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pseudoephedrine/desloratadine (Clarinex-D 12 Hr, Clarinex-D 24 Hr)

 

Classes: Antihistamine/Decongestant Combos

Dosing and uses of Clarinex-D 12 Hr, Clarinex-D 24 Hr (pseudoephedrine-desloratadine)

 

Adult dosage forms and strengths

pseudoephedrine/desloratadine

tablet

  • 120mg/2.5mg
  • 240mg/5mg

 

Allergic Rhinitis/Congestion

Clarinex-D 12 hr: 1 tablet (2.5 mg desloratadine/120 mg pseudoephedrine) PO q12hr

Clarinex-D 24 hr: 1 tablet (5 mg desloratadine/240 mg pseudoephedrine) PO q24hr

 

Renal Impairment

Not recommended

 

Hepatic Impairment

Not recommended

 

Administration

Tablet should be swallowed whole and not broken, dissolved, or chewed

 

Pediatric dosage forms and strengths

pseudoephedrine/desloratadine

tablet

  • 120mg/2.5mg
  • 240mg/5mg

 

Allergic Rhinitis/Congestion

<12 years

  • Safety and efficacy not established

≥12 years

  • Clarinex-D 12 hr: 1 tablet (2.5 mg desloratadine/120 mg pseudoephedrine) PO q12hr
  • Clarinex-D 24 hr: 1 tablet (5 mg desloratadine/240 mg pseudoephedrine) PO qDay

 

Renal Impairment

Not recommended

 

Hepatic Impairment

Not recommended

 

Administration

Tablet should be swallowed whole and not broken, dissolved or chewed

 

Clarinex-D 12 Hr, Clarinex-D 24 Hr (pseudoephedrine-desloratadine) adverse (side) effects

>10%

Desloratadine

  • Fever (12%)
  • Irritability (12%)
  • Headache (12%)
  • Diarrhea (15-21%)
  • Cough (11%)
  • Upper respiratory tract infection (11-21%)

 

1-10%

Desloratadine

  • Pharyngitis (4.1%)
  • Dry mouth (3%)
  • Myalgia (2.1%)
  • Emotional lability (3%)
  • Erythema (3%)
  • Macopapular rash (3%)
  • Dizziness (4%)
  • Fatigue (2.1%)
  • Somnolence (2.1%)
  • Urinary tract infection (4%)
  • Dyspepsia (3%)
  • Insomnia (5%)
  • Dysmenorrhea (2.1%)

 

Frequency not defined

Pseudoephedrine

  • CNS (tremor, restlessness, etc)
  • Insomnia
  • Arrhythmia
  • Hypotension
  • Tachycardia
  • Fatigue
  • Rash
  • Urticaria
  • Anorexia
  • Xerostomia
  • Dysuria
  • Polyuria
  • Nausea
  • Vomiting
  • Ischemic colitis

 

Postmarketing Reports

Hypersensitivity reactions (eg, rash, edema, dyspnea, anaphylaxis)

CNS: Headache, somnolence, dizziness

Cardiovascular: Tachycardia

eurologic: Movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures

Hepatic: Elevated liver enzymes and bilirubin, hepatitis (rare)

 

Warnings

Contraindications

Hypersensitivity; adverse reaction to sympathomimetics

Severe HTN, severe coronary artery disease

Concurrent MAO inhibitors, or within 2 wk of discontinuance of MAO inhibitors

Hepatic impairment

Urinary retention

Narrow-angle glaucoma

Clarinex-D 12 hr: also renal impairment

 

Cautions

Caution in renal impairment, HTN, diabetes mellitus, ischemic heart disease, increase IOP, hyperthyroidism, BPH

Concomitant antihistamines or decongestants (generally avoid)

Seizures and tachycardia reported

 

Pregnancy and lactation

Pregnancy category: C

Lactation: both drugs pass into breast milk, pseudoephedrine is concentrated in breast milk; use caution

 

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-D 12 Hr, Clarinex-D 24 Hr (pseudoephedrine-desloratadine)

Mechanism of action

Pseudoephedrine: Sympathomimetic; exerts decongestant action on nasal mucosa; stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction

Desloratadine: Selective histamine-1 receptor antagonist; inhibits histamine release from mast cells

 

Protein Binding

Desloratadine: 82-87%

 

Excretion

Pseudoephedrine: Urine

Desloratadine: Urine

 

Peak Plasma Time

Pseudoephedrine: 6-9 hr

Desloratadine: 4-7 hr

 

Peak Plasma Concentration

Pseudoephedrine: 363 ng/mL

Desloratadine: 1.09 ng/mL

 

AUC

Pseudoephedrine: 4,588 ng·hr/mL

Desloratadine: 31.6 ng·hr/mL

 

Metabolism

Pseudoephedrine: <1% metabolized in liver

Desloratadine: major metabolite of loratadine; extensively metabolized by glucuronidation to active metabolite 3-hydroxydesloratadine

 

Half-Life

Pseudoephedrine: 3-6 hr (urine pH 5); 9-16 hr (urine pH 8)

Desloratadine: 27 hr