Nasalide Indications, Dosage, Storage, Stability - Flunisolide (Nasal Spray)

Nasalide Indications, Dosage, Storage, Stability - Flunisolide (Nasal Spray)

INDICATIONS

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

DOSAGE AND ADMINISTRATION

For adults, the recommended starting dose of NASAREL 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 NASAREL 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.NASAREL 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 present pump unit again if it has not been used for 5 days or more, or if it has been disassembled for cleaning. NASAREL and NASALIDE 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 NASAREL Nasal Spray.

WARNING

Do not spray in eyes.

HOW SUPPLIED

Each 25 mL of NASAREL 0.025% nasal spray (6.25 mg flunisolide) is supplied in a white, HDPE, spray bottle fitted with a meter pump, nasal adapter and a protective cap (NDC 59310-037-25). The unit contains 200 metered sprays and comes with a patient instruction leaflet. Store at 15° to 30°C (59° to 86°F).

CONTENTS MADE IN CANADA.

Manufactured for:
IVAX LABORATORIES INC.
Miami, FL 33137

By:
PATHEON INC.
Mississauga, Ontario
Canada L5N 7K9