Clarinex (desloratadine)

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Desloratadine is administered orally once daily without regard to meals.

Desloratadine orally disintegrating tablets are administered by placing a tablet on the tongue, allowing it to disintegrate, and then subsequently swallowing with or without water. Patients receiving desloratadine orally disintegrating tablets should be instructed not to remove a tablet from the blister until just prior to dosing. Desloratadine oral solution should be administered using a commercially available dropper or syringe that is calibrated to deliver 2 or 2.5 mL. Extended-release tablets containing desloratadine in fixed combination with pseudoephedrine sulfate should be swallowed intact and should not be chewed, broken, or crushed.

Commercially available desloratadine conventional tablets and oral solution are bioequivalent. The currently available reformulated orally disintegrating tablets containing 5 mg of desloratadine are bioequivalent to the original orally disintegrating formulation (no longer commercially available), which previously was shown to be bioequivalent to desloratadine conventional tablets and oral solution.

No formal drug interaction studies have been performed with the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate. When using this preparation, consider the drug interactions associated with pseudoephedrine (e.g., monoamine oxidase (MAO) inhibitors).

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Agents That Affect Iodide/Radioactive Iodide

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1)

CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1)

PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less.

PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(2) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(3)

DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1)

Agents That Affect Iodide/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2)

CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2)

PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less.

PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(3) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(4)

DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2)

There are no moderate interactions for this drug.

Known hypersensitivity to desloratadine, loratadine, or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

• Child-pugh class A hepatic impairment
• Child-pugh class B hepatic impairment
• Child-pugh class C hepatic impairment
• Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min
• Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
• Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Disease of liver

There are no moderate contraindications for this drug.

Adverse effects reported in 2% or more of patients 12 years of age and older receiving desloratadine for management of allergic rhinitis and occurring more frequently than placebo include pharyngitis, dry mouth, myalgia, fatigue, somnolence, and dysmenorrhea. Adverse effects reported in at least 2% of patients 12 years of age and older receiving desloratadine for management of chronic idiopathic urticaria and more frequently than placebo include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia, and myalgia.

Adverse effects reported in 2% or more of pediatric patients (2-5 years of age) receiving desloratadine and occurring more frequently than placebo include fever, urinary tract infection, and varicella (chicken pox). Adverse effects reported in 2% or more of patients 12-23 months of age and occurring more frequently than placebo include fever, diarrhea, upper respiratory tract infection, coughing, increased appetite, emotional lability, epistaxis, parasitic infection, pharyngitis, and maculopapular rash. Adverse effects reported in 2% or more of patients 6-11 months of age and occurring more frequently than placebo include upper respiratory tract infection, diarrhea, fever, irritability, coughing, somnolence, bronchitis, otitis media, vomiting, anorexia, pharyngitis, insomnia, rhinorrhea, erythema, and nausea.

Adverse effects reported in 2% or more of patients 12 years of age and older receiving the fixed combination of desloratadine and pseudoephedrine sulfate include dry mouth, headache, insomnia, fatigue, pharyngitis, somnolence, nausea, dizziness, nervousness, hyperactivity, and anorexia.

Rare or Very Rare

• Abnormal hepatic function tests
• Acquired dystonia
• Anaphylaxis
• Dyspnea
• Extrapyramidal disease
• Hepatitis
• Hyperbilirubinemia
• Hypersensitivity drug reaction
• Increased appetite
• Motor tic disorder
• Seizure disorder
• Tachycardia
• Urticaria

More Frequent

• Drowsy
• Dysmenorrhea
• Fatigue
• Headache disorder
• Myalgia
• Pharyngitis
• Pruritus of skin
• Skin rash
• Xerostomia

Less Frequent

• Dizziness
• Dyspepsia
• Nausea

Rare or Very Rare

• Edema
• Nervousness
• Palpitations

No enhanced messaging available.

Safety and efficacy have not been established for symptomatic management of seasonal allergic rhinitis in children younger than 2 years of age.

Safety and efficacy have not been established for symptomatic management of perennial allergic rhinitis or chronic idiopathic urticaria in children younger than 6 months of age.

Safety and efficacy of the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate for symptomatic management of seasonal allergic rhinitis have not been established in children younger than 12 years of age.

Overdosage and toxicity (including death) have been reported in children younger than 2 years of age receiving nonprescription (over-the-counter, OTC) preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Clinicians should ask caregivers about use of nonprescription cough and cold preparations to avoid overdosage. For additional information on precautions associated with the use of cough and cold preparations in pediatric patients, see Cautions: Pediatric Precautions in the Antihistamines General Statement 4:00.

Category C. (See Users Guide.)

Desloratadine is distributed into milk. Discontinue nursing or the drug, taking into account the importance of the drug to the woman. Exercise caution if the fixed-combination preparation containing desloratadine and pseudoephedrine sulfate is used in nursing women.

Experience with desloratadine in those 65 years of age and older is insufficient to determine whether they respond differently from younger adults. In one study, peak plasma concentrations and area under the plasma concentration-time curve (AUC) of desloratadine were increased (by 20%) and plasma elimination half-life was prolonged in geriatric patients compared with younger adults; however, these age-related differences do not appear to be clinically important. Nevertheless, dosage should be selected with caution because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients.