AVAMYS 27.5 MCG

What is AVAMYS?

AVAMYS 27.5 MCG contains FLUTICASONE FUROATE : 27.5 MCG. It is listed in the Health Canada Drug Product Database under DIN 02298589, held by GLAXOSMITHKLINE INC, supplied as SPRAY, METERED DOSE for NASAL administration. Health Canada currently lists it as marketed, status dated 22-Oct-2007. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is AVAMYS used for?

AVAMYS (fluticasone furoate nasal spray) is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients 2 years of age and older. Seasonal allergic rhinitis: also called “hay fever"; Perennial allergic rhinitis: year round allergies.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Adults and adolescents 12 years of age and older: The recommended dosage is two sprays (27.5 mcg of fluticasone furoate per spray) in each nostril once daily (total daily dose, 110 mcg). Pediatrics (2 to < 12 years of age): The recommended starting dosage is one spray (27.5 mcg of fluticasone furoate per spray) in each nostril once daily (total daily dose, 55 mcg). Patients not adequately responding to one spray in each nostril once daily (total daily dose, 55 mcg) may use two sprays in each nostril once daily (total daily dose, 110 mcg). Once adequate control of symptoms is achieved, dose reduction to one spray in each nostril once daily (total daily dose, 55 mcg) is recommended. For full therapeutic benefit, regular scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration in Seasonal Allergic Rhinitis (SAR) and as early as 24 hours after initial administration in Perennial Allergic Rhinitis (PAR). It may take several days of treatment to achieve maximum benefit. An absence of an immediate effect should be explained to the patient. Similarly, when corticosteroids are discontinued, symptoms may not return for several days. AVAMYS should be administered only by the intranasal route. It is necessary to prime the pump with 6 actuations before first use or after 30 days of non-use or if the cap has been left off for more than 5 days. AVAMYS may be administered at any time of day. Illustrated instructions for proper use appear in PATIENT MEDICATION INFORMATION. Missed Dose: If a single dose is missed, instruct the patient to take the next dose when it is due. Do not instruct the patient to take an extra dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store the device between 4 and 30°C, in the upright position with the cap in place. Do not refrigerate or freeze. Keep out of reach and sight of children.

How is it supplied?

AVAMYS 27.5 mcg is supplied in an amber glass bottle enclosed in a nasal device with a small, short nozzle and a side-actuated mist-release button to actuate the spray. Each bottle contains a net fill weight of 4.5 g or 10 g and will provide 30 or 120 metered sprays, respectively, after the initial priming. The nasal device should be discarded after the labelled amount of sprays has been used.

Contraindications

AVAMYS is contraindicated in patients with a hypersensitivity to any of its ingredients.

Warnings and precautions

Ear/Nose/Throat: Epistaxis and Nasal Ulceration, Candida albicans infection, Impaired wound healing, Nasal Septal Perforation. Endocrine and Metabolism: Hypercorticism and Adrenal Suppression, Effects on Growth. Hepatic/Biliary/Pancreatic: Fluticasone furoate undergoes extensive first-pass metabolism by the liver enzyme CYP3A4, therefore the pharmacokinetics of AVAMYS in patients with moderate and severe liver disease may be altered. Based on data with another glucocorticoid metabolized by CYP3A4, coadministration with ritonavir is not recommended because of the risk of systemic effects secondary to increased exposure to fluticasone furoate. Immune: As with all medications containing a corticosteroid, AVAMYS should be administered with caution, and only if necessary, in patients with active or quiescent tuberculosis infections of the respiratory tract; chronic or untreated infections such as systemic fungal, bacterial, viral, or parasitic; or ocular herpes simplex. Corticosteroids may mask some signs of infection and new infections may appear. A decreased resistance to localized infections has been observed during corticosteroid therapy; this may require treatment with appropriate therapy or stopping the administration of AVAMYS nasal spray. Ophthalmologic: Nasal and inhaled corticosteroids may result in the development of glaucoma, cataracts and/or central serous chorioretinopathy (CSCR). Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure (IOP), glaucoma, cataracts, and/or CSCR.

Who else supplies FLUTICASONE FUROATE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. FLUTICASONE FUROATE appears in 9252 registered pack listings across 12 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.