Abstract
Meloxicam is a new enol carboxamide nonsteroidal antiinflammatory drug (NSAID). Preclinical studies have indicated that it possesses a high antiinflammatory potency and a low ulcerogenic potency. This open, randomized, crossover study was conducted to examine the effects of aspirin, the antacid Maalox (Rhone-Poulenc Rorer, Cologne, Germany), and cimetidine on the pharmacokinetics and bioavailability of a single oral dose of meloxicam 30 mg in healthy male volunteers. Plasma concentrations of meloxicam were determined and subjected to noncompartmental pharmacokinetic analysis. Meloxicam was well tolerated, and concomitant treatment with cimetidine or Maalox had little or no effect on the plasma concentration-time curves, maximum plasma concentration (Cmax), or the area under the plasma concentration-time curve (AUC0-infinity) of meloxicam. Concurrent treatment with aspirin increased plasma concentrations of meloxicam, increasing Cmax by approximately 25% and AUC0-infinity by 10%. These differences were not considered to be clinically relevant, and no adjustments of meloxicam dose should be required with coadministration of aspirin, Maalox, or cimetidine.
Publication types
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Clinical Trial
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Randomized Controlled Trial
MeSH terms
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Administration, Oral
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Adult
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Aluminum Hydroxide / adverse effects
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Aluminum Hydroxide / pharmacokinetics
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Aluminum Hydroxide / pharmacology*
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Antacids / adverse effects
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Antacids / pharmacokinetics
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Antacids / pharmacology*
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Anti-Inflammatory Agents, Non-Steroidal / adverse effects
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Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics
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Anti-Inflammatory Agents, Non-Steroidal / pharmacology*
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Anti-Ulcer Agents / adverse effects
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Anti-Ulcer Agents / pharmacokinetics
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Anti-Ulcer Agents / pharmacology*
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Aspirin / adverse effects
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Aspirin / pharmacokinetics
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Aspirin / pharmacology*
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Biological Availability
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Chromatography, High Pressure Liquid
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Cimetidine / adverse effects
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Cimetidine / pharmacokinetics
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Cimetidine / pharmacology*
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Cross-Over Studies
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Drug Combinations
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Drug Interactions
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Histamine H2 Antagonists / adverse effects
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Histamine H2 Antagonists / pharmacokinetics
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Histamine H2 Antagonists / pharmacology*
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Humans
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Magnesium Hydroxide / adverse effects
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Magnesium Hydroxide / pharmacokinetics
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Magnesium Hydroxide / pharmacology*
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Male
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Meloxicam
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Middle Aged
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Thiazines / adverse effects
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Thiazines / pharmacokinetics
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Thiazines / pharmacology*
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Thiazoles / adverse effects
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Thiazoles / pharmacokinetics
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Thiazoles / pharmacology*
Substances
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Antacids
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Anti-Inflammatory Agents, Non-Steroidal
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Anti-Ulcer Agents
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Drug Combinations
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Histamine H2 Antagonists
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Thiazines
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Thiazoles
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aluminum hydroxide, magnesium hydroxide, drug combination
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Aluminum Hydroxide
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Cimetidine
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Magnesium Hydroxide
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Aspirin
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Meloxicam