Drug Detail:Clarinex (Desloratadine [ des-lor-a-ta-deen ])
Drug Class: Antihistamines
Highlights of Prescribing Information
CLARINEX® (desloratadine) Tablets, RediTabs®, and Oral Solution for oral use
Initial U.S. Approval: 2001
Indications and Usage for Clarinex
CLARINEX is a histamine-1 (H1) receptor antagonist indicated for:
- Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. (1.1)
- Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months 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 6 months of age and older. (1.3)
Clarinex Dosage and Administration
Dosage (by age):
Adults and Adolescents 12 Years of Age and Over:
- CLARINEX Tablets - one 5 mg tablet once daily or
- CLARINEX RediTabs Tablets - one 5 mg tablet once daily or
- CLARINEX Oral Solution - 2 teaspoonfuls (5 mg in 10 mL) once daily (2)
Children 6 to 11 Years of Age:
- CLARINEX Oral Solution - 1 teaspoonful (2.5 mg in 5 mL) once daily or
- CLARINEX RediTabs Tablets - one 2.5 mg tablet once daily (2)
Children 12 Months to 5 Years of Age:
- CLARINEX Oral Solution - ½ teaspoonful (1.25 mg in 2.5 mL) once daily (2)
Children 6 to 11 Months of Age:
- CLARINEX Oral Solution - 2 mL (1 mg) once daily (2)
Dosage Forms and Strengths
- CLARINEX Tablets - 5 mg (3)
Contraindications
- Hypersensitivity (4, 6.2)
Warnings and Precautions
- Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported. In such cases, stop CLARINEX at once and consider alternative treatments. (5.1)
Adverse Reactions/Side Effects
- 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)
To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use In Specific Populations
- Renal impairment: dosage adjustment is recommended (2.5, 8.6, 12.3)
- Hepatic impairment: dosage adjustment is recommended (2.5, 8.7, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2022
Related/similar drugs
prednisone, fluticasone nasal, cetirizine, loratadine, Benadryl, promethazine, ZyrtecFull Prescribing Information
1. Indications and Usage for Clarinex
1.1 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.
2. Clarinex Dosage and Administration
Although the oral solution and the orally disintegrating tablet formulation of desloratadine may be available in the marketplace, CLARINEX® Oral Solution and CLARINEX® RediTabs® Tablets are no longer marketed.
CLARINEX Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place CLARINEX (desloratadine) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.
The age-appropriate dose of CLARINEX Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon).
2.1 Adults and Adolescents 12 Years of Age and Over
The recommended dose of CLARINEX Tablets or CLARINEX RediTabs Tablets is one 5-mg tablet once daily. The recommended dose of CLARINEX Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.
2.2 Children 6 to 11 Years of Age
The recommended dose of CLARINEX Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. The recommended dose of CLARINEX RediTabs Tablets is one 2.5-mg tablet once daily.
2.3 Children 12 Months to 5 Years of Age
The recommended dose of CLARINEX Oral Solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.
2.4 Children 6 to 11 Months of Age
The recommended dose of CLARINEX Oral Solution is 2 mL (1 mg) 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
CLARINEX Tablets are supplied as:
- Light blue, film-coated tablets embossed with “C5” containing 5 mg desloratadine.
- Light blue, film-coated tablets embossed with an elongated letters “S” and “P” on one side and plain on the other, containing 5 mg desloratadine.
4. Contraindications
CLARINEX Tablets, RediTabs, and Oral Solution 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 CLARINEX should be stopped and alternative treatment should be considered. [See Adverse Reactions (6.2).]
6. Adverse Reactions/Side Effects
The following adverse reactions are discussed in greater detail in other sections of the label:
- Hypersensitivity reactions. [See Warnings and Precautions (5.1).]
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.
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.
Adverse Event | CLARINEX 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 CLARINEX and placebo-treated patients.
There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.
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 H2-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
8.4 Pediatric Use
The recommended dose of CLARINEX Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of CLARINEX 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 CLARINEX 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 CLARINEX Tablets in adults. The safety and effectiveness of CLARINEX 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).]
9. Drug Abuse and Dependence
There is no information to indicate that abuse or dependency occurs with CLARINEX 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 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)].
11. Clarinex Description
CLARINEX (desloratadine) Tablets are light blue, round, film-coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. CLARINEX Tablets also contain the following excipients: 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.
Desloratadine is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure:
12. Clarinex - Clinical Pharmacology
12.1 Mechanism of Action
Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-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 H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro. Results of a radiolabeled tissue distribution study in rats and a radioligand H1-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.
Special Populations
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 coadministered 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 (Cmax and AUC0-24 hrs) 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 tests, vital signs, and adverse events.
Desloratadine | 3-Hydroxydesloratadine | |||
---|---|---|---|---|
Cmax | AUC0-24 hrs | Cmax | AUC0-24 hrs | |
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% |
14. Clinical Studies
14.1 Seasonal Allergic Rhinitis
The clinical efficacy and safety of CLARINEX 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 CLARINEX 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 CLARINEX 5 mg in the treatment of adult and adolescent patients with seasonal allergic rhinitis. In a dose-ranging trial, CLARINEX 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, CLARINEX Tablets 5 mg once daily improved rhinitis symptoms, with no decrease in pulmonary function. This supports the safety of administering CLARINEX Tablets to adult patients with seasonal allergic rhinitis with mild to moderate asthma.
CLARINEX 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.
Treatment Group (n) | Mean Baseline*
(SEM) | Change from Baseline†
(SEM) | Placebo Comparison (P-value) |
---|---|---|---|
SEM=Standard Error of the Mean | |||
|
|||
CLARINEX
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 CLARINEX Tablets 5 mg across subgroups of patients defined by gender, age, or race.
14.2 Perennial Allergic Rhinitis
The clinical efficacy and safety of CLARINEX 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 CLARINEX 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 CLARINEX Tablets 5 mg once daily was shown to significantly reduce the Total Symptom Score in patients with perennial allergic rhinitis (Table 4).
Treatment Group (n) | Mean Baseline*
(SEM) | Change from Baseline†
(SEM) | Placebo Comparison (P-value) |
---|---|---|---|
SEM=Standard Error of the Mean | |||
|
|||
CLARINEX
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 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.
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 | |||
|
|||
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 is Clarinex supplied
CLARINEX Tablets:
- Embossed “C5”, light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 78206-119-01).
- Embossed with elongated letters “S” and “P”, light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 78206-188-01).
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.
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
desloratadine tablet, film coated |
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CLARINEX
desloratadine tablet, film coated |
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Labeler - Organon LLC (117494753) |