Flunisolide (Oral Inhalation)

• If you have an allergy to flunisolide or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with flunisolide.

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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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 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 (oral inhalation).
• 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 this medicine, use a rescue inhaler and get medical help right away.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about flunisolide, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

• This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about flunisolide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using flunisolide.

Review Date: October 4, 2017

Decreases airway inflammation by suppression of endogenous inflammatory mediators (kinins, histamine, liposomal enzymes, prostaglandins). Inhibits inflammatory cell migration and reverses increased capillary permeability to decrease access of inflammatory cells to the site of inflammation; does not depress hypothalamus.

Absorption

Rapid

Distribution

Extensive; Vd: 170-350 L

Metabolism

Rapid and extensive hepatic metabolism via CYP3A4 to a minimally active metabolite (6 beta-OH flunisolide); also undergoes conjugation

Excretion

Rapid; not detectable in plasma 12-hours post dose; urine (<1% as unchanged drug)

Time to Peak

Within 5-10 minutes

Half-Life Elimination

1.3-1.7 hours

Asthma: Maintenance treatment of asthma as prophylactic therapy in patients ≥6 years.

Limitations of use: Not indicated for relief of acute bronchospasm.

Guideline recommendations:A low-dose inhaled corticosteroid (in addition to an as-needed short acting beta2-agonist) is the initial preferred long term control medication for children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a step-wise treatment approach (GINA 2017; NAEPP 2007).

Primary treatment of status asthmaticus or other acute asthma episodes

Refer to adult dosing.

Asthma: Metered-dose inhaler: Inhalation:

Note: The recommended starting dose is based upon previous asthma therapy and disease severity; may increase dose after 2 weeks of therapy in patients who are not adequately controlled.

Children 6 to 11 years: Initial: 80 mcg twice daily; maximum dose: 160 mcg twice daily

Children ≥12 years and Adolescents: Refer to adult dosing.

Asthma Guidelines (NAEPP 2007) (administer in divided doses twice daily):

Children 5 to 11 years:

“Low” dose: 160 mcg daily

“Medium” dose: 320 mcg daily

“High” dose: ≥640 mcg daily

Children ≥12 years and Adolescents: Refer to adult dosing.

Conversion: Conversion from oral systemic corticosteroids to orally inhaled corticosteroids: Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.