Desloratadine + Pseudoephedrine Sulphate

Desloratadine is a long-acting, tricyclic, non-sedating, selective peripheral histamine H1-receptor antagonist which inhibits the release of pro-inflammatory mediators from human mast cells and basophils. Pseudoephedrine is both an α- and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa and reduces nasal congestion.

• Allergic rhinitis
• Common cold and nasal congestion
• Sneezing, itching, watery eyes
• Hives, skin rash

Desloratadine is a long-acting, tricyclic, non-sedating, selective peripheral histamine H1-receptor antagonist which inhibits the release of pro-inflammatory mediators from human mast cells and basophils. Pseudoephedrine is both an α- and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa and also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Desloratadine blocks H1-receptors to relieve allergy symptoms; Pseudoephedrine causes vasoconstriction via α-adrenergic stimulation to reduce nasal congestion.

Adults: 1 tablet (2.5 mg desloratadine/120 mg pseudoephedrine) every 12 hours; OR 1 tablet (5 mg/240 mg) every 24 hours.
Children (≥12 years): Same as adult dosing.
Hepatic/renal impairment: Not recommended.

May be taken with or without food. Swallow whole, do not chew/break/crush.

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

Desloratadine (>10%): Fever (12%), Irritability (12%), Headache (12%), Diarrhea (15-21%), Cough (11%), Upper respiratory tract infection (11-21%).
Desloratadine (1-10%): Pharyngitis (4.1%), Dry mouth (3%), Myalgia (2.1%), Emotional lability (3%), Erythema (3%), Macopapular rash (3%), Dizziness (4%), Fatigue (2.1%), Somnolence (2.1%), UTI (4%), Dyspepsia (3%), Insomnia (5%), Dysmenorrhea (2.1%).
Pseudoephedrine: CNS (tremor, restlessness), Insomnia, Arrhythmia, Hypotension, Tachycardia, Fatigue, Rash, Urticaria, Anorexia, Xerostomia, Dysuria, Polyuria, Nausea, Vomiting, Ischemic colitis.

Severe renal or hepatic failure; children <6 months; elderly; epilepsy; pregnancy and lactation. Both drugs pass into breast milk; pseudoephedrine is concentrated in breast milk.

Hypersensitivity.

Drugs affecting hepatic enzymes (azithromycin, cimetidine, erythromycin, fluoxetine, ketoconazole): May increase plasma concentrations.
Cardiac glycosides, quinidine, TCAs: Increased risk of hypertension and arrhythmias.
Ergot alkaloids, oxytocin: Increased risk of vasoconstrictor effects.
MAOIs: May cause hypertensive crisis.
Halogenated anaesthetics, antihypertensives: Caution required.

May be taken with or without food. Caution is advised when consuming alcohol.

Limited data in pregnant women; not sufficient to inform drug-associated risk for major birth defects and miscarriage. Most studies did not find association with increased risk of congenital anomalies with pseudoephedrine.

Desloratadine and pseudoephedrine both pass into breast milk. Pseudoephedrine may decrease milk production and cause irritability in infants. Decision should be made to discontinue nursing or discontinue drug.

Safety and effectiveness in children under 12 years have not been established.

Use with caution in elderly patients.

Not recommended in severe renal or hepatic impairment.

No adequate information on overdose is available.

Store in a cool and dry place, protected from light.

Desloratadine + Pseudoephedrine Sulphate