WHAT IS AEROMIDE?

Aeromide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled Aeromide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Aeromide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled Aeromide may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

Aeromide is available only with your doctor's prescription.

AEROMIDE INDICATIONS

Aeromide (Aeromide) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

Aeromide (Aeromide) is NOT indicated for the relief of acute bronchospasm.

HOW SHOULD I USE AEROMIDE?

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

• An extra patient leaflet is available with Aeromide foam. Talk to your pharmacist if you have questions about this information.
• Aeromide foam is for rectal use only. Do not take Aeromide foam by mouth.
• Before using Aeromide foam, use the bathroom to empty your bowels.
• If you need more lubricant for the applicator, you may use petrolatum or petroleum jelly.
• Warm Aeromide foam before use by holding the can in your hands and shaking it for 10 to 15 seconds.
• You can use Aeromide foam while standing, lying down, or sitting.
• If you are using Aeromide foam in the evening, use right before bedtime. After using Aeromide foam, try to avoid emptying your bowels until the next morning.
• Aeromide foam is flammable. Avoid fire, flame, and smoking while you use Aeromide foam and right after using it.
• Use Aeromide foam on a regular schedule to get the most benefit from it.
• Do not eat grapefruit or drink grapefruit juice while you use Aeromide foam.
• If you miss a dose of Aeromide foam, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

USES OF AEROMIDE IN DETAILS

This medication is used to treat certain bowel conditions (such as Crohn's disease, ulcerative colitis). While Aeromide does not cure these conditions, it may decrease symptoms such as pain and diarrhea. Aeromide is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body's natural defense response (immune response).

How to use Aeromide

Read the Patient Information Leaflet provided by your pharmacist before you start using Aeromide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Swallow this medication whole. Do not crush or chew. Doing so can release all of the drug at once, increasing the risk of side effects. If you are using the extended-release tablets, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage and length of treatment are based on your medical condition, response to treatment, and age.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit may increase the amount of certain medications in your body. Consult your doctor or pharmacist for more details.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. You may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication when you are taking Aeromide. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.

Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed because this may increase your risk of serious side effects.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition persists or worsens.

AEROMIDE DESCRIPTION

Turbuhaler: One metered dose contains Budesonide 100 micrograms or 200 micrograms.

Respules: Each single-dose unit of 2 ml contains 0.5 mg or 1 mg Aeromide.

Respules: The active ingredient, Aeromide, is a non-halogenated glucocorticoid structurally related to 16-α- hydroxyprednisolone. The chemical name is 16α, 17α -22R, S-propylmethylenedioxy-pregna-1, 4-diene-11ß, 21-diol-3, 20-dione; MW 430.5.

Aeromide is a white to off-white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Aeromide melts with decomposition between 224°C and 231.5°C.

Aeromide RESPULES nebulising suspension for inhalation is a white to off-white suspension in plastic single dose units. Aeromide RESPULES contain Aeromide 0.5 mg/2 mL or 1.0 mg/2 mL as the active ingredient plus disodium edetate, sodium chloride, polysorbate 80 (E 433) citric acid - anhydrous (E 330), sodium citrate (E 331) and water for injections.

Excipients/Inactive Ingredients: Turbuhaler: Aeromide contains no excipients.

Respules: Disodium edetate, sodium chloride, polysorbate 80 (E 433) citric acid anhydrous (E 330), sodium citrate (E 331) and water for injections.

AEROMIDE DOSAGE

he recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of Aeromide (Aeromide) Nasal Spray 32 mcg once daily. Some patients who do not achieve symptom control at the recommended starting dosage may benefit from an increased dosage. The maximum recommended dosage for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of Aeromide (Aeromide) Nasal Spray 32 mcg and the maximum recommended dose for pediatric patients (6 to < 12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of Aeromide (Aeromide) Nasal Spray 32 mcg.

It is always desirable to titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. An improvement in nasal symptoms may be noted in patients within 10 hours of first using Aeromide (Aeromide) Nasal Spray, however, clinical improvement usually takes 1 -2 days with maximum benefit in approximately 2 weeks. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage may be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled on higher dosages.

Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears. Shake the container gently before each use.

Illustrated Patient's Instructions for Use accompany each package of Aeromide (Aeromide) Nasal Spray 32 mcg. 

How supplied

Dosage Forms and Strengths

Aeromide (Aeromide) Nasal Spray is a nasal spray suspension. Each spray delivers 32 mcg of Aeromide. Each bottle of Aeromide (Aeromide) Nasal Spray 32 mcg contains 120 metered sprays after initial priming.

Aeromide (Aeromide) Nasal Spray 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a green protection cap. Aeromide (Aeromide) Nasal Spray 32 mcg (NDC 0186-1070-08) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The Aeromide (Aeromide) Nasal Spray 32 mcg bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after 120 sprays following initial priming, since the amount of Aeromide delivered per spray thereafter may be substantially less than the labeled dose. Each spray delivers 32 mcg of Aeromide to the patient.

Aeromide (Aeromide) Nasal Spray should be stored at controlled room temperature, 20 to 25°C (68 to 77°F) with the valve up. Do not freeze. Protect from light. Shake gently before use. Do not spray in eyes.