Nasoflu

Approved Indications:

• Allergic Rhinitis (Seasonal and Perennial):
  Treatment of nasal symptoms such as congestion, rhinorrhea, sneezing, and nasal itching in adults and children (generally from 4 years of age).
• Asthma (Maintenance Therapy):
  Long-term control and prevention of asthma symptoms in patients aged 4 years and older, used alone or with long-acting beta2-agonists (LABAs).
• Chronic Obstructive Pulmonary Disease (COPD):
  As part of combination therapy for patients with a history of exacerbations.
• Nasal Polyps:
  Treatment of nasal polyps to reduce size and symptoms.
• Atopic Dermatitis and Other Dermatoses:
  Topical formulations used to reduce inflammation and pruritus.

Off-label / Clinically Accepted Uses:

• Adjunct therapy in certain upper respiratory tract inflammations.
• Use in some inflammatory skin conditions beyond labeled dermatological indications.

Intranasal Spray (Allergic Rhinitis, Nasal Polyps):

• Adults and Adolescents (12 years and older): 1-2 sprays (50 mcg each) per nostril once daily; maximum 200 mcg/day.
• Children (4-11 years): Usually 1 spray per nostril once daily; adjust per physician's advice.

Inhalation (Asthma Maintenance):

• Adults and Adolescents: Typical starting dose is 100-250 mcg twice daily; maximum 1000 mcg/day.
• Children (4-11 years): Typically 100 mcg twice daily.

Topical (Dermatological Use):

• Apply a thin layer to affected area once or twice daily as directed. Treatment duration depends on clinical response and physician guidance.

Special Populations:

• Elderly: No specific dose adjustments; monitor for side effects.
• Hepatic/Renal Impairment: No recommended dose adjustment but monitor closely.

Duration:

• Depends on indication; for allergic rhinitis, often seasonal or continuous as needed.
• For asthma and COPD, continuous long-term therapy.
• For dermatologic uses, duration is limited and monitored to prevent side effects.

Fluticasone propionate is a potent synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It binds intracellular glucocorticoid receptors, modulating gene transcription to inhibit multiple inflammatory mediators such as prostaglandins, leukotrienes, and cytokines. This reduces infiltration of inflammatory cells, mucosal edema, and hyperresponsiveness in airways and nasal passages. The result is effective suppression of symptoms related to allergic inflammation and respiratory airway constriction.

• Absorption: Poor systemic bioavailability (<2%) due to extensive first-pass metabolism after nasal or inhaled administration.
• Distribution: Highly protein-bound (>90%) mainly to albumin.
• Metabolism: Extensively metabolized by hepatic CYP3A4 enzymes to inactive metabolites.
• Half-life: Terminal half-life approximately 7-8 hours after inhalation.
• Elimination: Excreted primarily via feces, negligible renal clearance.

• Pregnancy: Category C (FDA). Animal studies have shown potential risks at high doses; human data are limited. Use only if benefits outweigh risks.
• Lactation: Minimal systemic absorption suggests low breast milk secretion; however, caution is advised during breastfeeding. Monitor infant for adverse effects.

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

• Hypersensitivity to fluticasone propionate or formulation excipients.
• Untreated systemic infections or localized infections of nasal or respiratory mucosa.
• Acute bronchospasm or status asthmaticus requiring emergency treatment.

• Risk of adrenal suppression with high doses or prolonged use.
• Possible immunosuppression leading to increased risk of infections, including fungal infections.
• Monitor pediatric patients for growth retardation during long-term inhaled therapy.
• Caution in patients with glaucoma, cataracts, or ocular hypertension.
• Nasal irritation, dryness, or epistaxis may occur with nasal formulations.

Common:

• Nasal irritation, dryness, sneezing, epistaxis (nasal use).
• Throat irritation, cough (inhaled).
• Skin thinning, burning, or itching (topical).

Serious/Rare:

• Hypersensitivity reactions including anaphylaxis.
• Adrenal insufficiency with prolonged systemic exposure.
• Glaucoma or cataracts with chronic use.
• Pneumonia risk in COPD patients.

• CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir): Increase systemic exposure, raising risk of corticosteroid side effects.
• Other corticosteroids: Concomitant use increases risk of systemic corticosteroid effects.
• Vaccines: May reduce immune response to live vaccines; avoid live vaccines during treatment.

• Emphasis on once or twice daily dosing regimens to improve adherence in allergic rhinitis and asthma.
• Ongoing evaluation of safety in long-term COPD treatment regimens.
• Guidelines support use as first-line intranasal corticosteroid for allergic rhinitis management.

• Store at 20°C to 25°C (68°F to 77°F); excursions allowed between 15°C and 30°C.
• Protect from moisture, heat, and direct sunlight.
• Keep nasal sprays and inhalers capped and clean.
• Do not freeze.
• Topical formulations stored in tightly closed containers away from heat and light.