Telfast” Oral suspension
Fexofenadine hydrochloride
Composition :
Each 5 ml suspension contains:
Fexofenadine Hydrochloride 30mg
Excipients: Propylene Glycol, Edetate Disodium, Propylparaben, Butylparaben,
Xanthan Gum, Poloxamer 407, Titanium Dioxide, Sodium Phosphate Monobasic Monohydrate, Sodium Phosphate Dibasic heptahydrate, Artificial Raspberry Cream Flavor, Sucrose, Xylitol
Pharmaceutical form :
Oral suspension.
Pharmacological action :
Pharmacodynamics: Fexofenadine is an antihistamine with selective peripheral H’l-receptor antagonist activity. Fexofenadine inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. In laboratory animals, no anticholinergic or alpha l-adrenergic-receptor blocking effects were observed. Moreover, no sedative or other central nervous system effects were observed. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier.
Pharmacokinetics :
Fexofenadine hydrochloride is rapidly absorbed following oral administration. Tmax occurred approximately 1-3 hours post dose. A 5 mL dose of suspension containing 30 mg of fexofenadine hydrochloride is bioequivalent to a 30 mg dose of fexofenadine hydrochloride tablets. Fexofenadine is 60% to 70% bound to plasma proteins.
Indications :
– Relief of symptoms associated with seasonal allergic rhinitis such as sneezing, itchy, runny or blocked nose/palate/throat, itchy/watery/red eyes
– Relief of symptoms associated with chronic idiopathic urticarial such as itch i ng, swell i ng a nd rashes.
Dosage and administration :
Pediatrics:
The recommended dose for seasonal allergic rhinitis is 30 mg twice daily in patients 2 toll years of age. The recommended dose for chronic idiopathic urticaria is 30 mg twice daily in patients 2 years to 11 years of age and 15 mg twice daily in patients 6 months to less than 2 years of age. The efficacy and safety of fexofenadine hydrochloride have not been established in children under 2 years of age for seasonal allergic rhinitis and under 6 months of age for chronic idiopathic urticaria.
Special Populations :
Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.
Contraindications :
Telfast” is contraindicated in patients with known hypersensitivity to a ny of its i ngred ients.
Side Effects :
In placebo-controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients, adverse events were comparable in fexofenadine- and placebo treated patients. The most frequent adverse events reported with fexofenadine include: > 3%: headache, 1-3%: drowsiness, dizziness and nausea.
Events that have been reported during controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients with incidences less than 1% and similar to placebo and have been reported rarely during postmarketing surveillance include: fatigue, insomnia, nervousness, and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported. In placebo-controlled trials involving pediatric seasonal allergic rhinitis patients (6-11years of age), adverse events were similar to those
observed in trials involving seasonal allergic rhinitis patients 12 years and older.
In controlled clinical trials involving pediatric patients 6 months to 5 years of age, there were no unexpected adverse events in patients treated with fexofenadine hydrochloride.
Drug Interactions :
The coadministration of Telfast” with erythromycin or ketoconazole resulted in no significant increases in QTc. No differences in adverse effects were reported whether these agents were administered alone or in combination.
Administration of an antacid containing aluminum and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminum and magnesium containing antacids.
No interaction between fexofenadine and omeprazole was observed.
Pregnancy :
There are no studies of Telfast” in pregnant women. Telfast” should be used in pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Lactation :
There are no studies of Telfast” in lactating women. Telfast” should oe used in nursing women only if the-potential benefit outweighs the potential risk to the infant.
Warnings & Precautions :
Patients and pa rents/ea regivers of pediatric patients taking Telfast” tablets or suspension should receive the following information: Telfast” tablets or suspension are prescribed for the relief of symptoms of seasonal allergic rhinitis or for the relief of symptoms of chronic idiopathic urticaria (hives). Patients should be instructed to
take Telfast” only as prescribed.
Do not exceed the recommended dose. If any unwanted effects occur while taking Telfast” discontinue use and consult a doctor. The products should not be used by patients who are hypersensitive to any of the ingredients.
These products should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant.
Patients and parents/caregivers of pediatric patients should be
advised to shake the Telfast” Oral suspension bottle well, before each use.
Patients and pa rents/ea regivers of pediatric patients should also be advised to store the medication in a tightly closed container in a cool, dry place, away from children.
Storage :
Store at tempertaure not exceding 30° C.
Package :
Carton Box containing brown glass bottle hydrolytic class III cripmed with plastic screw cap fitted with tri-sealliner of 100 ml oral suspen- sion plus insert and measuring cup.
Keep all medicines out of reach of children
Produced by :
SANOFI Egypt s.a.e. Under license of sanofi – aventis
/France and its subsidiary sanofi – aventis / USA
