NDC 0085-1322 Clarinex-d 12 Hour

Desloratadine And Pseudoephedrine Sulfate

NDC Product Code 0085-1322

NDC CODE: 0085-1322

Proprietary Name: Clarinex-d 12 Hour What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Desloratadine And Pseudoephedrine Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information 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. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Desloratadine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.

Product Characteristics

Color(s):
BLUE (C48333)
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
15 MM
Imprint(s):
D12
Score: 1

NDC Code Structure

  • 0085 - Merck Sharp & Dohme Corp.

NDC 0085-1322-01

Package Description: 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Product Information

Clarinex-d 12 Hour with NDC 0085-1322 is a a human prescription drug product labeled by Merck Sharp & Dohme Corp.. The generic name of Clarinex-d 12 Hour is desloratadine and pseudoephedrine sulfate. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Merck Sharp & Dohme Corp.

Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clarinex-d 12 Hour Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DESLORATADINE 2.5 mg/1
  • PSEUDOEPHEDRINE SULFATE 120 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • ALUMINUM OXIDE (UNII: LMI26O6933)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Merck Sharp & Dohme Corp.
Labeler Code: 0085
FDA Application Number: NDA021313 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Desloratadine

Desloratadine is pronounced as (des lor at' a deen)

Why is desloratadine medication prescribed?
Desloratadine is used to relieve hay fever and allergy symptoms, including sneezing; runny nose; and red, itchy, tearing eyes. It is also used to treat hives. Desloratadi...
[Read More]
Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)
Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

* Please review the disclaimer below.

Clarinex-d 12 Hour Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1.1 Seasonal Allergic Rhinitis

CLARINEX-D® 12 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 12 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 12 HOUR Extended Release Tablet by the oral route only. Do not break, chew, or crush the tablet. Swallow the tablet whole.

2.1 Adults And Adolescents 12 Years Of Age And Over

The recommended dose of CLARINEX-D 12 HOUR Extended Release Tablets is 1 tablet twice a day, administered approximately 12 hours apart and with or without a meal. Higher doses or increased dosing frequency of CLARINEX-D 12 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 12 HOUR Extended Release Tablets have been associated with adverse effects at higher doses [see Overdosage (10.1) and (10.2)].

3 Dosage Forms And Strengths

CLARINEX-D 12 HOUR Extended Release Tablets are oval shaped, blue and white bilayer tablets with "D12" embossed in the blue layer. Each tablet contains 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate USP in the white extended-release layer.

4 Contraindications

  • CLARINEX-D 12 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 glaucomaPatients with urinary retentionPatients 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

5.1 Cardiovascular And Central Nervous System Effects

The pseudoephedrine sulfate contained in CLARINEX-D 12 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 12 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 12 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 and narrow-angle glaucoma may occur [see Contraindications (4)].

5.3 Co-Administration With Monoamine Oxidase (Mao) Inhibitors

CLARINEX-D 12 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 12 HOUR Extended Release Tablets. If such a reaction occurs, therapy with CLARINEX-D 12 HOUR Extended Release Tablets should be stopped and alternative treatment should be considered [see Adverse Reactions (6.2)].

5.5 Renal Impairment

CLARINEX-D 12 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment [see Clinical Pharmacology (12.3)].

5.6 Hepatic Impairment

CLARINEX-D 12 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: Cardiovascular and Central Nervous System effects [see Warnings and Precautions (5.1)]Increased intraocular pressure [see Warnings and Precautions (5.2)]Urinary retention in patients with prostatic hypertrophy [see Warnings and Precautions (5.2)]Hypersensitivity reactions [see Warnings and Precautions (5.4)]Severe Skin Reactions

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 12 HOUR Extended Release Tablets that included 1248 patients with seasonal allergic rhinitis, of which 414 patients received CLARINEX-D 12 HOUR Extended Release Tablets twice daily for up to 2 weeks. The majority of patients were between 18 and <65 years of age with a mean age of 35.8 years and were predominantly women (64%). Patient ethnicity was 82% Caucasian, 9% Black, 6% Hispanic and 3% Asian/other ethnicity. The percentage of subjects receiving CLARINEX-D 12 HOUR Extended Release Tablets and who discontinued from the clinical trials because of an adverse event was 3.6%. Adverse reactions that were reported by ≥2% of subjects receiving CLARINEX-D 12 HOUR Extended Release Tablets are shown in Table 1.Table 1: Incidence of Adverse Reactions Reported by ≥2% of Subjects Receiving CLARINEX-D 12 HOUR Extended Release TabletsAdverse ReactionCLARINEX-D 12 HOUR BID (N=414)Desloratadine 5 mg QD (N=412)Pseudoephedrine 120 mg BID (N=422)Gastrointestinal DisordersMouth Dry8%2%8%Nausea2%1%3%General Disorders and Administration Site ConditionsFatigue4%2%2%Metabolism and Nutrition DisordersAnorexia2%0%2%Nervous System DisordersHeadache8%8%9%Somnolence3%4%2%Dizziness3%2%2%Psychiatric DisordersInsomnia10%3%13%Respiratory, Thoracic, and Mediastinal DisordersPharyngitis3%3%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 listed above, adverse events have been identified during post approval use of CLARINEX-D 12 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 12 HOUR Extended Release Tablets include tachycardia, palpitations, dyspnea, rash and pruritus.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 and rarely hypersensitivity reactions (such as urticaria, edema and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin and, very rarely, hepatitis and 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 12 HOUR Extended Release Tablets.

7.1 Monoamine Oxidase Inhibitors

CLARINEX-D 12 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 12 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 12 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 12 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)].

8.3 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 12 HOUR Extended Release Tablets, taking into account the benefit of the drug to the nursing mother and the possible risk to the child.

8.4 Pediatric Use

CLARINEX-D 12 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=10) ≥65 years old treated with CLARINEX-D 12 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 12 HOUR Extended Release Tablets were conducted in subjects with renal impairment.CLARINEX-D 12 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 12 HOUR Extended Release Tablets or pseudoephedrine were conducted in subjects with hepatic impairment.CLARINEX-D 12 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 12 HOUR Extended Release Tablets.

8.9 Race

No studies have been conducted to evaluate the effect of race on the pharmacokinetics of CLARINEX-D 12 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 12 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 post-marketing 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)].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 exposure was approximately 810 times the human daily oral dose on an mg/m2 basis).

10.2 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.

11 Description

CLARINEX-D 12 HOUR Extended Release Tablets are oval-shaped blue and white bilayer tablets containing 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate USP in the white extended-release layer which is released slowly, allowing for twice-daily administration.The inactive ingredients contained in CLARINEX-D 12 HOUR Extended Release Tablets are hypromellose USP, microcrystalline cellulose NF, povidone USP, silicon dioxide NF, magnesium stearate NF, corn starch NF, edetate disodium USP, citric acid anhydrous USP, stearic acid NF, and FD&C Blue No. 2 aluminum lake dye.Desloratadine, 1 of the 2 active ingredients of CLARINEX-D 12 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 12 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:

12.1 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.

Other

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 SubjectsDesloratadine3-hydroxydesloratadineCmaxAUC 0-24hrsCmaxAUC 0-24hrsErythromycin(500 mg Q8h)+24%+14%+43%+40%Ketoconazole(200 mg Q12h)+45%+39%+43%+72%Azithromycin(500 mg Day 1,250 mg QD × 4 days)+15%+5%+15%+4%Fluoxetine(20 mg QD)+15%+0%+17%+13%Cimetidine(600 mg Q12h)+12%+19%-11%-3%

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).

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC., Whitehouse Station, NJ 08889, USAFor patent information: www.merck.com/product/patent/home.htmlThe trademarks depicted herein are owned by their respective companies.Copyright © 2006-2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved.Revised: 02/2018usppi-mk4117a-t-d12-1802r006

13.1 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.

14.1 Seasonal Allergic Rhinitis

The clinical efficacy and safety of CLARINEX-D 12 HOUR Extended Release Tablets was evaluated in two 2-week multicenter, randomized parallel group clinical trials involving 1248 subjects 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received CLARINEX-D 12 HOUR Extended Release Tablets. In the 2 trials, subjects were randomized to receive CLARINEX-D 12 HOUR Extended Release Tablets twice daily, CLARINEX Tablets 5 mg once daily, or sustained-release pseudoephedrine tablet 120 mg twice daily for 2 weeks. The majority of patients were between 18 and <65 years of age with a mean age of 35.8 years and were predominantly women (64%). Patient ethnicity was 82% Caucasian, 9% Black, 6% 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 four non-nasal symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears/palate) on a 4 point scale (0=none, 1=mild, 2=moderate, and 3=severe). In both trials, the antihistaminic efficacy of CLARINEX-D 12 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 12 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-D 12 HOUR Comparison to ComponentsThe comparison of interest is shown bolded. (P-value)SEM=Standard Error of the MeanTotal Symptom Score (Excluding Nasal Congestion)CLARINEX-D 12 HOUR Extended Release Tablets BID(199)14.18 (0.21)-6.54 (-46.0) (0.30)-Pseudoephedrine tablet 120 mg BID(197)14.06 (0.21)-5.07 (-35.9) (0.30)P<0.001CLARINEX 5 mg Tablets QD(197)14.82 (0.21)-5.09 (-33.5) (0.30)P<0.001Nasal Stuffiness/CongestionCLARINEX-D 12 HOUR Extended Release Tablets BID(199)2.47 (0.027)-0.93 (-37.4) (0.046)-Pseudoephedrine tablet 120 mg BID (197)2.46 (0.027)-0.75 (-31.2) (0.046)P=0.006CLARINEX 5 mg Tablets QD(197)2.50 (0.027)-0.66 (-26.7) (0.046)P<0.001There were no significant differences in the efficacy of CLARINEX-D 12 HOUR Extended Release Tablets across subgroups of subjects defined by gender, age, or race.

16 How Supplied/Storage And Handling

CLARINEX-D 12 HOUR Extended Release Tablets are oval-shaped, blue and white bilayer tablets with "D12" embossed in the blue layer, containing 2.5 mg desloratadine in the blue immediate-release layer and 120 mg of pseudoephedrine sulfate USP in the white extended-release layer. CLARINEX-D 12 HOUR Extended Release Tablets are supplied in high-density polyethylene bottles of 100 (NDC 0085-1322-01).

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 12 HOUR Extended Release Tablets may cause cardiovascular or central nervous system effects such as insomnia, dizziness, tremor, or arrhythmia.

17.2 Dosing

Patients should be advised not to increase the dose or dosing frequency of CLARINEX-D 12 HOUR Extended Release Tablets.

17.3 Additional Antihistamines And/Or Decongestants

Patients should be advised against the concurrent use of CLARINEX-D 12 HOUR Extended Release Tablets with other antihistamines and/or decongestants.

17.4 Monoamine Oxidase (Mao) Inhibitors

Patients should be informed that due to its pseudoephedrine component, they should not use CLARINEX-D 12 HOUR with a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor.

17.5 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 12 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.

Spl Patient Package Insert

  • PATIENT INFORMATIONCLARINEX-D® (CLA-RI-NEX) 12 Hour Extended Release Tablets(desloratadine and pseudoephedrine sulfate)Read the Patient Information that comes with CLARINEX-D 12 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® 12 Hour Extended Release Tablets?CLARINEX-D 12 Hour Extended Release Tablets is a prescription medicine that contains the medicines desloratadine (an antihistamine) and pseudoephedrine (a nasal decongestant). CLARINEX-D 12 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 12 Hour Extended Release Tablets is not for children under 12 years of age.Who should not take CLARINEX-D® 12 Hour Extended Release Tablets?Do not take CLARINEX-D 12 Hour Extended Release Tablets if you:are allergic to desloratadine or pseudoephedrine sulfate or any of the ingredients in CLARINEX-D 12 Hour Extended Release Tablets. See the end of this leaflet for a complete list of ingredients in CLARINEX-D 12 Hour Extended Release Tablets.are allergic to loratadine (Alavert, Claritin)have narrow-angle glaucomahave 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 pressurehave severe heart diseaseTalk to your doctor before taking this medicine if you have any of these conditions.What should I tell my doctor before taking CLARINEX-D® 12 Hour Extended Release Tablets?Before you take CLARINEX-D 12 Hour Extended Release Tablets, tell your doctor if you:have any of the conditions listed in the section "Who should not take CLARINEX-D 12 Hour Extended Release Tablets?"diabeteshyperthyroidismhave prostate problemshave liver or kidney problemshave any other medical conditionsare pregnant or plan to become pregnant. It is not known if CLARINEX-D 12 Hour Extended Release Tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.are breastfeeding or plan to breastfeed. CLARINEX-D 12 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 12 Hour Extended Release Tablets.Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. CLARINEX-D® 12 Hour Extended Release Tablets may affect the way other medicines work, and other medicines may affect how CLARINEX-D 12 Hour Extended Release Tablets works. Especially tell your doctor if you take:Monoamine Oxidase Inhibitors (MAOIs). You should not use CLARINEX-D 12 Hour Extended Release Tablets if you take an MAOI or within 2 weeks of stopping an MAOI.methyldopareserpine (Serpalan)digitalis (Digoxin, Lanoxicaps, Lanoxin) ketoconazole (Nizoral)erythromycin (Ery-tab, Eryc, PCE)azithromycin (Zithromax, Zmax)antihistaminesother decongestant medicinesKnow 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® 12 Hour Extended Release Tablets?Take CLARINEX-D 12 Hour Extended Release Tablets exactly as your doctor tells you to take it.CLARINEX-D 12 Hour Extended Release Tablets can be taken with or without food.Swallow CLARINEX-D 12 Hour Extended Release Tablets whole. Do not break, crush, or chew CLARINEX-D 12 Hour Extended Release Tablets before swallowing. If you cannot swallow CLARINEX-D 12 Hour Extended Release Tablets whole, tell your doctor. You may need a different medicine.Take 1 CLARINEX-D 12 Hour Extended Release Tablet 2 times a day (every 12 hours).What are the possible side effects of CLARINEX-D® 12 Hour Extended Release Tablets?CLARINEX-D 12 Hour Extended Release Tablets may cause serious side effects, including:Cardiovascular and central nervous system effects, such as unable to sleep (insomnia)dizzinessweaknesstremorirregular heart beatseizurelow blood pressureIncreased sleepiness or tiredness can happen if you take more CLARINEX-D 12 Hour Extended Release Tablets than your doctor prescribed to you.Allergic reactions. Stop taking CLARINEX-D 12 Hour Extended Release Tablets and call your doctor right away or get emergency help if you have any of these symptoms: rashitchinghivesswelling of your lips, tongue, face, and throatshortness of breath or trouble breathingSevere skin reactions including signs and symptoms such as fever, reddening of the skin, or many small pimplesThe most common side effects of CLARINEX-D 12 HOUR Extended Release Tablets include:unable to sleep (insomnia)sore throatheadachedizzinessdry mouthnauseatirednessloss of appetitesleepinessTell 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 12 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® 12 Hour Extended Release Tablets?Store CLARINEX-D 12 Hour Extended Release Tablets at 59°F to 86°F (15°C to 30°C)Keep CLARINEX-D 12 Hour Extended Release Tablets dry and out of the light.Keep CLARINEX-D 12 Hour Extended Release Tablets and all medicines out of the reach of children.General information about CLARINEX-D® 12 Hour Extended Release TabletsMedicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use CLARINEX-D 12 Hour Extended Release Tablets for a condition for which it was not prescribed. Do not give CLARINEX-D 12 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 12 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 12 Hour Extended Release Tablets that is written for health professionals.What are the ingredients in CLARINEX-D® 12 Hour Extended Release Tablets?Active ingredients: desloratadine and pseudoephedrine sulfateInactive ingredients: hypromellose USP, microcrystalline cellulose NF, povidone USP, silicon dioxide NF, magnesium stearate NF, corn starch NF, edetate disodium USP, citric acid anhydrous USP, stearic acid NF, and FD&C Blue No. 2 aluminum lake dye.

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