Meloxicam (Page 4 of 9)

Pediatrics

Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to meloxicam with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with meloxicam were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven (< 2%) patients receiving meloxicam. No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving Meloxicam Tablets USP in clinical trials involving approximately 16,200 patients.

Body as a Whole

allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase

Cardiovascular

angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis

Central and Peripheral Nervous System

convulsions, paresthesia, tremor, vertigo

Gastrointestinal

colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative

Heart Rate and Rhythm

arrhythmia, palpitation, tachycardia

Hematologic

leukopenia, purpura, thrombocytopenia

Liver and Biliary System

ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis

Metabolic and Nutritional

dehydration

Psychiatric

abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence

Respiratory

asthma, bronchospasm, dyspnea

Skin and Appendages

alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria

Special Senses

abnormal vision, conjunctivitis, taste perversion, tinnitus

Urinary System

albuminuria, BUN increased, creatinine increased, hematuria, renal failure

6.2 Post-Marketing Experience

The following adverse reactions have been identified during post approval use of Meloxicam Tablets USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post-marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson Syndrome and toxic epidermal necrolysis.

7 DRUG INTERACTIONS

See also Clinical Pharmacology (12.3).

7.1 ACE-Inhibitors

NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking Meloxicam Tablets USP concomitantly with ACE-inhibitors.

7.2 Aspirin

When Meloxicam Tablets USP is administered with aspirin (1000 mg 3 times daily) to healthy volunteers, an increase in the AUC (10%) and Cmax (24%) of meloxicam was noted. The clinical significance of this interaction is not known; however, as with other NSAIDs concomitant administration of meloxicam and aspirin is not generally recommended because of the potential for increased adverse effects.

Concomitant administration of low-dose aspirin with Meloxicam Tablets USP may result in an increased rate of GI ulceration or other complications, compared to use of Meloxicam Tablets USP alone. Meloxicam Tablets USP is not a substitute for aspirin for cardiovascular prophylaxis.

7.3 Diuretics

Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. However, studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect. Furosemide single- and multiple-dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam. Nevertheless, during concomitant therapy with Meloxicam Tablets USP, patients should be observed closely for signs of renal failure [see Warnings and Precautions (5.6)] , as well as to ensure diuretic efficacy.

7.4 Lithium

In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 mg to 1072 mg twice daily with meloxicam 15 mg every day as compared to subjects receiving lithium alone. These effects have been attributed to inhibition of renal prostaglandin synthesis by Meloxicam Tablets USP. Closely monitor patients on lithium treatment for signs of lithium toxicity when Meloxicam Tablets USP is introduced, adjusted or withdrawn.

7.5 Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Therefore, NSAIDs may reduce the elimination of methotrexate, thereby enhancing the toxicity of methotrexate. Use caution when Meloxicam Tablets USP are administered concomitantly with methotrexate [see Clinical Pharmacology (12.3)].

7.6 Cyclosporine

Meloxicam Tablets USP, like other NSAIDs, may affect renal prostaglandins, thereby altering the renal toxicity of certain drugs. Therefore, concomitant therapy with Meloxicam Tablets USP may increase cyclosporine’s nephrotoxicity. Use caution when Meloxicam Tablets USP is administered concomitantly with cyclosporine.

7.7 Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Monitor anticoagulant activity, particularly in the first few days after initiating or changing Meloxicam Tablets USP therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding than with the use of either drug alone. Use caution when administering Meloxicam Tablets USP with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced [see Clinical Pharmacology (12.3)].

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.