Clarinex

DRUG DESCRIPTION

CLARINEX (desloratadine) Tablets are light blue, round, film coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. It also contains the following excipients: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn starch N F, talc USP, carnauba wax N F, white wax NF, coating material consisting of lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol, and FD&C Blue #2 Aluminum Lake.

CLARINEX (desloratadine) Syrup is a clear orange colored liquid containing 0.5 mg/1 mL desloratadine. The syrup contains the following inactive ingredients: propylene glycol USP, sorbitol solution USP, citric acid (anhydrous) USP, sodium citrate dihydrate USP, sodium benzoate N F, disodium edetate USP, purified water USP. It also contains granulated sugar, natural and artificial flavor for bubble gum and FDC Yellow #6 dye.

The CLARINEX RediTabs® brand of desloratadine orally-disintegrating tablets are light red, flat-faced, round, speckled tablets with an “A” debossed on one side for the 5 mg tablets and a “K” debossed on one side for the 2.5 mg tablets. Each RediTabs Tablet contains either 5 mg or 2.5 mg of desloratadine. It also contains the following inactive ingredients: mannitol USP, microcrystalline cellulose N F, pregelatinized starch, N F, sodium starch glycolate, N F, magnesium stearate N F, butylated methacrylate copolymer, crospovidone, NF, aspartame N F, citric acid USP, sodium bicarbonate USP, colloidal silicon dioxide, N F, ferric oxide red NF and tutti frutti flavoring.

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:

CLARINEX®
  (desloratadine) Structural Formula Illustration

What are the possible side effects of desloratadine (Clarinex, Clarinex Reditabs)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • fever, flu symptoms;
  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dry mouth, sore throat, cough;
  • ...

Read All Potential Side Effects and See Pictures of Clarinex »

What are the precautions when taking desloratadine (Clarinex)?

Before taking desloratadine, tell your doctor or pharmacist if you are allergic to it; or to loratadine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Limit alcohol intake, as it may intensify drug side effects.

Desloratadine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Clarinex »


Clarinex Consumer (continued)

SIDE EFFECTS: Throat discomfort, muscle pain, nausea, indigestion, loss of appetite, diarrhea, dizziness, fatigue, trouble sleeping, nosebleeds, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Desloratadine does not usually cause drowsiness when used at recommended doses and under normal circumstances. However, be sure of the drug's effects before engaging in activities that require alertness such as driving or using machinery.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this unlikely but serious side effect occurs: rapid or pounding heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occurs: dark urine, yellowing eyes or skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking desloratadine, tell your doctor or pharmacist if you are allergic to it; or to loratadine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Limit alcohol intake, as it may intensify drug side effects.

Desloratadine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.


Clarinex Patient Information Including Side Effects

Brand Names: Clarinex, Clarinex Reditabs

Generic Name: desloratadine (Pronunciation: DES lor A ta deen)

  • What is desloratadine (Clarinex)?
  • What are the possible side effects of desloratadine (Clarinex)?
  • What is the most important information I should know about desloratadine (Clarinex)?
  • What should I discuss with my healthcare provider before taking desloratadine (Clarinex)?
  • How should I take desloratadine (Clarinex)?
  • What happens if I miss a dose (Clarinex)?
  • What happens if I overdose (Clarinex)?
  • What should I avoid while taking desloratadine (Clarinex)?
  • What other drugs will affect desloratadine (Clarinex)?
  • Where can I get more information?

What is desloratadine (Clarinex)?

Desloratadine is an antihistamine that reduces 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 other purposes not listed in this medication guide.

What are the possible side effects of desloratadine (Clarinex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • fever, flu symptoms;
  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dry mouth, sore throat, cough;
  • muscle pain;
  • drowsiness, tired feeling;
  • nausea, diarrhea; or
  • headache;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about desloratadine (Clarinex)?

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).

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