Drugplain

Wixela Inhub 250 ug/1

fluticasone propionate and salmeterol · POWDER · Mylan Pharmaceuticals Inc.

No Recall HistoryCurrently in Shortage
Plain English

Wixela Inhub is a powder containing fluticasone propionate and salmeterol at 250 ug/1, taken respiratory (inhalation). Manufactured by Mylan Pharmaceuticals Inc..

Key Facts

Brand Name
Wixela Inhub
Generic Name
fluticasone propionate and salmeterol
NDC Code (Product)
0378-9321
Manufacturer
Mylan Pharmaceuticals Inc.
Strength
250 ug/1
Dosage Form
POWDER
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
ANDA208891
Marketing Start
02/11/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

product dose omission issue1,871 reports
dyspnoea710 reports
drug ineffective701 reports
off label use665 reports
device issue505 reports
cough402 reports
asthma340 reports
product use issue315 reports
wrong technique in product usage process208 reports
headache196 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Wixela Inhub ® is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma Wixela Inhub ® is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub ® should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use Wixela Inhub ® is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease Wixela Inhub ® 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), inc…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Wixela Inhub ® should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. More frequent administration or a greater number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of Wixela Inhub ® is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using Wixela Inhub ® should not use additional LABA for any reason. [See Warnings and Precautions (5.3 , 5.12) .] For oral inhalation only. ( 2 ) • Treatment of asthma in patients aged 12 years and older: 1 inhalation of Wixela Inhub ® 100/50, Wixela Inhub ® 250/50, or Wixela Inhub ® 500/50 twice daily. Starting dosage is based on asthma severity. ( 2.1 ) • Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of Wixela Inhub ® 100/50 twice daily. ( 2.1 ) • Maintenance treatment of COPD: 1 inhalation of Wixela Inhub ® 250/50 twice daily. ( 2.2 ) 2.1 Asthma If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -…

Contraindications

4 CONTRAINDICATIONS The use of Wixela Inhub ® is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions (5.2) ] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precautions (5.11) , Adverse Reactions (6.3) , Description (11) ] . • Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. ( 4 ) • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Fluticasone propionate and salmeterol inhalation powder has been used concomitantly with other drugs, including short-acting beta 2 -agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD without adverse drug reactions [see Clinical Pharmacology (12.2) ] . No formal drug interaction trials have been performed with fluticasone propionate and salmeterol inhalation powder. • Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. 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 Wixela Inhub ® , ar…

Adverse Reactions

6 ADVERSE REACTIONS Use of LABA may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ] • Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12) ] Systemic and local corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions (5.4) ] • Pneumonia in patients with COPD [see Warnings and Precautions (5.5) ] • Immunosuppression [see Warnings and Precautions (5.6) ] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8) ] • Reduction in bone mineral density [see Warnings and Precautions (5.13) ] • Growth effects [see Warnings and Precautions (5.14) ] • Glaucoma and cataracts [see Warnings and Precautions (5.15) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (incidence ≥ 3%) include: • Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysph…

Frequently Asked Questions

What is Wixela Inhub used for?

Wixela Inhub contains fluticasone propionate and salmeterol. It is a powder taken respiratory (inhalation). Consult your doctor for specific uses.

Is Wixela Inhub a controlled substance?

Wixela Inhub is not classified as a controlled substance by the DEA.

What is the generic name for Wixela Inhub?

The generic name for Wixela Inhub is fluticasone propionate and salmeterol. There are 10 other brand versions of fluticasone propionate and salmeterol.

What is the NDC code for Wixela Inhub 250 ug/1?

The NDC (National Drug Code) for Wixela Inhub 250 ug/1 is 0378-9321, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-9321

Package NDC

0378-9321-32

Other Wixela Inhub Dosages

Other Fluticasone Brands

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

Data from openFDA · Public domain (CC0 1.0)