Fastofen 120 mg

DOSAGEANDADMINISTRATION

Seasonal Allergic Rhinitis andChronic Idiopathic Urticaria AdultsandChildren12YearsandOlder.TherecommendeddoseofFASTOFEN tabletsis60mg twicedaily withwater.A doseof 60mg oncedaily isrecommended asthe starting doseinpatients withdecreased renal function. Children6to 11Years. TherecommendeddoseofFASTOFEN tabletsis30mgtwicedailywithwater.Adoseof30mg oncedaily isrecommended asthe starting doseinpediatricpatientswithdecreasedrenal function.

CONTRAINDICATIONS

FASTOFEN tablets are contraindicated inpatients with known hypersensitivity to fex of enadineandany of the ingredients of FASTOFEN. Rare cases of hypersensitivityreactionswithmanifestationssuchasangioedema,chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

ADVERSEREACTIONS

Seasonal Allergic Rhinitis Adversereactions insubjectsaged 12yearsandolder: Fexofenadine60mg TwiceDaily Adverseexperiences reportedinpediatric subjectsaged 6yearsto 11yearsFexofenadine30mg TwiceDaily :Headache,AccidentalInjury,Coughing,Fever,Pain,OtitisMedia,UpperRespiratoryTractInfection Adverseexperiences reportedinpediatric subjectswithallergic rhinitisaged 6monthsto 5yearsof age:Vomiting,Pyrexia,Cough,Otitis media,Diarrhoea,Rhinorrhoea,Upperrespiratorytractinfection, Somnolence. Chronic Idiopathic Urticaria Adverseexperiences reportedinsubjects12yearsof age andolder:Fexofenadine60mg TwiceDaily. Dyspepsia,Myalgia, BackPain,Dizziness, Paininextremity. Headach,Nasopharyngitis,Upperrespiratorytractinfection. insomnia,nervousness, andsleep disorders orparoniria. In rarecases, rash,urticaria,pruritusand hypersensitivityreactionswithmanifestations suchasangioedema, chest tightness, dyspnea,flushing and systemic anaphylaxis havebeenreported.

DRUGINTERACTIONS

Drug InteractionwithErythromycin andKetoconazole ketoconazoleorerythromycin leadto increased plasma concentrationsof fexofenadine ketoconazole orerythromycin co-administration enhances fexofenadinegastrointestinal absorption. ketoconazole decreases fexofenadine gastrointestinal secretion,while erythromycin may also decrease biliary excretion. Drug InteractionswithAntacids administrationof fexofenadine hydrochloride within15minutesof analuminum andmagnesiumcontaining antacid decreased fexofenadine AUCby41%andCmax by43%.Fexofenadine hydrochloride should not betakenclosely intime withaluminum andmagnesium containing antacids. InteractionswithFruit Juices Fruitjuicessuchasgrapefruit, orange andapple may reducethe bioavailability andexposureoffexofenadine. Therefore,tomaximizetheeffectsoffexofenadine,itisrecommendedthatFASTOFENTabletsshouldbetaken withwater.

USEINSPECIFICPOPULATIONS

Pregnancy Therearenoadequate andwell controlled studiesinpregnant women. Fexofenadinehydrochloride should be usedduring pregnancy onlyif the potentialbenefit justifies thepotential risktothe fetus. NursingMothers Itisnot knownif fexofenadine isexcretedinhuman milk. Therearenoadequateandwell-controlled studiesin womenduring lactation. Becausemany drugs areexcretedinhuman milk, cautionshould beexercisedwhen fexofenadinehydrochloride isadministered toanursing woman. Pediatric use Thesafety andeffectivenessof fexofenadinehydrochloride inpediatricpatients under6months ofage havenot beenestablished. Geriatricuse Thisdrug isknown tobesubstantially excretedbythekidney, andthe riskof toxicreactionsto thisdrug may be greaterinpatientswithimpaired renal function.Because elderly patientsaremore likely tohavedecreasedrenal function,careshould betakenindoseselection, andit maybeuseful to monitor renal function. Overdose dizziness,drowsiness, anddrymouth havebeen reported. Inthe eventofoverdose, considerstandardmeasures to removeanyunabsorbeddrug. Symptomaticand supportivetreatment isrecommended. Following administration of terfenadine,hemodialysis didnot effectively removefexofenadine, the majoractivemetabolite of terfenadine,from blood (upto1.7%removed). CLINICAL