Seroflo Inhaler represents a significant advancement in the management of persistent asthma and chronic obstructive pulmonary disease (COPD). This fixed-dose combination therapy integrates a potent inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA) into a single, convenient delivery device. By targeting both airway inflammation and bronchoconstriction simultaneously, Seroflo provides superior symptom control and improved lung function compared to monotherapy components. It is designed for patients requiring a step-up in treatment to achieve and maintain disease stability, reduce exacerbation frequency, and enhance overall quality of life.

Features

• Fixed-dose combination of Fluticasone Propionate (inhaled corticosteroid) and Salmeterol Xinafoate (long-acting beta2-agonist).
• Available in multiple strength configurations (e.g., Seroflo 100/50, 250/50, 500/50 mcg) to allow for individualized dosing.
• Delivered via a pressurized metered-dose inhaler (pMDI) with a dose counter for accurate administration tracking.
• Formulated with HFA (hydrofluoroalkane) propellant, which is chlorofluorocarbon (CFC)-free.
• Designed for twice-daily (BID) maintenance therapy.

Benefits

• Provides comprehensive dual-action therapy by simultaneously reducing airway inflammation and preventing bronchospasm.
• Significantly improves lung function parameters (FEV1) and peak expiratory flow rates.
• Reduces the frequency and severity of asthma exacerbations and COPD flare-ups.
• Enhances overall symptom control, leading to reduced rescue medication use.
• Offers the convenience of two medications in a single inhaler, improving adherence to prescribed therapy.
• Contributes to a better quality of life by allowing for greater participation in daily activities and improved sleep.

Common use

Seroflo Inhaler is indicated for the regular maintenance treatment of:

• Asthma: In patients where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate. This is typically for patients not adequately controlled on inhaled corticosteroids and “as-needed” short-acting beta2-agonists, or whose disease severity clearly warrants initiation of treatment with both components.
• Chronic Obstructive Pulmonary Disease (COPD): Specifically for patients with a history of exacerbations, despite regular bronchodilator therapy. It is indicated to alleviate symptoms and reduce future exacerbation risk.

It is crucial to note that Seroflo is not indicated for the relief of acute bronchospasm and should not be used as a rescue inhaler.

Dosage and direction

The dosage must be individualized based on disease severity and prior therapy. The following is general guidance; the prescribing physician’s instructions must always be followed.

• For Asthma:
  • Adults and adolescents (12 years and older): The recommended starting dose is typically one or two inhalations of Seroflo 100/50 or Seroflo 250/50 twice daily (morning and evening, approximately 12 hours apart). The strength and frequency are determined by the physician.
  • Children (4 to 11 years): The recommended dose is two inhalations of Seroflo 100/50 twice daily.
• For COPD:
  • Adults: The recommended dose is two inhalations of Seroflo 250/50 twice daily.

Directions for Use:

1. Remove the mouthpiece cover. Check the mouthpiece for foreign objects.
2. Shake the inhaler well for 5 seconds before each inhalation.
3. Breathe out fully, away from the inhaler.
4. Place the mouthpiece between your teeth and close your lips around it.
5. While breathing in deeply and slowly through your mouth, press down firmly on the canister to release one puff of medication.
6. Hold your breath for about 10 seconds, or for as long as is comfortable, then breathe out slowly.
7. If a second inhalation is prescribed, wait about 30 seconds, shake the inhaler again, and repeat steps 3-6.
8. Rinse your mouth with water after each use to help prevent oral candidiasis (thrush) and hoarseness.
9. Wipe the mouthpiece clean and replace the cover.

Precautions

• Paradoxical Bronchospasm: Seroflo can produce life-threatening paradoxical bronchospasm (immediate wheezing and shortness of breath after dosing). If this occurs, discontinue use immediately and institute alternative therapy.
• Cardiovascular Effects: Salmeterol, like other LABAs, can produce clinically significant cardiovascular effects such as increases in pulse rate and blood pressure. Use with caution in patients with cardiovascular disorders (e.g., coronary artery disease, cardiac arrhythmias, hypertension).
• Systemic Corticosteroid Effects: Long-term use of high doses of inhaled fluticasone may lead to systemic corticosteroid effects such as hypercorticism, adrenal suppression, and reduced bone mineral density. Patients are at increased risk if transferred from systemic corticosteroids.
• Osteoporosis: Long-term administration of corticosteroids is associated with a reduction in bone mineral density. This should be considered in patients with major risk factors for bone loss.
• Ocular Effects: Long-term use of inhaled corticosteroids may increase the risk of cataracts or glaucoma. Regular eye examinations should be considered.
• Immunosuppression: Patients on corticosteroid therapy may exhibit a reduced response to vaccines and an increased susceptibility to infections (e.g., chickenpox, measles).
• Hypokalemia and Hyperglycemia: Beta2-agonists may produce significant hypokalemia and hyperglycemia in some patients, especially at high doses. Electrolyte levels and blood glucose should be monitored in at-risk patients.

Contraindications

Seroflo Inhaler is contraindicated in patients with:

• A known hypersensitivity to fluticasone propionate, salmeterol xinafoate, or any ingredient in the formulation.
• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
• Significant, untreated fungal, bacterial, viral (including herpes simplex of the eye), or tubercular infections of the respiratory tract.

Possible side effects

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

Very common (may affect more than 1 in 10 people):

• Headache.

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

• Oral candidiasis (thrush).
• Hoarseness or dysphonia.
• Throat irritation.
• Palpitations.
• Tremor.
• Muscle cramps.
• Cough.

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

• Tachycardia (fast heart rate).
• Skin reactions (rash, urticaria).
• Anxiety, sleep disturbances.
• Nausea.

Rare (may affect up to 1 in 1,000 people):

• Allergic reactions (including anaphylaxis, angioedema, bronchospasm).
• Psychiatric effects (nervousness, restlessness, depression, aggression).
• Vision disturbances (blurred vision).
• Hypokalemia.
• Hyperglycemia.

Frequency not known:

• Adrenal suppression (especially in children and with high doses).
• Glaucoma, cataracts.
• Osteoporosis.
• Growth retardation in children and adolescents.

Drug interaction

Concurrent use of the following drugs may require caution or dosage adjustment:

• Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir, Clarithromycin): Concomitant use is not recommended as they can significantly increase systemic exposure to fluticasone, increasing the risk of systemic corticosteroid side effects.
• Beta-blockers: Non-selective beta-blockers (e.g., propranolol) may antagonize the bronchodilator effects of beta-agonists and produce severe bronchospasm in asthmatic patients. Cardioselective beta-blockers should be used with caution.
• Diuretics: Beta2-agonists can potentiate the possible hypokalemic effect of non-potassium-sparing diuretics (e.g., loop or thiazide diuretics).
• Other Sympathomimetic Agents: Concomitant use with other adrenergic drugs (e.g., epinephrine, decongestants) may potentiate the sympathetic effects of salmeterol.
• Xanthine Derivatives (e.g., Theophylline) and Steroids: May potentiate the hypokalemic effect of salmeterol.
• Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of beta2-agonists.

Missed dose

• If a dose is missed, it should be taken as soon as it is remembered.
• However, if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time.
• Do not take a double dose to make up for a forgotten one.

Overdose

• Overdose of Salmeterol: May be expected to produce effects typical of excessive beta-adrenergic stimulation: tachycardia, arrhythmias, tremor, headache, muscle cramps, hyperglycemia, hypokalemia, and hypotension. Cardiac arrest and even death may occur.
• Overdose of Fluticasone: Acute overdose is unlikely. During chronic overdose, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear.
• Management: Treatment consists of discontinuation of Seroflo together with institution of appropriate symptomatic and supportive therapy. Cardioselective beta-blockers may be considered but should be used with caution in asthmatic patients due to the risk of inducing bronchospasm.

Storage

• Store at room temperature (15°C to 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 contents are under pressure. Do not puncture or burn the canister, even after it is apparently empty.
• Keep out of the sight and reach of children.
• Discard the inhaler when the dose counter reads “000” or 3 months after removal from the foil pouch, whichever comes first.

Disclaimer

This information is for educational purposes only and 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 names are trademarks of their respective owners.

Reviews

• Clinical Trial Data: Extensive randomized, double-blind, placebo-controlled trials have consistently demonstrated the efficacy of the fluticasone/salmeterol combination in improving lung function (FEV1), reducing symptom scores, decreasing rescue medication use, and significantly lowering the rate of exacerbations in both asthma and COPD patients compared to placebo and individual components.
• Real-World Evidence: Post-marketing surveillance and observational studies support the long-term effectiveness and generally acceptable safety profile of Seroflo in diverse patient populations when used as prescribed. Patient-reported outcomes often highlight improved daily symptom control and quality of life.
• Professional Endorsement: Seroflo and its generic equivalents are recommended in major international treatment guidelines (GINA, GOLD) as a preferred option for patients requiring Step 3 or 4 therapy for asthma and for specific COPD patient phenotypes with a history of exacerbations.