Axofen (Susp) Usp 30mg/5ml;suspension

Axofen Suspension 30 mg/5 ml (Fexofenadine HCl) — Clinical Overview

What is Axofen Suspension?

Axofen Suspension is a paediatric oral antihistamine manufactured by ACI Limited, Bangladesh, containing fexofenadine hydrochloride 30 mg per 5 ml. Fexofenadine is a second-generation, non-sedating antihistamine — the active metabolite of terfenadine — that selectively blocks peripheral histamine H1 receptors without penetrating the blood-brain barrier. The suspension formulation makes accurate weight-based dosing straightforward for children who cannot swallow tablets.

Axofen Suspension is indicated for children aged 6–11 years with seasonal allergic rhinitis or chronic idiopathic urticaria. Unlike first-generation antihistamines (e.g., promethazine, diphenhydramine), fexofenadine does not cause sedation, cognitive impairment, or anticholinergic side effects in children — making it the preferred option for school-age children who need to remain alert and focused.

Mechanism of Action

Fexofenadine selectively and competitively antagonises peripheral histamine H1 receptors, preventing histamine from binding to these receptors on blood vessels, mucous membranes, and skin. This blocks the downstream cascade of allergic symptoms:

• Sneezing and rhinorrhoea — blocked by reducing histamine stimulation of nasal mucosa
• Ocular itching and lacrimation — reduced via conjunctival H1 receptor blockade
• Urticarial wheals and flare — suppressed by preventing histamine-induced vasodilation and plasma protein extravasation

Because fexofenadine has extremely low CNS penetration (P-glycoprotein efflux at the blood-brain barrier actively pumps it out), it does not block central H1 receptors — preserving normal histamine-mediated wakefulness and CNS function in children.

Indications

• Seasonal allergic rhinitis (children 6–11 years): Sneezing, runny nose, nasal itching, watery eyes from seasonal pollen or allergens
• Perennial allergic rhinitis: Year-round symptoms from house dust mites, pet dander, or mould
• Chronic idiopathic urticaria (children 6–11 years): Recurring hives and itch without an identifiable cause

Dosage and Administration

• Children 6–11 years: 30 mg (5 ml) twice daily — morning and evening, 12 hours apart
• Renal impairment: Reduce to 30 mg (5 ml) once daily in children with significant renal impairment

Shake well before each use. Measure doses using the graduated oral syringe or measuring spoon provided. May be given with or without food. Avoid administration with fruit juice (orange, apple, grapefruit) — give with water only, as fruit juices can reduce fexofenadine absorption by up to 36% by inhibiting intestinal OATP transport proteins. Store below 30°C; do not refrigerate unless stated on the label. Discard any remaining suspension after the expiry date.

Diabetes and Allergic Disease in Children — Special Considerations

Children with Type 1 diabetes are no less susceptible to allergic conditions than non-diabetic children. Managing allergy treatment appropriately in this group requires careful consideration:

• Sugar content of suspension: Check the product labelling for sucrose or glucose content in the suspension base. Parents of children with Type 1 diabetes should account for any sugar-containing excipients when calculating insulin doses. If the suspension base is sugar-free, this concern is eliminated.
• Non-sedating advantage for children with diabetes: Older antihistamines (promethazine, diphenhydramine) cause sedation that may mask hypoglycaemic symptoms in children — particularly dangerous for those on insulin regimens. Fexofenadine's non-sedating profile ensures symptoms of hypoglycaemia remain recognisable.
• No anticholinergic effects: Anticholinergic antihistamines can cause blurred vision, dry mouth, and urinary retention — all conditions that can be confused with diabetic autonomic complications. Fexofenadine avoids these entirely.
• No drug interactions: Fexofenadine is not significantly metabolised by CYP450 enzymes. It does not interact with insulin, metformin, or any antidiabetic commonly used in paediatric practice.
• Nasal corticosteroid combination: For children with moderate-to-severe allergic rhinitis, fexofenadine suspension is often combined with intranasal corticosteroids. Inhaled/intranasal steroids can cause minor blood glucose elevation — monitor accordingly.

Side Effects

• Common: Headache, upper respiratory tract infection (incidence similar to placebo in clinical trials)
• Uncommon: Nausea, vomiting, fatigue
• Rare: Hypersensitivity reactions; paradoxical CNS stimulation (very rare in children)

Fexofenadine has an exceptionally clean safety profile — in paediatric clinical trials, its side effect incidence was indistinguishable from placebo for most parameters including sedation and cognitive effects.

Frequently Asked Questions (FAQ)