Diclofenac Potassium

Dosage form: ntsiav tshuaj, zaj duab xis coated
Chav kawm tshuaj: Nonsteroidal anti-inflammatory tshuaj

Ntawm nplooj ntawv no

• Boxed Warning
• Kev piav qhia
• Clinical Pharmacology
• Indications thiab siv
• Contraindications
• Ceeb toom
• Cov kev ceev faj
• Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob
• Cov tshuaj sib cuam tshuam
• Cov Kev Phem Tsis Zoo/Sib Phem
• Kev noj ntau dhau
• Dosage thiab Administration
• Yuav Ua Li Cas Muab / Cia thiab tuav
• Phau Ntawv Qhia Tshuaj

Kab mob plawv Thrombotic

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Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) ua rau muaj kev pheej hmoo siab ntawm cov kab mob plawv loj heev, suav nrog myocardial infarction thiab stroke, uas tuaj yeem ua rau tuag taus. Qhov kev pheej hmoo no tuaj yeem tshwm sim ntxov hauv kev kho mob thiab tuaj yeem nce ntxiv nrog lub sijhawm siv (saib CEEB TOOM ).

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Diclofenac Potassium ntsiav tshuaj yog contraindicated nyob rau hauv qhov chaw ntawm coronary artery bypass graft (CABG) phais (saib CONTRAINDICATIONS , CEEB TOOM ).

Gastrointestinal los ntshav, ulceration, thiab perforation

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NSAIDs ua rau muaj kev pheej hmoo siab ntawm kev mob plab hnyuv loj (GI) cov xwm txheej tsis zoo xws li los ntshav, rwj, thiab perforation ntawm lub plab lossis cov hnyuv, uas tuaj yeem ua rau tuag taus. Cov xwm txheej no tuaj yeem tshwm sim txhua lub sijhawm thaum siv thiab tsis muaj cov tsos mob ceeb toom. Cov neeg laus thiab cov neeg mob uas muaj keeb kwm yav dhau los ntawm tus kab mob peptic ulcer thiab / lossis GI los ntshav yog qhov pheej hmoo siab dua rau cov xwm txheej GI loj (saib CEEB TOOM ).

Diclofenac Potassium Description

Diclofenac Potassium ntsiav tshuaj, USP yog benzeneacetic acid derivative. Diclofenac Potassium ntsiav tshuaj, USP muaj nyob rau hauv cov ntsiav tshuaj ntawm 50 mg (lub teeb xim av) rau kev tswj qhov ncauj. Lub npe tshuaj yog 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium ntsev. Qhov hnyav molecular yog 334.25. Nws cov qauv molecular yog C14H10Cl2 uaNKOob, thiab nws muaj cov qauv hauv qab no:

Txhua ntsiav tshuaj Diclofenac Potassium, USP npaj rau kev tswj qhov ncauj, muaj 50 mg Diclofenac Potassium rau kev tswj qhov ncauj. Tsis tas li ntawd, txhua lub ntsiav tshuaj muaj cov khoom xyaw hauv qab no: colloidal silicon dioxide, hydroxyethyl cellulose, hlau oxide liab, magnesium stearate, methanol, polyethylene glycol, povidone, sodium bicarbonate, titanium dioxide thiab daj hlau oxide.

Diclofenac Potassium - Kev Kho Mob Pharmacology

Mechanism ntawm Action

Diclofenac muaj analgesic, anti-inflammatory, thiab antipyretic zog.

Cov txheej txheem ntawm kev ua ntawm Diclofenac Potassium ntsiav tshuaj, zoo li lwm cov NSAIDs, tsis to taub tag nrho tab sis cuam tshuam nrog inhibition ntawm cyclooxygenase (COX-1 thiab COX-2).

Diclofenac yog ib qho muaj zog inhibitor ntawm prostaglandin synthesishauv vitro. Diclofenac concentrations mus txog thaum kho tau tsimnyobteebmeem. Prostaglandins sensitize afferent qab haus huv thiab potentiate qhov kev txiav txim ntawm bradykinin inducing mob nyob rau hauv cov tsiaj qauv. Prostaglandins yog cov tshuaj kho mob ntawm o. Vim tias diclofenac yog ib qho inhibitor ntawm prostaglandin synthesis, nws hom kev ua yuav yog vim qhov txo qis ntawm prostaglandins hauv cov ntaub so ntswg peripheral.

Pharmacokinetics

Diclofenac yog 100% absorbed tom qab noj qhov ncauj piv rau IV tswj raws li ntsuas los ntawm cov zis rov qab. Txawm li cas los xij, vim yog cov metabolism hauv thawj zaug, tsuas yog kwv yees li 50% ntawm cov tshuaj absorbed yog muaj nyob rau hauv (saib Table 1). Hauv qee cov neeg ua haujlwm yoo mov, ntsuas cov ntshav plasma tau pom hauv 10 feeb ntawm kev siv tshuaj Diclofenac Potassium ntsiav tshuaj. Peak plasma qib tau ua tiav kwv yees li 1 teev hauv kev yoo mov ib txwm ua haujlwm pab dawb, nrog rau ntau yam ntawm .33 mus rau 2 teev. Cov zaub mov tsis muaj txiaj ntsig tseem ceeb ntawm qhov nqus ntawm diclofenac. Txawm li cas los xij, feem ntau muaj qhov ncua sij hawm pib ntawm kev nqus thiab txo qis hauv cov ntshav plasma ntawm kwv yees li 30%.

Qhov pom meej ntim ntawm kev faib (V / F) ntawm Diclofenac Potassium yog 1.3 L / kg.

Diclofenac yog ntau tshaj 99% khi rau tib neeg cov ntshav cov protein, feem ntau rau albumin. Serum protein binding yog tas li nyob rau hauv ntau qhov concentration (0.15-105 mcg / mL) ua tiav nrog cov koob tshuaj pom zoo.

Diclofenac diffuses mus rau hauv thiab tawm ntawm cov kua synovial. Diffusion rau hauv kev sib koom ua ke tshwm sim thaum cov ntshav plasma siab dua cov hauv cov kua dej synovial, tom qab ntawd cov txheej txheem thim rov qab thiab cov kua dej synovial siab dua li cov ntshav plasma. Nws tsis paub meej tias kev sib kis mus rau hauv kev sib koom ua ke ua lub luag haujlwm hauv kev ua haujlwm ntawm diclofenac.

Metabolism

Tsib diclofenac metabolites tau txheeb xyuas hauv tib neeg cov ntshav thiab zis. Cov metabolites suav nrog 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4', 5-dihydroxy- thiab 3'-hydroxy-4'-methoxy-diclofenac. Qhov loj diclofenac metabolite, 4'-hydroxy-diclofenac, muaj cov tshuaj tsis muaj zog heev. Kev tsim ntawm 4'-hydroxy-diclofenac feem ntau yog kho los ntawm CYP2C9. Ob qho tib si diclofenac thiab nws cov oxidative metabolites tau txais glucuronidation los yog sulfation tom qab los ntawm cov kua tsib tso tawm. Acylglucuronidation kho los ntawm UGT2B7 thiab oxidation mediated los ntawm CYP2C8 kuj tseem tuaj yeem ua lub luag haujlwm hauv diclofenac metabolism. CYP3A4 yog lub luag haujlwm rau kev tsim cov metabolites me, 5-hydroxy thiab 3'-hydroxy-diclofenac. Hauv cov neeg mob lub raum tsis ua haujlwm, qhov siab tshaj plaws ntawm cov metabolites 4'-hydroxy thiab 5-hydroxy-diclofenac yog kwv yees li 50% thiab 4% ntawm cov niam txiv sib xyaw tom qab noj ib qhov ncauj piv rau 27% thiab 1% hauv cov kev noj qab haus huv ib txwm muaj.

Kev tso tawm

Diclofenac raug tshem tawm los ntawm cov metabolism thiab tom qab tso zis thiab biliary excretion ntawm glucuronide thiab sulfate conjugates ntawm cov metabolites. Me me lossis tsis pub dawb tsis hloov pauv diclofenac raug tso tawm hauv cov zis. Kwv yees li 65% ntawm cov koob tshuaj tau tawm hauv cov zis thiab kwv yees li 35% hauv cov kua tsib raws li kev sib txuas ntawm cov tsis hloov pauv diclofenac ntxiv rau cov metabolites. Vim tias kev tshem tawm lub raum tsis yog ib txoj hauv kev tseem ceeb ntawm kev tshem tawm rau qhov tsis hloov pauv diclofenac, kev hloov kho koob tshuaj rau cov neeg mob uas mob me me mus rau lub raum tsis ua haujlwm tsis tsim nyog. Lub davhlau ya nyob twg ib nrab ntawm lub neej tsis hloov pauv diclofenac yog kwv yees li 2 teev.

Cov pejxeem tshwj xeeb

Cov tshuaj pharmacokinetics ntawm Diclofenac Potassium ntsiav tshuaj tsis tau tshawb xyuas hauv cov neeg mob menyuam yaus.

Pharmacokinetic sib txawv vim haiv neeg tsis tau txheeb xyuas.

Hepatic metabolism suav txog yuav luag 100% ntawm Diclofenac Potassium ntsiav tshuaj tshem tawm, yog li cov neeg mob uas muaj kab mob siab yuav tsum tau txo cov tshuaj Diclofenac Potassium ntsiav tshuaj piv rau cov neeg mob uas muaj lub siab ua haujlwm.

Diclofenac pharmacokinetics tau tshawb xyuas hauv cov neeg mob lub raum tsis txaus. Tsis muaj qhov sib txawv hauv cov tshuaj pharmacokinetics ntawm diclofenac tau kuaj pom hauv cov kev tshawb fawb ntawm cov neeg mob raum tsis zoo. Hauv cov neeg mob lub raum tsis zoo (insulin clearance 60-90, 30-60, thiab<30 mL/min; N = 6 in each group), AUC values and elimination rate were comparable to those in healthy subjects.

Kev Tshawb Fawb Kev Sib Tham Txog Tshuaj

Thaum siv nrog voriconazole (inhibitor ntawm CYP2C9, 2C19 thiab 3A4 enzyme), C.maxthiab AUC ntawm diclofenac nce los ntawm 114% thiab 78%, feem (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ).

Thaum NSAIDs tau muab tshuaj nrog tshuaj aspirin, cov protein khi ntawm NSAIDs raug txo, txawm hais tias qhov kev tshem tawm ntawm NSAID dawb tsis hloov pauv. Lub chaw kho mob tseem ceeb ntawm qhov kev sib tshuam no tsis paub. Saib Table 2 rau kev soj ntsuam cov tshuaj tseem ceeb ntawm NSAIDs nrog tshuaj aspirin (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ).

Cov lus qhia thiab kev siv rau Diclofenac Potassium

Ua tib zoo xav txog cov txiaj ntsig thiab kev pheej hmoo ntawm Diclofenac Potassium ntsiav tshuaj thiab lwm yam kev kho mob ua ntej txiav txim siab siv Diclofenac Potassium ntsiav tshuaj. Siv cov koob tshuaj qis tshaj plaws rau lub sijhawm luv tshaj plaws raws li tus neeg mob lub hom phiaj kho mob (saib CEEB TOOM: Txoj hnyuv plab los ntshav, ulceration, thiab perforation ).

Diclofenac Potassium ntsiav tshuaj yog qhia:

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Rau kev kho mob ntawm thawj dysmenorrhea

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Rau kev kho mob me me mus rau nruab nrab

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Rau kev pab ntawm cov tsos mob thiab cov tsos mob ntawm osteoarthritis

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Rau kev kho mob ntawm cov tsos mob thiab cov tsos mob ntawm rheumatoid mob caj dab

Contraindications

Diclofenac Potassium ntsiav tshuaj yog contraindicated nyob rau hauv cov neeg mob hauv qab no:

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Paub qhov tsis hnov ​​​​tsw (piv txwv li, cov tshuaj tiv thaiv anaphylactic thiab cov tshuaj tiv thaiv tawv nqaij hnyav) rau diclofenac lossis ib qho ntawm cov khoom siv tshuaj (saib CEEB TOOM: Cov tshuaj tiv thaiv anaphylactic , Cov tawv nqaij tawv heev ).

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Keeb kwm ntawm mob hawb pob, urticaria, lossis kev tsis haum tshuaj tom qab noj tshuaj aspirin lossis lwm yam NSAIDs. Kev mob hnyav, qee zaum ua rau tuag taus, cov tshuaj tiv thaiv anaphylactic rau NSAIDs tau tshaj tawm hauv cov neeg mob no (saib CEEB TOOM: Cov tshuaj tiv thaiv anaphylactic , Exacerbation ntawm Asthma ntsig txog Aspirin Sensitivity ).

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Hauv kev teeb tsa ntawm coronary artery bypass graft (CABG) phais (saib CEEB TOOM: Cov Kab Mob Ntshav Qab Zib Thrombotic ).

Ceeb toom

Kab mob plawv Thrombotic

Kev sim tshuaj ntsuam xyuas ntawm ntau COX-2 xaiv thiab tsis xaiv NSAIDs txog li peb xyoos ntev tau pom tias muaj kev pheej hmoo ntau ntxiv ntawm cov kab mob plawv (CV) thrombotic, suav nrog myocardial infarction (MI) thiab mob stroke, uas tuaj yeem ua rau tuag taus. Raws li cov ntaub ntawv muaj, nws tsis paub meej tias qhov kev pheej hmoo rau CV thrombotic txheej xwm zoo ib yam rau txhua NSAIDs. Cov txheeb ze nce nyob rau hauv cov xwm txheej loj CV thrombotic dhau qhov pib tau hais los ntawm kev siv NSAID zoo nkaus li zoo ib yam li cov neeg muaj thiab tsis paub CV kab mob lossis cov xwm txheej pheej hmoo rau CV kab mob. Txawm li cas los xij, cov neeg mob uas paub txog kab mob CV lossis cov teeb meem muaj feem cuam tshuam tau muaj qhov tshwm sim ntau dua ntawm cov xwm txheej CV thrombotic hnyav, vim lawv qhov pib nce ntxiv. Qee cov kev tshawb fawb soj ntsuam pom tau tias qhov kev pheej hmoo ntawm CV thrombotic loj tshwm sim pib ntxov li thawj lub lis piam ntawm kev kho mob. Qhov kev nce hauv CV thrombotic kev pheej hmoo tau raug pom feem ntau tsis tu ncua ntawm cov koob tshuaj ntau dua.

Txhawm rau txo qhov muaj feem pheej hmoo rau qhov tshwm sim tsis zoo CV hauv cov neeg mob kho NSAID, siv cov koob tshuaj qis tshaj plaws rau lub sijhawm luv tshaj plaws. Cov kws kho mob thiab cov neeg mob yuav tsum tau ceev faj txog kev txhim kho cov xwm txheej zoo li no, thoob plaws hauv kev kho mob tag nrho, txawm tias tsis muaj cov tsos mob CV yav dhau los. Cov neeg mob yuav tsum raug ceeb toom txog cov tsos mob ntawm cov xwm txheej CV loj thiab cov kauj ruam yuav ua yog tias lawv tshwm sim.

Tsis muaj pov thawj zoo sib xws uas siv cov tshuaj aspirin ib txhij txo qhov kev pheej hmoo ntawm CV thrombotic loj tshwm sim cuam tshuam nrog kev siv NSAID. Kev siv cov tshuaj aspirin thiab NSAID ib txhij, xws li diclofenac, ua rau muaj kev pheej hmoo ntawm kev mob plab hnyuv loj (GI) (saib CEEB TOOM: Txoj hnyuv plab los ntshav, ulceration, thiab perforation ).

Ob qhov loj, tswj, kev sim tshuaj ntsuam xyuas ntawm COX-2 xaiv NSAID rau kev kho mob ntawm thawj 10-14 hnub tom qab kev phais CABG pom muaj qhov tshwm sim ntawm myocardial infarction thiab mob stroke. NSAIDs yog contraindicated nyob rau hauv qhov chaw ntawm CABG (saib CONTRAINDICATIONS ).

Cov kev tshawb fawb soj ntsuam ua nyob rau hauv Danish National Registry tau pom tias cov neeg mob kho nrog NSAIDs nyob rau hauv lub sij hawm tom qab MI tau muaj kev pheej hmoo ntawm reinfarction, CV-txog kev tuag, thiab tag nrho cov-ua rau tuag pib nyob rau hauv thawj lub lim tiam ntawm kev kho mob. Hauv tib pawg neeg no, qhov tshwm sim ntawm kev tuag hauv thawj xyoo tom qab MI yog 20 rau 100 tus neeg xyoo hauv cov neeg mob uas tau kho NSAID piv rau 12 rau 100 tus neeg xyoo hauv cov neeg mob uas tsis yog NSAID raug. Txawm hais tias qhov tseeb ntawm kev tuag tau poob qis me ntsis tom qab thawj xyoo tom qab MI, qhov muaj feem cuam tshuam txog kev tuag ntawm cov neeg siv NSAID tau mob siab rau tsawg kawg plaub xyoos tom ntej ntawm kev soj ntsuam.

Zam tsis txhob siv cov ntsiav tshuaj Diclofenac Potassium hauv cov neeg mob uas muaj MI tsis ntev los no tshwj tsis yog tias cov txiaj ntsig xav tau ntau dua qhov kev pheej hmoo ntawm cov xwm txheej CV thrombotic. Yog tias cov ntsiav tshuaj Diclofenac Potassium tau siv rau cov neeg mob uas muaj MI tsis ntev los no, saib xyuas cov neeg mob kom pom cov tsos mob ntawm lub plawv ischemia.

Gastrointestinal los ntshav, ulceration, thiab perforation

NSAIDs, suav nrog diclofenac, ua rau mob plab hnyuv loj (GI) cuam tshuam nrog rau qhov mob, los ntshav, rwj, thiab perforation ntawm txoj hlab pas, plab, hnyuv me, lossis txoj hnyuv loj, uas tuaj yeem ua rau tuag taus. Cov xwm txheej tsis zoo no tuaj yeem tshwm sim txhua lub sijhawm, nrog lossis tsis muaj cov tsos mob ceeb toom, hauv cov neeg mob kho nrog NSAIDs. Tsuas yog ib ntawm tsib tus neeg mob, uas tsim muaj qhov tshwm sim loj GI siab ntawm kev kho NSAID, yog cov tsos mob. Upper GI rwj, los ntshav tag nrho los yog perforation los ntawm NSAIDs tshwm sim nyob rau hauv kwv yees li 1% ntawm cov neeg mob kho rau 3-6 lub hlis, thiab nyob rau hauv li 2% -4% ntawm cov neeg mob kho rau ib xyoos. Txawm li cas los xij, txawm tias kev kho mob luv luv tsis yog yam tsis muaj kev pheej hmoo.

Cov neeg mob uas muaj keeb kwm yav dhau los ntawm tus kab mob peptic ulcer thiab / lossis GI los ntshav uas siv NSAIDs muaj ntau dua 10-fib ntxiv kev pheej hmoo rau kev tsim cov ntshav GI piv rau cov neeg mob uas tsis muaj cov kev pheej hmoo no. Lwm yam tseem ceeb uas ua rau muaj kev pheej hmoo ntawm GI los ntshav hauv cov neeg mob kho nrog NSAIDs suav nrog kev siv NSAID ntev dua, kev siv tshuaj sib xyaw ntawm qhov ncauj corticosteroids, aspirin, anticoagulants, lossis xaiv serotonin reuptake inhibitors (SSRIs); Kev haus luam yeeb, haus cawv, hnub nyoog laus, thiab kev noj qab haus huv tsis zoo. Feem ntau cov ntawv tshaj tawm txog kev tuag ntawm GI tshwm sim hauv cov neeg laus lossis cov neeg mob tsis muaj zog. Tsis tas li ntawd, cov neeg mob uas muaj kab mob siab heev thiab / lossis coagulopathy muaj qhov pheej hmoo siab rau GI los ntshav.

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Siv cov tshuaj qis tshaj plaws rau lub sijhawm luv tshaj plaws.

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Tsis txhob noj ntau tshaj ib NSAID ib zaug.

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Tsis txhob siv rau hauv cov neeg mob uas muaj kev pheej hmoo siab dua tshwj tsis yog tias cov txiaj ntsig xav tau ntau dua qhov kev pheej hmoo los ntshav. Rau cov neeg mob zoo li no, nrog rau cov neeg uas muaj GI los ntshav, xav txog lwm txoj kev kho mob uas tsis yog NSAIDs.

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Tseem ceeb toom rau cov tsos mob thiab cov tsos mob ntawm GI ulceration thiab los ntshav thaum kho NSAID.

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Yog tias xav tias muaj qhov tshwm sim tsis zoo ntawm GI, pib ntsuas thiab kho tam sim, thiab txiav tawm cov ntsiav tshuaj Diclofenac Potassium kom txog thaum qhov tshwm sim tsis zoo GI raug txiav tawm.

Hauv kev teeb tsa ntawm kev siv cov tshuaj aspirin qis rau kev tiv thaiv kab mob plawv, saib xyuas cov neeg mob kom zoo dua rau cov pov thawj ntawm GI los ntshav (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ).

Hepatotoxicity

Hauv kev sim tshuaj diclofenac uas muaj cov khoom lag luam, qhov muaj txiaj ntsig nce siab (piv txwv li, ntau dua 3 npaug ntawm ULN) ntawm AST (SGOT) tau pom nyob hauv kwv yees li 2% ntawm kwv yees li 5,700 tus neeg mob nyob rau qee lub sijhawm thaum kho diclofenac (ALT tsis tau ntsuas hauv txhua qhov kev tshawb fawb) .

Hauv qhov loj, qhib-daim ntawv lo, tswj kev sim ntawm 3,700 tus neeg mob kho nrog qhov ncauj diclofenac sodium rau 2-6 lub hlis, cov neeg mob tau saib xyuas thawj zaug ntawm 8 lub lis piam thiab 1,200 tus neeg mob tau saib xyuas dua ntawm 24 lub lis piam. Lub ntsiab lus nce siab ntawm ALT thiab / lossis AST tshwm sim hauv kwv yees li 4% ntawm cov neeg mob thiab suav nrog kev nce siab (ntau dua 8 npaug ntawm ULN) hauv kwv yees li 1% ntawm 3,700 tus neeg mob. Nyob rau hauv txoj kev tshawb no qhib daim ntawv lo, qhov tshwm sim ntau dua ntawm ciam teb (tsawg dua 3 npaug ntawm ULN), nruab nrab (3-8 npaug ntawm ULN), thiab cim (ntau dua 8 npaug ntawm ULN) qhov siab ntawm ALT lossis AST tau pom hauv cov neeg mob. tau txais diclofenac thaum piv rau lwm cov NSAIDs. Kev nce hauv transaminases tau pom ntau zaus hauv cov neeg mob osteoarthritis dua li cov neeg mob rheumatoid mob caj dab.

Yuav luag tag nrho cov ntsiab lus nce siab hauv transaminases tau kuaj pom ua ntej cov neeg mob ua cov tsos mob. Kev ntsuam xyuas txawv txav tshwm sim thaum thawj 2 lub hlis ntawm kev kho mob nrog diclofenac hauv 42 ntawm 51 tus neeg mob hauv txhua qhov kev sim uas tsim cov cim transaminase nce.

Hauv cov ntawv tshaj tawm tom khw, cov neeg mob ntawm cov tshuaj tiv thaiv kab mob hepatotoxicity tau tshaj tawm thawj lub hlis, thiab qee zaum, thawj 2 lub hlis ntawm kev kho mob, tab sis tuaj yeem tshwm sim txhua lub sijhawm thaum kho nrog diclofenac. Kev soj ntsuam tom qab muag tau tshaj tawm cov xwm txheej ntawm cov kab mob siab hnyav, suav nrog daim siab necrosis, jaundice, fulminant kab mob siab nrog thiab tsis muaj jaundice, thiab daim siab tsis ua haujlwm. Qee qhov xwm txheej no tau ua rau muaj neeg tuag lossis hloov lub siab.

Nyob rau hauv ib tug European retrospective pej xeem-raws li, cov ntaub ntawv-tswj txoj kev tshawb no, 10 mob ntawm diclofenac txuam tshuaj-induced lub siab raug mob nrog tam sim no siv piv nrog tsis siv cov diclofenac yog txuam nrog ib tug tseem ceeb statistical 4-fold kho qhov sib txawv ntawm daim siab mob. Hauv qhov kev tshawb fawb tshwj xeeb no, raws li tag nrho ntawm 10 tus neeg mob lub siab raug mob cuam tshuam nrog diclofenac, qhov hloov pauv qhov sib txawv tau nce ntxiv nrog poj niam txiv neej, koob tshuaj 150 mg lossis ntau dua, thiab siv sijhawm ntev dua 90 hnub.

Cov kws kho mob yuav tsum ntsuas cov tshuaj transaminases ntawm lub hauv paus thiab ib ntus hauv cov neeg mob uas tau txais kev kho mob ntev nrog diclofenac, vim tias mob hepatotoxicity hnyav tuaj yeem tshwm sim yam tsis muaj qhov sib txawv ntawm cov tsos mob. Lub sijhawm zoo tshaj plaws rau kev ntsuas thawj thiab tom qab transaminase tsis paub. Raws li kev soj ntsuam cov ntaub ntawv thiab cov kev paub tom qab muag, kev hloov pauv yuav tsum tau saib xyuas hauv 4 mus rau 8 lub lis piam tom qab pib kho nrog diclofenac. Txawm li cas los xij, kev mob siab hnyav tuaj yeem tshwm sim txhua lub sijhawm thaum kho nrog diclofenac.

Yog tias qhov kev kuaj mob siab tsis zoo tshwm sim los yog hnyav zuj zus, yog tias cov tsos mob tshwm sim thiab / lossis cov tsos mob zoo ib yam nrog cov kab mob siab, lossis yog tias cov tsos mob tshwm sim (xws li, eosinophilia, ua pob, mob plab, raws plab, zis tsaus nti, thiab lwm yam), Diclofenac Potassium ntsiav tshuaj yuav tsum yog. txiav tam sim ntawd.

Qhia cov neeg mob txog cov cim ceeb toom thiab cov tsos mob ntawm hepatotoxicity (xws li xeev siab, qaug zog, lethargy, raws plab, pruritus, jaundice, sab xis sab sauv quadrant tenderness, thiab 'zoo li khaub thuas' cov tsos mob). Yog tias cov tsos mob tshwm sim thiab cov tsos mob zoo ib yam nrog cov kab mob siab, lossis yog tias muaj cov tsos mob tshwm sim (piv txwv li, eosinophilia, pob khaus, thiab lwm yam), txiav cov ntsiav tshuaj Diclofenac Potassium tam sim ntawd, thiab ua cov tshuaj ntsuam xyuas ntawm tus neeg mob.

Txhawm rau txo qhov muaj feem pheej hmoo rau kev mob siab rau lub siab hauv cov neeg mob kho nrog Diclofenac Potassium ntsiav tshuaj, siv cov koob tshuaj qis tshaj plaws rau lub sijhawm luv tshaj plaws. Kev ceev faj thaum muab tshuaj Diclofenac Potassium ntsiav tshuaj nrog cov tshuaj sib xyaw ua ke uas paub tias muaj peev xwm ua rau hepatotoxic (xws li acetaminophen, tshuaj tua kab mob, tshuaj tiv thaiv kab mob vwm).

Ntshav siab

NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj tuaj yeem ua rau muaj qhov pib mob ntshav siab tshiab lossis ua rau mob ntshav siab ntxiv, ob qho tib si tuaj yeem ua rau muaj qhov tshwm sim ntawm CV. Cov neeg mob noj cov tshuaj angiotensin converting enzyme (ACE) inhibitors, thiazides diuretics lossis voj diuretics yuav muaj kev cuam tshuam tsis zoo rau cov kev kho no thaum noj NSAIDs (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ).

Saib xyuas ntshav siab (BP) thaum pib kho NSAID thiab thoob plaws hauv chav kho mob.

Lub plawv Failure thiab Edema

Coxib thiab ib txwm NSAID Trialists 'Kev sib koom ua ke meta-kev tshuaj xyuas ntawm kev sim tswj cov kev sim ntsuas tau pom muaj kwv yees li ob npaug ntawm kev mus pw hauv tsev kho mob rau lub plawv tsis ua hauj lwm hauv COX-2 xaiv cov neeg mob thiab cov neeg mob uas tsis xaiv NSAID-kho piv rau cov neeg mob uas tau txais cov placebo. Hauv Danish National Registry txoj kev tshawb fawb ntawm cov neeg mob plawv tsis ua hauj lwm, NSAID siv ua rau muaj kev pheej hmoo ntawm MI, mus pw hauv tsev kho mob rau lub plawv tsis ua hauj lwm, thiab kev tuag.

Tsis tas li ntawd, cov dej tuav thiab edema tau pom nyob rau hauv qee cov neeg mob kho nrog NSAIDs. Kev siv diclofenac tuaj yeem cuam tshuam CV los ntawm ntau cov tshuaj kho mob siv los kho cov mob no (xws li, diuretics, ACE inhibitors, lossis angiotensin receptor blockers [ARBs]) (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ).

Tsis txhob siv cov ntsiav tshuaj Diclofenac Potassium hauv cov neeg mob uas muaj lub plawv tsis ua haujlwm hnyav tshwj tsis yog tias cov txiaj ntsig xav tau ntau dua qhov kev pheej hmoo ua rau lub plawv tsis ua haujlwm. Yog tias cov ntsiav tshuaj Diclofenac Potassium tau siv rau hauv cov neeg mob uas muaj lub plawv tsis ua haujlwm hnyav, saib xyuas cov neeg mob kom pom cov tsos mob ntawm lub plawv tsis ua haujlwm.

Lub raum Toxicity thiab Hyperkalemia

Kev tswj hwm ntev ntev ntawm NSAIDs tau ua rau lub raum papillary necrosis thiab lwm yam mob raum.

Lub raum toxicity kuj tau pom hauv cov neeg mob uas lub raum prostaglandins muaj lub luag haujlwm them nyiaj rau kev saib xyuas lub raum perfusion. Hauv cov neeg mob no, kev tswj hwm ntawm NSAID tuaj yeem ua rau txo qis hauv kev tsim cov tshuaj prostaglandin thiab, qhov thib ob, hauv cov ntshav hauv lub raum, uas tuaj yeem ua rau lub raum tsis zoo. Cov neeg mob uas muaj kev pheej hmoo loj tshaj plaws ntawm cov tshuaj tiv thaiv no yog cov neeg muaj lub raum tsis ua haujlwm, lub cev qhuav dej, hypovolemia, plawv tsis ua haujlwm, lub siab ua haujlwm tsis zoo, cov tshuaj diuretics thiab ACE-inhibitors lossis ARBs, thiab cov neeg laus. Kev txiav tawm ntawm NSAID txoj kev kho feem ntau yog ua raws li kev rov qab mus rau lub xeev pretreatment.

Tsis muaj cov ntaub ntawv muaj los ntawm kev tswj xyuas kev tshawb fawb txog kev siv Diclofenac Potassium ntsiav tshuaj hauv cov neeg mob uas mob raum siab. Cov teebmeem ntawm lub raum ntawm Diclofenac Potassium ntsiav tshuaj tuaj yeem ua kom nrawm rau kev ua haujlwm ntawm lub raum tsis ua haujlwm hauv cov neeg mob uas muaj kab mob hauv lub raum.

Kho qhov ntim cov xwm txheej hauv cov neeg mob lub cev qhuav dej lossis cov neeg mob hypovolemic ua ntej pib siv cov ntsiav tshuaj Diclofenac Potassium. Saib xyuas lub raum ua haujlwm hauv cov neeg mob uas lub raum lossis lub siab tsis ua haujlwm, lub plawv tsis ua haujlwm, lub cev qhuav dej, lossis hypovolemia thaum siv cov ntsiav tshuaj Diclofenac Potassium (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ). Tsis txhob siv cov ntsiav tshuaj Diclofenac Potassium hauv cov neeg mob uas muaj kab mob raum siab tshwj tsis yog tias cov txiaj ntsig xav tau ntau dua qhov kev pheej hmoo ntawm lub raum ua haujlwm tsis zoo. Yog tias cov ntsiav tshuaj Diclofenac Potassium tau siv rau hauv cov neeg mob uas mob raum siab, saib xyuas cov neeg mob kom pom cov tsos mob ntawm lub raum ua haujlwm tsis zoo.

Kev nce ntxiv hauv cov ntshav cov poov tshuaj ntau ntxiv, suav nrog hyperkalemia, tau tshaj tawm nrog kev siv NSAIDs, txawm tias qee tus neeg mob tsis muaj lub raum tsis zoo. Hauv cov neeg mob uas lub raum ua haujlwm tsis zoo, cov teebmeem no tau raug ntaus nqi rau lub xeev hyporeninemic-hypoaldosteronism.

Anaphylactic Reactions

Diclofenac tau cuam tshuam nrog cov tshuaj tiv thaiv anaphylactic hauv cov neeg mob uas muaj thiab tsis paub qhov ua rau diclofenac thiab hauv cov neeg mob uas muaj cov tshuaj aspirin-sensitive asthma (saib CONTRAINDICATIONS , CEEB TOOM: Exacerbation of Asthma ntsig txog Aspirin Sensitivity ).

Exacerbation ntawm Asthma ntsig txog Aspirin Sensitivity

Ib pawg neeg ntawm cov neeg mob hawb pob tuaj yeem muaj cov tshuaj aspirin-sensitive asthma uas tuaj yeem muaj xws li mob rhinosinusitis nyuaj los ntawm qhov ntswg polyps; hnyav, tej zaum yuav tuag taus bronchospasm; thiab/los yog intolerance rau cov tshuaj aspirin thiab lwm yam NSAIDs. Vim tias qhov sib txawv ntawm cov tshuaj aspirin thiab lwm yam NSAIDs tau raug tshaj tawm hauv cov neeg mob aspirin-rhiab heev, Diclofenac Potassium ntsiav tshuaj yog contraindicated rau cov neeg mob uas muaj daim ntawv no ntawm cov tshuaj aspirin rhiab heev (saib CONTRAINDICATIONS ). Thaum cov ntsiav tshuaj Diclofenac Potassium siv rau cov neeg mob uas muaj mob hawb pob ua ntej (tsis paub cov tshuaj aspirin rhiab heev), saib xyuas cov neeg mob rau kev hloov pauv ntawm cov tsos mob thiab cov tsos mob ntawm tus mob hawb pob.

Cov tawv nqaij tawv heev

NSAIDs, suav nrog diclofenac, tuaj yeem ua rau muaj qhov tsis zoo ntawm daim tawv nqaij xws li exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), thiab toxic epidermal necrolysis (TEN), uas tuaj yeem ua rau tuag taus. Cov xwm txheej loj no yuav tshwm sim yam tsis tau ceeb toom. Qhia rau cov neeg mob txog cov tsos mob thiab cov tsos mob ntawm cov tawv nqaij mob hnyav thiab txiav kev siv cov ntsiav tshuaj Diclofenac Potassium thaum thawj zaug tshwm sim ntawm daim tawv nqaij pob liab liab lossis lwm yam cim ntawm hypersensitivity. Diclofenac Potassium ntsiav tshuaj yog contraindicated nyob rau hauv cov neeg mob uas muaj yav tas los kev loj hlob ntawm daim tawv nqaij tshwm sim rau NSAIDs (saib CONTRAINDICATIONS ).

Cov tshuaj tiv thaiv nrog Eosinophilia thiab Cov tsos mob ntawm lub cev (DRESS) tau tshaj tawm hauv cov neeg mob noj NSAIDs xws li Diclofenac Potassium ntsiav tshuaj. Qee qhov xwm txheej no tau ua rau tuag taus lossis ua rau muaj kev phom sij. DRESS feem ntau, txawm tias tsis yog tshwj xeeb, tshwm sim nrog kub taub hau, ua pob liab liab, lymphadenopathy, thiab / lossis lub ntsej muag o. Lwm yam kev kho mob tshwm sim muaj xws li kab mob siab, nephritis, hematological abnormalities, myocarditis, los yog myositis. Qee zaum cov tsos mob ntawm DRESS tuaj yeem zoo li tus kab mob kis mob hnyav. Eosinophilia feem ntau tshwm sim. Vim tias qhov teeb meem no txawv txav hauv nws qhov kev nthuav qhia, lwm yam hauv nruab nrog cev tsis tau sau tseg ntawm no tuaj yeem koom nrog. Nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov tias qhov tshwm sim thaum ntxov ntawm hypersensitivity, xws li kub taub hau lossis lymphadenopathy, tuaj yeem tshwm sim txawm tias pob liab liab tsis pom tseeb. Yog tias muaj cov cim qhia lossis cov tsos mob tshwm sim, txiav tawm Diclofenac Potassium ntsiav tshuaj thiab tshuaj xyuas tus neeg mob tam sim ntawd.

Fetal Toxicity

Kev kaw ntxov ntxov ntawm Fetal Ductus Arteriosus

Tsis txhob siv NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj, hauv cov poj niam cev xeeb tub thaum xeeb tub txog 30 lub lis piam thiab tom qab ntawd. NSAIDs suav nrog Diclofenac Potassium ntsiav tshuaj, ua rau muaj kev pheej hmoo ntawm kev kaw ntxov ntxov ntawm tus menyuam hauv plab ductus arteriosus ntawm kwv yees li qhov gestational.
hnub nyoog.

Kev siv cov NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj, ntawm kwv yees li 20 lub lis piam cev xeeb tub lossis tom qab cev xeeb tub tuaj yeem ua rau lub raum tsis ua haujlwm ua rau oligohydramnios thiab, qee zaum, lub raum tsis ua haujlwm rau menyuam yaus. Cov txiaj ntsig tsis zoo no tau pom, qhov nruab nrab, tom qab hnub mus rau lub lis piam ntawm kev kho mob, txawm hais tias oligohydramnios tau raug tshaj tawm tsis tu ncua sai li 48 teev tom qab NSAID pib. Oligohydramnios yog feem ntau, tab sis tsis yog ib txwm, thim rov qab nrog kev kho tsis txuas ntxiv. Cov teeb meem ntawm lub sijhawm ntev oligohydramnios tuaj yeem, piv txwv li, muaj xws li limb contractures thiab qeeb lub ntsws maturation. Hauv qee qhov kev muag khoom tom qab ntawm lub raum tsis ua haujlwm ntawm lub raum tsis ua haujlwm, yuav tsum muaj cov txheej txheem cuam tshuam xws li kev hloov pauv lossis lim ntshav.

Yog tias kev kho NSAID tsim nyog nyob nruab nrab ntawm kwv yees li 20 lub lis piam thiab 30 lub lis piam gestation, txwv tsis pub Diclofenac Potassium ntsiav tshuaj siv rau cov koob tshuaj qis tshaj plaws thiab lub sijhawm luv tshaj plaws. Xav txog kev soj ntsuam ultrasound ntawm amniotic kua yog tias Diclofenac Potassium ntsiav tshuaj kev kho mob ncua ntev tshaj 48 teev. Txiav tawm Diclofenac Potassium ntsiav tshuaj yog tias oligohydramnios tshwm sim thiab ua raws li kev kho mob. (saib COV KEV CEEV FAJ : Kev xeeb tub ).

Hematological Toxicity

Anemia tau tshwm sim hauv cov neeg mob uas tau kho NSAID. Qhov no tej zaum yuav yog vim occult los yog tag nrho cov ntshav poob, kua retention, los yog ib tug piav qhia tsis tiav cov nyhuv rau erythropoiesis. Yog tias tus neeg mob tau kho nrog Diclofenac Potassium ntsiav tshuaj muaj cov tsos mob lossis cov tsos mob ntawm cov ntshav ntshav, saib xyuas hemoglobin lossis hematocrit.

NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj, tuaj yeem ua rau muaj kev pheej hmoo los ntshav. Cov kab mob xws li coagulation disorders, concomitant siv warfarin thiab lwm yam anticoagulants, antiplatelet agents (xws li, aspirin), serotonin reuptake inhibitors (SSRIs) thiab serotonin norepinephrine reuptake inhibitors (SNRIs) yuav ua rau kom qhov kev pheej hmoo no. Saib xyuas cov neeg mob no kom pom cov tsos mob los ntshav (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ).

Cov kev ceev faj

General

Diclofenac Potassium ntsiav tshuaj tsis tuaj yeem xav tias yuav hloov pauv corticosteroids lossis kho corticosteroid insufficiency. Kev ncua tsis tu ncua ntawm corticosteroids tuaj yeem ua rau muaj tus kab mob exacerbation. Cov neeg mob ntawm kev kho corticosteroid ntev ntev yuav tsum muaj lawv txoj kev kho mob qeeb qeeb yog tias txiav txim siab txiav tawm cov tshuaj corticosteroids thiab tus neeg mob yuav tsum tau saib xyuas kom zoo rau cov pov thawj ntawm qhov tsis zoo, suav nrog adrenal tsis txaus thiab exacerbation ntawm cov tsos mob ntawm kev mob caj dab.

Kev ua haujlwm tshuaj ntawm Diclofenac Potassium ntsiav tshuaj hauv kev txo qis kub taub hau thiab mob tuaj yeem ua rau txo qis kev siv hluav taws xob ntawm cov kab mob no hauv kev txheeb xyuas cov teeb meem ntawm kev xav tias tsis muaj kab mob, mob.

Cov ntaub ntawv rau cov neeg mob

Qhia rau tus neeg mob kom nyeem cov ntawv pom zoo FDA tus neeg mob ( Phau Ntawv Qhia Tshuaj ) uas nrog rau txhua daim ntawv muab tshuaj. Qhia rau cov neeg mob, tsev neeg, lossis lawv cov neeg saib xyuas txog cov ntaub ntawv hauv qab no ua ntej pib kho nrog Diclofenac Potassium ntsiav tshuaj thiab ib ntus thaum lub sijhawm kho tsis tu ncua.

Qhia rau cov neeg mob kom ceev faj txog cov tsos mob ntawm cov kab mob plawv, nrog rau mob hauv siab, ua tsis taus pa, tsis muaj zog, lossis hais lus tsis txaus ntseeg, thiab tshaj tawm cov tsos mob no rau lawv tus kws kho mob tam sim ntawd (saib CEEB TOOM: Cov Kab Mob Ntshav Qab Zib Thrombotic ).

Qhia cov neeg mob kom tshaj tawm cov tsos mob ntawm qhov mob thiab los ntshav, suav nrog mob epigastric, dyspepsia, melena, thiab hematemesis rau lawv tus kws kho mob. Hauv kev teeb tsa ntawm kev siv cov tshuaj aspirin qis rau kev tiv thaiv kab mob plawv, qhia cov neeg mob txog qhov muaj feem pheej hmoo rau cov tsos mob thiab cov tsos mob ntawm GI los ntshav (saib CEEB TOOM: Txoj hnyuv plab los ntshav, ulceration, thiab perforation ).

Qhia rau cov neeg mob txog cov cim ceeb toom thiab cov tsos mob ntawm hepatotoxicity (xws li xeev siab, qaug zog, lethargy, pruritus, raws plab, jaundice, sab xis sab sauv quadrant tenderness, thiab cov tsos mob zoo li mob khaub thuas). Yog tias qhov no tshwm sim, qhia cov neeg mob kom nres Diclofenac Potassium ntsiav tshuaj thiab nrhiav kev kho mob tam sim ntawd (saib CEEB TOOM: Hepatotoxicity ).

Qhia rau cov neeg mob kom ceeb toom rau cov tsos mob ntawm congestive plawv tsis ua hauj lwm nrog rau ua tsis taus pa luv, unexplained yuag, los yog edema thiab hu rau lawv tus kws kho mob yog hais tias cov tsos mob tshwm sim (saib CEEB TOOM: Lub plawv Failure thiab Edema ).

Qhia cov neeg mob txog cov tsos mob ntawm cov tshuaj tiv thaiv anaphylactic (piv txwv li, ua pa nyuaj, o ntawm lub ntsej muag lossis caj pas). Qhia cov neeg mob kom nrhiav kev pab thaum muaj xwm txheej ceev yog tias qhov no tshwm sim (saib CEEB TOOM: Cov tshuaj tiv thaiv anaphylactic ).

Qhia rau cov neeg mob kom nres Diclofenac Potassium ntsiav tshuaj tam sim yog tias lawv tsim cov pob liab liab thiab tiv tauj lawv tus kws kho mob sai li sai tau (saib CEEB TOOM ).

Qhia cov poj niam ntawm kev muaj peev xwm xeeb tub uas xav xeeb tub uas NSAIDs, suav nrog VOLTAREN®, tej zaum yuav cuam tshuam nrog kev ncua ncua ntawm ovulation (saib CEEB TOOM: Carcinogenesis, Mutagenesis, Impairment of Fertility ).

Qhia rau cov poj niam cev xeeb tub kom tsis txhob siv cov ntsiav tshuaj Diclofenac Potassium thiab lwm yam NSAIDs pib thaum cev xeeb tub 30 lub lis piam vim muaj kev pheej hmoo ntawm kev kaw ntxov ntxov ntawm fetal ductus arteriosus. Yog xav tau kev kho mob nrog Diclofenac Potassium ntsiav tshuaj rau tus poj niam cev xeeb tub ntawm li 20 mus rau 30 lub lis piam gestation, qhia nws tias nws yuav tsum tau saib xyuas rau oligohydramnios, yog tias kev kho mob txuas ntxiv ntev dua 48 teev (saib CEEB TOOM: Fetal Toxicity , CEEB TOOM: Kev xeeb tub ).

Qhia rau cov neeg mob tias kev siv cov ntsiav tshuaj Diclofenac Potassium nrog lwm cov NSAIDs lossis salicylates (piv txwv li, diflunisal, salsalate) tsis pom zoo vim tias muaj kev pheej hmoo ntawm plab hnyuv toxicity, thiab kev ua tau zoo me me los yog tsis muaj kev nce ntxiv (saib CEEB TOOM: Txoj hnyuv plab los ntshav, ulceration, thiab perforation thiab Cov tshuaj sib cuam tshuam ). Ceeb toom cov neeg mob tias NSAIDs tuaj yeem muaj nyob rau hauv cov tshuaj tom khw muag khoom rau kev kho mob khaub thuas, ua npaws, lossis insomnia.

Qhia rau cov neeg mob kom tsis txhob siv cov tshuaj aspirin qis ua ke nrog Diclofenac Potassium ntsiav tshuaj kom txog thaum lawv tham nrog lawv tus kws kho mob (saib CEEB TOOM: Cov tshuaj sib cuam tshuam ).

Masking ntawm Inflamation thiab kub taub hau

Kev ua haujlwm tshuaj ntawm Diclofenac Potassium ntsiav tshuaj hauv kev txo qis kub taub hau thiab mob, thiab tejzaum nws ua npaws, tuaj yeem txo cov nqi hluav taws xob ntawm cov kab mob no hauv kev kuaj xyuas kab mob.

Laboratory saib xyuas

Vim tias cov ntshav GI hnyav, hepatotoxicity, thiab lub raum raug mob tuaj yeem tshwm sim yam tsis muaj kev ceeb toom lossis cov tsos mob tshwm sim, xav txog kev saib xyuas cov neeg mob ntawm kev kho mob NSAID mus sij hawm ntev nrog CBC thiab chemistry profile ib ntus (saib CEEB TOOM: Txoj hnyuv plab los ntshav, ulceration thiab perforation , thiab Hepatotoxicity ).

Cov tshuaj sib cuam tshuam

Saib Table 2 rau kev kho mob tseem ceeb ntawm cov tshuaj sib cuam tshuam nrog diclofenac.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Kev tshawb nrhiav carcinogenicity ntev nyob rau hauv nas muab diclofenac sodium mus txog 2 mg / kg / hnub (kwv yees li 0.1 npaug ntawm qhov siab tshaj plaws pom zoo tib neeg koob tshuaj (MRHD) ntawm Diclofenac Potassium ntsiav tshuaj, 200 mg / hnub, raws li qhov chaw ntawm lub cev (BSA) sib piv) tau qhia tias tsis muaj qhov tshwm sim loj ntawm qog nqaij hlav. Ib txoj kev tshawb nrhiav carcinogenicity 2 xyoos ua rau cov nas ua haujlwm diclofenac sodium ntawm koob tshuaj txog 0.3 mg / kg / hnub (kwv yees li 0.007 npaug ntawm MRHD raws li kev sib piv BSA) hauv cov txiv neej thiab 1 mg / kg / hnub (kwv yees li 0.02 npaug ntawm MRHD raws li Kev sib piv BSA) hauv cov poj niam tsis tau qhia txog qhov muaj peev xwm ntawm oncogenic.

Kuv yuav coj mucinex nrog Advil

Diclofenac sodium tsis tau qhia txog kev ua mutagenic hauvhauv vitropoint mutation assays nyob rau hauv mammalian (nas lymphoma) thiab microbial (poov tshuaj, Ames) xeem systems thiab yog nonmutagenic nyob rau hauv ntau yam tsiaj.hauv vitrothiabnyobKev ntsuam xyuas, suav nrog kev ua kom tuag taus thiab txiv neej cov kab mob epithelial chromosomal kev tshawb fawb hauv nas, thiab nucleus anomaly thiab chromosomal aberration kev tshawb fawb hauv Suav hamsters.

Diclofenac sodium muab rau txiv neej thiab poj niam nas ntawm 4 mg / kg / hnub (kwv yees li 0.2 npaug ntawm MRHD raws li kev sib piv BSA) tsis cuam tshuam rau kev xeeb tub.

Raws li cov txheej txheem ntawm kev ua, kev siv cov tshuaj prostaglandin-mediated NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj, tuaj yeem ncua lossis tiv thaiv kev tawg ntawm zes qe menyuam, uas tau cuam tshuam nrog kev rov qab tsis muaj menyuam hauv qee tus poj niam. Cov kev tshawb fawb tsiaj luam tawm tau pom tias kev tswj hwm ntawm prostaglandin synthesis inhibitors muaj peev xwm cuam tshuam prostaglandin-mediated follicular rupture xav tau rau ovulation. Cov kev tshawb fawb me me hauv cov poj niam tau kho nrog NSAIDs kuj tau qhia txog qhov rov qab qeeb hauv ovulation. Xav txog kev tshem tawm NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj, hauv cov poj niam uas muaj teeb meem xeeb tub lossis cov uas tab tom tshawb nrhiav kev xeeb tub.

Kev xeeb tub

Kev siv cov NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj, tuaj yeem ua rau lub raum tsis ua haujlwm ntxov ntxov ntawm lub raum tsis ua haujlwm thiab lub raum tsis ua haujlwm ua rau oligohydramnios thiab, qee zaum, lub raum tsis ua haujlwm rau menyuam yaus. Vim tias cov kev pheej hmoo no, txwv cov koob tshuaj thiab lub sijhawm ntawm Diclofenac Potassium ntsiav tshuaj siv li ntawm 20 thiab 30 lub lis piam ntawm cev xeeb tub, thiab zam Diclofenac Potassium ntsiav tshuaj siv li ntawm 30 lub lis piam ntawm cev xeeb tub thiab tom qab cev xeeb tub (saib CEEB TOOM: Fetal Toxicity ).

Kev kaw ntxov ntxov ntawm Fetal Ductus Arteriosus

Kev siv cov NSAIDs, suav nrog Diclofenac Potassium ntsiav tshuaj, ntawm kwv yees li 30 lub lis piam gestation lossis tom qab cev xeeb tub ua rau muaj kev pheej hmoo ntawm kev kaw ntxov ntxov ntawm fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment

Kev siv NSAIDs ntawm kwv yees li 20 lub lis piam gestation lossis tom qab cev xeeb tub tau cuam tshuam nrog cov xwm txheej ntawm lub raum tsis ua haujlwm ua rau oligohydramnios, thiab qee zaum, lub raum tsis ua haujlwm hauv lub cev.

Cov ntaub ntawv los ntawm kev soj ntsuam kev tshawb fawb txog lwm yam muaj peev xwm embryofetal txaus ntshai ntawm kev siv NSAID rau cov poj niam hauv thawj peb lub hlis thib ob ntawm cev xeeb tub yog qhov tsis lees paub. Hauv kev tshawb fawb txog kev yug tsiaj, tsis muaj pov thawj ntawm teratogenicity tau pom nyob rau hauv nas, nas, lossis luav muab diclofenac thaum lub sijhawm organogenesis ntawm koob tshuaj txog li 0.5, 0.5, thiab 1 zaug, raws li, qhov siab tshaj plaws pom zoo tib neeg koob tshuaj (MRHD) ntawm Diclofenac. Cov ntsiav tshuaj Potassium, txawm hais tias muaj kev cuam tshuam ntawm niam thiab menyuam hauv plab hauv cov koob tshuaj no [saib Cov ntaub ntawv ]. Raws li cov ntaub ntawv tsiaj, prostaglandins tau pom tias muaj lub luag haujlwm tseem ceeb hauv endometrial vascular permeability, blastocyst implantation, thiab decidualization. Hauv kev tshawb fawb tsiaj, kev tswj hwm ntawm prostaglandin synthesis inhibitors xws li diclofenac, ua rau muaj zog ua ntej thiab tom qab cog qoob loo. Prostaglandins kuj tau pom tias muaj lub luag haujlwm tseem ceeb hauv lub raum kev loj hlob. Hauv kev tshawb fawb tsiaj luam tawm, prostaglandin synthesis inhibitors tau tshaj tawm tias ua rau lub raum tsis zoo thaum siv tshuaj kho mob.

Kev kwv yees keeb kwm yav dhau los ntawm kev yug me nyuam loj thiab nchuav menyuam rau cov neeg uas tau qhia 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

Fetal/Neonatal Adverse Reactions

Kev kaw ntxov ntxov ntawm Fetal Ductus Arteriosus

Tsis txhob siv cov NSAIDs rau cov poj niam thaum muaj hnub nyoog 30 lub lis piam thiab tom qab cev xeeb tub, vim tias NSAIDs, suav nrog cov ntsiav tshuaj Diclofenac Potassium, tuaj yeem ua rau lub cev kaw ntxov ntxov ntawm fetal ductus arteriosus (saib CEEB TOOM: Fetal Toxicity ).

Oligohydramnios/Neonatal Renal Impairment

Yog tias qhov NSAID tsim nyog ntawm kev xeeb tub li 20 lub lis piam lossis tom qab cev xeeb tub, txwv kev siv rau qhov qis tshaj plaws thiab lub sijhawm luv tshaj plaws. Yog tias Diclofenac Potassium ntsiav tshuaj kho tau ntev dua 48 teev, xav txog kev saib xyuas nrog ultrasound rau oligohydramnios. Yog tias oligohydramnios tshwm sim, txiav tawm Diclofenac Potassium ntsiav tshuaj thiab ua raws li kev kho mob (saib CEEB TOOM: Fetal Toxicity ).

Kev kaw ntxov ntxov ntawm Fetal Ductus Arteriosus

Tshaj tawm cov ntaub ntawv tshaj tawm hais tias kev siv NSAIDs ntawm kwv yees li 30 lub lis piam ntawm cev xeeb tub thiab tom qab cev xeeb tub tuaj yeem ua rau lub cev tsis muaj zog ntawm fetal ductus arteriosus.

Cov kev tshawb fawb luam tawm thiab cov ntawv tshaj tawm kev lag luam piav qhia txog kev siv NSAID rau niam txiv ntawm kwv yees li 20 lub lis piam gestation lossis tom qab lub cev xeeb tub cuam tshuam nrog lub raum tsis ua haujlwm ntawm lub raum ua rau oligohydramnios, thiab qee zaum, lub raum tsis zoo hauv lub cev. Cov txiaj ntsig tsis zoo no tau pom, qhov nruab nrab, tom qab hnub mus rau lub lis piam ntawm kev kho mob, txawm hais tias oligohydramnios tau raug tshaj tawm tsis tu ncua sai li 48 teev tom qab NSAID pib. Hauv ntau qhov xwm txheej, tab sis tsis yog tag nrho, qhov txo qis hauv amniotic kua yog ib ntus thiab thim rov qab nrog kev txiav tawm ntawm cov tshuaj. Muaj qee cov ntaub ntawv qhia txog kev siv niam txiv NSAID thiab lub raum tsis ua haujlwm tsis zoo uas tsis muaj oligohydramnios, qee qhov tsis tuaj yeem thim rov qab. Qee qhov xwm txheej ntawm lub raum tsis ua haujlwm yuav tsum tau kho nrog cov txheej txheem invasive, xws li kev hloov pauv lossis lim ntshav.

Cov kev txwv ntawm cov kev tshawb fawb postmarketing thiab cov ntaub ntawv no suav nrog tsis muaj pawg tswj hwm; txwv cov ntaub ntawv hais txog koob tshuaj, lub sijhawm, thiab lub sijhawm ntawm kev raug tshuaj; thiab siv lwm yam tshuaj sib xyaw ua ke. Cov kev txwv no txwv tsis pub tsim qhov kev kwv yees txhim khu kev qha ntawm qhov kev pheej hmoo ntawm qhov tshwm sim tsis zoo ntawm tus menyuam hauv plab thiab menyuam yaus nrog kev siv NSAID niam. Vim hais tias cov ntaub ntawv kev nyab xeeb luam tawm ntawm cov txiaj ntsig ntawm cov menyuam mos uas muaj feem cuam tshuam feem ntau cov menyuam mos yug ntxov, qhov dav dav ntawm qee qhov kev tshaj tawm txog kev pheej hmoo rau tus menyuam mos tag nrho raug rau NSAIDs los ntawm kev siv niam yog tsis paub tseeb.

Cov kev tshawb fawb txog kev yug me nyuam thiab kev loj hlob ntawm cov tsiaj pom tau hais tias diclofenac sodium kev tswj hwm thaum lub sij hawm organogenesis tsis tsim teratogenicity txawm tias induction ntawm leej niam toxicity thiab fetus toxicity nyob rau hauv cov nas ntawm qhov ncauj koob tshuaj txog 20 mg / kg / hnub (kwv yees li 0.5 npaug ntawm qhov siab tshaj plaws pom zoo tib neeg koob tshuaj [MRHD. ] ntawm Diclofenac Potassium ntsiav tshuaj, 200 mg / hnub, raws li qhov sib piv ntawm lub cev saum npoo (BSA)), thiab hauv nas thiab luav ntawm qhov ncauj koob tshuaj txog 10 mg / kg / hnub (kwv yees li 0.5 thiab 1 zaug, raws li MRHD. ntawm BSA sib piv). Nyob rau hauv ib txoj kev tshawb no uas cev xeeb tub nas tau hais lus 2 mg / kg los yog 4 mg / kg diclofenac (0.1 thiab 0.2 npaug ntawm MRHD raws li BSA) los ntawm Gestation Day 15 txog rau lactation Day 21, tseem ceeb leej niam toxicity (peritonitis, mortality) tau sau tseg. . Cov koob tshuaj tiv thaiv niam txiv no tau cuam tshuam nrog dystocia, lub cev xeeb tub ntev, txo qhov hnyav thiab kev loj hlob, thiab txo tus menyuam hauv plab. Diclofenac tau pom tias hla lub placental barrier hauv nas, nas, thiab tib neeg.

Kev ua haujlwm lossis kev xa khoom

Tsis muaj kev tshawb fawb txog cov txiaj ntsig ntawm Diclofenac Potassium ntsiav tshuaj thaum lub sijhawm ua haujlwm lossis kev xa menyuam. Hauv kev tshawb fawb tsiaj, NSAIDs, suav nrog diclofenac, inhibit prostaglandin synthesis, ua rau ncua kev yug me nyuam, thiab ua rau muaj qhov tshwm sim ntawm kev yug menyuam.

Niam laus

Raws li cov ntaub ntawv muaj, diclofenac tuaj yeem muaj nyob hauv tib neeg cov kua 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 Diclofenac Potassium ntsiav tshuaj thiab ib qho kev cuam tshuam tsis zoo rau tus menyuam mos los ntawm cov ntsiav tshuaj Diclofenac Potassium lossis los ntawm tus menyuam hauv plab.

Ib tug poj niam kho qhov ncauj nrog diclofenac ntsev, 150 mg / hnub, muaj mis nyuj diclofenac qib ntawm 100 mcg / L, sib npaug rau cov me nyuam mos noj li ntawm 0.03 mg / kg / hnub. Diclofenac tsis pom nyob rau hauv cov kua mis hauv 12 tus poj niam uas siv diclofenac (tom qab 100 mg / hnub ntawm qhov ncauj rau 7 hnub lossis ib zaug 50 mg intramuscular koob tshuaj nyob rau lub sijhawm tom qab yug menyuam).

Kev siv menyuam yaus

Kev nyab xeeb thiab kev ua tau zoo hauv cov neeg mob menyuam yaus tsis tau tsim.

Kev siv Geriatric

Cov neeg mob laus, piv rau cov neeg mob hluas, muaj kev pheej hmoo ntau dua rau NSAID-koom nrog mob plawv, plab hnyuv, thiab / lossis lub raum tsis zoo, Yog tias cov txiaj ntsig xav tau rau cov neeg mob laus tshaj qhov muaj peev xwm txaus ntshai, pib noj tshuaj tsawg kawg ntawm kev siv tshuaj. ntau yam, thiab saib xyuas cov neeg mob rau qhov tsis zoo (saib CEEB TOOM: Cov Kab Mob Ntshav Qab Zib Thrombotic , Gastrointestinal los ntshav, ulceration, thiab perforation , Hepatotoxicity , Lub raum Toxicity thiab Hyperkalemia , CEEB TOOM: Laboratory saib xyuas ).

Diclofenac paub tias yuav raug tshem tawm los ntawm lub raum, thiab qhov kev pheej hmoo ntawm kev tsis zoo rau cov tshuaj no yuav muaj ntau dua rau cov neeg mob uas lub raum tsis ua haujlwm. Vim tias cov neeg laus muaj peev xwm ua rau lub raum tsis ua haujlwm, yuav tsum tau saib xyuas hauv kev xaiv tshuaj, thiab nws yuav pab tau rau kev saib xyuas lub raum ua haujlwm (saib CLINICAL PHARMACOLOGY , TXOJ CAI TSHIAB ).

Kev Phem Tsis Zoo

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

•

Cov Txheej Txheem Mob plawv Thrombotic (saib CEEB TOOM )

•

GI Bleeding, Ulceration thiab Perforation (saib CEEB TOOM )

•

Hepatotoxicity (saib CEEB TOOM )

•

Ntshav siab (saib CEEB TOOM )

•

Heart Failure thiab Edema (saib CEEB TOOM )

•

Lub raum Toxicity thiab Hyperkalemia (saib CEEB TOOM )

•

Anaphylactic Reactions (saib CEEB TOOM )

•

Cov tawv nqaij mob hnyav (saib CEEB TOOM )

•

Hematologic Toxicity (saib CEEB TOOM )

Kev sim tshuaj ntsuam xyuas

Vim tias kev sim tshuaj tau ua nyob rau hauv ntau yam sib txawv, cov tshuaj tiv thaiv tsis zoo uas tau pom nyob rau hauv kev sim tshuaj ntawm cov tshuaj tsis tuaj yeem ncaj qha piv rau cov nqi hauv kev sim tshuaj ntawm lwm cov tshuaj thiab tej zaum yuav tsis cuam tshuam txog cov nqi kev coj ua.

Hauv 718 tus neeg mob tau kho rau lub sijhawm luv, piv txwv li, 2 lub lis piam lossis tsawg dua, nrog Diclofenac Potassium ntsiav tshuaj, cov tshuaj tiv thaiv tsis zoo tau tshaj tawm ib nrab mus rau ib feem kaum ntau npaum li cov neeg mob tau kho ntev dua. Hauv 6 lub hlis, ob qhov muag tsis pom kev sib piv piv rau Diclofenac Potassium ntsiav tshuaj (N = 196) piv rau diclofenac sodium ncua sij hawm-tso ntsiav tshuaj (N = 197) piv rau ibuprofen (N = 197), cov kev phiv tshwm sim zoo sib xws hauv qhov xwm txheej thiab zaus.

Hauv cov neeg mob noj Diclofenac Potassium ntsiav tshuaj lossis lwm yam NSAIDs, feem ntau tshaj tawm cov kev mob tshwm sim tshwm sim hauv kwv yees li 1% -10% ntawm cov neeg mob yog:

Cov kev paub hauv plab hnyuv muaj xws li: mob plab, cem quav, raws plab, dyspepsia, flatulence, los ntshav tag nrho / perforation, kub siab, xeev siab, GI rwj (pas plab / duodenal) thiab ntuav.

Lub raum ua haujlwm tsis zoo, ntshav tsis txaus, kiv taub hau, edema, nce siab hauv siab enzymes, mob taub hau, nce los ntshav lub sijhawm, pruritus, ua pob liab vog thiab tinnitus.

Cov kev tsis zoo ntxiv uas tau tshaj tawm qee zaus suav nrog:

Lub cev tag nrho:ua npaws, kab mob, sepsis

Cardiovascular System:congestive lub plawv tsis ua hauj lwm, kub siab, tachycardia, syncope

Digestive System:qhov ncauj qhuav, esophagitis, plab / peptic ulcers, gastritis, gastrointestinal los ntshav, glossitis, hematemesis, kab mob siab, jaundice

Hemic thiab Lymphatic System:ecchymosis, eosinophilia, leukopenia, melena, purpura, qhov quav los ntshav, stomatitis, thrombocytopenia

Metabolic thiab Nutrition:hnyav hloov

Lub paj hlwb:ntxhov siab vim, asthenia, tsis meej pem, kev nyuaj siab, npau suav txawv txav, tsaug zog, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo.

Ua pa System:hawb pob, dyspnea

Daim tawv nqaij thiab Appendages:alopecia, photosensitivity, tawm hws nce

Tshwj xeeb Senses:qhov muag tsis pom kev

Urogenital System:cystitis, dysuria, hematuria, interstitial nephritis, oliguria / polyuria, proteinuria, lub raum tsis ua haujlwm

Lwm yam kev phiv tshwm sim, uas tshwm sim tsis tshua muaj yog:

Lub cev tag nrho:anaphylactic tshwm sim, qab los noj mov hloov, tuag

Cardiovascular System:arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis

Digestive System:colitis eructation, fulminant kab mob siab nrog thiab tsis muaj jaundice, daim siab tsis ua hauj lwm, daim siab necrosis, pancreatitis

Hemic thiab Lymphatic System:agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Metabolic thiab Nutrition:hyperglycemia

Lub paj hlwb:convulsions, coma, hallucinations, meningitis

Ua pa System:ua pa nyuaj siab, mob ntsws

Daim tawv nqaij thiab Appendages:angioedema, tshuaj lom epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome, urticaria

Tshwj xeeb Senses:conjunctivitis, tsis hnov ​​lus

QhiaSUSPECTED ADVERSE EVENTS, hu rau Amici Pharmaceuticals LLC. ntawm 1-877-938-4525 lossis FDA ntawm 1- 800- FDA-1088 lossis http://www.fda.gov/medwatch rau kev yeem qhia txog kev phiv tshuaj.

Kev noj ntau dhau

Cov tsos mob tom qab mob NSAID overdosages feem ntau yog txwv rau kev qaug zog, tsaug zog, xeev siab, ntuav, thiab mob epigastric, uas feem ntau rov qab los nrog kev txhawb nqa. Txoj hnyuv los ntshav tau tshwm sim. Ntshav siab, mob raum tsis ua haujlwm, ua pa nyuaj siab thiab coma tau tshwm sim, tab sis tsis tshua muaj (saib CEEB TOOM: Cov Kab Mob Ntshav Qab Zib Thrombotic , Gastrointestinal los ntshav, ulceration, thiab perforation , Ntshav siab , Lub raum Toxicity thiab Hyperkalemia ).

rogaine rau txiv neej cov kev mob tshwm sim

Tswj cov neeg mob uas muaj cov tsos mob thiab kev txhawb nqa tom qab noj NSAID ntau dhau. Tsis muaj cov tshuaj tiv thaiv tshwj xeeb. Xav txog emesis thiab/los yog activated charcoal (60 mus rau 100 grams rau cov neeg laus, 1 mus rau 2 grams ib kg ntawm lub cev qhov hnyav nyob rau hauv cov neeg mob) thiab/los yog osmotic cathartic nyob rau hauv cov tsos mob pom nyob rau hauv plaub teev ntawm kev noj nyob rau hauv cov neeg mob uas overdose loj (5 mus rau 10 npaug ntawm qhov pom zoo noj). Kev quab yuam diuresis, alkalinization ntawm cov zis, hemodialysis, lossis hemoperfusion yuav tsis muaj txiaj ntsig vim muaj protein ntau khi.

Yog xav paub ntxiv txog kev kho mob ntau dhau, hu rau lub chaw tswj tshuaj lom (1-800-222-1222).

Diclofenac Potassium Dosage thiab Kev Tswj Xyuas

Ua tib zoo xav txog cov txiaj ntsig thiab kev pheej hmoo ntawm Diclofenac Potassium ntsiav tshuaj thiab lwm yam kev kho mob ua ntej txiav txim siab siv Diclofenac Potassium ntsiav tshuaj. Siv cov koob tshuaj qis tshaj plaws rau lub sijhawm luv tshaj plaws raws li tus neeg mob lub hom phiaj kho mob (saib CEEB TOOM: Txoj hnyuv plab los ntshav, ulceration, thiab perforation ).

Tom qab soj ntsuam cov lus teb rau kev kho thawj zaug nrog Diclofenac Potassium ntsiav tshuaj, koob tshuaj thiab zaus yuav tsum tau hloov kho kom haum rau tus neeg mob cov kev xav tau.

Rau kev kho mob ntawm qhov mob lossis thawj dysmenorrhea qhov pom zoo noj yog 50 mg peb zaug ib hnub. Nrog kev paub dhau los, cov kws kho mob yuav pom tau tias hauv qee cov neeg mob pib koob tshuaj 100 mg ntawm Diclofenac Potassium ntsiav tshuaj, ua raws li 50 mg koob tshuaj, yuav pab tau zoo dua.

Rau kev kho mob ntawm osteoarthritis cov tshuaj pom zoo yog 100-150 mg / hnub hauv kev faib tshuaj, 50 mg ob zaug ib hnub lossis peb zaug hauv ib hnub.

Rau kev kho mob ntawm rheumatoid mob caj dab, koob tshuaj pom zoo yog 150-200 mg / hnub hauv kev faib tshuaj, 50 mg peb zaug ib hnub lossis plaub zaug hauv ib hnub.

Cov tshuaj sib txawv ntawm diclofenac (diclofenac sodium enteric-coated ntsiav tshuaj; diclofenac sodium ncua-tso ntsiav tshuaj; Diclofenac Potassium tam sim-tso ntsiav tshuaj) tsis tas yuav bioequivalent txawm tias lub zog milligram yog tib yam.

Diclofenac Potassium muab li cas

Diclofenac Potassium Tablets, USP 50 mg yog muaj rau kev tswj hwm qhov ncauj raws li lub teeb xim av, puag ncig zoo li, tsis tau qhab nia, cov ntsiav tshuaj coated films, imprinted AMI ntawm ib sab thiab DP tshaj 50 nyob rau sab nraud. Lawv muab raws li hauv qab no:

Lub raj mis ntawm 100 NDC 69292-550-01

Muab tso rau hauv lub thawv nruj, lub teeb-tiv taus raws li tau hais tseg hauv USP siv lub kaw me nyuam tiv taus.

Khaws lub thawv kaw kom nruj.

Khaws ntawm 20 ° txog 25 ° C (68 ° txog 77 ° F). [Saib USP Tswj Chav Kub Kub.]

Tiv thaiv los ntawm noo noo.

Tus kws tshuaj:Muab Daim Ntawv Qhia Tshuaj nrog rau txhua daim ntawv tshuaj.

AMICI PHARMACEUTICALS LLC.

Diclofenac Potassium TABLETS USP 50 mg

Muab faib los ntawm:Amici Pharmaceuticals LLC.
Melville, NY 11747 Revision date: Peb Hlis 2021

Phau Ntawv Qhia Tshuaj rau Non-steroidal Anti-Inflammatory Drugs (NSAIDs)

Phau Ntawv Qhia Tshuaj no tau pom zoo los ntawm US Food and Drug Administration.

Cov npe teev npe yog cov cim lag luam ntawm lawv cov tswv.

Amici Pharmaceuticals LLC.
Melville, NY 11747 USA

Kho tshiab: 03/2021

Pob / Label Zaub Vaj Huam Sib Luag

PRINCIPAL DISPLAY PANEL/ CONTAINER LABEL - 50 mg

NDC 69292-550-01

Diclofenac Potassium ntsiav tshuaj USP 50 mg

PHARMACIST: Muab Daim Ntawv Qhia Txog Tshuaj muab cais rau txhua tus neeg mob.

100 ntsiav tshuaj

Rx xwb

Txhua ntsiav tshuaj muaj: Diclofenac Potassium, USP 50 mg

Muab tso rau hauv lub thawv nruj, lub teeb-tiv taus raws li tau hais tseg hauv USP siv lub kaw me nyuam-tiv taus.

Khaws lub thawv kaw kom nruj.

Khaws qhov no thiab tag nrho cov tshuaj kom deb ntawm cov menyuam yaus.

Khaws ntawm 20 ° txog 25 ° C (68 ° txog 77 ° F). [Saib USP Tswj Chav Kub Kub.]

Tiv thaiv los ntawm noo noo.

Kev Noj Qab Haus Huv Ib txwm: Saib nrog cov ntaub ntawv sau tshuaj.

Phau Ntawv Qhia Tshuaj muaj nyob ntawmwww.amicipharma.com/products

Tshaj tawm los ntawm: Amici Pharmaceuticals LLC.
Melville, NY 11747 USA

Kho tshiab: 03/2021