Recommended Topic Related To:

Clarinex-D 24hr

"Feb. 25, 2013 (San Antonio, Texas) -- The asthma drug Xolair appears to be a safe and effective treatment for chronic hives, a new study shows.

The results of the study were presented at a news conference here at the American Academy"...

Clarinex-D 24hr

Clarinex-D 24hr

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Cardiovascular And Central Nervous System Effects

The pseudoephedrine sulfate contained in CLARINEX-D 24 HOUR Extended Release Tablets, like other sympathomimetic amines, can produce cardiovascular and central nervous system (CNS) effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, CLARINEX-D 24 HOUR Extended Release Tablets should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or severe coronary artery disease.

Coexisting Conditions

CLARINEX-D 24 HOUR Extended Release Tablets contain pseudoephedrine sulfate, a sympathomimetic amine, and therefore should be used with caution in patients with diabetes and hyperthyroidism. Also use with caution in patients with prostatic hypertrophy or increased intraocular pressure, as urinary retention or narrow-angle glaucoma may occur [see CONTRAINDICATIONS].

Co-Administration With Monoamine Oxidase (MAO) Inhibitors

CLARINEX-D 24 HOUR Extended Release Tablets should not be used in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment as an increase in blood pressure or hypertensive crisis, may occur [see CONTRAINDICATIONS and DRUG INTERACTIONS].

Hypersensitivity Reactions

Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine a component of CLARINEX-D 24 HOUR Extended Release Tablets. If such a reaction occurs, therapy with CLARINEX-D 24 HOUR Extended Release Tablets should be stopped and alternative treatment should be considered [see ADVERSE REACTIONS

Renal Impairment

CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see CLINICAL PHARMACOLOGY].

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION).

Cardiovascular And Central Nervous System Effects

Patients should be informed that pseudoephedrine, one of the active ingredients in CLARINEX-D 24 HOUR Extended Release Tablets may cause cardiovascular or central nervous system effects such as insomnia, dizziness, tremor, or arrhythmia.

Dosing

Patients should be advised not to increase the dose or dosing frequency of CLARINEX-D 24 HOUR Extended Release Tablets.

Additional Antihistamines And/Or Decongestants

Patients should be advised against the concurrent use of CLARINEX-D 24 HOUR Extended Release Tablets with other antihistamines and/or decongestants.

Monoamine Oxidase (MAO) Inhibitors

Patients should be informed that due to its pseudoephedrine component, they should not use CLARINEX-D 24 HOUR with a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor.

Coexisting Conditions

Patients with severe hypertension or severe coronary artery disease, narrow-angle glaucoma, or urinary retention should be advised not to use CLARINEX-D 24 HOUR Extended Release Tablets.

Instructions For Use

Patients should be instructed not to break, crush or chew the tablet. The tablet should be swallowed whole, and can be taken without regard to meals.

For patent information: See PATIENT INFORMATION and/or www.merck.com/product/patent/home.html

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There are no animal or laboratory studies on the combination product of desloratadine and pseudoephedrine sulfate to evaluate carcinogenesis, mutagenesis, or impairment of fertility.

Carcinogenicity Studies

The carcinogenic potential of desloratadine was assessed using a loratadine study in rats and a desloratadine study in mice. In a 2-year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 30 times the AUC in humans at the recommended daily oral dose). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine and in males and females given 25 mg/kg/day of loratadine. The estimated desloratadine and desloratadine metabolite exposures in 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 desloratadine is not known.

In a 2-year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day desloratadine, respectively, did not show significant increases in the incidence of any tumors. The estimated desloratadine and desloratadine metabolite exposures in mice at these doses were 12 and 27 times, respectively, the AUC in humans at the recommended daily oral dose.

Genotoxicity Studies

In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay).

Impairment of Fertility

There was no effect on female fertility in rats at desloratadine doses up to 24 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 130 times the AUC in humans at the recommended daily oral dose). A male specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic testicular changes, occurred at an oral desloratadine dose of 12 mg/kg in rats (estimated desloratadine and desloratadine metabolite exposures were approximately 45 times the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on fertility in rats at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 8 times the AUC in humans at the recommended daily oral dose).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of desloratadine and pseudoephedrine in combination in pregnant women. Neither are there animal reproduction studies conducted with the combination of desloratadine and pseudoephedrine. Desloratadine was not teratogenic in rats or rabbits but affected implantation in rats. Because animal reproduction studies are not always predictive of human response, CLARINEX-D 24 HOUR Extended Release Tablets should be used during pregnancy only if clearly needed.

Desloratadine was not teratogenic in rats or rabbits at approximately 210 and 230 times, respectively, the AUC in humans at the recommended daily oral dose. An increase in pre-implantation loss and a decreased number of implantations and fetuses were noted, however, in a separate study in female rats at approximately 120 times the AUC in humans at the recommended daily oral dose. Reduced body weight and slow righting reflex were reported in pups at approximately 50 times or greater than the AUC in humans at the recommended daily oral dose. Desloratadine had no effect on pup development at approximately 7 times the AUC in humans at the recommended daily oral dose. The AUCs in comparison referred to the desloratadine exposure in rabbits and the sum of desloratadine and its metabolites exposures in rats, respectively [see Nonclinical Toxicology].

Nursing Mothers

Desloratadine and pseudoephedrine both pass into breast milk; therefore, a decision should be made whether to discontinue nursing or to discontinue CLARINEX-D 24 HOUR Extended Release Tablets, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.

Pediatric Use

CLARINEX-D 24 HOUR Extended Release Tablets are not indicated for use in pediatric patients under 12 years of age.

Geriatric Use

The number of subjects (n=8) ≥ 65 years old treated with CLARINEX-D 24 HOUR Extended Release Tablets was too limited to make any formal statistical comparison regarding the efficacy or safety of this drug product in this age group, or to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients, although the elderly are more likely to have adverse reactions to sympathomimetic amines. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see CLINICAL PHARMACOLOGY].

Pseudoephedrine, desloratadine, and their metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor the patient for adverse events [see CLINICAL PHARMACOLOGY].

Renal Impairment

No studies with CLARINEX-D 24 HOUR Extended Release Tablets were conducted in subjects with renal impairment. CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Hepatic Impairment

No studies with CLARINEX-D 24 HOUR Extended Release Tablets or pseudoephedrine have been conducted in subjects with hepatic impairment.

CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Gender

No clinically significant gender-related differences were observed in the pharmacokinetic parameters of desloratadine, 3- hydroxydesloratadine or pseudoephedrine following administration of CLARINEX-D 24 HOUR Extended Release Tablets.

Race

No studies have been conducted to evaluate the effect of race on the pharmacokinetics of CLARINEX-D 24 HOUR Extended Release Tablets.

Last reviewed on RxList: 5/5/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Clarinex-D 24hr - User Reviews

Clarinex-D 24hr User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Clarinex-D 24hr sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Allergies & Asthma

Improve treatments & prevent attacks.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations