Comment
Author: Admin | 2025-04-28
AND PRECAUTIONS].Anaphylactic ReactionsInform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].Serious Skin Reactions, Including DRESSAdvise patients to stop taking meloxicam capsules immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see WARNINGS AND PRECAUTIONS].Fetal ToxicityInform pregnant women to avoid use of meloxicam capsules and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with meloxicam capsules is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].Avoid Concomitant Use Of NSAIDsInform patients that the concomitant use of meloxicam capsules with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.Use Of NSAIDs And Low-Dose AspirinInform patients not to use low-dose aspirin concomitantly with meloxicam capsules until they talk to their healthcare provider [see DRUG INTERACTIONS].Nonclinical ToxicologyCarcinogenesis, Mutagenesis, And Impairment Of FertilityCarcinogenesisThere was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.8- and 3.9-times, respectively, the maximum recommended daily dose (MRDD) of 10 mg of meloxicam capsules based on body surface area (BSA) comparison).MutagenesisMeloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.Impairment Of FertilityIn previous studies of meloxicam, there was no impairment of male or female fertility in rats at oral doses up to 9
Add Comment