TELLERGE 120 mg (film-coated tablets)
TELLERGE 180 mg (film-coated tablets)
(and dosage form):
TELLERGE 120 mg (film-coated tablets)
TELLERGE 180 mg (film-coated tablets)
Each TELLERGE 120 mg tablet contains Fexofenadine Hydrochloride 120 mg equivalent to Fexofenadine 112 mg base.
Each TELLERGE 180 mg tablet contains Fexofenadine Hydrochloride 120 mg equivalent to Fexofenadine 168 mg base
A 5.7.1 Antihistaminics.
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.
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 and 494 ng/mL following the administration of a 120 mg and 180 mg dose once daily, respectively. The volume of distribution is 5.4-5.8 L/kg. Fexofenadine does not cross the blood brain barrier.
Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes negligible metabolism (about 5% of the total dose is metabolized, mostly by the intestinal mucosa, with only 0.5-1.5% of the dose undergoing hepatic biotransformation), 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 (faeces), 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.
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.
TELLERGE 120 is indicated for the relief of symptoms associated with seasonal allergic rhinitis (SAR).
TELLERGE 180 is indicated for the relief of symptoms associated with chronic idiopathic urticaria (CIU).
Safety in pregnancy and lactation has not been established. (See "WARNINGS" below). The safety and efficacy of TELLERGE has not been studied in children under the age of 12 years.
Patients with known hypersensitivity to TELLERGE or any of its ingredients.
There is only limited data for the use in elderly and renally or hepatically impaired patients. TELLERGE should be administered with care in these special risk groups.
TELLERGE has been detected in breast milk.
TELLERGE may affect the ability to drive or operate machinery.
Interaction with other medicaments and other forms of interaction
TELLERGE does not undergo hepatic biotransformation. Co-administration of TELLERGE with erythromycin or ketoconazole has been found to result in 2-3 times increase in the level of TELLERGE 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 individually.
The increase in plasma levels of TELLERGE observed after co-administration 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 TELLERGE and omeprazole was observed. However, the administration of antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to TELLERGE causes a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of TELLERGE and aluminium and magnesium hydroxide containing antacids.
PREGNANCY AND LACTATION:
There is no experience with TELLERGE in pregnant women.
TELLERGE should not be taken during pregnancy or lactation.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children aged 12 years and over
Chronic idiopathic urticaria (CIU): One 180 mg tablet daily.
Seasonal allergic rhinitis (SAR): One 120 mg tablet daily.
Children under 12 years of age
The efficacy and safety of TELLERGE has not been studied in children under 12.
Special risk groups (See "WARNINGS")
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.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Adverse events reported include:
Immune system disorders
Rare: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing, and systemic anaphylaxis have been reported.
Nervous system disorders
Frequent: Headache, drowsiness, dizziness
Less frequent: Insomnia, nervousness and sleep disorders or paroniria
Respiratory, thoracic and mediastinal disorders
The following side-effects have been reported and frequencies are unknown:
Sinusitis and viral infections such as cold or flu.
The following side-effects have been reported and frequencies are unknown:Dyspepsia
Skin and subcutaneous tissue disorders
Rare: Rash, urticaria, pruritus
Musculoskeletal, connective tissue and bone disorders
Less frequent: Fatigue
Reproductive system disorders
The following side-effects have been reported and frequencies are unknown: Dysmenorrhoea
TELLERGE 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.
See "PHARMACOLOGICAL ACTIONS" (pharmacokinetics), "INTERACTIONS" and "WARNINGS" above.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Most reports of TELLERGE 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 TELLERGE from blood.
TELLERGE 120 mg: Peach coloured, oblong, bi-convex, film-coated tablet. plain on both sides.
TELLERGE 180 mg: Yellow coloured, oblong, bi-convex, film-coated tablet. plain on one side with a central breakline on the other.
TELLERGE 120 mg and TELLERGE 180 mg film-coated tablets will be packaged in a blister pack composed of colourless, transparent PVC/PVDC film and hard-tempered, aluminium foil. The TELLERGE 120 mg strips are packed in cardboard cartons which will be comprised of pack sizes of 10's or 30's. the TELLERGE 180 mg strips are packed in cardboard cartons which will be comprised of pack sites of 30's
Store below 25°C. Keep the blister strip in the unit carton until required for use.
KEEP OUT OF THE REACH OF CHILDREN.
TELLERGE 120 mg: 41/5.7.1/0352
TELLERGE 180 mg: 41/5.7.1/0353
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
DATE OF PUBLICATION OF THE PACKAGE INSERT:
14 September 2007
New addition to this site: September 2010
Source: Pharmaceutical Industry
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