AirDuo RespiClick 113 ug/1

Fluticasone Propionate and Salmeterol · POWDER, METERED · Teva Respiratory, LLC

No Recall HistoryCurrently in Shortage

Plain English

AirDuo RespiClick is a powder, metered containing fluticasone propionate and salmeterol at 113 ug/1, taken respiratory (inhalation). Manufactured by Teva Respiratory, LLC.

Key Facts

Brand Name: AirDuo RespiClick
Generic Name: Fluticasone Propionate and Salmeterol
NDC Code (Product): 59310-812
Manufacturer: Teva Respiratory, LLC
Strength: 113 ug/1
Dosage Form: POWDER, METERED
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA208799
Marketing Start: 04/20/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

product dose omission issue1,560 reports

off label use275 reports

product use issue260 reports

drug ineffective234 reports

dyspnoea194 reports

cough96 reports

wrong technique in product usage process94 reports

accidental underdose85 reports

asthma77 reports

product use in unapproved indication62 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AIRDUO ® RESPICLICK ® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). Limitations of Use : AIRDUO RESPICLICK is not indicated for the relief of acute bronchospasm. AIRDUO RESPICLICK is a combination of fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). ( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) 1 inhalation of AIRDUO RESPICLICK 55 mcg/14 mcg, 113 mcg/14 mcg or 232 mcg/14 mcg twice daily. ( 2.2 ) Do not use with a spacer or volume holding chamber. ( 2.2 ) 2.1 Administration Instructions AIRDUO RESPICLICK is for oral inhalation and does not require priming. Do not use AIRDUO RESPICLICK with a spacer or volume holding chamber. Do not use more than two times every 24 hours. More frequent administration or a greater number of daily inhalations (more than one inhalation twice daily) is not recommended as some patients are more likely to experience adverse reactions with higher salmeterol dosages. Avoid the concomitant use of other long acting beta 2 -adrenergic agonist (LABAs) [see Warnings and Precautions ( 5.3 , 5.11 )]. If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. 2.2 Recommended Dosage Administer 1 inhalation of AIRDUO RESPICLICK twice daily by oral inhalation (approximately 12 hours apart at the same time every day). Rinse the mouth with water with…

Contraindications

4 CONTRAINDICATIONS AIRDUO RESPICLICK is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . patients with known severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to fluticasone propionate or any of the excipients [see Warnings and Precautions ( 5.10 ) and Description ( 11 )]. Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 ) Severe hypersensitivity to milk proteins or any ingredients of AIRDUO RESPICLICK. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS AIRDUO RESPICLICK has been used concomitantly with other drugs, including short‑acting beta 2 ‑agonists, and intranasal corticosteroids, commonly used in patients with asthma without adverse drug reactions [see Clinical Pharmacology ( 12.2 )] . No formal drug interaction trials have been performed with AIRDUO RESPICLICK. Avoid strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): May increase risk of systemic corticosteroid and cardiovascular effects. ( 7.1 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. ( 7.2 ) Beta‑blockers: Use with caution. May block bronchodilatory effects of beta‑agonists and produce severe bronchospasm. ( 7.3 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non‑potassium‑sparing diuretics may worsen with concomitant beta‑agonists. ( 7.4 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate and salmeterol, the individual components of AIRDUO RESPICLICK, are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itra…

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] Oropharyngeal candidiasis [see Warnings and Precautions ( 5.4 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.5 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Cardiovascular and central nervous system effects [see Warnings and Precautions ( 5.11 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.12 )] Growth effects in pediatrics [see Warnings and Precautions ( 5.13 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.14 )] Most common adverse reactions (greater than or equal to 3%): nasopharyngitis, oral candidiasis, headache, cough and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience in Asthma Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot b…

Frequently Asked Questions

What is AirDuo RespiClick used for?

AirDuo RespiClick contains Fluticasone Propionate and Salmeterol. It is a powder, metered taken respiratory (inhalation). Consult your doctor for specific uses.

Is AirDuo RespiClick a controlled substance?

AirDuo RespiClick is not classified as a controlled substance by the DEA.

What is the generic name for AirDuo RespiClick?

The generic name for AirDuo RespiClick is Fluticasone Propionate and Salmeterol. There are 12 other brand versions of Fluticasone Propionate and Salmeterol.

What is the NDC code for AirDuo RespiClick 113 ug/1?

The NDC (National Drug Code) for AirDuo RespiClick 113 ug/1 is 59310-812, listed by Teva Respiratory, LLC.

Product NDC

59310-812

Package NDC

59310-812-06

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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