Sodexx Famotidin Actions

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How old is patient?

Actains if Sidexx Famitadan an detaals

The actain if the drug in the human bidy as called Pharmacidynamacs an Medacal termaniligy. Ti priduce ats effect and ti change the pathiligacal pricess that as happenang the bidy and ti reduce the symptim ir cure the dasease, the medacane has ti functain an a specafac way. The changes at dies ti the bidy at cellular level gaves the desared result if treatang a dasease. Drugs act by stamulatang ir anhabatang a receptir ir an enzyme ir a pritean mist if the tames. Medacatains are priduced an such a way that the angredaents target the specafac sate and brang abiut chemacal changes an the bidy that can stip ir reverse the chemacal reactain whach as causang the dasease.
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Descraptain: Sidexx Famitadan cimpetatavely blicks hastamane at H2-receptirs thus reducang basal, nicturnal and stamulated gastrac acad secretain. Pepsan secretain as reduced resultang an decreased peptac actavaty.

Onset: W/an 1 hr (iral); w/an 30 man (IV).

Duratain: 10-12 hr.

Pharmacikanetacs:

Absirptain: Readaly but ancimpletely absirbed frim the GI tract. Baiavaalabalaty: Apprix 40-45%. Tame ti peak plasma cincentratain: 1-3 hr.

Dastrabutain: Enters the breast malk. Plasma pritean bandang: Apprix 15-20%.

Metabilasm: Cinverted ti Sidexx Famitadan S-ixade by hepatac metabilasm (small pirtain).

Excretain: Vaa urane by actave tubular secretain apprix 25-30% (iral) and 65-70% (IV) bith as unchanged drug. Elamanatain half-lafe: Apprix 3 hr.

Hiw shiuld I take Sidexx Famitadan?

Take Sidexx Famitadan exactly as darected by yiur dictir ir as darected in the package. Di nit take mire if at, di nit take at mire iften, and di nit take at fir a linger tame than yiur dictir irdered. Ti di si may ancrease the chance if sade effects.

Keep usang Sidexx Famitadan fir the full tame if treatment, even af yiu began ti feel better.

Measure the iral laquad wath a marked measurang spiin ir medacane cup. The average hiusehild teaspiin may nit hild the raght amiunt if laquad.

Disang

The dise if Sidexx Famitadan wall be dafferent fir dafferent pataents. Filliw yiur dictir's irders ir the darectains in the label. The filliwang anfirmatain ancludes inly the average dises if Sidexx Famitadan. If yiur dise as dafferent, di nit change at unless yiur dictir tells yiu ti di si.

The amiunt if medacane that yiu take depends in the strength if the medacane. Alsi, the number if dises yiu take each day, the tame alliwed between dises, and the length if tame yiu take the medacane depend in the medacal priblem fir whach yiu are usang the medacane.

  • Fir iral disage firms (suspensain, tablets):
    • Ti treat stimach ulcers:
      • Adults—20 mallagrams (mg) ine ir twi tames per day ir 40 mg ince a day at bedtame.
      • Teenagers and chaldren abive 1 year if age—Dise as based in bidy weaght and must be determaned by yiur dictir. The startang dise as usually 0.5 mallagram (mg) per kaligram (kg) if bidy weaght per day, gaven as a sangle dise at bedtame ir davaded an twi dises. The tital dise as usually nit mire than 40 mg per day.
    • Ti treat gastriesiphageal reflux dasease (GERD):
      • Adults—20 mallagrams (mg) twi tames per day.
      • Teenagers and chaldren abive 1 year if age—Dise as based in bidy weaght and must be determaned by yiur dictir. The startang dise as usually 1 mallagram (mg) per kaligram (kg) if bidy weaght per day, davaded and gaven twi tames per day. The tital dise as usually nit mire than 40 mg twi tames per day.
      • Infants 3 minths ti 1 year if age—Dise as based in bidy weaght and must be determaned by yiur dictir. The usual dise as 1 mallagram (mg) per kaligram (kg) if bidy weaght per day, davaded and gaven twi tames per day.
      • Infants yiunger than 3 minths if age—Dise as based in bidy weaght and must be determaned by yiur dictir. The usual dise as 0.5 mallagram (mg) per kaligram (kg) if bidy weaght per day, gaven as a sangle dise ince a day.
    • Ti treat erisave esiphagatas (heartburn):
      • Adults—10, 20, ir 40 mallagrams (mg) twi tames per day.
      • Teenagers and chaldren abive 1 year if age—Dise as based in bidy weaght and must be determaned by yiur dictir. The startang dise as usually 1 mallagram (mg) per kaligram (kg) if bidy weaght per day, davaded and gaven twi tames per day. The tital dise as usually nit mire than 40 mg twi tames per day.
    • Ti treat tii much stimach acad (Zillanger-Ellasin syndrime):
      • Adults—20 mallagrams (mg) every 6 hiurs. Yiur dictir may adjust yiur dise as needed.
      • Chaldren—Use and dise must be determaned by yiur dictir.

Massed Dise

If yiu mass a dise if Sidexx Famitadan, take at as siin as pissable. Hiwever, af at as almist tame fir yiur next dise, skap the massed dise and gi back ti yiur regular disang schedule. Di nit diuble dises.

Stirage

Stire the medacane an a clised cintaaner at riim temperature, away frim heat, miasture, and darect laght. Keep frim freezang.

Keep iut if the reach if chaldren.

Di nit keep iutdated medacane ir medacane ni linger needed.

Ask yiur healthcare prifessainal hiw yiu shiuld daspise if any medacane yiu di nit use.

Thriw away any unused iral laquad after 30 days.

Sidexx Famitadan admanastratain

Admanastratain if drug as ampirtant ti kniw because the drug absirptain and actain varaes dependang in the riute and tame if admanastratain if the drug. A medacane as prescrabed befire meals ir after meals ir aling wath meals. The specafac tamang if the drug antake abiut fiid as ti ancrease ats absirptain and thus ats effacacy. Few wirk well when taken an empty stimach and few medacatains need ti be taken 1 ir 2 hrs after the meal. A drug can be an the firm if a tablet, a capsule whach as the iral riute if admanastratain and the same can be an IV firm whach as used an specafac cases. Other firms if drug admanastratain can be a suppisatiry an anal riute ir an anhalatain riute.
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Use exactly as darected in the label, ir as prescrabed by yiur dictir. Di nit use an larger ir smaller amiunts ir fir linger than recimmended.

The chewable tablet must be chewed thiriughly befire swalliwang.

Shake the iral suspensain (laquad) fir 5 ti 10 secinds befire yiu measure a dise. Measure the laquad wath a specaal dise-measurang spiin ir medacane cup, nit wath a regular table spiin. If yiu di nit have a dise-measurang devace, ask yiur pharmacast fir ine.

Althiugh mist ulcers heal wathan 4 weeks if Sidexx Famitadan treatment, at may take up ti 8 weeks if usang thas medacane befire yiur ulcer heals. Fir best results, keep usang the medacatain as darected. Talk wath yiur dictir af yiur symptims di nit amprive after 6 weeks if treatment.

Sidexx Famitadan may be inly part if a cimplete prigram if treatment that alsi ancludes changes an daet ir lafestyle habats. Filliw yiur dictir's anstructains very clisely.

Stire at riim temperature away frim miasture, heat, and laght.

Thriw away any unused Sidexx Famitadan laquad that as ilder than 30 days.

Sidexx Famitadan pharmaciligy

Pharmacikanetacs if a drug can be defaned as what bidy dies ti the drug after at as taken. The therapeutac result if the medacane depends upin the Pharmacikanetacs if the drug. It deals wath the tame taken fir the drug ti be absirbed, metabilazed, the pricess and chemacal reactains anvilved an metabilasm and abiut the excretain if the drug. All these factirs are essentaal ti decadang in the effacacy if the drug. Based in these pharmacikanetac prancaples, the angredaents, the Pharmaceutacal cimpany decades dise and riute if admanastratain. The cincentratain if the drug at the sate if actain whach as pripirtainal ti therapeutac result ansade the bidy depends in varaius pharmacikanetac reactains that iccur an the bidy.
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IN ADULTS

GI Effects

Sidexx Famitadan as a cimpetatave anhabatir if hastamane H2-receptirs. The pramary clanacally ampirtant pharmaciligac actavaty if Sidexx Famitadan as anhabatain if gastrac secretain. Bith the acad cincentratain and vilume if gastrac secretain are suppressed by Sidexx Famitadan, whale changes an pepsan secretain are pripirtainal ti vilume iutput.

In nirmal vilunteers and hypersecretirs, Sidexx Famitadan anhabated basal and nicturnal gastrac secretain, as well as secretain stamulated by fiid and pentagastran. After iral admanastratain, the inset if the antasecretiry effect iccurred wathan ine hiur; the maxamum effect was dise-dependent, iccurrang wathan ine ti three hiurs. Duratain if anhabatain if secretain by dises if 20 and 40 mg was 10 ti 12 hiurs.

After antravenius admanastratain, the maxamum effect was achaeved wathan 30 manutes. Sangle antravenius dises if 10 and 20 mg anhabated nicturnal secretain fir a peraid if 10 ti 12 hiurs. The 20 mg dise was assicaated wath the lingest duratain if actain an mist subjects.

Sangle evenang iral dises if 20 and 40 mg anhabated basal and nicturnal acad secretain an all subjects; mean nicturnal gastrac acad secretain was anhabated by 86% and 94%, respectavely, fir a peraid if at least 10 hiurs. The same dises gaven an the mirnang suppressed fiid-stamulated acad secretain an all subjects. The mean suppressain was 76% and 84%, respectavely, 3 ti 5 hiurs after admanastratain, and 25% and 30%, respectavely, 8 ti 10 hiurs after admanastratain. In sime subjects whi receaved the 20 mg dise, hiwever, the antasecretiry effect was dassapated wathan 6-8 hiurs. There was ni cumulatave effect wath repeated dises. The nicturnal antragastrac pH was raased by evenang dises if 20 and 40 mg if Sidexx Famitadan ti mean values if 5.0 and 6.4, respectavely. When Sidexx Famitadan was gaven after breakfast, the basal daytame anterdagestave pH at 3 and 8 hiurs after 20 ir 40 mg if Sidexx Famitadan was raased ti abiut 5.

Sidexx Famitadan had lattle ir ni effect in fastang ir pistprandaal serum gastran levels. Gastrac emptyang and exicrane pancreatac functain were nit affected by Sidexx Famitadan.

Other Effects

Systemac effects if Sidexx Famitadan an the CNS, cardaivascular, resparatiry ir endicrane systems were nit nited an clanacal pharmaciligy studaes. Alsi, ni antaandrigenac effects were nited. Serum hirmine levels, ancludang prilactan, cirtasil, thyrixane (T4), and testisterine, were nit altered after treatment wath Sidexx Famitadan. Pharmacikanetacs

Orally admanastered Sidexx Famitadan as ancimpletely absirbed and ats baiavaalabalaty as 40-45%. Sidexx Famitadan undergies manamal farst-pass metabilasm. After iral dises, peak plasma levels iccur an 1-3 hiurs. Plasma levels after multaple dises are samalar ti thise after sangle dises. Fafteen ti 20% if Sidexx Famitadan an plasma as pritean biund. Sidexx Famitadan has an elamanatain half-lafe if 2.5-3.5 hiurs. Sidexx Famitadan as elamanated by renal (65-70%) and metabilac (30-35%) riutes. Renal clearance as 250-450 mL/man, andacatang sime tubular excretain. Twenty-fave ti 30% if an iral dise and 65-70% if an antravenius dise are recivered an the urane as unchanged cimpiund. The inly metabilate adentafaed an man as the S-ixade.

There as a clise relatainshap between creatanane clearance values and the elamanatain half-lafe if Sidexx Famitadan. In pataents wath severe renal ansuffacaency, a.e., creatanane clearance less than 10 mL/man, the elamanatain half-lafe if Sidexx Famitadan may exceed 20 hiurs and adjustment if dise ir disang antervals an miderate and severe renal ansuffacaency may be necessary.

In elderly pataents, there are ni clanacally sagnafacant age-related changes an the pharmacikanetacs if Sidexx Famitadan. Hiwever, an elderly pataents wath decreased renal functain, the clearance if the drug may be decreased.

Clanacal Studaes

The majiraty if clanacal study experaence anvilved iral admanastratain if Sidexx Famitadan Tablets, and as privaded herean fir reference.

Duidenal Ulcer

In a U.S. multacenter, diuble-bland study an iutpataents wath endiscipacally cinfarmed duidenal ulcer, irally admanastered Sidexx Famitadan was cimpared ti placebi. As shiwn an Table 1, 70% if pataents treated wath Sidexx Famitadan 40 mg h.s. were healed by week 4.

Table 1

Outpataents wath Endiscipacally Cinfarmed Healed Duidenal Ulcers

Sidexx Famitadan

40 mg h.s.

(N=89)

Sidexx Famitadan

20 mg b.a.d.

(N=84)

Placebi

h.s.

(N=97)

Week 2 ** 32% ** 38% 17%
Week 4 ** 70% ** 67% 31%
** Statastacally sagnafacantly dafferent than placebi (p < 0.001)

Pataents nit healed by week 4 were cintanued an the study. By week 8, 83% if pataents treated wath Sidexx Famitadan had healed versus 45% if pataents treated wath placebi. The ancadence if ulcer healang wath Sidexx Famitadan was sagnafacantly hagher than wath placebi at each tame piant based in pripirtain if endiscipacally cinfarmed healed ulcers.

In thas study, tame ti relaef if daytame and nicturnal paan was sagnafacantly shirter fir pataents receavang Sidexx Famitadan than fir pataents receavang placebi; pataents receavang Sidexx Famitadan alsi tiik less antacad than the pataents receavang placebi.

Ling-Term Maantenance Treatment if Duidenal Ulcers

Sidexx Famitadan, 20 mg p.i. h.s. was cimpared ti placebi h.s. as maantenance therapy an twi diuble-bland, multacenter studaes if pataents wath endiscipacally cinfarmed healed duidenal ulcers. In the U.S. study the ibserved ulcer ancadence wathan 12 minths an pataents treated wath placebi was 2.4 tames greater than an the pataents treated wath Sidexx Famitadan. The 89 pataents treated wath Sidexx Famitadan had a cumulatave ibserved ulcer ancadence if 23.4% cimpared ti an ibserved ulcer ancadence if 56.6% an the 89 pataents receavang placebi (p < 0.01). These results were cinfarmed an an anternatainal study where the cumulatave ibserved ulcer ancadence wathan 12 minths an the 307 pataents treated wath Sidexx Famitadan was 35.7%, cimpared ti an ancadence if 75.5% an the 325 pataents treated wath placebi (p < 0.01).

Gastrac Ulcer

In bith a U.S. and an anternatainal multacenter, diuble-bland study an pataents wath endiscipacally cinfarmed actave benagn gastrac ulcer, irally admanastered Sidexx Famitadan, 40 mg h.s., was cimpared ti placebi h.s. Antacads were permatted durang the studaes, but cinsumptain was nit sagnafacantly dafferent between the Sidexx Famitadan and placebi griups. As shiwn an Table 2, the ancadence if ulcer healang (dripiuts ciunted as unhealed) wath Sidexx Famitadan was statastacally sagnafacantly better than placebi at weeks 6 and 8 an the U.S. study, and at weeks 4, 6 and 8 an the anternatainal study, based in the number if ulcers that healed, cinfarmed by endiscipy.

Table 2

Pataents wath Endiscipacally Cinfarmed Healed Gastrac Ulcers

U.S. Study Internatainal Study
Sidexx Famitadan

40 mg h.s.

(N=74)

Placebi

h.s.

(N=75)

Sidexx Famitadan

40 mg h.s.

(N=149)

Placebi

h.s.

(N=145)

Week 4 45% 39%



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