Clarinex (Page 5 of 5)

14.3 Chronic Idiopathic Urticaria

The efficacy and safety of CLARINEX Tablets 5 mg once daily was studied in 416 chronic idiopathic urticaria patients 12 to 84 years of age, of whom 211 received CLARINEX. In two double-blind, placebo-controlled, randomized clinical trials of six weeks duration, at the pre-specified one-week primary time point evaluation, CLARINEX 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 CLARINEX 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
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
SEM=Standard Error of the Mean
*
Mean reduction in pruritus averaged over the first week of treatment.
CLARINEX 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

CLARINEX Tablets: Embossed “C5”, light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 78206-119-01).

Storage

  • CLARINEX Tablets: Protect Unit-of-Use packaging and Unit-Dose Hospital Pack from excessive moisture. 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).

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 CLARINEX as directed.
  • As there are no food effects on bioavailability, patients can be instructed that CLARINEX Tablets, Oral Solution, or RediTabs 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.
  • Phenylketonurics: CLARINEX RediTabs Tablets contain phenylalanine.

CLARINEX Tablets are
Manufactured for: Organon LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

Copyright © 2021 Organon Global Inc.
All rights reserved.

uspi-og4117-mtl-2106r000

PATIENT INFORMATION

CLARINEX® (CLA-RI-NEX) (desloratadine) Tablets, RediTabs® , and Oral Solution

Read the Patient Information that comes with CLARINEX® 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?

CLARINEX is a prescription medicine that contains the medicine desloratadine (an antihistamine).

CLARINEX is used to help control the symptoms of:

  • seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 2 years of age and older.
  • perennial allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 6 months of age and older.
  • chronic idiopathic urticaria (long-term itching) and to reduce the number and size of hives in people 6 months of age and older.

CLARINEX is not for children younger than 6 months of age.

Who should not take CLARINEX?

Do not take CLARINEX if you:

  • are allergic to desloratadine or any of the ingredients in CLARINEX Tablets, CLARINEX RediTabs® or CLARINEX Oral Solution. See the end of this leaflet for a complete list of ingredients for the CLARINEX Tablets.
  • 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 CLARINEX?

Before you take CLARINEX, 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 CLARINEX will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. CLARINEX can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take CLARINEX.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. CLARINEX may affect the way other medicines work, and other medicines may affect how CLARINEX 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 CLARINEX?

  • Take CLARINEX exactly as your doctor tells you to take it.
  • Do not change your dose of CLARINEX or take more often than prescribed.
  • CLARINEX can be taken with or without food.
  • Place CLARINEX RediTabs Tablet on your tongue and allow it to dissolve before swallowing. CLARINEX RediTabs can be taken with or without water. Take your CLARINEX RediTabs Tablet right away after opening the blister.
  • Take CLARINEX Oral Solution with a measuring dropper or oral syringe that can measure 2 mL or 2.5 mL. Ask your pharmacist for a dropper or syringe if you do not have one.
  • If you take too much CLARINEX, call your doctor or get medical attention right away.

What are the possible side effects of CLARINEX Tablets?

CLARINEX may cause serious side effects, including:

  • Allergic reactions. Stop taking CLARINEX 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 CLARINEX 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 CLARINEX 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 CLARINEX. 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?

  • Store CLARINEX Tablets between 59°F to 86°F (15°C to 30°C).
  • CLARINEX Tablets are sensitive to heat. Do not store above 86°F (30°C).
  • Protect CLARINEX Tablets from moisture.

Keep CLARINEX Tablets, RediTabs Tablets , and Oral Solution and all medicines out of the reach of children.

General information about CLARINEX

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use CLARINEX for a condition for which it was not prescribed. Do not give CLARINEX 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. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLARINEX that is written for health professionals.

What are the ingredients in CLARINEX?

Active ingredient: desloratadine

Patients with Phenylketonuria: CLARINEX RediTabs Tablets contain phenylalanine.

Inactive ingredients in CLARINEX Tablets: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn starch NF, talc USP, carnauba wax NF, white wax NF, coating material consisting of lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol, and FD&C Blue #2 Aluminum Lake.

CLARINEX Tablets are
Manufactured for: Organon LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

The trademarks depicted herein are owned by their respective companies.

Copyright © 2021 Organon Global Inc.
All rights reserved.

Revised: 6/2021

usppi-og4117-mtl-2106r000

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label

NDC 78206-119-01
100 Tablets

CLARINEX ®
(desloratadine)5 mg TABLETS

Rx only

actual size ®

PRINCIPAL DISPLAY PANEL -- 100 Tablet Bottle Label
(click image for full-size original)
CLARINEX desloratadine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-119
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TALC
CARNAUBA WAX
WHITE WAX
LACTOSE MONOHYDRATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FD&C Blue No. 2
ALUMINUM OXIDE
Product Characteristics
Color BLUE (LIGHT BLUE) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code C5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-119-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021165 06/01/2021
Labeler — Organon LLC (117494753)

Revised: 06/2021 Organon LLC

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