ArmonAir RespiClick

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Overview

What is ArmonAir RespiClick?

The active component of ARMONAIR RESPICLICK 55 mcg, ARMONAIR RESPICLICK 113 mcg, and ARMONAIR RESPICLICK 232 mcg is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure:

Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is CHFOS. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

ARMONAIR RESPICLICK is a multidose dry powder inhaler for oral inhalation only. It contains a formulation blend of fluticasone propionate and alpha lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 11.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate. Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream.

Under standardized in vitro test conditions, the ARMONAIR RESPICLICK inhaler delivers 51 mcg, 103 mcg, or 210 mcg of fluticasone propionate with lactose from the mouthpiece when tested at a flow rate of 88 L/min for 1.4 seconds.

The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the ARMONAIR RESPICLICK inhaler was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the ARMONAIR RESPICLICK inhaler was 106.72 L/min (range: 73.64 to 125.51 L/min).

What does ArmonAir RespiClick look like?

What are the available doses of ArmonAir RespiClick?

Inhalation Powder. ARMONAIR RESPICLICK is a multidose, inhalation-driven, dry powder inhaler for oral inhalation that meters 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate from the device reservoir and delivers 51 mcg, 103 mcg, or 210 mcg of fluticasone propionate, respectively, from the mouthpiece per actuation. ARMONAIR RESPICLICK is supplied as a white dry powder inhaler with a green cap in a sealed foil pouch with desiccant.

What should I talk to my health care provider before I take ArmonAir RespiClick?

Hepatic impairment: Monitor for systemic corticosteroid effects. ()

How should I use ArmonAir RespiClick?

ARMONAIR RESPICLICK is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Important Limitation of Use

ARMONAIR RESPICLICK should be administered only by the orally inhaled route . Advise the patient to rinse his/her mouth with water without swallowing after each dose.

What interacts with ArmonAir RespiClick?

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What are the warnings of ArmonAir RespiClick?

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What are the precautions of ArmonAir RespiClick?

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What are the side effects of ArmonAir RespiClick?

Sorry No records found

What should I look out for while using ArmonAir RespiClick?

Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. ()

Severe hypersensitivity to milk proteins or any ingredients of ARMONAIR RESPICLICK. ()

What might happen if I take too much ArmonAir RespiClick?

Chronic overdosage may result in signs/symptoms of hypercorticismInhalation by healthy volunteers of a single dose of 4,000 mcg of fluticasone propionate inhalation powder or single doses of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

How should I store and handle ArmonAir RespiClick?

Store at 20° to 25°C (68° to 77°F)Protect from moisture.Store at 20° to 25°C (68° to 77°F)Protect from moisture.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Protect from Moisture.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The clinical significance of these findings is unknown.

Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.

Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately. Individual patients will experience a variable time of onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone propionate. This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic availability (<1%), and the minimal pharmacological activity of the only metabolite detected in man.

Non-Clinical Toxicology

Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. ()

Severe hypersensitivity to milk proteins or any ingredients of ARMONAIR RESPICLICK. ()

Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and co-administration of other drugs affecting blood pressure may result in pharmacodynamic interactions.

In clinical trials, the development of localized infections of the mouth and pharynx with has occurred in subjects treated with ARMONAIR RESPICLICK. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with ARMONAIR RESPICLICK continues, but at times therapy with ARMONAIR RESPICLICK may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.

Systemic and local corticosteroid use may result in the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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