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desloratadine (Clarinex, Clarinex RediTabs)

 

Classes: Antihistamines, 2nd Generation

Dosing and uses of Clarinex, Clarinex RediTabs (desloratadine)

 

Adult dosage forms and strengths

tablet

  • 5mg

tablet, oral disintegrating

  • 2.5mg
  • 5mg

oral syrup

  • 0.5mg/mL

 

Allergic Rhinitis & Urticaria

5 mg PO qDay

 

Chronic Idiopathic Urticaria

Indicated for relief of pruritus and hives associated with chronic iodiopathic urticaria

5 mg PO qDay

 

Dosage modifications

Renal impairment: 5 mg PO every other day

Hepatic impairment: Not studied

 

Pediatric dosage forms and strengths

tablet

  • 5mg

tablet, oral disintegrating

  • 2.5mg
  • 5mg

oral syrup

  • 0.5mg/mL

 

Perennial Allergic Rhinitis, Chronic Idiopathic Urticaria

<6 months: Safety and efficacy not established

6-12 months: 1 mg PO qDay

1-5 years: 1.25 mg PO qDay

6-12 years: 2.5 mg PO qDay

12 years or older: 5 mg PO qDay

 

Allergic Rhinitis & Urticaria

2-5 years: 1.25 mg PO qDay

6-12 years: 2.5 mg PO qDay

 

Dosage modifications

Use in renal or hepatic impairment not studied in children

 

Clarinex, Clarinex RediTabs (desloratadine) adverse (side) effects

Varies in incidence & severity with the individual drug; also individual patients vary in susceptibility

 

>10%

Headache (14%)

Fever (12%)

Irritability (12%)

Diarrhea (15%)

Upper respiratory infection (11%)

Cough (11%)

 

1-10%

Dizziness (4%)

Somnolence (2%)

Dizziness (4%)

Fatigue (2%)

Erythema (2%)

Macupopular rash (3%)

Dysmenorrhea (2%)

Urinary tract infection (4%)

Bronchitis (6%)

Epistaxis (3%)

 

Postmarketing Reports

Tachycardia, palpitation

Hypersensitivity reactions, rare (eg, rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis)

Psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures

Elevated liver enzymes including bilirubin, hepatitis (rare)

 

Warnings

Contraindications

Documented hypersensitivity to desloratidine or loratidine

Preemies & neonates

Nursing women

 

Cautions

Caution in narrow angle glaucoma, slow metabolizers, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction

Use with caution in hepatic/renal impairment

 

Pregnancy and lactation

Pregnancy category: C

Lactation: excretion in milk unknown/not recommended

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Clarinex, Clarinex RediTabs (desloratadine)

Mechanism of action

Long-acting antihistamine (H1 receptor antagonist)

 

Pharmacokinetics

Half-Life: 27 hr

Onset: 1 hr

Duration: 24 hr

Peak Plasma Time: 3 hr

Protein Bound: 82-87%

Metabolism: Liver

Metabolites: 3-hydroxydesloratadine

Excretion: Urine 50%, feces 50%