Detailed Drug Information:

DRUG CLASS AND MECHANISM: Fluticasone propionate is a man-madesteroid of the glucocorticoid family which is related to thenaturally-occurring steroid hormone, cortisol or hydrocortisone, producedby the adrenal glands. Glucocorticoid steroids have potent anti-inflammatory actions. When used as an inhaler, fluticasone propionate goesdirectly to the airways of the lung. In asthmatic patients, thesuppression of inflammation within the airways reduces the spasm thatnarrows the airways and makes getting air into and out of the lungsdifficult. When used in lower doses, very little fluticasone propionate isabsorbed into the body. When higher doses are used, fluticasone isabsorbed and may cause side effects elsewhere in the body.

PREPARATIONS: Inhalation aerosol unit in 44 µg, 110 µgor 220 µg per actuation.

STORAGE: Fluticasone propionate should be kept at roomtemperature, 4-30°C (39-86°F) and should be shaken well beforeeach use.

PRESCRIBED FOR: Fluticasone propionate is used for the controlof asthma in persons requiring continuous treatment. Such patients mayinclude those with frequent asthmatic episodes requiring medications todilate (expand) airways or those with asthmatic episodes at night.

DOSING: Doses vary from patient to patient, but recommendationsfor inhalation are similar for most corticosteroids including fluticasonepropionate. The canister containing the fluticasone propionate should beshaken well before administering. The lungs are emptied of air bybreathing out completely. The mouthpiece is placed between the open lips,and the lips are closed firmly around the mouthpiece. The canister'sactuating valve is depressed one time while breathing in deeply andslowly. The breath is held for a count of 10, and then normal breathing isresumed. If more than a single inhalation is prescribed, a minute shouldpass between inhalations.

A tube acting as a spacer, which can be attached to the canister, may behelpful for persons who are unable to coordinate breathing in and pressingdown on the canister's valve. Following administration, the mouthshould be rinsed thoroughly with water or mouthwash which is then spit outto minimize dry mouth, irritation of the throat, and hoarseness. Theinhaler must be cleaned frequently by removing the canister and cap fromthe inhaler and then rinsing the inhaler with warm water and drying it.

If a bronchodilator aerosol spray (a spray that causes the airways toexpand), for example, albuterol (Proventil; Ventolin), is used, it shouldbe used first, and then 5 - 15 minutes later the fluticasone propionateshould be used.

DRUG INTERACTIONS: No drug interactions have been describedwith inhaled fluticasone propionate.

PREGNANCY: Adequate and well-controlled studies regarding theuse of fluticasone during pregnancy have not been done. Fluticasone useduring pregnancy should be avoided unless the potential benefit justifiesthe potential but unknown risk to the fetus.

NURSING MOTHERS: It is not known if fluticasone propionate is secreted in breast milk. Other medications in the same class asfluticasone propionate are secreted into breast milk. It is not knownwhether the small amounts that may appear in the milk are of consequenceto the infant.

SIDE EFFECTS: The most commonly noted side effects associatedwith inhaled fluticasone propionate are mild cough or wheezing; theseeffects may be minimized by using a bronchodilator inhaler (e.g. albuterolor Ventolin) first. Oral candidiasis or thrush (a fungal infection) mayoccur in between 1 in 50 and 1 in 20 persons who use fluticasonepropionate (without a spacer), the risk being higher with higher doses.The risk for candidiasis in children is lower than in adults. Using aspacer and washing the mouth out with water following each use reduces therisk of candidiasis. Hoarseness may also occur, and here also, a spacerand washing the mouth out with water following each use reduces the risk.

High doses of inhaled glucocorticoids may decrease formation andincrease break-down of bone thereby weakening bones and promotingfractures. Still higher doses may cause suppression of the body's abilityto make its own natural glucocorticoid in the adrenal gland. It ispossible that these effects are shared by higher-dose fluticasonepropionate. People with suppression of their adrenal glands (which can bediagnosed by a doctor) would need increased amounts of glucocorticoids,probably by the oral or intravenous route, during periods of high physicalstress when glucocorticoids are particularly important.