Leracet 500mg obat J.URIACH kanggo kejang (6 blister x 10 tablet)

Bentuk sediaan Kothak 6 blister x 10 tablet
Spesifikasi Levetiracetam

Komposisi

Informasi komposisi	Isi
Levetiracetam	500 mg

Migunakake

indikasi

Obat Leracet 500 dituduhake ing kasus ing ngisor iki:

Gunakake perawatan terapeutik tunggal kanggo perawatan konvulsi wiwitan lokal kanthi utawa tanpa bahan kimia mukosa ing pasien anyar sing didiagnosis epilepsi umur 16 lan luwih. (Juvenlie Myoclonic Epilepsi). Obat anti epilepsi saiki.

Levetiracetam ningkatake proteksi anti-kejang ing pirang-pirang model kejang lokal lan kabeh tangan pisanan ing kewan tanpa efek kejang. Metabolit wiwitan ora aktif.

Ing manungsa, obat kasebut bisa digunakake ing epilepsi lokal lan wutuh (gaya epilepsi/gaya dramatis kanggo stimulasi cahya) sing wis negesake spektrum sing wiyar saka pendahulu obat kasebut.

Mekanisme tumindak

Mekanisme tumindak levetiracetam durung diterangake kanthi lengkap. In vitro lan in vivo nuduhake yen levetiracetam ora ngganti sifat dhasar sel lan neurotransmiter normal.

Panliten in vitro nuduhake yen levetiracetam tumindak ing konsentrasi Ca2+ ing sel saraf kanthi nyandhet bagean Ca2+ lan nyuda pelepasan Ca2+ saka cadangan ing sel saraf. Kajaba iku, studi in vitro nuduhake yen levetiracetam digandhengake karo lokasi tartamtu ing jaringan otak tikus. Posisi kohesi iki minangka protein 2A ing tas sinap, sing dianggep ana hubungane karo tas sing rusak lan pelepasan neurotransmitter. Riset swara stimulasi ing tikus epilepsi nuduhake yen Levetiracetam nduweni karemenan tartamtu karo protein 2A ing tas Synap, sing cocog karo aktivitas anti-epileptik obat kasebut. Iki nuduhake yen interaksi antarane levetiracetam lan protein 2A ing tas sinap bisa nyumbang kanggo mekanisme anti-epileptik obat kasebut.

farmakokinetik

wong diwasa lan remaja

panyerepan

Levetiracetam cepet diserep nalika digunakake sacara lisan. Bioavailabilitas lisan pancen meh 100%. Konsentrasi puncak ing plasma (CMAX) tekan 1,3 jam sawise ngombe. Status stabil diraih sawise 2 dina kanthi mode dosis 2 kali dina. Konsentrasi puncak khas (CMAX) yaiku 31 lan 43 μg/ml sawise dosis siji 1.000 mg lan sawise dosis mbaleni 1.000 mg kaping pindho saben dina.

distribusi

Ora ana distribusi data ing jaringan manungsa. Levetiracetam lan metabolit wiwitane ora ana hubungane karo protein plasma (

transformasi

Ing Levetiracetam wong meh kurang metabolized. Jalur metabolisme utama (24% saka dosis) yaiku hidrolisis asetamida kanthi ragi. Isomer enzim ati sitokrom P450 ora melu ing proses metabolisme asli, UCB L057. Ngukur hidropikitas asetamida ing pirang-pirang jaringan kalebu sel getih. Metabolit UCB L057 ora duwe aktivitas farmakologis.

Wong uga ngenali rong metabolit cilik. Zat sing dipikolehi hidrogen hidrolidon (1,6% saka dosis) lan sisa zat sing dipikolehi kanthi mbukak cincin pirolidon (0,9% saka dosis). Komponen liyane sing ora dingerteni mung 0,6% saka dosis.

Ora ana bukti transformasi Levetiracetam Invivo lan metabolit wiwitane.

Invitro, Levetiracetam lan metabolit wiwitane katon minangka non-inhibisi isomer utama enzim ati sitokrom P450 (CYP3A4, 246, 2C9, 2D6, 2E1 lan 1A2), Glucuronyl Transferase (UGT1A1 lan UGT1Axylase pangolahan. Kajaba iku, levetiracetam ora mengaruhi glukuronilasi asam Valproic ing Invitro.

Ing kultur sel ati, levetiracetam cilik utawa ora mengaruhi pembentukan ethinylestradiol utawa CYP1A1/2. Ing konsentrasi dhuwur (680 μg / ml) levetiracetam nyebabake iritasi entheng CYP2B6 lan CYP3A4, nanging ing konsentrasi sing cedhak karo CMAX sing diraih sawise dosis bola-bali 1,500 mg kaping pindho saben dina, efek kasebut dianggep relevansi non-biologis. Dadi levetiracetam ora bisa sesambungan karo zat liya utawa kosok balene.

Eliminasi

Wektu semi-dumping ing manungsa yaiku 7 ± 1 jam lan ora owah miturut dosis, gula utawa dosis bola-bali. Reresik awak rata-rata yaiku 0,96 ml/min/kg.

Garis eliminasi utama yaiku liwat urin, kanthi rata-rata 95% dosis (udakara 93% dosis diilangi sajrone 48 jam). Mung 0,3% saka dosis sing diekskripsikake liwat feces.

Ing 48 jam pisanan, akumulasi ekskresi saka saluran kemih Levetiracetam lan metabolit awal yaiku 66% lan 24% saka dosis. Reresik ginjel saka levetiracetam lan UCB L057 sing cocog karo 0,6 lan 4,2 ml / min / kg nuduhake yen levetiracetam ngilangi filtrasi glomerular kanthi reabsorpsi ing tubulus ginjal lan nuduhake yen metabolit awal uga diekskresi liwat ekskresi aktif liwat tubulus ginjal bebarengan karo filtrasi glomerular. Eliminasi Levetiracetam ana hubungane karo reresik kreatinin.

Wong tuwa

Wektu adol mundhak udakara 40% (10 nganti 11 jam) ing wong tuwa amarga fungsi ginjel.

Anak (4 nganti 12 taun)

Umur setengah Levetiracetam yaiku 6 jam sawise njupuk dosis siji 20 mg / kg ing bocah-bocah sing nandhang epilepsi (4 nganti 12 taun). Konsentrasi puncak plasma diamati sawise ngombe kira-kira 0,5 - 1 jam. Konsentrasi puncak ing plasma lan area ing ngisor kurva linear lan proporsional sebanding karo dosis. Wektu dodolan udakara 5 jam.

gagal ginjel

Reresik awak saka levetiracetam lan metabolit wiwitane ana hubungane karo reresik kreatinin. Mulane, kanggo pasien kanthi gagal ginjel medium lan abot, dosis pangopènan saben dina levetiracetam didhasarake ing reresik bun.

Ing pasien karo penyakit ginjel tahap pungkasan, setengah umur dirusak ing antarane tahap pamisahan lan sajrone tahap pemisahan sing cocog kira-kira 25 lan 3.1 jam. Tingkat levetiracetam yaiku 51% ing siklus pamisahan 4 jam.

gagal ati

Ora ana owah-owahan ing farmakokinetik levetiracetam ing pasien kanthi gangguan ati entheng (Child-Pugh a) lan rata-rata (Child-Pugh B). Ing pasien kanthi gagal ati sing abot (Child-Pugh C), reresik awak saka levetiracetam 50% dibandhingake karo wong normal, utamane amarga nyuda reresik ginjel. Ora ana panyesuaian dosis ing pasien kanthi gagal ati sing entheng nganti moderat. Ing pasien kanthi gagal ati sing abot, reresik bun bisa uga ora netepake tingkat gagal ginjal kanthi lengkap. Mulane, 50% saka dosis pangopènan saben dina kudu dikurangi nalika ngresiki kreatinin

Sadurunge njupuk Leracet 500mg obat J.URIACH kanggo kejang (6 blister x 10 tablet)

How to use drink levetiracetam with sufficient amount of liquid (such as water). Dosage Drugs can be taken with or not with meals, daily dose is divided evenly for two drinks. Unit of treatment adults and teenagers aged 16 and over Normal dose: From 1000 mg (2 tablets) to 3000 mg (6 tablets) per day. When starting to use levetiracetam, the doctor will set the lower doses for 2 weeks before using the lowest normal dose. Multi -therapy adults and adolescents (12 - 17 years old) weighs 50 kg or more Normal dose: From 1000 mg (2 tablets) to 3000 mg (6 tablets) per day. infant (6 - 23 months), children (2 - 11 years old), adolescents (12 - 17 years old) weighing less than 50 kg The doctor will prescribe medication suitable for age, weight and dose. Oral solution is a form suitable for babies and children under 6 years old. Common dose: From 20 mg/kg to 60 mg/kg of body weight per day. babies (1 - 6 months) Oral solution is a form suitable for babies. Elderly (from 65 years of age) Recommendations to adjust the dose in elderly patients with impaired renal function (see the item of patients with renal failure below). Renal failure Daily dose should be adjusted based on kidney function. For adults, refer to the following table and adjust the dose as directed. To use this dose table, it is necessary to estimate creatinine clearance (CLCR) (ml/min) of the patient. It is possible to estimate the CLCR (ml/min) based on the determination of serum creatinine (mg/dl) for adults and adolescents weighing 50 kg or more according to the following formula: CLCR (ml/min) = {[140 - age (year)] x Weight (kg)}: [72 x Creatinine serum (mg/dl)] x (0.85 for women). Then, CLCR is adjusted according to the body surface area (BSA) as follows: CLCR (ml/min/1.73 m2) = Clcr (ml/min): BSA (m2) x 1.73 m2. Adjusting the dose for adults and adolescents weighing 50 kg or more is impaired kidney function: Renal failure Creatinine clearance (ml/min/1.73 m2) Dosage and number of times used 500 - 1500 mg x 2 times/day 500 - 1000 mg x 2 times/day 250 - 750 mg x 2 times/day 250 - 500 mg x 2 times/day 500 - 1000 mg x 1 time/day (2) (2): Additional dose recommends 250 - 500 mg after the appraisal. In children with renal failure, the dose adjustment must be based on renal function because the levetiracetam clearance is related to kidney function. This recommendation is based on research in adults with renal failure. CLCR (ml/min/1.73 m2) can be estimated by determining the level of creatinine in serum (mg/dl) for teenagers and children according to the following formula (Schwartz formula): CLCR (ml/min/1.73 m2) = height (cm) x ks: Creatinine concentration in serum (mg/dl). Adjusting the dose for babies, children, teenagers weighing less than 50 kg with renal function:

Efek sisih

When using the drug, there are common unwanted effects (ADR) such as: The most unwanted effects are rhinitis, drowsiness, headache, fatigue and dizziness. The unwanted effects are presented below based on placebo clinical tests in all research indications with a total of 3,416 patients treated with levetiracetam. These data are added with the use of levetiracetam in the corresponding open label expansion studies as well as in experience after circulation. The unwanted effect of levetiracetam is generally similar between age groups (adults and children) and between approved epilepsy indications. Unwanted effects are reported in clinical studies (in adults, adolescents, children and babies more than 1 month old) and from experience after circulation listed in the table below on each organ system and frequency appears. The unwanted effects are listed in the order of severe reduction and the frequency of appearance is as follows: Very common (≥1/10); Common (≥1/100 to

Pènget

Sadurunge nggunakake obat kasebut, sampeyan kudu maca instruksi kasebut kanthi teliti lan deleng informasi ing ngisor iki.

contraindicated

Obat Leracet 500 contraindicated ing kasus ing ngisor iki:

Hipersensitivitas kanggo levetiracetam, turunan pyrrolidon, utawa bahan saka
.

Ati-ati nalika nggunakake

Mangga deleng informasi luwih lengkap babagan obat ing lembar instruksi panggunaan obat sing dilampirake.

Ati-ati ing bocah-bocah.

Miturut praktik klinis saiki, yen sampeyan kudu mandheg ngobati levetiracetam, sampeyan kudu nyuda dosis kanthi bertahap (contone, ing wong diwasa: nyuda 500 mg kaping pindho saben dina saben rong utawa patang minggu; ing bocah-bocah, aja nyuda dosis luwih saka 100 mg / kg kaping pindho saben dina saben rong minggu).

Nyetel dosis nalika nggunakake levetiracetam kanggo pasien gagal ginjel. Kanggo pasien gagal ati sing abot, fungsi ginjel kudu ditaksir sadurunge milih dosis.

Ana laporan babagan bunuh diri, nyoba bunuh diri lan arep bunuh diri ing pasien sing diobati karo levetiracetam. Sampeyan kudu menehi saran marang pasien supaya langsung ngandhani gejala depresi lan/utawa niat bunuh diri menyang dhokter sing nambani.

Efek obat kasebut ing kemampuan nyopir lan ngoperasikake mesin

Amarga sensitivitas saben individu bisa beda-beda, sawetara pasien bisa ngantuk utawa duwe gejala liyane sing ana gandhengane karo sistem saraf pusat nalika miwiti utawa sawise nambah dosis. Dadi ati-ati nalika nyopir utawa ngoperasikake mesin.

Gunakake obat kanggo wanita nalika meteng lan laktasi

Ora ana data babagan panggunaan levetiracetam ing wanita ngandhut. Pasinaon kewan nuduhake obat sing nyebabake keracunan reproduksi. Wong ora ngerti risiko potensial kanggo manungsa. Levetiracetam ora kena digunakake nalika meteng kajaba perlu.

Kaya obat anti-epilepsi liyane, owah-owahan fisiologis nalika meteng bisa mengaruhi konsentrasi levetiracetam. Ana laporan babagan nyuda konsentrasi levetiracetam nalika meteng.

Levetiracetam dikenal liwat susu manungsa, mula aja nyusoni nalika nggunakake levetiracetam. Nanging, yen Levetiracetam perlu digunakake ing wanita sing nyusoni, perlu kanggo nimbang keuntungan / resiko, nimbang pentinge nyusoni.

Obat interaktif

Mangga ngandhani dhokter utawa apoteker babagan obat sing sampeyan duwe utawa lagi njupuk, kalebu obat over-the-counter.

levetiracetam bisa dijupuk sajrone mangan utawa ing njaba. Aja nggunakake panganan utawa ombenan alkohol sajrone perawatan karo levetiracetam.

Data nuduhake yen Levetiracetam ora mengaruhi konsentrasi serum obat anti-epilepsi saiki (Phenytoin, Carbamazepine, Valproic, Phenobarbital, Lamotrigine, Gabapentine lan Primidone) lan anti-kejang kasebut uga ora mengaruhi dinamika levetiracetam. nggunakake. Nanging, pangaturan dosis ora dianjurake. Levetiracetam ora mengaruhi konsentrasi plasma carbamazepine, valproate, topiramate utawa lamotrigine.

Probenecid (dosis 500 mg kaping papat dina), inhibitor sing diekskresi ing tubulus ginjal, nuduhake inhibisi mode penghapusan ginjel saka zat metabolik awal nanging ora nyandhet reresik ginjel saka levetiracetam. Nanging, konsentrasi metabolit iki tetep sithik. Dikira obat liya sing diekskresi kanthi ekskresi aktif liwat tubulus ginjal uga bisa nyuda reresik metabolit ginjel. Dampak levetiracetam marang probenecid durung diteliti lan ora ngerti efek levetiracetam marang obat-obatan sing diekskresi aktif liyane, kayata obat anti-inflamasi non-mineroid (NSAIDs), sulfonamide lan methotrexate.

Dosis Levetiracetam 1000 mg saben dina ora mengaruhi farmakokinetik kontrasepsi oral (Ethinyl estradiol lan levonorgestrel) lan parameter endokrin (LH lan Progesteron) ora diganti. Dosis Levetiracetam 2000 mg saben dina ora mengaruhi farmakokinetik Digoxin, kontrasepsi oral lan warfarin ora mengaruhi farmakokinetik levetiracetam.

Ora ana data babagan efek antacid ing panyerepan levetiracetam sing ora kena pengaruh panganan nanging tingkat panyerepan rada suda.

Ora ana data babagan interaksi obat antarane levetiracetam lan omben-omben.

Panyimpenan

Simpen ing suhu ora ngluwihi 30 ° C, ngindhari cahya.

Obat liyane

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