Loratadine + Pseudoephedrine


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Allergic rhinitis, Common cold
Adult: Available preparations:
Loratadine 5 mg and pseudoephedrine 120 mg extended-release tab
Loratadine 10 mg and pseudoephedrine 240 mg extended-release tab

For the temporary relief of symptoms including sneezing, runny nose, sinus or nasal congestion, itchy nose or throat, and watery eyes: As 5 mg loratadine/120 mg pseudoephedrine extended-release tab: 1 tab 12 hourly. As 10 mg loratadine/240 mg pseudoephedrine extended-release tab: 1 tab once daily. Seek medical advice if symptoms do not improve within 7 days.
Child: ≥12 years Same as adult dose.
Suy gan
Dose adjustment may be necessary.
Cách dùng
extended-release: May be taken with or without food. Swallow whole, do not break, chew or dissolve.
Chống chỉ định
Severe hypertension, severe coronary artery disease, urinary retention, hyperthyroidism, narrow-angle glaucoma; history of dysphagia, known upper gastrointestinal narrowing, abnormal oesophageal peristalsis. Concomitant use or within 14 days of discontinuing MAOI.
Thận trọng
Patient with CV disease including ischaemic heart disease and hypertension; diabetes mellitus, thyroid dysfunction, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hyperplasia, genitourinary obstruction. Patient receiving digitalis treatment. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: CNS stimulation, excitability, convulsions or CV collapse with hypotension; drug abuse or dependence. Rarely, mechanical upper gastrointestinal tract obstruction (particularly in patients with history of dysphagia).
Cardiac disorders: Tachycardia, palpitation.
Gastrointestinal disorders: Dry mouth, abdominal distress, nausea, dyspepsia.
General disorders and administration site conditions: Fatigue, thirst.
Hepatobiliary disorders: Rarely, abnormal hepatic function.
Investigations: Increased intraocular pressure.
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Headache, drowsiness, somnolence, dizziness, hyperkinesia.
Psychiatric disorders: Insomnia, nervousness, irritability, confusion.
Renal and urinary disorders: Urinary retention.
Respiratory, thoracic and mediastinal disorders: Cough, nasal irritation, pharyngitis, dyspnoea.
Vascular disorders: Hypertension.
Thông tin tư vấn bệnh nhân
This drug may cause drowsiness, if affected, do not drive or operate machinery. 
Quá liều
Symptoms: CNS depression (e.g. sedation, apnoea, decreased mental alertness, cyanosis, coma, CV collapse) to CNS stimulation (e.g. insomnia, hallucination, tremors, convulsions), excitement, euphoria, palpitations, tachycardia, thirst, perspiration, nausea, dizziness, tinnitus, ataxia, blurred vision and hypertension or hypotension. Management: Symptomatic and supportive treatment. Induce emesis using ipecac syrup (except in patients with impaired consciousness), then may give activated charcoal. Perform gastric lavage if vomiting is contraindicated or unsuccessful. Administer vasopressors to treat hypotension, and diazepam, short-acting barbiturates or paraldehyde to control seizures. Provide ventilatory support for apnoea.
Tương tác
Loratadine: Elevated plasma concentrations with ketoconazole, erythromycin and cimetidine.
Pseudoephedrine: Increased ectopic pacemaker activity with digitalis. May antagonise the antihypertensive action of methyldopa, mecamylamine, reserpine, and veratrum alkaloids. Enhanced rate of absorption with antacids.
Potentially Fatal: Pseudoephedrine: Increased risk of hypertensive crisis with MAOIs.
Tương tác với thức ăn
Loratadine: Delayed time to peak plasma concentration and increased bioavailability with food. Enhanced CNS depressant effects with alcohol.
Ảnh hưởng đến kết quả xét nghiệm
Loratadine: May diminish the wheal and flare reactions to skin test antigens.
Pseudoephedrine: May cause false-positive result with urine detection of amphetamine.
Tác dụng
Description: Loratadine is a long-acting, tricyclic non-sedating antihistamine. It selectively inhibits the effects of histamine H1-receptors on effector cells.
Pseudoephedrine is a sympathomimetic agent that relieves nasal congestion by directly stimulating the α-adrenergic receptors resulting in vasoconstriction of respiratory mucosa, and the β-adrenergic receptors causing relaxation of bronchial muscles, and increased heart rate and contractility.
Onset: Loratadine: 1-3 hours.
Pseudoephedrine: Decongestant effect: 30 minutes.
Duration: Loratadine: >24 hours.
Pseudoephedrine: 3-8 hours (immediate-release).
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract.
Loratadine: Food delays time to peak plasma concentration and increases bioavailability. Time to peak plasma concentration: Approx 1-1.5 hours (loratadine); approx 1.5-3.7 hours (desloratadine).
Pseudoephedrine: Time to peak plasma concentration: 1-3 hours (immediate-release).
Distribution: Enters breast milk.
Loratadine: Volume of distribution: 119 L/kg. Plasma protein binding: Approx 97-99% (loratadine); approx 73-76% (desloratadine).
Pseudoephedrine: Volume of distribution: 2.64-3.51 L/kg.
Metabolism: Loratadine: Extensively metabolised in the liver by CYP3A4 and CYP2D6 isoenzymes to desloratadine or descarboethoxyloratadine (active metabolite).
Pseudoephedrine: Incompletely metabolised in the liver via N-demethylation to norpseudoephredrine (active metabolite).
Excretion: Loratadine: Via urine (40%) and faeces (approx 40%) as metabolites. Elimination half-life: Loratadine: 8.4 hours (range: 3-20 hours); Desloratadine: 28 hours (range: 8.8-92 hours).
Pseudoephedrine: Via urine (43-96% as unchanged drug, 1-6% as norpseudoephedrine). Elimination half-life: 9-16 hours (pH 8); 3-6 hours (pH 5). Excretion is dependent on urine pH and flow rate; alkaline urine decreases renal elimination.
Đặc tính

Chemical Structure Image
Loratadine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3957, Loratadine. https://pubchem.ncbi.nlm.nih.gov/compound/3957. Accessed July 26, 2022.


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 June 28, 2022.

Bảo quản
Store in a dry place between 20-25°C. Protect from light.
Phân loại MIMS
Thuốc kháng histamin & kháng dị ứng / Thuốc chống sung huyết mũi & các chế phẩm khác dùng cho mũi
Phân loại ATC
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
Tài liệu tham khảo
Alavert Allergy Sinus D-12 Extended Release Film Coated Tablet (GlaxoSmithKline Consumer Healthcare Holdings [US] LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/07/2021.

Anon. Loratadine and Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/07/2021.

Anon. Loratadine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/07/2021.

Anon. Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/07/2021.

Buckingham R (ed). Loratadine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/07/2021.

Clarinase Extended Release Tablet (Bayer HealthCare Limited). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 07/07/2021.

Clarinase Repetabs (Bayer Co. [Malaysia] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/07/2021.

Claritin-D 24 Hour Extended Release Tablet (Bayer Healthcare LLC.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/07/2021.

Loratadine; Pseudoephedrine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 07/07/2021.

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