Loratadine


Concise Prescribing Info
Indications/Uses
Allergic conditions.
Dosage/Direction for Use
Adult : PO 10 mg once daily or 5 mg bid.
Dosage Details
Oral
Allergic conditions
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. 
Renal Impairment
CrCl (mL/min)  Dosage
 <30  10 mg every other day.
Hepatic Impairment
Severe: Initially, 10 mg every other day.
Administration
May be taken with or without food.
Special Precautions
Severe hepatic and renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Headache, somnolence, drowsiness, fatigue, nervousness.
Cardiac disorders: Palpitation, tachycardia, hypotension.
Gastrointestinal disorders: Dry mouth, abdominal pain, nausea, vomiting, diarrhoea, gastritis.
General disorders and admin site conditions: Malaise.
Hepatobiliary disorders: Jaundice, hepatitis, hepatic necrosis.
Investigations: Elevated liver enzymes, weight gain.
Metabolism and nutrition disorders: Increased appetite.
Nervous system disorders: Dizziness.
Skin and subcutaneous tissue disorders: Rash, alopecia.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
Overdosage
Symptoms: Somnolence, tachycardia, drowsiness, headache. Management: Symptomatic and supportive treatment. May administer activated charcoal and may perform gastric lavage.
Drug Interactions
May increase plasma concentrations with ketoconazole, fluconazole, erythromycin, clarithromycin, cimetidine.
Food Interaction
Food delays time to peak plasma concentration and increases bioavailability. Increase risk of CNS depression with 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 antihistamine which selectively inhibits histamine H1-receptors on effector cells.
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: Approx 1-1.5 hours (loratadine); approx. 1.5-3.7 hours (desloratadine).
Distribution: Enters breast milk. Volume of distribution: 119 L/kg. Plasma protein binding: Approx 97-99% (loratadine); approx 73-76% (desloratadine).
Metabolism: Extensively undergoes first-pass metabolism in the liver via CYP2D6 and CYP3A4 to desloratadine as the active metabolite.
Excretion: Via urine (40%); faeces (approx 40% as metabolites). Elimination half-life: 8.4 hours (loratadine); 28 hours (desloratadine).
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)

Storage
Store between 20-25°C. Protect from heat, light and moisture.
ATC Classification
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
References
AFT Pharmaceuticals Ltd. Loraclear 10 mg Tablet data sheet September 2013. Medsafe. http://www.medsafe.govt.nz/. Accessed 13/03/2019.

Anon. Loratadine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 13/03/2019.

Anon. Loratadine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/03/2019.

Bells Healthcare Children’s Allergy Relief 5 mg/5 mL Oral Solution (Relonchem Limited). MHRA. https://products.mhra.gov.uk/. Accessed 13/03/2019.

Boots Hayfever Relief Instant-Melts 10 mg Orodispersible Tablets (Sandoz Limited). MHRA. https://products.mhra.gov.uk/. Accessed 13/03/2019.

Buckingham R (ed). Loratadine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/03/2019.

Children’s Loratadine Tablet, Chewable (Ohm Laboratories Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 13/03/2019.

Clarityn Allergy 1 mg/mL Syrup (Bayer plc). MHRA. https://products.mhra.gov.uk/. Accessed 13/03/2019.

Loratadine Capsule, Liquid Filled (Bionpharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 13/03/2019.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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