Nasal spray: 50 mcg Fluticasone in each puff
Indication & usage:
Flomist Nasal Spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and non-allergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of Flomist Nasal Spray in children below 4 years of age have not been adequately established.
Dosage & Administration:
Administer Flomist Nasal Spray by the intranasal route only. Prime Nasal Spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face. Shake Flomist Nasal Spray gently before each use.
Patients should use Flomist Nasal Spray at regular intervals since its effectiveness depends on its regular use. Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom relief.
The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective.
The recommended starting dosage in adolescents and children, aged 4 years and older is 1 spray in each nostril once daily (total daily dose, 100 mcg). Patients not adequately responding to 1 spray in each nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg).
The most common adverse reactions (>3%) are headache, pharyngitis, epistaxis, nasal burning/nasal irritation, nausea/vomiting, asthma symptoms, and cough.
Systemic and local corticosteroid use may result in the following:
- Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing
- Cataracts and glaucoma
- Hypercorticism and adrenal suppression
- Effect on growth
Hypersensitivity to any ingredient.
Strong cytochrome P450 3A4 inhibitors (e.g., Ritonavir, Ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.
Warning & Precautions:
- Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
- Close monitoring for glaucoma and cataracts is warranted.
- Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported after administration of FLONASE Nasal Spray. Discontinue Flomist Nasal Spray if such reactions occur.
- Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Flomist Nasal Spray slowly. Monitor growth of pediatric patients.
Pregnancy & Lactation:
Pregnancy Category C. There are no adequate and well-controlled trials with Fluticasone Propionate Nasal Spray in pregnant women.
Lactation: It is not known whether fluticasone propionate is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Since there are no data from controlled trials on the use of intranasal Flomist Nasal Spray by nursing mothers, caution should be exercised when Flomist Nasal Spray is administered to a nursing woman.
Keep this medicine upright and store below 30°C but do not freeze.
Protect from light.
Shake well before each use .
Keep out of the reach of children.
Carton containing 1HDPE bottle of 100 metered dose in each.