Meloxicam

Standard tablets/suspension treat OA and RA signs/symptoms. Tablets cover pauciarticular/polyarticular JRA at≥60 kg; suspension covers JRA from age 2. The 5/10 mg capsules(Vivlodex formulation) are for adult OA pain.

Xifyrm treats adult moderate-to-severe pain alone or with non-NSAID analgesics. Delayed onset makes IV meloxicam unsuitable alone when rapid relief is required. Anjeso had this indication but is listed discontinued, for reasons other than safety/effectiveness.

Tablets: 7.5 mg once daily only at≥60 kg; do not use below 60 kg. Suspension: age≥2, 0.125 mg/kg once daily, max 7.5 mg; 1.5 mg/mL concentration. Higher doses gave no additional benefit. Capsule and IV pediatric safety/effectiveness are unestablished.

Standard oral products: severe renal impairment not recommended; dialysis maximum 7.5 mg/day for tablet/suspension versus 5 mg/day for 5/10 mg capsules. IV products: not recommended with moderate/severe renal insufficiency; contraindicated when such patients risk renal failure from volume depletion. Mild/moderate hepatic impairment generally needs no oral adjustment; severe disease is poorly studied and warrants caution/monitoring. IV hepatic data are limited. For IV therapy, consider dose reduction and adverse-effect monitoring in known/suspected poor CYP2C9 metabolizers; the label gives no fixed alternate regimen.

Standard tablets/suspension may be taken with or without food; gently shake suspension and measure accurately. Labels warn against assuming equivalent exposure across oral formulations. The suspension label specifically permits corresponding 7.5/15 mg standard-tablet substitution, alongside a broader non-interchangeability warning; prescriber/pharmacist must verify the exact switch. 5/10 mg capsules are not equivalent to standard tablets.

Meloxicam/product hypersensitivity, prior serious NSAID skin reaction, aspirin/NSAID-triggered asthma or allergic reactions, and CABG surgery. IV products additionally contraindicate moderate/severe renal insufficiency with volume-depletion renal-failure risk.

Selected products warn of potentially fatal MI/stroke and GI bleeding, ulceration or perforation. Risk may begin early; older adults and prior ulcer/GI-bleeding patients face greater GI risk. CABG use is contraindicated.

Oral effects include dyspepsia, diarrhea, nausea, headache and edema. IV trials commonly reported constipation, increased GGT and anemia. Severe allergy, skin reactions, hepatic/renal injury and blood disorders are reported. Overdose requires urgent supportive care; no specific antidote exists and high protein binding limits dialysis usefulness.

• Anticoagulants, aspirin, antiplatelets, SSRIs/SNRIs: monitor bleeding. Analgesic-dose aspirin/other NSAIDs are generally not recommended.
• ACE inhibitors/ARBs/beta-blockers: monitor BP; assess renal function/hydration with ACE inhibitors/ARBs.
• Diuretics: monitor renal function and diuretic/BP response.
• Lithium, methotrexate and cyclosporine: monitor toxicity; capsule label also directs digoxin-level monitoring.
• Pemetrexed: coordinate oncology-directed interruption at least 5 days before, treatment day and 2 days after; monitor toxicity at CrCl 45–79 mL/min. Standard-tablet label advises against concomitant use below 45.

Between about 20–30 weeks, use only when necessary at lowest dose/shortest duration; consider amniotic-fluid ultrasound beyond 48 hours and stop for oligohydramnios. Avoid at about 30 weeks onward. NSAIDs may reversibly delay ovulation; consider withdrawal when investigating infertility.

Human milk/infant-effect data are unavailable; individualize breastfeeding decisions. JRA age/weight limits apply by oral form; do not extrapolate to capsules/IV. Older adults face greater GI, CV and renal risk. Xifyrm also describes animal male-fertility findings of uncertain human relevance.

Analgesic/anti-inflammatory activity involves COX-1/COX-2 inhibition; the complete mechanism is not established.

Binding

Approximately 99% protein-bound.

Metabolism

Extensive hepatic metabolism; CYP2C9 with smaller CYP3A4 contribution.

Half-life

Approximately 15–20 hours orally; selected Xifyrm study mean 21 hours.

Clearance

Metabolites excreted in urine/feces; not effectively dialyzable.

• Assess pain/function and duration; IV product is not for long-term treatment.
• Monitor BP, edema and renal function/potassium in at-risk patients.
• Consider periodic CBC/chemistry with prolonged oral NSAID treatment; assess hemoglobin for anemia symptoms.
• Check GI bleeding, skin/allergy and liver-injury symptoms; pregnancy ultrasound as directed.

Seek emergency care for chest pain, focal weakness, breathing difficulty or GI bleeding. Stop for rash or liver-injury symptoms and obtain assessment. Check OTC products for NSAIDs, discuss aspirin before combining, and verify formulation each refill.

Strength / appearance

7.5 mg light-yellow round tablet.

Imprint

U and L /7.5.

Distributor

Unichem Pharmaceuticals(USA), Inc.

Example NDC

29300-124-13 ·30 tablets.

U. S. status

Prescription medicine.

Standard oral

7.5/15 mg tablets; 7.5 mg/5 mL suspension.

Selected low-dose capsule

5/10 mg; separate dose/exposure limits.

IV

Xifyrm 30 mg/mL, 1 mL single-dose vial; historical Anjeso 30 mg/mL.

Outside scope

ODT, other suspensions and combination/local-surgical products have separate labels.

Tablets: 20–25°C, dry, tight container. Selected suspension: 25°C, excursions 15–30°C, tightly closed. Capsules: 20–25°C, original tightly closed bottle for moisture protection. Xifyrm: 20–25°C, carton for light protection; inspect and discard unused vial contents.