Each tablet TELFAST 180 mg contains 168 mg of the active ingredient
fexofenadine (as 180 mg of fexofenadine
Excipients: Mycrocrystalline cellulose, pregelatinised maize starch,
croscarmellose sodium, magnesium stearate. hydroxypropyl methylcellulose
(E-15), hydroxypropyl methylcellulose (E-5), povidone, titanium dioxide (E
171), colloidal anhydrous silica, macrogol 400 and pink iron oxide, yellow
iron oxide blend.
Wheal and Flare: Human histamine skin wheal and flare studies in
adults following single and twice daily doses of 20 and 40 mg fexofenadine
hydrochloride demonstrated that the drug exhibits an antihistamine effect by
I hour, achieves maximum effect at 2 to 3 hours, and an effect is still seen
at 12 hours. There was no evidence of tolerance to these effects after 28
days of dosing. The clinical significance of these observations is unknown.
Histamine skin wheal and flare studies in 7 to 12 year old subjects showed
that following a single dose of 30 or 60 mg, antihistamine effect was
observed at 1 hour and reached a maximum by 3 hours. Greater than 49%
inhibition of wheal area, and 74% inhibition of flare area were maintained
for 8 hours following the 30 and 60 mg dose.
No statistically significant increase in mean QTc interval compared to
placebo was observed in 714 adult subjects with seasonal allergic rhinitis
given fexofenadine hydrochloride capsules in doses of 60 to 240 mg twice
daily for 2 weeks. Pediatric subjects from 2 placebo-controlled trials
(n=855) treated with up to 60 mg fexofenadine hydrochloride twice daily
demonstrated no significant treatment- or dose-related increases in QTc. In
addition, no statistically significant increase in mean QTc interval
compared to placebo was observed in 40 healthy adult subjects given
fexofenadine hydrochloride as an oral solution at doses up to 400 mg twice
daily for 6 days, or in 230 healthy adult subjects given fexofenadine
hydrochloride 240 mg once daily for 1 year. In subjects with chronic
idiopathic urticaria, there were no clinically relevant differences for any
ECG intervals, including QTc, between those treated with fexofenadine
hydrochloride 180 mg once daily (n=163) and those treated with placebo
(n=91) for 4 weeks.
The pharmacokinetics of fexofenadine hydrochloride in subjects with seasonal
allergic rhinitis and subjects with chronic urticaria were similar to those
in healthy subjects.
TELFAST tablets: Fexofenadine hydrochloride was absorbed following
oral administration of a single dose of two 60 mg capsules to healthy male
subjects with a mean time to maximum plasma concentration occurring at 2.6
hours post-dose. After administration of a single 60 mg capsule to healthy
adult subjects, the mean maximum plasma
concentration (Cmax) was 131 ng/mL.
Following single dose oral
administrations of either the 60 and 180
mg tablet to healthy adult male subjects,
mean Cmax were 142 and 494 ng/mL,
respectively. The tablet formulations are
bioequivalent to the capsule when
administered at equal doses.
pharmacokinetics are linear for oral
doses up to a total daily dose of 240 mg
(120 mg twice daily). The administration
of the 60 mg capsule contents mixed
with applesauce did not have a
significant effect on the
pharmacokinetics of fexofenadine in
adults. Co-administration of 180 mg
fexofenadine hydrochloride tablet with a
high fat meal decreased the mean area
under the curve (AUC) and (Cmax) of
fexofenadine by 21 and 20% respectively.
Fexofenadine hydrochloride is 60% to
70% bound to plasma-proteins, primarily
albumin and α1-acid glycoprotein.
Approximately 5% of the total dose of
fexofenadine hydrochloride was
eliminated by hepatic metabolism.
The mean elimination half-life of
fexofenadine was 14.4 hours following
administration of 60 mg twice daily in
healthy adult subjects.
Human mass balance studies
documented a recovery of approximately
80% and 11% of the [14C] fexofenadine
hydrochloride dose in the feces and
urine, respectively. Because the absolute
bioavailability of fexofenadine
hydrochloride has not been established,
it is unknown if the fecal component
represents primarily unabsorbed drug or
is the result of biliary excretion.
Pharmacokinetics in renally and
hepatically impaired subjects and
geriatric subjects, obtained after a single
dose of 80 mg fexofenadine
hydrochloride, were compared to those
from healthy subjects in a separate study
of similar design.
In subjects with mild to moderate
(creatinine clearance 41-80 mL/min) and
severe (creatinine clearance 11-40
mL/min) renal impairment, peak plasma
concentrations of fexofenadine were 87%
and 111% greater, respectively, and mean
elimination half-lives were 59% and 72%
longer, respectively, than observed in
healthy subjects. Peak plasma
concentrations in subjects on dialysis
(creatinine clearance ≤10 mL/min) were
82% greater and half-life was 31% longer
than observed in healthy subjects. Based
on increases in bioavailability and
half-life, a dose of 60 mg once daily is
recommended as the starting dose in
adult patients with decreased renal
function. For pediatric patients with
decreased renal function, the
recommended starting dose of
fexofenadine is 30 mg once daily for
patients 2 to 11 years of age and 15 mg
once daily for patients 6 months to less
than 2 years of age [see Dosage and
The pharmacokinetics of fexofenadine
hydrochloride in subjects with hepatic
impairment did not differ substantially
from that observed in healthy subjects.
In older subjects (≥65 years old), peak
plasma levels of fexofenadine were 99%
greater than those observed in younger
subjects (<65 years old). Mean
fexofenadine elimination halflives were
similar to those observed in younger
Effect of Gender:
Across several trials, no clinically
significant gender-related differences
were observed in the pharmacokinetics
of fexofenadine hydrochloride.
TELFAST 180mg is indicated for the relief
of symptoms associated with chronic
idiopathic urticaria and allergic rhinitis
in adults and children 12 years of age
and older. Symptoms treated effectively
include sneezing, rhinorrhea, itchy nose/
palate/ throat, itchy/ watery red eyes.
DOSAGE AND ADMINISTRATION
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria
Adults and Children 12 Years and Older:
The recommended dose of TELFAST tablets is 180 mg once daily with water. A
dose of 60 mg once daily is recommended as the starting dose in patients
with decreased renal function [see Clinical Pharmacology].
TELFAST tablets are contraindicated in patients with known hypersensitivity
to fexofenadine and any of the ingredients of TELFAST. Rare cases of
hypersensitivity reactions with manifestations such as angioedema, chest
tightness, dyspnea flushing and systemic anaphylaxis have been reported.
WARNINGS AND PRECAUTIONS
As with most new drug there is only limited data in the elderly and renally
or hepatically impaired patients. Fexofenadine hydrochloride should be
administered with care in these special groups.
USE IN SPECIFIC POPULATIONS
Teratogenic Effects: Pregnancy Category C. There was no evidence of
teratogenicity in rats or rabbits at oral doses of terfenadine up to 300
mg/kg (which led to fexofenadine exposures that were approximately 4 and 30
times, respectively, the exposure at the maximum recommended human daily
oral dose of 180 mg of fexofenadine hydrochloride based on comparison of
In mice, no adverse effects and no teratogenic effects during gestation were
observed with fexofenadine hydrochloride at oral doses up to 3730 mg/kg
(which led to fexofenadine exposures that were approximately 15 times the
exposure at the maximum recommended human daily oral dose of 180 mg of
fexofenadine hydrochloride based on comparison of AUCs).
There are no adequate and well controlled studies in pregnant women.
Fexofenadine hydrochloride should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: Dose-related decreases in pup weight gain and
survival were observed in rats exposed to an oral dose of 150 mg/kg of
terfenadine (which led to fexofenadine exposures that were approximately 3
times the exposure at the maximum recommended human daily oral dose of 180
mg of fexofenadine hydrochloride based on comparison of AUCs).
It is not known if fexofenadine is excreted in human milk. There are no
adequate and well-controlled studies in women during lactation. Because many
drugs are excreted in human milk, caution should be exercised when
fexofenadine hydrochloride is administered to a nursing woman.
Clinical studies of TELFAST tablets and capsules did not include sufficient
numbers of subjects aged 65 years and over to determine whether this
population responds differently from younger subjects. Other reported
clinical experience has not identified differences in responses between the
geriatric and younger subjects. This drug is known to be substantially
excreted by the kidney, and the risk of toxic reactions to this drug may be
greater in patients with impaired renal function. Because elderly patients
are more likely to have decreased renal function, care should be taken in
dose selection, and it may be useful to monitor renal function (see
Based on increases in bioavailability and half-life a dose of 60 mg once as
the starting dose in adult patients with decreased renal function (mild,
moderate or severe renal impairment). For pediatric patients with decreased
renal function (mild, moderate or severe renal impairment). For pediatric
patients with decreased renal function (mild, moderate or severe renal
impairment), the recommended starting dose of fexofenadine is 30 mg once
daily for patients 2 to 11 years of age and 15 mg once daily for patients 6
months to less than 2 years of age [See Dosage and Administration and
The pharmacokinetics of fexofenadine hydrochloride in subjects with hepatic
impairment did not differ substantially from that observed in healthy
Effects on ability to drive and use machines
On the basis of the pharmacodynamic profile and reported adverse events it
is unlikely that fexofenadine hydrochloride tablets will produce an effect
on the ability to drive or use machines. In objective tests. TELFAST 180 has
been shown to have no significant effects on central nervous system
function. This means that patients may drive or perform tasks that require
However, in order to identify sensitive people who have an unusual reaction
to drugs, it is advisable to check the individual response before driving or
performing complicated tasks.
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may
not reflect the rates observed in practice.
The safety data described below reflect exposure to fexofenadine
hydrochloride in 5083 patients in trials for allergic rhinitis and chronic
In these trials, 3010 patients 12 years of age and older with seasonal
allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 20
to 240 mg twice daily or 120 to 180 mg once daily.
A total of 646 patients 6 to 11 years of age with seasonal allergic rhinitis
were exposed to fexofenadine hydrochloride at doses of 15 to 60 mg twice
daily. The duration of treatment in these trials was 2 weeks. A total of 534
patients 6 months to 5 years of age with allergic rhinitis were exposed to
fexofenadine hydrochloride at doses of 15 to 30 mg twice daily. The duration
of treatment in these trials ranged from 1 day to 2 weeks. There were 893
patients 12 years of age and older with chronic idiopathic urticaria exposed
to fexofenadine hydrochloride at doses of 20 to 240 mg twice daily or 180 mg
once daily. The duration of treatment in these trials was 4 weeks.
Seasonal Allergic Rhinitis
Adults and Adolescents: In placebo-controlled seasonal allergic
rhinitis clinical trials in subjects 12 years of age and older, 2439
subjects received fexofenadine hydrochloride capsules at doses of 20 mg to
240 mg twice daily. All adverse reactions that were reported by greater than
1% of subjects who received the recommended daily dose of fexofenadine
hydrochloride (60 mg capsules twice daily) are listed in Table 1.
In another placebo-controlled clinical study in the United States, 571
subjects aged 12 years and older received fexofenadine hydrochloride tablets
at doses of 120 or 180 mg once daily. Table 1 also lists adverse reactions
that were reported by greater than 2% of subjects treated with fexofenadine
hydrochloride tablets at doses of 180 mg once daily.
The incidence of adverse reactions, including somnolence/fatigue, was not
dose-related and was similar across subgroups defined by age, gender, and