#pulmicort

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Budesonide

Brand Name: Pulmicort

Common Dosage Forms:

Suspension for Inhalation: Each Respule (vial) contains 2 mL of sterile liquid budesonide suspension in either a 0.25 mg, 0.5 mg, or 1 mg strength. Supplied in foil envelopes each containing five Respules with 30 Respules per carton.

Metered Dose Inhaler (Flexhaler): 90 mcg (80 mcg budesonide) per actuation or 180 mcg (160 mcg budesonide) per actuation.

FDA Indications/Dosages:

For the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age: Respules should be administered via jet nebulizer. In patients currently taking bronchodilators alone, start with 0.5 mcg once or twice a day (max of 0.5 mg per day). In patients taking inhaled corticosteroids, start with 0.5 mg once or twice a day (max of 1 mg per day). In patients taking oral corticosteroids, start with 1 mg daily, given in one or two divided doses (max 1 mg per day).

For the maintenance treatment of asthma and as prophylactic therapy in adults and pediatric patients 6 years of age or older: Use the Flexhaler as directed. The recommended starting dose is 180 mcg (children) or 360 mcg (adults) twice a day. The maximum dosage should not exceed 360 mcg (children) or 720 mcg (adults) twice a day. A slow withdrawal of oral corticosteroids should be made after the patient is maintained on inhaled Pulmicort. *In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, once a day dose may be considered.

Monitor: FEV, BMD, IOP.

Pharmacology/Pharmacokinetics: Adrenocorticoids bind to certain receptor proteins found in the cytoplasm of sensitive cells to form a steroid-receptor complex. This steroid-receptor complex enters the nucleus of the cell where it reacts with chromatin, or DNA. The steroid (or possibly the receptor) then uses stored information to stimulate, or in some cases inhibit, the transcription of mRNA. The stimulation of mRNA results in the synthesis of specific proteins and ultimately specific proteins enzymes that carry out its anti-allergy and anti-inflammatory actions. Budesonide has strong glucocorticoid and weak mineralocorticoid activity. ALmost all of an inhaled dose is absorbed systemically with peak plasma concentrations occurring within 30 minutes of an inhaled dose. Metabolism occurs via cytochrome P450 3A to inactive metabolism.

Drug Interactions: Ketoconazole may increase plasma levels.

Contraindications/Precautions: Use is contraindicated in the primary treatment of status asthmaticus. LONG-ACTING BETA-2-ADRENERGIC AGONISTS INCREASE THE RISK OF ASTHMA-RELATED DEATH. Use in caution in patients who are being transferred from systemic corticosteroids to Pulmicort because deaths due to adrenal insufficiency have occurred during and after transfer to aerosolized steroids. Systemic steroids should be administered to these patients during periods of stress or during an acute asthma attack. Pulmicort is not to be regarded as a bronchodilator and should not be given for rapid relief of bronchospasm. Secondary fungal infections of the oral cavity may occur and may require antifungal treatment. Response of the hypothalamic-pituitary-adrenal (HPA) function is highly individualized. Pregnancy Category B.

Adverse Effects: Adverse effects with the Turbohaler include headache, asthenia, pain, dyspepsia, nausea, oral candidiasis, arthralgia, cough, respiratory infection, rhinitis, and sinusitis. Adverse effects from Respules include respiratory infection, rhinitis, cough, otitis media, vomiting, diarrhea, abdominal pain, and rash.

Patient Consultation:

Avoid contact with the eyes.

Contact a physician if the above side effects are severe or persistent.

If a dose is missed, skip it and return to normal dosing schedule.

Pulmicort is not intended to provide immediate relief of bronchospasm. To receive the full benefits of therapy, use on a regular basis. Although benefits can be seen after 2 days of treatment, up to four weeks may be needed to observe benefits.

Use any prescribed bronchodilators a few minutes prior to using Pulmicort.

Follow enclosed instructions for inhalation technique of the Turbohaler: (1) prime the inhaler the first time it is used by holding it in an upright position (mouthpiece up), turn the brown grip fully to the right and then to the left until it clicks, (2) to load a dose, hold it in an upright position (mouthpiece up), turn the brown grip fully to the right and then to the left until it clicks, and (3) Hold the Turbohaler in the upright or horizontal position, place the mouthpiece between the lips and inhale forcefully and deeply. Exhale through the nose and do not shake in inhaler.

The Respules should be gently shaken before use in an approved jet nebulizer and should not be mixed with other solutions.

Rise the mouth out without swallowing after each use.

A red mark will appear in the indicator window when there is 20 or fewer doses left in the Turbohaler.

Patients should avoid exposure to chickenpox or measles and if they are exposed promptly notify their physician.

Pulmicort Turbohaler should not be used with a spacer.

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Experience with Montelukast / Pulmicort? : Asthma Hey guys, I have been feeling very short of breathe and having very bad asthma with just a little bit of exercise (a light jog for a couple minutes would wind me).

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