Bexxam 15

Bexxam 15 Special Precautions





JustRight Healthcare
Full Prescribing Info
Special Precautions
Cross-sensitivity and/or related problems: Patients who have experienced asthma, urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs should not be given Meloxicam; severe, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Carcinogenicity: No carcinogenic effect of Meloxicam was observed in rats given oral doses up to 0.8 mg/kg/day (approximately 0.4-fold the human dose of 15 mg/day for a 50 Kg adult based on body surface area conversion) for 104 weeks or in mice given oral doses up to 8.0 mg/Kg/day (approximately 2.2 - fold the human dose) for 99 weeks.
Mutagenicity: Meloxicam was not mutagenic in an Ames assay. No clastogenic effect was observed in the chromosome aberration assay with human lymphocytes or in the in vivo micronucleus test in mouse bone marrow.
Pediatrics: For treatment of osteoarthritis and rheumatoid arthritis: No information is available on the relationship of age to the effects of Meloxicam in children up to 18 years of age. Safety and efficacy have not been established.
For treatment of juvenile rheumatoid arthritis: Safety and effectiveness in pediatric patients from 2 to 17 years of age have been evaluated.
Geriatrics: As with any NSAID, caution should be exercised in treating the elderly (65 years and older). Elderly patients are at greater risk for serious gastrointestinal events. Plasma concentrations of Meloxicam and steady state pharmacokinetics in elderly men (≥65 years of age) were similar to those in young males. Elderly females (≥65 years of age) had a 47% higher AUC and 32% higher Cmax when compared to younger females (≤55 years of age). Despite the difference in total concentrations, the adverse event profiles were comparable in elderly men and elderly women.
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