Adult Dosing

Seasonal allergic rhinitis (Clarinex-D 12 Hour)

• Recommended dose: 2.5 mg/120 mg PO bid, administered 12 hrs apart with or without a meal

Seasonal allergic rhinitis (Clarinex-D 24 Hour)

• Recommended dose: 5 mg/240 mg PO qd, administered with or without a meal

Note:

• Do not break/chew/crush the tablet; swallow the tablet whole
• Do not exceed the recommended dose as desloratadine and pseudoephedrine have been associated with adverse effects at higher doses

Pediatric Dosing

Seasonal allergic rhinitis (Clarinex-D 12 Hour)

Children >12 yrs

• Recommended dose: 2.5 mg/120 mg PO bid, administered 12 hrs apart with or without a meal

Seasonal allergic rhinitis (Clarinex-D 24 Hour)

Children >12 yrs

• Recommended dose: 5 mg/240 mg PO qd, administered with or without a meal

Note:

• Not indicated for use in pediatric patients <12 yrs of age
• Do not break/chew/crush the tablet; swallow the tablet whole
• Do not exceed the recommended dose as desloratadine and pseudoephedrine have been associated with adverse effects at higher doses

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients 12 yrs of age and older

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to loratadine
• Hepatic impairment
• Renal impairment
• Narrow angle glaucoma
• Urinary retention
• Concomitant use of monoamine oxidase inhibitor (MAOI) or within 14 days of its use
• Severe hypertension
• Severe coronary artery disease

• N/A

Renal Dose Adjustment

• Renal impairment: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

• Pseudoephedrine can produce cardiovascular and CNS adverse effects such as insomnia, dizziness, weakness, tremor, arrhythmias, convulsions, and cardiovascular collapse with accompanying hypotension. Use cautiously in patients with cardiovascular disorders; avoid use in patients with severe hypertension or severe coronary artery disease
• Use cautiously in patients with diabetes and hyperthyroidism. Urinary retention and narrow-angle glaucoma have been reported in patients with prostatic hypertrophy and increased intraocular pressure; use with caution in such patients
• Avoid using therapy in patients receiving monoamine oxidase (MAO) inhibitor therapy or within 14 days of stopping such treatment as an increase in blood pressure or hypertensive crisis may occur
• Hypersensitivity reactions such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after receiving desloratadine/psuedoephedrine. If such reactions occur, discontinue therapy and consider alternative treatment
• Desloratadine/psuedoephedrine should be avoided in patients with renal or hepatic impairment

Cautions: Use cautiously in

• Hypertension
• CAD

Pregnancy Category:C

Breastfeeding: Maternal use of desloratadine is unlikely to affect a breastfed infant or milk production because of its low milk levels and lack of sedation and anticholinergic effects. When used in combination with a sympathomimetic agent such as pseudoephedrine, it might produce a negative effect on lactation. Pseudoephedrine: Small amounts of pseudoephedrine excreted in breastmilk are unlikely to harm the nursing infant; however, it may cause occasional irritability. A single dose of pseudoephedrine decreases milk production acutely and repeated use seems to interfere with lactation. Mothers with newborns whose lactation is not well established or those having difficulties producing sufficient milk should not receive pseudoephedrine. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 6 July 2011). As per manufacturer's data, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• CV: Arrhythmias, hypertension, cardiovascular collapse, palpitations
• CNS: Seizures, headache, somnolence, dizziness
• PSYCHIATRY: Nervousness, insomnia, psychomotor hyperactivity
• GI: Dry mouth, nausea, anorexia, hepatitis
• GU: Urinary retention
• EENT: Increased intraocular pressure
• RESP: Pharyngitis
• HYPERSENSITIVITY: Hypersensitivity reactions
• MISC: Fatigue

Desloratadine

• Antihistamine; competes with free histamine for binding at peripheral histamine H1-receptors, which blocks the action of endogenous histamine leading to temporary relief of symptoms such as nasal congestion and watery eyes brought on by histamine
• Metabolized primarily in the liver to 3-hydroxydesloratadine, an active metabolite
• Excretion: Approximately 87% is excreted in urine and feces
• Half-life: 27 hrs

Pseudoephedrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction and reducing nasal congestion. Also, relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors
• Partially metabolized in the liver
• Renally excreted (55-96% unchanged)
• Half-life: 3-6 hrs (urine pH 5)
• Half-life: 9-16 hrs (urine pH 8)

US Trade Name(s)

• Clarinex-D 24 Hour
• Clarinex-D 12 Hour

US Availability

desloratadine/pseudoephedrine (generic)

• ETABS: 5 mg/240 mg

Clarinex-D 24 Hour (desloratadine/pseudoephedrine)

• ETABS: 5 mg/240 mg

Clarinex-D 12 Hour (desloratadine/pseudoephedrine)

• ETABS: 2.5 mg/120 mg

Canadian Trade Name(s)

• Aerius Dual Action 12 Hour

Canadian Availability

Aerius Dual Action 12 Hour (desloratadine/pseudoephedrine)

• ETABS: 2.5 mg/120 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Nasal Preparations

Antihistamines & Decongestants

Allergy & Immunology

Nasal Preparations

Antihistamines & Decongestants

Pricing data from www.DrugStore.com in U.S.A.

• Clarinex-D 12 Hour 2.5-120 MG TB12 [Bottle] (SCHERING)
  100 mg = $340.99
  300 mg = $965.96
• Clarinex-D 24 Hour 5-240 MG TB24 [Bottle] (SCHERING)
  30 mg = $161.98
  90 mg = $472.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Clarinex-D (desloratadine 2.5 MG / pseudoephedrine 120 MG) 12 HR Extended Release Tablet

Ingredient(s): Desloratadine mixture with Pseudoephedrine

Imprint: D12

Color(s): Blue, White

Shape: Oval

Size (mm): 15.00

Score: 1

Inactive Ingredient(s): hypromellose / cellulose, microcrystalline / povidone / silicon dioxide / magnesium stearate / starch, corn / edetate disodium / anhydrous citric acid / stearic acid / fd&c blue no. 2 / aluminum oxide

Drug Label Author:
Schering Plough Corporation

DEA Schedule:
Non-Scheduled

Drug Name: Clarinex-D (desloratadine 5 mg / pseudoephedrine 240 mg) 24 HR Extended Release Tablet

Ingredient(s): Desloratadine mixture with Pseudoephedrine

Imprint: D;24

Color(s): Blue

Shape: Oval

Size (mm): 15.00

Score: 1

Inactive Ingredient(s): hypromellose / ethylcellulose / dibasic calcium phosphate dihydrate / magnesium stearate / povidone / silicone dioxide / talc / polyacrylate dispersion / polyethylene glycol / simethicone / blue lake blend 50726 / fd&c blue no. 2 lake / titanium dioxide / edetate disodium / ink opacode® s-1-17746 / opacode® s-1-4159

Drug Label Author:
Schering Corporation

DEA Schedule:
Non-Scheduled