تزریق سولفات روی

تزریق سولفات روی در بیماران بزرگسال و کودکان به عنوان منبع روی برای تغذیه تزریقی زمانی که تغذیه خوراکی یا روده ای ممکن نیست، کافی نیست یا منع مصرف دارد، نشان داده می شود. تزریق سولفات روی یک عنصر کمیاب است که در بیماران بزرگسال و کودکان به عنوان منبع روی برای تغذیه تزریقی در زمانی که تغذیه خوراکی یا روده ای امکان پذیر نیست، کافی نیست یا منع مصرف دارد، نشان داده می شود. (1)

تزریق سولفات روی، USP: 10 میلی گرم در 10 میلی لیتر (1 میلی گرم در میلی لیتر) روی به عنوان محلول شفاف و بی رنگ در یک ویال بسته بندی فله داروخانه 10 میلی لیتری. 30 میلی گرم در 10 میلی لیتر (3 میلی گرم بر میلی لیتر) روی به عنوان محلول شفاف و بی رنگ در ویال بسته بندی فله داروخانه 10 میلی لیتری. 25 میلی‌گرم/5 میلی‌لیتر (5 میلی‌گرم/میلی‌لیتر) روی به‌عنوان محلول شفاف و بی‌رنگ در ویال بسته‌بندی فله داروخانه‌ای 5 میلی‌لیتری. تزریق سولفات روی، USP: 10 میلی‌گرم در 10 میلی‌لیتر (1 میلی‌گرم بر میلی‌لیتر) روی به‌عنوان ویال بسته‌بندی فله داروخانه. (3) 30 میلی گرم در 10 میلی لیتر (3 میلی گرم بر میلی لیتر) روی به عنوان ویال بسته بندی فله داروخانه. (3)

تزریق سولفات روی در بیماران با حساسیت مفرط شناخته شده به روی منع مصرف دارد [به هشدارها و اقدامات احتیاطی (5.6) مراجعه کنید]. حساسیت شناخته شده به روی. ( 4 , 5.6 )

No zinc-related adverse reactions have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered parenteral nutrition solutions containing zinc sulfate within the recommended dosage range. The following were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Adverse reactions with other components of parenteral nutrition solutions: Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] Aluminum toxicity [see Warnings and Precautions ( 5.3 )] Adverse reactions with the use of zinc-containing products administered by other routes of administration: Copper deficiency [see Warnings and Precautions ( 5.5 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.6 )] No zinc-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing zinc within the recommended dosage range. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

There are reported cases of overdosage with intravenous zinc in parenteral nutrition: Seven adult patients received an inadvertent overdosage of 50 mg to 75 mg elemental zinc per day in parenteral nutrition solution for 26 days to 60 days; 6 of the 7 patients developed hyperamylasemia (peak amylase values of 557 Klein units to 1850 Klein units; normal: 130 to 310). Amylase was not reported in one patient. Serum zinc concentrations ranged from 310 mcg/dL to 670 mcg/dL. None of the patients developed clinical signs of pancreatitis. Five of the 7 patients died of septic complications. One adult patient died of infectious complications after receiving an inadvertent overdosage of 7.4 grams of zinc sulfate (equivalent to 1.2 grams of elemental zinc per day for 2.5 days) in parenteral nutrition solution over 60 hours. The serum zinc concentration was 4184 mcg/dL. Symptoms of zinc overdosage also included hyperamylasemia, thrombocytopenia, anemia, vomiting and diarrhea. One preterm infant born at 26 weeks gestation died of cardiac failure following a medication error in which the parenteral nutrition solution contained 330 mg/100 mL instead of 330 mcg/100 mL of zinc sulfate (overdosage of 1000-fold). Management There is no known antidote for acute zinc toxicity. Management of zinc overdosage is supportive care based on presenting signs and symptoms.

8.1 Pregnancy Risk Summary Administration of the approved recommended dose of Zinc Sulfate Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous zinc sulfate. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. Pregnant women have an increased metabolic demand for trace elements, including zinc. Parenteral nutrition with zinc should be considered if a pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.

8.2 Lactation Risk Summary Zinc is present in human milk. Administration of the approved recommended dose of Zinc Sulfate Injection in parenteral nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of zinc sulfate on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Zinc Sulfate Injection and any potential adverse effects on the breastfed infant from Zinc Sulfate Injection or from the underlying maternal condition.

8.4 Pediatric Use Zinc Sulfate Injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see Dosage and Administration ( 2.2 )] . Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Zinc Sulfate Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions ( 5.3 )] .

8.5 Geriatric Use Reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. In general, dose selection should be individualized based on the patient's clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

Risk Summary Administration of the approved recommended dose of Zinc Sulfate Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous zinc sulfate. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. Pregnant women have an increased metabolic demand for trace elements, including zinc. Parenteral nutrition with zinc should be considered if a pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake.

Zinc Sulfate Injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see Dosage and Administration ( 2.2 )] . Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Zinc Sulfate Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions ( 5.3 )] .

Reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. In general, dose selection should be individualized based on the patient's clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

Zinc Sulfate Injection, USP is a sterile, non-pyrogenic, clear, colorless, and odorless solution intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial : Each mL contains 1 mg of zinc present as 2.47 mg of zinc sulfate and water for injection q.s. 30 mg/10 mL Pharmacy Bulk Package vial : Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection q.s. 25 mg/5 mL Pharmacy Bulk Package vial : Each mL contains 5 mg of zinc present as 12.34 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of Zinc Sulfate Injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate has a molecular weight of 287.54 g/mol and a formula of ZnSO 4 ·7H 2 O. Image Image

12.1 Mechanism of Action Zinc is an essential trace element. Zinc functions as a cofactor of various enzymes including DNA polymerases, RNA polymerases, alcohol dehydrogenase, and alkaline phosphatases. Zinc is a coordinator of protein structural folding, such as folding of "Zinc finger" motif that interacts with a variety of proteins, lipids, and nucleic acids. In addition, zinc is a catalyst of essential biochemical reactions, including activation of substrates of carbonic anhydrase in erythrocyte. Also, zinc is a signaling mediator modulating multiple signaling pathways.

12.2 Pharmacodynamics Zinc sulfate exposure-response relationships and the time course of pharmacodynamic responses are unknown.

12.3 Pharmacokinetics Distribution Over 85% of total body zinc is found in skeletal muscle and bone. Other organs containing zinc are the liver, kidney, skin, brain, and heart. In blood, zinc is mainly localized within erythrocytes. Approximately 80% of serum zinc is bound to albumin and the remainder to alpha2-macroglobulin and amino acids. Elimination In adults, zinc is primarily excreted via the gastrointestinal tract and eliminated in the feces. A smaller amount of zinc is excreted via the kidneys in the urine. Urinary zinc excretion rates in very low birth weight preterm infants are relatively high in the neonatal period, and they decline to a level on a body weight basis that is similar to that of normal adults by two months of age. Additionally, endogenous zinc loss occurs from hair, skin desquamation and sweat.

Zinc is an essential trace element. Zinc functions as a cofactor of various enzymes including DNA polymerases, RNA polymerases, alcohol dehydrogenase, and alkaline phosphatases. Zinc is a coordinator of protein structural folding, such as folding of "Zinc finger" motif that interacts with a variety of proteins, lipids, and nucleic acids. In addition, zinc is a catalyst of essential biochemical reactions, including activation of substrates of carbonic anhydrase in erythrocyte. Also, zinc is a signaling mediator modulating multiple signaling pathways.

Zinc sulfate exposure-response relationships and the time course of pharmacodynamic responses are unknown.

Distribution Over 85% of total body zinc is found in skeletal muscle and bone. Other organs containing zinc are the liver, kidney, skin, brain, and heart. In blood, zinc is mainly localized within erythrocytes. Approximately 80% of serum zinc is bound to albumin and the remainder to alpha2-macroglobulin and amino acids. Elimination In adults, zinc is primarily excreted via the gastrointestinal tract and eliminated in the feces. A smaller amount of zinc is excreted via the kidneys in the urine. Urinary zinc excretion rates in very low birth weight preterm infants are relatively high in the neonatal period, and they decline to a level on a body weight basis that is similar to that of normal adults by two months of age. Additionally, endogenous zinc loss occurs from hair, skin desquamation and sweat.

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Zinc Sulfate Injection: Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] Aluminum toxicity [see Warnings and Precautions ( 5.3 )] Copper deficiency [see Warnings and Precautions ( 5.5 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.6 )] Manufactured by: Zydus Lifesciences Ltd. Vadodara - 391510, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 06/23