FLONASE ALLERGY RELIEF Aqueous nasal spray Ref.[27773] Active ingredients: Fluticasone

Source: Health Products and Food Branch (CA)  Revision Year: 2019 

Indications and clinical use

Flonase Allergy Relief (fluticasone propionate aqueous nasal spray) is indicated for:

  • the treatment of the symptoms associated with seasonal allergic rhinitis including hay fever, and perennial rhinitis.
  • the management of sinus pain and pressure symptoms associated with allergic rhinitis.

Geriatrics (>65 years of age)

A limited number of patients 65 years of age and older have been treated with Flonase Allergy Relief in clinical trials. The adverse events reported in this population were similar to those reported in younger patients.

Pediatrics and Adolescents (<18 years of age)

Flonase Allergy Relief is not recommended for children and adolescents younger than 18 years of age.

Dosage and administration

Dosing Considerations

Flonase Allergy Relief is available without a prescription for adults and adolescents 18 years of age and older. Flonase Allergy Relief is not recommended for children under 4 years of age.

The therapeutic effects of corticosteroids, unlike those of decongestants, are not immediate. An improvement of symptoms usually becomes apparent within a few days after the start of therapy, some patients may start to feel relief as soon as the first day. However, symptomatic relief may not occur in some patients for as long as two weeks. An absence of an immediate effect should be explained to the patient. Similarly, when corticosteroids are discontinued, symptoms may not return for several days. Flonase Allergy Relief should not be continued beyond three weeks in the absence of significant symptomatic improvement.

In the presence of excessive nasal mucous secretion or edema of the nasal mucosa, the drug may fail to reach the site of action. In such cases it is advisable to use a nasal vasoconstrictor for two to three days prior to starting treatment with Flonase Allergy Relief. Patients should carefully follow the correct method of use, which is to blow the nose, then insert the nozzle carefully into the nostril, compress the opposite nostril and actuate the spray while inspiring through the nose, with the mouth closed (see PART III PATIENT MEDICATION INFORMATION). Patients should consult a pharmacist or doctor if they have difficulties or are unsure how to use Flonase Allergy Relief.

Careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids when transferred to Flonase Allergy Relief. Initially, Flonase Allergy Relief and the systemic corticosteroid must be given concomitantly, while the dose of the latter is gradually decreased. The usual rate of withdrawal of the systemic steroid is the equivalent of 1.0 mg of prednisone every four days if the patient is under close supervision. If continuous supervision is not feasible, the withdrawal of the systemic steroid should be slower, approximately 1.0 mg of prednisone (or equivalent) every ten days. If withdrawal symptoms appear, the previous dose of the systemic steroid should be resumed for a week before further decrease is attempted.

Recommended Dose and Dosage Adjustment

Adults (18 years of age and older)

The usual dosage is two sprays (50 mcg each) in each nostril once a day (total daily dosage, 200 mcg). If the patient’s symptoms are under control after one week of use, the dose should be lowered to one spray in each nostril once a day.

After three months of daily use, the patient should consult the doctor if he/she can keep using.

If the symptoms do not improve after 7 days of starting use, stop to use and consult a doctor as you may have something more than allergies, such as infections.

Pediatrics and Adolescents (<18 years of age)

Flonase Allergy Relief is not recommended in this patient population.

Geriatrics (>65 years of age)

No dosage adjustment is required in patients over 65 years of age.

Hepatic impairment

Formal pharmacokinetic trials using Flonase Allergy Relief have not been conducted in subjects with hepatic impairment. Since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. Therefore, patients with hepatic disease should be closely monitored. Renal Impairment: Formal pharmacokinetic trials using Flonase Allergy Relief have not been conducted in subjects with renal impairment.

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.

Administration

Flonase Allergy Relief should be administered only by the intranasal route. It is necessary to prepare the nasal spray by pressing down on the nozzle several times before first use or after a few days of non-use or if the nozzle has just been cleaned. Flonase Allergy Relief may be administered at any time of day. Illustrated instructions for proper use appear in PART III: PATIENT MEDICATION INFORMATION.

Overdosage

Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. However, when used chronically in excessive doses or in conjunction with other corticosteroid formulations, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of fluticasone propionate should be discontinued slowly, consistent with accepted procedures for discontinuation of chronic steroid therapy (see DOSAGE AND ADMINISTRATION).

The restoration of HPA axis function may be slow. During periods of pronounced physical stress (i.e. severe infections, trauma, surgery) a supplement with systemic steroids may be advisable.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Storage and stability

Store between 4° and 30°C. Shake gently before use.

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