Nasalide

(Generic versions may still be available.)

DRUG DESCRIPTION

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 245C. 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.

What are the precautions when taking flunisolide (nasal spray) (Nasalide)?

Before using nasal flunisolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make it more...

Read All Potential Precautions of Nasalide


Nasalide Consumer (continued)

SIDE EFFECTS: Temporary nose/throat dryness or irritation, cough, nosebleeds, sneezing and unpleasant taste/smell may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these rare but serious side effects occur: loss of taste or smell, pain/sores in your nose.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as flunisolide). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor immediately if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using nasal flunisolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Rarely, infants born to mothers who have been using corticosteroids (including flunisolide) for a long time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. Discuss the risks and benefits with your doctor.

It is unknown if nasal flunisolide passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.



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