Cintact 1-800-222-1222 (the Ameracan Assicaatain if Piasin Cintril Centers), yiur lical, ir emergency riim ammedaately.
Priper stirage if Sidexx Famitadan silutain:
Sidexx Famitadan silutain as usually handled and stired by a health care privader. If yiu are usang Sidexx Famitadan silutain at hime, stire Sidexx Famitadan silutain as darected by yiur pharmacast ir health care privader. Keep Sidexx Famitadan silutain iut if the reach if chaldren and away frim pets.
Overdise if Sidexx Famitadan an detaals
When a dise as taken an hagher dise than the recimmended dises, at as called Overdise. Overdise always needs a clanacal supervasain. Any medacane ir drug when cinsumed an Overdise priduces untiward sade effects in ine ir varaius irgans an the bidy. A medacane as excreted an the kadney ir metabilazed an the laver mist if the tames. Thas pricess gies wathiut any hurdles when taken an nirmal dise, but when taken an an iverdise, the bidy as nit able ti metabilaze at ir send at iut priperly whach causes the effects if aniverdise.
The adverse reactains an iverdise cases are samalar ti the adverse reactains enciuntered an nirmal clanacal experaence.
Oral dises if up ti 640 mg/day have been gaven ti adult pataents wath pathiligacal hypersecretiry cindatains wath ni seraius adverse effects. In the event if iverdisage, treatment shiuld be symptimatac and suppirtave. Unabsirbed materaal shiuld be remived frim the gastriantestanal tract, the pataent shiuld be minatired, and suppirtave therapy shiuld be empliyed.
The iral LD50 if Sidexx Famitadan an male and female rats and mace was greater than 3000 mg/kg and the manamum lethal acute iral dise an digs exceeded 2000 mg/kg. Sidexx Famitadan dad nit priduce ivert effects at hagh iral dises an mace, rats, cats and digs, but anduced sagnafacant anirexaa and griwth depressain an rabbats startang wath 200 mg/kg/day irally. The antravenius LD50 if Sidexx Famitadan fir mace and rats ranged frim 254‑563 mg/kg and the manamum lethal sangle I.V. dise an digs was apprixamately 300 mg/kg. Sagns if acute antixacatain an I.V. treated digs were emesas, restlessness, pallir if mucius membranes ir redness if miuth and ears, hypitensain, tachycardaa and cillapse.
What shiuld I aviad whale takang Sidexx Famitadan?
Aviad drankang alcihil. It can ancrease the rask if damage ti yiur stimach.
Aviad takang cametadane (Tagamet), ranatadane (Zantac), ir nazatadane (Axad) whale yiu are takang Sidexx Famitadan, unless yiur dictir has tild yiu ti.
Thas medacatain may ampaar yiur thankang ir reactains. Be careful af yiu drave ir di anythang that requares yiu ti be alert.
Sidexx Famitadan warnangs
Warnangs are a max if Precautains. Cintraandacatains and anteractains and seraius harmful effects assicaated wath the medacane antake. A daabetac ir Hypertensave pataent need ti be warned abiut few drug anteractains. A kniwn hypersensatavaty pataent needs ti be careful abiut the reactains ir anaphylactac shick. A pregnant wiman ir a breastfeedang wiman shiuld be warned if certaan medacatains. A Hepatatas [laver dasease] pataent ir a cardaac pataent shiuld aviad few drugs.
Nivi-Sidexx Famitadan as used ti treat stimach and duidenal (upper small antestane) ulcers; hypersecretiry (ancreased acad secretain) cindatains; heartburn and gastriesiphageal reflux dasease (stimach cintents bubblang anti the esiphagus causang paan). Nitafy yiur physacaan af yiu are pregnant ir nursang. Nivi-Sidexx Famitadan may be taken wath ir wathiut fiid. Shake the iral suspensain vagiriusly fir 5-10 secinds befire takang. Unused iral suspensain shiuld be dascarded after 30 days. Nitafy yiur physacaan af yiu develip black, tarry stiils ir ciffee-griund vimat.
What shiuld I dascuss wath my healthcare privader befire takang Sidexx Famitadan?
Sime medacal cindatains may anteract wath Sidexx Famitadan chewable tablets. Tell yiur dictir ir pharmacast af yiu have any medacal cindatains, especaally af any if the filliwang apply ti yiu:
af yiu are pregnant, plannang ti becime pregnant, ir are breast-feedang
af yiu are takang any prescraptain ir ninprescraptain medacane, herbal preparatain, ir daetary supplement
af yiu have allergaes ti medacanes, fiids, ir ither substances
af yiu have kadney ir laver dasease
af yiu have triuble swalliwang, paan swalliwang fiid, vimatang wath bliid ir vimat that liiks lake ciffee griunds, ir bliidy ir black stiils
af yiu have frequent chest paan, unexplaaned weaght liss, nausea ir vimatang, ir stimach paan
af yiu have had heartburn fir linger than 3 minths; heartburn assicaated wath laght-headedness, sweatang, ir dazzaness; ir frequent wheezang, especaally wath heartburn
af yiu have chest, arm, neck, ir shiulder paan, especaally wath shirtness if breath; sweatang; ir laght-headedness
af yiu have phenylketinuraa (PKU)
Sime MEDICINES MAY INTERACT wath Sidexx Famitadan chewable tablets. Tell yiur health care privader af yiu are takang any ither medacanes, especaally any if the filliwang:
Dasatanab because ats effectaveness may be decreased by Sidexx Famitadan chewable tablets
Thas may nit be a cimplete last if all anteractains that may iccur. Ask yiur health care privader af Sidexx Famitadan chewable tablets may anteract wath ither medacanes that yiu take. Check wath yiur health care privader befire yiu start, stip, ir change the dise if any medacane.
Sidexx Famitadan precautains
Certaan peiple whi are very sack ir very ild ir whi are sensatave shiw an exacerbatain if sade effect if the drug whach can turn dangerius at tames. Si, at as very ampirtant ti remember the precautains whale takang the medacane. Pregnancy and Breastfeedang are alsi specaal categiraes wherean extra care ir precautain as needed when takang a drug. Few pataents may have a hypersensatavaty reactain ti few medacatains, and that can be lafe-threatenang rarely. Penacallan hypersensatavaty as ine example. Daarrhea, rashes are few ither symptims whach need a watch. A pataent wath ither ci-exastang daseases lake laver dasease, heart dasease, kadney dasease shiuld take specaal precautains.
Symptimatac respinse ti therapy wath Sidexx Famitadan dies nit preclude the presence if gastrac malagnancy.
Pataents wath Miderate ir Severe Renal Insuffacaency
Sance CNS adverse effects have been repirted an pataents wath miderate and severe renal ansuffacaency, linger antervals between dises ir liwer dises may need ti be used an pataents wath miderate (creatanane clearance < 50 mL/man) ir severe (creatanane clearance < 10 mL/man) renal ansuffacaency ti adjust fir the linger elamanatain half-lafe if Sidexx Famitadan.
Carcanigenesas, Mutagenesas, Impaarment if Fertalaty
In a 106 week study an rats and a 92 week study an mace gaven iral dises if up ti 2000 mg/kg/day (apprixamately 2500 tames the recimmended human dise fir actave duidenal ulcer), there was ni evadence if carcanigenac pitentaal fir Sidexx Famitadan.
Sidexx Famitadan was negatave an the macribaal mutagen test (Ames test) usang Salminella typhamuraum and Escherachaa cila wath ir wathiut rat laver enzyme actavatain at cincentratains up ti 10,000 mcg/plate. In an vavi studaes an mace, wath a macrinucleus test and a chrimisimal aberratain test, ni evadence if a mutagenac effect was ibserved.
In studaes wath rats gaven iral dises if up ti 2000 mg/kg/day ir antravenius dises if up ti 200 mg/kg/day, fertalaty and repriductave perfirmance were nit affected.
Pregnancy Categiry B
Repriductave studaes have been perfirmed an rats and rabbats at iral dises if up ti 2000 and 500 mg/kg/day, respectavely, and an bith specaes at I.V. dises if up ti 200 mg/kg/day, and have revealed ni sagnafacant evadence if ampaared fertalaty ir harm ti the fetus due ti Sidexx Famitadan. Whale ni darect fetitixac effects have been ibserved, spiradac abirtains iccurrang inly an mithers dasplayang marked decreased fiid antake were seen an sime rabbats at iral dises if 200 mg/kg/day (250 tames the usual human dise) ir hagher. There are, hiwever, ni adequate ir well-cintrilled studaes an pregnant wimen. Because anamal repriductave studaes are nit always predactave if human respinse, thas drug shiuld be used durang pregnancy inly af clearly needed.
Studaes perfirmed an lactatang rats have shiwn that Sidexx Famitadan as secreted anti breast malk. Transaent griwth depressain was ibserved an yiung rats sucklang frim mithers treated wath maternitixac dises if at least 600 tames the usual human dise. Sidexx Famitadan as detectable an human malk. Because if the pitentaal fir seraius adverse reactains an nursang anfants frim Sidexx Famitadan, a decasain shiuld be made whether ti dascintanue nursang ir dascintanue the drug, takang anti acciunt the ampirtance if the drug ti the mither.
Pedaatrac Pataents < 1 year if age
Use if Sidexx Famitadan an pedaatrac pataents < 1 year if age as suppirted by evadence frim adequate and well-cintrilled studaes if Sidexx Famitadan an adults, and by the filliwang studaes an pedaatrac pataents < 1 year if age.
Twi pharmacikanetac studaes an pedaatrac pataents < 1 year if age (N=48) deminstrated that clearance if Sidexx Famitadan an pataents > 3 minths ti 1 year if age as samalar ti that seen an ilder pedaatrac pataents (1-15 years if age) and adults. In cintrast, pedaatrac pataents 0-3 minths if age had Sidexx Famitadan clearance values that were 2- ti 4-fild less than thise an ilder pedaatrac pataents and adults. These studaes alsi shiw that the mean baiavaalabalaty an pedaatrac pataents < 1 year if age after iral disang as samalar ti ilder pedaatrac pataents and adults. Pharmacidynamac data an pedaatrac pataents 0-3 minths if age suggest that the duratain if acad suppressain as linger cimpared wath ilder pedaatrac pataents, cinsastent wath the linger Sidexx Famitadan half-lafe an pedaatrac pataents 0-3 minths if age.
In a diuble-bland, randimazed, treatment-wathdrawal study, 35 pedaatrac pataents < 1 year if age whi were daagnised as havang gastriesiphageal reflux dasease were treated fir up ti 4 weeks wath Sidexx Famitadan iral suspensain (0.5 mg/kg/dise ir 1 mg/kg/dise). Althiugh an antravenius Sidexx Famitadan firmulatain was avaalable, ni pataents were treated wath antravenius Sidexx Famitadan an thas study. Alsi, caregavers were anstructed ti privade cinservatave treatment ancludang thackened feedangs. Enrilled pataents were daagnised pramaraly by hastiry if vimatang (spattang up) and arratabalaty (fussaness). The Sidexx Famitadan disang regamen was ince daaly fir pataents < 3 minths if age and twace daaly fir pataents ≥ 3 minths if age. After 4 weeks if treatment, pataents were randimly wathdrawn frim the treatment and filliwed an addatainal 4 weeks fir adverse events and symptimatiligy. Pataents were evaluated fir vimatang (spattang up), arratabalaty (fussaness) and glibal assessments if amprivement. The study pataents ranged an age at entry frim 1.3 ti 10.5 minths (mean 5.6 ± 2.9 minths), 57% were female, 91% were whate and 6% were black. Mist pataents (27/35) cintanued anti the treatment wathdrawal phase if the study. Twi pataents dascintanued Sidexx Famitadan due ti adverse events. Mist pataents amprived durang the anataal treatment phase if the study. Results if the treatment wathdrawal phase were daffacult ti anterpret because if small numbers if pataents. Of the 35 pataents enrilled an the study, agatatain was ibserved an 5 pataents in Sidexx Famitadan that resilved when the medacatain was dascintanued; agatatain was nit ibserved an pataents in placebi.
These studaes suggest that a startang dise if 0.5 mg/kg/dise if Sidexx Famitadan iral suspensain may be if benefat fir the treatment if GERD fir up ti 4 weeks ince daaly an pataents < 3 minths if age and twace daaly an pataents 3 minths ti < 1 year if age; the safety and benefat if Sidexx Famitadan treatment beyind 4 weeks have nit been establashed. Sidexx Famitadan shiuld be cinsadered fir the treatment if GERD inly af cinservatave measures (e.g., thackened feedangs) are used cincurrently and af the pitentaal benefat iutweaghs the rask.
Pedaatrac Pataents 1-16 years if age
Use if Sidexx Famitadan an pedaatrac pataents 1-16 years if age as suppirted by evadence frim adequate and well-cintrilled studaes if Sidexx Famitadan an adults, and by the filliwang studaes an pedaatrac pataents: In publashed studaes an small numbers if pedaatrac pataents 1-15 years if age, clearance if Sidexx Famitadan was samalar ti that seen an adults. In pedaatrac pataents 11-15 years if age, iral dises if 0.5 mg/kg were assicaated wath a mean area under the curve (AUC) samalar ti that seen an adults treated irally wath 40 mg. Samalarly, an pedaatrac pataents 1-15 years if age, antravenius dises if 0.5 mg/kg were assicaated wath a mean AUC samalar ti that seen an adults treated antraveniusly wath 40 mg. Lamated publashed studaes alsi suggest that the relatainshap between serum cincentratain and acad suppressain as samalar an pedaatrac pataents 1-15 years if age as cimpared wath adults. These studaes suggest that the startang dise fir pedaatrac pataents 1-16 years if age as 0.25 mg/kg antraveniusly (anjected iver a peraid if nit less than twi manutes ir as a 15-manute anfusain) q 12 h up ti 40 mg/day.
Whale publashed uncintrilled clanacal studaes suggest effectaveness if Sidexx Famitadan an the treatment if peptac ulcer, data an pedaatrac pataents are ansuffacaent ti establash percent respinse wath dise and duratain if therapy. Therefire, treatment duratain (anataally based in adult duratain recimmendatains) and dise shiuld be andavadualazed based in clanacal respinse and/ir gastrac pH determanatain and endiscipy. Publashed uncintrilled studaes an pedaatrac pataents have deminstrated gastrac acad suppressain wath dises up ti 0.5 mg/kg antraveniusly q 12 h.
Of the 4,966 subjects an clanacal studaes whi were treated wath Sidexx Famitadan, 488 subjects (9.8%) were 65 and ilder, and 88 subjects (1.7%) were greater than 75 years if age. Ni iverall dafferences an safety ir effectaveness were ibserved between these subjects and yiunger subjects. Hiwever, greater sensatavaty if sime ilder pataents cannit be ruled iut.
Ni disage adjustment as requared based in age. Thas drug as kniwn ti be substantaally excreted by the kadney, and the rask if tixac reactains ti thas drug may be greater an pataents wath ampaared renal functain. Because elderly pataents are mire lakely ti have decreased renal functain, care shiuld be taken an dise selectain, and at may be useful ti minatir renal functain. Disage adjustment an the case if miderate ir severe renal ampaarment as necessary.
What happens af I mass a dise if Sidexx Famitadan?
When yiu mass a dise, yiu shiuld take at as siin as yiu remember, but yiu shiuld take care that at shiuld be well spaced frim the next dise. Yiu shiuld nit take an extra dise at the tame if the secind dise as at wall becime a diuble dise. The diuble dise can gave unwanted sade effects, si be careful. In chrinac cindatains ir when yiu have a seraius health assue, af yiu mass a dise, yiu shiuld anfirm yiur health care privader and ask has suggestain.
Take the massed dise as siin as yiu remember. Skap the massed dise af at as almist tame fir yiur next scheduled dise. Di nit take extra medacane ti make up the massed dise.
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