VERAMYST Nasal spray

VERAMYST ® (fluticasone furoate) Nasal Spray Initial U.S. Approval: 2007

• INDICATIONS AND USAGE

VERAMYST Nasal Spray is a corticosteroid indicated for treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children ≥ 2 years.

• DOSAGE AND ADMINISTRATION For intranasal use only. Usual starting dosages: 

1. Adults and adolescents ≥ 12 years: 110 mcg (2 sprays per nostril) once daily.
2. Children 2-11 years: 55 mcg (1 spray per nostril) once daily.
3. Priming Information: Prime VERAMYST Nasal Spray before using for the first time, when not used for more than 30 days, or if the cap has been left off the bottle for 5 days or longer.

• DOSAGE FORMS AND STRENGTHS Nasal spray: 27.5 mcg of fluticasone furoate in each 50-microliter spray. (3) Supplied in 10-g bottle containing 120 sprays.

• CONTRAINDICATIONS Hypersensitivity to ingredients.

• WARNINGS AND PRECAUTIONS

1. Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, 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. 
2. Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. 
3. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria may occur after administration of VERAMYST Nasal Spray 
4. Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. 
5. Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible indi viduals. If such changes occur, discontinue VERAMYST Nasal Spray slowly. 
6. Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving VERAMYST Nasal Spray. 

• ADVERSE REACTIONS The most common adverse reactions (>1% incidence) included headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia, and cough.
  To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

• DRUG INTERACTIONS  Potent inhibitors of cytochrome P450 3A4 (CYP 3A4) may increase exposure to fluticasone furoate. • Co-administration of ritonavir is not recommended. (5.5, 7) • Use caution with co-administration of other potent CYP 3A4 inhibitors, such as ketoconazole. (5.5, 7) 

• USE IN SPECIFIC POPULATIONS  Hepatic impairment may increase exposur e to fluticasone furoate. Use with caution in patients with severe hepatic impairment. 

Source: FDA You can also see FLONASE Fluticasone nasal spray