Nipotin 10000

Nipotin 1000010000IU/ml

Type:Injection

Generic Name:Erythropoietin

Manufacturer:Aristopharma Limited

Price:4200.00

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Indication

Anemia associated with Chronic Renal Failure, including patients on dialysis (ESRD) and patients not on dialysis, Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, Anemic patients (hemoglobin > 10 to < 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions, Anemia related to therapy with zidovudine in HIV-infected patients.

Adult Dose

Chronic Kidney Disease-Associated Anemia Reduction of need for red blood cell (RBC) transfusion in patients with chronic kidney disease (CKD) Patient not on dialysis: 50-100 units/kg IV/SC 3 times weekly initially Initiate only when (1) hemoglobin level <10 g/dL, (2) rate of hemoglobin decline indicates likely necessity of RBC transfusion, and (3) reducing risk of alloimmunization or other risks related to RBC transfusion is goal; if hemoglobin level >10 g/dL, reduce or interrupt dose and use lowest dose sufficient to reduce need for RBC transfusion Patient on dialysis: 50-100 units/kg IV 3 times weekly initially Initiate when hemoglobin level <10 g/dL; if hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose Zidovudine-Related Anemia Treatment of anemia due to zidovudine administered at <4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of <500 milliunits/mL 100 units/kg IV/SC 3 times weekly initially Chemotherapy-Related Anemia Treatment of anemia in patients with nonmyeloid malignancies where anemia is due to effect of concomitant myelosuppressive chemotherapy for >2 months 150 units/kg IV/SC 3 times weekly initially; alternatively, 40,000 units SC once weekly until completion of chemotherapy course Preparation for Surgery With High Risk of Blood Loss Reduction of need for allogeneic RBC transfusions in patients with perioperative hemoglobin >10 g/dL but ?13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery 300 units/kg SC once daily for 15 consecutive days (10 days preceding surgery, day of surgery, 4 days following surgery); alternatively, 600 units/kg SC in 4 doses administered 21, 14, and 7 days before surgery and on day of surgery

Child Dose

Chronic Kidney Disease-Associated Anemia <1 month: Safety and efficacy not established >1 month: 50 units/kg IV/SC 3 times weekly initially; if patient on dialysis, IV route recommended Initiate when hemoglobin level <10 g/dL; if hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose Prematurity-Related Anemia 25-100 units/kg SC 3 times weekly or 200-400 units/kg SC/IV q24-48hr for 2-6 weeks Zidovudine-Related Anemia <8 months: Safety and efficacy not established 8 months-17 years: 50-400 units/kg SC/IV 2-3 times weekly Chemotherapy-Related Anemia <5 years: Safety and efficacy not established 5-18 years: 600 units/kg IV once weekly; not to exceed 40,000 units

Contraindication

Uncontrolled hypertension, hypersensitivity to mammalian cell products and human albumin.

Mode of Action

Erythropoietin regulates erythropoiesis by stimulating the differentiation and proliferation of erythroid precursors, stimulating the release of reticulocytes into the circulation, and synthesis of cellular haemoglobin. Recombinant human erythropoietin is available as epoetin alfa and epoetin beta which are used in the management of anaemias associated with CRF, cancer chemotherapy and anti-AIDS drug zidovudine.

Precaution

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product. Iron evaluation: Prior to and during Epoetin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/mL. Virtually all patients will require supplemental iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis. Lactation: Unknown whether drug is excreted in breast milk; use with caution; avoid administering multidose vials

Side Effect

>10% Pyrexia (10-42%),Nausea (11-35%),Hypertension (14-27%),Cough (4-26%),Vomiting (12-28%),Pruritus (12-21%),Rash (2-19%),Headache (5-18%),Arthralgias (10-16%) 1-10% Arthralgia (10%),Myalgia (10%),Stomatitis (10%),Diarrhea (9%),Dizziness (9%),Edema (9%),Fatigue (9%),Weight decrease (9%),Medical device malfunction (artificial kidney clotting during dialysis) (8%),Vascular occlusion (vascular access thrombosis) (8%),Vomiting (8%),Asthenia (7%),Chest pain (7%),Injection-site irritation (7%),Muscle spasm (7%),Upper respiratory tract infection (URTI) (7%),Urticaria (3%),Seizures (2.5%),Pulmonary embolism (1%),Respiratory tract congestion (1%) Potentially Fatal: Hypertensive crisis with encephalopathy-like symptoms e.g. headache, confusion, generalised seizures. Thrombosis.

Interaction

Haematinics enhance efficiency. Increased dose of heparin in patients undergoing dialysis.

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