DESLORATADINE: Package Insert and Label Information (Page 3 of 3)

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 tablets, 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 3.

Table 3 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 )
Desloratadine Tablets 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)
SEM=Standard Error of the Mean *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.

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 desloratadine tablets 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 4TOTAL 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 )
Desloratadine Tablets 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)
SEM=Standard Error of the Mean *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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Desloratadine tablets USP, 5 mg are light blue, circular, biconvex, film-coated tablets, debossed “LU” on one side and “S71” on other side. They are supplied as follows:

NDC 68180-153-06 Bottles of 30

NDC 68180-153-01 Bottles of 100

NDC 68180-153-02 Bottles of 500

NDC 68180-153-03 Bottles of 1000

NDC 68180-153-12 3×10’s unit dose blisters

NDC 68180-153-13 10×10’s unit dose blisters

Storage:

Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

Heat Sensitive.

Avoid exposure at or above 30°C (86°F).

Dispense in 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

  • 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.

The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa 403 722

INDIA

Revised: February 2020 ID#: 263035

PATIENT INFORMATION LEAFLET

DESLORATADINE (DES-lor-A-ta-deen)

TABLETS USP

Rx only

Read the Patient Information that comes with desloratadine 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 are desloratadine tablets?

Desloratadine tablets are prescription medicine that contains the medicine desloratadine (an antihistamine).

Desloratadine tablets are used to help control the symptoms of:

  • 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.

Desloratadine tablets are not for children younger than 12 years of age.

Who should not take desloratadine tablets?

Do not take desloratadine tablets if you:

  • 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).

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:

  • have liver or kidney problems.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if desloratadine tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. Desloratadine can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take desloratadine tablets.

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 works. Especially tell your doctor if you take:

  • ketoconazole (Nizoral)
  • erythromycin (Ery-tab, Eryc, PCE)
  • azithromycin (Zithromax, Zmax)
  • antihistamines
  • fluoxetine (Prozac)
  • cimetidine (Tagamet)

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?

  • Take desloratadine tablets exactly as your doctor tells you to take it.
  • 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 much desloratadine tablets, call your doctor or get medical attention right away.

What are the possible side effects of desloratadine tablets?

Desloratadine tablets may cause serious side effects, including:

• 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
  • swelling of your lips, tongue, face, and throat
  • shortness of breath or trouble breathing

The most common side effects of desloratadine tablets in adults and children 12 years of age and older with allergic rhinitis include:

  • sore throat
  • dry mouth
  • muscle pain
  • tiredness
  • sleepiness
  • menstrual pain

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 Lupin Pharmaceuticals, Inc at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

How should I store desloratadine tablets?

• Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F).

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

• Protect desloratadine tablets from moisture.

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 it was not prescribed. Do not give desloratadine 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 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.

What are the ingredients in desloratadine tablets?

Active ingredient: desloratadine

Inactive ingredients in desloratadine tablets: anhydrous lactose, colloidal silicon dioxide, FD&C Blue#2/Indigo Carmine Aluminium Lake, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, pregelatinised starch and titanium dioxide.

The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa 403 722

INDIA

Revised: December 2019 ID#: 263068

Desloratadine Tablets

Rx Only

5 mg

NDC 68180-153-11

BLISTER FOIL LABEL

10 TABLETS SINGLE UNIT PACKAGE

Img-1
(click image for full-size original)

Desloratadine Tablets

Rx Only

5 mg

NDC 68180-153-01

BOTTLE LABEL

100 TABLETS

Img-2
(click image for full-size original)

Desloratadine Tablets

Rx Only

5 mg

NDC 68180-153-12

CARTON LABEL

30 (3 x 10) UNIT DOSE TABLETS

Img-3
(click image for full-size original)
DESLORATADINE desloratadine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-153
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESLORATADINE (DESLORATADINE) DESLORATADINE 5 mg
Product Characteristics
Color BLUE (light blue) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code LU;S71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-153-02 500 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68180-153-06 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68180-153-03 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68180-153-12 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68180-153-11)
4 NDC:68180-153-11 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68180-153-12)
5 NDC:68180-153-01 100 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:68180-153-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68180-153-11)
6 NDC:68180-153-11 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (68180-153-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078352 02/25/2013
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (68180-153), PACK (68180-153)

Revised: 02/2020 Lupin Pharmaceuticals, Inc.

Page 3 of 3 1 2 3

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.