The Foracort Inhaler is a prescription-only, fixed-dose combination inhaler designed for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD) in patients requiring both corticosteroid and long-acting bronchodilator therapy. It combines two active ingredients, Budesonide and Formoterol, to provide superior anti-inflammatory action and sustained bronchial smooth muscle relaxation. This dual-mechanism approach offers a comprehensive solution for managing obstructive airway diseases, helping to reduce exacerbation frequency and improve overall lung function and quality of life. It is intended for regular use as a controller medication and is not for the relief of acute bronchospasm.

Features

• Fixed-dose combination of Budesonide (an inhaled corticosteroid) and Formoterol (a long-acting beta2-agonist).
• Available in multiple strength formulations (e.g., Budesonide 100mcg/Formoterol 6mcg, 200mcg/6mcg, 400mcg/6mcg per actuation) to allow for individualized dosing.
• Delivered via a pressurized metered-dose inhaler (pMDI) device for consistent and reliable dosing.
• Engineered with a low global warming potential (GWP) propellant, aligning with modern environmental and safety standards.
• Features a dose counter to monitor the number of inhalations remaining, promoting adherence and preventing unexpected depletion.

Benefits

• Provides superior control of airway inflammation and bronchoconstriction through a synergistic dual-drug mechanism.
• Significantly reduces the frequency and severity of asthma and COPD exacerbations, potentially decreasing the need for oral corticosteroids and hospitalizations.
• Improves lung function parameters (FEV1) and overall symptom control, leading to enhanced exercise tolerance and daily activity levels.
• Offers the convenience of two essential maintenance medications in a single inhaler, simplifying complex treatment regimens and improving patient compliance.
• Helps achieve long-term disease stability, contributing to an improved quality of life for individuals with chronic respiratory conditions.

Common use

The Foracort Inhaler is indicated for the regular maintenance treatment of asthma where a combination of an inhaled corticosteroid and a long-acting bronchodilator is appropriate. It is also indicated for the symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with short-acting bronchodilators. It is crucial to understand that this is a controller medication and must be used daily, even when the patient feels well, to maintain underlying disease control. It is not indicated for the relief of acute symptoms; a separate short-acting bronchodilator (e.g., salbutamol) should be prescribed for rescue therapy.

Dosage and direction

Dosage is individualized based on disease severity and patient response. The inhaler must be shaken well before each use.

• Asthma (Adults and Adolescents 12 years and older): The usual recommended dose is 1 or 2 inhalations twice daily. The starting dose should be the lowest that effectively controls symptoms.
• Asthma (Children 6-11 years): The usual recommended dose is 2 inhalations twice daily of the 100mcg/6mcg strength.
• COPD (Adults): The usual recommended dose is 2 inhalations twice daily of the 200mcg/6mcg or 400mcg/6mcg strength.

Directions for Use:

1. Remove the mouthpiece cover and check the interior and mouthpiece for foreign objects.
2. Shake the inhaler vigorously for 5 seconds.
3. Breathe out fully, away from the inhaler.
4. Place the mouthpiece between your teeth and close your lips around it firmly.
5. While breathing in deeply and slowly through your mouth, press down firmly on the canister to release one puff of medication.
6. Continue to breathe in slowly and hold your breath for about 10 seconds, or for as long as is comfortable.
7. Breathe out slowly away from the inhaler.
8. If a second inhalation is prescribed, wait about 30 seconds, shake the inhaler again, and repeat steps 3-7.
9. Replace the cap after use.

Crucial Note: Rinse your mouth with water and spit it out after each use to help prevent oral thrush (candidiasis) and hoarseness.

Precautions

• Foracort is not a bronchodilator and should not be used to treat acute asthma attacks or episodes of acute bronchospasm. Always have a fast-acting rescue inhaler available.
• Patients must be instructed on the proper inhalation technique by a healthcare professional to ensure adequate drug delivery to the lungs. Technique should be checked regularly.
• Systemic effects of corticosteroids may occur, particularly at high doses and over prolonged periods. These may include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, and glaucoma. The lowest effective dose should always be used.
• An increase in the use of short-acting bronchodilators signifies deteriorating asthma control. Patients should be instructed to seek medical advice if their rescue inhaler use increases.
• Paradoxical bronchospasm (immediate worsening of breathing difficulties after dosing) can occur. If this happens, treatment should be discontinued immediately and alternative therapy instituted.
• Be cautious in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, severe cardiovascular disorders, and convulsive disorders due to the beta-agonist component.
• Hypokalaemia may occur; this effect may be potentiated by concomitant treatments. Serum potassium levels should be monitored in severe cases.

Contraindications

Foracort Inhaler is contraindicated in patients with:

• Hypersensitivity to Budesonide, Formoterol, or any of the excipients.
• The treatment of acute asthma attacks or status asthmaticus where intensive measures are required.

Possible side effect

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (May affect up to 1 in 10 people):

• Oral candidiasis (fungal infection in the mouth)
• Hoarseness and dysphonia
• Headache
• Palpitations
• Tremor
• Cough

Uncommon (May affect up to 1 in 100 people):

• Tachycardia (fast heart rate)
• Muscle cramps
• Agitation, restlessness, nervousness
• Nausea
• Dizziness
• Skin rash, urticaria, pruritus
• Bruising

Rare/Very Rare:

• Angioedema (swelling of the face, lips, tongue)
• Anaphylactic reactions
• Cardiac arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia)
• Psychiatric effects such as depression, behavioural disturbances (primarily in children)
• Hyperglycaemia
• Glaucoma, cataracts
• Adrenal suppression (with high doses)

Drug interaction

• Beta-blockers (e.g., propranolol): May antagonize the effect of Formoterol and produce severe bronchospasm in patients with asthma. Avoid concomitant use unless there is a compelling reason.
• Diuretics, corticosteroids, xanthine derivatives: May potentiate the hypokalaemic effect of beta2-agonists. Serum potassium levels should be monitored.
• MAOIs and Tricyclic Antidepressants: May potentiate the cardiovascular effects of beta2-agonists. Use with caution.
• QT-prolonging drugs (e.g., certain antibiotics, antifungals, antipsychotics): Concomitant use may increase the risk of ventricular arrhythmias.
• Ketoconazole and other potent CYP3A4 inhibitors: May increase plasma concentrations of Budesonide, increasing the risk of systemic corticosteroid side effects. The combination should be avoided unless the benefit outweighs the increased risk.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. Do not take a double dose to make up for a forgotten one. Simply resume the regular dosing schedule.

Overdose

• Formoterol Overdose: Symptoms are typical of excessive beta-adrenergic stimulation and may include tachycardia, arrhythmias, tremor, headache, muscle cramps, nausea, vomiting, hyperglycaemia, hypokalaemia, and hypotension. Cardiac monitoring is recommended. Treatment is supportive and symptomatic. Cardioselective beta-blockers may be considered but should be used with extreme caution in asthmatic patients due to the risk of inducing bronchospasm.
• Budesonide Overdose: Acute overdose is unlikely to cause clinical problems. During chronic overdose, systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur. Treatment involves gradual reduction of the corticosteroid dose under medical supervision.

Storage

• Store below 30°C. Do not freeze.
• Keep the canister in the original container to protect from light and moisture.
• Keep away from direct heat and sunlight (e.g., do not leave in a car on a hot day).
• The canister is pressurized. Do not puncture, break, or burn it, even when apparently empty.
• Keep out of the sight and reach of children.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The product information provided may not be exhaustive or fully up-to-date.

Reviews

• “As a pulmonologist, I find Foracort to be a highly effective cornerstone therapy for many of my moderate-to-severe asthma patients. The combination provides excellent control and the dose counter is a practical feature for adherence.” – Dr. A. Sharma, Respiratory Specialist
• “Switching to Foracort significantly reduced my nighttime symptoms and the number of exacerbations I experience. It has given me back a sense of control over my COPD.” – Patient, 68
• “The convenience of a combination inhaler has greatly improved my compliance with my medication regimen. My peak flow readings have been consistently stable since starting this treatment.” – Patient, 42
• “While effective, my child did develop oral thrush initially. This was completely resolved after we were more diligent about rinsing and spitting after each use. A crucial step that must be emphasized.” – Parent of a patient, 9