Minoxidil Tablets - RxList

The recommended initial dosage of minoxidil tablets is 5 mg of minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) given as a single daily ... Minoxidil GenericName:minoxidiltabletsBrandName:Minoxidil DrugClass:Vasodilators LastupdatedonRxList:3/22/2021 home drugsa-zlist sideeffectsdrugcenterminoxidil(minoxidiltablets)drug HealthResources DrugSideEffects PROFESSIONAL CONSUMER SIDEEFFECTS DrugDescription Indications Dosage SideEffects&DrugInteractions Warnings Precautions Overdosage&Contraindications ClinicalPharmacology MedicationGuide DrugDescription FindLowestPriceson WhatisMinoxidilandhowisitused? MinoxidilisaprescriptionmedicineusedtotreatthesymptomsofSevereorRefractoryHypertension(highbloodpressure).Minoxidilmaybeusedaloneorwithothermedications. MinoxidilbelongstoaclassofdrugscalledVasodilators. ItisnotknownifMinoxidilissafeandeffectiveinchildrenyoungerthan12yearsofage. WhatarethepossiblesideeffectsofMinoxidil? Minoxidilmaycauseserioussideeffectsincluding: neworworseningchestpain, chestpainspreadingtoyourjaworshoulder, fastorpoundingheartbeats, swellinginyourlegs,ankles,orfeet, rapidweightgain,especiallyinyourfaceandmidsection, shortnessofbreath, lightheadedness, painwhenyoubreathe, wheezing, gaspingforbreath, coughwithfoamymucus, fever, sorethroat, swellinginyourfaceortongue, burninginyoureyes,and skinpain,followedbyredorpurpleskinrashthatspreadsandcausesblisteringandpeeling Getmedicalhelprightaway,ifyouhaveanyofthesymptomslistedabove. ThemostcommonsideeffectsofMinoxidilinclude: changesincolor,length,orthicknessofbodyorfacialhair, nausea, vomiting, rash,and breastpainortenderness Tellthedoctorifyouhaveanysideeffectthatbothersyouorthatdoesnotgoaway. ThesearenotallthepossiblesideeffectsofMinoxidil.Formoreinformation,askyourdoctororpharmacist. WARNING Minoxidiltabletscontainthepowerfulantihypertensiveagent,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),whichmayproduceseriousadverseeffects.Itcancausepericardialeffusion,occasionallyprogressingtotamponade,andanginapectorismaybeexacerbated.Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)shouldbereservedforhypertensivepatientswhodonotrespondadequatelytomaximumtherapeuticdosesofadiureticandtwootherantihypertensiveagents. Inexperimentalanimals,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)causedseveralkindsofmyocardiallesionsaswellasotheradversecardiaceffects(seeCardiacLesionsinAnimals). Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)mustbeadministeredunderclosesupervision,usuallyconcomitantlywiththerapeuticdosesofabeta-adrenergicblockingagenttopreventtachycardiaandincreasedmyocardialworkload.Itmustalsousuallybegivenwithadiuretic,frequentlyoneactingintheascendinglimboftheloopofHenle,topreventseriousfluidaccumulation.Patientswithmalignanthypertensionandthosealreadyreceivingguanethidine(seeWARNINGS)shouldbehospitalizedwhenminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isfirstadministeredsothattheycanbemonitoredtoavoidtoorapid,orlargeorthostatic,decreasesinbloodpressure. DESCRIPTION Minoxidiltabletscontainminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),anantihypertensiveperipheralvasodilator.Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)occursasawhitetooff-white,crystallinepowder,solubleinalcoholandpropyleneglycol;sparinglysolubleinmethanol;slightlysolubleinwater;practicallyinsolubleinchloroform,acetoneandethylacetate.Thechemicalnameforminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)is2,4-Pyrimidinediamine,6-(1-piperidinyl)-,3-oxide.Thestructuralformulaisrepresentedbelow: C9H15N5O........M.W.209.25 Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletsfororaladministrationcontaineither2.5mgor10mgofminoxidil. Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)TabletsUSP2.5mgand10mgcontainthefollowinginactiveingredients:anhydrouslactose,docusatesodium,magnesiumstearate,microcrystallinecellulose,sodiumbenzoateandsodiumstarchglycolate. Indications INDICATIONS Becauseofthepotentialforseriousadverseeffects,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletsareindicatedonlyinthetreatmentofhypertensionthatissymptomaticorassociatedwithtargetorgandamageandisnotmanageablewithmaximumtherapeuticdosesofadiureticplustwootherantihypertensivedrugs.Atthepresenttimeuseinmilderdegreesofhypertensionisnotrecommendedbecausethebenefit-riskrelationshipinsuchpatientshasnotbeendefined.Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)reducedsupinediastolicbloodpressureby20mmHgorto90mmHgorlessinapproximately75%ofpatients,mostofwhomhadhypertensionthatcouldnotbecontrolledbyotherdrugs. QUESTION Saltandsodiumarethesame. SeeAnswer Dosage DOSAGEANDADMINISTRATION Patientsover12yearsofage Therecommendedinitialdosageofminoxidiltabletsis5mgofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)givenasasingledailydose.Dailydosagecanbeincreasedto10,20andthento40mginsingleordivideddosesifrequiredforoptimumbloodpressurecontrol.Theeffectivedosagerangeisusually10to40mgperday.Themaximumrecommendeddosageis100mgperday. Patientsunder12yearsofage Theinitialdosageis0.2mg/kgminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)asasingledailydose.Thedosagemaybeincreasedin50to100%incrementsuntiloptimumbloodpressurecontrolisachieved.Theeffectivedosagerangeisusually0.25to1mg/kg/day.Themaximumrecommendeddosageis50mgdaily(seePediatricUseunderPRECAUTIONS).Dosefrequency:Themagnitudeofwithin-dayfluctuationofarterialpressure duringtherapywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isdirectlyproportionaltotheextentofpressure reduction.Ifsupinediastolicpressurehasbeenreducedlessthan30mmHg, thedrugneedbeadministeredonlyonceaday;ifsupinediastolicpressure hasbeenreducedmorethan30mmHg,thedailydosageshouldbedividedinto twoequalparts. Frequencyofdosageadjustment Dosagemustbetitratedcarefullyaccordingtoindividualresponse.Intervalsbetweendosageadjustmentsnormallyshouldbeatleast3dayssincethefullresponsetoagivendoseisnotobtainedforatleastthatamountoftime.Whereamorerapidmanagementofhypertensionisrequired,doseadjustmentscanbemadeevery6hoursifthepatientiscarefullymonitored. Concomitanttherapy:Diureticandbeta-blockerorothersympathetic nervoussystemsuppressant. Diuretics:Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)mustbeusedinconjunctionwithadiureticinpatientsrelyingonrenalfunctionformaintainingsaltandwaterbalance.Diureticshavebeenusedatthefollowingdosageswhenstartingtherapywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets):hydrochlorothiazide(50mg,b.i.d.)orotherthiazidesatequieffectivedosage;chlorthalidone(50to100mg,oncedaily);furosemide(40mg,b.i.d.).Ifexcessivesaltandwaterretentionresultsinaweightgainofmorethan5pounds,diuretictherapyshouldbechangedtofurosemide;ifthepatientisalreadytakingfurosemide,dosageshouldbeincreasedinaccordancewiththepatient'srequirements. Beta-blockerorothersympatheticnervoussystemsuppressants Whentherapywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isbegun,thedosageofabeta-adrenergicreceptorblockingdrugshouldbetheequivalentof80to160mgofpropranololperdayindivideddoses. Ifbeta-blockersarecontraindicated,methyldopa(250to750mg,b.i.d.)maybeusedinstead.Methyldopamustbegivenforatleast24hoursbeforestartingtherapywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)becauseofthedelayintheonsetofmethyldopa'saction.Limitedclinicalexperienceindicatesthatclonidinemayalsobeusedtopreventtachycardiainducedbyminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets);theusualdosageis0.1to0.2mgtwicedaily. Sympatheticnervoussystemsuppressantsmaynotcompletelypreventanincreaseinheartrateduetominoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)butusuallydopreventtachycardia.Typically,patientsreceivingabeta-blockerpriortoinitiationoftherapywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)haveabradycardiaandcanbeexpectedtohaveanincreaseinheartratetowardnormalwhenminoxidilisadded.Whentreatmentwithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)andbeta-blockerorothersympatheticnervoussystemsuppressantarebegunsimultaneously,theiropposingcardiaceffectsusuallynullifyeachother,leadingtolittlechangeinheartrate. HOWSUPPLIED Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)TabletsUSP2.5mgare9/32",scored,round,whitetabletsimprinted"DAN5642"and"2.5"suppliedinbottlesof100and500. Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)TabletsUSP10mgare9/32",scored,round,whitetabletsimprinted"DAN5643"and"10"suppliedinbottlesof100and500. Dispenseinatightcontainerwithchild-resistantclosure. Storeatcontrolledroomtemperature15°-30°C(59°-86°F). WatsonLaboratories,Inc.Corona,CA92880,USA.Revised:October2002.FDARevdate:6/8/2001 SideEffects&DrugInteractions SIDEEFFECTS SaltandWaterRetention(seeWARNINGS: ConcomitantUseofanAdequateDiureticisRequired)-Temporaryedemadeveloped in7%ofpatientswhowerenotedematousatthestartoftherapy. Pericarditis,PericardialEffusion,andTamponade(seeWARNINGS). Dermatologic-Hypertrichosis-Elongation,thickening,andenhanced pigmentationoffinebodyhairareseeninabout80%ofpatientstakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets) tablets.Thisdevelopswithin3to6weeksafterstartingtherapy.Itisusually firstnoticedonthetemples,betweentheeyebrows,betweenthehairlineand theeyebrows,orintheside-burnareaoftheupperlateralcheek,laterextending totheback,arms,legs,andscalp.Upondiscontinuationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),new hairgrowthstops,but1to6monthsmayberequiredforrestorationtopretreatment appearance.Noendocrineabnormalitieshavebeenfoundtoexplaintheabnormal hairgrowth;thus,itishypertrichosiswithoutvirilism.Hairgrowthisespecially disturbingtochildrenandwomenandsuchpatientsshouldbethoroughlyinformed aboutthiseffectbeforetherapywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isbegun.Allergic-Rashes havebeenreported,includingrarereportsofbullouseruptions,andStevens-JohnsonSyndrome. Hematologic-Thrombocytopeniaandleukopenia(WBC<3000/mm3) haverarelybeenreported. Gastrointestinal-Nauseaand/orvomitinghasbeenreported.Inclinical trialstheincidenceofnauseaandvomitingassociatedwiththeunderlying diseasehasshownadecreasefrompretriallevels. Miscellaneous-Breasttenderness-Thisdevelopedinlessthan1%of patients. AlteredLaboratoryFindings-(a)ECGchanges-ChangesindirectionandmagnitudeoftheECGT-wavesoccurinapproximately60%ofpatientstreatedwithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).InrareinstancesalargenegativeamplitudeoftheT-wavemayencroachupontheS-Tsegment,buttheS-Tsegmentisnotindependentlyaltered.Thesechangesusuallydisappearwithcontinuanceoftreatmentandreverttothepretreatmentstateifminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isdiscontinued.Nosymptomshavebeenassociatedwiththesechanges,norhavetherebeenalterationsinbloodcellcountsorinplasmaenzymeconcentrationsthatwouldsuggestmyocardialdamage.Long-termtreatmentofpatientsmanifestingsuchchangeshasprovided noevidenceofdeterioratingcardiacfunction.Atpresentthechangesappear tobenonspecificandwithoutidentifiableclinicalsignificance.(b)-Effects ofhemodilution-hematocrit,hemoglobinanderythrocytecountusuallyfall about7%initiallyandthenrecovertopretreatmentlevels.(c)Other-Alkaline phosphataseincreasedvaryinglywithoutotherevidenceofliverorboneabnormality. Serumcreatinineincreasedanaverageof6%andBUNslightlymore,butlater declinedtopretreatmentlevels. DRUGINTERACTIONS See"InteractionwithGuanethidine"underWARNINGS. SLIDESHOW HowtoLowerBloodPressure:ExerciseTips SeeSlideshow Warnings WARNINGS SaltandWaterRetention CongestiveHeartFailure-concomitantuseofanadequatediureticis required-Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletsmustusuallybeadministeredconcomitantlywitha diureticadequatetopreventfluidretentionandpossiblecongestiveheartfailure; ahighceiling(loop)diureticisalmostalwaysrequired.Bodyweightshould bemonitoredclosely.Ifminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isusedwithoutadiuretic,retentionof severalhundredmilliequivalentsofsaltandcorrespondingvolumesofwater canoccurwithinafewdays,leadingtoincreasedplasmaandinterstitialfluid volumeandlocalorgeneralizededema.Diuretictreatmentalone,orincombination withrestrictedsaltintake,willusuallyminimizefluidretention,although reversibleedemadiddevelopinapproximately10%ofnondialysispatientsso treated.Asciteshasalsobeenreported.Diureticeffectivenesswaslimited mostlybydisease-relatedimpairedrenalfunction.Theconditionofpatients withpre-existingcongestiveheartfailureoccasionallydeterioratedinassociation withfluidretentionalthoughbecauseofthefallinbloodpressure(reductionofafterload),morethantwiceasmanyimprovedthanworsened.Rarely,refractory fluidretentionmayrequirediscontinuationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).Providedthatthepatientisunderclosemedicalsupervision,itmaybepossibletoresolverefractorysaltretentionbydiscontinuingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)for1or2daysandthenresumingtreatmentinconjunctionwithvigorousdiuretictherapy. ConcomitantTreatmenttoPreventTachycardiaisUsuallyRequired Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)increasestheheartrate.Anginamayworsenorappearforthefirsttimeduringminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)treatment,probablybecauseoftheincreasedoxygendemandsassociatedwithincreasedheartrateandcardiacoutput.Theincreaseinrateandtheoccurrenceofanginagenerallycanbepreventedbytheconcomitantadministrationofabeta-adrenergicblockingdrugorothersympatheticnervoussystemsuppressant.Theabilityofbeta-adrenergicblockingagentstominimizepapillarymusclelesionsinanimalsisfurtherreasontoutilizesuchanagentconcomitantly.Round-the-clockeffectivenessofthesympatheticsuppressantshouldbeensured. Pericarditis,PericardialEffusion,andTamponade Therehavebeenreportsofpericarditisoccurringinassociationwiththeuseofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).Therelationshipofthisassociationtorenalstatusisuncertain.Pericardialeffusion,occasionallywithtamponade,hasbeenobservedinabout3%oftreatedpatientsnotondialysis,especiallythosewithinadequateorcompromisedrenalfunction.Althoughinmanycases,thepericardialeffusionwasassociatedwithaconnectivetissuedisease,theuremicsyndrome,congestiveheartfailure,ormarkedfluidretention,therehavebeeninstancesinwhichthesepotentialcausesofeffusionwerenotpresent.Patientsshouldbeobservedcloselyforanysuggestionofapericardialdisorder,andechocardiographicstudiesshouldbecarriedoutifsuspicionarises.Morevigorousdiuretictherapy,dialysis,pericardiocentesis,orsurgerymayberequired.Iftheeffusionpersists,withdrawalofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)shouldbeconsideredinlightofothermeansofcontrollingthehypertensionandthepatient'sclinicalstatus. InteractionwithGuanethidine Althoughminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)doesnotitselfcauseorthostatichypotension,itsadministrationtopatientsalreadyreceivingguanethidinecanresultinprofoundorthostaticeffects.Ifatallpossible,guanethidineshouldbediscontinuedwellbeforeminoxidilisbegun.Wherethisisnotpossible,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)therapyshouldbestartedinthehospitalandthepatientshouldremaininstitutionalizeduntilsevereorthostaticeffectsarenolongerpresentorthepatienthaslearnedtoavoidactivitiesthatprovokethem. HazardofRapidControlofBloodPressure Inpatientswithveryseverebloodpressureelevation,toorapidcontrolofbloodpressure,especiallywithintravenousagents,canprecipitatesyncope,cerebrovascularaccidents,myocardialinfarctionandischemiaofspecialsenseorganswithresultingdecreaseorlossofvisionorhearing.Patientswithcompromisedcirculationorcryoglobulinemiamayalsosufferischemicepisodesoftheaffectedorgans.Althoughsucheventshavenotbeenunequivocallyassociatedwithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)use,totalexperienceislimitedatpresent. Anypatientwithmalignanthypertensionshouldhaveinitialtreatmentwith minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)carriedoutinahospitalsetting,bothtoassurethatbloodpressure isfallingandtoassurethatitisnotfallingmorerapidlythanintended. Precautions PRECAUTIONS GeneralPrecautions Monitorfluidandelectrolytebalanceandbodyweight(seeWARNINGS: SaltandWaterRetention). Observepatientsforsignsandsymptomsofpericardialeffusion(seeWARNINGS: Pericarditis,PericardialEffusion,andTamponade). Useaftermyocardialinfarction-Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletshavenotbeenusedin patientswhohavehadamyocardialinfarctionwithintheprecedingmonth. Itispossiblethatareductionofarterialpressurewithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)might furtherlimitbloodflowtothemyocardium,althoughthismightbecompensated bydecreasedoxygendemandbecauseoflowerbloodpressure. Hypersensitivity-Possiblehypersensitivitytominoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),manifestedas askinrash,hasbeenseeninlessthan1%ofpatients;whetherthedrugshould bediscontinuedwhenthisoccursdependsontreatmentalternatives. Renalfailureordialysispatientsmayrequiresmallerdosesofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets) andshouldhaveclosemedicalsupervisiontopreventexacerbationofrenal failureorprecipitationofcardiacfailure. InformationforPatients Thepatientshouldbefullyawareoftheimportanceofcontinuingallofhisantihypertensivemedicationsandofthenatureofsymptomsthatwouldsuggestfluidoverload.Apatientbrochurehasbeenpreparedandisincludedwitheachminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)package.Thetextofthisbrochureisreprintedattheendoftheinsert. LaboratoryTests Thoselaboratorytestswhichareabnormalatthetimeofinitiationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)therapy,suchasurinalysis,renalfunctiontests,EKG,chestx-ray,echocardiogram,etc.,shouldberepeatedatintervalstoascertainwhetherimprovementordeteriorationisoccurringunderminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)therapy.Initiallysuchtestsshouldbeperformedfrequently,e.g.,1-3monthintervals;laterasstabilizationoccurs,atintervalsof6-12months. Carcinogenesis,Mutagenesis,andImpairmentofFertility Two-yearcarcinogenicitystudiesofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)havebeenconductedbythedermalandoral(dietary)routesofadministrationinmiceandrats.Therewerenopositivefindingswiththeoral(dietary)routeofadministrationinrats. Inthetwo-yeardermalstudyinmice,anincreasedincidenceofmammaryadenomas andadenocarcinomasinthefemalesatalldoselevels(8,25and80mg/kg/day) wasattributedtoincreasedprolactinactivity. Hyperprolactinemiaisawell-knownmechanismintheenhancementofmousemammary tumors,buthasnotbeenassociatedwithmammarytumorigenesisinwomen.Additionally, topicalminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)hasnotbeenshowntocausehyperprolactinemiainwomenon clinicaltrials.Absorptionofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)throughrodentskinisgreaterthan wouldbeexperiencedbypatientstreatedtopicallywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)forhairloss. Dietaryadministrationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tomiceforupto2yearswasassociated withanincreasedincidenceofmalignantIymphomasinfemalesatalldoselevels (10,25and63mg/kg/day)andanincreasedincidenceofhepaticnodulesinmales (63mg/kg/day).Therewasnoeffectofdietaryminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)ontheincidenceof malignantlivertumors. Inthetwo-yeardermalstudyinratsthereweresignificantincreasesinincidence ofpheochromocytomasinmalesandfemalesandpreputialglandadenomasinmales. Changesinincidenceofneoplasmsfoundtobeincreasedinthedermalororal carcinogenicitystudiesweretypicalofthoseexpectedinrodentstreatedwith otherhypotensiveagents(adrenalpheochromocytomasinrats),treatment-related hormonalalterations(mammarycarcinomasinfemalemice;preputialglandadenomas inmalerats)orrepresentativeofnormalvariationswithintherangeofhistorical incidenceforrodentneoplasms(malignantIymphomas,livernodules/adenomas inmice).Basedondifferencesinabsorptionofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)andmechanismsof tumorigenesisintheserodentspecies,noneofthesechangeswereconsidered toberelevanttothesafetyofpatientstreatedtopicallywithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)for hairloss. Therewasnoevidenceofepithelialhyperplasiaortumorigenesisatthesites oftopicalapplicationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)ineitherspeciesinthetwo-yeardermal carcinogenesisstudies.Noevidenceofcarcinogenicitywasdetectedinrats orrabbitstreatedtopicallywithminoxidilforoneyear.Topicalminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets) (2%and5%)didnotsignificantly(p<0.05)reducethelatencyperiodofUV light-initiatedskintumorsinhairlessmice,ascomparedtocontrols,ina 12-monthphotocarcinogenicitystudy. Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)wasnotmutagenicintheSalmonella(Ames)test,theDNAdamagealkaline elutionassay,theinvitrorathepatocyteunscheduledDNAsynthesis (UDS)assay,theratbonemarrowmicronucleusassay,orthemousebonemarrow micronucleusassay.Anequivocalresultwasrecordedinaninvitrocytogenetic assayusingChinesehamstercellsatlongexposuretimes,butasimilarassay usinghumanlymphocyteswasnegative. Inastudyinwhichmaleandfemaleratsreceivedoneorfivetimesthemaximumrecommendedhumanoralantihypertensivedoseofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)(multiplesbasedona50kgpatient)therewasadose-dependentreductioninconceptionrate. Pregnancy TeratogenicEffects PregnancyCategoryC.Oraladministrationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)hasbeenassociatedwithevidenceofincreasedfetalresorptioninrabbits,butnotrats,whenadministeredatfivetimesthemaximumrecommendedoralantihypertensivehumandose.Therewasnoevidenceofteratogeniceffectsinratsandrabbits.Subcutaneousadministrationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)topregnantratsat80mg/kg/daywasmaternallytoxicbutnotteratogenic.Highersubcutaneousdosesproducedevidenceofdevelopmentaltoxicity.Therearenoadequateandwellcontrolledstudiesinpregnantwomen.Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)shouldbeusedduringpregnancyonlyifthepotentialbenefitjustifiesthepotentialrisktothefetus. Laboranddelivery Theeffectsonlaboranddeliveryareunknown. NursingMothers Therehasbeenonereportofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)excretioninthebreastmilkofawomantreatedwith5mgoralminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)twicedailyforhypertension.Becauseofthepotentialforadverseeffectsinnursinginfantsfromminoxidilabsorption,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)shouldnotbeadministeredtoanursingwoman. PediatricUse Useinpediatricpatientshasbeenlimitedtodate,particularlyininfants. TherecommendationsunderDOSAGEANDADMINISTRATIONcanbeconsidered onlyaroughguideatpresentandacarefultitrationisessential. GeriatricUse Clinicalstudiesofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletsdidnotincludesufficientnumbersofsubjectsaged65andovertodeterminewhethertheyresponddifferentlyfromyoungersubjects.Otherreportedclinicalexperiencehasnotidentifieddifferencesinresponsesbetweentheelderlyandyoungerpatients.Ingeneral,doseselectionforanelderlypatientshouldbecautious,usuallystartingatthelowendofthedosingrange,reflectingthegreaterfrequencyofdecreasedhepatic,renal,orcardiacfunction,andofconcomitantdiseaseorotherdrugtherapy. UnapprovedUse Useofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tablets,inanyformulation,topromotehairgrowthisnot anapprovedindication.Whileclinicaltrialswithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)topicalsolution 2%demonstratedthatformulationanddosageweresafeandeffective,theeffects ofextemporaneousformulationsanddosageshavenotbeenshowntobesafeor effective.Becausesystemicabsorptionoftopicallyapplieddrugmayoccurand isdependentonvehicleand/ormethodofuse,extemporaneoustopicalformulations madefromminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)shouldbeconsideredtoshareinthefullrangeofCONTRAINDICATIONS, WARNINGS,PRECAUTIONS,andADVERSEREACTIONS listedinthisinsert.Inaddition,skinintolerancetodrugand/orvehicle mayoccur. Overdosage&Contraindications OVERDOSE Therehavebeenonlyafewinstancesofdeliberateoraccidentaloverdosagewithminoxidiltablets.Onepatientrecoveredaftertaking50mgofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)togetherwith500mgofabarbiturate.Whenexaggeratedhypotensionisencountered,itismostlikelytooccurinassociationwithresidualsympatheticnervoussystemblockadefromprevioustherapy(guanethidine-likeeffectsoralpha-adrenergicblockage),whichpreventstheusualcompensatorymaintenanceofbloodpressure.Intravenousadministrationofnormalsalinewillhelptomaintainbloodpressureandfacilitateurineformationinthesepatients.Sympathomimeticdrugssuchasnorepinephrineorepinephrineshouldbeavoidedbecauseoftheirexcessivecardiacstimulatingaction.Phenylephrine,angiotensinll,vasopressin,anddopamineallreversehypotensionduetominoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),butshouldonlybeusedifunderperfusionofavitalorganisevident. Radioimmunoassaycanbeperformedtodeterminetheconcentrationofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)intheblood.Atthemaximumadultdoseof100mg/day,peakbloodlevelsof1641ng/mLand2441ng/mLwereobservedintwopatients,respectively.Duetopatient-to-patientvariationinbloodlevels,itisdifficulttoestablishanoverdosagewarninglevel.Ingeneral,asubstantialincreaseabove2000ng/mLshouldberegardedasoverdosage,unlessthephysicianisawarethatthepatienthastakennomorethanthemaximumdose. OralLD50inratshasrangedfrom1321-3492mg/kg;inmice,2456-2648 mg/kg. CONTRAINDICATIONS Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletsarecontraindicatedinpheochromocytoma,becauseitmaystimulatesecretionofcatecholaminesfromthetumorthroughitsantihypertensiveaction.Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)iscontraindicatedinthosepatientswithahistoryofhypersensitivitytoanyofthecomponentsofthepreparation. ClinicalPharmacology CLINICALPHARMACOLOGY GeneralPharmacologicProperties Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isanorallyeffectivedirectactingperipheralvasodilatorthatreduceselevatedsystolicanddiastolicbloodpressurebydecreasingperipheralvascularresistance.Microcirculatorybloodflowinanimalsisenhancedormaintainedinallsystemicvascularbeds.Inman,forearmandrenalvascularresistancedecline;forearmbloodflowincreaseswhilerenalbloodflowandglomerularfiltrationratearepreserved. Becauseitcausesperipheralvasodilation,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)elicitsanumberofpredictablereactions.Reductionofperipheralarteriolarresistanceandtheassociatedfallinbloodpressuretriggersympathetic,vagalinhibitory,andrenalhomeostaticmechanisms,includinganincreaseinreninsecretion,thatleadtoincreasedcardiacrateandoutputandsaltandwaterretention.Theseadverseeffectscanusuallybeminimizedbyconcomitantadministrationofadiureticandabeta-adrenergicblockingagentorothersympatheticnervoussystemsuppressant. Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)doesnotinterferewithvasomotorreflexesandthereforedoesnotproduceorthostatichypotension.Thedrugdoesnotenterthecentralnervoussysteminexperimentalanimalsinsignificantamounts,anditdoesnotaffectCNSfunctioninman. EffectsonBloodPressureandTargetOrgans Theextentandtime-courseofbloodpressurereductionbyminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)donot correspondcloselytoitsconcentrationinplasma.Afteraneffectivesingle oraldose,bloodpressureusuallystartstodeclinewithinone-halfhour,reaches aminimumbetween2and3hoursandrecoversatanarithmeticallylinearrate ofabout30%/day.Thetotaldurationofeffectisapproximately75hours.When minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isadministeredchronically,onceortwiceaday,thetimerequired toachievemaximumeffectonbloodpressurewithagivendailydoseisinversely relatedtothesizeofthedose.Thus,maximumeffectisachievedon10mg/day within7days,on20mg/daywithin5days,andon40mg/daywithin3days. Thebloodpressureresponsetominoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)islinearlyrelatedtothelogarithmofthedoseadministered.Theslopeofthislog-lineardose-responserelationshipisproportionaltotheextentofhypertensionandapproacheszeroatasupinediastolicbloodpressureofapproximately85mmHg. Whenusedinseverelyhypertensivepatientsresistanttoothertherapy,frequentlywithanaccompanyingdiureticandbeta-blocker,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletsusuallydecreasedthebloodpressureandreversedencephalopathyandretinopathy. AbsorptionandMetabolism Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isatleast90%absorbedfromtheGltractinexperimentalanimalsandman.Plasmalevelsoftheparentdrugreachmaximumwithinthefirsthouranddeclinerapidlythereafter.Theaverageplasmahalf-lifeinmanis4.2hours.Approximately90%oftheadministereddrugismetabolized,predominantlybyconjugationwithglucuronicacidattheN-oxidepositioninthepyrimidinering,butalsobyconversiontomorepolarproducts.Knownmetabolitesexertmuchlesspharmacologiceffectthanminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)itself;allareexcretedprincipallyintheurine.Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)doesnotbindtoplasmaproteins,anditsrenalclearancecorrespondstotheglomerularfiltrationrate.Intheabsenceoffunctionalrenaltissue,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)anditsmetabolitescanberemovedbyhemodialysis. CardiacLesionsinAnimals Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)producesseveralcardiaclesionsinanimals.Somearecharacteristicofagentsthatcausetachycardiaanddiastolichypotension(beta-agonistslikeisoproterenol,arterialdilatorslikehydralazine)whileothersareproducedbyanarrowerrangeofagentswitharterialdilatingproperties.Thesignificanceoftheselesionsforhumansisnotclear,astheyhavenotbeenrecognizedinpatientstreatedwithoralminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)atsystemicallyactivedoses,despiteformalreviewofover150autopsiesoftreatedpatients. Papillarymuscle/subendocardialnecrosis Themostcharacteristiclesionofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),seeninrat,dog,andminipig(butnotmonkeys)isfocalnecrosisofthepapillarymuscleandsubendocardialareasoftheleftventricle.Theselesionsappearrapidly,withinafewdaysoftreatmentwithdosesof0.5to10mg/kg/dayinthedogandminipig,andarenotprogressive,althoughtheyleaveresidualscars.Theyaresimilartolesionsproducedbyotherperipheralarterialdilators,bytheobromine,andbybeta-adrenergicreceptoragonistssuchasisoproterenol,epinephrine,andalbuterol.Thelesionsarethoughttoreflectischemiaprovokedbyincreasedoxygendemand(tachycardia,increasedcardiacoutput)andrelativedecreaseincoronaryflow(decreaseddiastolicpressureanddecreasedtimeindiastole)causedbythevasodilatoryeffectsoftheseagentscoupledwithreflexordirectlyinducedtachycardia. Hemorrhagiclesions Afteracuteoralminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)treatment(0.5to10mg/kg/day)indogsandminipigs,hemorrhagiclesionsareseeninmanypartsoftheheart,mainlyintheepicardium,endocardium,andwallsofsmallcoronaryarteriesandarterioles.Inminipigsthelesionsoccurprimarilyintheleftatriumwhileindogstheyaremostprominentintherightatrium,frequentlyappearingasgrosslyvisiblehemorrhagiclesions.Withexposureof1-20mg/kg/dayinthedogfor30daysorlonger,thereisreplacementofmyocardialcellsbyproliferatingfibroblastsandangioblasts,hemorrhageandhemosiderinaccumulation.Theselesionscanbeproducedbytopicalminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)administrationthatgivessystemicabsorptionof0.5to1mg/kg/day.Otherperipheraldilators,includinganexperimentalagent,nicorandil,andtheobromine,haveproducedsimilarlesions. Epicarditis Alessfullystudiedlesionisfocalepicarditis,seenindogsafter2daysoforalminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).Morerecently,chronicproliferativeepicarditiswasobservedindogstreatedtopicallytwiceadayfor90days.Inaoneyearoraldogstudy,serosanguinouspericardialfluidwasseen. HypertrophyandDilation Oralandtopicalstudiesinrats,dogs,monkeys(oralonly),andrabbits(dermalonly)showcardiachypertrophyanddilation.Thisispresumedtorepresenttheconsequencesofprolongedfluidoverload;thereispreliminaryevidenceinmonkeysthatdiureticspartlyreversetheseeffects. Autopsiesofover150patientswhodiedofvariouscausesafterreceivingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)forhypertensionhavenotrevealedthecharacteristichemorrhagic(especiallyatrial)lesionsseenindogsandminipigs.Whileareasofpapillarymuscleandsubendocardialnecrosiswereoccasionallyseen,theyoccurredinthepresenceofknownpre-existingcoronaryarterydiseaseandwerealsoseeninpatientsneverexposedtominoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)inanotherseriesusingsimilar,butnotidentical,autopsymethods. MedicationGuide PATIENTINFORMATION Minoxidiltabletscontainminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),amedicineforthetreatmentofhighbloodpressureinthepatientwhohasnotbeencontrolledorisexperiencingunacceptablesideeffectswithothermedications.Itmustusuallybetakenwithothermedicines. Beabsolutelysuretotakeallofyourmedicinesforhighbloodpressureaccordingtoyourdoctor'sinstructions.Donotstoptakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)unlessyourdoctortellsyouto.Donotgiveanyofyourmedicinetootherpeople. Itisimportantthatyoulookforthewarningsignalsofcertainundesiredeffectsofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).Callyourdoctoriftheyoccur.Yourdoctorwillneedtoseeyouregularlywhileyouaretakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).Besuretokeepallyourappointmentsortoarrangefornewonesifyoumustmissone. Donothesitatetocallyourdoctorifanydiscomfortsorproblemsoccur. Theinformationhereisintendedtohelpyoutakeminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)properly.Itdoesnottellyouallthereistoknowaboutminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).Thereisamoretechnicalleafletthatyoumayrequestfromthepharmacist;youmayneedyourdoctor'shelpinunderstandingpartsofthatleaflet. WhatisMinoxidil? Minoxidiltabletscontainminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)whichisadrugforloweringthebloodpressure.Itworksbyrelaxingandenlargingcertainsmallbloodvesselssothatbloodflowsthroughthemmoreeasily. Whylowerbloodpressure? Yourdoctorhasprescribedminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)toloweryourbloodpressureandprotectvitalpartsofyourbody.Uncontrolledbloodpressurecancausestroke,heartfailure,blindness,kidneyfailure,andheartattacks. Mostpeoplewithhighbloodpressureneedtotakemedicinestotreatitfortheirwholelives. WhoshouldtakeMinoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)Tablets? Therearemanypeoplewithhighbloodpressure,butmostofthemdonotneedminoxidil.Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)isusedONLYwhenyourdoctordecidesthat: yourhighbloodpressureissevere; yourhighbloodpressureiscausingsymptomsordamagetovitalorgans; and othermedicinesdidnotworkwellenoughorhadverydisturbingsideeffects. Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)shouldbetakenonlywhenadoctorprescribesit.Nevergiveanyofyourminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tablets,oranyotherhighbloodpressuremedicine,toafriendorrelative. Pregnancy:Insomecasesdoctorsmayprescribeminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)forwomenwho arepregnantorwhoareplanningtohavechildren.However,itssafeusein pregnancyhasnotbeenestablished.Laboratoryanimalshadareducedabilitytobecomepregnantandareducedsurvivalofoffspringwhiletakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets). Ifyouarepregnantorareplanningtobecomepregnant,besuretotellyourdoctor. HowtotakeMinoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)Tablets? Usually,yourdoctorwillprescribetwoothermedicinesalongwithminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets).Thesewillhelplowerbloodpressureandwillhelppreventundesiredeffectsofminoxidil. Often,whenamedicinelikeminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)lowersbloodpressure,yourbodytriestoreturnthebloodpressuretotheoriginalhigherlevel.Itdoesthisbyholdingontowaterandsalt(sotherewillbemorefluidtopump)andbymakingyourheartbeatfaster.Topreventthis,yourdoctorwillusuallyprescribeawatertablettoremovetheextrasaltandwaterfromyourbody(adiuretic:dye-u-RET-tic)andanothermedicinetoslowyourheartbeat. Youmustfollowyourdoctor'sinstructionsexactly,takingalltheprescribedmedicines,intherightamounts,eachday. Thesemedicineswillhelpkeepyourbloodpressuredown.Thewatertabletandheartbeatmedicinewillhelppreventtheundesiredeffectsofminoxidil. Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletscomeintwostrengths(2.5milligramsand10milligrams)thataremarkedoneachtablet.Paycloseattentiontothetabletmarkingstobesureyouaretakingthecorrectstrength.Yourdoctormayprescribehalfatablet;thetabletsarescored(partlycutononeside)sothatyoucaneasilybreakthem. Whenyoufirststarttakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),yourdoctormayneedtoseeyouofteninordertoadjustyourdosage.Takeallyourmedicineaccordingtothescheduleprescribedbyyourdoctor.Donotskipanydoses.Ifyoushouldforgetadoseofminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets),waituntilitistimeforyournextdose,thencontinuewithyourregularschedule.Remember:donotstoptakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tablets,oranyotherhighbloodpressuremedicines,withoutcheckingwithyourdoctor.Makesurethatanydoctortreatingorexaminingyouknowsthatyouaretakinghighbloodpressuremedicines,includingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets). WARNINGSIGNALS Evenifyoutakeallyourmedicinescorrectly,minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletsmaycauseundesiredeffects.Someoftheseareseriousandyoushouldbeonthelookoutforthem.Ifanyofthefollowingwarningsignalsoccur,youmustcallyourdoctorimmediately: 1.Increaseinheartrate-Youshouldmeasureyourheartratebycountingyourpulseratewhileyouareresting.Ifyouhaveanincreaseof20beatsormoreaminuteoveryournormalpulse,contactyourdoctorimmediately.Ifyoudonotknowhowtotakeyourpulserate,askyourdoctor.Alsoaskyourdoctorhowoftentocheckyourpulse. 2.Rapidweightgainofmorethan5pounds-Youshouldweighyourselfdaily.Ifyouquicklygainfiveormorepounds,orifthereisanyswellingorpuffinessintheface,hands,ankles,orstomacharea,thiscouldbeasignthatyouareretainingbodyfluids.Yourdoctormayhavetochangeyourdrugsorchangethedoseofyourdrugs.Youmayalsoneedtoreducetheamountofsaltyoueat.Asmallerweightgain(2to3pounds)oftenoccurswhentreatmentisstarted. Youmaylosethisextraweightwithcontinuedtreatment. 3.Increaseddifficultyinbreathing,especiallywhenIyingdown.Thistoo maybeduetoanincreaseofbodyfluids.Itcanalsohappenbecauseyourhigh bloodpressureisgettingworse.Ineithercase,youmightrequiretreatment withothermedicines. 4.Neworworseningofpaininthechest,arm,orshoulderorsignsofsevereindigestion-Thesecouldbesignsofseriousheartproblems. 5.Dizziness,lightheadednessorfainting-Thesecanbesignsofhighblood pressureortheymaybesideeffectsfromoneofthemedicines.Yourdoctor mayneedtochangeoradjustthedosageofthemedicinesyouaretaking. OTHERUNDESIREDEFFECTS Minoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tabletscancauseotherundesiredeffectssuchasnauseaand/orvomiting thatareannoyingbutnotdangerous.Donotstoptakingthedrugbecauseof theseotherundesiredeffectswithouttalkingtoyourdoctor. Hairgrowth:About8outofevery10patientswhohavetakenminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets) noticedthatfinebodyhairgrewdarkerorlongeroncertainpartsofthebody. Thishappenedabout3to6weeksafterbeginningtreatment.Thehairmayfirst benoticedontheforeheadandtemples,betweentheeyebrows,orontheupper partofthecheeks.Later,hairmaygrowontheback,arms,legs,orscalp. Althoughhairgrowthmaynotbenoticeabletosomepatients,itoftenisbothersome inwomenandchildren.Unwantedhaircanbecontrolledwithahairremoveror byshaving.Theextrahairisnotpermanent,itdisappearswithin1to6months ofstoppingminoxidil.Nevertheless,youshouldnotstoptakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets)tablets withoutfirsttalkingtoyourdoctor. Afewpatientshavedevelopedarashorbreasttendernesswhiletakingminoxidil(minoxidil(minoxidil(minoxidiltablets)tablets)tablets) tablets,butthisisunusual.Storeatcontrolledroomtemperature15°-30°C (59°-86°F). 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