ArmonAir Digihaler
ArmonAir Digihaler Uses, Dosage, Side Effects, Food Interaction and all others data.
ArmonAir Digihaler propionate is a glucocorticoid with high topical anti-inflammatory potency, but a low HPA-axis suppressive activity after dermal administration. It, therefore, has a therapeutic index which is greater than most of the commonly available steroids. ArmonAir Digihaler propionate has a high degree of selectivity for the glucocorticoid receptor. In vitro studies show that fluticasone propionate has a strong affinity for, and agonist activity at, human glucocorticoid receptors. This receptor is believed to be responsible for the anti-inflammatory properties of glucocorticoids.
ArmonAir Digihaler propionate has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the ArmonAir Digihaler propionate glucocorticoid-receptor complex is approximately 10 hours.
Systemically, in vitro experiments show ArmonAir Digihaler furoate activates glucocorticoid receptors, inhibits nuclear factor kappa b, and inhibits lung eosinophilia in rats. ArmonAir Digihaler propionate performs similar activity but is not stated to affect nuclear factor kappa b. ArmonAir Digihaler propionate as a topical formulation is also associated with vasoconstriction in the skin.
Trade Name | ArmonAir Digihaler |
Availability | Prescription only |
Generic | Fluticasone |
Fluticasone Other Names | Fluticason, Fluticasona, Fluticasone, Fluticasonum |
Related Drugs | Dupixent, Xolair, ProAir Digihaler, dexamethasone, prednisolone, Symbicort, Breo Ellipta, Decadron, Ventolin, Xopenex |
Type | Inhalation Powder, Metered, Inhalation Aerosol |
Formula | C22H27F3O4S |
Weight | Average: 444.51 Monoisotopic: 444.158215012 |
Protein binding | Fluticasone furoate is >99% protein bound in serum and may be as high as 99.6%. Fluticasone propionate is 99% protein bound in serum. Topical Fluticasone propionate is only 91% protein bound in serum however. |
Groups | Approved, Experimental |
Therapeutic Class | Fluticasone & combined preparations topical |
Manufacturer | |
Available Country | United States |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
ArmonAir Digihaler Propionate is used for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive eczema or dermatitis.
ArmonAir Digihaler is also used to associated treatment for these conditions: Asthma, Bronchostenosis, Skin discomfort, Moderate, severe Chronic Obstructive Pulmonary Disease (COPD)
How ArmonAir Digihaler works
ArmonAir Digihaler furoate and ArmonAir Digihaler propionate work through an unknown mechanism to affect the action of various cell types and mediators of inflammation. In vitro experiments show ArmonAir Digihaler furoate activating glucocorticoid receptors, inhibiting nuclear factor kappa b, and inhibiting lung eosinophilia in rats. ArmonAir Digihaler propionate performs similar activity but is not stated to affect nuclear factor kappa b.
Dosage
ArmonAir Digihaler dosage
Cream: Apply a thin layer of ArmonAir Digihaler propionate cream to the affected skin areas once daily.
Ointment: Apply a thin layer of ArmonAir Digihaler propionate Ointment to the affected skin areas twice daily.
Side Effects
The fluticasone propionate preparations are usually well tolerated; local burning and pruritus have been reported. If signs of hypersensitivity appear, application should be stopped immediately. Prolonged and intensive treatment with potent corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, dilatation of the superficial blood vessels, hypertrichosis and hypopigmentation.
Secondary infection, particularly when occlusive dressings are used or when skin folds are involved and allergic contact dermatitis have also been reported with corticosteroid use. Exacerbation of the signs and symptoms of the dermatoses have been reported with corticosteroid use.
Prolonged use of large amounts of corticosteroids, or treatment of extensive areas, can result in sufficient systemic absorption to produce the features of hypercorticism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. In infants, the napkin may act as an occlusive dressing.
Toxicity
ArmonAir Digihaler furoate administered nasally may be associated with adrenal suppression or an increase in QTc interval though the association has not been well demonstrated in studies. ArmonAir Digihaler furoate requires no dosage adjustment in renal impairment but must be used in caution in hepatic impairment due to the elimination mechanisms. ArmonAir Digihaler furoate is not associated with carcinogenicity, mutagenicity, or impairment of fertility. There are no well controlled studies in pregnancy or lactation though animal studies have shown teratogenicity and hypoadrenalism in the offspring of treated mothers and other corticosteroids are known to be excreted in breast milk. Generally, there are no reported adverse effects with fluticasone in pregnancy. Pediatric patients should be given the lowest possible dose and monitored for reduction in growth velocity. There is insufficient evidence to determine whether geriatric patients respond differently to other patients. Systemic exposure may be 27-49% higher in Japanese, Korean, and Chinese patients compared to Caucasian patients. Caution should be exercised in these patients and the benefit and risk should be assessed before deciding on a treatment.
ArmonAir Digihaler propionate's use in specific populations has not been well studied. ArmonAir Digihaler propionate is not carcinogenic, mutagenic, or clastogenic, nor did it affect fertility in animal studies. Subcutaneous ArmonAir Digihaler propionate has been shown to produce teratogenic effects in rats though oral administration does not. Generally, there are no reported adverse effects with fluticasone in pregnancy. ArmonAir Digihaler propionate in human milk may cause growth suppression, effects on endogenous corticosteroid production, or other effects. Pediatric patients treated with ArmonAir Digihaler propionate ointment experienced adrenal suppression. Geriatric patients treated with ArmonAir Digihaler propionate did not show any difference in safety or efficacy compared to other patient groups, though older patients may be more sensitive to adverse effects. There is no difference in the clearance of ArmonAir Digihaler propionate across genders or race. Patients with hepatic impairment should be closely monitored due to the elimination mechanism.
Precaution
ArmonAir Digihaler propionate has a very low propensity for systemic absorption, nevertheless, prolonged application of high doses to large areas of body surface, especially in infants and small children might lead to adrenal suppression. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
The face, more than other areas of the body, may exhibit atropic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating severe eczema.
Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressing, and so the skin should be cleansed before a fresh dressing is applied.
Food Interaction
No interactions found.ArmonAir Digihaler Drug Interaction
Minor: fluticasone / salmeterol, fluticasone / salmeterol, albuterol, albuterol, budesonide / formoterol, budesonide / formoterolUnknown: omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, montelukast, montelukast, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, cetirizine, cetirizine
ArmonAir Digihaler Disease Interaction
Moderate: hepatic impairment, hyperadrenocorticism, infections, ocular herpes simplex, ocular toxicities, osteoporosis
Volume of Distribution
608L at steady state for intravenous administration of ArmonAir Digihaler furoate. Other reports suggest the mean volume of distribution at steady state is 661L. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 704L following intravenous administration.
The volume of distribution of intravenous ArmonAir Digihaler propionate is 4.2L/kg. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 577L following intravenous administration.
Elimination Route
["\"ArmonAir Digihaler Propionate (Flonase) Nasal Spray FDA Label\" href=\"#reference-F4358ArmonAir Digihaler propionate is very low but can change depending on a number of factors including integrity of the skin and the presence of inflammation or disease. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 9.0%.<\/p>\n"]Half Life
15.1 hours for intranasal ArmonAir Digihaler furoate and 24 hours for the inhaled formulation. A study of 24 healthy Caucasian males showed a half life of 13.6 hours following intravenous administration and 17.3-23.9 hours followed inhalation.
7.8 hours for intravenous ArmonAir Digihaler propionate. A study of 24 healthy Caucasian males shows a half life of 14.0 hours following intravenous administration and 10.8 hours following inhalation.
Clearance
57.8L/h for ArmonAir Digihaler furoate. A study of 24 healthy Caucasian males showed a clearance of 71.8L/h following intravenous administration.
1093mL/min for ArmonAir Digihaler propionate. A study of 24 healthy Caucasian males showed a clearance of 63.9L/h following intravenous administration.
Elimination Route
ArmonAir Digihaler furoate is eliminated ≥90% in the feces and 1-2% in the urine.
ArmonAir Digihaler propionate is mainly eliminated in the feces with
Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. The excretion of fluticasone propionate into human breast milk has not been investigated. Plasma levels in patients following dermal application of fluticasone propionate at recommended doses are likely to be low. When fluticasone propionate is used in breast feeding mothers, the therapeutic benefits must be weighed against the potential hazards to mother and baby.Pregnancy & Breastfeeding use
Contraindication
ArmonAir Digihaler propionate is contraindicated in Rosacea, Acne vulgaris, Peri-oral dermatitis, Primary cutaneous viral infections (e.g., herpes simplex, chicken pox), Hypersensitivity to any of the ingredients, Perianal and genital pruritus, etc. The use of ArmonAir Digihaler propionate is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria and dermatoses in children under one year of age, including deramtitis and napkin eruptions.
Acute Overdose
Acute overdosage is very unlikely to occur, however, in case of cronic overdosage or misuse the features of hypercorticism may appear, and in this situation, as with any corticosteroid, application should be discontinued. Overdosage by ingestion of fluticasone propionate cream or ointment is extremely unlikely to occur due to the very low oral bioavailability of fluticasone propionate.
Storage Condition
Store below 30˚ C. Do not freeze.
Innovators Monograph
You find simplified version here ArmonAir Digihaler
ArmonAir Digihaler contains Fluticasone see full prescribing information from innovator ArmonAir Digihaler Monograph, ArmonAir Digihaler MSDS, ArmonAir Digihaler FDA label