Meloxicam


Full Prescribing Info
Dosage/Direction for Use

Oral
Rheumatoid arthritis
Adult: 15 mg daily. May adjust dose depending on the response and severity of patient condition, may be reduced to 7.5 mg daily. Max: 15 mg daily.
Elderly: 7.5 mg daily.
Renal impairment: Patient on dialysis: As tab: Max: 7.5 mg daily.
Hepatic impairment:
Severe: Contraindicated.

Oral
Ankylosing spondylitis
Adult: 15 mg daily. May adjust dose depending on the response and severity of patient condition, may be reduced to 7.5 mg daily. Max: 15 mg daily.
Elderly: 7.5 mg daily.
Renal impairment: Patient on dialysis: As tab: Max: 7.5 mg daily.
Hepatic impairment:
Severe: Contraindicated.

Oral
Osteoarthritis
Adult: As tab: 7.5 mg daily, may be increased to Max of 15 mg daily if necessary. As capsule: 5 mg daily. Max: 10 mg daily.
Renal impairment: Patient on dialysis: As tab: Max: 7.5 mg daily. As cap: Max: 5 mg daily.
Hepatic impairment:
Severe: Contraindicated.

Oral
Juvenile idiopathic arthritis
Child: ≥60 kg: 7.5 mg once daily.
Administration
May be taken with or without food. May be taken w/ meals if GI discomfort occurs.
Contraindications
Hypersensitivity to meloxicam, aspirin or other NSAIDs. History of or active gastrointestinal bleeding, ulceration or perforation related to NSAID use. Active inflammatory bowel disease (e.g. Crohn's disease of ulcerative colitis), severe heart failure. Treatment of perioperative pain in the setting of CABG surgery. Severe hepatic impairment. Pregnancy (3rd trimester) and lactation.
Special Precautions
Patient with asthma, history of or recent ulcer disease or gastrointestinal bleeding, hypertension, recent MI, other CV risk factors (e.g. hyperlipidaemia, diabetes mellitus, smoking), fluid retention and oedema, hypovolaemia, coagulopathy. Dehydrated and debilitated patient. Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy (1st-2nd trimester). Concomitant use of other NSAIDs, corticosteroids, antiplatelets, anticoagulants. Patient Counselling This drug may cause minimal visual disturbances, vertigo or drowsiness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure during initial treatment and throughout therapy, CBC and chemistry profile periodically (prolonged use), occult blood loss, liver function tests and renal function (e.g. urine output, serum BUN and creatinine). Monitor for signs or symptoms of gastrointestinal bleeding and ototoxicity.
Adverse Reactions
Significant: Fluid retention, oedema, renal insufficiency, acute renal failure, renal papillary necrosis (prolonged use), hyperkalemia, blurred vision, anaemia, rarely, agranulocytosis, thrombocytopenia, leukopaenia. Cardiac disorders: Cardiac failure, rarely, palpitations. Gastrointestinal disorders: Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea, melaena, haematemesis, ulcerative stomatitis, rarely, gastritis. General disorders and administration site conditions: Malaise, fatigue. Immune system disorders: Angioedema. Investigations: Increased serum transaminase levels, increased serum bilirubin, increased serum creatinine and BUN, weight gain or loss. Metabolism and nutrition disorders: Hyperkalaemia, dehydration. Nervous system disorders: Headache, vertigo, paraesthesia. Psychiatric disorders: Anxiety, abnormal dreams, confusion, depression, nervousness. Renal and urinary disorders: Haematuria, albuminuria. Skin and subcutaneous tissue disorders: Pruritus, rash, photosensitivity, rarely, urticaria. Vascular disorders: Hypertension, hypotension, vasculitis, hot flushes, syncope.
Potentially Fatal: Hypersensitivity reactions, CV thrombotic events including MI and stroke, gastrointestinal bleeding, ulceration or perforation; very rarely, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatitis, liver necrosis, hepatic failure, bronchospasm.
ROUTE(S) : PO: C
ROUTE(S) : PO: D Avoid during 3rd trimester or near delivery
Overdosage
Symptoms: Lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely, hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, CV collapse, and cardiac arrest. Management: Initiate symptomatic and supportive treatment. Administration of activated charcoal and/or induction of emesis may be considered within 4 hours of ingestion. May administer 4 g oral colestyramine for accelerated clearance.
Drug Interactions
Increased risk of gastrointestinal ulceration or bleeding with anticoagulants (e.g. heparin, warfarin), antiplatelet agents, SSRIs, corticosteroids (e.g. glucocorticoids), salicylates, other NSAIDs (including aspirin). May decrease antihypertensive effects of diuretics, ACE inhibitors, angiotensin II antagonists and β-blockers. May enhance nephrotoxicity of calcineurin inhibitors (e.g. ciclosporin, tacrolimus). Increased serum concentration of lithium, digoxin and methotrexate. Increased elimination with colestyramine.
Lab Interference
May cause false-positive aldosterone/renin ratio (ARR).
Action
Meloxicam, an oxicam derivative, is NSAID that exhibits anti-inflammatory, analgesic and antipyretic activities. It reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and -2), thereby inhibiting synthesis of prostaglandins.
Absorption: Well absorbed from the gastrointestinal tract. Absolute bioavailability: 89% (cap). Time to peak plasma concentration: Within 2 hours (cap), 4-5 hours (tab).
Distribution: Volume of distribution: Approx 10 L. Plasma protein binding: Approx 99.4%, mainly to albumin.
Metabolism: Metabolised in the liver via oxidation by CYP2C9 and CYP3A4 to inactive metabolites.
Excretion: Via urine (<1% as unchanged drug), faeces as inactive metabolites. Elimination half-life: Approx 15-22 hours.
Storage
Oral: Store at 25°C. Protect from moisture.
ATC Classification
M01AC06 - meloxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.
Disclaimer: This information is independently developed by CIMS based on meloxicam from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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