DESLORATADINE

Main information

  • Trade name:
  • DESLORATADINE- desloratadine tablet, film coated
  • Composition:
  • DESLORATADINE 5 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DESLORATADINE- desloratadine tablet, film coated
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older. Desloratadine tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older. Desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)] . The limited available data with desloratadine 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 in pregnant women. Desloratadine given during organogenesis to pregnant rats was not teratoge
  • Product summary:
  • Desloratadine Tablets, USP are available containing 5 mg of desloratadine, USP. The 5 mg tablets are red, film-coated, round, unscored tablets debossed with M on one side of the tablet and D17 on the other side. They are available as follows: NDC 0378-4017-01 bottles of 100 tablets NDC 0378-4017-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Heat sensitive. Avoid exposure at or above 30ºC (86ºF). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 0378-4017-01, 0378-4017-05
  • Last update:
  • 07-06-2019

Summary of Product characteristics: dosage, interactions, side effects

DESLORATADINE- desloratadine tablet, film coated

Mylan Pharmaceuticals Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DESLORATADINE TABLETS safely and

effectively. See full prescribing information for DESLORATADINE TABLETS.

DESLORATADINE tablets, for oral use

Initial U.S. Approval: 2001

INDICATIONS AND USAGE

Desloratadine tablets are a histamine-1 (H1) receptor antagonist indicated for:

DOSAGE AND ADMINISTRATION

Dosage (by age):

Adults and Adolescents 12 Years of Age and Over:

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX), or FDA

at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 4/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Seasonal Allergic Rhinitis

1.2 Perennial Allergic Rhinitis

Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.1)

Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.2)

Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in

patients 12 years of age and older. (1.3)

Desloratadine tablets - one 5 mg tablet once daily

Desloratadine tablets - 5 mg (3)

Hypersensitivity (4, 6.2)

Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported. In

such cases, stop desloratadine tablets at once and consider alternative treatments. (5.1)

The most common adverse reactions (reported in ≥ 2% of adult and adolescent patients with allergic rhinitis and

greater than placebo) were pharyngitis, dry mouth, myalgia, fatigue, somnolence, dysmenorrhea. (6.1)

Renal impairment: dosage adjustment is recommended (2.5, 8.6, 12.3)

Hepatic impairment: dosage adjustment is recommended (2.5, 8.7, 12.3)

1.3 Chronic Idiopathic Urticaria

2 DOSAGE AND ADMINISTRATION

2.1 Adults and Adolescents 12 Years of Age and Over

2.5 Adults with Hepatic or Renal Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

7.1 Inhibitors of Cytochrome P450 3A4

7.2 Fluoxetine

7.3 Cimetidine

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

9 DRUG ABUSE AND DEPENDENCE

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Seasonal Allergic Rhinitis

14.2 Perennial Allergic Rhinitis

14.3 Chronic Idiopathic Urticaria

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Seasonal Allergic Rhinitis

Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal

allergic rhinitis in patients 12 years of age and older.

Sections or subsections omitted from the full prescribing information are not listed.

1.2 Perennial Allergic Rhinitis

Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial

allergic rhinitis in patients 12 years of age and older.

1.3 Chronic Idiopathic Urticaria

Desloratadine tablets are indicated for the symptomatic relief of pruritus, reduction in the number of

hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

Desloratadine tablets may be taken without regard to meals.

2.1 Adults and Adolescents 12 Years of Age and Over

The recommended dose of desloratadine tablets is one 5 mg tablet once daily.

2.5 Adults with Hepatic or Renal Impairment

In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is

recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal

impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Desloratadine Tablets, USP are available containing 5 mg of desloratadine, USP.

4 CONTRAINDICATIONS

Desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any

of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been

reported after administration of desloratadine. If such a reaction occurs, therapy with desloratadine

should be stopped and alternative treatment should be considered. [See Adverse Reactions (6.2).]

6 ADVERSE REACTIONS

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

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 5 mg tablets are red, film-coated, round, unscored tablets debossed with M on one side of the

tablet and D17 on the other side.

Hypersensitivity reactions. [See Warnings and Precautions (5.1).]

Adults and Adolescents

Allergic Rhinitis

In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received desloratadine

tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose

of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between desloratadine

and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events

was 2.4% in the desloratadine group and 2.6% in the placebo group. There were no serious adverse

events in these trials in patients receiving desloratadine. All adverse events that were reported by

greater than or equal to 2% of patients who received the recommended daily dose of desloratadine

tablets (5 mg once daily), and that were more common with desloratadine tablets than placebo, are listed

in Table 1.

Table 1: Incidence of Adverse Events Reported by ≥ 2% of Adult and Adolescent Allergic

Rhinitis Patients Receiving Desloratadine Tablets

Adverse Event

Desloratadine Tablets

5 mg

(n = 1655)

Placebo

(n = 1652)

Infections and Infestations

Pharyngitis

4.1%

2.0%

Nervous System Disorders

Somnolence

2.1%

1.8%

Gastrointestinal Disorders

Dry Mouth

3.0%

1.9%

Musculoskeletal and Connective Tissue

Disorders

Myalgia

2.1%

1.8%

Reproductive System and Breast Disorders

Dysmenorrhea

2.1%

1.6%

General Disorders and Administration Site

Conditions

Fatigue

2.1%

1.2%

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in

desloratadine and placebo-treated patients.

There were no differences in adverse events for subgroups of patients as defined by gender, age, or

race.

Chronic Idiopathic Urticaria

In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or

older received desloratadine tablets and 205 received placebo. Adverse events that were reported by

greater than or equal to 2% of patients who received desloratadine tablets and that were more common

with desloratadine than placebo were (rates for desloratadine and placebo, respectively): headache

(14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia

(3%, 1%), and myalgia (3%, 1%).

Pediatrics

Two hundred and forty-six pediatric subjects 6 months to 11 years of age received CLARINEX Oral

Solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years

received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11

months of age received 1.0 mg once a day.

In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the

subjects.

In subjects 2 to 5 years of age, adverse events reported for desloratadine and placebo in at least 2

percent of subjects receiving CLARINEX Oral Solution and at a frequency greater than placebo were

fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).

In subjects 12 months to 23 months of age, adverse events reported for the desloratadine product and

placebo in at least 2 percent of subjects receiving CLARINEX Oral Solution and at a frequency greater

than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections

(10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%,

0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular

(3.1%, 0%).

In subjects 6 months to 11 months of age, adverse events reported for desloratadine and placebo in at

least 2 percent of subjects receiving CLARINEX Oral Solution and at a frequency greater than placebo

were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7%, 8.1%), fever (12.1%, 1.6%),

irritability (12.1%, 11.3%), coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%),

otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%),

insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3.0%, 1.6%), and nausea (3.0%, 0%).

There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc

interval. Only one of the 246 pediatric subjects receiving CLARINEX Oral Solution in the clinical

trials discontinued treatment because of an adverse event.

6.2 Post-Marketing Experience

Because adverse 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. The

following spontaneous adverse events have been reported during the marketing of desloratadine:

Cardiac Disorders: tachycardia, palpitations

Respiratory, Thoracic and Mediastinal Disorders: dyspnea

Skin and Subcutaneous Tissue Disorders: rash, pruritus

Nervous System Disorders: psychomotor hyperactivity, 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 urticaria, edema and anaphylaxis)

Investigations: elevated liver enzymes including bilirubin

Hepatobiliary Disorders: hepatitis

Metabolism and Nutrition Disorders: increased appetite

7 DRUG INTERACTIONS

7.1 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).]

7.2 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).]

7.3 Cimetidine

In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H -

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

8.1 Pregnancy

Risk Summary

The limited available data with desloratadine 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 in pregnant women. 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 F 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

Animal Data

Desloratadine was given orally during organogenesis to pregnant rats at doses of 6, 24 and 48

mg/kg/day (approximately 50, 200 and 320 times the summed AUC-based exposure of desloratadine and

its metabolite at the RHD). No fetal malformations were present. Reduced fetal weights and skeletal

variations noted at doses of 24 and 48 mg/kg/day were likely secondary to the maternal toxicities of

reduced body weight gain and food consumption observed at the same doses. Desloratadine was also

given orally during organogenesis to pregnant rabbits at doses of 15, 30 and 60 mg/kg/day

(approximately 30, 70 and 230 times the AUC-based exposure of desloratadine at the RHD). No

adverse effects to the fetus were noted. Reduced maternal body weight gain was noted in rabbits at 60

mg/kg/day. In a peri-and post-natal development study, desloratadine was given to rats orally during the

perinatal (Gestation Day 6) through lactation periods (Postpartum Day 21) at doses of 3, 9 and 18

mg/kg/day. Reduced body weight and slow righting reflex were reported in F pups at doses of 9

mg/kg/day or greater (approximately 70 times or greater than the summed AUC-based exposure of

desloratadine and its metabolite at the RHD). Desloratadine had no effect on F pup development at 3

mg/kg/day (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite

at the RHD). Maternal toxicities including reduced body weight gain and food consumption were noted

at 18 mg/kg/day for F dams. F offspring were subsequently mated and there was no developmental

toxicity for F pups observed

8.2 Lactation

Risk Summary

Desloratadine passes 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. The decision should be made

whether to discontinue nursing or to discontinue desloratadine, 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 or from the underlying maternal condition.

8.3 Females and Males of Reproductive Potential

Infertility

There are no data available on human infertility associated with desloratadine.

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

The recommended dose of CLARINEX Oral Solution in the pediatric population is based on cross-

study comparison of the plasma concentration of desloratadine in adults and pediatric subjects. The

safety of CLARINEX Oral Solution has been established in 246 pediatric subjects aged 6 months to 11

years in three placebo-controlled clinical studies. Since the course of seasonal and perennial allergic

rhinitis and chronic idiopathic urticaria and the effects of desloratadine are sufficiently similar in the

pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients.

The effectiveness of CLARINEX Oral Solution in these age groups is supported by evidence from

adequate and well-controlled studies of desloratadine tablets in adults. The safety and effectiveness of

desloratadine tablets or CLARINEX Oral Solution have not been demonstrated in pediatric patients less

than 6 months of age. [See Clinical Pharmacology (12.3).]

The CLARINEX RediTabs

2.5 mg tablet has not been evaluated in pediatric patients. Bioequivalence

of the CLARINEX RediTabs Tablet and the previously marketed RediTabs Tablet was established in

adults. In conjunction with the dose-finding studies in pediatrics described, the pharmacokinetic data for

CLARINEX RediTabs supports the use of the 2.5 mg dose strength in pediatric patients 6 to 11 years of

age.

8.5 Geriatric Use

Clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to

determine whether they respond differently from younger subjects. Other reported clinical experience

has not identified differences between the elderly and younger patients. 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).]

8.6 Renal Impairment

Dosage adjustment for patients with renal impairment is recommended [see Dosage and Administration

(2.5) and Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

Dosage adjustment for patients with hepatic impairment is recommended [see Dosage and Administration

(2.5) and Clinical Pharmacology (12.3)].

9 DRUG ABUSE AND DEPENDENCE

There is no information to indicate that abuse or dependency occurs with desloratadine 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.

Information regarding acute overdosage is limited to experience from post-marketing adverse event

reports and from clinical trials conducted during the development of the desloratadine product. 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 desloratadine 45 mg for 10 days [see Clinical

Pharmacology (12.2)].

11 DESCRIPTION

Desloratadine tablets, USP are red, film-coated, round, unscored tablets debossed with M on one side

of the tablet and D17 on the other side containing 5 mg of desloratadine, an antihistamine, to be

administered orally. Desloratadine tablets also contain the following excipients: colloidal silicon

dioxide, FD&C Red No. 40 Aluminum Lake, magnesium stearate, microcrystalline cellulose,

polyethylene glycol, polyvinyl alcohol, pregelatinized starch (corn), sodium lauryl sulfate, talc and

titanium dioxide.

Desloratadine, USP is a white to off-white powder that is slightly soluble in water, but very soluble in

ethanol and propylene glycol. It has a molecular formula: C

H ClN and a molecular weight of 310.8.

The chemical name is 8-Chloro-6,11-dihydro-11-(piperidin-4-ylidene)-5H-

benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure:

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Desloratadine is a long-acting tricyclic histamine antagonist with selective H -receptor histamine

antagonist activity. Receptor binding data indicates that at a concentration of 2-3 ng/mL (7 nanomolar),

desloratadine shows significant interaction with the human histamine H -receptor. Desloratadine

inhibited histamine release from human mast cells in vitro. Results of a radiolabeled tissue distribution

study in rats and a radioligand H -receptor binding study in guinea pigs showed that desloratadine did

not readily cross the blood brain barrier. The clinical significance of this finding is unknown.

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

Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs

obtained in this study were manually read in a blinded fashion by a cardiologist. In desloratadine-treated

subjects, there was an increase in mean heart rate of 9.2 bpm relative to placebo. The QT interval was

corrected for heart rate (QTc) by both the Bazett and Fridericia methods. Using the QTc (Bazett) there

was a mean increase of 8.1 msec in desloratadine-treated subjects relative to placebo. Using QTc

(Fridericia) there was a mean increase of 0.4 msec in desloratadine-treated subjects relative to placebo.

No clinically relevant adverse events were reported.

12.3 Pharmacokinetics

Absorption

Following oral administration of a desloratadine 5 mg tablet once daily for 10 days to normal healthy

volunteers, the mean time to maximum plasma concentrations (T

) occurred at approximately 3 hours

post dose and mean steady state peak plasma concentrations (C

) and AUC of 4 ng/mL and 56.9

nghr/mL were observed, respectively. Neither food nor grapefruit juice had an effect on the

bioavailability (C

and AUC) of desloratadine.

The pharmacokinetic profile of CLARINEX Oral Solution was evaluated in a three-way crossover

study in 30 adult volunteers. A single dose of 10 mL of CLARINEX Oral Solution containing 5 mg of

desloratadine was bioequivalent to a single dose of 5 mg desloratadine tablet. Food had no effect on the

bioavailability (AUC and C

) of CLARINEX Oral Solution.

The pharmacokinetic profile of CLARINEX RediTabs Tablets was evaluated in a three-way crossover

study in 24 adult volunteers. A single CLARINEX RediTabs Tablet containing 5 mg of desloratadine

was bioequivalent to a single 5 mg CLARINEX RediTabs Tablet (original formulation) for both

desloratadine and 3-hydroxydesloratadine. Food and water had no effect on the bioavailability (AUC

and C

) of CLARINEX RediTabs Tablets.

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 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 identified, a total of 94

poor metabolizers and 123 normal metabolizers were enrolled and treated with CLARINEX Oral

Solution for 15-35 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.

Elimination

The mean plasma elimination half-life of desloratadine was approximately 27 hours. C

and AUC

values increased in a dose proportional manner following single oral doses 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

C-desloratadine

dose, which was equally distributed in urine and feces as metabolic products. Analysis of plasma 3-

hydroxydesloratadine showed similar T

and half-life values compared to desloratadine.

Special Populations

Geriatric Subjects

In older subjects (≥ 65 years old; n = 17) following multiple-dose administration of desloratadine

tablets, the mean C

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 two 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

versus younger subjects. These age-related differences are unlikely to be clinically relevant and no

dosage adjustment is recommended in elderly subjects.

Pediatric Subjects

In subjects 6 to 11 years old, a single dose of 5 mL of CLARINEX Oral Solution containing 2.5 mg of

desloratadine, resulted in desloratadine plasma concentrations similar to those achieved in adults

administered a single 5 mg desloratadine tablet. In subjects 2 to 5 years old, a single dose of 2.5 mL of

CLARINEX Oral Solution containing 1.25 mg of desloratadine, resulted in desloratadine plasma

concentrations similar to those achieved in adults administered a single 5 mg desloratadine tablet.

However, the C

and AUC of the metabolite (3-hydroxydesloratadine) were 1.27 and 1.61 times

higher for the 5 mg dose of Oral Solution administered in adults compared to the C

and AUC

obtained in children 2 to 11 years of age receiving 1.25-2.5 mg of CLARINEX Oral Solution.

A single dose of either 2.5 mL or 1.25 mL of CLARINEX Oral Solution containing 1.25 mg or 0.625

mg, respectively, of desloratadine was administered to subjects 6 to 11 months of age and 12 to 23

months of age. The results of a population pharmacokinetic analysis indicated that a dose of 1 mg for

subjects aged 6 to 11 months and 1.25 mg for subjects 12 to 23 months of age is required to obtain

desloratadine plasma concentrations similar to those achieved in adults administered a single 5 mg dose

of CLARINEX Oral Solution.

The CLARINEX RediTabs 2.5 mg tablet has not been evaluated in pediatric patients. Bioequivalence of

the CLARINEX RediTabs Tablet and the original CLARINEX RediTabs Tablets was established in

adults. In conjunction with the dose-finding studies in pediatrics described, the pharmacokinetic data for

CLARINEX RediTabs Tablets supports the use of the 2.5 mg dose strength in pediatric patients 6 to 11

years of age.

Renally Impaired

Desloratadine pharmacokinetics following a single dose of 7.5 mg were characterized in patients with

mild (n = 7; creatinine clearance 51-69 mL/min/1.73 m ), moderate (n = 6; creatinine clearance 34-43

mL/min/1.73 m ), and severe (n = 6; creatinine clearance 5-29 mL/min/1.73 m ) renal impairment or

hemodialysis dependent (n = 6) patients. In patients with mild and moderate renal impairment, median

and AUC values increased by approximately 1.2- and 1.9-fold, respectively, relative to subjects

with normal renal function. In patients with severe renal impairment or who were hemodialysis

dependent, C

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. Dosage adjustment for patients with

renal impairment is recommended [see Dosage and Administration (2.5)].

Hepatically Impaired

Desloratadine pharmacokinetics were characterized following a single oral dose in patients with mild (n

= 4), moderate (n = 4), and severe (n = 4) hepatic impairment as defined by the Child-Pugh classification

of hepatic function and 8 subjects with normal hepatic function. Patients 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 patients 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 patients with hepatic impairment was observed. For 3-

hydroxydesloratadine, the mean C

and AUC values for patients with hepatic impairment were not

statistically significantly different from subjects with normal hepatic function. Dosage adjustment for

patients with hepatic impairment is recommended [see Dosage and Administration (2.5)].

Gender

Female subjects treated for 14 days with desloratadine tablets had 10% and 3% higher desloratadine

and AUC values, respectively, compared with male subjects. The 3-hydroxydesloratadine C

and AUC values were also increased by 45% and 48%, respectively, in females compared with males.

However, these apparent differences are not likely to be clinically relevant and therefore no dosage

adjustment is recommended.

Race

Following 14 days of treatment with desloratadine tablets, the C

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 C

and AUC values in Blacks

compared to Caucasians. These differences are not likely to be clinically relevant and therefore no

dose adjustment is recommended.

Drug Interactions

In two controlled crossover clinical pharmacology studies in healthy male (n = 12 in each study) and

female (n = 12 in each study) volunteers, desloratadine 7.5 mg (1.5 times the daily dose) once daily was

coadministered with erythromycin 500 mg every 8 hours or ketoconazole 200 mg every 12 hours for

10 days. In three 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 normal healthy male and female volunteers. Although increased plasma

concentrations (C

and AUC

) 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

0-24 hrs

tests, vital signs, and adverse events.

Table 2: Changes in Desloratadine and 3-Hydroxydesloratadine Pharmacokinetics in Healthy

Male and Female Volunteers

Des loratadine

3-Hydroxydes loratadine

C

AUC

C

AUC

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

Carcinogenicity Studies

The carcinogenic potential of desloratadine was assessed using a loratadine study in rats and a

desloratadine study in mice. In a 2-year study in rats, loratadine was administered in the diet at doses up

to 25 mg/kg/day (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.

Genotoxicity Studies

In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse

mutation assay (Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for

chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone

marrow micronucleus assay).

Impairment of Fertility

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

max

0-24 hrs

max

0-24 hrs

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).

14 CLINICAL STUDIES

14.1 Seasonal Allergic Rhinitis

The clinical efficacy and safety of desloratadine tablets were evaluated in over 2300 patients 12 to 75

years of age with seasonal allergic rhinitis. A total of 1838 patients received 2.5 to 20 mg/day of

desloratadine in 4 double-blind, randomized, placebo-controlled clinical trials of 2 to 4 weeks’ duration

conducted in the United States. The results of these studies demonstrated the efficacy and safety of

desloratadine 5 mg in the treatment of adult and adolescent patients with seasonal allergic rhinitis. In a

dose-ranging trial, desloratadine 2.5 to 20 mg/day was studied. Doses of 5, 7.5, 10, and 20 mg/day were

superior to placebo; and no additional benefit was seen at doses above 5.0 mg. In the same study, an

increase in the incidence of somnolence was observed at doses of 10 mg/day and 20 mg/day (5.2% and

7.6%, respectively), compared to placebo (2.3%).

In two 4-week studies of 924 patients (aged 15 to 75 years) with seasonal allergic rhinitis and

concomitant asthma, desloratadine tablets 5 mg once daily improved rhinitis symptoms, with no decrease

in pulmonary function. This supports the safety of administering desloratadine tablets to adult patients

with seasonal allergic rhinitis with mild to moderate asthma.

Desloratadine tablets 5 mg once daily significantly reduced the Total Symptom Score (the sum of

individual scores of nasal and non-nasal symptoms) in patients with seasonal allergic rhinitis. See Table

Table 3: TOTAL SYMPTOM SCORE (TSS) Changes in a 2-Week Clinical Trial in Patients with

Seasonal Allergic Rhinitis

SEM = Standard Error of the Mean

Treatment Group

(n)

Mean Baseline

(SEM)

Change from

Bas eline

(SEM)

Placebo

Comparis on

(P-value)

Des loratadine

5.0 mg (171)

14.2 (0.3)

-4.3 (0.3)

P < 0.01

Placebo (173)

13.7 (0.3)

-2.5 (0.3)

There were no significant differences in the effectiveness of desloratadine tablets 5 mg across

subgroups of patients defined by gender, age, or race.

14.2 Perennial Allergic Rhinitis

The clinical efficacy and safety of desloratadine tablets 5 mg were evaluated in over 1300 patients 12 to

80 years of age with perennial allergic rhinitis. A total of 685 patients received 5 mg/day of

At baseline, a total nasal symptom score (sum of 4 individual symptoms) of at least 6 and a total non-nasal

symptom score (sum of 4 individual symptoms) of at least 5 (each symptom scored 0 to 3 where 0 = no symptom

and 3 = severe symptoms) was required for trial eligibility. TSS ranges from 0 = no symptoms to 24 = maximal

symptoms.

Mean reduction in TSS averaged over the 2-week treatment period.

desloratadine in two double-blind, randomized, placebo-controlled clinical trials of 4 weeks’ duration

conducted in the United States and internationally. In one of these studies desloratadine tablets 5 mg

once daily was shown to significantly reduce the Total Symptom Score in patients with perennial

allergic rhinitis (Table 4).

Table 4: TOTAL SYMPTOM SCORE (TSS) Changes in a 4-Week Clinical Trial in Patients with

Perennial Allergic Rhinitis

SEM = Standard Error of the Mean

Treatment Group

(n)

Mean Baseline

(SEM)

Change from

Bas eline

(SEM)

Placebo

Comparis on

(P-value)

Des loratadine

5.0 mg (337)

12.37 (0.18)

-4.06 (0.21)

P = 0.01

Placebo (337)

12.30 (0.18)

-3.27 (0.21)

14.3 Chronic Idiopathic Urticaria

The efficacy and safety of desloratadine tablets 5 mg once daily was studied in 416 chronic idiopathic

urticaria patients 12 to 84 years of age, of whom 211 received desloratadine. In two double-blind,

placebo-controlled, randomized clinical trials of six weeks duration, at the pre-specified one week

primary time point evaluation, desloratadine tablets significantly reduced the severity of pruritus when

compared to placebo (Table 5). Secondary endpoints were also evaluated, and during the first week of

therapy desloratadine tablets 5 mg reduced the secondary endpoints, “Number of Hives” and the “Size

of the Largest Hive,” when compared to placebo.

Table 5: PRURITUS SYMPTOM SCORE Changes in the First Week of a Clinical Trial in

Patients with Chronic Idiopathic Urticaria

Pruritus scored 0 to 3 where 0 = no symptom to 3 = maximal symptom

SEM = Standard Error of the Mean

Treatment Group

(n)

Mean Baseline (SEM)

Change from Baseline

(SEM)

Placebo Comparison

(P-value)

Desloratadine

5.0 mg (115)

2.19 (0.04)

-1.05 (0.07)

P < 0.01

Placebo (110)

2.21 (0.04)

-0.52 (0.07)

The clinical safety of CLARINEX Oral Solution was documented in three, 15-day, double-blind,

placebo-controlled safety studies in pediatric subjects with a documented history of allergic rhinitis,

chronic idiopathic urticaria, or subjects who were candidates for antihistamine therapy. In the first

study, 2.5 mg of CLARINEX Oral Solution was administered to 60 pediatric subjects 6 to 11 years of

age. The second study evaluated 1.25 mg of CLARINEX Oral Solution administered to 55 pediatric

subjects 2 to 5 years of age. In the third study, 1.25 mg of CLARINEX Oral Solution was administered

to 65 pediatric subjects 12 to 23 months of age and 1.0 mg of CLARINEX Oral Solution was

administered to 66 pediatric subjects 6 to 11 months of age. The results of these studies demonstrated

the safety of CLARINEX Oral Solution in pediatric subjects 6 months to 11 years of age.

At baseline, average of total symptom score (sum of 5 individual nasal symptoms and 3 non-nasal symptoms,

each symptom scored 0 to 3 where 0 = no symptom and 3 = severe symptoms) of at least 10 was required for

trial eligibility. TSS ranges from 0 = no symptoms to 24 = maximal symptoms.

Mean reduction in TSS averaged over the 4 -week treatment period.

Mean reduction in pruritus averaged over the first week of treatment.

16 HOW SUPPLIED/STORAGE AND HANDLING

Desloratadine Tablets, USP are available containing 5 mg of desloratadine, USP.

The 5 mg tablets are red, film-coated, round, unscored tablets debossed with M on one side of the tablet

and D17 on the other side. They are available as follows:

NDC 0378-4017-01

bottles of 100 tablets

NDC 0378-4017-05

bottles of 500 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Heat sensitive. Avoid exposure at or above 30ºC (86ºF).

Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

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

17.1 Information for Patients

Patient Information

Desloratadine Tablets, USP

(des′′ lor a′ ta deen)

Read the Patient Information that comes with desloratadine tablets before you start taking them 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 are desloratadine tablets?

Desloratadine tablets are a prescription medicine that contains the medicine desloratadine (an

antihistamine).

Desloratadine tablets are used to help control the symptoms of:

Who should not take desloratadine tablets?

Patients should be instructed to use desloratadine tablets as directed.

As there are no food effects on bioavailability, patients can be instructed that desloratadine tablets

may be taken without regard to meals.

Patients should be advised not to increase the dose or dosing frequency as studies have not

demonstrated increased effectiveness at higher doses and somnolence may occur.

seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 12

years of age and older.

perennial allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 12

years of age and older.

chronic idiopathic urticaria (long-term itching) and to reduce the number and size of hives in

people 12 years of age and older.

Who should not take desloratadine tablets?

Do not take desloratadine tablets if you:

Talk to your doctor before taking this medicine if you have any questions about whether or not to take

this medicine.

What should I tell my doctor before taking desloratadine tablets?

Before you take desloratadine tablets, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription

medicines, vitamins and herbal supplements. Desloratadine tablets may affect the way other medicines

work, and other medicines may affect how desloratadine tablets work. Especially tell your doctor if you

take:

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

when you get a new medicine.

How should I take desloratadine tablets?

What are the possible side effects of desloratadine tablets?

Desloratadine tablets may cause serious side effects, including:

are allergic to desloratadine or any of the ingredients in desloratadine tablets. See the end of this

leaflet for a complete list of ingredients.

are allergic to loratadine (Alavert

, Claritin ).

have liver or kidney problems.

have any other medical conditions.

are pregnant or plan to become pregnant. It is not known if desloratadine 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. Desloratadine can pass into your breast milk. Talk to

your doctor about the best way to feed your baby if you take desloratadine tablets.

ketoconazole (Nizoral

erythromycin (Ery-tab

, Eryc

, PCE

azithromycin (Zithromax

, Zmax

antihistamines

fluoxetine (Prozac

cimetidine (Tagamet

Take desloratadine tablets exactly as your doctor tells you to take them.

Do not change your dose of desloratadine tablets or take more often than prescribed.

Desloratadine tablets can be taken with or without food.

If you take too many desloratadine tablets, call your doctor or get medical attention right away.

Allergic reactions. Stop taking desloratadine tablets and call your doctor right away or get

emergency help if you have any of these symptoms:

rash

itching

hives

The most common side effects of desloratadine tablets in adults and children 12 years of age and older

with allergic rhinitis include:

Increased sleepiness or tiredness can happen if you take more desloratadine tablets than your doctor

prescribed to you.

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 desloratadine 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 desloratadine tablets?

Keep desloratadine tablets and all medicines out of the reach of children.

General information about desloratadine tablets

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet.

Do not use desloratadine tablets for a condition for which they were not prescribed. Do not give

desloratadine tablets to other people, even if they have the same condition you have. They may harm

them.

This Patient Information leaflet summarizes the most important information about desloratadine tablets. If

you would like more information, talk with your doctor. You can ask your pharmacist or doctor for

information about desloratadine tablets that is written for health professionals.

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in desloratadine tablets?

Active ingredient: desloratadine

Inactive ingredients in desloratadine tablets: colloidal silicon dioxide, FD&C Red No. 40 Aluminum

Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,

pregelatinized starch (corn), sodium lauryl sulfate, talc and titanium dioxide.

The brands listed are registered trademarks of their respective owners.

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Revised: 4/2019

swelling of your lips, tongue, face, and throat

shortness of breath or trouble breathing

sore throat

dry mouth

muscle pain

tiredness

sleepiness

menstrual pain

Store desloratadine tablets at 20° to 25°C (68° to 77°F).

Desloratadine tablets are sensitive to heat. Do not store above 30°C (86°F).

Protect desloratadine tablets from moisture.

DSLD:R7ppt/PL:DSLD:R6p/PL:DSLD:R6pt

PRINCIPAL DISPLAY PANEL - 5 mg

NDC 0378-4017-01

Desloratadine

Tablets, USP

5 mg

Rx only 100 TABLETS

Each film-coated tablet contains:

Desloratadine, USP 5 mg

Dispense in a tight, light-resistant

container as defined in the USP

using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication

out of the reach of children.

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room

Temperature.]

Heat sensitive. Avoid exposure at

or above 30°C (86°F).

Protect from moisture.

Usual Dosage: See accompanying

prescribing information.

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Mylan.com

RM4017A3

DESLORATADINE

desloratadine tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 378 -40 17

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DESLO RATADINE (UNII: FVF8 6 538 8 R) (DESLORATADINE - UNII:FVF8 6 538 8 R)

DESLORATADINE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

M;D17

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 378 -40 17-

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/0 2/20 12

0 6 /30 /20 19

2

NDC:0 378 -40 17-

50 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/0 2/20 12

0 6 /30 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 351

0 7/0 2/20 12

0 6 /30 /20 19

Mylan Pharmaceuticals Inc.

Labeler -

Mylan Pharmaceuticals Inc. (059295980)

Revised: 4/2019