Clarinex

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

• Hypersensitivity reactions. [See WARNINGS AND PRECAUTIONS]

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.

Adults and Adolescents

Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received CLARINEX 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 CLARINEX and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the CLARINEX 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 CLARINEX Tablets (5 mg once daily), and that were more common with CLARINEX 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 CLARINEX Tablets

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in CLARINEX and placebotreated 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 CLARINEX Tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received CLARINEX Tablets and that were more common with CLARINEX than placebo were (rates for CLARINEX 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 CLARINEX 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 CLARINEX 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 CLARINEX 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.

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: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.

CLARINEX®
(CLA-RI-NEX)
(desloratadine) Tablets 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 or CLARINEX Oral Solution. 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 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.
• 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.
• Store CLARINEX Oral Solution between 59°F to 86°F (15°C to 30°C). Protect CLARINEX Oral Solution from light. Keep CLARINEX 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.

For more information, go to www.CLARINEX.com

What are the ingredients in CLARINEX?

Active ingredient: desloratadine

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.

Inactive ingredients in CLARINEX Oral Solution: propylene glycol USP, sorbitol solution USP, citric acid (anhydrous) USP, sodium citrate dihydrate USP, sodium benzoate NF, disodium edetate USP, purified water USP. It also contains granulated sugar, natural and artificial flavor for bubble gum and FDC Yellow #6 dye.

Clarinex may cause serious side effects. See "Drug Precautions" section.

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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Clarinex there are no specific foods that you must exclude from your diet when receiving Clarinex.

Tell your doctor if you are pregnant or if you are planning to become pregnant. It is not known if Clarinex will harm your unborn baby.

• 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 on your tongue and allow it to dissolve before swallowing. Clarinex RediTabs can be taken with or without water. Take your Clarinex RediTabs 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.

If you have taken too much Clarinex seek emergency medical attention or call your local Poison Control Center right away.

• Allergic Cascade
• Allergy (Allergies)
• Allergy Drugs: Prescription and OTC
• Eye Allergy
• Hay Fever (Allergic Rhinitis)
• Hives (Urticaria & Angioedema)

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Desloratadine is usually taken once per day. Follow your doctor's instructions.

Do not crush, chew, or break the regular desloratadine tablet. Swallow the pill whole.

Measure the liquid form of desloratadine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To take desloratadine orally disintegrating tablet (Clarinex RediTabs):

• Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

• Using dry hands, remove the tablet and place it on your tongue. It will begin to dissolve right away.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

• Swallow several times as the tablet dissolves. If desired, you may drink water to help swallow the dissolved tablet.

Store at room temperature away from moisture and heat.

Call your doctor if your symptoms do not improve.

• Importance of adhering to prescribed dosage regimen and directions for use; increase in dosage or dosing frequency not recommended since higher dosages provide no additional benefit but may increase risk of adverse effects (e.g., somnolence).1

• Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.1

• Importance of avoiding concomitant use of fixed-combination preparation with OTC antihistamines and/or decongestants.18

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information. (See Cautions.)

Seasonal Allergic Rhinitis

Clarinex® is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.

Perennial Allergic Rhinitis

Clarinex is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older.

Chronic Idiopathic Urticaria

Clarinex is indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older.

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 Clarinex 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 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 exposures were approximately 290 times the human daily oral dose on a mg/m2 basis). No deaths occurred at oral doses up to 250 mg/kg in monkeys (estimated desloratadine exposures were approximately 810 times the human daily oral dose on a mg/m2 basis).

See FDA-Approved Patient Labeling (Patient Information).

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 and Oral Solution are
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Clarinex Tablets are
Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

Clarinex Oral Solution is
Manufactured by: Bayer Inc.
Pointe Claire, Quebec H9R 1B4, Canada

For patent information: www.merck.com/product/patent/home.html

Copyright © 2004, 2005, 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk4117-mtl-1511r008

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.
• 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.
• Store Clarinex Oral Solution between 59°F to 86°F (15°C to 30°C). Protect Clarinex Oral Solution from light.

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.

For more information, go to www.Clarinex.com

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.

Inactive ingredients in Clarinex Oral Solution: propylene glycol USP, sorbitol solution USP, citric acid (anhydrous) USP, sodium citrate dihydrate USP, sodium benzoate NF, disodium edetate USP, purified water USP. It also contains granulated sugar, natural and artificial flavor for bubble gum and FDC Yellow #6 dye.

Clarinex Tablets and Oral Solution are
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Clarinex Tablets are
Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

Clarinex Oral Solution is
Manufactured by: Bayer Inc.
Pointe Claire, Quebec H9R 1B4, Canada

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 11/2015

usppi-mk4117-mtl-1511r007

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 0085-1264-01
100 Tablets

Clarinex®
(desloratadine)
5 mg TABLETS

Rx only

actual size

PRINCIPAL DISPLAY PANEL - 16 fl oz Bottle Carton

NDC 0085-1334-01
16 fl oz

Clarinex®
ORAL
SOLUTION
(desloratadine)
0.5 mg per 1 mL

Usual Dose: See package insert.
Each teaspoonful (5 mL) contains:
2.5 mg desloratadine.
Read accompanying directions carefully.

Rx only

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Clarinex.

There may be other drugs that can interact with Clarinex. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Desloratadine has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Desloratadine is only recommended for use during pregnancy when benefit outweighs risk.

LactMed Record Number

82

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.