Finished product reference
Meloxicam
Tablet, Orally Disintegrating · Oral · 7.5 mg
- List code
- 53100
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning . Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.
What it is and how it works
Mechanism of Action Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of meloxicam, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Meloxicam is a potent inhibitor of prostaglandin synthesis in vitro . Meloxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.
Mechanism class: Cyclooxygenase Inhibitors
Indications
Meloxicam tablet USP is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) Rheumatoid Arthritis (RA) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg Osteoarthritis (OA Meloxicam tablets USP are indicated for relief of the signs and symptoms of osteoarthritis . Rheumatoid Arthritis (RA) Meloxicam tablets USP are indicated for relief of the signs and symptoms of rheumatoid arthritis . Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets USP are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg .
Dosage and administration (summary)
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals OA and RA : Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily JRA : 7.5 mg once daily in children ≥60 kg Meloxicam Tablets are not interchangeable with approved formulations of oral meloxicam even if the total milligram strength is the same General Dosing Instructions Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals .
Contraindications
Meloxicam is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Warnings and precautions
Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Pregnancy
Pregnancy Risk Summary Use of NSAIDs, including meloxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
Storage and supply
Meloxicam Tablets USP are available as light yellow coloured, round, biconvex tablets, plain on one side and debossed with '7.5' on other side containing meloxicam 7.5 mg or as light yellow coloured, oval shaped, biconvex tablets, plain on one side and debossed with '15' on other side containing meloxicam 15 mg.
Source: Meloxicam (Meloxicam) — US FDA prescribing information, 2024-08-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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