This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.
Description, Dosage, Side Effects, Contraindications. Data from EMA, URPL, openFDA and other regulatory sources.
| Salbutamol | Salmeterol | |
|---|---|---|
| Active Substances | Salbutamolum | Salmeterolum |
| ATC Code | R03CC02 | R03AC12 |
| Form | Roztwór do wstrzykiwań | Proszek do inhalacji, podzielony |
| Dosage | 0,5 mg/ml | 50 mcg/dawkę inh. |
| Route | domięśniowa, dożylna, podskórna | wziewna |
| Manufacturer | Zakłady Farmaceutyczne POLPHARMA S.A. | Polfarmex S.A. |
| Indications | Asthalin Inhaler is indicated in adults, adolescents and children aged 4 to 11 years. For babies and children under 4 years of age, see sections 4.2 and 5.1. Asthalin Inhaler provides short-acting (4 to 6 hour) bronchodilation with fast onset (within 5 minutes) in reversible airways obstruction. It is particularly suitable for the relief and prevention of asthma symptoms. It should be used to relieve symptoms when they occur, and to prevent them in those circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure). Asthalin Inhaler may also be used in the treatment of the reversible component of airways obstruction. |
Salbutamol (INN: Salbutamolum, ATC R03CC02) and Salmeterol (INN: Salmeterolum, ATC R03AC12) differ in active substance, indications, and safety profile. The table above summarizes the clinical differences from regulatory documents.
Combination safety depends on mechanisms and your health profile. Use our interactions checker and always consult your doctor or pharmacist before combining medications.
Both drugs are approved when used per label. Safety is patient-specific — the better choice depends on your condition, other medications, allergies, and comorbidities. Consult a healthcare professional for personalized advice.
This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.
| AirFluSal Forspiro is indicated for use in adults 18 years of age and older only. Asthma AirFluSal Forspiro is indicated in the regular treatment of adults with severe asthma where use of a combination product (long-acting β 2 agonist [LABA] and inhaled corticosteroid [ICS]) is appropriate: Patients not adequately controlled on a lower strength corticosteroid combination product or Patients already controlled on a high dose inhaled corticosteroid and long-acting β 2 agonist. Chronic Obstructive Pulmonary Disease (COPD) AirFluSal Forspiro is indicated for the symptomatic treatment of adults with COPD, with a forced expiratory volume in one second (FEV 1 ) <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy. |
| Side Effects | Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) including isolated reports and not known (cannot be estimated from the available data). Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data. Immune system disorders Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse. Metabolism and nutrition disorders Rare: Hypokalaemia (especially in combination with xanthine derivatives, corticosteroids and diuretics) increased serum lactate levels and acidosis lactic. Psychiatric disorders Common: Tenseness Rare: Sleep disturbances and hallucinations (especially in children) Very rare : Insomnia, Hyperactivity Nervous system disorders Common: Headache, Dizziness, Fine tremor (particularly in hands) Cardiac disorders Common: Tachycardia Uncommon: Palpitations, Very rare : Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) –especially if used concomitantly with other ß 2 -agonists Not known : Myocardial ischaemia, chest pain (see section 4.4) Vascular disorders Rare: Peripheral vasodilatation. Respiratory, thoracic and mediastinal disorders Uncommon: Throat irritation Very rare: Paradoxical bronchospasm (with an immediate increase in wheezing after dosing). (As with other inhalation therapy, paradoxical bronchospasm may occur immediately after dosing. If this occurs, salbutamol should be discontinued immediately and, if needed, an alternative therapy instituted). Gastrointestinal disorders Uncommon : Mouth irritation Rare : nausea, vomiting, dry mouth, sore mouth. Skin and subcutaneous tissue disorders Very rare: Pruritus Musculoskeletal and connective tissue disorders Uncommon: Myalgia , muscle cramps Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. | As AirFluSal Forspiro contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Frequencies were derived from clinical trial data. The incidence in placebo was not taken into account. System Organ Class Adverse Event Frequency Infections & Infestations Candidiasis of the mouth and throat Pneumonia (in COPD patients) Bronchitis Oesophageal candidiasis Common Common 1,3,5 Common 1,3 Rare Immune System Disorders Hypersensitivity reactions with the following manifestations: Cutaneous hypersensitivity reactions Angioedema (mainly facial and oropharyngeal oedema) Respiratory symptoms (dyspnoea) Respiratory symptoms (bronchospasm) Anaphylactic reactions including anaphylactic shock Uncommon Rare Uncommon Rare Rare Endocrine Disorders Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density Rare 4 Metabolism & Nutrition Disorders Hypokalaemia Hyperglycaemia Common 3 Uncommon 4 Psychiatric Disorders Anxiety Sleep disorders Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in children) Depression, aggression (predominantly in children) Uncommon Uncommon Rare Not known Nervous System Disorders Headache Tremor Very Common 1 Uncommon Eye Disorders Cataract Glaucoma Vision, blurred (see also section 4.4) Uncommon Rare 4 Not known Cardiac Disorders Palpitations Tachycardia Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles). Atrial fibrillation Angina pectoris Uncommon Uncommon Rare Uncommon Uncommon Respiratory, Thoracic & Mediastinal Disorders Nasopharyngitis Throat irritation Hoarseness/dysphonia Sinusitis Paradoxical bronchospasm Very Common 2,3 Common Common Common 1,3 Rare 4 Skin and subcutaneous tissue disorders Contusions Common 1,3 Musculoskeletal & Connective Tissue Disorders Muscle cramps Arthralgia Myalgia Traumatic fractures Common Common Common Common 1,3 1 Reported commonly in placebo 2 Reported very commonly in placebo 3 Reported over 3 years in a COPD study 4 See section 4.4 5 See section 5.1. Description of selected adverse reactions The pharmacological side effects of β 2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. AirFluSal Forspiro should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely, of the oesophagus can occur in some patients. Both hoarseness and the incidence of mouth and throat candidiasis may be relieved by rinsing the mouth with water and spitting the water out and/or brushing the teeth after using the product. Symptomatic mouth and throat candidiasis can be treated with topical anti-fungal therapy whilst still continuing with a fixed-dose combination of salmeterol and fluticasone propionate. Paediatric population AirFluSal Forspiro is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2). Possible systemic effects in these age groups include Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents (see Section 4.4). Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). |
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| Contraindications | Hypersensitivity to salbutamol or to any of the excipients listed in section 6.1. Non i.v. formulations of salbutamol are contraindicated for use in arresting uncomplicated premature labour and threatened abortion. | Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. |
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| Warnings | As the canister is pressurised, it should not be punctured or disposed of by burning. | Any unused medicinal product or waste material should be disposed of in accordance with local requirements. |
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