Obat Hataphar Cubabute 200mg kanggo perawatan infeksi ringan nganti medium, bronkitis (2 blister x 10 tablet)

Bentuk sediaan Kothak 2 blister x 10 tablet
Spesifikasi Ceftibuten
Komposisi Ha Tay Pharmaceutical Joint Stock Company - Vietnam

Komposisi

Informasi komposisi	Isi
Ceftibuten	200 mg

Migunakake

indications CubeTo drugs are indicated in the following cases: The drug is indicated to treat mild to medium infections due to sensitive bacteria strains such as: The acute phase of chronic bronchitis caused by Haemophilus Influenzae (including B -Lactamase seminarians), Moraxella Catatrhalis (including seminarians - lactamase) or Streptococcus pneumoniae (indicated strains sensitive to penicillin). Chronic in clinical trials, where Moraxella Catrhalis is isolated from infected phlegm at the beginning, CEFTIBUTEN's clinical effect is 22% lower than the level of control. Acute otitis media caused by bacteria caused by Haemophilus influenzae (including B-Lactamase seminarians), Moraxella CatVrhalis (including B-Lactamase strains) or Streptococcus Pyogenes. The middle of acute in clinical/ microbiological, effective anti -Streptococcus pneumoniae decreased by 23% compared to the level of control. Therefore, Cevtibuten should only be experimented when there is sufficient evidence of the anti -Streptococcus pneumoniae effect of Cevtibuten. Sore throat and tonsillitis due to streptococcus pyogenes. CEFTIBUTEN is often effective in killing streptococcus pyogenes from the pharyngeal area, but there is no data on the effectiveness of CEFTIBUTEN in the prevention of acute rheumatism. Pharmacokinetics ATC code: J01DD14. ceftibuten is an antibiotic of semi -synthetic cephalosporin groups, third generation, orally. The bactericidal effect of Ceftibuten is due to inhibition of bacterial cell walls by attaching to the target protein. CEFTIBUTEN is sustainable with penicillinase and cephalosporinase. Many Beta-lactamase bacteria are resistant to penicillin, which may be sensitive to ceftibuten. CEFTIBUTEN has been shown in vitro and clinically acting on most of the following bacteria strains: Gram-positive aerobic bacteria: Streptococcus pneumoniae (except for penicillin resistance lines), Streptococcus pyogenes. Klebsiella sp., Salmonella sp., Shigella sp. Pneumoniae and Pyogenes). CEFTIBUTEN has a weak printing effect on anaerobic bacteria, including the majority of Bacteroides. Anti -drug information: CEFTIBUTEN is sustainable with most beta-lactamase through plasmid intermediaries but is not sustainable with cephalosporinase through chromosomes in bacteria such as Bacteroides, Citrobacter, Entobacter, Morganella and Serratia. Like other beta-lactam, CEFTIBUTEN should not be used for beta-lactam resistance strains with conventional mechanisms such as changes in penicillin-mounted protein changes like S. Pneumoniae resistant penicillin. The index of the characteristics of the physical and pharmacokinetics (PK/PD): CEFTIBUTEN is an antibiotic belonging to the B-Lactam group (time-dependent antibacterial antibiotic), has a PK/PD index T> M mic, meaning that the time of antibiotic concentration is higher than the mic. CEFTIBUTEN as well as other antibiotics of this group achieve the highest therapeutic effect when reaching a concentration of over 4 times mic. Higher concentration than this value will not increase bactericidal ability. Therefore, T> MIC is the optimal indicator to evaluate the effectiveness of CEFTIBUTEN treatment. With Ceftibuten as well as with most B-Lactam, T> Mic reaches> 40-50% compared to the dosage range is considered to be effective treatment. pharmacokinetics absorption: Ceftibuten is quickly absorbed after drinking. CEFTIBUTEN concentration in plasma into the pharmacokinetics parameters of cevtibuten after taking a single dose of 400 mg Ceftibuten on 12 male mature male volunteers (20 - 39 years old) is shown in Table 1. Plasma is about 20%. Parameters CEFTIBUTEN concentration in plasma (µgg/ml) after taking a single dose of 400 mg ceftibuten and pharmacokinetic parameters (± 1 sd) (n = 12 healthy adult men) Now 6.1 (5.1) 1.5 hours 9.9 (5.9) 2.0 hours 11.3 (5.2) (3,0) 4.0 hours 11.2 (2.9) 6.0 hours 5.8 (1.6) Now 1,1 (0.4) cmax, µg/ml 15.0 (3,3) TMAX, hour 2.6 (0.9) auc, µg. > Ceftibuten concentration in plasma in children is proportional to the dose of Ceftibuten 200 mg and 400 mg. distribution: The average distribution volume (V/F) of Cevtibuten in 6 adults is 0.21 1/kg (± 1 sd = 0.03 1/kg). Links to protein: 65% CEFTIBUTEN is linked to plasma proteins. The ratio of binding with protein does not depend on the concentration of ceftibuten in plasma. tissue penetration: Bronchial secretion: In a study of over 15 adults, a single dose of 400 mg of ceftibuten and is expected to undergo bronchodoscopes, the average concentration in the epithelium and bronchodilator epidemic is 15% and 37% of plasma concentrations. In a study of 24 adults using CEFTIBUTEN 200 mg or 400 mg once a day, the average cmax in phlegm is 1.5 Ug/ml at 2 hours after oral and medium cmax in plasma 17 ng/ml in after 2 hours after taken. MEF on average is about 70% AUC in plasma. In the same study, CMAX value is 14.3 ± 2.7 kg/ml in MEF at 4 hours after taking the drug and 14.5 ± 3.7 Ug/ml in plasma at 2 hours after taking the drug. ready. Metabolism: A study with Ceftibuten on 6 healthy male volunteers proves that CIS -ceftibuten is the main component in both total blood and urine. About 10% of Ceftibuten is transformed into a page isomer, this substance is active in about 1/8 of the activity of CIS isomers. excretion: Cevtibuten's waste time in plasma is about 2.0 to 2,344, and lasts longer in patients with renal failure. A significant amount of drugs are removed from the body by hemolysis. CEFTIBUTEN is excreted in urine, 95% of the used ceftibuten has been restored in urine or in feces. Of the six healthy male volunteers, about 56% of the dosage of Ceftibuten has been restored from urine and 39% from stool within 24 hours. Because the excretion through the kidney is a significant removal path of CEFTIBUTEN, patients with kidney dysfunction and dialysis patients need to be adjusted. The effect of food: The effect of food on biochemical biochemistry of Cevtibuten is considered over 26 healthy male volunteers to drink 400 mg of Ceftibuten after waking up or right after the standard breakfast. The results showed that the food slowed down the time to reach CMAX 1.75 hours, reduced CMAX to 18% and reduced the absorption (AUC) to 8%. pharmacokinetics in some special patients: Elderly patients CEFTIBUTEN pharmacokinetics have been studied in the elderly (≥ 65 years old) with the number of male (n = 8) and women (n = 4). Each volunteer is taken for Ceftibuten 200 mg twice a day for 3 days. The average CMAX is 17.5 (3.7 ng/ml after 3 days compared to 12.9 (2.1) ng/ml) after the first dose; The accumulation of ceftibeten in a stable state in plasma is 40%. Information about the kidney function of these volunteers is not available, so the importance of this finding for the use of CEFTIBUTEN cysts clinically on elderly patients is not clear. It may be necessary to adjust the doses of ceftibuten in elderly patients. Patients with renal failure CEFTIBUTEN pharmacokinetics have been studied in adult patients with renal dysfunction. Cevtibuten's plasma waste time increases and the total clearance (CI/F) decreases corresponding to the level of increased renal dysfunction. Of the 6 patients with moderate kidney dysfunction (30 to 49 ml/minute creatinine clearance), cevtibuten plasma waste time increased to 7.1 hours and CI/F decreased to 30 ml/min. Of the 6 patients with severe renal dysfunction (creatinine clearance from 5 to 29 ml/minute), the selling time increased to 13.4 hours and CI/F decreased to 16 ml/min. Among 6 kidney patients with creatinine clearance

Sadurunge njupuk Obat Hataphar Cubabute 200mg kanggo perawatan infeksi ringan nganti medium, bronkitis (2 blister x 10 tablet)

Cara nggunakake

obat oral, njupuk obat 1 jam sadurunge mangan utawa 2 jam sawise mangan.

Dosis

Wong diwasa lan bocah umur 12 lan luwih: 400mg (2 kapsul) / wektu / dina x 10 dina.

Bocah-bocah ing umur 12 taun nggunakake bobot liyane

5 kg: Gunakake bobot ing umur 12 taun. dosis kaya wong diwasa.

Pasien gagal ginjel diwasa:

Reresik kreatinin> 50ml/menit: Ora ana pengurangan dosis. Utawa 400mg (2 kapsul) / wektu / 2 dina. Utawa 400mg/wektu/4 dina.

Cathetan: Dosis ing ndhuwur mung kanggo referensi. Dosis spesifik gumantung saka kahanan lan tingkat kemajuan penyakit kasebut. Kanggo dosis sing cocog, sampeyan kudu takon dhokter utawa spesialis medis. Apa sing kudu ditindakake nalika overdosis?

Cara nangani: Perawatan anti-seizure. Mbusak ceftibuten kanthi hemolisis gastrointestinal. Efektivitas durung ditemtokake kanggo ngilangi obat saka pupuk peritoneal.

Apa sing kudu ditindakake yen sampeyan lali 1 dosis? Nanging, yen wektu kanggo ngendhokke karo dosis sabanjuré cendhak banget, skip dosis lan terus tanggalan tamba. Aja nggunakake dosis kaping pindho kanggo ngimbangi dosis sing ora kejawab.

Efek sisih

When using the drug often has unwanted effects (ADR) such as: Unwanted effects in clinical trials In clinical trials, 1728 adult patients (USA and 636 international) were treated with the recommended dose of Ceftibuten (400 mg daily). There is no death or permanent defect due to drug poisoning in any patient in these studies. 36/1728 (2%) Patients stop taking the drug due to investigators that may, perhaps, or almost certainly related to the toxicity of the drug. The causes of drug stops are mainly due to digestive disorders, usually diarrhea, vomiting or nausea. 6/1728 (0.3%) Patients stop taking drugs due to rash or itching because they think about the use of ceftibuten. In the US tests, the following adverse reactions are considered by investigators as possible, or almost certainly related to the use of CEFTIBUTEN capsules in multi -dose clinical trials (n = 1092 patients treated with CEFTIBUTEN). CEFTIBUTEN's adverse reactions in tablets in clinical trials in adult patients (n = 1092) Headache diarrhea Difficulty breathing Dizziness Abdominal pain Vomiting 4% 3% 3% 2% 1% 1% 1% The rate> 0.1% and

Pènget

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

Kontraindikasi

Obat CubeT dituduhake ing kasus ing ngisor iki:

Pasien sing alergi marang klompok antibiotik cephalosporin utawa bahan obat apa wae.

Ati-ati nalika nggunakake

kudu ati-ati banget nalika njupuk obat kanggo pasien ing kasus ing ngisor iki:

Ati-ati nalika nggunakake antibiotik cephalosporin kanggo pasien sing dicurigai utawa ngerti yen dheweke alergi marang penisilin. Kira-kira 10% pasien sing duwe riwayat alergi marang penisilin bereaksi karo cephalosporin. Reaksi hipersensitivitas abot (anafilaksis) uga wis kacarita ing pasien sing nggunakake penisilin lan cephalosporin lan reaksi hipersensitivitas kanggo anafilaksis uga katon. Yen reaksi anafilaksis katon karo ceftibuten, mungkasi obat kasebut lan gunakake terapi sing cocog. Anafilaksis sing abot kudu njupuk tindakan darurat sing cocog kayata epinefrin, kanggo napas oksigen, antihistamin, kortikosteroid, amina hipertensi lan ngawasi kanthi ati-ati.

Minangka antibiotik spektrum amba liyane, perawatan antibiotik sing dawa bisa nyebabake muncul lan pangembangan bakteri tahan, mula kudu dipantau kanthi ati-ati. Yen ana tandha-tandha superinfeksi, perlu kanggo njupuk perawatan sing cocog.

Dosis ceftibuten bisa uga kudu diatur ing pasien kanthi tingkat fungsi ginjel sing beda-beda, utamane ing pasien sing duwe bar bun ing ngisor 50 ml / min utawa pasien dialisis. Pasien dialisis dipantau kanthi teliti lan kudu nggunakake CEFTIBUTEN sakwise dialisis.

Ati-ati nalika nggunakake CEFTIBUTEN ing wong sing duwe riwayat penyakit gastrointestinal, utamane kolitis. Palm of colitis palsu wis dilaporake kanggo kabeh antibiotik spektrum sing amba kalebu Ceftibuten lan tingkat entheng nganti ngancam nyawa. Mula, diagnosa iki kudu digatekake ing pasien diare sawise nggunakake antibiotik spektrum luas. Perawatan karo antibiotik spektrum luas ngganti sistem bakteri normal ing saluran usus lan bisa nyebabake bakteri Clostridia ngluwihi. Pasinaon nuduhake yen racun sing diprodhuksi dening Clostridium difficile minangka panyebab utama kolitis sing ana gandhengane karo antibiotik.

Sawise diagnosa kolitis palsu, langkah-langkah perawatan sing cocog kudu ditindakake. Kasus colitis palsu entheng, asring saka mungkasi obat kasebut. Ing kasus kolitis palsu medium nganti abot, perlu kanggo nimbang ganti rugi lan elektrolit, suplemen protein lan perawatan karo obat antibakteri antibakteri marang Clostridium difficile.

Sampeyan kudu ngombe obat paling ora 2 jam sadurunge mangan utawa paling ora 1 jam sawise mangan.

Ing komposisi obat Aspartam ngemot phenylalanin sing akeh, sing bisa mbebayani kanggo wong sing duwe fenilceton urin kudu ati-ati nalika digunakake.

Efek obat ing nyopir lan ngoperasikake mesin

Ora ana data babagan pengaruh CEFTIBUTEN ing nyopir lan ngoperasikake mesin.

Amarga obat kasebut bisa nyebabake sirah, pusing, pusing, mula kudu ati-ati nalika digunakake nalika nyopir utawa ngoperasikake mesin.

Nggunakake obat kanggo wanita nalika ngandhut lan lactation

Nggunakake obat kanggo wanita ngandhut:

Panaliten kewan nuduhake manawa ora ana bukti efek mbebayani tumrap janin. Ora ana riset sing nyukupi lan dikontrol ing wanita ngandhut. Mula, obat kasebut mung kudu digunakake nalika meteng yen pancen perlu.

Gunakake obat kanggo wanita sing nyusoni:

Keamanan saka Ceftibuten durung kabukten, ora bisa digunakake nalika nyusoni.

Obat interaktif

Obat liyane - obat liyane:

Teofilin: 12 sukarelawan lanang sing sehat digunakake siji dosis 200 mg ceftibuten 2 kali / dina suwene 6 dina. Kanthi dosis Ceftibuten ing esuk dina Jum'at, saben sukarelawan yaiku dosis tunggal teofilin (4 mg / kg). Farmakokinetik teofilin ora owah. Pengaruh ceftibuten ing farmakokinetik teofilin durung diteliti.

antagonis anti-asam utawa reseptor H2: Efek pH lambung mundhak ing bioavailabilitas biokimia CEFTIBUTEN ditaksir ing 18 sukarelawan diwasa sing sehat. Saben sukarelawan dijupuk kanggo 400 mg CEFTIBUTEN. Dosis antacid cair ora mengaruhi CMAX utawa AUC saka Cevtibuten. Nanging, nalika nggunakake 150 mg ranitidin saben 12 jam / wektu ing 3 dina mundhak CMAX saka ceftibuten kanggo 23% lan nambah AUC saka Ceftibuten kanggo 16%. Relevansi klinis saka mundhak iki ora dingerteni.

Interaksi obat - Asil tes:

Ora ana interaksi kimia utawa tes sing direkam karo Ceftibuten. Asil positif palsu ing tes Coombs langsung wis dilaporake nalika nggunakake cephalosporin liyane. Nanging, asil tes nggunakake sel getih abang sing sehat kanggo nguji CEFTIBUTEN wis nyebabake reaksi karo tes Coombs in vitro kanggo nyegah reaksi positif, sanajan kanthi konsentrasi dhuwur nganti 40 mg/ml.

Obat - Pangan:

Kacepetan lan tingkat panyerepan CEFTIBUTEN ing wangun epidemi bisa uga kena pengaruh nalika digunakake karo panganan.

Kavaleri obat:

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

Panyimpenan

Ninggalake papan sing adhem, aja nganti cahya, suhu ngisor 30⁰C.

Supaya ora bisa digayuh bocah, waca manual pangguna kanthi teliti sadurunge digunakake.

Obat liyane

Disclaimer

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