Clarinex Reditabs (Oral)

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

Antihistamines work by blocking the effects of a substance called histamine, which the body produces. Histamine can cause itching, sneezing, a runny nose, and watery eyes. In some people, histamine can also tighten the bronchial tubes (the air passages in the lungs) and make breathing hard. Additionally, histamine can cause 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.

If your symptoms do not improve within a few days or if they get worse, contact your doctor.

This medicine may make some people feel drowsy, dizzy, or less alert than usual. Be aware of how this medicine affects you before driving, using machines, or doing anything else that could be risky if you are dizzy or not alert.

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, 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 aged 6 months and older. At effective doses, it has not been shown to cause different side effects or problems in children compared to 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 may cause serious or possibly life-threatening side effects.

Geriatric

Desloratadine has been tested in patients aged 65 years and older and has not been shown to cause different side effects or problems in older adults compared to 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 adjust your desloratadine dose if you have kidney or liver problems.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction might occur. If necessary, your doctor may change the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been selected based on their potential significance and may not be a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Abiraterone Acetate
• Pitolisant

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Liver disease or
• Kidney disease—The effects of desloratadine may be stronger due to slower removal from the body.

• Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can worsen your condition.

• Slow metabolizers of desloratadine—May increase the chances of unwanted effects.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

Rare

• Anaphylaxis, which may include cough, trouble swallowing, dizziness, fast heartbeat, hives, itching, swelling or puffiness of eyelids, face, lips, or tongue, shortness of breath, skin rash, tightness in the chest, unusual tiredness or weakness, wheezing
• dyspnea, which may include shortness of breath, difficult or labored breathing, tightness in the chest, wheezing
• edema, which means swelling
• pruritus, which means itching skin
• rash
• tachycardia, which may include fast, pounding, or irregular heartbeat or pulse
• urticaria, which may include hives or welts, itching, skin redness, skin rash.

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to prevent or lessen 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, which means painful or difficult menstruation
• dyspepsia, which may include acid or sour stomach, belching, heartburn, indigestion, stomach discomfort, upset or pain
• fatigue, which means unusual tiredness or weakness
• myalgia, which may include joint pain, swollen joints, muscle aching or cramping, muscle pains or stiffness, difficulty in moving
• pharyngitis, which may include body aches, congestion, cough, dryness or soreness of throat, fever, hoarseness, runny nose, swollen glands in the neck, trouble swallowing, voice changes
• somnolence, which means 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Clarinex
• Clarinex Reditabs

Available Dosage Forms:

• Tablet, Disintegrating
• Tablet

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Piperidine

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.

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