![]() There were no instances of nasal ulceration or nasal septal perforation observed in clinical trials with DYMISTA.īecause of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should avoid use of DYMISTA until healing has occurred. Instances of nasal ulceration and nasal septal perforation have been reported in patients following the nasal application of corticosteroids. In clinical trials of 2 to 52 weeks' duration, epistaxis was observed more frequently in patients treated with DYMISTA than those who received placebo. ( 5.7, 8.4)įULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Important Administration Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Somnolence 5.2 Local Nasal Effects 5.3 Glaucoma and Cataracts 5.4 Immunosuppression and Risk of Infections 5.5 Hypercorticism and Adrenal Suppression 5.6 Use of Cytochrome P450 3A4 Inhibitors 5.7Ğffect on Growth 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Central Nervous System Depressants 7.2Ĝytochrome P450 3A4 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Monitor growth routinely in pediatric patients receiving DYMISTA.
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