Clarinex-D

Clarinex-D is part of the drug class:

• Other antihistamines for systemic use

Clarinex-D may cause serious side effects, including:

• Cardiovascular and central nervous system effects, such as
  • unable to sleep (insomnia)
  • dizziness
  • weakness
  • tremor
  • irregular heart beat
  • seizure
  • low blood pressure
• Increased sleepiness or tiredness can happen if you take more Clarinex-D than your doctor prescribed to you.
• Allergic reactions. Stop taking Clarinex-D 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-D include:

• unable to sleep (insomnia)
• sore throat
• headache
• dizziness
• dry mouth
• nausea
• tiredness
• loss of appetite
• sleepiness
• nervousness
• restlessness

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-D. 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.

Tell your doctor about all the medicines your take, including prescription and non-prescription medicines, vitamins and herbal supplements. Clarinex-D may affect the way other medicines work, and other medicines may affect how Clarinex-D works. Especially tell your doctor if you take:

• Monoamine Oxidase Inhibitors (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), and rasagiline (Azilect). You should not use desloratadine/pseudoephedrine if you take a MAOI or within 2 weeks of stopping an MAOI.

• methyldopa
• reserpine (Serpalan)
• ketoconazole (Nizoral)
• digitalis (Digoxin, Lanoxicaps, Lanoxin) ketoconazole (Nizoral)
• erythromycin (Ery-tab, Eryc, PCE)
• azithromycin (Zithromax, Zmax)
• antihistamines
• other decongestant medicines

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.

Do not take Clarinex-D if you:

• are allergic to desloratadine or pseudoephedrine sulfate or any of the ingredients in Clarinex-D
• are allergic to loratadine (Alavert, Claritin)
• have narrow angle glaucoma
• have problems with urination (urinary retention)
• take a Monoamine Oxidase Inhibitor (MAOI) medicine to treat depression, or if you stopped taking an MAOI medicine within the last 2 weeks. Ask your doctor or pharmacist if you are not sure if you take an MAOI medicine.
• have severe high blood pressure
• have severe heart disease

Talk to your doctor before taking this medicine if you have any of these conditions.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Clarinex-D, there are no specific foods that you must exclude from your diet when receiving this medication.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Clarinex-D (desloratadine/pseudoephedrine) 12 Hour is one tablet 2 times a day (every 12 hours).

The recommended dose of Clarinex-D (desloratadine/pseudoephedrine) 24 Hour is one tablet once daily.

• Store Clarinex-D 12 Hour tablets at 59°F to 86°F (15°C to 30°C).
• Store Clarinex-D 24 Hour tablets at 77°F (25°C).
• Keep Clarinex-D dry and out of the light.

Keep Clarinex-D and all medicines out of the reach of children.

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

Desloratadine and pseudoephedrine combination is not recommended for use in pediatric patients under 12 years of age.

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

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of desloratadine and pseudoephedrine combination in the elderly with use in other age groups, elderly patients are more likely to be sensitive to the effects of this drug.

Pregnancy

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. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

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.

• Guanethidine
• Iobenguane I 123
• Methyldopa
• Midodrine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Diabetes mellitus (sugar diabetes)—The decongestant in this medicine may put diabetic patients at a greater risk of having heart or blood vessel disease.

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Some of the effects of antihistamines may make urinary problems worse.

• Glaucoma—A slight increase in inner eye pressure may occur.

• Heart or blood vessel disease or
• High blood pressure—The decongestant in this medicine may cause blood pressure to increase and may also speed up the heart rate.

• Kidney disease—Higher blood levels of desloratadine may result, which may increase the chance of side effects. If you are taking the 24 hour extended-release tablets, the dosage may need to be reduced. The 12 hour extended-release tablets should generally be avoided if you have kidney disease.

• Liver disease—Higher blood levels of desloratadine may result, which may increase the chance of side effects. This medicine should generally be avoided if you have liver disease.

• Overactive thyroid—If an overactive thyroid has caused a fast heart rate, desloratadine in this medicine may cause the heart rate to speed up further.

• Urinary retention—Condition may be worsened with use of pseudoephedrine

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Not taking over-the-counter antihistamines and decongestants while taking desloratadine and pseudoephedrine combination.

When taking desloratadine and pseudoephedrine extended-release tablet:

• Swallow it whole.
• Do not crush, break, or chew before swallowing.

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 oral dosage form (extended-release tablets [12 hour]):
  • For nasal congestion or rhinorrhea
    • Adults and teenagers—Oral, one tablet (2.5 milligrams desloratadine, 120 milligrams pseudoephedrine) two times a day 12 hours apart, taken with or without a meal
    • Children 4 years of age and older—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 (extended-release tablets [24 hour]):
  • For nasal congestion or rhinorrhea
    • Adults and teenagers—Oral, one tablet (5 milligrams desloratadine, 240 milligrams pseudoephedrine) daily, taken with or without a meal
    • Children 4 years of age and older—Use and dose must be determined by your doctor.
    • 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.

The FDA has not approved use of over-the-counter cough and cold medications to children aged less than 2 years, and proper dosing for children in this age group has not been studied. Clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged less than 2 years. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient.