What is flunisolide used for?

Flunisolide is a prescription medicine that is used to treat asthma. Do not use flunisolide to treat an asthma attack. Use a rescue inhaler.

Description

Flunisolide Nasal Solution, USP 0.025% is intended for administration as a spray to the nasal mucosa. Flunisolide, the active component of Flunisolide Nasal Solution, is an anti-inflammatory steroid.

Flunisolide is represented by the following structural formula:

• C24H31FO6 • 1/2H2O
• Mol. Wt. 443.52

Chemical Name:

6α-fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (USAN).

Flunisolide is a white to creamy white crystalline powder. 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.

After initial priming (5 to 6 sprays), each spray of the unit delivers a metered droplet spray of 100 mg formulation containing 25 mcg of flunisolide. The size of the droplets produced by the unit is in excess of 8 microns to facilitate deposition on the nasal mucosa. The contents of one nasal spray bottle delivers 200 sprays.

Each mL contains: ACTIVE: Flunisolide 0.25 mg (0.025%); INACTIVES: Propylene Glycol, Polyethylene Glycol 3350, Butylated Hydroxyanisole, Edetate Disodium, Sodium Citrate, Citric Acid, and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (5.1–5.4). PRESERVATIVE: Benzalkonium Chloride 0.01%.

Before taking flunisolide, tell your doctor:

• If you are allergic to flunisolide; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take flunisolide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take flunisolide?

• Tell all of your health care providers that you take flunisolide. This includes your doctors, nurses, pharmacists, and dentists.
• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• If you have been taking flunisolide for many weeks, talk with your doctor before stopping. You may want to slowly stop flunisolide.
• It may take several weeks to see the full effects.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like flunisolide. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have your eye pressure checked if you are on flunisolide for a long time. Talk with your doctor.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with flunisolide may either raise the chance of an infection or make the vaccine not work as well.
• If you are 65 or older, use flunisolide with care. You could have more side effects.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using flunisolide while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is flunisolide best taken?

Use flunisolide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep using flunisolide as you have been told by your doctor or other health care provider, even if you feel well.
• For breathing in only.
• Shake well before use.
• Prime the inhaler before first use or if not used for more than 2 weeks by spraying it 2 times.
• Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
• Do not use near an open flame or while smoking. It may burst.
• Put the cap back on after you are done using your dose.
• Do not use a spacer with the inhaler.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of flunisolide that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped flunisolide.
• Redness or white patches in mouth or throat.
• Bone or joint pain.
• Change in eyesight.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using flunisolide, use a rescue inhaler and get medical help right away.

What are some other side effects of flunisolide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Throat irritation.
• Nose stuffiness.
• Runny nose.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out flunisolide?

• Store at room temperature. Do not freeze.
• Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 24208-344-25
• Flunisolide
  Nasal
  Solution,
  USP 0.025%
• FOR INTRANASAL
  USE ONLY
• Each Spray Delivers
  25 mcg Flunisolide
• 200 Metered Sprays
• Rx only
• 25 mL
• BAUSCH + LOMB

SRC: NLM .