DESLORATADINE  - desloratadine tablet, film coated 
Sun Pharmaceutical Industries Limited

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Desloratadine Tablets

DESCRIPTION


DESLORATADINE

19 19 2 H b
desloratadine-chemical-structure

CLINICAL PHARMACOLOGY

Mechanism of Action:


1 1 vitro.
 
1

Pharmacokinetics:


Absorption max max max

Distribution:

Metabolism

Elimination 14 max

Special Populations:


Geriatric max

Renally Impaired: 2 2 2 max max DOSAGE AND ADMINISTRATION

Hepatically Impaired: max DOSAGE AND ADMINISTRATION

Gender: max max

Race: max max

Drug Interactions: max 0-24 hrs
Table 1 Changes in Desloratadine and 3-Hydroxydesloratadine Pharmacokinetics in Healthy Male and Female Volunteers
  Desloratadine 3-Hydroxydesloratadine
  Cmax AUC 0-24 hrs Cmax AUC 0-24 hrs
Erythromycin
(500 mg Q8h)
+24%
+14%
+43%
+40%
Ketoconazole
(200 mg Q12 h)
+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 Q12 h)
+12%
+19%
-11%
-3%

Pharmacodynamics:


Wheal and Flare:

Effects on QTc : desloratadine c c OVERDOSAGE  c

Clinical Trials:


Seasonal Allergic Rhinitis:





Table 2 TOTAL SYMPTOM SCORE (TSS) Changes in a 2-week Clinical Trial in Patients with Seasonal Allergic Rhinitis
Treatment
Group
(n)
Mean Baseline* (sem) Change from Baseline (sem) Placebo
Comparison
(P- value)
*
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
 
 
 
5 mg (171)
14.2 (0.3)
-4.3 (0.3)
P<0.01
Placebo (173)
13.7 (0.3)
-2.5 (0.3)
 



Perennial Allergic Rhinitis:
Table 3 TOTAL SYMPTOM SCORE (TSS) Changes in a 4 Week Clinical Trial in Patients with Perennial Allergic Rhinitis
Treatment Group
(n)
Mean Baseline* (sem) Change from Baseline (sem) Placebo Comparison
(P- value)
*
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.
Desloratadine
5 mg (337)
 
12.37 (0.18)
 
-4.06 (0.21)
P=0.01
Placebo (337)
12.30 (0.18)
-3.27 (0.21)
 

Chronic Idiopathic Urticaria:
Table-4 PRURITUS SYMPTOM SCORE Changes in the First Week of a Clinical Trial in Patients with Chronic Idiopathic Urticaria
Treatment Group (n) Mean Baseline (sem) Change from Baseline* (sem) Placebo
Comparison
(P-value)
Pruritus scored 0 to 3 where 0=no symptom to 3= maximal symptom.
*
Mean reduction in pruritus averaged over the first week of treatment.
Desloratadine
5 mg (115)
 
2.19 (0.04)
 
-1.05 (0.07)
P<0.01
Placebo (110)
2.21 (0.04)
-0.52 (0.07)
 

INDICATIONS AND USAGE


Seasonal Allergic Rhinitis:
 
Perennial Allergic Rhinitis:
 
Chronic Idiopathic Urticaria

CONTRAINDICATIONS


PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility:






Salmonella/E. coli

Pregnancy Category C:


Nursing Mothers:


Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.

Pediatric Use:


Geriatric Use:


CLINICAL PHARMACOLOGY : Special Populations

Information for Patients:


ADVERSE REACTIONS


Adults and Adolescents

Allergic Rhinitis:
Table 5 Incidence of Adverse Events Reported by 2% or More of Adult and Adolescent Allergic Rhinitis Patients in Placebo-Controlled, Multiple-Dose Clinical Trials with the Tablet Formulation of Desloratadine.
Adverse Experience Desloratadine Tablets 5 mg
(n=1,655)
 
Placebo
(n=1,652)
Pharyngitis
4.1%
2%
Dry Mouth
3%
1.9%
Myalgia
2.1%
1.8%
Fatigue
2.1%
1.2%
Somnolence
2.1%
1.8%
Dysmenorrhea
2.1%
1.6%





Chronic Idiopathic Urticaria:

Observed During Clinical Practice:

DRUG ABUSE AND DEPENDENCE


OVERDOSAGE




c c c



2 2

DOSAGE AND ADMINISTRATION


Adults and Children 12 years of Age and Over:



HOW SUPPLIED









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



Caraco Pharmaceutical Laboratories, Ltd.



Sun Pharmaceutical Industries Ltd.




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 62756-523-88
Desloratadine Tablets
5 mg
Rx only
100 TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
label

DESLORATADINE 
desloratadine   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 62756-523
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESLORATADINE (DESLORATADINE) DESLORATADINE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
MEGLUMINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
SODIUM STEARYL FUMARATE  
HYPROMELLOSE 2910 (15 MPA.S)  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL  
POLYSORBATE 80  
FD&C BLUE NO. 2  
Product Characteristics
Color BLUE Score no score
Shape ROUND (circular) Size 6mm
Flavor Imprint Code 5
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62756-523-83 30 TABLET In 1 BOTTLE None
2 62756-523-88 100 TABLET In 1 BOTTLE None
3 62756-523-08 100 TABLET In 1 BOTTLE None
4 62756-523-18 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078359 11/24/2010

Labeler - Sun Pharmaceutical Industries Limited (650172430)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 MANUFACTURE, ANALYSIS
Revised: 11/2010 Sun Pharmaceutical Industries Limited