderly.

Hepatic Effects

Elevations of liver enzymes may occur with Melcam; discontinue if signs of liver disease develop or abnormal liver tests persist.

Fluid Retention and Heart Failure

Melcam may cause fluid retention and edema; use with caution in patients with fluid retention, hypertension, or heart failure.

Skin Reactions

NSAIDs, including Melcam, can rarely cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis; discontinue at the first sign of skin rash or hypersensitivity.

Melcam should be used at the lowest effective dose for the shortest duration consistent with the individual patient's treatment goals.

Symptoms of Melcam overdose may include drowsiness, lethargy, nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute kidney injury, and rarely, respiratory depression, coma, or anaphylactoid reactions.

There is no specific antidote for Melcam overdose. In case of suspected overdose, seek immediate medical attention or contact emergency services/a poison control center. Management is supportive and symptomatic; activated charcoal may be considered by medical professionals if given shortly after ingestion.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly

Elderly patients are at greater risk for NSAID-associated gastrointestinal, cardiovascular, and renal adverse effects with Melcam; use the lowest effective dose and monitor closely.

Renal Impairment

No dosage adjustment is needed in mild-to-moderate renal impairment, but Melcam should be used cautiously. Use in severe renal impairment is not recommended. In hemodialysis patients, the maximum dose is 7.5 mg/day.

Hepatic Impairment

No dosage adjustment is typically required in mild-to-moderate hepatic impairment; Melcam has not been studied in severe hepatic impairment and should be avoided.

Pediatric

Safety and efficacy of Melcam are established only for juvenile idiopathic arthritis in children 2 years and older using the oral suspension. Safety and efficacy for other indications or in children under 2 years of age have not been established.

Pregnancy and Lactation

See Pregnancy and Lactation section.

The duration of Melcam therapy should be individualized by the treating physician, using the lowest effective dose for the shortest period consistent with the patient's treatment goals, given dose- and duration-dependent cardiovascular and gastrointestinal risks. In chronic conditions such as osteoarthritis or rheumatoid arthritis, Melcam treatment may continue long-term under regular medical supervision and periodic reassessment.

Meloxicam belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class - Oxicam derivative; preferential COX-2 inhibitor.

Meloxicam inhibits the cyclooxygenase (COX) enzyme pathway, preferentially COX-2 over COX-1 at usual therapeutic doses, thereby reducing synthesis of the prostaglandins that mediate pain, inflammation, and fever, without fully sparing COX-1-mediated gastric protective effects at higher doses.

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Melcam oral suspension is approved for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile idiopathic arthritis (JIA) in children 2 years of age and older, at a dose of 0.125 mg/kg once daily (maximum 7.5 mg/day). Safety and efficacy of Melcam have not been established in children younger than 2 years of age or for indications other than JIA. Children receiving Melcam should be monitored for the same gastrointestinal, renal, and hypersensitivity risks seen in adults.