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Use caution when driving, operating machinery, or performing other hazardous activities. Although unlikely, desloratadine may cause dizziness or drowsiness. If you suspect an overdose, seek medical attention immediately. The safety of Clarinex Syrup has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. Since the course of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria and the effects of Clarinex are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients.
Recommended Dosage For ClarinexThe safety and effectiveness of Clarinex Tablets or Clarinex Syrup have not been demonstrated in pediatric patients less than 6 months of age. The Clarinex RediTabs Tablet 2.5 mg tablet has not been evaluated in pediatric patients. However, any medication taken in excess can have serious consequences. In multiple-dose placebo-controlled trials, 2,834 patients ages 12 years or older received Clarinex Tablets at doses of 2.5 mg to 20 mg daily, of whom 1,655 patients received the recommended daily dose of 5 mg. OverdosageADULTS AND CHILDREN 12 YEARS AND OLDER For adults and children 12 and older, the usual dose is 5 milligrams (1 tablet or 2 teaspoonfuls of syrup) once a day. In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received Clarinex Tablets and 205 received placebo. Human histamine skin wheal studies following single and repeated 5 mg doses of desloratadine have shown that the drug exhibits an antihistaminic effect by 1 hour; this activity may persist for as long as 24 hours. There was no evidence of histamine-induced skin wheal tachyphylaxis within the desloratadine 5 mg group over the 28-day treatment period. Clarinex Adverse ReactionsLittle is known about the effects of a Clarinex overdose. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day. In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects. In subjects 2 to 5 years of age, adverse events reported for Clarinex and placebo in at least 2 percent of subjects receiving Clarinex Syrup and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%), and varicella (3.6%, 0%). Desloratadine Drug InteractionsUsing QTc (Fridericia) there was a mean increase of 0.4 msec in Clarinex-treated subjects relative to placebo. No clinically relevant adverse events were reported. In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxy-desloratadine are not eliminated by hemodialysis. Information regarding acute overdosage is limited to experience from clinical trials conducted during the development of the Clarinex product. Using the QTc (Bazett) there was a mean increase of 8.1 msec in Clarinex-treated subjects relative to placebo. |
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