Fexofenadine Hydrochloride + Pseudoephedrine Hydrochloride

Fexofenadine Hydrochloride + Pseudoephedrine Hydrochloride is used for allergic rhinitis, hay fever, urticaria, sneezing, runny nose, hives, skin rash, common cold, allergy, itchy or watery eyes, and nasal congestion.

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.

• 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.

Non-sedating antihistamines

Antihistamine + Decongestant

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.

Fexofenadine blocks histamine H1 receptors to relieve allergy symptoms; pseudoephedrine causes vasoconstriction to relieve nasal congestion.

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.

Take on empty stomach with water only; swallow whole; do not chew, crush, or split tablet.

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.

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

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

Contraindications:

• Severe hypertension
• Phaeochromocytoma

Drug Interactions:

• Cardiac glycosides, quinidine, TCAs: Increased risk of hypertension and arrhythmias.
• Ergot alkaloids or oxytocin: Increased risk of vasoconstrictor effects.
• MAOIs: May cause hypertensive crisis.

Food Interactions: Caution is advised when consuming alcohol; consult your doctor.

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

Use in Lactation: Avoid; not known if enters breast milk.

Pediatric Use: Safety and efficacy not established in children under 12 years.

Geriatric Use: Use with caution; dizziness, sedation, and hypotension may occur.

Renal Impairment: Avoid.

Hepatic Impairment: Use with caution in patients with liver disease.

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.

Fexofenadine Hydrochloride + Pseudoephedrine Hydrochloride