INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TELFAST 120 tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

TELFAST 120 tablets

COMPOSITION
Telfast 120:
Fexofenadine base 112 mg (as
fexofenadine hydrochloride 120 mg) per tablet

PHARMACOLOGICAL CLASSIFICATION
A 5.7.1 Antihistaminics.

PHARMACOLOGICAL ACTION
Fexofenadine hydrochloride is a pharmacologically active metabolite of terfenadine and is a non-sedating, selective histamine H1-receptor antagonist.
Fexofenadine exhibits an antihistaminic effect beginning within one hour, achieving maximum effect at 6 hours and lasting 24 hours. There was no evidence of tolerance to these effects after 28 days of dosing.
Fexofenadine is absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/mL following the administration of a 120 mg dose once daily.
Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes negligible metabolism, as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours, after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of the ingested dose is excreted unchanged through the urine.
Effect of age
In older subjects (>65 years old), peak plasma levels of fexofenadine were 99% greater than those observed in normal volunteers (<65 years old). Mean elimination half-lives were similar to those observed in normal volunteers.
Renally impaired
In patients with mild (creatinine clearance 41-80 mL/min) to severe (creatinine clearance 11-40 mL/min) renal impairment, peak plasma levels of fexofenadine were 87% and 111 % greater, respectively and mean elimination half-lives were 59% and 72% longer, respectively, than observed in normal volunteers. Peak plasma levels in patients on dialysis (creatinine clearance <10 mL/min) were 82% greater and half-life was 31% longer than observed in normal volunteers. Based on increases of bioavailability and half-life, a dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function. (See Dosage and Directions for use).

INDICATIONS
Telfast 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR).

CONTRA-INDICATIONS
Telfast 120 is contra-indicated in patients with known hypersensitivity to fexofenadine hydrochloride or any of its ingredients.
There is no experience with Telfast 120 in pregnant women. Telfast 120 should not be taken during pregnancy or by mothers breast feeding their babies.

WARNINGS
There is only limited data for the use in elderly and renally or hepatically impaired patients. Telfast 120 should be administered with care in these special risk groups.
Interaction with other medicaments and other forms of interaction:
Fexofenadine does not undergo hepatic biotransformation. Coadministration of Telfast 120 with erythromycin or ketoconazole has been found to result in 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse events compared to the drugs given singly.
Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.
No interaction between fexofenadine and omeprazole was observed. However, the administration of antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of Telfast 120 and aluminium and magnesium hydroxide containing antacids.
The efficacy and safety of Telfast 120 has not been studied in children under the age of 12 years.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children aged 12 years and over:
One 120 mg tablet daily.
A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function. (See Pharmacokinetics)

Children under 12 years of age:
The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12.

Special risk groups: (See Pharmacokinetics and Warnings)

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
In controlled clinical trials, the most frequent adverse events reported include:
>3%: headache
1-3%: drowsiness, dizziness and nausea.
Events that have been reported during controlled trials and during post-marketing surveillance with incidences less than 1%, include: fatigue, insomnia, nervousness and sleep disorders or paranoia.
In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis have been reported.
Special Precautions
Fexofenadine lacks sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks.
This effect may be compounded by simultaneous intake of alcohol or other central nervous system depressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Most reports of fexofenadine hydrochloride overdose contain limited information. However, dizziness, drowsiness and dry mouth have been reported. Standard measures should be considered to remove any unabsorbed drug. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.

IDENTIFICATION
Peach, oblong, biconvex, film-coated tablets. One face is embossed "012", the other face blank.

PRESENTATION
Blister strips of 5, 10 or 15 tablets are packed into cartons of 5, 10 or 30 tablets.

STORAGE INSTRUCTIONS
Store in a well-closed container below 25°C.
KEEP OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER
32/5.7.1/0446

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hoechst Marion Roussel Limited
16th Road
Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT :
04 September 1998

Südafr./Telfast120        138053 A

Updated on this site: February 2002

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