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Desloratadine

Medically reviewed by Drugs.com. Last updated on Oct 8, 2020.

Pronunciation

(des lor AT a deen)

Dosage Forms

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

Syrup, Oral:

Clarinex: 0.5 mg/mL (473 mL [DSC]) [contains edetate disodium, fd&c yellow #6 (sunset yellow), propylene glycol, sodium benzoate; bubble-gum flavor]

Tablet, Oral:

Clarinex: 5 mg [contains fd&c blue #2 aluminum lake]

Generic: 5 mg

Tablet Disintegrating, Oral:

Generic: 2.5 mg, 5 mg

Brand Names: U.S.

  • Clarinex

Pharmacologic Category

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

Pharmacology

Desloratadine, a major active metabolite of loratadine, is a long-acting tricyclic antihistamine with selective peripheral histamine H1 receptor antagonistic activity.

Metabolism

Hepatic to active metabolite, 3-hydroxydesloratadine (specific enzymes not identified); subsequently undergoes glucuronidation. Decreased in slow metabolizers of desloratadine. Not expected to affect or be affected by medications metabolized by CYP with normal doses.

Excretion

Urine (87%) and feces (as metabolites)

Onset of Action

Within 1 hour

Time to Peak

Children 2 to 5 years: Mean: 3.17 hours (range: 1.5 to 8 hours) (Gupta 2007).

Children 6 to 11 years: Mean: 3.57 hours (range: 4 to 12 hours) (Gupta 2007).

Adults: 3 hours.

Duration of Action

24 hours

Half-Life Elimination

Children 2 to 5 years: Mean: 16.4 hours (Gupta 2007).

Children 6 to 11 years: Mean: 19.4 hours (Gupta 2007).

Adults: 27 hours.

Protein Binding

Desloratadine: 82% to 87%; 3-hydroxydesloratadine (active metabolite): 85% to 89%

Special Populations: Renal Function Impairment

AUC and Cmax are increased.

Special Populations: Hepatic Function Impairment

AUC and half-life are increased.

Special Populations: Elderly

Cmax and AUC are 20% higher. The half-life is 33.7 hours.

Special Populations: Children

Systemic exposure in children (based on AUC and Cmax) is similar to adults (Gupta 2007).

Use: Labeled Indications

Allergic rhinitis: Relief of nasal and non-nasal symptoms of seasonal (SAR) and perennial (PAR) allergic rhinitis

Urticaria: Symptomatic relief of pruritus, reduction in number of hives, and reduction in size of hives associated with chronic idiopathic urticaria (CIU)

Off Label Uses

NSAID-associated urticaria (prophylaxis)

Data from a retrospective study with a limited number of patients suggest that desloratadine may be beneficial for prophylactic therapy in patients with NSAID-associated urticaria prior to receiving a strong COX-1 inhibitor. Additional trials may be needed to further define the role of desloratadine in this setting [Trautmann 2016].

Contraindications

Hypersensitivity to desloratadine, loratadine, or any component of the formulation

Dosing: Adult

Chronic idiopathic urticaria: Oral: 5 mg once daily. In one clinical trial, the titrated use of higher doses (up to 10 mg twice daily) in adults demonstrated clinical improvement (Staevska 2010).

Seasonal or perennial allergic rhinitis: Oral: 5 mg once daily

NSAID-associated urticaria, prophylaxis (off-label use): Oral: 5 mg 30 minutes before intake of a strong COX-1 inhibitor (Trautmann 2016).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Perennial allergic rhinitis: Oral:

Infants 6 to ≤11 months: 1 mg once daily.

Children ≤5 years: 1.25 mg once daily.

Children 6 to ≤11 years: 2.5 mg once daily.

Children ≥12 years and Adolescents: 5 mg once daily.

Seasonal allergic rhinitis: Oral:

Children 2 to ≤5 years: 1.25 mg once daily.

Children 6 to ≤11 years: 2.5 mg once daily.

Children ≥12 years and Adolescents: 5 mg once daily.

Urticaria, chronic idiopathic: Oral:

Infants 6 to ≤11 months: 1 mg once daily.

Children ≤5 years: 1.25 mg once daily.

Children 6 to ≤11 years: 2.5 mg once daily.

Children ≥12 years and Adolescents: 5 mg once daily.

Administration

May be taken with or without food.

RediTabs should be placed on the tongue; tablet will disintegrate immediately. Take immediately after removing from blister package. Allow tablet to dissolve completely before swallowing. May be taken with or without water.

Dietary Considerations

Some products may contain phenylalanine.

Storage

Syrup, tablet, orally-disintegrating tablet: Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 85°F). Protect from moisture and excessive heat. Use orally-disintegrating tablet immediately after opening blister package. Syrup should be protected from light.

Drug Interactions

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

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

Amezinium: Antihistamines may enhance the stimulatory effect of Amezinium. Monitor therapy

Amphetamines: May diminish the sedative effect of Antihistamines. 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. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Consider therapy modification

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

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

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

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

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 at lower doses in patients already receiving CNS depressants. Consider therapy modification

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

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

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

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

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

CYP2C8 Inhibitors (Moderate): May increase the serum concentration of Desloratadine. Monitor therapy

CYP2C8 Inhibitors (Strong): May increase the serum concentration of Desloratadine. Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. 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 (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Consider therapy modification

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

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Consider therapy modification

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

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

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

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Consider therapy modification

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

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Monitor therapy

Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Monitor therapy

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

Methotrimeprazine: May enhance the CNS depressant effect of CNS Depressants. CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Consider therapy modification

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

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

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

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

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

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

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

Oxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interupt oxybate salt treatment during short-term opioid use. Consider therapy modification

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. 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

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

Pitolisant: Antihistamines may diminish the therapeutic effect of Pitolisant. Avoid combination

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

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

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

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

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

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

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

>10%:

Central nervous system: Headache (14%), irritability (infants: 12%)

Gastrointestinal: Diarrhea (infants: 15% to 20%)

Respiratory: Upper respiratory tract infection (infants: 11% to 21%), cough (infants: 11%)

Miscellaneous: Fever (infants: 12% to 17%)

1% to 10%:

Central nervous system: Drowsiness (infants: 9%), insomnia (infants: 5%), fatigue (2% to 5%), dizziness (4%), emotional lability (infants: 3%)

Dermatologic: Erythema of skin (infants: 3%), maculopapular rash (infants: 3%)

Gastrointestinal: Vomiting (infants: 6%), anorexia (infants: 5%), nausea (infants and children: 3% to 5%), dyspepsia (3%), increased appetite (infants: 3%), xerostomia (adults: 3%)

Genitourinary: Urinary tract infection (children: 4%)

Infection: Varicella zoster infection (4%), parasitic infection (infants: 3%)

Neuromuscular & skeletal: Myalgia (3%)

Otic: Otitis media (infants: 6%)

Respiratory: Bronchitis (infants: 6%), rhinorrhea (infants: 5%), pharyngitis (3% to 5%), epistaxis (infants: 3%)

Postmarketing and/or case reports: Dyspnea, hepatitis, hyperbilirubinemia, hypersensitivity reaction, increased liver enzymes, movement disorder, palpitations, pruritus, psychomotor agitation, seizure, skin rash, tachycardia

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions (including anaphylaxis) have been reported with use; discontinue therapy immediately with signs/symptoms of hypersensitivity.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with severe hepatic impairment.

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

Concurrent drug therapy issues:

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

Special populations:

• Slow metabolizers: Use with caution in patients known to be slow metabolizers of desloratadine (incidence of side effects may be increased).

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 suggest 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

Guidelines for the use of antihistamines in the treatment of allergic rhinitis or urticaria in pregnancy are generally the same as in nonpregnant females. Second generation antihistamines may be used for the treatment of allergic rhinitis and urticaria during pregnancy; however, information related to the use of desloratadine in pregnancy is limited and other medications may be preferred (BSACI [Powell 2015]; BSACI [Scadding 2017]; Zuberbier 2018).

Patient Education

What is this drug used for?

• It is used to ease allergy signs.

• It is used to treat hives.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Dry mouth

• Sore throat

• Muscle pain

• Feeling sleepy

• Feeling tired or weak

• Menstrual pain

• Upset stomach

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Shortness of breath

• Irritability

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.