Ascor Txhaj

Lub npe dav: ascorbic acid
Dosage form: txhaj tshuaj
Chav kawm tshuaj: Cov vitamins



Ntawm nplooj ntawv no
Nthuav

HIGHIGHTS NTAWM PRESCRIBING INFORMATION



HIGHIGHTS NTAWM PRESCRIBING INFORMATION

Cov ntsiab lus tseem ceeb no tsis suav nrog tag nrho cov ntaub ntawv xav tau los siv ASCOR® kom nyab xeeb thiab ua tau zoo. Saib tag nrho cov ntaub ntawv sau npe rau ASCOR.



ASCOR (ascorbic acid txhaj), rau kev siv cov tshuaj txhaj tshuaj Initial US Pom zoo: 1947

1. Kev qhia thiab kev siv

ASCOR yog vitamin C qhia rau lub sij hawm luv luv (txog 1 lub lis piam) kev kho mob ntawm scurvy nyob rau hauv cov neeg laus thiab cov me nyuam muaj hnub nyoog 5 hli thiab laus dua rau cov uas qhov ncauj tswj tsis tau, tsis txaus los yog contraindicated.

Kev txwv kev siv



ASCOR tsis tau qhia rau kev kho mob ntawm vitamin C tsis txaus uas tsis cuam tshuam nrog cov tsos mob thiab cov tsos mob ntawm scurvy.

2. KEV PAB CUAM THIAB KEV PAB CUAM

Cov Lus Qhia Tseem Ceeb Txog Kev Npaj thiab Kev Tswj Xyuas

  • ASCOR vials muaj 25,000 mg ntawm ascorbic acid thiab qhov loj tshaj plaws pom zoo ib koob tshuaj yog 200 mg. Tsis txhob muab tag nrho cov ntsiab lus ntawm lub vial rau ib tus neeg mob.
  • Tsis txhob muab ASCOR raws li qhov tsis muaj tshuaj tiv thaiv kab mob.
  • Txo qhov raug rau lub teeb vim ASCOR yog lub teeb rhiab heev.
  • ASCOR yog muab los ua ibPharmacy Bulk Package(PBP) uas yog npaj rau kev xa tawm ib koob tshuaj rau ntau tus neeg mob hauv lub tsev muag tshuaj cov tshuaj sib xyaw thiab txwv rau kev npaj cov tshuaj sib tov rau infusion:

ib. Siv tsuas yog nyob rau hauv ib cheeb tsam uas tsim nyog ISO Class 5 ua hauj lwm xws li laminar flow hood (los yog ib qho sib npaug ntawm cov huab cua ntshiab compounding cheeb tsam)

cov kev mob tshwm sim ntawm montelukast

b. Nkag mus rau txhua PBP vial kawib zaug xwbnrog rau cov khoom siv tsis zoo hloov mus los lossis cov khoom xa tawm uas tso cai rau ntsuas qhov ntsuas ntawm cov khoom. Muab qhov siab tuaj yeem tsim nyob rau hauv lub vial thaum lub sijhawm khaws cia, ceev faj thaum tshem tawm cov ntsiab lus ntawm lub vial.

c. Thaum lub kaw lus kaw tau nkag mus,ua kom tiav tag nrho cov xa tawm los ntawm PBP vial hauv 4 teev.Txhua koobyuav tsum tau siv tam sim ntawd. Tshem tawm qhov tsis siv.

d. Ua ntej kev tswj hwm, ASCOR yuav tsum tau diluted nyob rau hauv ib tug haum infusion tov thiab zaum kawg tov rau infusion yuav tsum yog isotonic.(tsis muaj cov osmolarity ntawm ASCOR yog kwv yees li 5,900 mOsmol / L). Ua ntej npaj cov tshuaj tov rau infusion, xam cov osmolarity ntawm lub npaj admixture rau infusion. Ntxiv ib koob tshuaj ASCOR txhua hnub ncaj qha mus rau qhov tsim nyog ntim ntawm cov tshuaj infusion tsim nyog (piv txwv li, 5% Dextrose Txhaj, Dej tsis muaj tshuaj rau txhaj) thiab ntxiv cov tshuaj uas tsim nyog, raws li qhov tsim nyog, ua kom cov tshuaj isotonic kawg.Sterile Dej rau Txhaj yog heev hypotonic; kho cov ntsiab lus solute, raws li qhov tsim nyog, ua rau qhov kawg infusion daws isotonic ua ntej txhaj tshuaj.Tsis txhob sib tov ASCOR nrog cov kev daws teeb meem uas muaj cov ntsiab lus uas tuaj yeem txo qis (piv txwv li, tooj liab). Qhov concentration ntawm ascorbic acid nyob rau hauv qhov kawg, cov tshuaj tov rau infusion yog qhov ntau ntawm 1 mus rau 25 mg ntawm ascorbic acid ib mL. Piv txwv li, rau cov koob tshuaj loj tshaj plaws uas pom zoo:

Ntxiv 200 mg ntawm ascorbic acid (sib npaug rau 0.4 mL ntawm ASCOR) rau 7.5 mL ntawm Sterile Dej rau Txhaj Tshuaj los tsim cov tshuaj infusion uas muaj kwv yees li osmolarity ntawm 290 mOsmol / L. Hauv qhov piv txwv tshwj xeeb no, kev sib ntxiv ntawm cov tshuaj tsis tsim nyog vim tias cov tshuaj isotonic.

e. Npaj cov koob tshuaj pom zoo raws li cov neeg mob [saib Dosage and Administration (2.2) , (23) ].

f. Kev kuaj pom pom cov teeb meem tsis zoo thiab tsis muaj xim ua ntej kev tswj hwm (cov tshuaj ASCOR diluted yuav tsum tsis muaj xim rau daj ntseg daj).

g. Tam sim ntawd muab cov tshuaj sib tov rau infusion raws li kev tso dej qeeb qeeb [saib Pom Zoo Dosage, (2.2) ]

Pom zoo noj

Table 1 muab kev pom zoo koob tshuaj ASCOR raws li cov neeg mob cov neeg mob thiab infusion tus nqi ntawm diluted ASCOR tov.

Table 1: Pom zoo koob tshuaj ASCOR thiab Infusion Rate of Diluted ASCOR Solution
Cov neeg mob ASCOR
Ib zaug noj txhua hnub
(mg)
Infusion tus nqi ntawm
Diluted ASCOR
Kev daws (mg / feeb)
Cov neeg mob menyuam yaus hnub nyoog 5 hli mus rau tsawg dua 12 lub hlis tsib caug 1.3
Cov neeg mob menyuam yaus hnub nyoog 1 xyoos txog qis dua 11 xyoos 100 3.3
Cov neeg laus thiab menyuam yaus hnub nyoog qis dua 11 xyoos 200 33

Qhov kev pom zoo ntev tshaj plaws ntawm kev kho mob niaj hnub nrog ASCOR yog xya hnub. Yog tias tsis muaj kev txhim kho hauv cov tsos mob scorbutic tom qab ib lub lim tiam ntawm kev kho mob, tawm mus kom txog thaum pom cov tsos mob ntawm scorbutic.

Kev noj tshuaj rov ua dua tsis raug pom zoo rau cov neeg mob menyuam yaus hnub nyoog qis dua 11 xyoos.

Kev txo qis hauv cov neeg tshwj xeeb

Cov poj niam cev xeeb tub los yog lactating thiab cov neeg mob uas muaj piam thaj-6-dehydrogenase deficiency yuav tsum tsis txhob ntau tshaj US Pom Zoo Dietary Allowance (RDA) los yog niaj hnub noj txaus (AI) qib rau ascorbic acid rau lawv cov hnub nyoog thiab mob [cov saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.2) thiab siv nyob rau hauv cov neeg tshwj xeeb (8.1 , 8.2) ].

3. PHAU NTAWV HAUJ LWM THIAB HAUJ LWM

Txhaj tshuaj: 25,000 mg / 50 mL (500 mg / mL) muab los ua Pharmacy Bulk Package (ntshiab, tsis muaj xim rau daj ntseg daj)

4. KEV PAB CUAM

Tsis muaj.

5. CEEB TOOM THIAB TSEEM CEEB

Oxalate Nephropathy thiab Nephrolithiasis

Mob hnyav thiab mob ntev oxalate nephropathy tau raug tshaj tawm nrog kev siv sijhawm ntev ntawm cov tshuaj ascorbic acid ntau. Acidification ntawm cov zis los ntawm ascorbic acid tuaj yeem ua rau nag lossis daus ntawm cysteine, urate lossis oxalate pob zeb. Cov neeg mob lub raum nrog rau lub raum tsis ua haujlwm, keeb kwm ntawm oxalate raum pob zeb, thiab cov neeg mob laus tuaj yeem muaj kev pheej hmoo siab rau oxalate nephropathy thaum tau txais kev kho mob nrog ascorbic acid. Cov menyuam yaus hnub nyoog qis dua 2 xyoos tuaj yeem muaj kev pheej hmoo siab rau oxalate nephropathy thaum kho nrog ascorbic acid vim lawv lub raum tsis paub qab hau.[saib Kev Siv Hauv Cov Pej Xeem Tshwj Xeeb ( 8.4 ib , 8.5 , 8.6 )].Saib xyuas lub raum ua haujlwm hauv cov neeg mob uas muaj kev pheej hmoo siab tau txais ASCOR. Tso tseg ASCOR hauv cov neeg mob uas tsim oxalate nephropathy thiab kho txhua qhov xav tias oxalate nephropathy.

ASCOR tsis tau qhia rau kev tswj xyuas ntev (qhov siab tshaj plaws lub sijhawm pom zoo yog ib lub lis piam)[saib Dosage and Administration ( 2.1 )].

Hemolysis hauv cov neeg mob nrog Glucose-6-Phosphate Dehydrogenase Deficiency

Hemolysis tau tshaj tawm nrog kev tswj hwm ntawm ascorbic acid hauv cov neeg mob uas tsis muaj qabzib-6-phosphate dehydrogenase. Cov neeg mob uas muaj cov piam thaj-6-phosphate dehydrogenase tuaj yeem ua rau muaj kev pheej hmoo siab hemolysis hnyav thaum kho nrog ascorbic acid. Saib xyuas hemoglobin thiab ntshav suav thiab siv qhov txo qis ntawm ASCOR hauv cov neeg mob uas tsis muaj piam thaj-6-phosphate dehydrogenase.[saib Dosage and Administration ( 23 )]. Txiav kev kho nrog ASCOR yog tias xav tias hemolysis thiab kho raws li qhov xav tau.

tshuaj vistaril siv rau dab tsi

Laboratory Test cuam tshuam

Ascorbic acid tuaj yeem cuam tshuam nrog kev kuaj sim raws li oxidation-txo cov tshuaj tiv thaiv, suav nrog kev kuaj ntshav thiab zis, qib nitrite thiab bilirubin, thiab kuaj cov leucocyte suav. Yog tias ua tau, kev sim tshuaj ntsuam xyuas raws li oxidation-txo cov tshuaj tiv thaiv yuav tsum ncua mus txog 24 teev tom qab infusion ntawm ASCOR.[saib Kev Sib Tham Txog Tshuaj ( 7.4 )].

6. KEV PAB CUAM

Cov kev cuam tshuam tsis zoo hauv qab no tau tham ntau dua hauv lwm ntu ntawm kev sau npe:

  • Oxalate nephropathy thiab Nephrolithiasis[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.1) ]
  • Hemolysis hauv cov neeg mob uas tsis muaj qabzib-6-phosphate dehydrogenase[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.2) ]

Cov kev tsis zoo hauv qab no cuam tshuam nrog kev siv cov ascorbic acid tau txheeb xyuas hauv cov ntaub ntawv. Vim tias cov tshuaj tiv thaiv no tau lees paub los ntawm cov pej xeem uas tsis paub meej qhov loj, nws tsis yog ib txwm ua tau los kwv yees lawv qhov kev ntseeg siab los yog tsim kom muaj kev sib raug zoo rau kev raug tshuaj yeeb:

Kev tswj xyuas qhov chaw tshuaj xyuas:mob thiab o.

ASCOR yuav tsum tsis txhob noj sai. Kev khiav dej num ceev ceev (> 250 mg / feeb) ntawm ASCOR tuaj yeem ua rau qaug zog ib ntus lossis xeev siab, lethargy, flushing, kiv taub hau, thiab mob taub hau (cov lus pom zoo ntawm cov tshuaj diluted ASCOR yog 1.3 mg / feeb (Cov neeg mob uas muaj hnub nyoog 5 hli mus rau tsawg dua). 12 lub hlis), 3.3 mg / feeb (Cov neeg mob menyuam yaus hnub nyoog 1 xyoos txog qis dua 11 xyoos) thiab 33 mg / feeb (Cov neeg laus thiab menyuam yaus hnub nyoog 11 xyoos thiab laus dua)[saib Dosage and Administration (2.2) ]).

Mob hnyav thiab mob ntev oxalate nephropathy tau tshwm sim nrog kev tswj hwm ntev ntawm cov tshuaj ascorbic acid.[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.1) ]. Hauv cov neeg mob uas muaj piam thaj-6-phosphate dehydrogenase deficiency hnyav hemolysis tau tshwm sim[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.2) ].

ntau yam kev tawm dag zog

7. Kev Sib Tham Txog Tshuaj

Tshuaj tua kab mob

Ascorbic acid tuaj yeem txo cov haujlwm ntawm erythromycin, kanamycin, streptomycin, doxycycline, thiab lincomycin. Bleomycin yog inactivated nyob rau hauv vitro los ntawm ascorbic acid. Yog tias qhov kev ua tau zoo ntawm cov tshuaj tua kab mob xav tias yuav txo qis los ntawm kev tswj hwm kev sib koom ua ke ntawm ASCOR, txiav tawm ASCOR kev tswj hwm.

Amphetamine & Lwm yam tshuaj cuam tshuam los ntawm Urine Acidification

Ascorbic acid tuaj yeem ua rau cov zis tso zis thiab qis dua cov tshuaj amphetamine los ntawm kev ua kom lub raum tso tawm (raws li kev cuam tshuam los ntawm kev hloov pauv hauv amphetamine tso zis). Nyob rau hauv cov ntaub ntawv ntawm txo cov nyhuv amphetamine txiav tawm ASCOR kev tswj hwm. Kev tshuaj xyuas tus qauv ntawm kev kho yog lav.

Tsis tas li ntawd, acidification ntawm cov zis los ntawm ascorbic acid yuav hloov lub excretion ntawm tej yam tshuaj cuam tshuam los ntawm pH ntawm cov zis (xws li, fluphenazine) thaum noj concurrently. Nws tau raug tshaj tawm tias kev tswj hwm ib txhij ntawm ascorbic acid thiab fluphenazine tau ua rau txo qis fluphenazine plasma concentrations. Kev tshuaj xyuas tus qauv ntawm kev kho yog lav.

Warfarin

Cov ntawv ceeb toom txwv tsis pub muaj kev cuam tshuam ntawm ascorbic acid nrog cov tshuaj tiv thaiv coagulation ntawm warfarin, txawm li cas los xij, cov neeg mob ntawm kev kho mob warfarin kho nrog cov tshuaj ascorbic acid txog li 1000 mg / hnub (5 zaug qhov loj tshaj plaws pom zoo ib koob) rau 2 lub lis piam (ob zaug qhov siab tshaj plaws tau pom zoo. ntev), tsis muaj kev cuam tshuam. Kev saib xyuas tus qauv rau kev tiv thaiv coagulation yuav tsum txuas ntxiv thaum kho ascorbic acid, raws li tus qauv kev saib xyuas.

Laboratory Test cuam tshuam

Vim tias ascorbic acid yog ib qho muaj zog txo tus neeg sawv cev, nws tuaj yeem cuam tshuam nrog ntau qhov kev kuaj sim raws li oxidation-txo cov tshuaj tiv thaiv (xws li, qabzib, nitrite thiab bilirubin qib, leukocyte suav, thiab lwm yam). Cov txheej txheem kuaj tshuaj raws li cov tshuaj tiv thaiv colorimetric feem ntau yog cov kev ntsuam xyuas cuam tshuam. Ascorbic acid tuaj yeem ua rau cov txiaj ntsig tsis raug (cov txiaj ntsig tsis zoo) tau txais rau kev kuaj ntshav lossis zis qib qabzib, nitrite, bilirubin, thiab leukocytes yog kuaj thaum lossis hauv 24 teev tom qab txhaj tshuaj.[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.3) ].

8. Siv rau hauv cov neeg tshwj xeeb

Kev xeeb tub

Risk Summary

Tsis muaj cov ntaub ntawv muaj nyob rau ntawm kev siv ASCOR hauv cov poj niam cev xeeb tub los qhia txog kev pheej hmoo ntawm cov tshuaj muaj feem cuam tshuam txog kev loj hlob tsis zoo; Txawm li cas los xij, kev siv ascorbic acid (vitamin C) tau siv thaum cev xeeb tub rau ntau xyoo lawm thiab tsis muaj qhov tshwm sim tsis zoo tshwm sim hauv cov ntaub ntawv luam tawm.[saib cov ntaub ntawv]. Muaj kev hloov kho koob tshuaj rau ascorbic acid (vitamin C) siv thaum cev xeeb tub[saib Cov Kev Txiav Txim Kho Mob].

Kev tshawb fawb txog tsiaj yug tsiaj tsis tau ua nrog ASCOR.

Kev kwv yees keeb kwm yav dhau los ntawm kev yug me nyuam loj thiab nchuav menyuam rau cov pej xeem tsis paub. Txhua lub cev xeeb tub muaj keeb kwm yav dhau los ntawm kev yug me nyuam, poob, lossis lwm yam tshwm sim tsis zoo. Hauv Teb Chaws Asmeskas cov pej xeem, kwv yees keeb kwm kev pheej hmoo ntawm kev yug me nyuam loj thiab nchuav menyuam hauv kev kuaj mob pom zoo yog 2-4% thiab 15-20%, feem.

Kev txiav txim siab kho mob

Kev Kho Tshuaj Kho Thaum Cev Xeeb Tub thiab Lub Sij Hawm Tom Qab Ntsws

Ua raws li Teb Chaws Asmeskas Pom Zoo Noj Khoom Haus (RDA) rau cov poj niam cev xeeb tub thaum txiav txim siab siv ASCOR rau kev kho mob scurvy[saib Dosage and Administration (23) ].

Cov ntaub ntawv

Tib neeg cov ntaub ntawv

Tsis muaj cov ntaub ntawv hais txog kev siv ASCOR lossis lwm yam tshuaj ascorbic acid rau cov poj niam cev xeeb tub. Txawm li cas los xij, luam tawm meta-kev tshuaj xyuas ntawm cov kev tshawb fawb randomized ntsuam xyuas ntau tus poj niam cev xeeb tub uas tau noj qhov ncauj ascorbic acid (vitamin C) (los ntawm kev noj zaub mov thiab ntxiv) ntawm koob tshuaj xws li 500 mus rau 1000 mg / hnub (2.5 mus rau 5 npaug ntawm cov lus pom zoo niaj hnub tso rau hauv. koob tshuaj, ntsig txog)[saib Dosage and Administration (23) ]nruab nrab ntawm lub 9 thiab 16 lub lis piam ntawm cev xeeb tub tsis pom muaj kev pheej hmoo ntawm kev xeeb tub tsis zoo xws li nchuav menyuam, ua ntej ntxov ntxov rupture ntawm daim nyias nyias, yug ntxov ntxov los yog cev xeeb tub induced hypertension thaum piv rau cov placebo. Cov ntaub ntawv no tsis tuaj yeem tsim lossis tsis suav nrog qhov tsis muaj kev pheej hmoo nrog ascorbic acid (vitamin C) thaum cev xeeb tub.

lactation

Risk Summary

Tsis muaj cov ntaub ntawv hais txog qhov muaj ascorbic acid (vitamin C) hauv tib neeg cov kua mis tom qab txhaj tshuaj rau cov poj niam lactating. Ascorbic acid (vitamin C) muaj nyob rau hauv tib neeg cov kua mis tom qab niam txiv noj qhov ncauj. Cov niam txiv qhov ncauj tau txais ascorbic acid (vitamin C) ntau tshaj US Pom Zoo Dietary Allowances (RDA) rau lactation tsis cuam tshuam cov ascorbic acid (vitamin C) cov ntsiab lus hauv cov kua mis los yog kwv yees li niaj hnub tau txais los ntawm cov menyuam mos noj mis. Tsis muaj cov ntaub ntawv hais txog cov txiaj ntsig ntawm ascorbic acid (vitamin C) ntawm kev tsim cov mis nyuj lossis cov menyuam mos noj mis. Cov txiaj ntsig kev loj hlob thiab kev noj qab haus huv ntawm kev pub niam mis yuav tsum tau txiav txim siab nrog rau leej niam qhov kev xav tau ntawm kev kho mob rau ASCOR thiab ib qho kev cuam tshuam tsis zoo rau tus menyuam pub niam mis los ntawm ASCOR lossis los ntawm tus menyuam hauv plab. Ua raws li Teb Chaws Asmeskas Pom Zoo Noj Khoom Haus (RDA) rau cov poj niam cev xeeb tub thaum txiav txim siab siv ASCOR rau kev kho mob scurvy[saib Dosage and Administration (23) ].

Kev siv menyuam yaus

ASCOR tau qhia rau lub sijhawm luv luv (txog li 1 lub lis piam) kev kho mob ntawm scurvy hauv cov neeg mob menyuam yaus hnub nyoog 5 hlis thiab laus dua rau cov neeg siv qhov ncauj tsis tuaj yeem ua tau, tsis txaus lossis contraindicated. Kev nyab xeeb profile ntawm ascorbic acid nyob rau hauv cov neeg mob yog zoo ib yam li cov neeg laus; Txawm li cas los xij, cov neeg mob menyuam yaus hnub nyoog qis dua 2 xyoos tuaj yeem muaj kev pheej hmoo siab dua ntawm oxalate nephropathy tom qab kev tswj hwm ascorbic acid vim muaj hnub nyoog txog kev txo qis glomerular pom.[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.1) ].

ASCOR tsis tau qhia rau kev siv hauv cov neeg mob menyuam yaus hnub nyoog qis dua 5 lub hlis.

Kev siv Geriatric

Glomerular filtration rate yog paub tias yuav txo qis nrog lub hnub nyoog thiab xws li yuav ua rau muaj kev pheej hmoo rau oxalate nephropathy tom qab kev tswj hwm ascorbic acid hauv cov neeg laus.[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.1) ].

tshuaj tua kab mob dab tsi rau siv

Lub raum Impairment

ASCOR yuav tsum tau siv nrog ceev faj hauv cov neeg mob scorbutic uas muaj keeb kwm los yog kev pheej hmoo ntawm kev tsim lub raum oxalate pob zeb lossis cov pov thawj ntawm lub raum tsis zoo lossis lwm yam teeb meem (xws li, cov neeg mob ntshav lim ntshav, cov neeg mob ntshav qab zib nephropathy, thiab cov neeg tau txais kev hloov lub raum). Cov neeg mob no yuav muaj kev pheej hmoo ntau ntxiv ntawm kev mob hnyav lossis mob ntev oxalate nephropathy tom qab noj tshuaj ascorbic acid ntau.[saib Ceeb toom thiab ceev faj (5.1) ].

10. Tshaj dhau

Kev siv tshuaj ascorbic acid ntau dhau tuaj yeem ua rau xeev siab, ntuav, raws plab, ua npaws, ua pob, mob taub hau, qaug zog lossis ntxhov siab pw tsaug zog. Yog tias kev noj tshuaj ntau dhau ntawm ASCOR tshwm sim, tam sim ntawd txiav tawm kev tswj hwm thiab kho cov tsos mob thiab cov tsos mob ntawm kev noj tshuaj ntau dhau, zam kev noj tshuaj ascorbic acid ntxiv.

11. POM ZOO

ASCOR (ascorbic acid txhaj) rau kev siv cov hlab ntsha yog xim tsis muaj xim daj daj, tsis muaj tshuaj tiv thaiv, hypertonic, tsis muaj menyuam, tsis yog pyrogenic daws ntawm ascorbic acid. ASCOR yuav tsum tau diluted nrog cov tshuaj infusion tsim nyog (piv txwv li, 5% Dextrose Txhaj, USP, Sterile Dej rau Txhaj Tshuaj, USP)[saib Dosage and Administration (2.1) ].

Lub npe tshuaj ntawm Ascorbic Acid yogL- ascorbic acid. Cov mis mos molecular yog C6H8LUB6. Nws muaj cov qauv hauv qab no:

Txhua ASCOR, 50 mL, Pharmacy Bulk Package vial muaj 25,000 mg ascorbic acid, sib npaug rau 28,125 mg sodium ascorbate.

Txhua mL ntawm ASCOR muaj 500 mg ntawm ascorbic acid (sib npaug rau 562.5 mg ntawm sodium ascorbate uas yog 65 mg sodium / mL ntawm ASCOR), 0.25 mg ntawm edetate disodium, thiab dej rau kev txhaj tshuaj. Sodium hydroxide thiab sodium bicarbonate yog ntxiv rau kev hloov pH (pH ntau 5.6 txog 6.6). Nws tsis muaj bacteriostatic lossis antimicrobial tus neeg sawv cev.

12. Clinical Pharmaceuticals

Mechanism ntawm Action

Lub ntsiab mechanism ntawm kev txiav txim ntawm ascorbic acid rau kev kho mob ntawm cov tsos mob thiab cov tsos mob ntawm scurvy (ib tug kab mob tshwm sim los ntawm heev deficiency nyob rau hauv vitamin C) yog tsis paub; Txawm li cas los xij, kev tswj hwm ntawm ascorbic acid hauv cov neeg mob scurvy yog xav kom rov ua kom lub cev ntawm ascorbic acid.

Pharmacokinetics

Hauv ib txoj kev tshawb fawb pharmacokinetic, cov txiv neej noj qab haus huv thiab poj niam laus (n = 8) tau txais ib koob tshuaj ntawm 1000 mg ascorbic acid (5 npaug ntawm qhov loj tshaj plaws pom zoo ib koob tshuaj) tau siv sijhawm ntev li 30 feeb. Qhov nruab nrab qhov siab tshaj plaws rau ascorbic acid yog 436.2 µM thiab tshwm sim thaum kawg ntawm 30 feeb infusion.

Kev faib tawm

Ascorbic acid yog faib thoob plaws hauv lub cev, nrog ntau qhov ntau pom hauv daim siab, leukocytes, platelets, glandular cov ntaub so ntswg, thiab lub lens ntawm lub qhov muag. Raws li cov ntaub ntawv los ntawm qhov ncauj qhov ncauj, ascorbic acid paub tias muab faib rau hauv cov kua mis thiab hla cov placental barrier.

Kev tshem tawm

Thaum lub cev saturated nrog ascorbic acid, plasma concentration yuav zoo ib yam li lub raum pib; Yog hais tias ntau npaum li ntawd tau muab coj los siv, feem ntau ntawm nws yog tawm hauv cov zis. Thaum cov ntaub so ntswg hauv lub cev tsis saturated thiab plasma concentration tsawg, kev tswj hwm ntawm ascorbic acid ua rau me me lossis tsis muaj lub raum tso tawm. Qhov nruab nrab ± SD (N = 3) ib nrab-lub neej pom nyob rau hauv ib koob tshuaj PK kawm raws li tau piav qhia saum toj no, yog 7.4 ± 1.4 h.

Metabolism

humulin r vs humulin n

Ib txoj hauv kev tseem ceeb ntawm cov metabolism ntawm ascorbic acid suav nrog nws txoj kev hloov pauv mus rau urinary oxalate, suav tias yog los ntawm kev tsim nruab nrab ntawm nws cov khoom oxidized, dehydroascorbic acid.

Kev tso tawm

Muaj lub raum pib rau ascorbic acid (Vitamin C); cov vitamin raug tso tawm los ntawm lub raum ntau tsuas yog thaum lub plasma concentration siab tshaj qhov pib, uas yog kwv yees li 1.4 mg / 100 mL.

13. NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, thiab kev tshawb fawb fertility tsis tau ua nrog ASCOR.

16. YUAV UA LI CAS / NTAUB NTAWV THIAB HAUJ LWM

ASCOR rau kev siv cov hlab ntsha yog cov xim tsis muaj xim rau daj ntseg daj muab los ntawm:

  • NDC 67157-101-50 Ib 25,000 mg/50 mL (500 mg/mL) Pharmacy Bulk Package vial
  • NDC 67157-101-51 Lub tais ntim ntawm nees nkaum tsib 25,000 mg / 50 mL (500 mg / mL) Pharmacy Bulk Package vials

Khaws rau hauv lub tub yees ntawm 2 ° txog 8 ° C (36 ° txog 46 ° F).

Tiv thaiv los ntawm lub teeb. Cov khoom no tsis muaj preservative. Saib Dosage and Administration (2.1) , rau cov lus qhia ntxaws txog kev npaj, dilution, thiab kev tswj hwm ntawm ASCOR.

17. COV NTAUB NTAWV QHIA TXOG KEV PAB CUAM

  • Qhia rau cov neeg mob tias kev kho nrog ASCOR tuaj yeem ua rau lawv txoj kev pheej hmoo ntawm oxalate nephropathy[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.1) ].
  • Qhia rau cov neeg mob tias kev kho mob nrog ASCOR tuaj yeem cuam tshuam cov txiaj ntsig hauv chav kuaj, suav nrog kev kuaj ntshav thiab zis, mus txog 24 teev tom qab txhaj tshuaj.[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.3) ].
  • Qhia rau cov neeg mob uas tsis muaj qabzib-6-phosphate dehydrogenase tias kev kho nrog ASCOR tuaj yeem ua rau muaj kev pheej hmoo ntawm hemolysis.[saib Cov Lus Ceeb Toom thiab Kev Ceeb Toom (5.2) ].

Tsim los ntawm:

McGuff Pharmaceuticals, Inc., Santa Ana, CA 92704

M381-0073

PACKAGE LABEL PRINCIPAL DISPLAY

ASCOR
Kev txhaj tshuaj ascorbic acid
Cov ntaub ntawv khoom
Yam khoom HUMAN PRESCRIPTION DRUG LABEL Yam khoom Code (Source) NDC: 67157-101
Txoj kev tswj hwm INTRAVENOUS DEA Teem caij
Cov khoom xyaw nquag / Active Moiety
Cov khoom xyaw npe Lub hauv paus muaj zog Lub zog
ASCORBIC ACID muaj (ASCORBIC ACID) ASCORBIC ACID muaj 500 mg hauv 1 mL
Cov khoom xyaw uas tsis muaj zog
Cov khoom xyaw npe Lub zog
EDATE DISODIUM 0.25 mg 1 mL
SODIUM HYDROXIDE
SODIUM BICARBONATE
Ntim
# Yam khoom Code Pob piav qhia
ib NDC: 67157-101-50 1 VIAL, GLASS hauv 1 CARTON
ib 50 mL hauv 1 VIAL, GLASS
ob NDC: 67157-101-51 25 VIAL, iav hauv 1 TRAY
ob 50 mL hauv 1 VIAL, GLASS
Cov ntaub ntawv lag luam
Kev lag luam qeb Daim ntawv thov Number los yog Monograph Citation Hnub pib ua lag luam Hnub Kawg Ua Lag Luam
NDA NDA 209112 01/15/2018
Labeler -McGuff Pharmaceuticals, Inc. (134632103)
Sau npe -McGuff Pharmaceuticals, Inc. (134632103)
Kev tsim kho
Lub npe Chaw nyob ID/FEI Kev ua haujlwm
McGuff Pharmaceuticals, Inc. 134632103 ib tsim tawm (67157-101)
McGuff Pharmaceuticals, Inc.