Clarinex

Name: Clarinex

What Is Desloratadine?

Desloratadine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Desloratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.

Desloratadine may also be used for purposes not listed in this medication guide.

You should not take this medication if you are allergic to desloratadine or to loratadine (Claritin).

Before taking desloratadine, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not give this medication to a child younger than 2 years old without the advice of a doctor.

Desloratadine disintegrating tablets (Clarinex RediTabs) may contain phenylalanine. Talk to your doctor before using this form of desloratadine if you have phenylketonuria (PKU).

You should not take this medication if you are allergic to desloratadine or to loratadine (Claritin).

To make sure you can safely take desloratadine, tell your doctor if you have any of these other conditions:

  • kidney disease; or
  • liver disease.

FDA pregnancy category C. It is not known whether desloratadine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Desloratadine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 18 years old without the advice of a doctor.

Desloratadine disintegrating tablets (Clarinex RediTabs) may contain phenylalanine. Talk to your doctor before using this form of desloratadine if you have phenylketonuria (PKU).

Do not give this medication to a child younger than 2 years old without the advice of a doctor.

Uses of Clarinex

Clarinex is a prescription medicine used to treat 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.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Manufacturer

  • Merck Sharp & Dohme Corp.

Clarinex Dosage

Take Clarinex exactly as your doctor prescribes it. Follow the directions on your prescription bottle carefully.

In adults and adolescents 12 years of age and older, the recommended dose of Clarinex is 5 mg once daily. Your doctor will probably lower the dose if you have liver or kidney problems. The recommended dose of Clarinex  in children 6 to 11 years of age is 2.5 mg once daily. The recommended dose of Clarinex in children 12 months to 5 years of age is 1.25 mg once daily. For children 6 to 11 months of age, the recommended dose is 1 mg daily.

What is desloratadine (clarinex, clarinex reditabs)?

Desloratadine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Desloratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.

Desloratadine may also be used for purposes not listed in this medication guide.

What happens if i miss a dose (clarinex, clarinex reditabs)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Uses for Clarinex

Allergic Rhinitis

Symptomatic relief of nasal and nonnasal symptoms of perennial allergic rhinitis.1

Symptomatic relief (alone or in fixed combination with pseudoephedrine sulfate) of nasal and nonnasal symptoms of seasonal (e.g., hay fever) allergic rhinitis.1 9 18 19 Use fixed-combination preparation only when both antihistamine and nasal decongestant activity are desired.18

Improves nasal and nonnasal symptoms in patients with seasonal allergic rhinitis and concomitant mild to moderate asthma without impairing pulmonary function.1 2 6 9

Chronic Idiopathic Urticaria

Symptomatic treatment of pruritus and urticaria associated with chronic idiopathic urticaria.1

Cautions for Clarinex

Contraindications

  • Known hypersensitivity to desloratadine, loratadine, or any ingredient in the formulation.1

Warnings/Precautions

General Precautions

Shares the toxic potentials of loratadine and other second generation antihistamines; observe usual precautions related to therapy with such drugs.1

Use of Fixed Combination

When using fixed-combination preparation containing pseudoephedrine sulfate, consider the cautions, precautions, and contraindications associated with pseudoephedrine.18

Phenylketonuria

Clarinex RediTabs contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 1.4 or 2.9 mg of phenylalanine per 2.5- or 5-mg tablet, respectively.1

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk.1 18 Discontinue nursing or the drug.1 18 Caution if fixed-combination preparation is used in nursing women.18

Pediatric Use

Safety and efficacy not established for seasonal allergic rhinitis in children <2 years of age.1

Safety and efficacy not established for perennial allergic rhinitis or chronic idiopathic urticaria in children <6 months of age.1

Safety and efficacy of fixed combination for seasonal allergic rhinitis not established in children <12 years of age.18

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.22 23 Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1 18 Select dosage with caution.1 18 (See Elimination: Special Populations, under Pharmacokinetics.)

Hepatic Impairment

Conventional tablets, oral solution, or orally disintegrating tablets: Dosage reduction recommended.1 (See Hepatic Impairment under Dosage and Administration and also see Elimination: Special Populations, under Pharmacokinetics.)

Fixed-combination desloratadine/pseudoephedrine sulfate preparation: Use not recommended.18

Renal Impairment

Conventional tablets, oral solution, or orally disintegrating tablets: Dosage reduction recommended.1 (See Renal Impairment under Dosage and Administration and also see Absorption: Special Populations, under Pharmacokinetics.)

Fixed-combination desloratadine/pseudoephedrine sulfate preparation: Dosage reduction recommended.18 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Children 6–11 months of age receiving oral solution: Upper respiratory tract infection, diarrhea, fever, irritability, coughing, somnolence, bronchitis, otitis media, vomiting.1

Children 12–23 months of age receiving oral solution: Fever, diarrhea, upper respiratory tract infection, coughing.1

Children 2–5 years of age receiving oral solution: Fever.1

Adults and children ≥12 years of age receiving conventional or orally disintegrating tablets for management of allergic rhinitis: Pharyngitis,1 3 4 9 dry mouth.1 3 4 9

Adults and children ≥12 years of age receiving conventional or orally disintegrating tablets for management of chronic idiopathic urticaria: Headache,1 7 9 nausea,1 fatigue.1 7

Fixed-combination desloratadine/pseudoephedrine sulfate preparation: Dry mouth, headache, insomnia.18

Clarinex Pharmacokinetics

Absorption

Bioavailability

Conventional tablets and oral solution are bioequivalent.1 Reformulated orally disintegrating tablets are bioequivalent to the original orally disintegrating formulation (no longer commercially available);1 original formulation previously shown to be bioequivalent to conventional tablets and oral solution.20

Peak plasma concentrations occur at approximately 3 or 6–7 hours following administration of conventional tablets or fixed-combination extended-release preparation, respectively.1 18

Onset

Following single- and multiple-dose administration, antihistaminic effects occur within 1 hour.1 Symptomatic (nasal and nonnasal) improvement observed as early as 1 day after initiation of therapy.2 4 5 6 9

Duration

Following single- and multiple-dose administration, antihistaminic effects persist for up to 24 hours.1 No evidence of histamine-induced skin wheal tachyphylaxis over 28-day treatment period.1

Food

Food or grapefruit juice does not appear to affect bioavailability following administration as conventional tablets, oral solution,1 or fixed-combination tablets;18 water does not appear to affect bioavailability following administration as orally disintegrating tablets.1

Special Populations

In patients with renal impairment and those who require hemodialysis, peak plasma desloratadine concentrations and AUC are increased.1

Distribution

Plasma Protein Binding

Approximately 82–87% (for desloratadine) and 85–89% (for 3-hydroxydesloratadine).1

Special Populations

Protein binding not altered in patients with renal impairment.1

Elimination

Metabolism

Extensively metabolized to 3-hydroxydesloratadine (active metabolite), which subsequently undergoes glucuronidation; enzyme(s) responsible for metabolism of desloratadine not identified.1

Elimination Route

Approximately 87% excreted as metabolic products in urine and feces in equal proportions.1

Desloratadine and 3-hydroxydesloratadine are poorly removed by hemodialysis.1

Half-life

27 hours for desloratadine and 3-hydroxydesloratadine.1

Special Populations

Approximately 6% of patients are poor metabolizers (decreased ability to form 3-hydroxydesloratadine); higher frequency of poor metabolizers in blacks (17%) than in Caucasians (2%) or Hispanics (2%).1 18 Substantially (approximately 6-fold) greater drug exposure in poor metabolizers than in normal metabolizers;1 however, no overall differences in safety observed between these groups.1 18 Nevertheless, an increased risk of adverse effects in poor metabolizers cannot be ruled out.1 18

In patients ≥65 years of age, plasma desloratadine concentrations are increased and elimination half-life is prolonged.1

In patients with hepatic impairment, AUC and elimination half-life are increased and clearance is decreased.1

Before Using Clarinex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children 6 months of age and older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Desloratadine has been tested in patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older patients are more likely to have kidney or liver problems which may make them more sensitive to the effects of desloratadine. Your doctor may give you a different desloratadine dose if you have kidney or liver problems.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Liver disease or
  • Kidney disease—Effects of desloratadine may be increased because of slower removal from the body.
  • Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.
  • Slow metabolizers of desloratadine—May increase chances of unwanted effects

Proper Use of desloratadine

This section provides information on the proper use of a number of products that contain desloratadine. It may not be specific to Clarinex. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For patients using the oral disintegrating tablet form of this medicine:

  • Make sure your hands are dry.
  • Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
  • Immediately place the tablet on top of the tongue.
  • The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

For patients using the syrup form of this medicine: Use a calibrated measuring dropper or syringe to measure the direct dose for your child based on your doctor's instructions. Do not use a regular teaspoon. If you are unsure about how much of the syrup to give to your child, ask your doctor or pharmacist.

  • For oral dosage form (oral disintegrating tablets):
    • For symptoms of chronic hives:
      • Adults and children 12 years of age and older—5 milligrams (mg) once a day.
      • Children 6 to 11 years of age—2.5 mg once a day.
      • Children 4 to 6 years of age—Use and dose must be determined by your doctor.
      • Children and infants up to 4 years of age—Use is not recommended .
    • For symptoms of hay fever:
      • Adults and children 12 years of age and older—5 mg once a day.
      • Children 6 to 11 years of age—2.5 mg once a day.
      • Children 4 to 6 years of age—Use and dose must be determined by your doctor.
      • Children and infants up to 4 years of age—Use is not recommended .
  • For oral dosage form (tablets):
    • For symptoms of chronic hives:
      • Adults and children 12 years of age and older—5 mg once a day.
      • Children 4 to 12 years of age—Use and dose must be determined by your doctor.
      • Children and infants up to 4 years of age—Use is not recommended .
    • For symptoms of hay fever:
      • Adults and children 12 years of age and older—5 mg once a day.
      • Children 4 to 12 years of age—Use and dose must be determined by your doctor.
      • Children and infants up to 4 years of age—Use is not recommended .
  • For oral dosage form (syrup):
    • For symptoms of chronic hives:
      • Adults and children 12 years of age and older—2 teaspoonfuls (5 milligrams [mg] in 10 milliliters [mL]) once a day.
      • Children 6 to 11 years of age—1 teaspoonful (2.5 mg in 5 mL) once a day
      • Children 4 to 5 years of age—½ teaspoonful (1.25 mg in 2.5 mL) once a day
      • Children and infants up to 4 years of age—Use is not recommended .
    • For symptoms of hay fever:
      • Adults and children 12 years of age and older—2 teaspoonfuls (5 milligrams [mg] in 10 milliliters [mL]) once a day.
      • Children 6 to 11 years of age—1 teaspoonful (2.5 mg in 5 mL) once a day
      • Children 4 to 5 years of age—½ teaspoonful (1.25 mg in 2.5 mL) once a day
      • Children and infants up to 4 years of age—Use is not recommended .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Important information

You should not take Clarinex if you are allergic to desloratadine or to loratadine (Claritin).

Before taking Clarinex, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not give this medication to a child younger than 2 years old without the advice of a doctor.

Desloratadine disintegrating tablets (Clarinex RediTabs) may contain phenylalanine. Talk to your doctor before using this form of desloratadine if you have phenylketonuria (PKU).

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