Loratadine


Generic Medicine Info
Indications and Dosage
Oral
Allergic rhinitis, Chronic idiopathic urticaria
Adult: 10 mg once daily or 5 mg bid.
Child: 2-12 years ≤30 kg: 5 mg once daily; >30 kg: 10 mg once daily. >12 years Same as adult dose. Dosage recommendations may vary among individual products or between countries (refer to detailed product guideline).
Renal Impairment
CrCl (mL/min) Dosage
<30
10 mg every other day.

Hepatic Impairment
Severe: Initially, 10 mg every other day. Alternatively, initial dose of 5 mg once daily may be given.
Administration
May be taken with or without food.
Special Precautions
Severe hepatic and renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Cardiac disorders: Very rarely, tachycardia, palpitation.
Gastrointestinal disorders: Very rarely, nausea, dry mouth, gastritis.
General disorders and administration site conditions: Fatigue (mainly in children).
Hepatobiliary disorders: Very rarely, abnormal hepatic function.
Immune system disorders: Very rarely, hypersensitivity reactions, including anaphylaxis and angioedema.
Investigations: Increased weight.
Metabolism and nutrition disorders: Increased appetite.
Nervous system disorders: Headache, drowsiness. Very rarely, dizziness, convulsion.
Psychiatric disorders: Insomnia; nervousness (mainly in children).
Skin and subcutaneous tissue disorders: Very rarely, rash, alopecia.
Patient Counseling Information
This drug may cause drowsiness, if affected, do not drive or operate machinery.
Overdosage
Symptoms: Somnolence, headache, and tachycardia. Management: Symptomatic and supportive treatment. Consider administration of activated charcoal or performing gastric lavage.
Drug Interactions
Plasma concentration may be increased by CYP3A4 or CYP2D6 inhibitors (e.g. ketoconazole, erythromycin, cimetidine).
Food Interaction
Food delays time to peak plasma concentrations and increases bioavailability. May increase the CNS depressant effects of alcohol.
Lab Interference
May diminish the wheal and flare reactions to skin test antigens.
Action
Description: Loratadine, a piperidine derivative, is a long-acting, non-sedating tricyclic antihistamine with no significant antimuscarinic properties. It exhibits a competitive and selective peripheral H1-receptor antagonistic activity.
Onset: 1-3 hours.
Duration: >24 hours.
Pharmacokinetics:
Absorption: Rapidly and well absorbed from the gastrointestinal tract. Food delays time to peak plasma concentration and increases bioavailability. Time to peak plasma concentration: 1-1.5 hours (loratadine); 1.5-3.7 hours (desloratadine).
Distribution: Enters breast milk. Volume of distribution: 119 L/kg. Plasma protein binding: 97-99% (loratadine); 73-76% (desloratadine).
Metabolism: Extensively metabolised in the liver mainly by CYP2D6 and CYP3A4 isoenzymes to form the major active metabolite, desloratadine (descarboethoxyloratadine). Undergoes first-pass metabolism.
Excretion: Via urine (approx 40%) and faeces (42%), mainly as metabolites. Elimination half-life: Loratadine: 8.4 hours (range: 3-20 hours). Desloratadine: 28 hours (range: 8.8-92 hours).
Chemical Structure

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.

Storage
Store below 30°C. Protect from moisture. Storage recommendations may vary among individual products or between countries (refer to detailed product guideline).
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
References
Anon. Loratadine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/07/2022.

Anon. Loratadine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/07/2022.

Boots Hayfever Relief Instant Melts 10 mg Orodispersible Tablets (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 25/07/2022.

Buckingham R (ed). Loratadine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/07/2022.

Children's Claritin Allergy (Grape Flavor) (Bayer HealthCare LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2022.

Claritin Chewables (Bayer HealthCare LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2022.

Claritin LiquiGels (Bayer HealthCare LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2022.

Claritin RediTabs (Bayer HealthCare LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2022.

Claritin Tablet (Bayer HealthCare LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 25/07/2022.

Clarityn 5 mg/5 mL Syrup Grape Flavour (Bayer [South East Asia] Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 25/07/2022.

Clarityne Tablet 10 mg (Bayer Co. [Malaysia] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 25/07/2022.

Joint Formulary Committee. Loratadine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/07/2022.

Loratadine 10 mg Tablets (Flamingo Pharma UK Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 25/07/2022.

Loratadine 5mg/5 mL Oral Solution (Torrent Pharma [UK] Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 25/07/2022.

Viatris Ltd. Lora-tabs Allergy and Hayfever 10 mg Tablet data sheet 18 November 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 05/07/2022.

Disclaimer: This information is independently developed by MIMS based on Loratadine 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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