Desloratadine (oral route)

Brand Name

US Brand Name

Clarinex

Clarinex Reditabs

Description

Desloratadine is an antihistamine. It is used to relieve the symptoms of hay fever and hives of the skin.

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some persons histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some persons to have hives, with severe itching of the skin.

This medicine is available only with your doctor's prescription.

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 .

This product is available in the following dosage forms:

Tablet, Disintegrating
Tablet

Before Using

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.

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.

Breastfeeding

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.

Drug Interactions

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acetate
Abiraterone Acetate, Micronized
Carbamazepine
Clopidogrel
Gemfibrozil
Pitolisant

Other Interactions

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.

Proper Use

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.

Precautions

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Anaphylaxis, such as, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of eyelids or around the eyes or face or lips or tongue, shortness of breath, skin rash, tightness in chest, unusual tiredness or weakness, wheezing
dyspnea, such as, shortness of breath, difficult or labored breathing, tightness in chest, wheezing
edema, such as, swelling
pruritus, such as, itching skin
rash
tachycardia, such as, fast, pounding, or irregular heartbeat or pulse
urticaria, such as, hives or welts, itching, redness of skin, skin rash.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Less common

Dizziness
dry mouth
dysmenorrhea, such as, difficult or painful menstruation
dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, stomach discomfort , upset or pain,
fatigue, such as, unusual tiredness or weakness
myalgia, such as, joint pain, swollen joints, muscle aching or cramping, muscle pains or stiffness, difficulty in moving
pharyngitis, such as, body aches or pain, congestion, cough, dryness or soreness of throat, fever, hoarseness, runny nose, tender swollen glands in neck, trouble in swallowing, voice changes.
somnolence, such as, sleepiness or unusual drowsiness
nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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