Flunisolide - Asthma Management Made Easy

Overview:

Flunisolide is an oral inhalation used to stop difficulty in breathing, tightness in the chest, wheezing, and coughing that happens in asthma in adults and children above the age of six years or older. It comes under the corticosteroids class of medicines. Flunisolide reduces swelling and irritation happening in the airways to allow breathing easily. It is a medicine used as a prophylactic for asthma. Inhalation aerosols are generally advised for asthmatic patients.

How Does the Flunisolide Work?

Flunisolide is a corticosteroid type of medication. It is sprayed directly inside the patient's nose, lowering the swelling and inflammation found in the nose caused by allergies. It shows anti-inflammatory properties in the pulmonary system of the body. It shows anti-inflammatory actions by releasing lipocortin's, and phospholipase A2 inhibitory protein; then, the arachidonic acid gets inhibited. The control of biosynthesis of leukotrienes and prostaglandins also takes place.

Flunisolide has been proven to relieve symptoms and control episodes of asthma. The exact mechanism of action of corticosteroids is not known. The inflammation of the airway is an essential factor in asthma, and Flunisolide is a corticosteroid that shows anti-inflammatory properties which inhibit the inflammation of mast cells, eosinophils, etc., which are known as inflammatory cells. It also prohibits inflammatory mediators, for example, histamine, eicosanoids, etc. These inflammatory mediators are responsible for allergic and non-allergic mediated inflammation. Such anti-inflammatory actions contribute to the efficient way of management of asthma.

How Is Flunisolide Used?

Flunisolide is an aerosol that has to be inhaled through the mouth. It is directed to take Flunisolide twice a day. It should be used at the same time every day. The directions are given on the prescription and should be read properly. If there is any doubt regarding using the medicine, should approach the pharmacist or the physician. Flunisolide should be used exactly as prescribed or directed. It should not be used less or more than the physician prescribes it. Discuss with the physician how the other oral or inhalation medicines for asthma should be used while on Flunisolide inhalation. If the patient is taking any other inhalation medicine, ask the physician if the medication should be inhaled for a specific amount of time before and after the inhalation of Flunisolide.

If the patient is taking oral steroids like Dexamethasone, Prednisone, and Methylprednisolone then the physician may gradually reduce the steroid dose beginning at least one week after the patient begins the Flunisolide inhalation.

Inhaling the Flunisolide will help the patient prevent asthma attacks but will not stop the ongoing attack. Flunisolide inhalation should not be done during an attack of asthma. The physician will prescribe a short-acting inhaler to use when an asthma attack happens.

The physician starts an average dose primarily and will adjust by increasing the dose if the symptoms worsen over time. The physician may reduce the dose once the symptoms are in control. Flunisolide has the potential to control the symptoms of asthma but does not cure it. Flunisolide may take two to four weeks or more to show effect, and the medication should not be stopped if the patient feels okay. The medication should not be stopped without asking the physician.

Dosage:

In Adults and Adolescents Aged Above 12 Years:

• Recommended Starting Dose: 160 mcg twice daily.
• Recommended the Highest Dose: 320 mcg twice daily.

In Children Six to Eleven Years of Age:

• Recommended Starting Dose: 80 mcg twice daily.
• Recommended the Highest Dose: 160 mcg twice daily.

Higher doses than mentioned doses have not been studied.

Dosage Form:

Flunisolide is supplied as an inhaled aerosol in a pressurized metered dose inhaler with a built-in spacer.

The Direction of Administration:

Flunisolide has to be administered through the inhalation route orally. It is used in asthmatic patients with age six years or older. The product in which Flunisolide is supplied for inhalation comes with a built-in spacer. Holding chamber devices or any external spacer should not be used with it. The patient should be directed to prepare the inhaler for usage by pulling the built-in purple actuator out from the gray spacer and snapping it into an “L” shape before use. Adult supervision is mandatory for the administration of the product in pediatric patients. A higher dose can be recommended for patients whose starting dose has no effect for three to four weeks.

Warning:

• Local Infections: In clinical studies with Flunisolide, localized infections such as Candida albicans or Aspergillus niger occur in the mouth and pharynx and also sometimes in the larynx. When oropharyngeal candidiasis forms, it should be treated with proper local or systemic antifungal therapy while still continuing with Flunisolide inhalation aerosol therapy, but at times therapy with Flunisolide inhalation aerosol may need to be temporarily interrupted under close medical supervision. The mouth should be rinsed after inhalation.

• Acute Asthma Episodes: Flunisolide inhalation aerosol is not under consideration as a bronchodilator and is not indicated for rapid relief of bronchospasm. During asthmatic episodes, patients may need therapy with systemic corticosteroids.

• Immunosuppression: Patients who use drugs that are responsible for suppressing the immune system are more exposed to infections than healthy individuals. For example, chickenpox and measles may have a more severe or deadly course in non-immune children. When the patient's chickenpox develops, treatment with antiviral agents can be regarded. Because of the possibility of worsening infections, the use of inhaled corticosteroids with caution should be made.

• Hypercorticism and Adrenal Suppression: In patients who respond, Flunisolide may permit control of asthmatic symptoms with less suppression of the Hypothalamus Pituitary Adrenal (HPA) axis function than therapeutically equivalent oral doses of prednisone. The beneficial effects of Flunisolide inhalation aerosol in minimizing or preventing hypothalamus pituitary adrenal axis dysfunction may be expected only when recommended dosages are not exceeded, and individual patients are titrated to the most down effective dose. Since individual sensitivity affects cortisol production, physicians must consider this data when prescribing Flunisolide inhalation aerosol. If such changes occur, decrease the Flunisolide inhalation aerosol dose gradually, uniform with accepted procedures for the management of asthma symptoms, and taper systemic corticosteroids.

• Reduction in Bone Mineral Density: Reduction in bone mineral density (BMD) has been marked with long-term administration of products containing inhaled corticosteroids, such as Flunisolide. The clinical importance of small changes in BMD with regard to long-term outcomes is not known. Patients should be observed who have major risk factors such as decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, poor nutrition, tobacco use, advanced age, chronic use of drugs that can lower bone mass (for example, anticonvulsants, and corticosteroids), and treat with established standards of care.

• Effects on Growth: Inhaled corticosteroids, such as Flunisolide, can cause a decrease in growth velocity if administered in pediatric patients. The growth pattern should be monitored in pediatric and teenage patients.

• Glaucoma and Cataracts: Glaucoma is a condition in which there is increased intraocular pressure, and cataracts are documented in patients who were under the long-term administration of inhaled corticosteroids, like Flunisolide. Patients should be monitored closely, specifically those who show a change in vision or have a record of increased intraocular pressure, glaucoma, or cataracts.

For Patients:

What Is Asthma?

Asthma is known as a condition in which the airways narrow and swell and can create extra mucus. This may make breathing difficult and trigger coughing, wheezing when you breathe out, and shortness of breath. Asthma is a condition that cannot be cured, but the symptoms of asthma can be controlled. The severity of this condition may vary from person to person.

Things to Consider:

Before the Administration of the Drug:

• The physician and the pharmacist must be informed if the patient is known to be allergic to Flunisolide, any other medications, or any of the ingredients in Flunisolide inhalation. Ask the pharmacist to provide a list of the ingredients.

• The physician and the pharmacist should be informed about all the prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products the patient is taking or plan to take. Any of the medications, such as oral steroids such as Dexamethasone, Methylprednisolone, and Prednisone, and medicines for seizures should be mentioned to the physician. The physician may need to change the doses of the medications or monitor them carefully for side effects. Many other medications can also interact with Flunisolide inhalation, so the patient should make sure to tell the physician about all the medications they are taking, even those that are not listed.

• Flunisolide should not be used when an asthma attack happens. The physician will prescribe a short-acting inhaler to use during asthma attacks. Call the physician if the patient has an asthma attack that fails to stop after using the fast-acting asthma medication or if the patient needs to use more of the fast-acting medication than usual.

• The physician should be informed if the patient has been on bedrest or could not move around for a longer timespan or if the patient or anyone in the family has or has ever had osteoporosis, tuberculosis, cataracts, or glaucoma or has any type of untreated infection anywhere in the body or a herpes eye infection.

• The physician should be informed if the patient is pregnant, plan to become pregnant, or is breastfeeding. If the patient becomes pregnant while using Flunisolide, the physician should be called.

• If the patient has surgery, even dental surgery, inform the physician or dentist.

• If the patient has any other medical conditions, such as asthma, arthritis, or eczema, they may worsen when the patient’s oral steroid dose is reduced. Tell the physician if this happens or if the patient experiences any of the symptoms during this time, such as fatigue, muscle weakness, or pain; sudden pain in the stomach, lower body, or legs; appetite loss, weight loss; upset stomach; vomiting; diarrhea; dizziness; fainting; depression; irritability; and darkening of the skin. The patient’s body may be less able to manage stress such as surgery, illness, severe asthma attack, or injury during this time. Call the physician right away if the patient gets sick, and be sure that all healthcare providers who treat the patient knows that the patient recently replaced the oral steroid with Flunisolide inhalation. A card should be carried, or medical identification bracelet should be worn to let emergency personnel know that the patient may need to be treated with steroids in an emergency.

• The physician should be informed if the patient has never had chickenpox or measles and the patient has not been vaccinated against these infections. The patients should be advised to remain at a distance from people who are sick, especially people who are suffering from chickenpox or measles. If the patient is exposed to one of these infections or if the patient develops symptoms of one of these infections, call the doctor right away. The patient may need treatment to be protected from these infections.

• The patient has to know that Flunisolide inhalation occasionally causes wheezing and difficulty breathing immediately after it is inhaled. If it happens, the fast-acting (rescue) asthma medication should be used right away, and the physician should be called immediately. The Flunisolide inhalation should not be used again unless the physician advises the patient to do so.

During the Administration of the Drug:

Unless the physician advises otherwise, the normal diet should be continued.

What Side Effects Can Flunisolide Medication Cause?

Flunisolide medication may cause certain side effects mentioned in the following:

• Patches are painful in the mouth and the throat.

• Headaches.

• Stuffy nose.

• Stuffy throat.

• Swelling of nose, sinuses, and throat.

• Nose bleeds and cough.

• Painful urination.

Some side effects can be severe such as:

• Rash.

• Hives.

• Itching.

• The tongue, face, throat, and lips are swelling.

• Difficulty breathing and swallowing.

• Chest tightness and pain.

• Vision problems.

• Fever, body aches, and chills.

• Flunisolide inhalation can cause slow growth in children. The child's physician will observe the child's growth carefully while the child is using Flunisolide inhalation. Talk to the child's physician about the risks of giving this medication to the child.

• Rarely, people who use Flunisolide inhalation for a long time may develop glaucoma or cataracts. Talk to the physician about the risks of using Flunisolide inhalation and how often the patient should have eyes examined during the treatment.

• Flunisolide inhalation may increase the risk of developing osteoporosis. Talk to the physician about the risks of using this medication.

When and Why Should This Medication Be Used?

Inhaling the Flunisolide will not stop the asthma attack but may prevent the attack from happening. The Flunisolide medication should be used as directed by the physician.

How Effective Is Flunisolide?

Flunisolide is observed to be highly effective in reducing wheezing and runny nose-like symptoms. It is also effective in controlling nasal rhinitis symptoms. It works by reducing the inflammation in the nose, which makes the patient breathe easier.

How Is Flunisolide Supplied?

Flunisolide inhalation aerosol is provided as a pressurized lined aluminum canister in boxes of one. Every canister is provided with a two-piece plastic purple actuator and gray spacer assembly, and instructions regarding the tear-off patients include a piece of patient information and an illustration.

How to Store and Dispose of Flunisolide?

When not in use, the Flunisolide inhalation aerosol should be kept away from the children. Pediatric patients should only administer Flunisolide inhalation aerosol under adult supervision. The plastic actuator that is purple in color and the gray spacer assembly provided as part of the Flunisolide inhalation aerosol shall not be used with any other product canisters, and the actuator from other products shall not be used with a Flunisolide inhalation aerosol canister. The purple actuator must not be separated from the gray spacer. This product cannot be used with any external spacer or holding chamber devices. Contents are under pressure and should not be punctured. It shall not be used or stored near heat or open flame. It should be protected from extremely cold temperatures and prolonged exposure to sunlight. If exposed to temperatures above 110°F (47°C), then it may cause flaring. It shall never be thrown into a fire or incinerator. It has to be stored at 24 °C (76 °F); expeditions allowed are from 15 to 30 °C. To get the best results, the canister should be kept at room temperature before use.

What Should Be Done in the Case of Flunisolide Overdose?

The administration of the drug should be stopped immediately, and the physician should be contacted. In severe cases, the patient should be taken to the emergency room. In some studies, no clinically deleterious effects were observed.

What Can Be Done if a Dose of Flunisolide Is Missed?

If the Flunisolide dose is missed, then the missed dose should be cut, and the regular dose should be continued as per the dosing schedule. A double dose shall not be used to make up for a missed one.

Other General Information Should Be Known About Flunisolide.

Medications are occasionally prescribed for objectives other than those listed in a patient information leaflet. The Flunisolide inhalation aerosol should not be utilized for a condition for which it was not advised. It should not be prescribed to people other than the patient, even if they have the same symptoms that the patient has. It has the potential to harm them. The patient information outlines the most significant information about Flunisolide inhalation aerosol. If the patient would like more information, then the healthcare provider should be contacted. The patients can ask their pharmacist or healthcare provider for information about the Flunisolide inhalation aerosol that is given to health professionals.

For Doctors:

Pharmacology:

• Mechanism of Action:

Flunisolide has demonstrated marked anti-inflammatory activity in classical test systems. It is a corticosteroid that many hundred times have more potential than cortisol in animal anti-inflammatory assays and many hundred times more potent than dexamethasone in anti-inflammatory effects as defined by the McKenzie skin blanching test. The clinical significance of these findings is unknown. The precise mechanism of corticosteroid action is not known. Airway inflammation is a vital component in the pathogenesis of asthma. The anti-inflammatory actions of corticosteroids can contribute to their efficacy in asthma.

• Pharmacodynamics: The dose-finding for Flunisolide inhalation aerosol was based on the comparability of systemic exposure to Flunisolide CFC inhalation aerosol. The impact of Flunisolide CFC inhalation aerosol and Flunisolide inhalation aerosol on pharmacokinetics and 12-hour plasma cortisol levels were examined in two random studies.

• Pharmacokinetics:

Absorption: Flunisolide has been quickly absorbed. Oral bioavailability is less than 7 %. Over the dose range of 80 micrograms to 320 micrograms of Flunisolide inhalation aerosol, values for Cmax increase proportionately with dose after single as well as multiple-dose administration.

Distribution: Flunisolide is broadly distributed in the body, with mean values for apparent volume of distribution in the ranges of 170 to 350 Liter after a single 320 micrograms dose of Flunisolide aerosol used for inhalation.

Metabolism: Flunisolide is rapidly and extensively metabolized after a single 320 microgram dose of Flunisolide inhalation aerosol and 0.71 microgram/milliliter after multiple doses of Flunisolide inhalation aerosol.

Elimination: When inhaled twice a day, administration of Flunisolide for up to 12 days did not result in an appreciable accumulation of Flunisolide. When multiple dosing with 160 micrograms and 320 micrograms, the Cmax values were 1.0 nanograms per milliliter and 2.1 nanograms per milliliter, respectively.

Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility:

In a study, Flunisolide at oral doses of up to 500 micrograms per kilogram per day did not demonstrate any carcinogenic effects. In a study, an administration of Flunisolide in the diet at a dose of 2.5 mcg/kg/day resulted in an increased incidence of mammary gland adenomas and islet cell adenomas of the pancreas in females. The significance of these findings for humans is unknown.

Warning and Precautions Before Prescribing:

• Local Infections: In some clinical studies with Flunisolide, localized infections with Candida albicans or Aspergillus niger have appeared in the mouth and pharynx and sometimes in the larynx. If oropharyngeal candidiasis forms, it should be treated with proper local or systemic antifungal therapy while still continuing with Flunisolide inhalation aerosol therapy, but at times therapy with Flunisolide inhalation aerosol has to be temporarily interrupted in close medical observation. Rinsing the mouth after inhalation is advised.

• Acute Asthma Episodes: Flunisolide inhalation aerosol cannot be considered a bronchodilator and is not indicated for the immediate relief of bronchospasm. Patients are being advised to contact their physician immediately when episodes of asthma that are not responsive to bronchodilators occur during the duration of treatment with Flunisolide inhalation aerosol. During such episodes, patients may need therapy with systemic corticosteroids.

• Immunosuppression: Patients who utilize drugs that stop the immune system are more sensitive to infections than individuals who are healthy. For example, chickenpox and measles may have more serious or even lethal courses in non-immune children or adults on corticosteroids. In such children or adults who do not suffer from such diseases or are adequately immunized, special care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of acquiring a disseminated infection is not known. The contribution of the underlying disease and before the corticosteroid treatment to the risk is also not known.

• Effects on Growth: Orally inhaled corticosteroids, like Flunisolide, may cause a decline in growth velocity when administered to pediatric patients. The growth should be monitored in pediatric patients.

• Glaucoma or Cataracts: The patient should visit the ophthalmologist regularly during the treatment with Flunisolide as cataracts and glaucoma may get developed in the eyes.

Indications and Uses:

Flunisolide inhalation aerosol is suggested for the treatment and management of asthma as prophylactic therapy in adult and pediatric patients of age six years and older. Flunisolide inhalation aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding Flunisolide inhalation aerosol may lower or eradicate the need for oral corticosteroids. Significant limitations are Flunisolide inhalation aerosol is not indicated for the relief of acute bronchospasm. Flunisolide inhalation aerosol is not indicated in children less than six years of age.

Dosage and Strength Forms:

Flunisolide is an inhalation aerosol in a pressurized metered dose inhaler with a built-in spacer that delivers 60 or 120-metered 80 micrograms doses.

Dosage and Administration:

• Dosage:

Adults and Adolescents of age 12 years and older:

Recommended Starting Dose: 160 mcg twice daily.

Highest Recommended Dose: 320 mg twice daily.

Children from age six to 11 years:

Recommended Starting Dose: 80 mcg twice daily.

Highest Recommended Dose: 160 mcg twice daily.

• Administration:

Flunisolide inhalation aerosol is advised to be administered orally inhaled route in asthmatic patients aged six years and older. This product contains a built-in spacer.

Considerations for Administration:

The applicable handling and disposal procedures should be followed. It has to be orally inhaled in asthmatic patients. It should be administered in pediatric patients under adult supervision. In case of emergency, the physician should be contacted, or the patient should be rushed to the emergency room in severe cases.

Contraindications: It is not recommended in the status asthmaticus immediate treatment or other acute episodes of asthma where intensive efforts are needed.

Drug Interactions: There is limited information regarding Flunisolide (inhalation) on the drug label.

Other Specifications:

• In Pregnant Women: There are insufficient and well-controlled studies of Flunisolide in pregnant women. Flunisolide inhalation aerosol is to be used while pregnancy only if the probable benefit explains the probable risk to the fetus. Some studies it has shown teratogenic effects. Hypoadrenalism can occur in infants born to mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

• Mothers who are lactating: It is unknown if Flunisolide is excreted in human milk. Because other corticosteroids are excreted in human milk, an alert should be exercised when Flunisolide inhalation aerosol is given to nursing women.

• Pediatric Use: Effects on growth can be seen, and pediatric patients should be monitored closely.

• Geriatric Use: Clinical studies of Flunisolide inhalation aerosol included some patients 60 to 78 years of age exposed to Flunisolide inhalation aerosol. These studies did not include adequate numbers of patients aged 60 years and over to decide whether they respond differently from younger patients. In general, dose selection for an older patient should be made cautiously, usually beginning at the low end of the dosing range, reflecting the greater frequency of reduced hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.