Neotison

Approved Indications:

• Allergic Rhinitis (Seasonal and Perennial):
  Indicated for relief of nasal symptoms including congestion, sneezing, rhinorrhea, and nasal itching in patients aged 2 years and older.
• Asthma (Maintenance Treatment):
  Used as a controller medication for asthma in patients aged 12 years and older, either as monotherapy or in combination with long-acting beta-agonists (LABAs), to reduce airway inflammation and prevent exacerbations.
• Chronic Obstructive Pulmonary Disease (COPD):
  Indicated as part of combination therapy with LABA for patients with severe COPD and a history of exacerbations.
• Eczema and Psoriasis (Topical Formulations):
  Used topically to reduce inflammation and itching in mild to moderate atopic dermatitis and plaque psoriasis.

Off-label/Clinically Accepted Uses:

• Nasal Polyps: Adjunctive treatment in nasal polyposis to reduce polyp size and symptoms.
• Other Inflammatory Skin Disorders: As directed by dermatologists for localized inflammatory dermatoses.

Intranasal (for Allergic Rhinitis):

• Adults and Adolescents (12 years and older): 1 spray (27.5 mcg) in each nostril once daily (total 55 mcg/day).
• Children (2 to 11 years): 1 spray (27.5 mcg) in each nostril once daily; use under pediatric supervision.

Inhalation (for Asthma):

• Adults and Adolescents: Typical maintenance doses range from 100 mcg to 200 mcg once daily. Maximum dose usually not exceeding 200 mcg/day.
• Administer via dry powder inhaler or other device as prescribed.

Topical (for Dermatologic Conditions):

• Apply a thin layer to affected area once or twice daily, as directed by a physician.

Special Populations:

• Elderly: No specific dosage adjustment but monitor for systemic corticosteroid effects.
• Hepatic Impairment: No dosage adjustment recommended; monitor clinically.
• Renal Impairment: No dosage adjustment necessary.

Duration:

• For allergic rhinitis, treatment may be continuous or seasonal depending on symptom duration.
• Asthma and COPD therapy is usually long-term for maintenance.
• Topical treatment duration varies based on clinical response; prolonged use should be supervised to avoid skin atrophy.

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory properties. It binds with high affinity to glucocorticoid receptors in the cytoplasm of target cells, leading to activation of anti-inflammatory genes and suppression of pro-inflammatory gene expression. This results in decreased release of inflammatory mediators such as cytokines, histamines, and prostaglandins, thereby reducing tissue inflammation, edema, and immune cell infiltration in the respiratory mucosa and skin. Its enhanced receptor binding affinity contributes to prolonged duration of action and effective symptom control.

• Absorption:
  Intranasal bioavailability is low (~0.5%) due to extensive first-pass metabolism; inhaled bioavailability is similarly low.
• Distribution:
  High plasma protein binding (>99%), mainly to albumin.
• Metabolism:
  Extensively metabolized by CYP3A4 in the liver to inactive metabolites.
• Half-life:
  Terminal elimination half-life is approximately 15 hours after inhalation.
• Elimination:
  Excreted mainly via feces (approximately 80%), with minimal renal elimination.

• Pregnancy:
  Category C (FDA). Animal studies show some risk at high doses; however, human data are limited. Use only if the potential benefit justifies the risk to the fetus. Intranasal and inhaled routes reduce systemic exposure.
• Lactation:
  Small amounts may be excreted into breast milk; the systemic absorption after intranasal or inhaled use is minimal. Use during breastfeeding only if clearly needed and after weighing benefits versus risks.

• Primary Class: Corticosteroid
• Subclass: Inhaled/Nasal/Topical glucocorticoid
• Generation: Second-generation corticosteroid with high receptor selectivity and prolonged action.

• Known hypersensitivity to fluticasone furoate or any formulation components.
• Untreated localized infections of the respiratory tract or skin (fungal, bacterial, viral).
• Acute asthma attacks or status asthmaticus requiring immediate systemic corticosteroid or bronchodilator therapy.

• Immunosuppression: Increased risk of infections; patients should avoid exposure to chickenpox or measles.
• HPA Axis Suppression: High doses or prolonged use may suppress adrenal function. Monitor in long-term therapy.
• Growth in Children: Monitor growth in pediatric patients receiving long-term inhaled corticosteroids.
• Glaucoma/Cataracts: Use with caution in patients with ocular hypertension or glaucoma; regular ophthalmologic monitoring recommended.
• Nasal Irritation/Bleeding: May cause nasal dryness, epistaxis, or irritation in intranasal use.

Common Side Effects:

• Respiratory: Nasal irritation, dryness, epistaxis, throat irritation, cough (intranasal/inhalation).
• Dermatologic: Mild burning, itching, skin thinning (topical).
• Systemic: Rare but possible adrenal suppression with prolonged high doses.

Serious/Rare Side Effects:

• Hypersensitivity reactions including anaphylaxis.
• Glaucoma and cataract development (with long-term use).
• Immunosuppression leading to opportunistic infections.

• CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir): Can increase systemic fluticasone levels, raising risk of systemic corticosteroid effects. Avoid or monitor closely.
• Other corticosteroids: Concurrent systemic corticosteroids increase risk of adrenal suppression.
• Vaccines: May reduce immune response to live vaccines; avoid live vaccines during therapy.

• Recent guidelines emphasize the use of fluticasone furoate for once-daily dosing in allergic rhinitis and asthma due to its long duration and improved patient adherence.
• Enhanced safety profile compared to older corticosteroids, with fewer systemic effects reported in newer studies.
• Ongoing research into its role in COPD management in combination therapy continues to evolve.

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Protect from moisture and direct sunlight.
• Keep inhalers and nasal sprays tightly closed when not in use.
• Do not freeze.
• Topical formulations should be stored in well-sealed containers to maintain stability.