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Buy Elopag 25 mg (Eltrombopag)
Original price was: $85.00.$70.00Current price is: $70.00.
Description
What is Elopag 25 mg (Eltrombopag)?
Eltrombopag is used to increase the number of platelets (cells that help the blood clot) to decrease the risk of bleeding in adults and children 1 year of age and older who have chronic immune thrombocytopenia (ITP; an ongoing condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood) and who have not been helped or cannot be treated with other treatments, including medications or surgery to remove the spleen. To know more visit here.
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First of all generic Elopag is very affordable version of Eltrombopag for thrombocytopenia and severe aplastic anemia patients. It is a verified generic version of Revolade. Everest pharmaceuticals Limited manufacture this generic version in Bangladesh. It is one of the renowned pharmaceutical companies who mostly made cancer medicine in Bangladesh. After the Directorate General of Drug Administration of Bangladesh approves to manufacture eltrombopag, they started to make it and sell it all over the world where generic medicine is allowed to use.
It is the 4th generic version of Revolade which is selling regularly all over the world. It is also 94% cheaper than the brand version of eltrombopag. Which cost you less than 150 dollars.
COMPOSITION
ELOPAG 25 Tablet: Each film coated tablet contains Eltrombopag Olamine INN which is equivalent to 25 mg Eltrombopag free acid.
ELOPAG 50 Tablet: Each film coated tablet contains Eltrombopag Olamine INN which is equivalent to 50 mg Eltrombopag free acid.
INDICATIONS AND USAGE
Treatment of Thrombocytopenia in Patients with Chronic ITP
ELOPAG is indicated for the treatment of thrombocvtopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ELOPAG should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
Treatment of Thrombocytopenia in Patients with Hepatitis C Infection
ELOPAG is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis IC to allow the initiation and maintenance of interferon-based therapy. ELOPAG should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy,
Treatment of Severe Aplastic Anemia
ELOPAG is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Limitations of Use
• ELOPAG is not indicated for the treatment of patients with myelodysplastic syndromes (MDS).
DOSAGE AND ADMINISTRATION
Chronic Immune (Idiopathic) Thrombocytopenia
Use the lowest dose of ELOPAG to achieve and maintain a platelet count greater than or equal to 50 x 10%/L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use ELOPAG to normalize platelet counts. In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting Eltrombopag and decreased within 1 to 2 weeks after discontinuing Eltrombopag.
Initial Dose Regimen
Adult and Pediatric Patients 6 Years and Older with ITP Initiate ELOPAG at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C). For patients of East Asian ancestry with IT, initiate ELOPAG at a reduced dose of 25 mg once daily.
For patients with IP and mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate ELOPAG at a reduced dose of 25 mg once daily. For patients of East Asian ancestry with IP and hepatic impairment (Child-Pugh Class A B, C), consider initiating ELOPAG at a reduced dose of 12.5 mg once daily.
Pediatric Patients with TP Aged 1 to 5 Years Initiate ELOPAG at a dose of 25 mg once daily.
Administration
Preparation of the Oral Suspension
Prior to use of the oral suspension, ensure patients or caregivers receive training on proper dosing, preparation, and administra-tion of ELOPAG for oral suspension. Administer the oral suspen-sion immediately after preparation. Discard any suspension not administered within 30 minutes after preparation. Prepare the suspension with water only. NOTE: Do not use hot
water to prepare the suspension.
Administration of Tablets and Oral Suspension
Take ELOPAG on an empty stomach (1 hour before or 2 hours after a meal). Take ELOPAG at least 2 hours before or 4 hours after other medications (e.g., antacids), calcium-rich foods (e.g., dairy products and calcium-fortified juices), or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc.
CONTRAINDICATIONS
Sensitivity to Eltrombopag Olamine or any of the added pharma-ceutical additives.
WARNINGS AND PRECAUTIONS
Hepatic Decompensation in Patients with Chronic Hepatitis C
In patients with chronic hepatitis C, ELOPAG in combination withinterferon and Ribavirin may increase the risk of hepatic decom- pensation. Patients with low albumin levels (less than 3.5 g/dL) or Model for End-Stage Liver Disease (MELD) has a greater risk for hepatic decompensation. Discontinue ELOPAG if antiviral therapy is discontinued.
Hepatotoxicity
ELOPAG may increase the risk of severe and potentially life-threat- ening hepatotoxicity. Measure serum ALT, AST, and bilirubin prior to initiation of ELOPAG, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. ELOPAG inhibits UDP-glucuronosyltransferase (UGT)1A1 and organic anion-transporting polypeptide (OAT)1B1, which may lead to indirect hyperbilirubinemia. Eltrombopag carries a boxed warning for risk for hepatic decompensation in patients with chronic hepatitis C and risk of hepatotoxicity.
The Risk of Death and Progression of Myelodysplastic Syndromes (MDS) to Acute Myeloid Leukemia (AML) is relatively high.
Thrombotic/Thromboembolic Complications
Thrombotic/thromboembolic complications may result from increases in platelet counts with Eltrombopag. Reported thrombotic/thromboembolic complications included both venous and arterial events and were observed at low and at normal platelet counts. To minimize the risk for thrombotic/thromboem-bolic complications, do not use Eltrombopag in an attempt to normalize platelet counts.
Cataracts
In the three controlled clinical trials in adults with chronic ITP cataracts developed or worsened in 15 (7%) patients who received 50 mg of Eltrombopag daily and 8 (7%) placebo-group patients. In the extension trial, cataracts developed or worsened in 11% of patients who underwent ocular examination prior to therapy with Eltrombopag. Cataracts were observed in toxicology studies of Eltrombopag in rodents.
ADVERSE REACTIONS
The following serious adverse reactions associated with Eltrombopag are described under WARNINGS AND PRECAU-TIONS: Hepatic Decompensation in Patients with Chronic Hepatitis C, Hepatotoxicity, Increased Risk of Death and Progres-sion of Myelodysplastic Syndromes to Acute Myeloid Leukemia, Thrombotic/Thromboembolic Complications, Cataracts. The most common adverse reactions occurring in at least 10% of patients included headache, dizziness, insomnia, cough ayspnoea, oropharyngeal pain, rhinorrhoea, nausea, diarrhoea, abdominal pain, transaminases increased, ecchymosis, arthralgia, muscle spasms, pain in extremity, fatigue, febrile neutropenia, and pyrexia.
DRUG INTERACTIONS
Polyvalent Cations (Chelation)
Eltrombopag chelates polyvalent cations (such as iron, calcium, aluminum, magnesium, selenium, and zinc) in foods, mineral supplements, and antacids. In a clinical trial, administration of Eltrombopagwith a polyvalent cation-containing antacid decreased plasma Eltrombopag systemic exposure by approxi-mately 70%.
Transporters
Use caution when concomitantly administering Eltrombopag and drugs that are substrates of OATP1B1 (e.g., atorvastatin, ezetimibe, fluvastatin,, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or BCRP (e.g. imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). Monitor patients closely for signs and symptoms of excessive exposure to the drugs that are substrates of OATP1B1 or BCRP and consider reduction of the dose of these drugs, if appropriate.
Protease Inhibitors
HIV Protease Inhibitors
No dose adjustment is recommended when Eltrombopag is coadministered with LPV/RTV. Drug interactions with other HIV protease inhibitors have not been evaluated.
Hepatitis C Virus (HCV) Protease Inhibitors
Coadministration of Eltrombopag with either boceprevir or telaprevir did not require any dose adjustments.
Peginterferon alfa-2a/b Therapy
Coadministration of Peginterferon alfa-2a or-2b did not affect Eltrombopag exposure in tWO randomized, double-blind. placebo-controlled trials with adult patients with chronic hepatitis C.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies of Eltrombopag use in pregnancy. In animal reproduction and developmental toxicity studies, there was evidence of embryold thality and reduced fetal weights at maternally toxic doses.
Nursing Mothers
It is not known whether Eltrombopag is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Eltrombopag taking into account the importance of Eltrombopag to the mother.
Pediatric Use
The safety and efficacy of Eltrombopag in pediatric patients younger than 1 year with ITP have not yet been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between aged (65 years of age and over) patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment
Hepatic impairment influences the exposure of Eltrombopag Reduce the initial dose of Eltrombopag in patients with chronic IT (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C). No dosage adjustment is necessary for patients with chronic hepatitis C and hepatic impairment.
Renal Impairment
No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.
Ethnicity
Patients of East Asian ethnicity (i.e., Japanese, Chinese, Taiwan-ese; and Korean) exhibit higher Eltrombopag exposures. A reduction in the initial dose of ELOPAG is recommended for patients of East Asian ancestry with IP (adult and pediatric patients 6 years and older only) or severe aplastic anemia. No dose reduction is needed in patients of East Asian ethnicity with chronic hepatitis C.
OVERDOSAGE
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complica-tions. In case of an overdose, consider oral administration of a metal cation-containing preparation, such as calcium, aluminum, or magnesium preparations to chelate Eltrombopag and thus limit absorption. Closely monitor platelet counts.
CLINICAL PHARMACOLOGY
Mechanism of Action
Eltrombopag is an orally bioavailable, small-molecule TPO-re-ceptor agonist that interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells.
Pharmacokinetics
Absorption
Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration. Based on urinary excretion and biotransformation products eliminated in feces, the oral absorption of drug-related material following administration of a single 75-mg solution dose was estimated to be at least 52%.
Distribution
The concentration of Eltrombopag in blood cells is approximate-ly 50% to 79% of plasma concentrations based on a radiolabel study. In vitro studies suggest that Eltrombopag is highly bound to human plasma proteins (greater than 99%). Eltrombopag is a substrate of BCRP, but is not a substrate for P-glycoprotein (P-gp) or OATP1B1.
Metabolism
Absorbed Eltrombopag is extensively metabolized, predomi- nantly through pathways including cleavage, oxidation, and conjugation with glucuronic acid, glutathione, or cysteine. In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for the oxidative metabolism of Eltrombopag. UGT1A1 and UGT1A3 are responsible for the glucuronidation of Eltrombopag.
Elimination
The predominant route of Eltrombopag excretion is via feces (59%), and 31% of the dose is found in the urine. Unchanged Eltrombopag in feces accounts for approximately 20% of the dose; unchanged Eltrombopag is not detectable in urine. The plasma elimination half-life of Eltrombopag is approximately 21 to 32 hours in healthy subjects and 26 to 35 hours in patients with ITP.
PHARMACEUTICAL INFORMATION OF ELOPAG
How Supplied
ELOPAG 25 Tablet: Each film coated tablet contains Eltrombopag Olamine INN which is equivalent to 25 mg Eltrombopag free acid, a silica gel desiccant and polyester coil with a child-resistant closure.
ELOPAG 50 Tablet: Each film coated tablet contains Eltrombopag Olamine INN which is equivalent to 50 mg Eltrombopag free acid) a silica gel desiccant and polyester coil with a child-resistant closure.
Storage
Store at room temperature, below 30°C (86°F). Do not remove desiccant. Dispense in original bottle. Keep ELOPAG out of the sight and reach of children. Protect from moisture & light.
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