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CLARINEX-D 24 HOUR (desloratadine 5 mg / pseudoephedrine sulfate 240 mg) Dailymed

  1. Human Prescription
  2. Archived
    • May Be Discontinued
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  3. Merck Sharp & Dohme Corp.

Generic: desloratadine and pseudoephedrine sulfate

CLARINEX-D 24 HOUR tablet, film coated, extended release - (desloratadine 5 mg / pseudoephedrine sulfate 240 mg) image

IMPRINT: D 24     SHAPE: oval
    COLOR: blue

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1 Indications And Usage



CLARINEX-D 24 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for:
  • Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. (1.1)

1.1 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 (12)].

2 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.


For oral use only (2)Adults and adolescents 12 years of age and over: The recommended dose of CLARINEX-D 24 HOUR Extended Release Tablets is one tablet once daily. (2.1)

2.1 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 (10.1,10.2)].

3 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.


Desloratadine 5 mg/Pseudoephedrine sulfate 240 mg tablets (3)

4 Contraindications


CLARINEX-D 24 HOUR Extended Release Tablets are contraindicated in:
  • Patients with hypersensitivity to any of its ingredients, or to loratadine [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)]
  • Patients with narrow angle glaucoma
  • Patients with urinary retention
  • Patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment [see Drug Interactions (7.1)].
  • Patients with severe hypertension or severe coronary artery disease.

  • Hypersensitivity (4)
  • Narrow Angle Glaucoma (4)
  • Urinary Retention (4)
  • Patients Receiving MAO Inhibitors or within 14 days of stopping such treatment (4)
  • Severe hypertension or severe coronary artery disease (4)

5 Warnings And Precautions


  • Cardiovascular and central nervous system effects: Use with caution in patients with cardiovascular disorders (5.1).
  • Coexisting conditions: Use with caution in patients with increased intraocular pressure, prostatic hypertrophy, diabetes mellitus, or hyperthyroidism (5.2).

5.1 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.

5.2 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 (4)].

5.3 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 (4) and Drug Interactions (7.1)].

5.4 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 (6.2)].

5.5 Renal Impairment


CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see Clinical Pharmacology (12.3)].

5.6 Hepatic Impairment


CLARINEX-D 24 HOUR Extended Release Tablets should generally be avoided in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

6 Adverse Reactions


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

  • The most common adverse reactions (reported in ≥2% of patients) were mouth dry, headache, insomnia, fatigue, pharyngitis, somnolence, nausea, dizziness, nervousness, psychomotor hyperactivity and anorexia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 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-D24 HOUR(N=708) Desloratadine5 mg(N=712) Pseudoephedrine240 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.

6.2 Post-Marketing Experience


In addition to the adverse reactions reported during clinical trials and uled 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: Cardiac disorders: palpitations Immune system disorders: urticaria Skin and subcutaneous tissue disorders: pruritus

In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: Cardiac disorders: tachycardia Nervous system disorders: headache, somnolence, dizziness, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures (reported in patients with and without a known seizure disorder) Immune system disorders: hypersensitivity reactions (such as rash, edema, dyspnea, and anaphylaxis) Investigations: elevated liver enzymes including bilirubin Hepatobiliary disorders: hepatitis Metabolism and nutrition disorders: increased appetite

Cases of severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.

7 Drug Interactions


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


Monoamine Oxidase (MAO) Inhibitors: Do not use. May potentiate the effect of pseudoephedrine on vascular system. (7.1)

7.1 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 (4) and Warnings and Precautions (5.3)].

7.2 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.

7.3 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.

7.4 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 (12.3)].

7.5 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 (12.3)].

7.6 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 (12.3)].

8 Use In Specific Populations


  • Renal impairment: Avoid in patients with renal impairment (8.6)
  • Hepatic impairment: Avoid in patients with hepatic impairment (8.7)

8.1 Pregnancy


Risk Summary

The limited available data with CLARINEX-D 24 HOUR in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. 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 or pseudoephedrine alone. Desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (AUC)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (RHD) of 5 mg/day. Desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the AUC-based exposures of desloratadine approximately 230 times that at the RHD. Desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of F1 pups at the summed AUC-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.


Data


Human Data


Animal Data

No animal reproduction studies were conducted with the combination of desloratadine and pseudoephedrine or pseudoephedrine alone.

8.2 Lactation



Risk Summary

Desloratadine and pseudoephedrine both pass into breast milk. There are not sufficient data on the effects of desloratadine on the breastfed infant or the effects of desloratadine on milk production. Pseudoephedrine has been reported to decrease milk production [see Data]. Pseudoephedrine has been reported to cause irritability in breastfed infants. The decision should be made whether to discontinue nursing or to discontinue CLARINEX-D 24 HOUR Extended Release Tablets, taking into account the developmental and health benefits of breastfeeding, the nursing mother's clinical need, and any potential adverse effects on the breastfed infant from desloratadine and pseudoephedrine or from the underlying maternal condition.


Data


Human Data

8.3 Females and Males of Reproductive Potential



Infertility

There are no data available on human infertility associated with desloratadine, pseudoephedrine, or the combination. There are no animal fertility studies with the combination or pseudoephedrine alone.

There were no clinically relevant effects of desloratadine on female fertility in rats. A male specific decrease in fertility occurred at an oral desloratadine dose of 12 mg/kg or greater in rats (approximately 65 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). [See Nonclinical Toxicology (13.1).]

8.4 Pediatric Use


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

8.5 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 (12.3)].

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 (12.3)] .

8.6 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 (5.5) and Clinical Pharmacology (12.3)].

8.7 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 (5.6) and Clinical Pharmacology (12.3)].

8.8 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.

8.9 Race


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

9 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.

10 Overdosage


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.

10.1 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 (12.2)].

10.2Sympathomimetics


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.

11 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:

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:

12 Clinical Pharmacology


12.1 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.

12.2 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.

12.3 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 (14.1)].

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 14C-desloratadine 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/1.73 m2) 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 3-hydroxydesloratadine, 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 AUC0-24 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 AUC0-24 hrs Cmax AUC0-24 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%

13 Nonclinical Toxicology


13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility


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


Carcinogenicity Studies:


Desloratadine

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 (approximately 45 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD) and in males and females given 25 mg/kg/day of loratadine. 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 (approximately 30 and 70 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD, respectively), did not show significant increases in the incidence of any tumors.


Pseudoephedrine

The carcinogenic potential of pseudoephedrine was assessed using ephedrine sulfate studies in F344/N rats and B6C3F1 mice conducted under the National Toxicology Program (NTP). In a 2-year dietary study in rats, male and female rats given up to 9 and 11 mg/kg/day ephedrine sulfate (approximately 0.4 and 0.5 times the RHD of 240 mg/day on a mg/m2 basis, respectively) did not show any evidence of tumorigenicity. In a 2-year dietary study in mice, male and female mice given up to 29 and 25 mg/kg/day ephedrine sulfate (approximately 0.7 and 0.6 times the RHD of pseudoephedrine on a mg/m2 basis, respectively) did not show any evidence of tumorigenicity.


Genotoxicity Studies:


Desloratadine

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).


Pseudoephedrine

Mutagenicity studies with pseudoephedrine have not been conducted.


Impairment of Fertility:


Desloratadine

In a female fertility study, desloratadine was given to female rats orally 14 days prior to and throughout mating until Gestation Day 7 at doses of 6, 12 and 24 mg/kg/day. An increase in preimplantation loss and a decrease in number of implantations and fetuses noted at 24 mg/kg (approximately 200 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD) was likely due to maternal toxicities including reduced body weight gain and food consumption. In a male fertility study in rats, desloratadine was given orally to male rats for 70 days prior to mating and throughout the mating period (total dosing period 106-108 days) at doses of 3, 12 and 40 mg/kg/day. Reduced body weight gain, food consumption, and absolute organ weights of testes, epididymis, and cauda epididymis were noted at 40 mg/kg/day. A male-specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic changes in testes and epididymis, occurred at a dose of 12 mg/kg or greater (approximately 65 times or greater than the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Desloratadine had no effect on male fertility in rats at 3 mg/kg/day (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD).


Pseudoephedrine

Fertility studies with pseudoephedrine have not been conducted.

14 Clinical Studies


14.1 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 BaselineTo 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). (SEM) Change (% change) from BaselineMean reduction in score averaged over the 2-week treatment period. (SEM) CLARINEX-D24 HOUR Comparison to componentsThe comparison of interest is shown bolded. (P-value)
SEM=Standard Error of the Mean
Total Symptom Score (Excluding Nasal Congestion)
CLARINEX-D 24 HOUR Extended Release Tablets(333) 14.84(0.15) -5.71 (-37.4)(0.22) -
Pseudoephedrine tablet240 mg(337) 15.03(0.15) -4.95 (-32.0)(0.22) p=0.015
CLARINEX 5 mg Tablets(337) 15.06(0.15) -4.78 (-30.8)(0.22) p=0.003
Nasal Stuffiness/Congestion
CLARINEX-D 24 HOUR Extended Release Tablets(333) 2.56(0.020) -0.85 (-32.3)(0.034) -
Pseudoephedrine tablet240 mg(337) 2.54(0.020) -0.70 (-27.1)(0.034) p=0.002
CLARINEX 5 mg Tablets(337) 2.57(0.020) -0.65 (-24.8)(0.034) p<0.001

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.

16 How Supplied/storage And Handling


CLARINEX-D 24 HOUR Extended Release Tablets are oval-shaped, light blue coated tablets with "D24" branded in black on one side 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 AND HANDLING SECTION


Storage:

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

17 Patient Counseling Information


Advise the patient to read the FDA-approved patient labeling (Patient Information).

17.1 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, convulsions or arrhythmia.

17.2 Dosing


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

17.3 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.

17.4Monoamine 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.

17.5Coexisting 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.

17.6 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.


Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 2005-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

uspi-mk4117a-t-d24-1903r010

Spl Patient Package Insert Section


PATIENT INFORMATION

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

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 ® 24 Hour 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 ul 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 uled 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 you 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 (MAOIs). You should not use CLARINEX-D 24 Hour Extended Release Tablets if you take an 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 ul 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 Tablet 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:
  • Cardiovascular and central nervous system effects, such as
    • unable to sleep (insomnia)
    • dizziness
    • weakness
    • tremor
    • irregular heart beat
    • seizure
    • low blood pressure
  • Increased sleepiness or tiredness can happen if you take more CLARINEX-D 24 Hour Extended Release Tablets than your doctor prescribed to you.
  • Allergic reactions. Stop taking CLARINEX-D 24 Hour Extended Release Tablets and call your doctor right away or get emergency help if you have any of these symptoms:
    • rash
    • itching
    • hives
    • swelling of your lips, tongue, face, and throat
    • shortness of breath or trouble breathing
  • Severe skin reactions including signs and symptoms such as fever, reddening of the skin, or many small pimples

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 about CLARINEX-D® 24 Hour Extended Release Tablets

Medicines are sometimes prescribed for purposes other than those uled 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.

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).


Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2005-2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

Revised: 03/2019

usppi-mk4117a-t-d24-1903r008

Package Label.principal Display Panel


PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 0085-1317-01100 Tablets

CLARINEX-D ® 24 HOUR

(desloratadine 5 mg/pseudoephedrine sulfate, USP 240 mg)

EXTENDED RELEASE TABLETS

Rx only

actual size

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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