Pseudoephedrine

Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Nasal congestion
Adult: For symptomatic relief of cases associated with common cold or upper respiratory allergies: As conventional tab, softgel cap, or oral solution: 60 mg 4-6 hourly. As extended-release cap: 120 mg 12 hourly. As extended-release tab: 120 mg 12 hourly or 240 mg 24 hourly. Max: 240 mg/24 hours. Dosage recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: For symptomatic relief of cases associated with common cold or upper respiratory allergies: 4-5 years As oral solution: 15 mg 4-6 hourly (Max: 60 mg/24 hours); 6-11 years As softgel cap or oral solution: 30 mg 4-6 hourly (Max: 120 mg/24 hours); ≥12 years Same as adult dose. Starting age for child dosing and dosage recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Các sản phẩm có chứa hoạt chất Pseudoephedrine tại Việt Nam?
  • Drill viêm mũi
Suy thận
Severe: Contraindicated. Recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Cách dùng
May be taken with or without food.
Chống chỉ định
Severe or uncontrolled hypertension, severe coronary artery disease. Severe renal impairment (including severe acute or chronic kidney failure). Concomitant use or within 2 weeks of discontinuing MAOI therapy.
Thận trọng
Patient with diabetes, CV disease (e.g. ischaemic heart disease, coronary artery disease), hypertension, hyperthyroidism, prostatic hypertrophy or bladder dysfunction, raised intraocular pressure, predisposition to angle-closure glaucoma; obstruction/narrowing of the gastrointestinal tract (extended-release formulation). Intended for short-term use only and should not be used for prolonged periods. Severe hepatic and mild to moderate renal impairment. Treatment with pseudoephedrine in children (especially under 6 years old) should be considered carefully due to potential risks and limited evidence on efficacy. Elderly. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Hallucinations, restlessness, sleep disturbances, severe skin reactions (e.g. acute generalised exanthematous pustulosis), ischaemic colitis, ischaemic optic neuropathy. Rarely, posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS); gastrointestinal obstruction (particularly when 24-hour extended-release tab is used in patients with severe narrowing of the oesophagus, stomach or intestine).
Cardiac disorders: Tachycardia, palpitations, arrhythmia.
Eye disorders: Angle-closure glaucoma.
Gastrointestinal disorders: Nausea, vomiting, dry mouth.
Immune system disorders: Hypersensitivity reactions.
Nervous system disorders: Headache, dizziness, tremor.
Psychiatric disorders: Insomnia, anxiety, irritability, excitability. Rarely, psychotic disorder.
Renal and urinary disorders: Urinary retention.
Skin and subcutaneous tissue disorders: Rash, erythematous nodular patches.
Vascular disorders: Hypertension, impaired circulation to the extremities.
Chỉ số theo dõi
Monitor cardiac and CNS changes. Assess for the signs and symptoms of severe skin reactions; PRES and RCVS (e.g. sudden, severe or thunderclap headache, sudden nausea and vomiting, visual disturbances, confusion, seizures).
Quá liều
Symptoms: Nervousness, irritability, tremor, anxiety, insomnia, nausea, vomiting, restlessness, dry mouth, cardiac arrhythmias, tachycardia, palpitations, convulsions, hypertension, urinary retention. Management: Supportive treatment. Consider administering activated charcoal. Alternatively, perform gastric lavage if it is within 1 hour of ingestion. Treat hypertension and convulsions as necessary. Monitor pulse, blood pressure and cardiac rhythm.
Tương tác
Concomitant use with other sympathomimetic agents (e.g. apraclonidine), appetite suppressants, amphetamine-like psychostimulants, TCAs, and furazolidone may increase the risk of hypertension. May attenuate the therapeutic effects of antihypertensive agents (e.g. methyldopa, guanethidine, reserpine, α-adrenergic blockers, β-blockers). May increase the risk of arrhythmias with cardiac glycosides, quinidine, volatile anaesthetics (e.g. cyclopropane, halothane), or anticholinergic drugs (e.g. TCAs). Increased risk of ergotism with ergot alkaloids, including ergotamine or methysergide. Elimination of pseudoephedrine may be enhanced or reduced by urinary acidifiers or urinary alkalinisers, respectively.
Potentially Fatal: Concomitant administration with MAOIs may result in hypertensive crisis.
Tương tác với thức ăn
Onset of effect may be delayed with food.
Ảnh hưởng đến kết quả xét nghiệm
May interfere with the urine detection of amphetamine causing false-positive results.
Tác dụng
Description:
Mechanism of Action: Pseudoephedrine, a direct- and indirect-acting sympathomimetic agent, is a stereoisomer of ephedrine with lower pressor activity and fewer CNS effects. It acts directly on α-adrenergic receptors of the respiratory mucosa causing vasoconstriction. Pseudoephedrine also directly stimulates β-adrenergic receptors resulting in bronchial relaxation, increased heart rate and contractility.
Onset: Decongestant: 30 minutes.
Duration: 3-8 hours (conventional tab).
Pharmacokinetics:
Absorption: Readily and completely absorbed from the gastrointestinal tract. Food may delay the onset of effect. Time to peak plasma concentration: 1-3 hours (conventional tab).
Distribution: Enters breast milk (small amounts).
Metabolism: Metabolised in the liver via N-demethylation into norpseudoephedrine (active metabolite).
Excretion: Via urine (43-96% as unchanged drug; 1-6% as active metabolite). Elimination half-life: 3-6 hours (urine pH 5); 9-16 hours (urine pH 8).
Đặc tính

Chemical Structure Image
Pseudoephedrine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 7028, Pseudoephedrine. https://pubchem.ncbi.nlm.nih.gov/compound/Pseudoephedrine. Accessed July 26, 2024.

Bảo quản
Store between 15-30°C. Protect from light.
Phân loại MIMS
Thuốc ho & cảm / Thuốc chống sung huyết mũi & các chế phẩm khác dùng cho mũi
Phân loại ATC
R01BA02 - pseudoephedrine ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
Tài liệu tham khảo
Anon. Pseudoephedrine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 17/07/2024.

Buckingham R (ed). Pseudoephedrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/05/2024.

Children's Sudafed Nasal Decongestant Solution (Johnson & Johnson Consumer Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/05/2024.

Contac Non Drowsy 12 Hour Relief (Omega Pharma Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 09/05/2024.

Galpseud Linctus (Thornton & Ross Ltd). MHRA. https://products.mhra.gov.uk. Accessed 09/05/2024.

Galpseud Tablets (Thornton & Ross). MHRA. https://products.mhra.gov.uk. Accessed 09/05/2024.

JNTL Consumer Health (New Zealand) Limited. Sudafed Sinus and Nasal Decongestant Tablet data sheet 12 April 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 09/05/2024.

Joint Formulary Committee. Pseudoephedrine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 17/07/2024.

Over-the-counter Cough and Cold Medicines for Children. Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 17/07/2024.

Pseudoephedrine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 17/07/2024.

Pseudoephedrine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/05/2024.

Pseudoephedrine: Very Rare Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS). Medicines & Healthcare products Regulatory Agency. https://www.gov.uk/drug-safety-update. Accessed 17/07/2024.

Sudafed Sinus Congestion 12 Hour, Film Coated, Extended Release (Johnson & Johnson Consumer Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/05/2024.

Sudafed Sinus Congestion 24 Hour, Film Coated, Extended Release (Johnson & Johnson Consumer Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/05/2024.

Zephrex D Gelatin Coated (L. Perrigo Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/05/2024.

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