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The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

Clarinex is taken once a day for 24-hour relief from the symptoms of year-round and seasonal allergies such as, sneezing; runny nose; and itchy, watery eyes. Therefore, if you take Clarinex in the morning you can wake up the next day with your symptoms under control.
Clarinex may be taken with or without food.
It is usually best to take your medication at the same time each day.
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Medication Clarinex Side Effects:
Side effects with Clarinex (desloratadine) Tablets 5 mg are similar to sugar pill, including sore throat, dry mouth and fatigue.

Desloratadine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
headache, upset stomach, dizziness, sore throat, dry mouth, muscle pain, extreme tiredness, painful menstruation.
Some side effects can be serious. The following symptom is uncommon, but if you experience it, call your doctor immediately:
difficulty breathing
Clarinex may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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Precautions on using Clarinex
Clarinex Tablets 5 mg are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to loratadine.
PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of Clarinex was assessed using loratadine studies. In an 18-month study in mice and a 2-year study in rats, oratadine was administered in the diet at doses up to 40 mg/kg/day in mice (estimated Clarinex and Clarinex metabolite exposures were approximately 3 times the AUC in humans at the recommended daily oral dose) and 25 mg/kg/day in rats (estimated Clarinex and desloratadine metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). Male mice given 0 mg/kg/day loratadine had a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) than concurrent controls. In rats, a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day and in males and females given 25 mg/kg/day. The estimated Clarinex and desloratadine metabolite exposures of rats given 10 mg/kg of loratadine were approximately 7 times the AUC in humans at the recommended daily oral dose.
The clinical significance of these findings during long-term use of Clarinex is not known.
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Medication Clarinex Drug Interaction:
In two controlled crossover clinical pharmacology studies in healthy male (n=12 in each study) and female (n=12 in each study) volunteers, desloratadine 7.5 mg (1.5 times the daily dose) once daily was coadministered with erythromycin 500 mg every 8 hours or ketoconazole 200 mg every 12 hours for 10 days. In 3 separate controlled, parallel group clinical pharmacology studies, desloratadine at the clinical dose of 5 mg has been coadministered with azithromycin 500 mg followed by 250 mg once daily for 4 days (n=18) or with fluoxetine 20 mg once daily for 7 days after a 23 day pretreatment period with fluoxetine (n=18) or with cimetidine 600 mg every 12 hours for 14 days (n=18) under steady state conditions to normal healthy male and female volunteers. Although increased plasma concentrations (Cmax and AUC 0-24 hrs) of Clarinex and 3-hydroxydesloratadine were observed (see Table 1), there were no clinically relevant changes in the safety profile of desloratadine, as assessed by electrocardiographic parameters (including the corrected QT interval), clinical laboratory tests, vital signs, and adverse events.
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Medication Clarinex Overdose:
Information regarding acute overdosage is limited to experience 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. Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs obtained in this study were manually read in a blinded fashion by a cardiologist. In Clarinex-treated subjects, there was an increase in mean heart rate of 9.2 bpm relative to placebo. The QT interval was corrected for heart rate (QTc) by both the Bazett and Fridericia methods. Using the QTc (Bazett) there was a mean increase of 8.1 msec in Clarinex-treated subjects relative to placebo. Using 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. Clarinex and 3-hydroxydesloratadine are not eliminated by hemodialysis. Lethality occurred in rats at oral doses of 250 mg/kg or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 120 times the AUC in humans at the recommended daily oral dose). The oral median lethal dose in mice was 353 mg/kg (estimated Clarinex exposures were approximately 290 times the human daily oral dose on a mg/m2 basis). No deaths occurred at oral doses up to 250 mg/kg in monkeys (estimated desloratadine exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).