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EPOGEN
Overview
What is EPOGEN?
Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin.
Epogen (epoetin alfa) injection for intravenous or subcutaneous administration is formulated as a sterile, clear, colorless liquid in vials in multiple formulations. Single-dose vials, formulated with an isotonic sodium chloride/sodium citrate-buffered solution, are supplied in multiple strengths. Each single-dose 1 mL vial contains 2,000, 3,000, 4,000, or 10,000 Units of epoetin alfa, Albumin (Human) (2.5 mg), citric acid (0.06 mg), sodium chloride (5.9 mg), and sodium citrate (5.8 mg) in Water for Injection, USP (pH 6.9 ± 0.3). Multiple-dose, 2 mL vials contain 10,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg) per 1 mL Water for Injection, USP (pH 6.1 ± 0.3). Multiple-dose 1 mL vials contain 20,000 Units epoetin alfa, albumin (human) (2.5 mg), benzyl alcohol (1%), sodium chloride (8.2 mg), citric acid (0.11 mg), and sodium citrate (1.3 mg), per 1 mL in Water for Injection, USP (pH 6.1 ± 0.3).
What does EPOGEN look like?
What are the available doses of EPOGEN?
Injection:
○ 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL of Epogen as a clear and colorless liquid in single-dose vials
○ 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units /mL of Epogen as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol).
What should I talk to my health care provider before I take EPOGEN?
How should I use EPOGEN?
Epogen is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.
Evaluation of Iron Stores and Nutritional Factors
Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.
Monitoring of Response to Therapy
Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Epogen. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. .
Selection of Formulation
In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation)
What interacts with EPOGEN?
Sorry No Records found
What are the warnings of EPOGEN?
Sorry No Records found
What are the precautions of EPOGEN?
Sorry No Records found
What are the side effects of EPOGEN?
Sorry No records found
What should I look out for while using EPOGEN?
Epogen is contraindicated in patients with:
Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in:
Chronic Kidney Disease:
Cancer:
Perisurgery:
What might happen if I take too much EPOGEN?
Epogen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Epogen dosage and/or with phlebotomy, as clinically indicated
Cases of severe hypertension have been observed following overdose with ESAs
How should I store and handle EPOGEN?
Store TEMODAR Capsules at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].Store TEMODAR for Injection refrigerated at 2–8°C (36–46°F). After reconstitution, store reconstituted product at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.Store TEMODAR Capsules at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].Store TEMODAR for Injection refrigerated at 2–8°C (36–46°F). After reconstitution, store reconstituted product at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation):Preserved, multiple-dose vial:Preserved, multiple-dose vial:Store at 36F to 46F (2C to 8C). Do not freeze.Do not shake. Do not use Epogen that has been shaken or frozen.Store Epogen vials in the original carton until use to protect from light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Epogen stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
Non-Clinical Toxicology
Epogen is contraindicated in patients with:Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in:
Chronic Kidney Disease:
Cancer:
Perisurgery:
Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.
The design and overall results of the 3 large trials comparing higher and lower hemoglobin targets are shown in Table 1.
Patients with
Chronic
Kidney Disease
Normal Hematocrit Study (NHS): A prospective, randomized, open-label study of 1265 patients with chronic kidney disease on dialysis with documented evidence of congestive heart failure or ischemic heart disease was designed to test the hypothesis that a higher target hematocrit (Hct) would result in improved outcomes compared with a lower target Hct. In this study, patients were randomized to epoetin alfa treatment targeted to a maintenance hemoglobin of either 14 ± 1 g/dL or 10 ± 1 g/dL. The trial was terminated early with adverse safety findings of higher mortality in the high hematocrit target group. Higher mortality (35% vs. 29%) was observed for the patients randomized to a target hemoglobin of 14 g/dL than for the patients randomized to a target hemoglobin of 10 g/dL. For all-cause mortality, the HR=1.27; 95% CI (1.04, 1.54); p=0.018. The incidence of nonfatal myocardial infarction, vascular access thrombosis, and other thrombotic events was also higher in the group randomized to a target hemoglobin of 14 g/dL.
CHOIR: A randomized, prospective trial, 1432 patients with anemia due to CKD who were not undergoing dialysis and who had not previously received epoetin alfa therapy were randomized to epoetin alfa treatment targeting a maintenance hemoglobin concentration of either 13.5 g/dL or 11.3 g/dL. The trial was terminated early with adverse safety findings. A major cardiovascular event (death, myocardial infarction, stroke, or hospitalization for congestive heart failure) occurred in 125 of the 715 patients (18%) in the higher hemoglobin group compared to 97 of the 717 patients (14%) in the lower hemoglobin group [hazard ratio (HR) 1.34, 95% CI: 1.03, 1.74; p = 0.03].
TREAT: A randomized, double-blind, placebo-controlled, prospective trial of 4038 patients with: CKD not on dialysis (eGFR of 20 – 60 mL/min), anemia (hemoglobin levels ≤ 11 g/dL), and type 2 diabetes mellitus, patients were randomized to receive either darbepoetin alfa treatment or a matching placebo. Placebo group patients also received darbepoetin alfa when their hemoglobin levels were below 9 g/dL. The trial objectives were to demonstrate the benefit of darbepoetin alfa treatment of the anemia to a target hemoglobin level of 13 g/dL, when compared to a "placebo" group, by reducing the occurrence of either of two primary endpoints: (1) a composite cardiovascular endpoint of all-cause mortality or a specified cardiovascular event (myocardial ischemia, CHF, MI, and CVA) or (2) a composite renal endpoint of all-cause mortality or progression to end stage renal disease. The overall risks for each of the two primary endpoints (the cardiovascular composite and the renal composite) were not reduced with darbepoetin alfa treatment (see Table 1), but the risk of stroke was increased nearly two-fold in the darbepoetin alfa -treated group versus the placebo group: annualized stroke rate 2.1% vs. 1.1%, respectively, HR 1.92; 95% CI: 1.38, 2.68; p < 0.001. The relative risk of stroke was particularly high in patients with a prior stroke: annualized stroke rate 5.2% in the darbepoetin alfa- treated group and 1.9% in the placebo group, HR 3.07; 95% CI: 1.44, 6.54. Also, among darbepoetin alfa -treated subjects with a past history of cancer, there were more deaths due to all causes and more deaths adjudicated as due to cancer, in comparison with the control group.
Patients with Cancer
An increased incidence of thromboembolic reactions, some serious and life-threatening, occurred in patients with cancer treated with ESAs.
In a randomized, placebo-controlled study (Study 2 in Table 2 ) of 939 women with metastatic breast cancer receiving chemotherapy, patients received either weekly epoetin alfa or placebo for up to a year. This study was designed to show that survival was superior when epoetin alfa was administered to prevent anemia (maintain hemoglobin levels between 12 and 14 g/dL or hematocrit between 36% and 42%). This study was terminated prematurely when interim results demonstrated a higher mortality at 4 months (8.7% vs. 3.4%) and a higher rate of fatal thrombotic reactions (1.1% vs. 0.2%) in the first 4 months of the study among patients treated with epoetin alfa. Based on Kaplan-Meier estimates, at the time of study termination, the 12-month survival was lower in the epoetin alfa group than in the placebo group (70% vs. 76%; HR 1.37, 95% CI: 1.07, 1.75; p = 0.012).
Patients Having Surgery
An increased incidence of deep venousthrombosis (DVT) in patients receiving epoetin alfa undergoing surgical orthopedic procedures was demonstrated . In a randomized, controlled study, 680 adult patients, not receiving prophylactic anticoagulation and undergoing spinal surgery, were randomized to 4 doses of 600 Units/kg epoetin alfa (7, 14, and 21 days before surgery, and the day of surgery) and standard of care (SOC) treatment (n = 340) or to SOC treatment alone (n = 340). A higher incidence of DVTs, determined by either color flow duplex imaging or by clinical symptoms, was observed in the epoetin alfa group (16 [4.7%] patients) compared with the SOC group (7 [2.1%] patients). In addition to the 23 patients with DVTs included in the primary analysis, 19 [2.8%] patients (n = 680) experienced 1 other thrombovascular event (TVE) each (12 [3.5%] in the epoetin alfa group and 7 [2.1%] in the SOC group). Deep venous thrombosis prophylaxis is strongly recommended when ESAs are used for the reduction of allogeneic RBC transfusions in surgical patients .
Increased mortality was observed in a randomized, placebo-controlled study of Epogen in adult patients who were undergoing CABG surgery (7 deaths in 126 patients randomized to Epogen versus no deaths among 56 patients receiving placebo). Four of these deaths occurred during the period of study drug administration and all 4 deaths were associated with thrombotic events.
The following serious adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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