Generic Name
Desloratadine
Brand Names
Clarinex, Clarinex-D 12
FDA approval date: January 11, 2013
Classification: Histamine-1 Receptor Antagonist
Form: Tablet, Solution
What is Clarinex (Desloratadine)?
CLARINEX is a histamine-1 receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older.
Approved To Treat
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Brand Information
Clarinex (Desloratadine)
1DOSAGE AND ADMINISTRATION
Although the oral solution and the orally disintegrating tablet formulation of desloratadine may be available in the marketplace, CLARINEX
CLARINEX Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place CLARINEX (desloratadine) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.
The age-appropriate dose of CLARINEX Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon)
1.1Adults and Adolescents 12 Years of Age and Over
The recommended dose of CLARINEX Tablets or CLARINEX RediTabs Tablets is one 5-mg tablet once daily. The recommended dose of CLARINEX Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.
1.2Children 6 to 11 Years of Age
The recommended dose of CLARINEX Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. The recommended dose of CLARINEX RediTabs Tablets is one 2.5-mg tablet once daily.
1.3Children 12 Months to 5 Years of Age
The recommended dose of CLARINEX Oral Solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.
1.4Children 6 to 11 Months of Age
The recommended dose of CLARINEX Oral Solution is 2 mL (1 mg) once daily.
1.5Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data
2DOSAGE FORMS AND STRENGTHS
CLARINEX Tablets are supplied as:
- Light blue, film-coated tablets embossed with “C5” containing 5 mg desloratadine.
- Light blue, film-coated tablets embossed with an elongated letters “S” and “P” on one side and plain on the other, containing 5 mg desloratadine.
3CONTRAINDICATIONS
CLARINEX Tablets, RediTabs, and Oral Solution are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Hypersensitivity reactions.
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
4.2Post-Marketing Experience
Because adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following spontaneous adverse events have been reported during the marketing of desloratadine:
Cardiac disorders: tachycardia, palpitations
Respiratory, thoracic and mediastinal disorders: dyspnea
Skin and subcutaneous tissue disorders: rash, pruritus
Nervous system disorders: psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures (reported in patients with and without a known seizure disorder)
Immune system disorders: hypersensitivity reactions (such as urticaria, edema and anaphylaxis)
Investigations: elevated liver enzymes including bilirubin
Hepatobiliary disorders: hepatitis
Metabolism and nutrition disorders: increased appetite
5DRUG ABUSE AND DEPENDENCE
There is no information to indicate that abuse or dependency occurs with CLARINEX Tablets.
6OVERDOSAGE
In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.
Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the CLARINEX product. In a dose-ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported.
In another study, no clinically relevant adverse events were reported in normal male and female volunteers who were given single daily doses of CLARINEX 45 mg for 10 days
7DESCRIPTION
CLARINEX (desloratadine) Tablets are light blue, round, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. CLARINEX Tablets also contain the following excipients: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn starch NF, talc USP, carnauba wax NF, white wax NF, coating material consisting of lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol, and FD&C Blue #2 Aluminum Lake.
Desloratadine is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C
8HOW SUPPLIED/STORAGE AND HANDLING
CLARINEX Tablets:
- Embossed “C5”, light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 78206-119-01).
- Embossed with elongated letters “S” and “P”, light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 78206-188-01).
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9.1Information for Patients
- Patients should be instructed to use CLARINEX as directed.
- As there are no food effects on bioavailability, patients can be instructed that CLARINEX Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals.
- Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur.
- Phenylketonurics: CLARINEX RediTabs Tablets contain phenylalanine.