Desloratadine & Pseudoephedrine

Desloratadine/pseudoephedrine is a prescription medication used to treat the symptoms of seasonal allergies (sneezing, itching, runny nose, and watery eyes) and nasal congestion. 

Desloratadine/pseudoephedrine is a single tablet that contains 2 medications, desloratadine and pseudoephedrine. Desloratadine is an antihistamine that inhibits histamine release from human mast cells to help relieve sneezing, itching, runny nose, and watery eyes. Pseudoephedrine is a decongestant that shrinks the blood vessels in the nose which results in reduced swelling and mucus formation in the nasal passages to help relieve nasal congestion (stuffy nose).

• Desloratadine/pseudoephedrine 12 Hour is taken two times a day.
• Desloratadine/pseudoephedrine 24 Hour once daily.

Desloratadine/pseudoephedrine is a prescription medicine used to treat the symptoms of seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in patients 12 years and older. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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

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

The recommended dose of desloratadine/pseudoephedrine 24 Hour is one tablet once daily.

Do not take desloratadine/pseudoephedrine if you:

• are allergic to desloratadine or pseudoephedrine sulfate or any of the ingredients in desloratadine/pseudoephedrine
• 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.

Desloratadine/pseudoephedrine 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 desloratadine/pseudoephedrine than your doctor prescribed to you.
• Allergic reactions. Stop taking desloratadine/pseudoephedrine 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 desloratadine/pseudoephedrine 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 desloratadine/pseudoephedrine. 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. Desloratadine/pseudoephedrine may affect the way other medicines work, and other medicines may affect how desloratadine/pseudoephedrine extended release tablets work. 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Desloratadine/pseudoephedrine falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Desloratadine/pseudoephedrine should be given to a pregnant woman only if clearly needed.

It is not known if desloratadine/pseudoephedrine will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed. Desloratadine/pseudoephedrine can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take desloratadine/pseudoephedrine.

Desloratadine/pseudoephedrine can cause you to have trouble falling asleep.

Desloratadine/pseudoephedrine can cause problems if you have high blood pressure. Ask your doctor before you start taking desloratadine/pseudoephedrine.