pseudoephedrine/desloratadine (Rx)

Brand and Other Names:Clarinex-D 12 Hr, Clarinex-D 24 Hr
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

pseudoephedrine/desloratadine

tablet

  • 120mg/2.5mg
  • 240mg/5mg
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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

Dosage Forms & Strengths

pseudoephedrine/desloratadine

tablet

  • 120mg/2.5mg
  • 240mg/5mg
more...

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

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Interactions

Interaction Checker

and pseudoephedrine/desloratadine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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)

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            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

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            Pregnancy & 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.

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            Pharmacology

            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

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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