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Ciclesonide

Also known as: Omnaris

Route: Nasal

2 interactions on record

Ciclesonide has 2 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Erythromycin, Ketoconazole. Patients taking Ciclesonide should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Moderate: 2

Moderate (2)

Ciclesonide + Erythromycin— Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesoni…
Ciclesonide + Ketoconazole— Co-administration of ciclesonide with ketoconazole, a potent CYP3A4 inhibitor, increased exposure (AUC) of des-ciclesoni…

Ciclesonide + Erythromycin🟡Moderate

Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of ciclesonide [see Clinical Pharmacology ( 12.3 )] .

Ciclesonide + Ketoconazole🟡Moderate

Co-administration of ciclesonide with ketoconazole, a potent CYP3A4 inhibitor, increased exposure (AUC) of des-ciclesonide approximately 3.6-fold at steady state.

Contraindications

4 CONTRAINDICATIONS OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray [see Warnings and Precautions ( 5.3 )] . Patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no data on ONMARIS nasal spray use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes . There is low systemic exposure following OMNARIS nasal spray administration at the recommended dose [see Clinical Pharmacology ( 12.3 )] . In animal reproduction studies, ciclesonide, administered by the oral route to pregnant rats, during the period of organogenesis, did not cause any evidence of fetal harm at doses up 45 times the maximum recommended human daily intranasal dose (MRHDID) of 200 mcg/day. Teratogenicity, characteristic of corticosteroids, decreased body weight and/or skeletal variations were observed in rabbit fetuses following administration of ciclesonide to pregnant rabbits by the subcutaneous route during the period of organogenesis at doses 0.5 times the MRHDID and higher on a mcg/m 2 basis (see Data ). No evidence of fetal harm was observed in rabbits at doses 0.1 times the MRHDID. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats dosed by the oral route during the period of organogenesis from gestation days 6 to 15, ciclesonide did not cause any evidence of fetal harm at doses up to 45 times the MRHDID in adults (on a mcg/m 2 basis with maternal oral dose up to 900 mcg/kg/day). Maternal toxicity, as evidenced by decreased body weight gain, was observed at 45 times the MRHDID in adults (on a mcg/m 2 basis at a maternal dose of 900 mcg/kg/day); however, no adverse effects were observed at doses 15 times the MRHDID and lower (on a mcg/m 2 basis with

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.