political beliefs Cupric Sulfate Injection Dosage Form: injection, solution Print this page Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Cupric Sulfate Injection, USP Rx Only STERILE, PYROGEN FREE, TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION (COPPER 0.4 mg/mL) Cupric Sulfate Injection Description Cupric Sulfate Injection, USP is a sterile, nonpyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Cupric Sulfate (Pentahydrate) 1.57 mg. It delivers elemental copper 0.4 mg/mL. The 10 mL vial is a single dose preservative free vial. Discard any unused portion. Cupric Sulfate Injection - Clinical Pharmacology Copper is essential as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin. Copper also helps maintain normal rates of red and white blood cell formation. Scorbutic type bone changes seen in infants fed exclusively with copper-poor cow s milk are believed due to decreased activity of ascorbate oxidase, a cuproenzyme. Providing copper during TPN prevents development of the following deficiency symptoms: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency. Indications and Usage for Cupric Sulfate Injection Cupric Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration helps to maintain serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. Contraindications Cupric Sulfate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis. Warnings This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Precautions Administration of copper in the absence of zinc may cause a decrease in plasma zinc levels. Periodic determinations of plasma zinc as well as copper are suggested as a guideline for subsequent copper administration. As copper is eliminated via the bile, the possibility of copper retention should be considered in patients with biliary tract obstruction. Decreasing or omitting copper supplements entirely may be necessary in such patients. Adverse Reactions The amount of copper present in Cupric Sulfate Injection, USP is very small, symptoms from copper toxicity are considered unlikely to occur. Cupric Sulfate Injection Dosage and Administration Cupric Sulfate Injection, USP provides 0.4 mg copper/mL. For the metabolically stable adult receiving TPN, the suggested additive dosage level is 0.5 to 1.5 mg copper/day. For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day. Aseptic addition of Cupric Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Copper is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN. Weekly monitoring of copper plasma levels is suggested as a guideline for subsequent administration. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Use in Pregnancy Safety for use in pregnancy has not been established. Use of copper in women of childbearing potential requires that anticipated benefits be weighed against possible hazards. Overdosage Symptoms of copper toxicity reported in the literature include prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia, and peripheral edema. D-pencillamine has been reported effective as an antidote. Symptoms of overdosage from copper given at 1.5 mg/day are considered unlikely. How is Cupric Sulfate Injection Supplied Cupric Sulfate Injection, USP (0.4 mg/mL) NDC 0517-6210-25 10 Ml SDV packed in a box of 25 Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN6210 Rev. 1/09 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL 10 mL Carton CUPRIC SULFATE INJECTION, USP Copper 4 mg/10 mL (0.4 mg/mL) Trace Element Additive NDC 0517-6210-25 25 x 10 mL SINGLE DOSE VIALS FOR INTRAVENOUS USE AFTER DILUTION PRESERVATIVE FREE Rx Only Each mL contains: Cupric Sulfate (Pentahydrate) 1.57 mg, Water for Injection q.s. pH adjusted with Sulfuric Acid when necessary. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 CUPRIC SULFATE Cupric Sulfate Injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-6210 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPRIC SULFATE (COPPER) CUPRIC SULFATE 1.57 mg in 1 mL Inactive Ingredients Ingredient Name Strength SULFURIC ACID WATER Packaging # Item Code Package Description 1 NDC:0517-6210-25 25 VIAL, SINGLE-DOSE (VIAL) in 1 TRAY 1 10 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/30/1990 Labeler - American Regent, Inc. (622781813) Revised: 10/2011 American Regent, Inc. 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