Mometasone is a corticosteroid sold in the U.S. under 7 brand and generic names, for facial dermatoses, foot dermatoses and hand dermatoses. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Asmanex Hfa (application NDA205641). Other mometasone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administration Information Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. After administration, advise patients to rinse the mouth with water and spit out contents without swallowing. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients ≥12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established. For oral inhalation only. ( 2 ) Instruct patients to inhale rapidly and deeply and, after administration, rinse mouth with water and spit out contents without swallowing. ( 2 ) Recommended Dosages for ASMANEX TWISTHALER Treatment Previous Therapy Recommended Starting Dose Highest Recommended Daily Dose , , , Please refer to section 2.1 for full dosage recommendations and details. Patients ≥12 years who received bronchodilators alone 220 mcg once daily in the evening 440 mcg Patients ≥12 years who received inhaled corticosteroids 220…
The following clinically significant adverse reactions are described elsewhere in the labeling: Oropharyngeal Candidiasis [see Warnings and Precautions (5.1) ] Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ] Growth Effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Glaucoma and Cataracts [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence ≥5%) are headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, and dyspepsia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience The safety data described below reflect exposure to ASMANEX TWISTHALER in 2380 patients with asthma exposed for 8 to 12 weeks and 627 patients with asthma exposed for 1 year in a total of 17 clinical trials. In adult and adolescent patients 12 years of age and older, ASMANEX TWISTHALER was studied in 10 placebo-controlled clinical trials of 8 to 12 weeks duration with a total of 1750 patients receiving ASMANEX TWISTHALER. There were…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Spray/Inhaler | Generic | $0 | View → | |
| 2 | 70/100 | Prescription | Spray/Inhaler | Generic |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Glenmark Pharmaceuticals Inc., USA · Sep 24, 2024
Asmanex Twisthaler
Defective Container
Organon Llc · May 28, 2024
Asmanex Twisthaler
Defective Container
Organon Llc · May 28, 2024
Asmanex Twisthaler
Defective Container
Organon Llc · May 28, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
ASMANEX TWISTHALER is contraindicated: Status Asthmaticus: in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity: in patients with known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER [see Warnings and Precautions (5.3) and Description (11) ]. Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Patients with a known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER. ( 4 )
In clinical studies, the concurrent administration of ASMANEX TWISTHALER and other drugs commonly used in the treatment of asthma was not associated with any unusual adverse reactions. Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects [see Clinical Pharmacology (12.3) ] . Caution should be exercised when considering the coadministration of ASMANEX TWISTHALER with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.
| $0 |
| View → |
| 3 | 70/100 | Prescription | Topical | Generic | $0 | View → |
| 4 | 70/100 | Prescription | Spray/Inhaler | Generic | $0 | View → |
| 5 | 62/100 | Prescription | Topical | Generic | $0 | View → |
| 6 | 58/100 | Over-the-counter | Spray/Inhaler | Generic | $0 | View → |
| 7 | Not yet rated | Prescription | Implant | Generic | $0 | View → |