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Loratadine

Pronunciation

Pronunciation

(lor AT a deen)

Index Terms

  • Tavist ND

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Claritin: 10 mg [contains brilliant blue fcf (fd&c blue #1)]

Solution, Oral:

Childrens Loratadine: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; fruit flavor]

Loratadine Hives Relief: 5 mg/5 mL (120 mL) [alcohol free, dye free, sugar free; contains propylene glycol, sodium benzoate; grape flavor]

Syrup, Oral:

Allergy Relief: 5 mg/5 mL (236 mL [DSC]) [alcohol free; contains propylene glycol, sodium benzoate]

Allergy Relief For Kids: 5 mg/5 mL (120 mL) [contains propylene glycol, sodium benzoate; fruit flavor]

Childrens Loratadine: 5 mg/5 mL (120 mL) [fruit flavor]

Childrens Loratadine: 5 mg/5 mL (120 mL) [alcohol free, dye free; contains propylene glycol, sodium benzoate, sodium metabisulfite; grape flavor]

Claritin: 5 mg/5 mL (60 mL, 120 mL, 150 mL) [alcohol free, color free, dye free, sugar free; contains edetate disodium, propylene glycol, sodium benzoate; grape flavor]

Loratadine Childrens: 5 mg/5 mL (120 mL) [sugar free; contains polyethylene glycol, propylene glycol, sodium benzoate, sodium metabisulfite; grape flavor]

Tablet, Oral:

Alavert: 10 mg

Allergy: 10 mg

Allergy Relief: 10 mg

Claritin: 10 mg

Loradamed: 10 mg

QlearQuil 24 Hour Relief: 10 mg

Generic: 10 mg

Tablet Chewable, Oral:

Claritin: 5 mg [contains aspartame, fd&c blue #2 aluminum lake; grape flavor]

Tablet Dispersible, Oral:

Alavert: 10 mg [contains aspartame]

Alavert: 10 mg [contains aspartame; bubble-gum flavor]

Alavert: 10 mg [contains aspartame; citrus flavor]

Allergy: 10 mg [contains aspartame; fruit flavor]

Allergy Relief: 10 mg [contains aspartame]

Allergy Relief: 10 mg [contains aspartame; fruit flavor]

Claritin Reditabs: 5 mg, 10 mg

Triaminic Allerchews: 10 mg

Brand Names: U.S.

  • Alavert [OTC]
  • Allergy Relief For Kids [OTC]
  • Allergy Relief [OTC]
  • Allergy [OTC]
  • Childrens Loratadine [OTC]
  • Claritin Reditabs [OTC]
  • Claritin [OTC]
  • Loradamed [OTC]
  • Loratadine Childrens [OTC]
  • Loratadine Hives Relief [OTC]
  • QlearQuil 24 Hour Relief [OTC]
  • Triaminic Allerchews [OTC]

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation
  • Piperidine Derivative

Pharmacology

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

Absorption

Rapid

Distribution

Vd: 119 L/kg (Haria 1994); binds preferentially to peripheral nervous system H1 receptors; no appreciable entry into CNS (Claritin prescribing information 2000)

Metabolism

Extensively hepatic via CYP2D6 and 3A4 to active metabolite (descarboethoxyloratadine) (Claritin prescribing information 2000)

Excretion

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

Onset of Action

1-3 hours; Peak effect: 8-12 hours

Time to Peak

Loratadine: 1.3 hours (loratadine), 2.3 hours (metabolite) (Claritin prescribing information 2000)

Duration of Action

>24 hours

Half-Life Elimination

8.4 hours (range 3 to 20 hours) (loratadine), 28 hours (range 8.8 to 92 hours) (metabolite) (Claritin prescribing information 2000); hepatic impairment: 24 hours (loratadine), 37 hours (metabolite) (Claritin prescribing information 2000)

Protein Binding

97% to 99% (loratadine), 73% to 76% (metabolite) (Haria 1994)

Special Populations: Renal Function Impairment

With CrCl less than 30 mL/min, AUC and Cmax are increased approximately 73% for loratadine and 120% for its metabolite.

Special Populations: Hepatic Function Impairment

AUC and Cmax doubled for loratadine

Special Populations: Elderly

AUC and Cmax are increased approximately 50%, and t½ ranged from 6.7 to 37 h.

Use: Labeled Indications

Allergic rhinitis: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis

Urticaria: Treatment of itching due to hives (urticarial)

Contraindications

Hypersensitivity to loratadine or any component of the formulation

Dosing: Adult

Seasonal allergic rhinitis, urticaria: Oral: 10 mg daily once daily or 5 mg twice daily (RediTabs)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Children 2-5 years: Seasonal allergic rhinitis, urticaria: Oral: 5 mg once daily

Children ≥6 years: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling; however, the following recommendations have been recommended (Aronoff, 2007):

Adults:

CrCl 10-50 mL/minute: Recommended dose every 24 to 48 hours.

CrCl <10 mL/minute: Recommended dose every 48 hours.

Dialysis: Recommended dose every 48 hours.

Continuous renal replacement therapy (CRRT): No dosage adjustment necessary if clearance is 2000 mL/minute.

Children ≥2 years: No dosage adjustment necessary for any degree of renal impairment.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling; however, hepatic impairment increases systemic exposure to loratadine.

Administration

May be administered without regard to meals.

Dispersible tablet: Place in mouth and allow to dissolve. Swallow with or without water.

Dietary Considerations

May be taken without regard to meals. Some products may contain phenylalanine and/or sodium.

Storage

Store at 20°C to 25°C (68°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.

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Amiodarone: May increase the serum concentration of Loratadine. Management: Due to reported QT interval prolongation and Torsades de Pointes with this combination, consider an alternative to loratadine when possible. Consider therapy modification

Amodiaquine: CYP2C8 Inhibitors may increase the serum concentration of Amodiaquine. Avoid combination

Amphetamines: May diminish the sedative effect of Antihistamines. Monitor therapy

Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Exceptions: Levocabastine (Nasal). Monitor therapy

ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Consider therapy modification

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving antihistamines (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Hydrocodone: CNS Depressants may enhance the CNS depressant effect of Hydrocodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

Metyrosine: CNS Depressants may enhance the sedative effect of Metyrosine. Monitor therapy

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Test Interactions

May suppress the wheal and flare reactions to skin test antigens

Adverse Reactions

Central nervous system: Headache (12% adults), somnolence (8% adults), nervousness (4% ages 6-12 years), fatigue (4% adults; 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: Xerostomia (3% adults), stomatitis (2% to 3% ages 2-5 years), abdominal pain (2% ages 6-12 years)

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

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

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

Miscellaneous: Flu-like syndrome (2% to 3% ages 2-5 years), viral infection (2% to 3% ages 2-5 years)

<2% (Limited to important or life-threatening): Abnormal hepatic function, agitation, alopecia, altered lacrimation, altered micturition, altered salivation, altered taste, amnesia, anaphylaxis, angioneurotic edema, anorexia, arthralgia, back pain, blepharospasm, blurred vision, breast enlargement, breast pain, bronchospasm, chest pain, confusion, depression, dizziness, dysmenorrhea, dyspnea, erythema multiforme, hemoptysis, hepatic necrosis, hepatitis, hypotension, impaired concentration, impotence, insomnia, irritability, jaundice, menorrhagia, migraine, nausea, palpitation, paresthesia, paroniria, peripheral edema, photosensitivity, pruritus, purpura, rigors, seizure, supraventricular tachyarrhythmia, syncope, tachycardia, tremor, urinary discoloration, urticaria, thrombocytopenia, vaginitis, vertigo, vomiting, weight gain

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Hepatic impairment increases systemic exposure. Use with caution.

• Renal impairment: Use with caution in patients with renal impairment.

Concurrent drug therapy issues:

• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Phenylalanine: Some products may contain phenylalanine.

Pregnancy Considerations

Maternal use of loratadine has not been associated with an increased risk of major malformations. The use of antihistamines for the treatment of rhinitis during pregnancy is generally considered to be safe at recommended doses. Although safety data is limited, loratadine may be the preferred second generation antihistamine for the treatment of rhinitis or urticaria during pregnancy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache or fatigue. Have patient report immediately to prescriber severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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