Axodin Tablet, Oral Suspension

Axodin Hydrochloride is an antihistamine with selective peripheral H1 receptor antagonist activity. It inhibits histamine release from peritoneal mast cells. No anticholinergic, α-1 adrenergic or β-adrenergic receptor blocking effects has been observed. No sedative or other central nervous system effect has been observed. It does not appear to cross the blood brain barrier. 

Axodin is rapidly absorbed after oral administration with peak plasma concentration being reached in 2-3 hours. Elimination half-life of about 14 hours has been reported although this may be prolonged in patients with renal impairment.

Uses

It is used for the relief of symptoms associated with seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

Axodin is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Chronic Idiopathic Urticaria, Seasonal Allergic Rhinitis, Antihistamine

Trade Name Axodin
Generic Fexofenadine
Other Names Carboxyterfenadine, Fexofenadina, Fexofenadine, Terfenadine acid metabolite, Terfenadine carboxylate, Terfenadine-COOH
Weight 60mg, 120mg, 180mg, 30mg/5ml
Type Tablet, Oral Suspension
Formula C32H39NO4
Weight Average: 501.6564
Monoisotopic: 501.287908741
Protein binding

Fexofenadine is 60-70% bound to plasma proteins, primarily to albumin and α1-acid glycoprotein. The extent of protein binding is decreased to 56-68% and 56-75% in patients with renal and hepatic impairment, respectively.

Therapeutic Class Non-sedating antihistamines
Manufacturer Beximco Pharmaceuticals Ltd
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:20 am

Dosage

Axodin dosage

Adults-

  • Allergic rhinitis: 120 mg once daily or 60 mg twice daily
  • Urticaria: 180 mg once daily

Children-

  • 2-11 years: 30 mg (1 spoonful) or 5 ml twice daily
  • 6 months-2 years: 15 mg (1/2 spoonful) or 2.5 ml twice daily

In case of decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

Side Effects

Axodin is generally well tolerated. The most commonly reported adverse events are headache, drowsiness, nausea, and dizziness. The incidence of these events observed with Axodin hydrochloride was similar to that observed with placebo.

Precaution

Studies in the elderly, patients with hepatic impairment and patients with cardiac disease exposed to Axodin showed no statistically significant differences compared to healthy individuals. As with most new drugs there is only limited data in the elderly and renally or hepatically impaired patients. Axodin hydrochloride should be administered with care in these special groups.

Interaction

Co-administration of Axodin Hydrochloride with either ketoconazole or erythromycin may cause increased plasma concentration of Axodin. Antacid containing Aluminium and Magnesium may reduce the absorption of Axodin. Fruit juices such as grapefruit, orange and apple may reduce the bioavailability of Axodin.

Food Interaction

  • Avoid fruit juice. Fruit juices like grapefruit, orange, and apple may reduce bioavailability and overall exposure to the medication.
  • Take with or without food. Co-administration with food does not significantly affect absorption.

Volume of Distribution

The volume of distribution is approximately 5.4-5.8 L/kg.

Half Life

The terminal elimination half-life is approximately 11-15 hours.

Clearance

The oral clearance of fexofenadine is approximately 50.6 L/h and the renal clearance is approximately 4.32 L/h.

Pregnancy & Breastfeeding use

Pregnancy Category B. There are no adequate and well controlled studies in pregnant women. Axodin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known if Axodin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Axodin is administered to a nursing woman.

Contraindication

Axodin is contraindicated in patients with known hypersensitivity to Axodin or any of the ingredients of Axodin Hydrochloride.

Special Warning

Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Axodin Hydrochloride in these patients.

Acute Overdose

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Axodin hydrochloride.

Storage Condition

Store Axodin at controlled room temperature 20-25 °C. Keep all medicines away from reach of children.

Axodin contains Fexofenadine see full prescribing information from innovator Monograph