Flunisolide, the active component of NASAREL nasal spray, is an anti-inflammatory glucocorticosteroid with the chemical name: 6(alpha)-fluoro-11(beta),16(alpha),17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone, hemihydrate. It has the following chemical structure:

Flunisolide is a white to creamy white crystalline powder with a molecular weight of 443.51 and molecular formula of C 24 H 31 FO 6 . It is soluble in acetone, sparingly soluble in chloroform, slightly soluble in methanol, and practically insoluble in water. It has a melting point of about 245°C. The octanol:water partition coefficient is 2.17 at neutral pH.

NASAREL is a metered dose manual pump spray unit containing 0.025% w/w flunisolide in an aqueous medium containing benzalkonium chloride, butylated hydroxytoluene, citric acid, edetate disodium, polyethylene glycol 400, polysorbate 20, propylene glycol, sodium citrate dihydrate, sorbitol and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH to a target of 5.2. Each 25 mL spray bottle contains 6.25 mg of flunisolide.

After initial priming (5 to 6 sprays), each spray of the pump spray unit delivers a metered spray of 100 mg formulation containing 29 mcg of flunisolide. The size of 99.5% of the droplets produced by the unit is greater than 8 microns. The contents of one nasal spray bottle delivers 200 sprays in addition to the priming sprays.

Last updated on RxList: 12/8/2004

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

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.

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

Last updated on RxList: 12/8/2004

The adverse events rates listed below are based on symptoms spontaneously reported in multidose controlled clinical trials in comparing NASAREL and NASALIDE for treatment of allergic rhinitis. In patients receiving NASAREL the most common adverse events were transient aftertaste (17%) and transient nasal burning and stinging (13%). These symptoms did not usually interfere with treatment.

Adverse Event Rates for NASAREL:

Incidence Greater than 1% (probably causally related)

Respiratory: Nasal burning/stinging (13%), epistaxis *, nasal dryness, pharyngitis, cough increased

Gastrointestinal: Nausea

Special Senses: Aftertaste (17%)

Incidence 1% or Less (probably causally related)

Respiratory: Hoarseness

Special Senses: Abnormal sense of smell

Incidence 1% or Less (causal relationship unknown) *

Respiratory: Sinusitis

Adverse Event Rates for NASALIDE:

Incidence Greater than 1% (probably causally related)

Respiratory: Nasal burning/stinging (44%), epistaxis *, nasal dryness *, pharyngitis *, cough increased

Gastrointestinal: Nausea

Special Senses: Aftertaste (8%)

Incidence 1% or Less (probably causally related)

Respiratory: Hoarseness, nasal ulcer

Incidence 1% or Less (causal relationship unknown)  

Respiratory: Sinusitis
________________________________________
*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.
  Reactions occurred under circumstances where the causal relationship has not been clearly established; they are presented as alerting information for physicians.
Cases of growth suppression have been reported for intranasal corticosteroids (including NASAREL) (see PRECAUTIONS, Pediatric Use section).

No information provided.

Last updated on RxList: 12/8/2004

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 NASAREL should be carefully monitored to avoid acute adrenal insufficiency in response to stress.

Careful attention must also be given to patients who have associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteroids may exacerbate their symptoms.

The use of NASAREL with systemic prednisone as alternate day therapy or with daily doses of less than 7.5 mg could increase the likelihood of hypothalamic-pituitary-adrenal axis suppression compared to a therapeutic dose of either one alone. Therefore, NASAREL treatment should be used with caution in patients already on prednisone regimens for any disease.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in nonimmune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a nonimmune patient is exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package insert for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered.

General:   Intranasal corticosteroids may also cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS, Pediatric Use section).

Symptomatic relief may not occur in some patients for as long as 2 weeks. Although systemic effects are minimal at recommended doses, NASAREL should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. In clinical studies with flunisolide administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops it may require treatment with appropriate local therapy or discontinuance of treatment with NASAREL. Since there is no evidence that exceeding the maximum recommended dose of NASAREL is more effective, higher doses should be avoided. Patients should be advised to clear their nasal passages of secretions prior to use. NASAREL should not be used in the presence of untreated local infection involving the nasal mucosa. Flunisolide should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, fungal, bacterial or systemic viral infections or ocular herpes simplex.

As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances with the use of flunisolide nasal sprays. Temporary or permanent loss of the sense of smell and taste have also been reported with the use of flunisolide nasal sprays.

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

Although systemic corticoid effects typical of Cushing's syndrome are minimal with recommended doses of topical steroids, this potential increases with excessive doses. If recommended doses are exceeded with long-term use, or if individuals are particularly sensitive, symptoms of hypercorticism could occur including suppression of hypothalamic-pituitary-adrenal function and/or retardation of growth in pediatric patients. Therefore, larger than recommended doses of NASAREL should be avoided.

Carcinogenesis:  Long-term studies were conducted in mice and rats using oral administration to evaluate the carcinogenic potential of the drug. Flunisolide was administered to mice at doses of 5, 50 and 500 mcg/kg/day (15, 150 and 1500 mcg/m 2 respectively), and to rats at doses of 0.5, 1 and 2.5 mcg/kg/day (3.0, 5.9 and 14.8 mcg/m 2 respectively). There was an increase in the incidence of benign pulmonary adenomas in mice, but not in rats. Female rats receiving the highest oral dose had an increased incidence of mammary adenocarcinoma compared to control rats. An increased incidence of this tumor type has been reported for other corticosteroids.

Impairment of Fertility:  Female rats receiving high doses of flunisolide (200 mcg/kg/day or 1180 mcg/m 2 body surface area) showed some evidence of impaired fertility. Reproductive performance in the low (8 mcg/kg/day or 47.2 mcg/m 2 ) and mid-dose (40 mcg/kg/day or 236 mcg/m 2 ) groups was comparable to controls.

Pregnancy:  Pregnancy Category C. As with other corticosteroids, flunisolide has been shown to be teratogenic and fetotoxic in rabbits and rats at oral doses of 40 and 200 mcg/kg/day (480 mcg/m 2 and 1180 mcg/m 2 ) respectively. 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.

Nursing Mothers:  It is not known whether this drug is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when flunisolide is administered to nursing women.

Pediatric Use:  NASAREL 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. For pediatric patients 6 years of age and over, recommended maximum daily doses should not be exceeded in order to minimize the risk of systemic corticoid effects, including potential growth retardation. (See INDIVIDUALIZATION OF DOSAGE and DOSAGE AND ADMINISTRATION) Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including NASAREL, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including NASAREL, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Geriatric Use:  Clinical studies of NASAREL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last updated on RxList: 12/8/2004

In mice, rats and dogs, intravenous flunisolide at doses up to 4 mg/kg showed no effect. One spray bottle contains 6.25 mg of flunisolide; therefore, acute overdosage is unlikely.

Hypersensitivity to any of the ingredients. NASAREL should not be used in the presence of untreated localized infection involving the nasal mucosa.

Last updated on RxList: 12/8/2004

General Pharmacology:   Flunisolide nasal spray has demonstrated potent glucocorticoid and weak mineralocorticoid activity in classical animal test systems. As a glucocorticoid it was 180 times more potent than the cortisol standard in a rat anti-granuloma assay.

Pharmacokinetics:   Flunisolide is well absorbed and is rapidly converted by the liver to the much less active primary metabolite and to glucuronide and sulfate conjugates. The primary metabolite results from the loss of the 6(alpha) fluorine and addition of a 6(beta) hydroxy group. Following administration of radiolabeled flunisolide to man, approximately half of the label is recovered in the urine and half in the stool. The primary metabolite accounts for 65% to 70% of the amount recovered in the urine. Due to first-pass liver metabolism, only 20% of an oral flunisolide dose reaches the systemic circulation unmetabolized as compared to 50% of an intranasal dose. The plasma half-life of flunisolide is 1 to 2 hours.

In a pharmacokinetic study comparing NASAREL with NASALIDE®, the original formulation, the two formulations were not bioequivalent. The total absorption of NASAREL was 25% less than that of NASALIDE, and the peak plasma concentration was 30% lower. The clinical significance of these differences is likely to be small, particularly since clinical efficacy is attributable to a local effect on nasal mucosa (see Pharmacodynamics).

Pharmacodynamics:   A study in approximately 100 patients compared control of hay fever symptoms by the recommended dose of flunisolide as NASALIDE (200 mcg/day), with control by an oral dose of flunisolide providing equivalent plasma levels. The results demonstrated that the clinical effectiveness was due to the direct topical effect of flunisolide and not to an indirect effect through systemic absorption.

The effects of flunisolide on hypothalamic-pituitary-adrenal (HPA) axis function have been studied in adult volunteers. Flunisolide as NASALIDE, the original nasal formulation, was administered to 20 subjects intranasally in average total daily doses ranging from approximately 350 mcg to 2200 mcg (equivalent to about 14 to 88 sprays per day) for 4 to 10 days. Early morning plasma cortisol concentrations and 24-hour urinary 17-ketogenic steroids were measured daily. There was no consistent effect on endogenous cortisol production, although evidence of mild adrenal suppression was seen in some subjects.

Controlled studies evaluated adult patients receiving average total daily doses ranging from approximately 50 to 400 mcg (equivalent to about 2 to 16 sprays per day) of NASALIDE, the original flunisolide nasal spray, for periods as long as 3 months. Three hundred and thirty-nine patients from these studies were entered into a long-term open label study. Morning plasma cortisol levels were available for 182 patients at baseline, 129 after 6 months, and 36 after 12 months of continuous treatment with flunisolide. No effect of flunisolide on cortisol production was detected.

The mechanisms responsible for anti-inflammatory action of corticosteroids and for their effect on the nasal mucosa are not completely understood.

CLINICAL TRIALS

The effectiveness of NASAREL was tested in 289 patients for up to 6 weeks at doses up to 300 mcg per day. NASAREL was shown to be effective in treating the symptoms of allergic rhinitis, including rhinorrhea, nasal congestion and sneezing.

A pivotal, 3-center trial involved 196 patients with seasonal allergic rhinitis randomized to NASALIDE, the vehicle of NASALIDE, NASAREL and the vehicle of NASAREL. Both active treatments were statistically significantly more effective than the vehicles. There was not statistically significant difference in efficacy between NASALIDE and NASAREL.

The two formulations do differ in the nature and incidence of adverse complaints. There were more reports of nasal burning and stinging with NASALIDE and more problems related to taste, such as aftertaste, with NASAREL, owing to the differences in their respective vehicles. Some patients may prefer one formulation to the other.

INDIVIDUALIZATION OF DOSAGE:   The therapeutic effects of corticosteroid nasal sprays, unlike those of decongestants, are not immediate. This should be explained to the patient in advance in order to ensure cooperation and continuation of treatment with the prescribed dosage regimen. Full therapeutic benefit requires regular use and is usually evident within a few days. A longer period of therapy may be required for some patients. However, NASAREL should not be continued beyond 3 weeks in the absence of significant symptomatic improvement (see PRECAUTIONS, WARNINGS, Information for Patients and ADVERSE REACTIONS sections).

A starting dose of 2 sprays in each nostril twice daily is recommended. If greater control of symptoms is needed, the dose may be increased to 2 sprays in each nostril 3 times a day. 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. Some patients with perennial rhinitis may be maintained on as little as 1 spray in each nostril per day. It is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects.

NASAREL and NASALIDE should not be considered to be identical. 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.

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). 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 the safety and efficacy have not been assessed in this age group.

Last updated on RxList: 12/8/2004

Information for Patients:   Patients should use NASAREL at regular intervals since its effectiveness depends on its regular use. Patients should take the medication as directed and should not exceed the prescribed dose. A decrease in symptoms can be expected to occur within a few days of initiating therapy in allergic rhinitis patients. Patients should contact their physician if the condition worsens, if sneezing or nasal irritation occurs, or if symptoms do not improve by 3 weeks.

Persons taking immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

For proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying Patient Instructions carefully.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FLUNISOLIDE - NASAL

(flew-NISS-oh-lide)

COMMON BRAND NAME(S): Nasalide, Nasarel

WARNING: Although this effect is uncommon, if you have switched from an oral corticosteroid (e.g., prednisone tablets) to this nasal spray within the past 12 months, or if you have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery or injury. Deaths due to low corticosteroid levels have sometimes occurred during such stresses. Tell your doctor immediately if any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) any type of corticosteroid. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress. Consult your doctor or pharmacist now for specific advice about stress situations. You may need to carry a supply of corticosteroid tablets as a precaution.

USES: Flunisolide nasal spray is used to help prevent nose symptoms such as stuffy and runny nose from hay fever (seasonal allergies). For those who must take antihistamines by mouth to control their seasonal allergies, flunisolide can be used to help decrease the dose of the medication that must be taken by mouth. This medication belongs to a class of drugs known as corticosteroids. It works to make breathing easier by reducing the swelling of the airways in the nose and sinuses.

This medication must be taken regularly to be effective. It does not work immediately and should not be used to relieve sudden allergy attacks. If an allergy attack occurs, use your antihistamine as prescribed. This medication usually takes up to 1 week to work.

HOW TO USE: This medication is inhaled into the nose using a special spray pump device. Shake the spray pump for about 10 seconds. Place the spray tip into one nostril. Tilt your head forward slightly, close the other nostril with a finger, and pump the spray quickly. Sniff gently at the same time. Repeat for the other nostril. If using more than 1 spray per nostril, repeat for each nostril.

Use this medication 2-3 times daily or as directed by your doctor. The dosage is based on your age, medical condition, and response to therapy.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. If you have any questions, ask your doctor or pharmacist.

Inform your doctor if your condition persists or worsens. If your hay fever symptoms do not improve after 3 weeks, your doctor may have you stop this medication.

SIDE EFFECTS: Sore throat, stinging/burning/dryness in the nose, nosebleeds, bad taste in the mouth, nausea, and a worsening of cough/headache/runny nose may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Tell your doctor immediately if any of these unlikely but serious side effects occur: white patches in the throat/nose, hoarse voice.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before using flunisolide nasal spray, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., beclomethasone, prednisone, dexamethasone); or if you have any other allergies.

Tell your doctor immediately if any of these unlikely but serious side effects occur: recent nose or sinus surgery, sores in the nose.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream, especially if you are younger than 6 years old and if this medication is used at higher doses. This may result in worsening of certain conditions. (See also Warning section.) Before using this medication, tell your doctor or pharmacist your medical history, especially of: untreated active fungal infections, certain eye diseases (cataracts, glaucoma, herpes of the eye), certain heart problems (e.g., congestive heart failure), high blood pressure, severe liver disease (cirrhosis), kidney disease, underactive thyroid (hypothyroidism), diabetes, stomach/intestinal problems (e.g., diverticulitis, ulcer, ulcerative colitis), brittle bones (osteoporosis), certain muscle/nerve problems (e.g., myasthenia gravis), current infections (e.g., tuberculosis, positive tuberculosis test, other herpes infections), HIV, inactive infections (e.g., Ameba, Toxoplasma, Cryptococcus), bleeding problems, history of blood clots, certain mental/mood conditions (e.g., psychosis, anxiety, depression), low salts in the blood (e.g., low potassium or calcium).

Before having surgery, tell your doctor or dentist that you are using this medication or have used it within the last 12 months.

Avoid exposure to chickenpox or measles infection while taking this medication unless you have previously had these infections (e.g., in childhood). If you are exposed to either of these infections and you have not previously had them, seek immediate medical attention.

If you have diabetes, this drug may rarely make it harder to control your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in children because there is a slight risk that it may temporarily slow down a child's growth rate, but this will probably not affect final adult height. Though this effect is rare with nasal steroids such as flunisolide, monitor your child's height regularly.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to the unborn baby when the mother was taking similar corticosteroids. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using high doses of flunisolide for an extended time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: natalizumab, other nasal sprays.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing/overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C). Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.