Elopag 50 - Tablet Eltrombopag Olamine - 50mg 7 Tablet(s) / Box Everest Pharmaceuticals Ltd. Introduction: Elopag 50 is used to treat low platelet count due to chronic immune (idiopathic) thrombocytopenic purpura (ITP) or chronic hepatitis C virus (HCV) infection. It is also used to treat severe aplastic anemia. Elopag 50 is a thrombopoietin agonist. It works by stimulating the formation of new platelets in the blood. The function of platelets is to help reduce bleeding. It should be taken in a dose and duration as advised by the doctor. You may take it on an empty stomach. This medicine is to be swallowed as a whole. Do not chew, crush or break it. Inform your... Uses of Elopag 50: Low platelet count due to ITP or HCV infection Side effects of Elopag 50: NauseaDiarrheaUpper respiratory tract infectionVomitingIncreased liver enzymesMuscle painUrinary tract infection How to use Elopag 50: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Elopag 50 is to be taken empty stomach. How Elopag 50 works: Elopag 50 is a thrombopoietin agonist. It works by stimulating the formation of new platelets in the blood. Platelets help to reduce or prevent bleeding. What if you forget to take Elopag 50?: If you miss a dose of Elopag 50, skip it and continue with your normal schedule. Do not double the dose. Indication: Adult chronic immune (idiopathic) thrombocytopenic purpura (ITP), Hepatitis C Virus (HCV) related, Thrombocytopenia, Aplastic anemia Administration: Should be taken on an empty stomach: Take at least 4 hr before or after antacids, dairy products or other Ca-containing food products or mineral supplements containing polyvalent cations. Adult Dose: Adult Chronic ITP: Initial dose 50 mg once daily. Adjust to maintain platelet count greater than or equal to 50×109 /L Chronic hepatitis C associated thrombocytopenia: Initial recommended dose is 50 mg once daily and do not exceed a daily dose of 100 mg. Severe aplastic anemia: Initial recommended dose is 50 mg once daily, adjust to maintain platelet count greater or equal 50×109 /L. Do not exceed 150 mg per day Max: 75 mg daily. After adjustment, platelet counts should be monitored at least weekly for 2-3 weeks. Wait for at least 2 weeks to see the effect of... Child Dose: Child 6 years or older Chronic ITP: Initial dose 50 mg once daily. Child 1 to 5 year The initial dose is 25 mg once daily. Adjust to maintain platelet count greater than or equal to 50×109 /L Renal Dose: Renal Impairment: No dose adjustment is necessary in ITP patients with renal impairment. Contraindication: Eltrombopag is contraindicated in patients with severe hepatic impairment and who are hypersensitive to any of its excipients. Mode of Action: Small-molecule thrombopoietin (TPO)-receptor agonist that interacts with human TPO receptor transmembrane domain of human TPO-receptor & initiates signaling cascades that induce proliferation & differentiation of megakaryocytes from bone marrow progenitor cells. Precaution: Regularly monitor clinical haematology, platelet counts & serum liver test throughout therapy. Renal & hepatic impairment; hepatic disease. Thrombotic/thromboembolic complications. Increased risk of bleeding upon discontinuation of treatment. Bone marrow reticulin formation & risk of bone marrow fibrosis. Malignancies & progression of malignancies. Pregnancy & lactation. Childn <18 yr, elderly. Side Effect: Most common adverse reactions are nausea diarrhea, upper respiratory tract infection, increased ALT, mayalgia, urinanry tract infection, fatigue, headache, Insomnia; headache, paraesthesia; cataract, dry eye; GI & hepatobiliary disorders; rash, pruritus, alopecia; arthralgia, muscle spasm, bone pain; fatigue, peripheral oedema; thromboembolic events. Pregnancy Category Note: Pregnancy Available data from published case reports and postmarketing experience with use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal data In animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses Effects were observed at doses resulting in exposures that were 6 times the human clinical exposure based on AUC in patients with chronic ITP at 75 mg/day, and 3 times the AUC in patients with chronic hepatitis C... Interaction: Increased plasma Cmax & AUC of HMG-CoA reductase inhibitors. Caution w/ methotrexate, topotecan. Increased conc w/ fluvoxamine; decreased conc w/ rifampicin & lopinavir/ritonavir. Reduced absorption by antacids, dairy products & other products containing polyvalent cations (eg Fe, Ca, Mg, Al, Se, Zn). Reduced plasma AUC & Cmax w/ high-calorie & -fat meal. Monitor platelet counts when used in combination w/ lopinavir/ritonavir & other drugs for treatment of idiopathic thrombocytopenic purpura (ITP).