Aerobid

Contraindications

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What is the most important information I should know about Aerobid?

AEROBID (Aerobid) Inhaler is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

Localized infections with Candida albicans or Aspergillus niger have occurred in the mouth and pharynx and occasionally in the larynx. Positive cultures for oral Candida may be present in up to 34% of patients. Although the frequency of clinically apparent infection is considerably lower, these infections may require treatment with appropriate antifungal therapy or discontinuance of treatment with AEROBID Inhaler. AEROBID Inhaler is not to be regarded as a bronchodilator and is not indicated for relief of bronchospasm.

Patients should be instructed to contact their physician immediately when episodes of asthma that are not responsive to bronchodilators occur during the course of treatment. During such episodes, patients may require therapy with systemic cortico-steroids. Theoretically, the use of inhaled corticosteroids with alternate day prednisone systemic treatment should be accompanied by more HPA suppression than a therapeutically equivalent regimen of either alone.

Transfer of patients from systemic steroid therapy to AEROBID Inhaler may unmask allergic conditions previously suppressed by the systemic steroid therapy, e.g. rhinitis, conjunctivitis, and eczema.

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 non-immune children or adults on cortico-steroids. In such children 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 the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If 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. If chicken pox develops, treatment with antiviral agents may be considered.

Undesirable effects

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What are the possible side effects of Aerobid?

Adverse events reported in controlled clinical trials and long-term open studies in 514 patients treated with Aerobid (Aerobid) are described below. Of those patients, 463 were treated for 3 months or longer, 407 for 6 months or longer, 287 for 1 year or longer, and 122 for 2 years or longer.

Musculoskeletal reactions were reported in 35% of steroid-dependent patients in whom the dose of oral steroid was being tapered. This is a well-known effect of steroid withdrawal.

Incidence 10% or greater:

Incidence 3-9%

Incidence 1-3%

Incidence less than 1%, judged by investigators as possibly or probably drug related:

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Aerobid (Aerobid) Inhaler is indicated in the maintenance treatment of asthma as prophylactic therapy. Aerobid is also indicated for asthma patients who require systemic corticosteroid administration, where adding Aerobid may reduce or eliminate the need for the systemic corticosteroids.

Aerobid Inhaler is NOT indicated for the relief of acute bronchospasm.

Treating asthma. Aerobid will not stop an asthma attack once it has started.

Aerobid is a corticosteroid. It works by reducing inflammatory reactions in the airways in response to allergens and irritants in the air.

Name of the medicinal product

Aerobid

Qualitative and quantitative composition

Aerobid (marketed as AeroBid, Nasalide, Nasarel) is a corticosteroid often prescribed as treatment for allergic rhinitishe principle mechanism of action of Aerobid is to activate glucocorticoid receptors. It also has anti-inflammatory action.

Special warnings and precautions for use

Use Aerobid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet and detailed instructions for use are available with Aerobid. Talk to your pharmacist if you have questions about this information.
• Aerobid comes with a built-in spacer. Do not use any other spacers or holding chamber devices. Open the inhaler into an "L" shape.
• Before you use the inhaler for the first time or if you have not used it for more than 2 weeks, you will need to prime the inhaler. Shake the inhaler. Point the mouthpiece away from your face and press down on the metal canister 2 times to release 2 test sprays into the air.
• Before using Aerobid, be sure that the canister is properly inserted into the inhaler unit. Remove the dust cap and inspect the mouthpiece for foreign objects before each use.
• Shake well before each inhalation.
• Hold the inhaler upright. Breathe out fully. Place the mouthpiece in your mouth and firmly close your lips around the mouthpiece. Start breathing in slowly. While breathing in, press the canister of medicine for at least 1 second. Continue to breathe in through your mouth for 3 more seconds. Remove the inhaler from your mouth but do not breathe out yet. Close your lips and hold your breath for at least 10 seconds or as long as comfortable. Breathe out slowly.
• If your doctor has prescribed 2 or more sprays at each use, wait at least 20 seconds between sprays.
• Rinse your mouth with water after each dose. Spit out the rinse water. This will help to decrease the risk of developing a fungal infection of the mouth from Aerobid.
• Do not use near open flame or while smoking.
• Keep track of the number of sprays left by using the chart that comes with Aerobid.
• With use, a white ring of residue may appear inside the spacer. This is normal and will not affect how the inhaler works. No cleaning is needed.
• Use Aerobid on a regular schedule to get the most benefit from it.
• Continue to use Aerobid even if you feel well. Do not miss any doses.
• If you miss a dose of Aerobid, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Aerobid.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications

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 beta-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 2018; NAEPP 2007).

Dosage (Posology) and method of administration

The AEROBID (Aerobid) Inhaler System is for oral inhalation only. Adults: The recommended starting dose is 2 inhalations twice daily, morning and evening, for a total daily dose of 1 mg. The maximum daily dose should not exceed 4 inhalations twice a day for a total daily dose of 2 mg. When the drug is used chronically at 2 mg/day, patients should be monitored periodically for effects on the hypothalamic-pituitary-adrenal (HPA) axis.

Pediatric Patients: For children and adolescents 6-15 years of age, two inhalations may be administered twice daily for a total daily dose of 1 mg. Higher doses have not been studied. Insufficient information is available to warrant use in children under age 6. With chronic use, pediatric patients should be monitored for growth as well as for effects on the HPA axis.

Rinsing the mouth after inhalation is advised.

Different considerations must be given to the following groups of patients in order to obtain the full therapeutic benefit ofAEROBID (Aerobid) Inhaler.

Patients Not Receiving Systemic Corticosteroids:

Patients who require maintenance therapy of their asthma may benefit from treatment with AEROBID at the doses recommended above. In patients who respond to AEROBID, improvement in pulmonary function is usually apparent within one to four weeks after the start of therapy. Once the desired effect is achieved, consideration should be given to tapering to the lowest effective dose.

Patients Maintained on Systemic Corticosteroids:

Clinical studies have shown that AEROBID may be effective in the management of asthmatics dependent or maintained on systemic corticosteroids and may permit replacement or significant reduction in the dosage of systemic corticosteroids.

The patient's asthma should be reasonably stable before treatment with AEROBID is started. Initially, AEROBID should be used concurrently with the patient's usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. Reductions may be made after an interval of one or two weeks, depending on the response of the patient. As low rate of withdrawal is strongly recommended. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal; e.g. joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with the inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly.

During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Aerobid?

No information provided.