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

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

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

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    Contraindicated

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        Significant - Monitor Closely

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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

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

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

            Skin reactions: Generalized exanthematous pustulosis, increased appetite

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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

            The limited available data in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; there are no adequate and well-controlled studies in pregnant women

            The majority of studies examining use of pseudoephedrine in pregnancy did not find an association with increased risk of congenital anomalies; a few case-control studies conducted reported potential associations with isolated congenital disorders; however, methodological limitations of these studies made the interpretation of results unreliable

            Reproductive potential

            • There are no data available on human infertility associated with desloratadine, pseudoephedrine, or combination; there are no animal fertility studies with combination or pseudoephedrine alone
            • Female: There were no clinically relevant effects of desloratadine on female fertility in rats
            • Male: A male specific decrease in fertility occurred at an oral desloratadine dose of ≥12 mg/kg in rats (approximately 65 times the RHD); male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the RHD)

            Animal data

            • Data on animal reproduction studies conducted with combination of desloratadine and pseudoephedrine or pseudoephedrine alone are also limited
            • Desloratadine given during organogenesis to pregnant rats was not teratogenic at approximately 320 times that at recommended human daily oral dose (RHD) of 5 mg/day
            • Desloratadine given during organogenesis to pregnant rabbits was not teratogenic at AUC-based exposures of desloratadine approximately 230 times that at RHD
            • Desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of F1 pups at exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD

            Lactation

            Desloratadine and pseudoephedrine both pass into breast milk; there are no sufficient data on effects of desloratadine on breastfed infant or effects of desloratadine on milk production

            Pseudoephedrine has been reported to decrease milk production and to cause irritability in breastfed infants; the decision should be made whether to discontinue nursing or to discontinue drug, taking into account developmental and health benefits of breastfeeding, the nursing mother’s clinical need, and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            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

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            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.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.