The medicine for seasonal allergic

The medicine for seasonal allergic

Fexofenadine Hydrochloride

Description

Vifas tablet may be a presentation of Fexofenadine Hydrochloride USP.

Fexofenadine Hydrochloride USP is that the synthetic hydrochloride salt

of fexofenadine, the acid metabolite of terfenadine. It is an

orally active non-sedating H1-receptor antagonist and is effective for

the relief of symptoms related to seasonal rhinitis

(sneezing, rhinorrhea, pruritus and lacrimation).

Composition

Vifas® 60: Each Film coated tablet contains Fexofenadine

Hydrochloride USP 60mg.

Vifas® 120: Each Film coated tablet contains Fexofenadine

Hydrochloride USP 120mg.

Vifas® 180: Each Film coated tablet contains Fexofenadine

Hydrochloride USP 180mg.

Pharmacokinetics

The pharmacokinetics of fexofenadine hydrochloride in subjects with

seasonal rhinitis and subjects with chronic urticaria were

similar to those in healthy subjects.

Absorption:

Fexofenadine hydrochloride was rapidly absorbed following oral

administration of one dose of two 60 mg tablets to healthy male

subjects with a mean solar time to maximum plasma concentration

occurring at 2.6 hours post-dose. After administration of one 60

mg tablet to healthy subjects, the mean maximum plasma

concentration (Cmax) was 131 ng/mL. Following single dose oral

administrations of either the 60 or 180 mg tablet to healthy adult

male subjects, mean Cmax were 142 and 494 ng/mL, respectively.

Fexofenadine hydrochloride pharmacokinetics is linear for oral doses

up to a complete daily dose of 240 mg (120 mg twice daily). Coadministration 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.

Distribution:

Fexofenadine hydrochloride is 60% to 70% sure to plasma proteins,

primarily albumin and α1-acid glycoprotein.

Metabolism:

Approximately 5% of the entire dose of fexofenadine hydrochloride

was eliminated by hepatic metabolism.

Elimination:

The mean elimination half-life of fexofenadine was 14.4 hours

following administration of 60 mg twice daily in healthy subjects.

Human mass balance studies documented a recovery of

approximately 80% and 11% of the fexofenadine hydrochloride dose

in the feces and urine, respectively. Because absolutely the

bioavailability of fexofenadine hydrochloride has not been

established.

Indications

Seasonal rhinitis

Vifas® is indicated for the relief of symptoms related to

seasonal rhinitis in adults and youngsters 6 years aged and

older. Symptoms treated effectively were sneezing, rhinorrhea, itchy

nose/palate/throat, itchy/watery/red eyes.

Chronic Idiopathic Urticaria

Vifas® is indicated for treatment of uncomplicated skin

manifestations of chronic idiopathic urticaria in adults and youngsters 6

years aged and older. It significantly reduces pruritus and therefore the

number of wheals.

Perennial rhinitis

Relief of symptoms related to perennial rhinitis .

Fexofenadine hydrochloride significantly reduces pruritus and therefore the

number of wheals.

Dosage and Administration

Perennial rhinitis

Adults and youngsters aged 12 years and older

The recommended dose of Vifas® is 60 mg twice daily as needed up

to a maximum 120mg once daily, or 180mg once daily. A dose of 60

mg once daily is suggested because the starting dose in patients with

decreased renal function.

Children 6 to 11 years

The recommended dose of Vifas® is 30 mg twice daily. A dose of 30

mg once daily is suggested because the starting dose in pediatric

patients with decreased renal function.

Seasonal rhinitis

Adults and youngsters 12 years and older

The recommended dose of Vifas® is 60 mg twice daily or as needed

up to a maximum 120mg once daily or 180mg once daily. A dose of

60 mg once daily is suggested because the starting dose in patients

with decreased renal function.

Children 6 to 11 years

The recommended dose of Vifas® is 30 mg twice daily. A dose of 30

mg once daily is suggested because the starting dose in pediatric

patients with decreased renal function.

Chronic Idiopathic Urticaria

Adults and youngsters 12 years and older

The recommended dose of Vifas® is 180 mg twice daily. A dose of 60

mg once daily is suggested because the starting dose in patients with

decreased renal function.

Children 6 to 11 years

The recommended dose of Vifas® is 30 mg twice daily. A dose of 30

mg once daily is suggested because the starting dose in pediatric

patients with decreased renal function.

Side Effects

Vifas® is usually well tolerated. In placebo controlled clinical trials

the most commonly reported adverse events were headache (>3%),

drowsiness, nausea, and dizziness (1-3%). The incidence of those

events observed with fexofenadine hydrochloride was almost like that

observed with placebo.

Contraindications

Vifas® is contraindicated in patients with known hypersensitivity to

any of its ingredients.

Pregnancy

There are not any adequate and well controlled studies in pregnant

women. Fexofenadine should be used during pregnancy as long as the

potential benefit justifies the potential risk to the fetus.

Lactation

There are not any 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.

Geriatric Use

Clinical studies of Fexofenadine didn't include sufficient numbers of

subjects aged 65 years and over to work out whether this

population responds differently from younger patients. Other

reported clinical experience has not identified differences in

responses between the geriatric and younger patients. This drug is

known to be substantially excreted by the kidney, and therefore the risk of

toxic reactions to the present drug could also be greater in patients with impaired

renal function. Because elderly patients are more likely to possess

decreased renal function, care should be taken in dose selection,

and may be useful to watch renal function.

Pediatric Use

The safety and effectiveness of fexofenadine hydrochloride in

pediatric patients under six years aged haven't been established.

Drug Interaction

Co-administration of fexofenadine hydrochloride with ketoconazole

and erythromycin increased plasma levels of fexofenadine

hydrochloride. Fexofenadine hydrochloride had no effect on the

pharmacokinetics of erythromycin and ketoconazole.

Vifas® shouldn't be taken closely in time with aluminum and

magnesium containing antacids.

Overdosage

No clinically relevant adverse events are reported. However in

the event of overdosage, symptomatic and supportive treatment is

recommended.

Most reports of fexofenadine hydrochloride overdose contain limited

information. However, dizziness, drowsiness and xerostomia have

been reported. Single doses up to 800 mg and doses up to 690mg

twice daily for 1 month were studied in healthy subjects without the

development of clinically significant adverse events.

Storage Requirement

Store in a cool and dry place below 30 degree celcious keep the product away from light.