TELFAST

What it is

Telfast Decongestant is a bilayer tablet containing 60 mg of fexofenadine hydrochloride in an immediate release formulation and 120 mg of pseudoephedrine hydrochloride in a wax matrix for sustained release.

Approved indications

— Relief of the symptoms of allergic rhinitis with nasal congestion when both the antiallergic properties of fexofenadine hydrochloride and the decongestant activity of pseudoephedrine hydrochloride are required.

Dosing overview

For adults and children over the age of 12 years, the recommended dosage of Telfast Decongestant is one tablet 12 hourly. The tablet should be swallowed whole and administration with or after a high fat meal should be avoided. The safety and efficacy of Telfast Decongestant in patients under the age of 12 years has not been established. For renally impaired patients, a dose of one tablet once daily is recommended as a starting dose.

Key safety warnings

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing products. The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure. Pseudoephedrine should be discontinued and immediate medical assistance sought if symptoms such as sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances occur. Sympathomimetics, such as pseudoephedrine, should be used with caution in patients with diabetes mellitus, hypertension, heart disease, increased intraocular pressure, hyperthyroidism, prostatic hypertrophy, renal disease and hyperreactivity to ephedrine, stroke and psychosis. Pseudoephedrine carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing. Pseudoephedrine should be used with caution in patients with renal disease as up to 90 per cent of pseudoephedrine is excreted unchanged in the urine.

Contraindications

Telfast Decongestant is contraindicated in patients with a known hypersensitivity to fexofenadine, pseudoephedrine, terfenadine or any excipient. Pseudoephedrine and thus Telfast Decongestant is contraindicated in patients with severe or uncontrolled hypertension or severe coronary artery disease, narrow angle glaucoma, urinary retention or those who have shown sensitivity to adrenergic events; in severe acute or chronic kidney disease or renal failure; in patients with urinary retention related to urethroprostatic disorders; in patients receiving monoamine oxidase (MAO) inhibitors or patients who have received MAO inhibitors in the previous 14 days; in patients with a history of seizures; and in patients using other vasoconstrictor agents used as nasal decongestants, whether administered orally or nasally.

Regulatory history

Telfast Decongestant was first registered on the Australian Register of Therapeutic Goods on 20 January 2000.