Nasosmart-FT Nasal Spray

Manufacturer

Lenus

Marketing in India

Koronis Pharmaceutical Private Limited

Contents

fluticasone furoate.

CIMS Class

Nasal Decongestants & Other Nasal Preparations

ATC Classification

D07AC17 - fluticasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used as nasal decongestants.
R03BA05 - fluticasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticooids.

Indication & Dosage

Nasal
Treatment and prophylaxis ofallergic rhinitis
Adult: 100 mcg into each nostril once daily, increased to 100 mcg bid.
Child: >4 yr: 50 mcg into each nostril once daily, increased to 50 mcg bid.
Nasal
Nasal polyps
Adult: As propionate: 200 mcg to be instilled into each nostril 1-2 times daily for at least 4-6 wk.
Inhalation
Asthma prophylaxis
Adult: As powder or aerosol: 100-250 mcg bid in mild cases, up to 500-1000 mcg bid in severe cases.
Child: As powder or aerosol: >4 yr: Initially, 50-100 mcg bid. May increase to 200 mcg, if necessary.
Inhalation
Severe asthma
Adult: As nebuliser: 0.5-2 mg bid.
Child: As nebuliser: 4-16 yr: 1 mg bid.
Inhalation
Chronic obstructive pulmonary disease
Adult: As powder or aerosol: 500 mcg bid.
Topical/Cutaneous
Corticosteroid-responsive dermatoses
Adult: As propionate: Apply a 0.05 or 0.005% cream/ointment onto affected area.

Contraindications

Hypersensitivity. Acne vulgaris, rosacea, perioral dermatitis, skin atrophy; hypersensitivity. Primary cutaneous viral infections (e.g. herpes simplex, chicken pox), perianal and genital pruritus, primary fungal or bacterial skin infections. Inhalation: Status asthmaticus.

Special Precautions

Children, pregnancy, lactation, concomitant skin infections. Concomitant skin/lung/systemic infections. Advised to rinse mouth with water every time after inhalation. Application to large areas, broken skin or under occlusive dressings.

Adverse Drug Reactions

Topical: Pruritus, hypertrichosis, dryness, numbness of fingers, burning, eruptions, hypopigmentation, allergic contact dermatitis, secondary infection, skin atrophy, Cushing's syndrome, reversible HPA-axis suppression. Inhalation: Oropharyngeal candidiasis, pharyngitis, dysphoria, cough, rhinitis, nasal congestion and headache. Systemic absorption may be seen when applied to large areas, when skin is broken or under occlusive dressings.
Potentially Fatal: Suppression of immune system.

Drug Interactions

May lead to increased plasma concentrations of fluticasone when used with CYP4503A4 inhibitors such as ritonavir.

Pregnancy Category (US FDA)

Category C : Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Storage

Inhalation: Store at 25°C. Nasal: Store at 4-30°C. Topical/Cutaneous: Store at 15-30 °C.

Mechanism of Action

Fluticasone utilises a fluorocarbothioate ester linkage at the C17 position. It has potent vasoconstrictive and anti-inflammatory activity, but weak HPA inhibitory effect when applied topically.
Absorption: Poorly absorbed from the GI tract (oral).
Distribution: Protein-binding: 91%.
Metabolism: Extensively hepatic; converted to 17β-carboxylic acid.
Excretion: Faeces (as unchanged drug and metabolites), urine (as metabolites).

CIMS Class

Antiasthmatic & COPD Preparations / Nasal Decongestants & Other Nasal Preparations / Topical Corticosteroids

ATC Classification

D07AC17 - fluticasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
R03BA05 - fluticasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticooids.
R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used as nasal decongestants.

Presentation/Packing

Form

Packing (Max Retail Price)


Nasosmart-FT nasal spray

27.5 mcg x 1 puff x 120md (250.00 INR)