Desloratadine/pseudoephedrine

What is Desloratadine/pseudoephedrine?

• Desloratadine/pseudoephedrine (clarinex-D; clarinex-D 12 Hour; clarinex-D 24 hour) is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist, used to help control the symptoms of seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in adults and children 12 years and older.

Desloratadine

Desloratadine 3D ball-and-stick

Pseudoephedrine Structure

Pseudoephedrine model

Pseudoephedrine-3d-CPK

What are the uses of this medicine?

• Desloratadine/pseudoephedrine (clarinex-D; clarinex-D 12 Hour; clarinex-D 24 hour) is a prescription medicine that contains the medicines desloratadine (an antihistamine) and pseudoephedrine (a nasal decongestant). clarinex-D 12 Hour Extended Release Tablets is used to help control the symptoms of seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in adults and children 12 years and older.

How does this medicine work?

Desloratadine:

• Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity.
• Desloratadine inhibited histamine release from human mast cells in vitro.

Pseudoephedrine:

• Pseudoephedrine sulfate is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa.
• Pseudoephedrine sulfate is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis.
• Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines.
• It has the potential for excitatory side effects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to desloratadine or pseudoephedrine sulfate or any of the ingredients in clarinex-D 12 Hour Extended Release Tablets.
• 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.
• have severe high blood pressure
• have severe heart disease

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• Monoamine Oxidase Inhibitors (MAOIs). You should not use clarinex-D 12 Hour Extended Release Tablets if you take an MAOI or within 2 weeks of stopping an MAOI.
• methyldopa
• reserpine (Serpalan)
• digitalis (Digoxin, Lanoxicaps, Lanoxin) ketoconazole (Nizoral)
• erythromycin (Ery-tab, Eryc, PCE)
• azithromycin (Zithromax, Zmax)
• antihistamines
• other decongestant medicines

Is this medicine FDA approved?

• Desloratadine/pseudoephedrine was approved for use in the United States in 2005 and in the European Union in July 2007.

How should this medicine be used?

Recommended dosage: Adults and adolescents 12 years of age and over:

• The recommended dose of clarinex-D 12 HOUR Extended Release Tablets is one tablet twice a day.

Administration:

• For oral use only.
• Take clarinex-D 12 Hour Extended Release Tablets exactly as your doctor tells you to take it.
• clarinex-D 12 Hour Extended Release Tablets can be taken with or without food.
• Swallow clarinex-D 12 Hour Extended Release Tablets whole.
• Do not break, crush, or chew clarinex-D 12 Hour Extended Release Tablets before swallowing.
• If you cannot swallow clarinex-D 12 Hour Extended Release Tablets whole, tell your doctor.
• You may need a different medicine.
• Take 1 clarinex-D 12 Hour Extended Release Tablet 2 times a day (every 12 hours).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Desloratadine 2.5 mg/Pseudoephedrine sulfate 120 mg tablets.

This medicine is available in fallowing brand namesː clarinex-D; clarinex-D 12 Hour; clarinex-D 24 hour

What side effects can this medication cause?

The most common side effects of this medicine include:

• Mouth Dry
• Nausea
• Fatigue
• Anorexia
• Headache
• Somnolence
• Dizziness
• Insomnia
• Pharyngitis

Less common, but serious side effects may include:

• Cardiovascular and Central Nervous System effects
• Increased intraocular pressure
• Urinary retention in patients with prostatic hypertrophy
• Hypersensitivity reactions
• Severe Skin Reactions

What special precautions should I follow?

• The pseudoephedrine sulfate contained in clarinex-D 12 HOUR Extended Release Tablets, like other sympathomimetic amines, can produce cardiovascular and central nervous system (CNS) effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. Therefore, clarinex-D 12 HOUR Extended Release Tablets should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or severe coronary artery disease.
• clarinex-D 12 HOUR Extended Release Tablets contain pseudoephedrine sulfate, a sympathomimetic amine, and therefore should be used with caution in patients with diabetes and hyperthyroidism.
• clarinex-D 12 HOUR Extended Release Tablets should not be used in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment as an increase in blood pressure or hypertensive crisis, may occur.
• Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine a component of clarinex-D 12 HOUR Extended Release Tablets. If such a reaction occurs, therapy with clarinex-D 12 HOUR Extended Release Tablets should be stopped and alternative treatment should be considered.
• clarinex-D 12 HOUR Extended Release Tablets should generally be avoided in patients with renal impairment.
• Patients should be advised not to increase the dose or dosing frequency of clarinex-D 12 HOUR Extended Release Tablets.
• Patients should be advised against the concurrent use of clarinex-D 12 HOUR Extended Release Tablets with other antihistamines and/or decongestants.
• Patients with severe hypertension or severe coronary artery disease, narrow-angle glaucoma, or urinary retention should be advised not to use clarinex-D 12 HOUR Extended Release Tablets.
• Patients should be instructed not to break, crush, or chew the tablet; the tablet should be swallowed whole, and can be taken without regard to meals.
• Desloratadine and pseudoephedrine both pass into breast milk. alk to your doctor about the best way to feed your baby if you take clarinex-D 12 Hour Extended Release Tablets.

What to do in case of emergency/overdose?

Symptoms of overdose may include: Desloratadine overdose:

• somnolence

Pseudoephedrine overdose:

• giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle weakness and tenseness, anxiety, restlessness, and insomnia.
• Many patients can present a toxic psychosis with delusions and hallucinations.
• Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.

Can this medicine be used in pregnancy?

• It is not known if clarinex-D 12 Hour Extended Release Tablets will harm your unborn baby.
• Talk to your doctor if you are pregnant or plan to become pregnant.

Can this medicine be used in children?

• clarinex-D 12 HOUR Extended Release Tablets are not indicated for use in pediatric patients under 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: desloratadine
• Inactive ingredients: corn starch, microcrystalline cellulose, meglumine, pregelatinized maize starch, sodium starch glycolate and sodium stearyl fumarate, coating material consisting of hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80 and FD&C Blue #2 Aluminum Lake.

Who manufactures and distributes this medicine?

Manufactured for:

• Organon LLC, a subsidiary of
• ORGANON & Co.,
• Jersey City, NJ, USA

What should I know about storage and disposal of this medication?

• Store clarinex-D 12 Hour Extended Release Tablets at 59°F to 86°F (15°C to 30°C)
• Keep clarinex-D 12 Hour Extended Release Tablets dry and out of the light.

• Dailymed label info on Desloratadine/pseudoephedrine
• FDA Desloratadine/pseudoephedrine

Desloratadine/pseudoephedrine Resources
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Second Generation Antihistamines

• Acrivastine
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• Levocetirizine
• Loratadine
• Desloratadine