Adult: In combination with an inhaled corticosteroid: As inhalation cap and metered-dose aerosol inhaler: 12 mcg bid. In severe cases, doses may be increased to up to 24 mcg bid. As metered-dose dry powder inhaler: 6-12 mcg 1-2 times daily. In severe cases, doses may be increased up to 24 mcg bid. Child: In combination with an inhaled corticosteroid: 6-11 years As inhalation cap: 12 mcg bid. ≥12 years As inhalation cap, metered-dose aerosol inhaler, and metered-dose dry powder inhaler: Same as adult dose.
Inhalation/Respiratory Prophylaxis of exercise-induced asthma
Adult: In combination with an inhaled corticosteroid: As inhalation cap: 12 mcg 15 minutes before exercise. Additional doses should not be taken within 12 hours. As metered-dose dry powder inhaler: 12 mcg before exercise. Child: In combination with an inhaled corticosteroid: ≥6 years As inhalation cap: 12 mcg 15 minutes before exercise. As metered-dose dry powder inhaler: 6-12 mcg before exercise.
Adult: As inhalation cap: 12 mcg bid. As metered-dose dry powder inhaler: 12 mcg 1-2 times daily. As metered-dose aerosol: 12 mcg bid. Additional doses may be given up to a Max of 48 mcg daily (24 mcg/dose). As solution for nebulisation: 20 mcg bid.
Các sản phẩm có chứa hoạt chất Formoterol tại Việt Nam?
Newitock
Chống chỉ định
Acute severe asthma and acute episodes of COPD. Treatment of asthma in the absence of an inhaled corticosteroid.
Thận trọng
Patient with CV disorders (e.g. hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, ischaemic heart disease, 3rd degree AV block, severe heart failure, cardiac arrythmias, severe hypertension); hypokalaemia; diabetes mellitus; thyrotoxicosis; phaeochromocytoma; seizure disorder. Not for use as initial therapy during an acute severe asthma exacerbation or during significant worsening or acutely deteriorating asthma (dry powder for inhalation). Not for use for acute episodes of COPD, not for initiation in patients with significantly worsening or acutely deteriorating COPD, not indicated for the treatment of asthma (solution for nebulisation). Children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Hypersensitivity reactions; hypokalaemia, hyperglycaemia; elevated blood pressure or heart rate; cardiac arrythmias and ECG changes (e.g. flattening of the T wave, prolongation of the QTc interval, and ST segment depression). Cardiac disorders: Angina pectoris, palpitations. Gastrointestinal disorders: Nausea, taste disturbances. Musculoskeletal and connective tissue disorders: Muscle cramps, myalgia. Nervous system disorders: Tremor, headache, dizziness. Psychiatric disorders: Agitation, restlessness. Respiratory, thoracic and mediastinal disorders: Cough, throat irritation. Potentially Fatal: Paradoxical bronchospasm.
Monitor FEV1, peak flow, and/or other pulmonary function tests; serum glucose, serum K, blood pressure, heart rate. Assess for signs and symptoms of CNS stimulation and/or asthma deterioration.
Quá liều
Symptoms: Headache, nervousness, tremor, seizures, muscle cramps, fatigue, malaise, insomnia, palpitations, tachycardia, arrythmias, hypertension or hypotension, dry mouth, nausea, vomiting, somnolence, hyperglycaemia, hypokalaemia, metabolic acidosis, angina, cardiac arrest, death. Management: Supportive and symptomatic treatment. May consider giving cardioselective β-blocker cautiously. Monitor cardiac function and serum K levels.
Tương tác
May cause ECG changes and hypokalaemia with non-K sparing diuretics (e.g. thiazides and loop diuretics). Enhanced hypokalaemic effect with xanthine derivatives and steroids. Increased risk of arrhythmias with halogenated hydrocarbons. May increase the risk of CV system related effects with TCAs or MAOIs. May attenuate the therapeutic effect with β-blockers. May cause additive effects and increase the risk of adverse drug effects with other sympathomimetic agents (e.g. ephedrine).
Tác dụng
Description: Mechanism of Action: Formoterol, a synthetic sympathomimetic amine, is a long-acting β2-adrenergic receptor agonist (LABA). It stimulates adenyl cyclase, an enzyme that leads to the conversion of adenosine triphosphate (ATP) to cyclic adenosine-3', 5'-monophosphate (cAMP). Increased levels of cAMP results in relaxation of bronchial smooth muscle and inhibition of release of proinflammatory mediators, particularly from mast cells. Onset: Within 3 minutes (dry powder for inhalation). Duration: Approx 12 hours. Pharmacokinetics: Absorption: Rapidly absorbed. Time to peak plasma concentration: 1-3 hours. Distribution: Plasma protein binding: 61-64%. Metabolism: Extensively metabolised in the liver via direct glucuronidation. Undergoes O-demethylation by the CYP2D6, CYP2C8/9, CYP2C19, and CYP2A6 isoenzymes. Excretion: Via urine (15-18% as direct glucuronide metabolites, 2-10% as unchanged drug). Terminal elimination half-life: Approx 10 hours.
Đặc tính
Formoterol Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3410, Formoterol. https://pubchem.ncbi.nlm.nih.gov/compound/Formoterol. Accessed Apr. 26, 2024.
Bảo quản
Inhalation cap: Store below 30°C. Metered-dose dry powder inhaler: Store below 30°C. Protect from moisture. Metered-dose aerosol inhaler: Prior to dispensing, store between 2-8°C (for a Max of 15 months); after dispensing, store below 30°C (for a Max of 3 months). Solution for nebulisation: Prior to dispensing, store between 2-8°C; after dispensing, store between 2-8°C or between 20-25°C (for up to 3 months). Storage recommendations may vary among countries and individual products. Refer to specific product guidelines.
R03AC13 - formoterol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Tài liệu tham khảo
Anon. Formoterol. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 12/02/2024.Anon. Formoterol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/02/2024.AstraZeneca Limited. Oxis 6 Turbuhaler, 4.5 micrograms/inhalation, Inhalation Powder datasheet 09 April 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 15/04/2024.Atimos Modulite 12 micrograms/actuation Pressurised Inhalation Solution (Chiesi Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/02/2024.Buckingham R (ed). Formoterol Fumarate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/02/2024.Formatris Novolizer 12 micrograms/actuation Inhalation Powder (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 15/04/2024.Formoterol Easyhaler 12 micrograms/dose Inhalation Powder (Orion Corporation). MHRA. https://products.mhra.gov.uk. Accessed 12/02/2024.Formoterol Fumarate Solution (Bryant Ranch Prepack). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/02/2024.Formoterol Neutec 12 mcg Capsair Hard Capsule Inhalation Powder (Neutec Inhaler Ilac Sanayi ve Ticaret. A.S). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/02/2024.Joint Formulary Committee. Formoterol Fumarate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/02/2024.Novartis New Zealand Limited. Foradil Formoterol Fumarate 12 microgram Inhalation Powder, Hard Capsules datasheet 01 July 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 12/02/2024.Oxis Turbohaler 12, Inhalation Powder (AstraZeneca UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 15/04/2024.
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