Loratadine

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Loratadine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Loratadine is an antihistamine that is FDA approved for the treatment of runny nose, sneezing, itchy, watery eyes, itching of the nose or throat. Common adverse reactions include xerostomia, headache, somnolence and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Seasonal allergic rhinitis

  • Dose: 10 mg PO daily

Idiopathic urticaria

  • Dose: 10 mg PO daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Loratadine in adult patients.

Non–Guideline-Supported Use

Asthma

  • 10-20 mg PO daily up to 8 weeks [1][2]

Eosinophilic nonallergic rhinitis

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Seasonal allergic rhinitis

  • Dose (2-5 years): 5 mg PO daily
  • Dose (>6 years): 10 mg PO daily

Idiopathic urticaria

  • Dose 2-5 years: 5 mg PO daily
  • Dose >6 years: 10 mg PO daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Loratadine in pediatric patients.

Non–Guideline-Supported Use

Asthma

  • <30 kg: 10 mg PO daily
  • >30 kg: 20 mg PO daily

Contraindications

Warnings

  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
  • When using this product do not take more than directed. Taking more than directed may cause drowsiness.
  • Stop use and ask a doctor is an allergic reaction to this product occurs. Seek medical help right away.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children.
  • In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

Dermatologic

Gastrointestinal

Hepatic

Neurologic

Respiratory

Other

Postmarketing Experience

There is limited information regarding Loratadine Postmarketing Experience in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

  • Ask a health professional before use.


Pregnancy Category (AUS): B1 There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Loratadine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Loratadine during labor and delivery.

Nursing Mothers

  • Ask a health professional before use.

Pediatric Use

  • In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Geriatic Use

There is no FDA guidance on the use of Loratadine in geriatric settings.

Gender

There is no FDA guidance on the use of Loratadine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Loratadine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Loratadine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Loratadine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Loratadine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Loratadine in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Monitoring

There is limited information regarding Loratadine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Loratadine and IV administrations.

Overdosage

There is limited information regarding Loratadine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Loratadine molecule.png
Loratadine
Systematic (IUPAC) name
Ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate
Identifiers
CAS number 79794-75-5
ATC code R06AX13
PubChem 3957
DrugBank DB00455
Chemical data
Formula C22H23ClN2O2 
Mol. mass 382.88 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability almost 100%
Protein binding 97–99%
Metabolism Hepatic (CYP2D6- and 3A4-mediated)
Half life 8 hours, active metabolite desloratadine 27 hours
Excretion 40% as conjugated metabolites into urine
Similar amount into the feces
Therapeutic considerations
Pregnancy cat.

B1(AU) B(US)

Legal status

?(CA) GSL(UK) OTC(US)

Routes oral

Mechanism of Action

Loratadine is a tricyclic antihistamine, which acts as a selective inverse agonist of peripheral histamine H1-receptors.

Structure

There is limited information regarding Loratadine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Loratadine Pharmacodynamics in the drug label.

Pharmacokinetics

Loratadine is given orally, is well absorbed from the gastrointestinal tract, and has rapid first-pass hepatic metabolism; it is metabolized by isoenzymes of the cytochrome P450 system, including CYP3A4, CYP2D6, and, to a lesser extent, several others.[3][4] Loratadine is almost totally (97–99%) bound to plasma proteins. Its metabolite desloratadine, which is largely responsible for the antihistaminergic effects, binds to plasma proteins by 73–76%.

Nonclinical Toxicology

There is limited information regarding Loratadine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Loratadine Clinical Studies in the drug label.

How Supplied

  • Supplied as tablets of 10 mg in 30 tablet carton and 40 tablet bottle carton.

Storage

  • Store at 20°-25°C (68°-77°F)

Images

Drug Images

Package and Label Display Panel

Loratadine FDA panel2.png
This image of the FDA label is provided by the National Library of Medicine.
Loratadine FDA panel1 .png
This image of the FDA label is provided by the National Library of Medicine.
Loratadine Package2.png
This image of the FDA label is provided by the National Library of Medicine.
Loratadine Package1.png
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Loratadine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Loratadine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Loratadine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Menardo JL, Horak F, Danzig MR, Czarlewski W (1997). "A review of loratadine in the treatment of patients with allergic bronchial asthma". Clin Ther. 19 (6): 1278–93, discussion 1523-4. PMID 9444440.
  2. Corren J, Harris AG, Aaronson D, Beaucher W, Berkowitz R, Bronsky E; et al. (1997). "Efficacy and safety of loratadine plus pseudoephedrine in patients with seasonal allergic rhinitis and mild asthma". J Allergy Clin Immunol. 100 (6 Pt 1): 781–8. PMID 9438487.
  3. Nelson, Wendel L. (2002). "Antihistamines and related antiallergic and antiulcer agents". In Williams, David H.; Foye, William O.; Lemke, Thomas L. Foye's principles of medicinal chemistry. Hagerstown, MD: Lippincott Williams & Wilkins. p. 805. ISBN 0-683-30737-1. Retrieved on 1 December 2009 through Google Book Search.
  4. Ghosal A, Gupta S, Ramanathan R; et al. (August 2009). "Metabolism of loratadine and further characterization of its in vitro metabolites". Drug Metab Lett. 3 (3): 162–70. doi:10.2174/187231209789352067. PMID 19702548.







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