Fixal Plus

• Allergic Rhinitis: Used for relief of symptoms associated with seasonal and perennial allergic rhinitis.
• Nasal Congestion: Used for treatment of nasal congestion.
• Urticaria and Allergies: Used for hives, sneezing, runny nose, and itching.

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.

Adult Dose (Oral):

• Seasonal Allergic Rhinitis with Nasal Congestion: 1 tab (60 mg fexofenadine/120 mg pseudoephedrine) BID.

Child Dose (>12 years): 1 tab bid; <12 years: Safety and efficacy not established.

Common Side Effects (1-10%):

• Headache (7.2%)
• Drowsiness (1.3%)
• Fatigue (1.3%)

Other Side Effects:

• CNS depression, dizziness, lassitude, disturbed coordination, muscular weakness, restlessness, insomnia, tremors, palpitation, seizures (less common)
• Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation
• Dryness of mouth, nose, and throat
• Dysuria, urinary retention
• Visual disturbances, blurred vision, diplopia
• Hypertension, hypotension

Use in Pregnancy: Category C; may be unsafe; animal studies have shown harmful effects on the developing baby.

Precautions:

• Hyperthyroidism, ischaemic heart disease, arrhythmia or tachycardia
• Occlusive vascular disorders (arteriosclerosis, hypertension, aneurysms)
• Diabetes mellitus and closed-angle glaucoma
• Renal impairment, prostatic enlargement
• Avoid during pregnancy and lactation

Overdose: Dizziness, drowsiness, fatigue and dry mouth reported; symptomatic treatment.

Storage: Keep in a dry place away from light and heat. Keep out of reach of children.