Seroflo represents a significant advancement in the management of chronic respiratory conditions, combining two established therapeutic agents into a single, convenient inhaler. This fixed-dose combination inhaler is specifically engineered for patients requiring maintenance therapy to achieve and sustain control over their asthma or Chronic Obstructive Pulmonary Disease (COPD). By integrating a potent corticosteroid with a long-acting bronchodilator, Seroflo targets both airway inflammation and bronchoconstriction—the two primary pathological components of these diseases. Its design aims to simplify treatment regimens, improve adherence, and deliver superior clinical outcomes compared to monotherapy approaches. This product card provides a comprehensive, expert-level overview of Seroflo for healthcare professionals.

Features

• Dual Pharmacological Action: Contains a fixed-dose combination of Fluticasone Propionate (an inhaled corticosteroid, or ICS) and Salmeterol (a long-acting beta2-agonist, or LABA).
• Mechanism of Delivery: Utilizes a hydrofluoroalkane (HFA) propellant in a metered-dose inhaler (MDI) format, ensuring consistent and accurate dosing.
• Available Strengths: Comes in various strength combinations (e.g., Fluticasone 100/250/500 mcg and Salmeterol 25/50 mcg) to allow for tailored therapeutic regimens based on disease severity.
• Dosing Counter: Many devices include an integrated dose counter to help patients and clinicians track remaining medication, promoting adherence and timely refills.
• Spacer-Compatible: The actuator can be used with an appropriate valved holding chamber (spacer) to improve lung deposition, particularly beneficial for patients with poor inhalation technique.

Benefits

• Superior Symptom Control: Provides more effective overall control of respiratory symptoms like wheezing, shortness of breath, and chest tightness compared to either component used alone.
• Reduced Exacerbation Risk: Significantly lowers the frequency and severity of asthma attacks and COPD flare-ups, leading to fewer emergency department visits and hospitalizations.
• Improved Lung Function: Demonstrated efficacy in enhancing forced expiratory volume in 1 second (FEV1) and other key spirometric parameters over a 24-hour period.
• Simplified Treatment Regimen: Combining two medications into one inhaler reduces the complexity of the treatment plan, which can enhance patient compliance and quality of life.
• Anti-inflammatory and Bronchodilatory Effects: Simultaneously addresses the underlying inflammation and the resultant bronchoconstriction, offering a comprehensive therapeutic approach.
• Long-Acting Relief: The LABA component provides sustained bronchodilation for up to 12 hours, supporting twice-daily dosing for maintenance therapy.

Common use

Seroflo is indicated for the regular maintenance treatment of asthma in patients where a combination product is appropriate, typically those not adequately controlled on inhaled corticosteroids and “as-needed” short-acting beta2-agonists, or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. It is also indicated for the symptomatic treatment of patients with COPD (chronic bronchitis and emphysema) with a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. It is crucial to note that Seroflo is not indicated for the relief of acute bronchospasm and should not be used as a rescue medication.

Dosage and direction

The dosage must be individualized based on the severity of the disease and the patient’s previous therapy. The following are general guidelines; the prescribing physician’s instructions always take precedence.

• For Asthma:
  • Adults and adolescents (12 years and older): The usual recommended dose is two inhalations twice daily (morning and evening, approximately 12 hours apart). The strength (e.g., 100/25, 250/25, or 500/50 mcg) is determined by the prescriber.
  • Children (4 to 11 years): A lower strength formulation (e.g., 100/25 mcg) is used. The recommended dose is two inhalations twice daily.
• For COPD:
  • Adults: The usual recommended dose is two inhalations of the 250/25 mcg strength twice daily.

Administration Technique:

1. Shake the inhaler well before each inhalation.
2. Breathe out fully, away from the mouthpiece.
3. Place the mouthpiece between your lips and form a tight seal.
4. While breathing in deeply and slowly through your mouth, press down firmly on the canister to release the medication.
5. Continue to breathe in slowly and hold your breath for about 10 seconds, or for as long as is comfortable.
6. Wait for about 30-60 seconds before shaking the inhaler again and repeating the process for the second puff.
7. Rinse your mouth with water and spit it out after each dose to help prevent oral candidiasis (thrush) and hoarseness.

Precautions

• Not for Acute Use: Seroflo is a maintenance controller medication and must not be used to treat acute asthma attacks or status asthmaticus. Patients must have a separate, fast-acting rescue inhaler (e.g., salbutamol) available at all times.
• Paradoxical Bronchospasm: As with any inhaled medication, Seroflo can cause immediate bronchospasm after dosing, with wheezing and increased shortness of breath. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
• Cardiovascular Effects: Salmeterol, a LABA, can produce clinically significant cardiovascular effects such as increases in pulse rate and blood pressure in some patients. Use with caution in patients with cardiovascular disorders (e.g., coronary artery disease, cardiac arrhythmias, hypertension).
• Systemic Effects: Although most of the corticosteroid is deposited in the lungs, some systemic absorption can occur, particularly at higher doses. Be mindful of potential systemic corticosteroid effects, including adrenal suppression, reduction in bone mineral density, cataracts, and glaucoma, especially with long-term use.
• Hypokalemia and Hyperglycemia: LABAs may cause significant hypokalemia and hyperglycemia in some patients, potentially exacerbated by hypoxia. This is particularly relevant in severe exacerbations and requires monitoring, especially in diabetic patients.
• Immunosuppression: Patients on corticosteroid therapy are more susceptible to infections. Chickenpox and measles can have a more serious or even fatal course in susceptible individuals. Exposure should be avoided; if exposed, medical advice should be sought promptly.

Contraindications

Seroflo is contraindicated in patients with a known hypersensitivity to Fluticasone Propionate, Salmeterol, or any of the excipients in the formulation (e.g., lactose). Its use to treat acute asthma symptoms or as a rescue medication is also contraindicated.

Possible side effect

Patients should be informed of the potential for side effects. Common side effects are often local and include:

• Headache
• Oropharyngeal candidiasis (thrush)
• Hoarseness or dysphonia
• Throat irritation
• Cough

Less common but more serious side effects require medical attention:

• Signs of systemic corticosteroid effects (e.g., easy bruising, adrenal insufficiency presenting as fatigue, weakness, nausea, vomiting, hypotension)
• Tachycardia, palpitations, chest pain
• Increased blood pressure
• Nervousness, tremor
• Paradoxical bronchospasm (wheezing immediately after inhalation)
• Signs of infection (e.g., fever, chills, persistent sore throat)
• Allergic reactions (e.g., rash, hives, swelling of the face, mouth, and tongue, breathing difficulties)

Drug interaction

Concomitant use of other drugs can potentiate the effects of Seroflo’s components. Important interactions include:

• Strong CYP3A4 Inhibitors: Drugs like ketoconazole, itraconazole, ritonavir, and clarithromycin can significantly increase the systemic exposure to Fluticasone, increasing the risk of systemic corticosteroid side effects, including Cushing’s syndrome and adrenal suppression. Concomitant use should be avoided unless the benefit outweighs the increased risk.
• Beta-blockers: Non-selective beta-blockers (e.g., propranolol) can antagonize the bronchodilatory effect of Salmeterol and may produce severe bronchospasm in patients with asthma or COPD. Cardioselective beta-blockers should be used with caution.
• Diuretics: Non-potassium-sparing diuretics can potentiate the ECG changes and hypokalemia that may be induced by beta2-agonist therapy.
• Other Sympathomimetic Agents: Concomitant use with other products containing LABAs or sympathomimetic agents (e.g., decongestants) should be undertaken with caution due to the potential for additive cardiovascular effects.

Missed dose

Instruct the patient to take the next dose at the regular scheduled time. Do not double the dose to make up for the missed one. Maintaining a consistent schedule is important for optimal control, but a single missed dose is not typically critical for long-term management.

Overdose

Overdose may manifest as exaggeration of the known pharmacologic effects of its components.

• Fluticasone Propionate: Chronic overdose could lead to systemic corticosteroid effects such as hypercorticism and adrenal suppression.
• Salmeterol: Overdose is likely to lead to manifestations of excessive beta-adrenergic stimulation, including tachycardia, arrhythmias, tremor, headaches, muscle cramps, hypertension, hypokalemia, and hyperglycemia.

There is no specific antidote. Treatment consists of discontinuation of Seroflo, supportive therapy, and appropriate symptomatic treatment. Cardiac monitoring is recommended in cases of significant overdose. Dialysis is not appropriate.

Storage

• Store at room temperature (between 15°C and 30°C). Do not freeze.
• Keep the canister away from direct sunlight and heat (e.g., do not store in a car on a hot day).
• The canister is pressurized. Do not puncture, break, or incinerate, even when apparently empty.
• Keep out of reach of children.

Disclaimer

This information is intended for educational purposes and for use by healthcare professionals only. It is a summary and does not include all possible information about this product. It does not constitute medical advice. The official prescribing information from the manufacturer is the ultimate authority. Patients must not make any decisions about their medical care based on this information alone and must always consult with a qualified healthcare provider for diagnosis and for answers to their medical questions. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• Clinical Consensus: Seroflo is widely regarded in the pulmonology community as a cornerstone of maintenance therapy for moderate-to-severe asthma and COPD. Its efficacy in improving lung function, reducing exacerbation rates, and improving quality of life is well-documented in numerous large-scale clinical trials and meta-analyses.
• Prescriber Feedback: Healthcare providers often report that the combination product simplifies patient education and improves adherence compared to prescribing two separate inhalers. The availability of different strengths allows for effective dose titration.
• Patient Feedback: Many patients report a significant improvement in daily symptom control and a reduced reliance on their rescue inhaler after starting Seroflo. Common praises include the convenience of a single device. Criticisms occasionally relate to the taste, the potential for oral thrush (which is often mitigated by proper rinsing), and the cost of the medication.
• Place in Therapy: It is consistently recommended in international treatment guidelines (e.g., GINA, GOLD) for the appropriate patient populations, solidifying its role as a first-line option for combination therapy.