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Flunisolide Nasal Solution

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Flunisolide Nasal Solution

INDICATIONS

Flunisolide nasal solution is indicated for the management of the nasal symptoms of seasonal or perennial rhinitis.

DOSAGE AND ADMINISTRATION

For adults, the recommended starting dose of flunisolide nasal solution (flunisolide nasal spray .025%) is 2 sprays (58 mcg) in each nostril 2 times a day (total dose 232 mcg/day): the effect should be assessed in 4 to 7 days (see Individualization Of Dosage section). Some relief can be expected in approximately two-thirds of patients within that time. This dose may be increased to 2 sprays in each nostril 3 times a day (total dose 348 mcg/day) if greater effect is needed. For adults, maximum total daily doses should not exceed 8 sprays in each nostril per day (464 mcg/day). After the desired clinical effect is obtained, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms (See Individualization Of Dosage section).

For pediatric patients 6 to 14 years of age, the recommended starting dose of flunisolide nasal solution (flunisolide nasal spray .025%) is one spray, (29 mcg) in each nostril 3 times a day (total dose 174 mcg/day) or 2 sprays (58 mcg) in each nostril 2 times a day (total dose 232 mcg/day). For pediatric patients 6 to 14 years of age, maximum daily doses should not exceed 4 sprays in each nostril per day (total dose 232 mcg/day) as the safety and efficacy of higher doses have not been established.

Flunisolide nasal solution (flunisolide nasal spray .025%) is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy, including possible adverse effects on growth, have not been assessed in this age group.

For priming and repriming of nasal spray unit after storage

The patient should remove the protective cap. Put two fingers on the "shoulders" and thumb on the bottom of the bottle. Push the bottle with your thumb FIRMLY and QUICKLY 5-6 times or until a fine mist appears. Now your preset pump is primed. The patient must prime the preset pump unit again if it has not been used for 5 days or more, or if it has been disassembled for cleaning.

Flunisolide nasal solution (flunisolide nasal spray .025%) (29 mcg per spray) and flunisolide nasal solution (flunisolide nasal spray .025%) (25 mcg per spray) should not be considered to be identical products. Physicians should consider the observed differences in the mean responses in terms of side effects (see ADVERSE REACTIONS) and flunisolide absorption (see Pharmacokinetics) in treating individual patients.

Directions for Use

A patient leaflet of instructions accompanies each package of Flunisolide Nasal Solution USP, 0.025% (Nasal Spray).

Warning

Do not spray in eyes

HOW SUPPLIED

Each 25 mL of Flunisolide Nasal Solution USP, 0.025% (Nasal Spray) (6.25 mg flunisolide) is supplied in a white, HDPE bottle fitted with a metered nasal spray pump, white actuator and a clear protective cap (NDC 60505-0824-0). The unit contains 200 metered sprays and comes with a patient instruction leaflet. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9. Manufactured for: Apotex Corp. Weston, FL 33326. June 2006. FDA rev date: 8/9/2007

Last reviewed on RxList: 12/30/2008
This monograph has been modified to include the generic and brand name in many instances.

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