Alvesco 80 ug/1
ciclesonide · AEROSOL, METERED · Covis Pharma US, Inc
Alvesco is a aerosol, metered containing ciclesonide at 80 ug/1, taken respiratory (inhalation). Manufactured by Covis Pharma US, Inc.
Key Facts
- Brand Name
- Alvesco
- Generic Name
- ciclesonide
- NDC Code (Product)
70515-711- Manufacturer
- Covis Pharma US, Inc
- Strength
- 80 ug/1
- Dosage Form
- AEROSOL, METERED
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA021658
- Marketing Start
- 03/26/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age. ALVESCO is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm or in pediatric patients less than 12 years of age. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2 ) Prime ALVESCO before first use or when inhaler not used for more than 10 days. ( 2 ) 1 Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions ( 5.1 )] . Previous Therapy Recommended Starting Dose Highest Recommended Dose Patients ≥ 12 years who received bronchodilators alone 80 mcg twice daily 160 mcg twice daily Patients ≥ 12 years who received inhaled corticosteroids 80 mcg twice daily 320 mcg twice daily Patients ≥ 12 years who received oral corticosteroids 1 320 mcg twice daily 320 mcg twice daily 2.1 Administration Information Administer ALVESCO by the orally inhaled route. After administration, rinse the mouth with water and spit out without swallowing to help reduce the risk of oropharyngeal candidiasis [see Warnings and Precautions ( 5.1 )] . Priming…
Contraindications
4 CONTRAINDICATIONS ALVESCO is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. patients with known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Patients with a known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS In clinical studies, concurrent administration of ciclesonide and other drugs commonly used in the treatment of asthma (albuterol, formoterol) had no effect on pharmacokinetics of des-ciclesonide [see Clinical Pharmacology ( 12.3 )] . In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see Clinical Pharmacology ( 12.3 )] . In a drug interaction study, co-administration of orally inhaled ciclesonide and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged.
Adverse Reactions
6 ADVERSE REACTIONS 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 ( 5.3 )] Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.6 )] Growth Effects [see Warnings and Precautions ( 5.7 )] Glaucoma and Cataracts [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (≥ 3%) are headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity and back pain. ( 6 ) Other adverse reactions have been reported. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience The safety data described below for adult and pediatric patients 12 years of age and older reflect exposure to ALVESCO in doses ranging from 80 mcg to 640 mcg twice daily in five double-blind placebo-controlled clinical trials. Studies with once daily dosing are …
Frequently Asked Questions
What is Alvesco used for?
Alvesco contains ciclesonide. It is a aerosol, metered taken respiratory (inhalation). Consult your doctor for specific uses.
Is Alvesco a controlled substance?
Alvesco is not classified as a controlled substance by the DEA.
What is the generic name for Alvesco?
The generic name for Alvesco is ciclesonide. There are 1 other brand versions of ciclesonide.
What is the NDC code for Alvesco 80 ug/1?
The NDC (National Drug Code) for Alvesco 80 ug/1 is 70515-711, listed by Covis Pharma US, Inc.