Rhinalar (Flunisolide)

RHINALAR®

Roche

Flunisolide Nasal Mist

Allergic Rhinitis Therapy

Action And Clinical Pharmacology: Flunisolide has demonstrated marked anti-inflammatory and antiallergic efficacy in classical animal test systems. It is a corticosteroid which is several hundred times more potent in animal anti-inflammatory assays than the cortisol standard. Clinical studies with flunisolide have shown a topical activity on the nasal mucous membrane with minimal associated systemic activity at the low spray doses administered. The improvement of symptoms is based on its direct local effect rather than on indirect effect through systemic absorption.

Indications And Clinical Uses: Treatment of perennial and seasonal allergic rhinitis when tolerance to or effectiveness of conventional treatment is unsatisfactory.

Contra-Indications: Active or quiescent tuberculosis or untreated fungal, bacterial or viral infections. Hypersensitivity to the product. Children under 6 years of age.

Manufacturers’ Warnings In Clinical States: Glucocorticoids may mask some signs of infection, and new infections may appear during their use.

Pregnancy: Safety in pregnancy has not been established. Use of Rhinalar during the first 3 months of pregnancy is not recommended. If used during the second and third trimester, weigh the expected benefits against the potential hazards to the fetus.

In patients previously on high doses of systemic corticosteroids, withdrawal of steroids may cause symptoms such as tiredness, aches and pains and depression. In severe cases, adrenal insufficiency may occur necessitating a temporary resumption of systemic corticosteroids.

Flunisolide is not recommended for those patients with a history of recurrent nasal bleeding.

Precautions: Replacement of systemic corticosteroids with flunisolide should be gradual and carefully monitored by a physician.

Although absorption sufficient to produce systemic effects has not been shown in clinical studies with flunisolide nasal mist, the potential of adrenal suppression still exists and this must be considered as a possibility with prolonged excessive usage. Patients on long-term therapy should be reassessed periodically to avoid unnecessary continued use.

Since onset of action may be somewhat slower than that of topical or oral sympathomimetic amines or antihistamines, it should be used for several days before evaluating therapy.

If beneficial effect is not evident after approximately 7 days, reevaluate the patient.

If hypersensitivity reactions occur, discontinue therapy and institute appropriate treatment.

Corticosteroid therapy can decrease resistance to localized infection. If nasopharyngeal infections occur during therapy, institute appropriate treatment.

Despite the very low absorption of flunisolide when administered intranasally, the following must be kept in mind:

a) corticosteroid effects may be enhanced in patients with hypothyroidism and in those with cirrhosis. b) in hypoprothrombinemia, acetylsalicylic acid should be used cautiously in conjunction with corticosteroids.

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

During local corticosteroid therapy, the possibility of atrophic rhinitis and/or pharyngeal candidiasis should be kept in mind.

Flunisolide should not be used during an asthmatic attack.

Because of the inhibitory effect of corticosteroids on wound healing, in patients who have had recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma, a nasal corticosteroid should be used with caution until healing has occurred.

Adverse Reactions: Side effects noted have been consistent with what one would expect in applying a topical medication to an already inflamed membrane. The most frequent adverse effect observed were aftertaste and a mild transient nasal burning and stinging. Occasionally, this was severe enough to warrant discontinuation of therapy.

Other adverse effects seen in patients, in order of decreasing prevalence were: nasal irritation, epistaxis, runny and stuffy nose, sore throat, hoarseness, throat irritation, change or loss in the sense of smell or taste and nasal septal perforation. Exceptionally, these may require discontinuation of therapy. Rarely, a permanent loss in the sense of smell and/or taste has been reported.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Acute overdosage has not been reported. When used at excessive doses, the potential of steroid effects such as hypercorticism and adrenal suppression does exist. Decreasing the dose will abolish these manifestations.

Dosage And Administration: Flunisolide nasal mist is for administration by the intranasal route only. Starting dose: adults, 2 sprays into each nostril twice daily. Increase to 3 times daily if needed. Children 6 to 14 years of age, 1 spray into each nostril 3 times daily.

Maintenance dose: After the desired clinical effect is obtained, the maintenance dose should be the smallest amount necessary to control the symptoms. Some patients may be maintained on as little as 1 spray (approximately 25 g) in each nostril/day. Patients on long-term therapy should be reassessed periodically to avoid unnecessary continued use. There is no evidence that exceeding the maximum recommended dosage is more effective. Therefore, maximum daily dose should not exceed 6 sprays in each nostril for adults and 3 sprays in each nostril for children 6 to 14 years of age.

The effect of flunisolide, unlike that of vasoconstrictors, is not immediate. Full therapeutic benefit requires regular usage. Explain the absence of an immediate effect to the patient in order to ensure cooperation and continuation of treatment with the regular dosage schedule.

In the presence of excessive nasal mucus secretion or edema of the nasal mucosa, the drug may fail to reach the site of action. In such cases, use a nasal vasoconstrictor for 2 to 3 days prior to flunisolide.

Availability And Storage: Each metered spray contains: approximately 25 g of flunisolide dissolved in an aqueous solution (0.025%) containing propylene glycol, polyethylene glycol, citric acid, sodium citrate and benzalkonium chloride as a preservative. Solution is formulated without fluorocarbons. Plastic bottles of 25 mL fitted with a metered pump device which delivers approximately 25 g of flunisolide/spray via a nozzle which is inserted into the nostril. Store at 15 to 30°C. Store bottle in an upright position.

RHINALAR® Roche Flunisolide Nasal Mist Allergic Rhinitis Therapy

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