Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** The recommended dose of TELFAST‐D Extended‐Release Tablets is ONE tablet twice daily administered on an empty stomach with water for adults and children 12 years of age and older. It is recommended that the administration of TELFAST‐D with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function. (See CLINICAL PHARMACOLOGY and PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.) TELFAST‐D must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of TELFAST‐D may be eliminated in the feces in a form that may resemble the original tablet. (See PRECAUTIONS, Information for Patients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.)
ORAL
Medical Information
**INDICATIONS** TELFAST‐D is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion. Telfast‐D should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired.
**CONTRAINDICATIONS** TELFAST‐D is contraindicated in patients with known hypersensitivity to any of its ingredients. Due to its pseudoephedrine component, TELFAST‐D is contraindicated in patients with narrow‐angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see Drug Interactions section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.
R01BA52
pseudoephedrine, combinations
Manufacturer Information
OPELLA HEALTHCARE SINGAPORE PTE. LTD.
Opella Healthcare International SAS