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Apa Kandungan dan Komposisi Epirubicin Ferron Pharmaceuticals?
Kandungan dan komposisi produk obat maupun suplemen dibedakan menjadi dua jenis yaitu kandungan aktif dan kandungan tidak aktif. Kandungan aktif adalah zat yang dapat menimbulkan aktivitas farmakologis atau efek langsung dalam diagnosis, pengobatan, terapi, pencegahan penyakit atau untuk memengaruhi struktur atau fungsi dari tubuh manusia.
Jenis yang kedua adalah kandungan tidak aktif atau disebut juga sebagai eksipien. Kandungan tidak aktif ini fungsinya sebagai media atau agen transportasi untuk mengantar atau mempermudah kandungan aktif untuk bekerja. Kandungan tidak aktif tidak akan menambah atau meningkatkan efek terapeutik dari kandungan aktif. Beberapa contoh dari kandungan tidak aktif ini antara lain zat pengikat, zat penstabil, zat pengawet, zat pemberi warna, dan zat pemberi rasa. Kandungan dan komposisi Epirubicin Ferron Pharmaceuticals adalah:Epirubicin
Epirubicin Ferron Pharmaceuticals Obat Apa?
Apa Indikasi, Manfaat, dan Kegunaan Epirubicin Ferron Pharmaceuticals?
Indikasi merupakan petunjuk mengenai kondisi medis yang memerlukan efek terapi dari suatu produk kesehatan (obat, suplemen, dan lain-lain) atau kegunaan dari suatu produk kesehatan untuk suatu kondisi medis tertentu. Epirubicin Ferron Pharmaceuticals adalah suatu produk kesehatan yang diindikasikan untuk:
Epirubicin in mono or combination therapy has produced responses in a wide range of neoplastic conditions,including breast,gastric,lung,and malignant lymphomas,soft tissue sarcoma. Intravesical administration of epirubicin has been found to be benefical in the treatment of papillary transitional cell cercinoma of the bladder, carcinoma-in-situ and in the prophylaxis of recurrences after transurethral resection.
| Kemoterapi sitotoksik adalah kemoterapi menggunakan agen sitotoksik untuk membunuh atau merusak sel-sel kanker yang bereproduksi. Terapi ini secara spesifik menargetkan sel kanker yang membelah dengan cepat. Kemoterapi dapat dianggap sebagai cara untuk merusak atau menekan sel, yang kemudian dapat menyebabkan kematian sel jika apoptosis dimulai. Efek samping dari kemoterapi seperti dapat merusak sel-sel normal yang membelah dengan cepat dan karenanya sensitif terhadap obat-obatan anti-mitosis: sel-sel di sumsum tulang, saluran pencernaan dan folikel rambut. Hal ini menghasilkan efek samping kemoterapi yang paling umum seperti: myelosuppression (penurunan produksi sel darah, karenanya juga imunosupresi), mukositis (peradangan pada lapisan saluran pencernaan), dan alopesia (kerontokan rambut). Karena efeknya pada sel-sel kekebalan tubuh (terutama limfosit), obat-obat kemoterapi sering digunakan dalam sejumlah penyakit yang diakibatkan oleh aktivitas berlebih yang berbahaya dari sistem kekebalan terhadap diri sendiri (disebut autoimunitas). Ini termasuk rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, vasculitis dan lain-lain. |
Kanker adalah penyakit yang disebabkan oleh ketidakteraturan perjalanan hormon yang mengakibatkan tumbuhnya daging pada jaringan tubuh yang normal atau sering dikenal sebagai tumor ganas. Selain itu gejala ini juga dikenal sebagai neoplasma ganas dan seringkali ditandai dengan kelainan siklus sel khas yang menimbulkan kemampuan sel untuk:
Tumor atau barah (bahasa Inggris: tumor, tumour) adalah sebutan untuk neoplasma atau lesi padat yang terbentuk akibat pertumbuhan sel tubuh yang tidak semestinya, yang mirip dengan simtoma bengkak. Tumor berasal dari kata tumere dalam bahasa latin yang berarti "bengkak". Pertumbuhannya dapat digolongkan sebagai ganas (malignan) atau jinak (benign). Tumor ganas disebut kanker. Kanker memiliki potensi untuk menyerang dan merusak jaringan yang berdekatan dan menciptakan metastasis. Tumor jinak tidak menyerang tissue berdekatan dan tidak menyebarkan benih (metastasis), tetapi dapat tumbuh secara lokal menjadi besar. Mereka biasanya tidak muncul kembali setelah penyingkiran melalui operasi. |
Berapa Dosis dan Bagaimana Aturan Pakai Epirubicin Ferron Pharmaceuticals?
Dosis adalah takaran yang dinyatakan dalam satuan bobot maupun volume (contoh: mg, gr) produk kesehatan (obat, suplemen, dan lain-lain) yang harus digunakan untuk suatu kondisi medis tertentu serta frekuensi pemberiannya. Biasanya kekuatan dosis ini tergantung pada kondisi medis, usia, dan berat badan seseorang. Aturan pakai mengacu pada bagaimana produk kesehatan tersebut digunakan atau dikonsumsi. Berikut ini dosis dan aturan pakai Epirubicin Ferron Pharmaceuticals:
Epirubicin is not active when given orally and should not be injected intramusculary or intrathecally. It is a advisable to give the drug via the tubing of a freely-running IV saline infusion after checking that needle is well placed in the vein. This method minimises the risk of drug extravasation and makes sure that the vein is flushed with saline after the administration of the drug, Exctravasation of epirubicin from the vein during injection into small vessels or repeated injections into the same vein.
Conventional doses:
when Epirubicin is used as a single agent,the recommended dosage in adults is 75-90/m2 body area; the drug should be injected IV over 3-5 minutes and depending on the patient’s haematomedullary status,the dose should be repeated at 21-day intervals.
High doses:
Epirubicin as a single agent for the treatment of lung cancer at high doses should be administered according to the following regimens: small cell lung cancer (previously untreated): 120mg/m2 day 1,every 3 weeks. non small cell lung cancer (squamous, large cell, and adenocarcinoma previously untreated): 135mg/m2 day 1 or 45 mg/m2 day 1,2,3 every 3 weeks. The drug should be given as an IV bolus over 3-5 minutes or as an infusion up to 30 minutes. Advanced breast cancer: 135mg/m2 ni monotherapy and 120mg/2 in combination therapy every 3-4 weeks. Lower doses (60-75mg/m2 for conventional treatment and 105-120mg/m2 for high dose schedules) are recommended for patients whose bone marrow function has already been impaired by previous chemotherapy or radiotherapy,by age,or neoplastic bine-marrow infiltration. The total dose per cycle may be divided over 2-3 successive days. When the drug is used in combination with other anti-tumours agents.the doses need to be adequately reduced. Since the major route of elimination of epirubicin is the hepatobiliary system,the dosage should be reduced in patients with impaired liver function,in order to avoid an increase of overall toxicity. Moderate liver impairment (bilirubin: 1,2-3mg/100ml) requires a 50% reduction of dose,while severe impairment (>3mg/100ml) necessitates a dose reduction of 75%.
Moderate renal impairment does not appear to require a dose reduction in view of the limited amount of epirubicin excreted by this route. To decrease the side effects rate in patients which can not afford the standart epirubucin therapy for medical reasons the following epirubicin dosage can be administered in the palliative therapy: weekly 20-30mg/m2.
Intravesical administration:
Epirubicin can be given by intravesical administration for the treatment of papillary carcinoma of the bladder and carcinoma-in-situ. It should not be used in this way for the treatment of invasive tumouors which have penetrated the bladder wall where systemic therapy or surgery is more appropriate. Epirubicin has also been successfully used intravesicularly as a prophylactic agent after transurethal resection of superficial tumours in order to prevent recurrences.
While many regimens have been used,the following may be helpful as a guide: for therapy,one weekly for 8 weeks instillation of 50mg/50ml (diluted with saline or dislited sterile water). In the case of local toxicity (chemical cystitis) a dose reduction to 30mg/50ml is advised. For carcinoma-in situ,depending on the individual tolerability of the patient,the dose may be increased up to 80mg/50ml. For prophylaxis, one weekly for 4 weeks administration of 50mg/50ml and then after 11 months instillation at the same dosage,is the schedule most commonly used. The solution should be retained intravesically for 1 hour. To avoid undue dilution with urine,the patient should be instructed not to drink any fluid in the 12 hours prior to instillation. During the instillation,the patient should be rotated occasionally and should be instructed to void at the end of instalation time.
Apa Saja Kontraindikasi Epirubicin Ferron Pharmaceuticals?
Kontraindikasi merupakan suatu petunjuk mengenai kondisi-kondisi dimana penggunaan obat tersebut tidak tepat atau tidak dikehendaki dan kemungkinan berpotensi membahayakan jika diberikan. Pemberian Epirubicin Ferron Pharmaceuticals dikontraindikasikan pada kondisi-kondisi berikut ini:
Epirubicin is contraindicated in patients with marked myellopsuppression induced by previous treatment with other antitumour agents or by radiotherapy and in patients already treated with maximal cumulatiev doses of other anthracyclines such as doxorubicin. The drug is contraindicated in patients with a current or previous history of cardiac impairment.
Apa saja Peringatan dan Perhatian Penggunaan Epirubicin Ferron Pharmaceuticals?
Epirubicin should be administered only under the supervision of a qualified physician experienced in antiblastic and cytotoxic therapy. Treatment with high dose epirubicin in particular requires the availability of faciilties for the care of patients with possible clinical complications due to myellopsuppression. Initial treatment calls for careful baseline monitoring of various laboratory parameters and cardiac function.
During each cycle of treatment with Epirubicin,patients must be carefully and frequently monitored. Red and white blood cells,neutriphils and platelet counts should be carefully assesed both before and during each cycle of therapy. Leukopenia and neutropenia are usually transient both with conventional and high doses,reaching a nadir between the 10th and 14th day and returning to normal values by the 21st day: they are more severe with high dose schedules. very few patients even receiving high doses,experiences thrombocytopenia (<100,000 platelest/mm3
Before starting therapy and if possible during treatment liver function should be evaluated (SGOT, SGPT,alkaline phosphatase, bilirubin). A cumulative dose of 900-1000mg/m2 should only be exceeded with extreme caution with both conventional and high doses. Above this level the risk of irreversible congestive caardiac failure increases greatly. there is objective evidence that cardiac toxicity may rarely occur below this range. However cardiac function must be carefully monitored during treatment to minimise the risk of heart failure of the type described for other anthracyclines. Heart failure can appear even several weeks after discontinuing treatment and may prove unresponsive to specific medical treatment. The potential risk of the mediastinal pericardial area. In establishing the maximal cultural doses of epirubicin any concomitant therapy with potentially cardiotoxic drugs should be taken into account.
It is recommended that an ECG before and after treatment cycle should be carried out. Alterations in the ECG tracing,such as flattening or inversion of the T wave, depression of the S-T segment,or the onset of arrhyhmias, generally transient and reversible, need not necessarily taken as indications to discontinue treatment. Cardiomyopathy induced by anthracyclines is associated with a persistent reduction of the QRS voltage, prolong action beyond normal limits of the systolic interval (PEP/LVET) and a reduction of the ejection fraction. Cardiac monitoring of patients receiving Epirubicin “Ebewe” treatment is highly important and it is advisable to assess cardiac function by non-invasive techniques such as ECG, echocardiography and if necessary, measurment of ejection fraction by radionuclide angiography. Like other cytotoxic agents,epirubicin may induce hyperuricemia as a result of rapid lysis of neoplastic cells. Blood uric acid levels should therefore be carefully checked so that this phenomenon may be controlled pharmacologically. Epirubicin may impart a red colour to the urine for 1-2 days after administration.
Apa Saja Interaksi Obat Epirubicin Ferron Pharmaceuticals?
Interaksi obat merupakan suatu perubahan aksi atau efek obat sebagai akibat dari penggunaan atau pemberian bersamaan dengan obat lain, suplemen, makanan, minuman, atau zat lainnya. Interaksi obat Epirubicin Ferron Pharmaceuticals antara lain:
Apart from myellopsuppression and cardiotoxicity (described under Precautions) the following adverse reactins have been described.
- alocepia,normally reversible,appears in 60-90% of treated cases; it is accompanied by lack of beard growth in males
- mucosit may appear 5-10 days after he start of treatment and usually involves stomatitis with areas of painful erosions,mainly along the side of the tongue and on the sublingual mucosa
- gastro-intestinal disturbances,such as nausea,vomiting and diarrhoea
- hyperpyrexia
Fever,chills and urticaria have been rarely reported; anaphylaxis occur. High doses of epirubicin have been safely administered in a large number of untreated patients having various solid tumours and has caused adverse events which are no different from those seen atconventional doses with the exception of reversible severe neutropenia (<500 neutrophils/mm2 for <7 days) which occured in the majority of patients. Only a few patients have required hospitalisation and supportive therapy for severe infectious complications at high doses. During intravesical administration, as drug absortion in minimal,systemic side effects are rare; more frequently chemical cystitis,sometimes haemorrhagic has been observed. The occurence of secondary acute myeloid leukaemia with or without a pre-leukaemic phase has been reported rarely in patients concurrently treated with epirubicin in association with DNA-damaging antineoplastic agents. Such cases should have a short (1-3 year) latency period.
Bagaimana Kemasan dan Sediaan Epirubicin Ferron Pharmaceuticals?
Vial 10 mg, 50 mg
Apa Nama Perusahaan Produsen Epirubicin Ferron Pharmaceuticals?
Produsen obat (perusahaan farmasi) adalah suatu perusahaan atau badan usaha yang melakukan kegiatan produksi, penelitian, pengembangan produk obat maupun produk farmasi lainnya. Obat yang diproduksi bisa merupakan obat generik maupun obat bermerek. Perusahaan jamu adalah suatu perusahaan yang memproduksi produk jamu yakni suatu bahan atau ramuan berupa tumbuhan, bahan hewan, bahan mineral, sari, atau campuran dari bahan-bahan tersebut yang telah digunakan secara turun-temurun untuk pengobatan. Baik perusahaan farmasi maupun perusahaan jamu harus memenuhi persyaratan yang telah ditetapkan.
Setiap perusahaan farmasi harus memenuhi syarat CPOB (Cara Pembuatan Obat yang Baik), sedangkan perusahaan jamu harus memenuhi syarat CPOTB (Cara Pembuatan Obat Tradisional yang Baik) untuk dapat melakukan kegiatan produksinya agar produk yang dihasilkan dapat terjamin khasiat, keamanan, dan mutunya. Berikut ini nama perusahaan pembuat produk Epirubicin Ferron Pharmaceuticals:Ferron Pharmaceuticals