Flunisolide

What is Flunisolide?

• Flunisolide (Nasarel; Nasalide) nasal spray is a synthetic corticosteroid with antiinflammatory and antiallergic properties used for the treatment of the nasal symptoms of seasonal or perennial rhinitis.
• Flunisolide nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold.
• Flunisolide should not be used in the presence of nasal infection.

Flunisolide

Flunisolide ball-and-stick

What are the uses of this medicine?

• Flunisolide (Nasarel; Nasalide) is used for the treatment of the nasal symptoms of seasonal or perennial rhinitis.

Limitations of use:

• Flunisolide nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold.
• Flunisolide should not be used in the presence of nasal infection.

How does this medicine work?

• Flunisolide has demonstrated potent glucocorticoid and weak mineral corticoid activity.
• The mechanisms responsible for the anti-inflammatory action of corticosteroids and for the activity of the aerosolized drug on the nasal mucosa are unknown.
• May be it works by blocking the release of certain natural substances that cause allergy symptoms.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with hypersensitivity to any of the ingredients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• prednisone (Rayos)

Is this medicine FDA approved?

• It was patented in 1958 and approved for medical use in 1978.

How should this medicine be used?

Recommended dosage: Adults:

• The recommended starting dose of flunisolide nasal solution is 2 sprays (50 mcg) in each nostril 2 times a day (total dose 200 mcg/day).
• If needed, this dose may be increased to 2 sprays in each nostril 3 times a day (total dose 300 mcg/day).

Pediatric Patients 6 to 14 years:

• The recommended starting dose of flunisolide nasal solution is 1 spray, (25 mcg) in each nostril 3 times a day or 2 sprays (50 mcg) in each nostril 2 times a day (total dose 150 to 200 mcg/day).

• Maximum total daily doses should not exceed 8 sprays in each nostril for adults (total dose 400 mcg/day) and 4 sprays in each nostril for pediatric patients under 14 years of age (total dose 200 mcg/day).

Administration:

• Flunisolide comes as a solution (liquid) to spray in the nose.
• It is usually sprayed in each nostril 2 to 3 times a day but may be used less frequently after your symptoms are controlled.
• Use flunisolide at around the same times every day.
• An adult should help children younger than 12 years old to use flunisolide nasal spray.
• Flunisolide nasal spray is only for use in the nose.
• Do not swallow the nasal spray and be careful not to spray it into your mouth or eyes.
• Each bottle of flunisolide nasal spray should only be used by one person.
• Do not share flunisolide nasal spray because this may spread germs.
• Your symptoms may improve several days after you first use flunisolide, but it may take 1 to 2 weeks before you feel the full benefit of flunisolide.
• Flunisolide works best when used regularly.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Flunisolide Nasal Solution USP 0.025% (Nasal Spray) is supplied in a nasal pump dispenser with dust cover

This medicine is available in fallowing brand namesː

• Nasarel; Nasalide

What side effects can this medication cause?

The most common side effects of this medicine include:

• nasal burning and stinging
• nasal congestion
• sneezing
• epistaxis
• bloody mucous
• nasal irritation
• watery eyes
• sore throat
• nausea
• vomiting
• headaches

Flunisolide may cause some serious side effects:

• nasal septal perforations
• Temporary or permanent loss of the sense of smell and taste
• hypercorticism, i.e., Cushing’s syndrome

What special precautions should I follow?

• Patients should use flunisolide at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. One to 2 weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, or if the condition worsens, or if sneezing or nasal irritation occurs.
• Intranasal corticosteroids may also cause a reduction in growth velocity when administered to pediatric patients.
• Persons who are on drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids.
• Flunisolide is absorbed into the circulation. Use of excessive doses of flunisolide may suppress hypothalamic-pituitary-adrenal function. Flunisolide should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract or in untreated fungal, bacterial or systemic viral infections or ocular herpes simplex.
• The replacement of a systemic corticosteroid with topical corticoid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to flunisolide should be carefully monitored to avoid acute adrenal insufficiency in response to stress.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Flunisolide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Flunisolide nasal solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy have not been assessed in this age group.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• FLUNISOLIDE

Inactive Ingredients:

• PROPYLENE GLYCOL
• POLYETHYLENE GLYCOL
• BUTYLATED HYDROXYANISOLE
• EDETATE DISODIUM
• SODIUM CITRATE
• CITRIC ACID MONOHYDRATE
• WATER
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID
• BENZALKONIUM CHLORIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Hi-Tech Pharmacal Co., Inc.
• Amityville, NY

Manufactured for:

• Rising Pharmaceuticals, Inc.
• Allendale, NJ

What should I know about storage and disposal of this medication?

• Store between 20° to 25°C (68° to 77°F).
• KEEP OUT OF REACH OF CHILDREN.

• Dailymed label info on Flunisolide
• FDA Flunisolide

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