Indications
Allergic rhinitis: Fexona is indicated for the relief of
symptoms associated with seasonal and perennial allergic rhinitis, in adults
and children 12 years of age and over. Symptoms treated effectively include
sneezing, rhinorrhea, lacrimation, itchy, red eyes and itchy nose/palate/throat
.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
The H1 histamine receptor is responsible for mediating
hypersensitivity and allergic reactions. Exposure to allergen results in the degranulation
of mast cells and basophils, which then release histamine and other
inflammatory mediators. Histamine binds to, and activates, H1 receptors, which
results in the further release of pro-inflammatory cytokines, such as
interleukins, from basophils and mast cells. These downstream effects of
histamine binding are responsible for a wide variety of allergic symptoms, such
as pruritus, rhinorrhea, and watery eyes.
Fexofenadine is considered an "inverse agonist" of
the H1 receptor because it binds to and stabilizes the inactive form of the
receptor, preventing its activation and subsequent downstream effects. It has a
potent and selective affinity for H1 receptors, and there is no evidence that
it carries antidopaminergic, antiserotonergic, anticholinergic, sedative, or
adrenergic blocking activity. Fexofenadine does not cross the blood-brain
barrier and thus is unlikely to cause significant CNS effects.
Dosage & Administration
Allergic Rhinitis-
Adults and children 12 years and older:
Tablet: 60 mg twice daily or 120 mg once daily or 180 mg
once daily
In case of impaired renal function: 60 mg once daily
Children from 6 to 11 years:
Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily
Children from 2 to 11 years
Suspension: 30 mg or 5 ml twice daily
In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Tablet: 60 mg twice daily or 120 mg once daily or 180 mg
once daily
In case of impaired renal function: 60 mg once daily
Children from 6 to 11 years:
Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily
Children from 6 months to less than 2 years:
Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
In case of impaired renal function: 15 mg or 2.5 ml (1/2
tsp) once daily
Children from 2 to 11 years:
Suspension: 30 mg or 5 ml (1 tsp) twice daily
In case of impaired renal function: 30 mg or 5 ml (1 tsp)
once daily
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
Fexona does not undergo hepatic biotransformation and
therefore will not interact with other medicinal products through hepatic
mechanisms. Coadministration of Fexona with erythromycin or ketoconazole has
been found to result in a 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 reactions compared to the
medicinal products given singly. No interaction between fexofenadine and
omeprazole was observed. However, the administration of an antacid containing
aluminium and magnesium hydroxide gels 15 minutes prior to Fexona caused a
reduction in bioavailability, most likely due to binding in the
gastrointestinal tract. It is advisable to leave 2 hours between administration
of Fexona and aluminium and magnesium hydroxide containing antacids.
Contraindications
Contraindicated in patients with known hypersensitivity to
Fexofenadine Hydrochloride or any of its ingredients.
Side Effects
The following frequency rating has been used, when
applicable: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000
and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000 and not
known (frequency cannot be estimated from the available data). Within each
frequency grouping, undesirable effects are presented in order of decreasing
seriousness. In adults, the following undesirable effects have been reported in
clinical trials, with an incidence similar to that observed with placebo:
Nervous system disorders- Common: headache, drowsiness, dizziness;
Gastrointestinal disorders- Common: nausea; General disorders and
administration site conditions- Uncommon: fatigue. In adults, the following
undesirable effects have been reported in post-marketing surveillance. The
frequency with which they occur is not known (cannot be estimated from
available data): Immune system disorders- hypersensitivity reactions with
manifestations such as angioedema, chest tightness, dyspnoea, flushing and
systemic anaphylaxis; Psychiatric disorders- insomnia, nervousness, sleep
disorders or nightmares/excessive dreaming (paroniria); Cardiac disorders-
tachycardia, palpitations; Gastrointestinal disorders- diarrhea; Skin and
subcutaneous tissue disorders- rash, urticaria, pruritus
Pregnancy & Lactation
There are no adequate data from the use of Fexofenadine
hydrochloride in pregnant women. Limited animal studies do not indicate direct
or indirect harmful effects with respect to effects on pregnancy,
embryonal/foetal development, parturition or postnatal development.
Fexofenadine hydrochloride should not be used during pregnancy unless clearly
necessary.
There are no data on the content of human milk after
administering Fexofenadine hydrochloride. However, when Terfenadine was
administered to nursing mothers Fexofenadine was found to cross into human
breast milk. Therefore, Fexofenadine hydrochloride is not recommended for
mothers breast-feeding their babies. No human data on the effect of
Fexofenadine hydrochloride on fertility are available. In mice, there was no
effect on fertility with Fexofenadine hydrochloride treatment.
Precautions & Warnings
As with most new medicinal products there is only limited
data in the older people and renally or hepatically impaired patients. Fexona
should be administered with care in these special groups. Patients with a
history of or ongoing cardiovascular disease should be warned that,
antihistamines as a medicine class, have been associated with the adverse
reactions, tachycardia and palpitations.
Effects on ability to drive and use machines: On the basis
of the pharmacodynamic profile and reported adverse reactions it is unlikely
that Fexona tablets will produce an effect on the ability to drive or use
machines. In objective tests, Fexona has been shown to have no significant
effects on central nervous system function. This means that patients may drive
or perform tasks that require concentration. However, in order to identify
sensitive people who have an unusual reaction to medicinal products, it is
advisable to check the individual response before driving or performing complicated
tasks.
Use in Special Populations
Renal and hepatic impaired patient: The pharmacokinetics of
fexofenadine are altered in individuals with renal impairment. Based on
increases in bioavailability and half-life, a dose of 60 mg once daily is
recommended as the starting dose in patients with decreased renal function.
Moderate to severe hepatic disease does not affect the pharmacokinetics of
fexofenadine substantially.
Elderly patient: Adverse events were similar in this group
compared to patients under 65 years of age. Nevertheless, the pharmacokinetics
of fexofenadine is altered (increased bioavailability) in individuals over 65
years of age.
Overdose Effects
Dizziness, drowsiness, fatigue and dry mouth have been
reported with overdose of Fexona. Single doses up to 800 mg and doses up to 690
mg twice daily for 1 month or 240 mg once daily for 1 year have been
administered to healthy subjects without the development of clinically
significant adverse reactions as compared with placebo. The maximum tolerated
dose of Fexona has not been established. Standard measures should be considered
to remove any unabsorbed medicinal product. Symptomatic and supportive
treatment is recommended. Haemodialysis does not effectively remove Fexona from
blood.
Therapeutic Class
Non-sedating antihistamines
Storage Conditions
Keep in a dry place away from light and heat. Keep out of
the reach of children.
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