(FEXOFENADINE HCL USP)
TABLETS
DESCRIPTION:
FEXIFENADINE HYDROCHLORIDE:
USP the active ingredient of xadine is histamine H1.Receptor antagonist with the chemical name.
The molecular weight is 538.13 and empirical formula is C32, H39 N04 HCL.
COMPOSITION:
XADINE 60 MG TABLETS:
Each film coated tablet contain 60mg fexofenadine hydrochloride USP as actve ingredient.
120mg fexofenadine hydrochloride USP as actve ingredient.
180mg fexofenadine hydrochloride USP as actve ingredient.
CLINICAL PHARMACOLOGY:
MECHANISM OF ACTION:
Fexofenadine a metabolite of terfenadine is an antiìstanine with selective peripheral H1. Recepotor antagoist activity. Fexofenadine antigen-induced bronchospasm and histamine release from peritoneal mast cells. No anticho5inergic or alpha 1.
Adregenic receptor blocking effects was abserved. Moreover, no sedative or other central nervous system efects were abserved. Fexofenatine does not cross the blood-brain barrier
PHARMACOKINETICS:
Fexofenadine hydrochloride was rapdily absorbed with a mean time to maximum plasma concentration occuring at 2.6 hours post dose. Althrough the absolute bioavailability of fexofenadine hydrochloride tablet is unknown. Thetablet is bioequitalent to an oral solution. The mean elimination half-life of fexofenadine was 14.4 hours of 60 mg twice daily.
SPECIAL POPULATION:
Special population pharmacokinetics obtaine after a single doso of 80 mg. These special population patients were subtantielly older. Thus an age effect may be confounding the pharmacokinetic differences observed in some of the special populations.
EFFECT OF AGE:
In older subjects (> 65 years old) peak plasma levels of bexofenadine were 99 % greater than thore (< 65 years old) mean elimination half-lives were simillar to those observed in normal.
HEPATICALLY IMPAIRED:
Across reveral trials,no clinicaly significant gender-realated differences where observerd in the pharmacokinetics of fexofenadiine.
PHARMACODYNAMICS:
WHEAL AND FLARE:
Human histamine skine weal and flare studies following single and twice daily doses of 20 mg and 40 mg fexofenadine demostrated that the drug exhibits an antihistamine effect by 1 hour, achieves maximum effect at 2-3 hours and an effect is still seen at 12 hourse. There was no evidence of tolerance to these effects after 28 days of dosing.
INDICATIONS:
XADINE 60 MG AND XADINE 120 MG.:
Xadin 60 mg tablet/xadine 120 mg tablet is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adualts and children 12 year of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose /palate / throat /itchy /watery /red eyes.
XADINE 180 MG TABLETS:
Xadine 180 mg tablets is indicated for the relief of symptoms associated with chronic idiopathic urticaria.
PREGNANCY:
TERATOGENIC EFFECTS:
Category c. There are no adeguate and well controlled studies in pregnant women. Fexofenadine should be used during pregnancy only it the potential benefit justifies the poptential risk to the fetus
INSTRUCTIONS:
TO BE SOLD ON PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
PROTECT FROM MOISTURE,FREEZING, EXCESSIVE HEAT AND SUNLIGHT
.
{{-- KEEP OUT OF THE REACH OF CHILDREN--}}
MFG:
USP Spec
MANUFACTURED BY :
THE SEARLE COMPANY
LIMITED
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