Loratadine + Pseudoephedrine


Generic Medicine Info
Indications and Dosage
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.
Hepatic Impairment
Dose adjustment may be necessary.
Administration
Extended-Release: May be taken with or without food. Swallow whole, do not break, chew or dissolve.
Contraindications
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.
Special Precautions
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.
Adverse Reactions
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.
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery. 
Overdosage
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.
Drug Interactions
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.
Food Interaction
Loratadine: Delayed time to peak plasma concentration and increased bioavailability with food. Enhanced CNS depressant effects with alcohol.
Lab Interference
Loratadine: May diminish the wheal and flare reactions to skin test antigens.
Pseudoephedrine: May cause false-positive result with urine detection of amphetamine.
Action
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.
Chemical Structure

Chemical Structure Image
Loratadine

Source: National Center for Biotechnology Information. PubChem Database. Loratadine, CID=3957, https://pubchem.ncbi.nlm.nih.gov/compound/Loratadine (accessed on Jan. 22, 2020)


Chemical Structure Image
Pseudoephedrine

Source: National Center for Biotechnology Information. PubChem Database. Pseudoephedrine, CID=7028, https://pubchem.ncbi.nlm.nih.gov/compound/Pseudoephedrine (accessed on Jan. 21, 2020)

Storage
Store in a dry place between 20-25°C. Protect from light.
MIMS Class
Antihistamines & Antiallergics / Nasal Decongestants & Other Nasal Preparations
ATC Classification
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
References
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.

Disclaimer: This information is independently developed by MIMS based on Loratadine + Pseudoephedrine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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