Clarinex-D 24hr (Desloratadine and Pseudoephedrine Sulfate)
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Clarinex-D 24hr (Desloratadine and Pseudoephedrine Sulfate)

CLARINEX-D 24 HOUR Extended Release
(desloratadine/pseudoephedrine sulfate)

DRUG DESCRIPTION

CLARINEX-D 24 HOUR Extended Release Tablets are light blue oval-shaped tablets containing 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in the tablet core for extended release.

The inactive ingredients contained in CLARINEX-D 24 HOUR Extended Release Tablets are hypromellose USP, ethylcellulose NF, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, povidone USP, silicone dioxide NF, talc USP, polyacrylate dispersion, polyethylene glycol NF, simethicone USP, Blue Lake Blend 50726 (FD&C Blue No. 2 Lake, titanium dioxide USP and edetate disodium USP), and ink (Opacode® S-1-17746 or Opacode® S-1-4159).

Desloratadine, 1 of the 2 active ingredients of CLARINEX-D 24 HOUR Extended Release Tablets, 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: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure:

Desloratadine Structural Formula Illustration

Pseudoephedrine sulfate, the other active ingredient of CLARINEX-D 24 HOUR Extended Release Tablets, is the synthetic salt of one of the naturally occurring dextrorotatory diastereomers of ephedrine and is classified as an indirect sympathomimetic amine. Pseudoephedrine sulfate is a colorless hygroscopic crystal or white, hygroscopic crystalline powder, practically odorless, with a bitter taste. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in ether. The empirical formula for pseudoephedrine sulfate is (C10H15NO)2• H2SO4; the chemical name is benzenemethanol, α-[1-(methylamino) ethyl]-,[S-(R*,R*)]-, sulfate (2:1)(salt); and the chemical structure is:

Pseudoephedrine sulfate Structural Formula Illustration

What are the possible side effects of desloratadine and pseudoephedrine (Clarinex-D 12 Hour, Clarinex-D 24 Hour)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your...

Read All Potential Side Effects and See Pictures of Clarinex-D 24hr »

What are the precautions when taking desloratadine and pseudoephedrine sulfate (Clarinex-D 24hr)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to desloratadine or pseudoephedrine; or to loratadine; or if you have any other allergies. Also, tell your doctor if you have had serious side effects from similar medications (such as other decongestants, including phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, difficulty urinating (such as due to an enlarged prostate), high blood pressure (hypertension), heart/blood vessel disease (such as coronary artery disease), overactive thyroid (hyperthyroidism), diabetes, kidney disease,...

Read All Potential Precautions of Clarinex-D 24hr »

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Seasonal Allergic Rhinitis

CLARINEX-D® 24 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. CLARINEX-D 24 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see CLINICAL PHARMACOLOGY].

DOSAGE AND ADMINISTRATION

Administer CLARINEX-D 24 HOUR Extended Release Tablet by the oral route only. Do not break, chew or crush the tablet. Swallow the tablet whole.

Adults and Adolescents 12 years of Age and Over

The recommended dose of CLARINEX-D 24 HOUR Extended Release Tablets is 1 tablet once daily, administered with or without a meal. Higher doses or increased dosing frequency of CLARINEX-D 24 HOUR Extended Release Tablets have not demonstrated increased effectiveness. Do not exceed the recommended dose as desloratadine and pseudoephedrine, the active components of CLARINEX-D 24 HOUR Extended Release Tablets have been associated with adverse effects at higher doses [see OVERDOSAGE].

HOW SUPPLIED

Dosage Forms And Strengths

CLARINEX-D 24 HOUR Extended Release Tablets are oval-shaped, light blue coated tablets with “D 24” branded in black on one side. Each tablet contains 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate, USP in an extended release core.

Storage And Handling

CLARINEX-D 24 HOUR Extended Release Tablets are oval-shaped, blue and white bilayer tablets with “D24” embossed in the blue layer containing 5 mg desloratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate USP in an extended release core. CLARINEX-D 24 HOUR Extended Release Tablets are supplied in high-density polyethylene bottles of 100 (NDC 0085-1317-01).

Storage

Store at 25°C (77°F), excursions permitted to 15-300C (59-860F) [see USP Controlled Room Temperature] Heat Sensitive. Avoid exposure at or above 30°C (86°F). Protect from excessive moisture. Protect from light.

Manufactured by Schering Corporation, a subsidiary of Schering-Plough Corporation, Kenilworth, NJ 07033 USA. Revised: December 2009

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

Clinical 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.

The safety data described below are from 2 clinical trials with CLARINEX-D 24 HOUR Extended Release Tablets that included 2852 patients, of which 708 patients received CLARINEX-D 24 HOUR Extended Release Tablets daily for up to 15 days. The majority of patients were between 18 and < 65 years of age with a mean age of 34.3 years and were predominantly women (63%). Patient ethnicity was 79 % Caucasian, 10% Black, 8 % Hispanic and 3% Asian/other ethnicity. The percentage of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets, and who discontinued from the clinical trials because of an adverse event was 3.4%. Adverse reactions that were reported by ≥ 2% of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets are shown in Table 1.

TABLE 1: Incidence of Adverse Reactions Reported by ≥ 2% of Subjects Receiving CLARINEX-D 24 HOUR Extended Release Tablets

Adverse Reaction CLARINEX-D® 24 HOUR
(N =708)
Desloratadine 5 mg
(N =712)
Pseudoephedrine 240 mg
(N =719)
Gastrointestinal Disorders
Mouth Dry 8% 2% 11%
Nausea 2% 1% 3%
Anorexia 2% 0% 2%
General Disorders and Administration Site Conditions
Fatigue 3% 3% 2%
Nervous System Disorders
Headache 6% 5% 7%
Somnolence 3% 2% 3%
Dizziness 2% 1% 2%
Psychomotor hyperactivity 2% 0% 2%
Psychiatric Disorders
Insomnia 5% 1% 8%
Nervousness 2% 1% 1%
Respiratory, Thoracic and Mediastinal Disorders
Pharyngitis 3% 2% 3%

There were no relevant differences in adverse reactions for subgroups of patients as defined by gender, age, or race.

Post-Marketing Experience

In addition to the adverse reactions reported during clinical trials and listed above, adverse events have been identified during post approval use of CLARINEX-D 24 HOUR Extended Release Tablets. Because these 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. Adverse events identified from post-marketing surveillance on the use of CLARINEX-D 24 HOUR Extended Release Tablets include palpitations, pruritus and urticaria.

In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: headache, somnolence, dizziness, tachycardia, and rarely hypersensitivity reactions (such as rash, edema, dyspnea, and anaphylaxis), and elevated liver enzymes including bilirubin and very rarely, hepatitis.

Read the Clarinex-D 24hr (desloratadine and pseudoephedrine sulfate) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No specific interaction studies have been conducted with CLARINEX-D 24 HOUR Extended Release Tablets.

Monoamine Oxidase 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 because the action of pseudoephedrine a component of CLARINEX-D 24 HOUR Extended Release tablets on the vascular system may be potentiated by these agents. (See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS )

Beta-adrenergic blocking agents

The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, and reserpine, may be reduced by sympathomimetics such as pseudoephedrine. Exercise caution when using CLARINEX-D 24 HOUR Extended Release Tablets with these agents.

Digitalis

Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Exercise caution when using CLARINEX-D 24 HOUR Extended Release Tablets with these agents.

Inhibitors of cytochrome P450 3A4

In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3- hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine. [See CLINICAL PHARMACOLOGY]

Fluoxetine

In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 -hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [See CLINICAL PHARMACOLOGY]

Cimetidine

In controlled clinical studies co-administration of desloratadine with cimetidine a histamine H2-receptor antagonist resulted in increased plasma concentrations of desloratadine and 3- hydroxydesloratadine but there were no clinically relevant changes in the safety profile of desloratadine [See CLINICAL PHARMACOLOGY]

Drug Abuse And Dependence

There is no information to indicate that abuse or dependency occurs with CLARINEX or CLARINEX-D 24 HOUR Extended Release Tablets.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

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 Post-marketing].

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]

Cardiovascular and Central Nervous System Effects

Patients should be informed that pseudoephedrine, on 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.

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.

For 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: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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.

Desloratadine

Information regarding acute overdosage with desloratadine is limited to experience from postmarketing adverse event reports and from clinical trials conducted during the development of the CLARINEX product. In the reported cases of overdose, there were no significant adverse events that were attributed to desloratadine. 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 [see CLINICAL PHARMACOLOGY].

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 desloratadine exposure was approximately 290 times the human daily oral dose on an 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 an mg/m² basis).

Sympathomimetics

In large doses, sympathomimetics such as pseudoephedrine may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.

CONTRAINDICATIONS

CLARINEX-D 24 HOUR Extended Release Tablets are contraindicated in:

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Receptor binding data indicate that at a concentration of 2 to 3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro . Results of a radiolabeled tissue distribution study in rats and a radioligand H1-receptor binding study in guinea pigs showed that desloratadine does not readily cross the blood brain barrier. The clinical significance of this finding is unknown.

Pseudoephedrine sulfate is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine sulfate is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.

Pharmacodynamics

Wheal and Flare

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. The clinical relevance of histamine wheal skin testing is unknown.

Effects on QTc

In clinical trials for CLARINEX-D 24 HOUR Extended Release Tablets, ECGs were recorded at baseline and after 2 weeks of treatment within 1 to 3 hours after dosing. No clinically meaningful changes were observed following treatment with CLARINEX-D 24 HOUR Extended Release Tablets for any ECG parameter, including the QTc interval. An increase in the ventricular rate of 6.7 and 5.4 bpm was observed in the CLARINEX-D 24 HOUR Extended Release Tablets and pseudoephedrine groups, respectively, compared to an increase of 2.8 bpm in subjects receiving desloratadine alone. Single daily doses of CLARINEX 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 the CLARINEX-treated subjects, there was a mean increase in the maximum heart rate of 9.2 bpm relative to placebo. The QT interval was corrected for heart rate (QTc) by both Bazett's and Fridericia methods. Using the QTc (Bazett), there was a mean increase of 8.1 msec in the 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.

Pharmacokinetics

Absorption

A bioequivalence study that compared CLARINEX-D 24 HOUR Extended Release Tablets to the monotherapy (desloratadine 5 mg, and pseudoephedrine 240 mg) showed that CLARINEX-D 24 HOUR Extended Release Tablets was not bioequivalent to the monotherapy (desloratadine 5 mg tablet). The systemic exposure to desloratadine and 3-hydroxydesloratadine was 15% to 20% lower from CLARINEX-D 24 HOUR Extended Release Tablets than those from desloratadine 5 mg tablet. Clinical trials were therefore necessary to support efficacy of CLARINEX-D 24 HOUR Extended Release Tablets [see Clinical Studies] .

In the above single dose pharmacokinetic study the mean time to maximum plasma concentrations (Tmax) for desloratadine occurred at approximately 6 to 7 hours post dose and mean peak plasma concentrations (Cmax) and area under the concentration-time curve (AUC(tf)) of approximately 1.79 ng/mL and 61.1 ng•hr/mL, respectively, were observed. In another pharmacokinetic study, food and grapefruit juice had no effect on the bioavailability (Cmax and AUC) of desloratadine.

For pseudoephedrine, the mean Tmax occurred at 8 to 9 hours post dose and mean peak plasma concentrations (Cmax) and AUC(tf) of 328 ng/mL and 6438 ng•hr/mL, respectively, were observed. The ingestion of food did not affect the absorption of pseudoephedrine from CLARINEX-D 24 HOUR Extended Release Tablets.

Following oral administration of CLARINEX-D 24 HOUR Extended Release Tablets once daily for 14 days in healthy volunteers, steady-state conditions were reached on Day 12 for desloratadine and 3-hydroxydesloratadine, and Day 10 for pseudoephedrine. For desloratadine, mean steady-state Cmax and AUC (0-24h) of approximately 2.44 ng/mL and 34.8 ng•hr/mL, respectively were observed. For pseudoephedrine, mean steady-state peak plasma concentrations (Cmax) and AUC (0-24h) of 523 ng/mL and 8795 ng•hr/mL, respectively, were observed.

Distribution

Desloratadine and 3-hydroxydesloratadine are approximately 82% to 87% and 85% to 89%, bound to plasma proteins, respectively. Protein binding of desloratadine and 3-hydroxydesloratadine was unaltered in subjects with impaired renal function.

Metabolism

Desloratadine (a major metabolite of loratadine) is extensively metabolized to 3-hydroxydesloratadine, an active metabolite, which is subsequently glucuronidated. The enzyme(s) responsible for the formation of 3-hydroxydesloratadine have not been identified. Data from clinical trials with desloratadine indicate that a subset of the general population has a decreased ability to form 3-hydroxydesloratadine, and are poor metabolizers of desloratadine. In pharmacokinetic studies (n=3748), approximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of 3-hydroxydesloratadine to desloratadine less than 0.1, or a subject with a desloratadine half-life exceeding 50 hours). These pharmacokinetic studies included subjects between the ages of 2 and 70 years, including 977 subjects aged 2 to 5 years, 1575 subjects aged 6 to 11 years, and 1196 subjects aged 12 to 70 years. There was no difference in the prevalence of poor metabolizers across age groups. The frequency of poor metabolizers was higher in Blacks (17%, n=988) as compared to Caucasians (2%, n=1462) and Hispanics (2%, n=1063). The median exposure (AUC) to desloratadine in the poor metabolizers was approximately 6-fold greater than in the subjects who are not poor metabolizers. Subjects who are poor metabolizers of desloratadine cannot be prospectively identified and will be exposed to higher levels of desloratadine following dosing with the recommended dose of desloratadine. In multidose clinical safety studies, where metabolizer status was prospectively identified, a total of 94 poor metabolizers and 123 normal metabolizers were enrolled and treated with CLARINEX Syrup for 15 to 35 days. In these studies, no overall differences in safety were observed between poor metabolizers and normal metabolizers. Although not seen in these studies, an increased risk of exposure-related adverse events in patients who are poor metabolizers cannot be ruled out.

Pseudoephedrine alone is incompletely metabolized (less than 1%) in the liver by N-demethylation to an inactive metabolite. The drug and its metabolite are excreted in the urine. About 55% to 96% of an administered dose of pseudoephedrine hydrochloride is excreted unchanged in the urine.

Elimination

Following single dose administration of CLARINEX-D 24 HOUR Extended Release Tablets, the mean plasma elimination half-life of desloratadine was similar to the desloratadine 5 mg tablet, approximately 24 and 27 hours, respectively. In another study, following administration of single oral doses of desloratadine 5 mg, Cmax and AUC values increased in a dose proportional manner between 5 and 20 mg. The degree of accumulation after 14 days of dosing was consistent with the half-life and dosing frequency. A human mass balance study documented a recovery of approximately 87% of the 14Cdesloratadine dose, which was equally distributed in urine and feces as metabolic products. Analysis of plasma 3-hydroxydesloratadine showed similar Tmax and half-life values compared to desloratadine.

The mean elimination half-life of pseudoephedrine is dependent on urinary pH. The elimination half-life is approximately 3 to 6 or 9 to-16 hours when the urinary pH is 5 or 8, respectively.

Geriatric Subjects

Following multiple-dose administration of CLARINEX Tablets, the mean Cmax and AUC values for desloratadine were 20% greater than in younger subjects ( < 65 years old). The oral total body clearance (CL/F) when normalized for body weight was similar between the 2 age groups. The mean plasma elimination half-life of desloratadine was 33.7 hr in subjects ≥ 65 years old. The pharmacokinetics for 3-hydroxydesloratadine appeared unchanged in older vs. younger subjects. These age-related differences are unlikely to be clinically relevant and no dosage adjustment is recommended in elderly patients.

Pediatric Subjects

CLARINEX-D 24 HOUR Extended Release Tablets are not an appropriate dosage form for use in pediatric patients below 12 years of age.

Renally Impaired

Following a single dose of desloratadine 7.5 mg, pharmacokinetics were characterized in subjects with mild (n=7; creatinine clearance 51-69 mL/min/1.73 m²), moderate (n=6; creatinine clearance 34-43 mL/min/1.73 m²), and severe (n=6; creatinine clearance 5-29 mL/min/1.73m²) renal impairment or hemodialysis dependent (n=6) subjects. In subjects with mild and moderate renal impairment, median Cmax and AUC values increased by approximately 1.2- and 1.9-fold, respectively, relative to subjects with normal renal function. In subjects with severe renal impairment or who were hemodialysis dependent, Cmax and AUC values increased by approximately 1.7- and 2.5-fold, respectively. Minimal changes in 3-hydroxydesloratadine concentrations were observed. Desloratadine and 3-hydroxydesloratadine were poorly removed by hemodialysis. Plasma protein binding of desloratadine and 3-hydroxydesloratadine was unaltered by renal impairment.

Pseudoephedrine is primarily excreted unchanged in the urine as unchanged drug; the remainder is apparently metabolized in the liver. Therefore, pseudoephedrine may accumulate in patients with renal impairment.

Hepatically Impaired

Following a single oral dose of desloratadine, pharmacokinetics were characterized in subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment as defined by the Child-Pugh classification of hepatic impairment and 8 subjects with normal hepatic function. Subjects with hepatic impairment, regardless of severity, had approximately a 2.4-fold increase in AUC as compared with normal subjects. The apparent oral clearance of desloratadine in subjects with mild, moderate, and severe hepatic impairment was 37%, 36%, and 28% of that in normal subjects, respectively. An increase in the mean elimination half-life of desloratadine in subjects with hepatic impairment was observed. For 3hydroxydesloratadine, the mean Cmax and AUC values for subjects with hepatic impairment were not statistically significantly different from subjects with normal hepatic function.

Gender

Female subjects treated for 14 days with CLARINEX Tablets had 10% and 3% higher desloratadine Cmax and AUC values, respectively, compared with male subjects. The 3-hydroxydesloratadine Cmax and AUC values were also increased by 45% and 48%, respectively, in females compared with males. However, these apparent differences are not considered to be clinically relevant.

Race

Following 14 days of treatment with CLARINEX Tablets, the Cmax and AUC values for desloratadine were 18% and 32% higher, respectively, in Blacks compared with Caucasians. For 3-hydroxydesloratadine there was a corresponding 10% reduction in Cmax and AUC values in Blacks compared to Caucasians. These differences are not considered to be clinically relevant.

Drug interaction

In 2 controlled crossover clinical pharmacology studies in healthy male (n=12 in each study) and female (n=12 in each study) subjects, desloratadine 7.5 mg (1.5 times the daily dose) once daily was co-administered 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 co-administered 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 healthy male and female subjects. Although increased plasma concentrations (Cmax and AUC 0-24 hrs) of desloratadine and 3-hydroxydesloratadine were observed (see Table 2), 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.

TABLE 2 : Changes in Desloratadine and 3-hydroxydesloratadine Pharmacokinetics in Healthy Male and Female Subjects

  Desloratadine 3-hydroxydesloratadine
Cmax AUC 0-24 hrs Cmax AUC 0-24 hrs
Erythromycin
(500 mg Q8h)
+24% +14% +43% +40%
Ketoconazole
(200 mg Q12h)
+45% +39% +43% +72%
Azithromycin
(500 mg Day 1, 250 mg QD x 4 days)
+15% +5% +15% +4%
Fluoxetine
(20 mg QD)
+15% +0% +17% +13%
Cimetidine
(600 mg Q12h)
+12% +19% -11% -3%

Animal Toxicology and/or Pharmacology

Reproductive Toxicology Studies

Desloratadine was not teratogenic in rats at doses up to 48 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 210 times the AUC in humans at the recommended daily oral dose) or in rabbits at doses up to 60 mg/kg/day (estimated desloratadine exposures were approximately 230 times the AUC in humans at the recommended daily oral dose). In a separate study, an increase in pre-implantation loss and a decreased number of implantations and fetuses were noted in female rats at 24 mg/kg (estimated desloratadine and desloratadine metabolite exposures were 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 doses of 9 mg/kg/day or greater (estimated desloratadine and desloratadine metabolite exposures were approximately 50 times or greater than the AUC in humans at the recommended daily oral dose). Desloratadine had no effect on pup development at an oral dose of 3 mg/kg/day (estimated desloratadine and desloratadine metabolite exposures were approximately 7 times the AUC in humans at the recommended daily oral dose).

Clinical Studies

Seasonal Allergic Rhinitis

The clinical efficacy and safety of CLARINEX-D 24 HOUR Extended Release Tablets was evaluated in two 2-week multicenter, randomized parallel group clinical trials involving 2852 subjects 12 to 78 years of age with seasonal allergic rhinitis, 708 of whom received CLARINEX-D 24 HOUR Extended Release Tablets. In the 2 trials, subjects were randomized to receive CLARINEX-D 24 HOUR Extended Release Tablets once daily, CLARINEX Tablets 5 mg once daily, or sustained-release pseudoephedrine tablet 240 mg once daily for two weeks. The majority of patients were between 18 and < 65 years of age with a mean age of 34.3 years and were predominantly women (63%). Patient ethnicity was 79 % Caucasian, 10% Black, 8 % Hispanic and 3% Asian/other ethnicity. Primary efficacy variable was twice-daily reflective patient scoring of 4 nasal symptoms (rhinorrhea, nasal stuffiness/congestion, nasal itching, and sneezing) and 4 non-nasal symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears/palate) on a four point scale (0=none, 1=mild, 2=moderate, and 3=severe). In both trials, the antihistaminic efficacy of CLARINEX-D 24 HOUR Extended Release Tablets, as measured by total symptom score excluding nasal congestion, was significantly greater than pseudoephedrine alone over the 2-week treatment period; and the decongestant efficacy of CLARINEX-D 24 HOUR Extended Release Tablets, as measured by nasal stuffiness/congestion, was significantly greater than CLARINEX (desloratadine alone) over the 2-week treatment period. Primary efficacy variable results from 1 of 2 trials are shown in Table 3.

TABLE 3 : Changes in Symptoms in a 2-Week Clinical Trial in Subjects With Seasonal Allergic Rhinitis

Treatment Group (n) Mean Baseline* (sem) Change (% change) from Baseline** (sem) CLARINEX-D® 24 HOUR Comparison to components*** (P- value)
  Total Symptom Score (Excluding Nasal Congestion)
CLARINEX-D 24 HOUR Extended Release Tablets (333) 14.84 -5.71 (-37.4) -
(0.15) (0.22)  
Pseudoephedrine tablet 240 mg (337) 15.03 -4.95 (-32.0) p=0.015
(0.15) (0.22)  
CLARINEX 5 mg Tablets (337) 15.06 -4.78 (-30.8) p=0.003
(0.15) (0.22)  
  Nasal Stuffiness/Congestion
CLARINEX-D®24 HOUR Extended Release Tablets (333) 2.56 -0.85 (-32.3) -
(0.020) (0.034)  
Pseudoephedrine tablet 240 mg (337) 2.54 -0.70 (-27.1) p=0.002
(0.020) (0.034)  
CLARINEX 5 mg Tablets (337) 2.57 -0.65 (-24.8) p < 0.001
(0.020) (0.034)  
* To qualify at Baseline, the sum of the twice-daily diary reflective scores for the 3 days prior to Baseline and the morning of the Baseline visit were to total ≥ 42 for total nasal symptom score (sum of 4 nasal symptoms of rhinorrhea, nasal stuffiness/congestion, nasal itching, and sneezing) and a total of ≥ 35 for total non-nasal symptoms score (sum of 4 non-nasal symptoms of itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears/palate), and a score of ≥ 14 for each of the individual symptoms of nasal stuffiness/congestion and rhinorrhea. Each symptom was scored on a 4-point severity scale (0=none, 1=mild, 2=moderate, 3=severe).
** Mean reduction in score averaged over the 2-week treatment period.
*** The comparison of interest is shown bolded. Sem=Standard Error of the Mean

There were no significant differences in the efficacy of CLARINEX-D 24 HOUR Extended Release Tablets across subgroups of subjects defined by gender, age, or race.

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

CLARINEX-D
(CLA-RI-NEX)
(desloratadine and pseudoephedrine sulfate) 24 Hour Extended Release Tablets

Read the Patient Information that comes with CLARINEX-D 24 Hour Extended Release Tablets before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

What is CLARINEX-D ® 24 Hour Extended Release Tablets?

CLARINEX-D 24 Hour Extended Release Tablets is a prescription medicine that contains the medicines desloratadine (an antihistamine) and pseudoephedrine (a nasal decongestant). CLARINEX-D 24 Hour Extended Release Tablets is used to help control the symptoms of seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in adults and children 12 years and older.

CLARINEX-D 24 Hour Extended Release Tablets is not for children under 12 years of age.

Who should not take CLARINEX-D ® 24Hour Extended Release Tablets?

Do not take CLARINEX-D 24 Hour Extended Release Tablets if you:

  • are allergic to desloratadine or pseudoephedrine sulfate or any of the ingredients in CLARINEX-D 24 Hour Extended Release Tablets. See the end of this leaflet for a complete list of ingredients in CLARINEX-D 24 Hour Extended Release Tablets.
  • are allergic to loratadine (Alavert, Claritin)
  • have narrow angle glaucoma
  • have problems with urination (urinary retention)
  • take a Monoamine Oxidase Inhibitor (MAOI) medicine to treat depression, or if you stopped taking an MAOI medicine within the last 2 weeks. Ask your doctor or pharmacist if you are not sure if you take an MAOI medicine.
  • have severe high blood pressure
  • have severe heart disease

Talk to your doctor before taking this medicine if you have any of these conditions.

What should I tell my doctor before taking CLARINEX-D ® 24 Hour Extended Release Tablets?

Before you take CLARINEX-D 24 Hour Extended Release Tablets, tell your doctor if you:

  • have any of the conditions listed in the section “Who should not take CLARINEX-D 24 Hour Extended Release Tablets?”
  • diabetes
  • hyperthyroidism
  • have prostate problems
  • have liver or kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if CLARINEX-D 24 Hour Extended Release Tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. CLARINEX-D 24 Hour Extended Release Tablets can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take CLARINEX-D 24 Hour Extended Release Tablets.

Tell your doctor about all the medicines your take, including prescription and non-prescription medicines, vitamins and herbal supplements. CLARINEX-D 24 Hour Extended Release Tablets may affect the way other medicines work, and other medicines may affect how CLARINEX-D 24 Hour Extended Release Tablets works. Especially tell your doctor if you take:

  • Monoamine Oxidase Inhibitors (MAOI). You should not use CLARINEX-D 24 Hour Extended Release Tablets if you take a MAOI or within 2 weeks of stopping an MAOI.
  • methyldopa
  • reserpine (Serpalan)
  • digitalis (Digoxin, Lanoxicaps, Lanoxin)
  • ketoconazole (Nizoral) erythromycin (Ery-tab, Eryc, PCE)
  • azithromycin (Zithromax, Zmax)
  • antihistamines
  • other decongestant medicines

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take CLARINEX-D 24 Hour Extended Release Tablets?

  • Take CLARINEX-D 24 Hour Extended Release Tablets exactly as your doctor tells you to take it.
  • CLARINEX-D 24 Hour Extended Release Tablets can be taken with or without food.
  • Swallow CLARINEX-D 24 Hour Extended Release Tablets whole. Do not break, crush, or chew CLARINEX-D 24 Hour Extended Release Tablets before swallowing. If you can not swallow CLARINEX-D 24 Hour Extended Release Tablets whole, tell your doctor. You may need a different medicine.
  • Take 1 CLARINEX-D 24 Hour Extended Release Tablets every day.

What are the possible side effects of CLARINEX-D ® 24 Hour Extended Release Tablets?

CLARINEX-D 24 Hour Extended Release Tablets may cause serious side effects, including:

The most common side effects of CLARINEX-D 24 HOUR Extended Release Tablets include:

  • dry mouth
  • headache
  • unable to sleep (insomnia)
  • tiredness
  • sore throat
  • sleepiness
  • nausea
  • dizziness
  • nervousness
  • restlessness
  • poor appetite

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of CLARINEX-D 24 Hour Extended Release Tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CLARINEX-D® 24 Hour Extended Release Tablets?

  • Store CLARINEX-D 24 Hour Extended Release Tablets at 59°F to 86°F (15°C to 30°C)
  • Keep CLARINEX-D 24 Hour Extended Release Tablets dry and out of the light.

Keep CLARINEX-D 24 Hour Extended Release Tablets and all medicines out of the reach of children.

General information CLARINEX-D® 24 Hour Extended Release Tablets

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use CLARINEX-D 24 Hour Extended Release Tablets for a condition for which it was not prescribed. Do not give CLARINEX-D 24 Hour Extended Release Tablets to other people, even if they have the same condition you have. It may harm them.

This patient information leaflet summarizes the most important information about CLARINEX-D 24 Hour Extended Release Tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLARINEX-D 24 Hour Extended Release Tablets that is written for health professionals.

For more information, go to www.CLARINEX.com.

What are the ingredients in CLARINEX-D® 24 Hour Extended Release Tablets?

Active ingredients: desloratadine and pseudoephedrine sulfate

Inactive ingredients: hypromellose USP, ethylcellulose NF, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, povidone USP, silicone dioxide NF, talc USP, polyacrylate dispersion, polyethylene glycol NF, simethicone USP, Blue Lake Blend 50726 (FD&C Blue No. 2 Lake, titanium dioxide USP and edetate disodium USP), and ink (Opacode® S-1-17746 or Opacode® S-1-4159).

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

CLARINEX-D
(CLA-RI-NEX)
(desloratadine and pseudoephedrine sulfate) 24 Hour Extended Release Tablets

Read the Patient Information that comes with CLARINEX-D 24 Hour Extended Release Tablets before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

What is CLARINEX-D ® 24 Hour Extended Release Tablets?

CLARINEX-D 24 Hour Extended Release Tablets is a prescription medicine that contains the medicines desloratadine (an antihistamine) and pseudoephedrine (a nasal decongestant). CLARINEX-D 24 Hour Extended Release Tablets is used to help control the symptoms of seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in adults and children 12 years and older.

CLARINEX-D 24 Hour Extended Release Tablets is not for children under 12 years of age.

Who should not take CLARINEX-D ® 24Hour Extended Release Tablets?

Do not take CLARINEX-D 24 Hour Extended Release Tablets if you:

  • are allergic to desloratadine or pseudoephedrine sulfate or any of the ingredients in CLARINEX-D 24 Hour Extended Release Tablets. See the end of this leaflet for a complete list of ingredients in CLARINEX-D 24 Hour Extended Release Tablets.
  • are allergic to loratadine (Alavert, Claritin)
  • have narrow angle glaucoma
  • have problems with urination (urinary retention)
  • take a Monoamine Oxidase Inhibitor (MAOI) medicine to treat depression, or if you stopped taking an MAOI medicine within the last 2 weeks. Ask your doctor or pharmacist if you are not sure if you take an MAOI medicine.
  • have severe high blood pressure
  • have severe heart disease

Talk to your doctor before taking this medicine if you have any of these conditions.

What should I tell my doctor before taking CLARINEX-D ® 24 Hour Extended Release Tablets?

Before you take CLARINEX-D 24 Hour Extended Release Tablets, tell your doctor if you:

  • have any of the conditions listed in the section “Who should not take CLARINEX-D 24 Hour Extended Release Tablets?”
  • diabetes
  • hyperthyroidism
  • have prostate problems
  • have liver or kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if CLARINEX-D 24 Hour Extended Release Tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. CLARINEX-D 24 Hour Extended Release Tablets can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take CLARINEX-D 24 Hour Extended Release Tablets.

Tell your doctor about all the medicines your take, including prescription and non-prescription medicines, vitamins and herbal supplements. CLARINEX-D 24 Hour Extended Release Tablets may affect the way other medicines work, and other medicines may affect how CLARINEX-D 24 Hour Extended Release Tablets works. Especially tell your doctor if you take:

  • Monoamine Oxidase Inhibitors (MAOI). You should not use CLARINEX-D 24 Hour Extended Release Tablets if you take a MAOI or within 2 weeks of stopping an MAOI.
  • methyldopa
  • reserpine (Serpalan)
  • digitalis (Digoxin, Lanoxicaps, Lanoxin)
  • ketoconazole (Nizoral) erythromycin (Ery-tab, Eryc, PCE)
  • azithromycin (Zithromax, Zmax)
  • antihistamines
  • other decongestant medicines

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take CLARINEX-D 24 Hour Extended Release Tablets?

  • Take CLARINEX-D 24 Hour Extended Release Tablets exactly as your doctor tells you to take it.
  • CLARINEX-D 24 Hour Extended Release Tablets can be taken with or without food.
  • Swallow CLARINEX-D 24 Hour Extended Release Tablets whole. Do not break, crush, or chew CLARINEX-D 24 Hour Extended Release Tablets before swallowing. If you can not swallow CLARINEX-D 24 Hour Extended Release Tablets whole, tell your doctor. You may need a different medicine.
  • Take 1 CLARINEX-D 24 Hour Extended Release Tablets every day.

What are the possible side effects of CLARINEX-D ® 24 Hour Extended Release Tablets?

CLARINEX-D 24 Hour Extended Release Tablets may cause serious side effects, including:

The most common side effects of CLARINEX-D 24 HOUR Extended Release Tablets include:

  • dry mouth
  • headache
  • unable to sleep (insomnia)
  • tiredness
  • sore throat
  • sleepiness
  • nausea
  • dizziness
  • nervousness
  • restlessness
  • poor appetite

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of CLARINEX-D 24 Hour Extended Release Tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CLARINEX-D® 24 Hour Extended Release Tablets?

  • Store CLARINEX-D 24 Hour Extended Release Tablets at 59°F to 86°F (15°C to 30°C)
  • Keep CLARINEX-D 24 Hour Extended Release Tablets dry and out of the light.

Keep CLARINEX-D 24 Hour Extended Release Tablets and all medicines out of the reach of children.

General information CLARINEX-D® 24 Hour Extended Release Tablets

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use CLARINEX-D 24 Hour Extended Release Tablets for a condition for which it was not prescribed. Do not give CLARINEX-D 24 Hour Extended Release Tablets to other people, even if they have the same condition you have. It may harm them.

This patient information leaflet summarizes the most important information about CLARINEX-D 24 Hour Extended Release Tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLARINEX-D 24 Hour Extended Release Tablets that is written for health professionals.

For more information, go to www.CLARINEX.com.

What are the ingredients in CLARINEX-D® 24 Hour Extended Release Tablets?

Active ingredients: desloratadine and pseudoephedrine sulfate

Inactive ingredients: hypromellose USP, ethylcellulose NF, dibasic calcium phosphate dihydrate USP, magnesium stearate NF, povidone USP, silicone dioxide NF, talc USP, polyacrylate dispersion, polyethylene glycol NF, simethicone USP, Blue Lake Blend 50726 (FD&C Blue No. 2 Lake, titanium dioxide USP and edetate disodium USP), and ink (Opacode® S-1-17746 or Opacode® S-1-4159).

Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Clarinex-D 24hr Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DESLORATADINE/PSEUDOEPHEDRINE EXTENDED-RELEASE - ORAL

(des-lor-AT-uh-deen/sue-doh-eff-ED-rin)

COMMON BRAND NAME(S): Clarinex-D 12 Hour, Clarinex-D 24 Hour

USES: This medication is used to relieve allergy symptoms such as watery eyes, runny/stuffy nose, itching eyes/nose, and sneezing. It contains 2 medications: desloratadine and pseudoephedrine. Desloratadine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Pseudoephedrine is a decongestant and works by narrowing the blood vessels in the nose to decrease swelling and congestion.

This medication is not recommended for use in children younger than 12 years of age due to the large amount of pseudoephedrine in it.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Do not increase your dose or take this medication more often than directed.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Clarinex-D 24hr Consumer (continued)

SIDE EFFECTS: Dizziness, tiredness, dry mouth, sore throat, trouble sleeping, nausea, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, shaking (tremor), mental/mood changes (such as anxiety, nervousness, restlessness).

Get medical help right away if you have any very serious side effects, including: seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Clarinex-D 24hr (desloratadine and pseudoephedrine sulfate) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to desloratadine or pseudoephedrine; or to loratadine; or if you have any other allergies. Also, tell your doctor if you have had serious side effects from similar medications (such as other decongestants, including phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma, difficulty urinating (such as due to an enlarged prostate), high blood pressure (hypertension), heart/blood vessel disease (such as coronary artery disease), overactive thyroid (hyperthyroidism), diabetes, kidney disease, liver disease.

This drug does not usually cause drowsiness when used at recommended doses. However, this drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Clarinex-D 24hr Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Do not take MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, selegiline, rasagiline, tranylcypromine) during treatment with this medication and for two weeks before treatment. In some cases a serious (possibly fatal) drug interaction may occur.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain similar ingredients (decongestants such as phenylephrine). Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including allergy skin testing), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, mental/mood changes (such as anxiety, restlessness), drowsiness, seizures.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised December 2011. Copyright(c) 2011 First Databank, Inc.

Clarinex-D 24hr Patient Information Including Side Effects

Brand Names: Clarinex-D 12 Hour, Clarinex-D 24 Hour

Generic Name: desloratadine and pseudoephedrine (Pronunciation: DES loe RAT a deen and SOO doe ee FED rin)

What is desloratadine and pseudoephedrine (Clarinex-D 24hr)?

Desloratadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of desloratadine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Desloratadine and pseudoephedrine is for use in adults and children who are at least 12 years old.

Desloratadine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

Clarinex-D 24 Hour

oval, blue, imprinted with D 24

What are the possible side effects of desloratadine and pseudoephedrine (Clarinex-D 24hr)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure);
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • dry mouth;
  • nausea, stomach pain, constipation;
  • mild loss of appetite, stomach upset;
  • warmth, redness, or tingly feeling under your skin;
  • sleep problems (insomnia);
  • feeling restless or excited (especially in children);
  • skin rash or itching;
  • dizziness, drowsiness; or
  • problems with memory or concentration.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Clarinex-D 24hr (desloratadine and pseudoephedrine sulfate) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about desloratadine and pseudoephedrine (Clarinex-D 24hr)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Desloratadine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Side Effects Centers

Clarinex-D 24hr Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking desloratadine and pseudoephedrine (Clarinex-D 24hr)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to desloratadine or pseudoephedrine, or if you have:

  • kidney disease;
  • diabetes;
  • glaucoma;
  • heart disease or high blood pressure;
  • a thyroid disorder;
  • an enlarged prostate; or
  • problems with urination.

FDA pregnancy category C. It is not known whether desloratadine and pseudoephedrine is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Desloratadine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take desloratadine and pseudoephedrine (Clarinex-D 24hr)?

Take this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Follow the directions on your prescription label. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take this medicine with a full glass of water.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store the medication at room temperature away from moisture and heat.

Side Effects Centers

Clarinex-D 24hr Patient Information including If I Miss a Dose

What happens if I miss a dose (Clarinex-D 24hr)?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Clarinex-D 24hr)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking desloratadine and pseudoephedrine (Clarinex-D 24hr)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

What other drugs will affect desloratadine and pseudoephedrine (Clarinex-D 24hr)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by desloratadine and pseudoephedrine.

Tell your doctor about all other medications you use, especially:

  • medicines to treat high blood pressure;
  • a diuretic (water pill);
  • medication to treat irritable bowel syndrome;
  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
  • salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with desloratadine and pseudoephedrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about desloratadine and pseudoephedrine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

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