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Home > Medications (Drugs) > Loratadine > More information about Loratadine

More information about Loratadine

Pronunciation

(lor AT a deen)


U.S. Brand Names

Alavert™ [OTC]; Claritin® [OTC]; Claritin® Hives Relief [OTC]; Dimetapp® Children's ND [OTC]; Tavist® ND [OTC]

Generic Available

Yes

Canadian Brand Names

Apo-Loratadine®; Claritin®; Claritin® Kids

Use

Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis; treatment of chronic idiopathic urticaria

Pregnancy Risk Factor

B

Pregnancy Implications

Loratadine was not found to be teratogenic in animal studies. There are no adequate and well-controlled studies in pregnant woman; use during pregnancy only if clearly needed.

Lactation

Enters breast milk/not recommended (AAP rates "compatible")

Contraindications

Hypersensitivity to loratadine or any component of the formulation

Warnings/Precautions

Use with caution and modify dose in patients with liver or renal impairment; safety and efficacy in children <2 years of age have not been established

Adverse Reactions

Adults:  

Central nervous system: Headache (12%), somnolence (8%), fatigue (4%)

Gastrointestinal: Xerostomia (3%)

Children:  

Central nervous system: Nervousness (4% ages 6-12 years), fatigue (3% ages 6-12 years, 2% to 3% ages 2-5 years), malaise (2% ages 6-12 years)

Dermatologic: Rash (2% to 3% ages 2-5 years)

Gastrointestinal: Abdominal pain (2% ages 6-12 years), stomatitis (2% to 3% ages 2-5 years)

Neuromuscular & skeletal: Hyperkinesia (3% ages 6-12 years)

Ocular: Conjunctivitis (2% ages 6-12 years)

Respiratory: Wheezing (4% ages 6-12 years), dysphonia (2% ages 6-12 years), upper respiratory infection (2% ages 6-12 years), epistaxis (2% to 3% ages 2-5 years), pharyngitis (2% to 3% ages 2-5 years), flu-like symptoms (2% to 3% ages 2-5 years)

Miscellaneous: Viral infection (2% to 3% ages 2-5 years)

Adults and Children:  <2%: Agitation, altered lacrimation, altered micturition, altered salivation, altered taste, amnesia, angioneurotic edema, anorexia, anxiety, appetite increased, arthralgia, back pain, blepharospasm, blurred vision, breast pain, bronchitis, bronchospasm, chest pain, confusion, constipation, cough, depression, dermatitis, diaphoresis increased, diarrhea, dizziness, dry hair, dry skin, dysmenorrhea, dyspepsia, dysphonia, dyspnea, earache, eye pain, flatulence, flushing, gastritis, hemoptysis, hiccup, hypertension, hypertonia, hypoesthesia, hypotension, impaired concentration, impotence, insomnia, irritability, laryngitis, leg cramps, libido decreased, loose stools, malaise, menorrhagia, migraine, myalgia, nasal dryness, nausea, palpitation, paresthesia, paroniria, photosensitivity, pruritus, purpura, rigors, sinusitis, sneezing, supraventricular tachyarrhythmia, syncope, tachycardia, thirst, tinnitus, tremor, urinary discoloration, urinary incontinence, urinary retention, urticaria, vaginitis, vertigo, vomiting, weakness, weight gain

Postmarketing and/or case reports: Abnormal hepatic function, alopecia, anaphylaxis, breast enlargement, erythema multiforme, hepatitis, hepatic necrosis, jaundice, peripheral edema, seizure, thrombocytopenia

Overdosage/Toxicology

Symptoms of overdose include somnolence, tachycardia, and headache. No specific antidote is available. Treatment is symptomatic and supportive. Loratadine is not eliminated by dialysis.

Drug Interactions

Substrate (minor) of CYP2D6, 3A4; Inhibits CYP2C19 (moderate), 2D6 (weak)

CYP2C19 substrates: Loratadine may increase the levels/effects of CYP2C19 substrates. Example substrates include citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline.

Protease inhibitors (amprenavir, ritonavir, nelfinavir) may increase the serum levels of loratadine

Increased toxicity: Other antihistamines

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (although sedation is limited with loratadine, may increase risk of CNS depression).

Food: Increases bioavailability and delays peak.

Herb/Nutraceutical: St John's wort may decrease loratadine levels.

Stability

Store at 2°C to 25°C (36°F to 77°F).

Rapidly-disintegrating tablets: Use within 6 months of opening foil pouch, and immediately after opening individual tablet blister. Store in a dry place.

Mechanism of Action

Long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic properties

Pharmacodynamics/Kinetics

Onset of action: 1-3 hours

Peak effect: 8-12 hours

Duration: >24 hours

Absorption: Rapid

Distribution: Significant amounts enter breast milk

Metabolism: Extensively hepatic via CYP2D6 and 3A4 to active metabolite

Half-life elimination: 12-15 hours

Excretion: Urine (40%) and feces (40%) as metabolites

Dosage

Oral: Seasonal allergic rhinitis, chronic idiopathic urticaria:

Children 2-5 years: 5 mg once daily

Children

6 years and Adults: 10 mg once daily

Elderly: Peak plasma levels are increased; elimination half-life is slightly increased; specific dosing adjustments are not available

Dosage adjustment in renal impairment:   Clcr

30 mL/minute:

Children 2-5 years: 5 mg every other day

Children

6 years and Adults: 10 mg every other day

Dosage adjustment in hepatic impairment:   Elimination half-life increases with severity of disease

Children 2-5 years: 5 mg every other day

Children

6 years and Adults: 10 mg every other day

Dietary Considerations

Take on an empty stomach. Alavert™ and Dimetapp® Children's ND contain phenylalanine 8.4 mg per 10 mg tablet.

Patient Education

Take as directed; do not exceed recommended dose. Avoid use of other depressants, alcohol, or sleep-inducing medications unless approved by prescriber. You may experience drowsiness or dizziness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or dry mouth or nausea (small, frequent meals, frequent mouth care, chewing gum, or sucking hard candy may help). Report persistent dizziness, sedation, or seizures; chest pain, rapid heartbeat, or palpitations; swelling of face, mouth, lips, or tongue; respiratory difficulty; changes in urinary pattern; yellowing of skin or eyes; dark urine or pale stool; or lack of improvement or worsening or condition. Breast-feeding precaution:   Consult prescriber if breast-feeding.

Rapidly-disintegrating tablets: Place tablet on tongue; it dissolves rapidly. May be used with or without water. Use within 6 months of opening foil pouch, and immediately after opening individual tablet blister.

Nursing Implications

Encourage patient to drink plenty of water; may cause dry mouth, sedation, drowsiness, and can impair judgment and coordination

Cardiovascular Considerations

At recommended doses, loratadine has not been associated with clinically relevant QT prolongation or ventricular arrhythmias (eg, torsade de pointes). Loratadine has been associated with supraventricular tachyarrhythmia.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

Drowsiness is common; may cause anxiety or depression

Mental Health: Effects on Psychiatric Treatment

None reported

Dosage Forms

Syrup (Claritin®): 1 mg/mL (120 mL) [contains sodium benzoate; fruit flavor]

Tablet (Alavert™, Claritin®, Claritin® Hives Relief; Tavist® ND): 10 mg

Tablet, rapidly-disintegrating: 10 mg

Alavert™: 10 mg [contains phenylalanine 8.4 mg/tablet]

Claritin® RediTabs®: 10 mg [mint flavor]

Dimetapp® Children's ND: 10 mg [contains phenylalanine 8.4 mg/tablet]

References

"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,"Pediatrics, 2001, 108(3):776-89.

Clissold SP, Sorkin EM, and Goa KL, "Loratadine: A Preliminary Review of Its Pharmacodynamic Properties and Therapeutic Efficacy,"Drugs, 1989, 37(1):42-57.

Crumb WJ, "Loratadine Blockade of K(+) Channels in Human Heart: Comparison With Terfenadine Under Physiological Conditions,"J Pharmacol Exp Ther, 2000, 292(1):261-4.

Crumb WJ, "Rate-Dependent Blockade of a Potassium Current in Human Atrium by the Antihistamine Loratadine,"Br J Pharmacol, 1999, 126(3):575-80.

Delpon E, Valenzuela C, Gay P, et al, "Block of Human Cardiac Kv1.5 Channels by Loratadine: Voltage-, Time-, and Use-Dependent Block at Concentrations Above Therapeutic Levels,"Cardiovasc Res, 1997, 35(2):341-50.

Lin CC, Radwanski E, Affrime M, et al, "Pharmacokinetics of Loratadine in Pediatric Subjects,"Am J Therapeut, 1995, 2:504-8.

Luck JC and Evrard HM, "Atrial Fibrillation Associated With Loratadine Use,"J Allergy Clin Immunol, 1995, 95(2):282.

Lutsky BN, Klose P, Melon J, et al, "A Comparative Study of the Efficacy and Safety of Loratadine Syrup and Terfenadine Suspension in the Treatment of 3 to 6 Year Old Children With Seasonal Allergic Rhinitis,"Clin Ther, 1993, 15(5):855-65.

Simons FE, "Loratadine, a Nonsedating H1-Receptor Antagonist (Antihistamine),"Ann Allergy, 1989, 63(4):266-8.

International Brand Names

Aerotina® (AR); Alarin® (TR); Alegra® (PL); Alerfan® (PL); Alergaliv® (BR); Alergan® (CL); Alergin® (EC); Alergit® (EC); Aleric® (PL); Alernitis® (ID); Alerpriv® (AR); Alledryl® (CL); Allerdine® (TH); Allerfre® (NL); Allernon® (AT); Allersil® (TH); Aller-Tab® (TH); Allohex® (ID); Alloris® (ID); Alorin® (IT); Anhissen® (ID); Anlos® (ID); Antor® (TR); AP-Loratadine® (ZA); Apo-Loratadine® (CA); Ardin® (SG); Artamina® (CL); Bedix® (AR); Belodin® (HR); Biloina® (AR); Carinose® (TH); Carin® (SG); Civeran® (ES); Claratyne® (AU, NZ); Clarid® (TH); Clarihis® (ID); Clarinese® (ZA); Claritin® (CA, ID); Claritine® (BE, BR, CH, CZ, HR, HU, LU, NL, PL, RO, RU, SI, TR, YU); Claritin® Kids (CA); Clarityn® (AT, DK, FI, GB, IT, NO, SE); Clarityne® (AR, BD, CL, CO, CR, DO, EC, ES, FR, GT, HK, HN, MX, NO, PA, SG, SV, TH, ZA); Clarityne Fast® (CL, CR, DO, GT, HN, PA, SV); Clarityne Rapitabs® (CO); Clarityn-S® (FI, SE); Cloratadd® (BR); Contral® (HR); Cronitin® (ID); Efectine® (CO); Eladin® (BD); Erolin® (HU); Ezede® (SG); Fadina® (ES); Finistan® (HN); Flonidan® (CZ, HR, HU, PL, RO, SI, YU); Folerin® (ID); Frenaler® (CL); Fristamin® (IT); Geklimon® (DK); Halodin® (TH); Hislorex® (ID); Histaclar® (IE); Histadin® (BR, TR); Histaloran® (GT, HN); Histalor® (BR, SG); Histaplus® (CL); Histaritin® (ID); Histidanyl® (CL); Imunex® (ID); Inclarin® (ID); Klinset® (ID); Larmax® (CL); Larotin® (EC); Latoren® (RO); Laura® (ZA); Lergia® (ID); Lertamine® (AR, MX); Lesidas® (ID); Lindine® (TH); Lisaler® (AR); Lisino® (DE); Livotab® (DE); Lobeta® (DE); Loisan® (AR); Lomilan® (RU); Lontadex® (CL); Lora Basics® (DE); Loracert® (CO); Loraclar® (DE); Loraderm® (DE); Loradif® (TR); Loradin® (BD, YU); Loradine® (TH); Loragalen® (DE); Loragamma® (DE); Lorahexal® (PL); Lorahist® (ZA); Loralerg® (BR, DE); Lora-Lich® (DE); Loramine® (CO); Loram® (PL); Loran® (ID); Loranil® (BR); Lorano® (AT, DE, ZA); Loranol® (CZ); Loranox® (TH); Lorantis® (TR); Lorapozzan® (PL); Lora-Puren® (DE); Lorastine® (IL); Lorastyne® (AU); Loratadin 1A Farma® (DK); Loratadin 1A Pharma® (DE); Loratadina Bayvit® (ES); Loratadina Bexal® (ES); Loratadina Biochemie® (CO); Loratadina® (BR, CL, EC); Loratadina Cinfa® (ES); Loratadin acis® (DE); Loratadina Combino Pharm® (ES); Loratadina Davur® (ES); Loratadina Geminis® (ES); Loratadina Genfar® (EC); Loratadina Kern® (ES); Loratadina Lasa® (ES); Loratadin AL® (DE); Loratadin Alpharma® (DK); Loratadina Merck® (ES); Loratadina MK® (CO, CR, DO, GT, HN, PA, SV); Loratadina Normon® (ES); Loratadina Pharmagenus® (ES); Loratadina Pliva® (ES); Loratadina Rimafar® (ES); Loratadina Tamarang® (ES); Loratadina Ur® (ES); Loratadina Vannier® (AR); Loratadin AZU® (DE); Loratadin Biochemie® (DK, FI, SE); Loratadin® (CZ, DE); Loratadine® (IL, TH); Loratadine-Teva® (IL); Loratadin GEA® (SE); Loratadin Generics® (FI); Loratadin Heumann® (DE); Loratadin KSK® (DE); Loratadin NM® (DK); Loratadin NM Pharma® (SE); Loratadin® (NO); Loratadin-ratiopharm® (DE); Loratadin "ratiopharm"® (DK); Loratadin ratiopharm® (DK, FI); Loratadin Sandoz® (DE); Loratadin Stada® (DE, DK, SE); Loratadin-Teva® (DE); loratadin von ct® (DE); Loratadura® (DE); Loratadyna® (PL); Loratagamma® (DE); Loratan® (PL); Loratin® (EC, RO); Loratine® (PL); Loratio® (PL); Loratrim® (IL); Loratyn® (AT); Loravis® (DE); Lordin® (TH); Loremix® (BR); Loretina® (CL); Lorex® (CO); Lorfast® (IN, SG); Loridin Rapitabs® (IN); Loridin® (SG); Lorita® (TH); Loritin® (DK); Loritine® (TR); Lorityne® (TH); Loropoz® (PL); Lorsedin® (TH); Mastocit® (GT); Mildin® (DK); Nalergine® (PL); Nastizol Antialergico® (AR); Nosedin® (ID); Novo-Vagran® (AR); Nularef® (AR); Omega 100 L® (AR); Optimin® (ES); Oradin® (BD); Oratyn® (DK); Pollentyme® (ZA); Pressing® (YU); Proactin® (CR, DO, EC, GT, HN, PA, SV); Prohistin® (ID); Pylor® (ID); Restamine® (EG, JO, KW, LB, SY); Ridamin® (SG, TH); Rihest® (ID); Rinolan® (HR); Rityne® (TH); Roletra® (SG, TH); Rotadin® (PL); Safetin® (ID); Sandoz Loratadine® (ZA); Sanelor® (BE, LU); Sensibit® (MX); Sinaler® (AR); Sinhistan® (DO, GT, HN, SV); Sohotin® (ID); Solusedante® (AR); Symphoral® (RO); Talorat® (CR, DO, GT, HN, PA, SV); Tinnic® (ID); Tiradine® (TH); Tirlor® (TH); Tricel® (EC); Velodan® (ES); Versal® (NO, SE); Vilamax® (EC); Vividrin Loratadin® (DE); Zeos® (ID); Zinlergia® (CL); Zoman® (DO)

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