CEPMOX-Clav 875mg/125mg Obat Imexpharm kanggo sinusitis akut sing disebabake dening bakteri, otitis media akut (2 blister x 7 tablet)

Bentuk sediaan Kothak 2 blister x 7 tablet
Spesifikasi Amoxicillin, asam clavulanic
Komposisi Perusahaan Imexpharm Pharmaceutical Joint Stock Company

Komposisi

Informasi komposisi	Isi
Amoxicillin	875 mg
Asam clavulanic	125 mg

Migunakake

Indications CEPMOX-CLAV 875mg/125mg drug is indicated in cases of infections caused by sensitive bacterial strains of the drug: Acute sinusitis caused by bacteria. Acute otitis media. Wide. ATC code: J01CR02. Amoxicilin is a synthetic antibiotic in the penicillin group, which has a bactericidal effect due to drugs attached to one or more protein near the penicillin of bacteria (PBPS) to inhibit peptidoglycan biosynthesis, which is an important component of bacterial cell walls. This inhibition weakens the cell wall leading to bacteria decomposed and dies. Amoxicillin is easily destroyed by beta-lactamase enzymes and therefore the antibacterial spectrum of the single amoxicillin does not include bacteria that produce these enzymes. Clavulanic acid is a beta-lactam, structurally related to penicillins. Clavulanic acid has the ability to inhibit beta-lactamase enzymes and thus prevent inactivity to amoxicillin. Clavulanic acid monomers do not have clinical antibacterial effects. resistance mechanism: Two resistance mechanisms with amoxicillin combination and clavulanic acid: Inactivity by beta-lactamase is not inhibited by clavulanic acid including beta-lactamase layer B, C, D. Change of penicillin -mounted proteins (Pbps), thus reducing the affection of antibacterial agents at the position. A decrease in the permeability of bacterial cells or pumping mechanisms can cause or contribute to the resistance of bacteria, especially in Gram -negative bacteria. antibacterial spectrum of the drug: Sensitive bacteria: Aerobic Gram -positive bacteria: Enterococcus Faecalis, Gardnerella Vaginalis, Staphylococcus aureus (Methicilin sensitive) 1, Staphylococcus spp. negative with coagulase (sensitive to methicilin), streptococcus agalactiae, streptococcus pneumoniae2, streptococcus pyogenes and streptococcus spp, other B hemolysis, streptococcus malidans. Eikenella Corrosens, Haemophilus Influenzae3, Moraxella Catatrhalis, Pasteurella Mulfocida. Right: Aerobic Gram -positive bacteria: Enterococcus Faecium4. Aerobic gramy bacteria: Acinetobacter sp., Citrobacter Freundii, Enterobacter sp. Chlamydophila Pneumoniae, Chlamydophila Psittaci, Coxiella Burnetii, Mycoplasma Pneumoniae. 1 all Staphylococcus spp. To resist methicilin is resistant to amoxicillin/acid Clavulanic. 2 Amoxicilin/Acid Clavulanic combination may not be suitable for treating streptococcus pneumoniae resistance to penicillin. 3 has reported on sensitive strains in some countries in the European Union (EU) with a frequency higher than 10%. 4 natural intermediaries have no resistance mechanism. Pharmacokinetics absorption Amoxicillin and clavulanic acid are completely dissociated in water solution in physiological pH. Both ingredients are well absorbed and quickly after drinking. Oral bioavailability of amoxicillin and clavulanic acid is about 70%. The characteristics of two plasma components are the same and the time to reach the peak concentration (TMAX) of each component is about 1 hour. Dynamic pharmacokinetic results in a study, oral amoxicillin/clavulanic acid (875 mg/125 mg, twice daily) in a state of hunger for healthy volunteers presented below: Average pharmacokinetic parameters (± standard deviation SD) . 875 mg/ 125 mg 875 11.64 ± 2.78 1.5 (1.0 - 2.5) 53.52 ± 12.31 1.19 ± 0.21 875 mg/ 125 mg 125 2.18 ± 0.99 (1.0 - 2.0) 10.16 ± 3.04 0.96 ± 0.12 * Middle (interval) Distribution About 25% of total clavulanic acid in plasma and 18% of total amoxicillin in plasma is linked to protein. Expression integral is about 0.3 - 0.4 l/kg for amoxicillin and about 0.2 l/kg for clavulanic acid. After intravenous injection, both amoxicillin and clavulanic acid have been found in the gallbladder, abdominal tissue, skin, fat, muscle tissue, fluid and abdominal fluid, face and pus of the wound. Amoxicillin does not allocate much in cerebrospinal fluid. Animal studies show that there is no storage of drug metabolites in the body. Like other antibiotics penicillin, amoxicillin can be distributed into tamarind milk. A very small salary Clavulanic acid has also been discovered in breast milk. both amoxicillin and clavulanic acid have passed the placenta fence. Metabolism about 10 - 25% amoxicillin in the starting dose is excreted in urine in the form of peniciloic acid that does not work. Clavulanic acid metabolizes a lot in the human body, excreted into urine, feces and in the form of carbon dioxid while exhaling. Elimination Amoxicillin is excreted mainly through the kidneys, while clavulanic acid is eliminated by the mechanism through both the kidneys and external kidneys. Combining amoxicillin/clavulanic acid has an average selling time for about 1 hour and the total clearance is about 25 l/hour in healthy people. Nearly 60 - 70% amoxicillin and 40 - 65% of Clavulanic acid are eliminated in urine in the form of unchanged in the first 6 hours after taking a single tablet with amoxicillin/clavulanic acid with a content of 250 mg/125 mg or 500 mg/125 mg. Different studies show that about 50 - 85% amoxicillin and 27 - 60% of Clavulanic acid are eliminated through urine after 24 hours. Clavulanic acid is most eliminated in the first 2 hours after taking the drug. Concentrated with probenecid may slow down amoxicillin, but does not affect the elimination of clavulanic acid through the kidney. Age Amoxicillin's sale time in children from 3 months to 2 years old is equivalent to older children and adults. In newborns (including premature babies), in the first week after birth, do not use more than 2 times/day because the emissions through the kidneys have not been fully developed. Because the elderly people have a higher impairment of renal function, it is necessary to be cautious when choosing the dose and monitoring the kidney function throughout the treatment process. Gender After drinking amoxicilin/clavulanic acid in healthy women and men shows that gender does not significantly affect the pharmacokinetics of both amoxicillin and clavulanic acid. kidney failure The total serum clearance coefficient of amoxicillin/clavulanic acid decreases corresponding to the impaired renal function. The decrease in amoxicillin clearance is more significant than clavulanic acid, because the ratio of amoxicillin elimination through the kidneys is higher, so the dose for patients with renal impairment must prevent excessive accumulation of amoxicilin while maintaining the appropriate level of clavulanic acid. Hepatic failure Patients with liver failure should be carefully indicated and monitored liver function periodically.

Sadurunge njupuk CEPMOX-Clav 875mg/125mg Obat Imexpharm kanggo sinusitis akut sing disebabake dening bakteri, otitis media akut (2 blister x 7 tablet)

How to use CEPMOX-CLAV 875mg/125mg drug used orally. To reduce the possibility of non -tolerant drugs in the gastrointestinal tract, should take medicine during meals. Dosage The dosage is usually shown according to the content of amoxicillin/clavulanic acid unless it is stated according to the dose of each individual ingredient. The choice of the dose of CEPMOX-clav 875mg/125mg depends on the following factors: The pathogenic bacteria and the ability to be sensitive to antibacterial agent. Clavulanic) should be considered when necessary. Adults and children ≥ 40 kg, the total daily dose of CEPMOX-Clav 875mg/125mg is 1750mg amoxicillin/250mg clavulanic acid, divided into 2 times/day and 2625mg amoxicillin/375 mg Clavulanic acid, divided into 3 times/day. For children

Efek sisih

The unwanted effects of the drug (ADRS) is the most common ADRS) is diarrhea, nausea and vomiting. ADRS is recorded from clinical studies and during the circulation of drugs. The frequency is determined as follows: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR

Pènget

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

Kontraindikasi

Obat CEPMOX-Clav 875mg/125mg ing kasus ing ngisor iki:

Pasien kanthi riwayat hipersensitivitas kanggo antibiotik beta-laktam, kayata penisilin, cephalosporin, carbapenem, monobactam utawa bahan-bahan obat apa wae.

Ati-ati nalika nggunakake

Sadurunge miwiti perawatan karo amoxicillin/asam klavulanat, kudu sinau babagan riwayat alergi pasien, utawa riwayat alergi beta-lactocilin karo penisilin.

Pasien sing diobati karo penisilin bisa uga ngalami reaksi hipersensitivitas sing abot lan kadhangkala fatal (anafilaksis). Reaksi kasebut bisa kedadeyan ing pasien sing duwe riwayat sensitivitas penisilin lan pasien alergi. Yen reaksi alergi kedadeyan, obat kasebut kudu mandheg lan duwe terapi alternatif sing cocog, yen bakteri wis diidentifikasi nyebabake sensitivitas kanggo amoxicillin, mula kudu ngalih menyang amoxicillin tunggal.

Ing kasus enzim beta-laktamase bakteri sing disekresi dening bakteri ora dicegah dening asam clavulanic, sing nyebabake resistensi bakteri karo antibiotik beta-laktam, ora nggunakake CEPMOX-CLAV 875mg / 125mg kanggo perawatan. Aja nggunakake obat iki kanggo nambani S. Pneumoniae tahan kanggo penisilin.

Kejang bisa kedadeyan ing pasien sing duwe fungsi ginjel cacat utawa pasien sing nggunakake dosis dhuwur.

Aja nggunakake amoxicillin/asam klavulanat kanggo pasien leukemia sel monon amarga ana risiko ruam ing pasien kasebut yen nggunakake amoxicillin. Panganggone allopurinol bebarengan karo amoxicilin bisa nambah risiko alergi kulit.

Ngombe obat-obatan sing kadhangkala bisa nyebabake pertumbuhan bakteri sing ora sensitif.

Munculé typhus kabeh awak kanthi pustula ing tahap pisanan perawatan bisa dadi gejala pustulosis exanthematous generalisata akut (AGEP). Yen ana pratandha, pasien kudu mandheg ngombe obat kasebut lan ora nggunakake obat sing ngemot amoxicillin kanggo nambani penyakit kasebut ing kasus mengko.

Ati-ati nalika nggunakake amoxicillin/asam Clavulanic kanggo pasien sing duwe fungsi ati sing cacat. Kasus ati dumadi utamane ing pasien lanang, pasien tuwa lan pasien sing dawa lan langka ing bocah-bocah. Biasane, pratandha lan gejala biasane kedadeyan sajrone perawatan utawa sawise perawatan kanggo wektu sing cendhak, nanging ing sawetara kasus bisa uga ora jelas nganti sawetara minggu sawise mungkasi perawatan. Gejala kasebut asring bisa pulih saka awake dhewe, nanging isih ana kasus sing abot, malah mati, nanging arang banget, asring kedadeyan ing pasien sing lara serius utawa digunakake ing kombinasi karo obat-obatan sing mengaruhi ati.

Kolitis sing disebabake dening antibiotik dumadi ing pirang-pirang antibiotik, kalebu amoxicillin, tingkat fluktuasi entheng nganti ngancam nyawa. Mulane, kudu dicathet yen pasien diare sajrone utawa sawise nggunakake antibiotik. Yen kolitis ana, mungkasi njupuk obat kasebut kanthi cepet, lan entuk terapi terapi sing cocog. Contraindicated anti-spasms ing kasus iki.

evaluasi sacara periodik fungsi sistem organ, kalebu ati, fungsi ginjel lan sistem hematopoietik sajrone perawatan sing dawa.

Tambah wektu pembekuan getih bisa kedadeyan lan arang banget ing pasien sing nggunakake asam amoxicillin/clavulanic. Kondisi pasien kudu dipantau nalika digunakake bebarengan karo antikoagulan lan nyetel dosis antikoagulan sing cocog kanggo njaga tingkat antikoagulan sing dikarepake.

Ing pasien sing duwe fungsi ginjel cacat, panyesuaian dosis kudu diatur miturut tingkat gagal ginjal.

Pasien urin cilik bisa ngalami kasus kristal nanging arang banget, utamane kedadeyan nalika njupuk obat injeksi. Nalika nggunakake amoxicillin dosis dhuwur, perlu kanggo ngimbangi jumlah banyu sing diombe lan ngeculake kanggo nyuda kemampuan kanggo mbentuk kristal amoxicillin. Priksa kanthi rutin tabung kandung kemih supaya ora macet.

Nalika ngobati amoxicillin, enzim glukosa oksidase kudu digunakake nalika tes glukosa dibutuhake ing urin amarga cara non-enzim bisa menehi asil positif palsu. Asam klavulanat nyebabake kohesi nonsense LGG lan albumin ing membran sel getih abang, nyebabake asil positif palsu saka tes Coombs.

Obat kasebut bisa nyebabake tes positif palsu Bio-Rad Laboratories Platelia Aspergillus EIA amarga reaksi silang karo polisakarida lan polyfuranose dudu Aspergillus. Mula, kanggo pasien sing njupuk amoxicillin/asam klavulanat, kudu ati-ati nalika maca asil yen ana asil positif nalika tes kanthi metode iki lan kudu didefinisikan maneh kanthi metode diagnostik liyane.

Nggunakake obat kanggo wanita nalika ngandhut lan lactation

Nggunakake obat kanggo wanita ngandhut:

Panaliten kewan nuduhake yen obat kasebut ora langsung utawa ora langsung mbebayani kanggo kemampuan kanggo ngandhut, perkembangan embrio, lair utawa perkembangan postpartum.

Data babagan panggunaan asam amoxicillin / clavulanic ing wanita ngandhut uga nuduhake yen ora nambah risiko cacat lair ing bocah-bocah, nanging data riset kasebut isih winates. Panaliten siji ing wanita prematur amarga cairan amniotik awal nuduhake yen perawatan prophylactic karo amoxicillin/asam klavulanat bisa nambah risiko necrotizing bowelitis ing bayi.

Mulane, pasien kudu ngindhari obat kasebut nalika meteng, kajaba diwenehake dening dokter.

Gunakake obat kanggo wanita sing nyusoni:

Amoxicilin lan asam clavulanic loro-lorone susu ibu (ora ana informasi babagan efek asam clavulanic ing bayi sing nyusoni). Mulane, diare lan infeksi jamur ing membran mukus bisa kedadeyan nalika nyusoni bayi, kudu mandheg nyusoni nalika bayi duwe manifestasi ing ndhuwur. Gunakake obat kasebut mung sajrone nyusoni sawise ngevaluasi keuntungan lan risiko saka dokter sing nambani.

Efek obat kasebut ing nyopir lan ngoperasikake mesin

durung cukup riset kanggo mbuktekake manawa obat kasebut mengaruhi kemampuan nyopir lan ngoperasikake mesin. Nanging, efek sing ora dikarepake kayata alergi, pusing, konvulsi, ... bisa mengaruhi kemampuan nyopir lan ngoperasikake mesin. Mula, ati-ati nalika nyopir lan ngoperasikake mesin yen nggunakake obat kasebut.

Obat interaktif

Obat antikoagulan oral

Antikoagulan oral lan antibiotik penisilin wis akeh digunakake ing praktik tanpa interaksi. Nanging, ing literatur, nuduhake nambah indeks normalisasi internasional (INR) ing pasien sing nggunakake acenocoumarol utawa warfarin bebarengan karo amoxicillin. Yen perlu kanggo nggunakake bebarengan, dianjurake kanggo ngawasi ginjel perlu prothrombin utawa wektu INR nalika miwiti utawa mungkasi amoxicillin / asam clavulanic. Bisa nyetel dosis antikoagulan yen perlu.

metotreksat: penisilin nyuda ekskresi metotreksat, saéngga nambah keracunan methotrexate.

Probenecid: Aja nggunakake bebarengan karo probenecid. Probenecid nyuda sekresi amoxicillin ing tubulus ginjal, saéngga nambah lan nambah konsentrasi amoxicillin ing getih nanging ora mengaruhi asam clavulanic.

mycophenolat mofetil:

Ing pasien sing njupuk Mycophenolat Mofetil, ana laporan babagan nyuda konsentrasi 50% sadurunge dosis metabolit kanthi aktivitas asam mycophenolic (MPA) sawise perawatan karo asam amoxicilin / clavulanic. Owah-owahan konsentrasi sadurunge dosis iki bisa uga ora nuduhake owah-owahan ing tingkat paparan MPa sakabèhé. Mulane, ora perlu nyetel dosis mycophenolat mofetil tanpa bukti klinis disfungsi grafting. Nanging, ngawasi klinis kudu dipantau kanthi rapet sajrone nggunakake obat kasebut lan sawetara wektu sawise mungkasi perawatan karo antibiotik.

mengaruhi tes:

Sampeyan kudu nggunakake metode enzim glukosa oksidase yen perlu kanggo nguji glukosa ing urin metode mikro-urine metode non-enzim bisa menehi asil positif palsu.

Asam klavulanat nyebabake kohesi nonsense LGG lan albumin ing membran sel getih abang, nyebabake asil positif palsu saka tes Coombs.

Obat kasebut bisa nyebabake tes positif palsu BIO-RAD Laboratories Platelia Aspergillus Elado Reaksi silang karo polisakarida lan polyfuranose dudu Aspergillus. Mula, kanggo pasien sing njupuk amoxicillin/asam klavulanat, kudu ati-ati nalika maca asil yen ana asil positif nalika tes kanthi metode iki lan kudu didefinisikan maneh kanthi metode diagnostik liyane.

Kavaleri obat:

Amarga ora ana studi babagan korespondensi obat kasebut, ora nyampur obat iki karo obat liya.

Panyimpenan

Ora luwih saka 30 ° C, supaya ora lembab lan cahya.

Obat liyane

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