Desloratadine + Pseudoephedrine Sulphate

Indications

Desloratadine + Pseudoephedrine Sulphate is used for: Allergic rhinitis, Itching, Sneezing, Watery eyes, Runny nose, Hives, Skin rash, Common cold, Nasal congestion

Adult Dose

PO: Adults: 1 tablet (2.5 mg desloratadine/120 mg pseudoephedrine) 12 hourly. 1 tablet (5 mg desloratadine/240 mg pseudoephedrine) 24 hourly. Hepatic Impairment Not recommended

Child Dose

PO: Child: 12 years or over : 1 tablet (2.5 mg desloratadine/120 mg pseudoephedrine) 12 hourly. 1 tablet (5 mg desloratadine/240 mg pseudoephedrine) 24 hourly.

Renal Dose

Not recommended

Administration

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

Contra Indications

Hypersensitivity.

Precautions

Severe renal or hepatic failure; children <6 mth, elderly, epilepsy, pregnancy and lactation. Lactation: both drugs pass into breast milk, pseudoephedrine is concentrated in breast milk; use caution

Pregnancy-Lactation

Pregnancy The limited available data in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage; there are no adequate and well-controlled studies in pregnant women The majority of studies examining use of pseudoephedrine in pregnancy did not find an association with increased risk of congenital anomalies; a few case-control studies conducted reported potential associations with isolated congenital disorders; however, methodological limitations of these studies made the interpretation of results unreliable Reproductive potential There are no data available on human infertility associated with desloratadine, pseudoephedrine, or combination; there are no animal fertility studies with combination or pseudoephedrine alone Female: There were no clinically relevant effects of desloratadine on female fertility in rats Male: A male specific decrease in fertility occurred at an oral desloratadine dose of ?12 mg/kg in rats (approximately 65 times the RHD); male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the RHD) Lactation Desloratadine and pseudoephedrine both pass into breast milk; there are no sufficient data on effects of desloratadine on breastfed infant or effects of desloratadine on milk production Pseudoephedrine has been reported to decrease milk production and to cause irritability in breastfed infants; the decision should be made whether to discontinue nursing or to discontinue drug, taking into account developmental and health benefits of breastfeeding, the nursing mother’s clinical need, and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

Interactions

Potential increase in plasma concentrations w/ drugs affecting hepatic microsomal enzymes (e.g. azithromycin, cimetidine, erythromycin, fluoxetine, ketoconazole). Increased risk of hypertension and arrhythmias if given with cardiac glycosides, quinidine or TCAs. Increased risk of vasoconstrictor effects if given with ergot alkaloids or oxytocin. Co-admin with MAOIs may cause hypertensive crisis. Anaesthetics e.g. cyclopropane, halothane and other halogenated anaesthestics; antihypertensive agents.

Adverse Effects

Side effects of Desloratadine + Pseudoephedrine Sulphate : >10% Desloratadine Fever (12%), Irritability (12%), Headache (12%), Diarrhea (15-21%), Cough (11%), Upper respiratory tract infection (11-21%) 1-10% Desloratadine 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%)Urinary tract infection (4%), Dyspepsia (3%), Insomnia (5%), Dysmenorrhea (2.1%) Frequency Not Defined Pseudoephedrine CNS (tremor, restlessness, etc), Insomnia, Arrhythmia, Hypotension, Tachycardia, Fatigue, Rash, Urticaria, Anorexia, Xerostomia, Dysuria, Polyuria, Nausea, Vomiting, Ischemic colitis

Mechanism of Action

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 ?-and ?-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of ?-adrenergic receptors of the respiratory mucosa. It also directly stimulates ?-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.