Fexotab Plus ER - Tablet Fexofenadine Hydrochloride + Pseudoephedrine Hydrochloride - 60mg+120mg 1 Tablet(s) / Tablet Veritas Pharmaceuticals Ltd. Indication: Allergic rhinitis, Hay fever, Urticaria, Sneezing, Runny nose, Hives, Skin rash, Common cold, Allergy, Itchy or watery eyes, Nasal congestion Administration: Take on empty stomach with water only Swallow whole; do not chew, crush, or split tablet Adult Dose: Oral Seasonal Allergic Rhinitis with Nasal Congestion Adult: 1 tab 60 mg fexofenadine/120 mg pseudoephedrine PO BID Child Dose: Child: >12 yr: 1 tab bid. <12 years: Safety and efficacy not established Renal Dose: Renal Impairment Avoid Contraindication: Severe hypertension, phaeochromocytoma. Mode of Action: Fexofenadine, an active metabolite of terfenadine, is a competitive peripheral histamine H1-receptor antagonist on effector cells in the GI tract, blood vessels and respiratory tract. Pseudoephedrine is both an alpha-and beta-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of alpha-adrenergic receptors of the respiratory mucosa. It also directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility. Precaution: Hyperthyroidism; ischaemic heart disease, arrhythmia or tachycardia; occlusive vascular disorders e.g. arteriosclerosis, hypertension or aneurysms; DM and closed-angle glaucoma; renal impairment, prostatic enlargement. Pregnancy; lactation. Lactation: avoid, not known if enters breast milk Side Effect: 1-10% Headache (7.2%),Drowsiness (1.3%),Fatigue (1.3%) Frequency Not Defined CNS depression,Sedation ranging from mild drowsiness to deep sleep (most frequent),Dizziness,Lassitude,Disturbed coordination,Muscular weakness,Restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures is less common,Epigastric distress,Anorexia,Nausea,Vomiting,Diarrhea,Constipation,Cholestasis, hepatitis, hepatic failure, hepatic function abnormality, jaundice is rare,Tachycardia, palpitation ECG changes (eg, widened QRS). Arrhythmias (eg, extrasystole, heart block),Hypotension,Hypertension,Dizziness, sedation, and hypotension may occur in geriatric patients,Dryness of mouth, nose, and throat,Dysuria,Urinary retention,Impotence,Vertigo,Visual disturbances,Blurred vision,Diplopia; tinnitus,Acute labyrinthitis,Tremors,Nervousness,Irritability,Facial dyskinesia,Tightness of the chest,Thickening of bronchial secretions,Wheezing,Nasal stuffiness,Sweating,Chills,Early menses,Toxic psychosis,Faintness,Paresthesia,Agranulocytosis,Hemolytic anemia,Leukopenia,Thrombocytopenia,Pancytopenia,Dysmenorrhea,Dyspepsia,Fatigue,Ischemic colitis (pseudoephedrine) Pregnancy Category Note: Pregnancy Category: C Lactation: avoid, not known if enters breast milk Interaction: 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.