HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to use
`ZINC SULFATE INJECTION safely and effectively. See full
`prescribing information for ZINC SULFATE INJECTION.
`
`ZINC SULFATE INJECTION, for intravenous use
`Initial U.S. Approval: 1957
`
`-------iNDICATIONS AND USAGE-----(cid:173)
`Zinc Sulfate Injection is a trace element indicated in adult and pediatric
`patients as a source of zinc for parenteral nutrition when oral or enteral
`nutrition is not possible, insufficient, or contraindicated. (1)
`
`------tDOSAGE AND ADMINISTRATION-----
`• Pharmacy Bulk Package. Not for direct intravenous infusion. (2.1)
`• See full prescribing information for information on preparation,
`administration, and general dosing considerations. (2.1, 2.2, 2.3, 2.4)
`
`Recommended Dosage and Monitoring (2.5)
`• Zinc Sulfate Injection provides 3 mg/ml or 5 mg/ml of zinc.
`• Individualize the dosage based upon the patient's clinical condition,
`nutritional requirements, and the contribution of oral or enteral zinc
`intake.
`
`is 3 mg/day for
`o Adults: The recommended adult dosage
`metabolically stable patients, with potential need for a higher daily
`dosage in monitored patients with small bowel fluid loss or excess
`stool or ileostomy output.
`
`o Pediatrics: The recommended dosage in pediatric patients is
`shown by age and estimated weight. The dosages in the table
`are general recommendations intended for most pediatric
`patients. However, based on clinical requirements, some
`patients may require a higher dosage.
`
`Population
`
`Estimated Weight for
`Age
`
`Pediatric Patients
`
`10 kg and above
`
`Recommended
`Daily
`Dosage
`50 mcg/kg
`(uo to 3 mo/davl
`100 mco/ko
`250 mca/ka*
`400 mcg/kg
`
`k
`5 o to less than 10 ko
`3 kg to less than 5 kg
`Less than 3 kg
`
`Term Neonates
`Preterm
`Neonates
`*Term neonates have higher requirements in the first 3 months of life
`
`• Monitor zinc concentrations and signs and symptoms of zinc
`deficiency, especially in pediatric patients, during treatment. Zinc
`concentrations may vary depending on the assay used and the
`
`laboratory reference range. The collection, processing, and storage
`of the blood samples for zinc analysis should be performed according
`to the laboratory's sample requirements. Zinc concentrations in
`hemolyzed samples are falsely elevated due to release of zinc from
`erythrocytes. The lower end of the reported range in healthy adults
`in serum is 60 mcg/dL.
`-----DOSAGE FORMS AND STRENGTHS----(cid:173)
`Zinc Sulfate Injection, USP:
`• 30 mg/10 ml (3 mg/ml) of zinc as a Pharmacy Bulk Package vial.
`(3)
`• 25 mg/5 ml (5 mg/ml) of zinc as a Pharmacy Bulk Package vial. (3)
`
`---------\.ONTRAINDICATIONS------(cid:173)
`• Known hypersensitivity to zinc. (4, 5.6)
`
`------WARNINGS AND PRECAUTIONS-----
`• Pulmonary Embolism due to Pulmonary Vascular Precipitates: If
`signs of pulmonary distress occur, stop the infusion and initiate a
`medical evaluation. (5.1)
`• Vein Damage and Thrombosis: Solutions with osmolarity of 900
`mOsm/L or more must be infused through a central catheter. (2.1,
`5.2)
`
`• Aluminum Toxicity: Increase risk in patients with renal impairment,
`including preterm infants (5.3, 8.4)
`• Monitoring and Laboratory Tests: Monitor fluid and electrolyte status,
`serum osmolarity, blood glucose, liver and kidney function, blood
`count and coagulation parameters throughout treatment. (5.4, 2.4)
`• Copper Deficiency: If signs and symptoms develop, interrupt
`treatment with Zinc Sulfate Injection and check zinc, copper, and
`seruloplasimceruloplasmin levels. (5.5)
`• Hypersensitivity Reactions: If reactions occur, discontinue Zinc
`Sulfate Injection and initiate appropriate medical treatment. (5.6)
`
`-------ADVERSE REACTIONS------(cid:173)
`No zinc-related adverse reactions in patients receiving intravenously
`administered parenteral nutrition solutions containing zinc within the
`(6)
`recommended dosage range.
`
`To report SUSPECTED ADVERSE REACTIONS, American Regent,
`or FDA at 1
`Inc. at 1-800-734-9236
`-800-FDA-1088 or
`www.fda.gov/medwatch.
`
`See 17 for PATIENT COUNSELING INFORMATION.
`
`Revised: 07/2019
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`1
`2
`
`INDICATIONS AND USAGE
`DOSAGE AND ADMINISTRATION
`2.1 Important Administration Information
`2.2 Preparation and Administration Instructions
`2.3 Preparation Instructions for Admixing Using a Parenteral
`Nutrition Container
`2.4 Dosing Considerations
`2.5 Recommended Dosage and Monitoring in Adult and Pediatric
`Patients
`3 DOSAGE FORMS AND STRENGTHS
`4 CONTRAINDICATIONS
`5 WARNINGS AND PRECAUTIONS
`5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates
`5.2 Vein Damage and Thrombosis
`5.3 Aluminum Toxicity
`5.4 Monitoring and Laboratory Tests
`5.5 Copper Deficiency
`5.6 Hypersensitivity Reactions
`
`6 ADVERSE REACTIONS
`8 USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`8.2 Lactation
`8.4 Pediatric Use
`8.5 Geriatric Use
`10 OVERDOSAGE
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`12.2 Pharmacodynamics
`12.3 Pharmacokinetics
`14 CLINICAL STUDIES
`16 HOW SUPPLIED/STORAGE AND HANDLING
`
`*Sections or subsections omitted from the full
`prescribing information are not listed.
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`FULL PRESCRIBING INFORMATION
`
`1
`
`INDICATIONS AND USAGE
`
`Zinc Sulfate Injection is indicated in adults and pediatric patients as a source of zinc for parenteral
`nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
`
`2
`
`DOSAGE AND ADMINISTRATION
`
`2.1 Important Administration Information
`
`Zinc Sulfate Injection is supplied as a pharmacy bulk package for admixing use only. It is not for
`direct intravenous infusion. Prior to administration, Zinc Sulfate Injection must be transferred to a
`separate parenteral nutrition container, diluted and used as an admixture in parenteral nutrition
`solutions.
`
`The final parenteral nutrition solution is for intravenous infusion into a central or peripheral vein. The
`choice of a central or peripheral venous route should depend on the osmolarity of the final infusate.
`Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see
`Warnings and Precautions (5.2)].
`
`2.2 Preparation and Administration Instructions
`
`• Zinc Sulfate Injection is not for direct intravenous infusion. Prior to administration, Zinc
`Sulfate Injection must be prepared and used as an admixture in parenteral nutrition solutions.
`
`• Zinc Sulfate Injection is to be prepared only in a suitable work area such as a laminar flow
`hood (or an equivalent clean air compounding area). The key factor in the preparation is
`careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions
`and addition of other nutrients.
`
`• Visually inspect the diluted parenteral nutrition solution containing Zinc Sulfate Injection for
`particulate matter before admixing, after admixing, and prior to administration. The solution
`should be clear and there should be no precipitates. A slight yellow color does not alter the
`quality and efficacy of this product.
`
`2.3 Preparation Instructions for Admixing Using a Parenteral Nutrition Container
`
`•
`
`Inspect Zinc Sulfate Injection Bulk Pharmacy Package for particulate matter.
`
`• Transfer Zinc Sulfate Injection to the parenteral nutrition container following the admixture of
`amino acids, dextrose, lipid emulsion (if added), and electrolytes solutions.
`
`• Because additives may be incompatible, evaluate all additions to the parenteral nutrition
`container for compatibility and stability of the resulting preparation. Consult with pharmacist,
`if available. Questions about compatibility may be directed to American Regent. If it is
`deemed advisable to introduce additives to the parenteral nutrition container, use aseptic
`technique.
`
`•
`
`Inspect the final parenteral nutrition solution containing Zinc Sulfate Injection to ensure that:
`o Precipitates have not formed during mixing or addition on additives.
`o The emulsion has not separated, if lipid emulsion has been added. Separation of the
`emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish
`droplets in the admixed emulsion.
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`o Discard if any precipitates are observed.
`
`Stability and Storage
`
`• Penetrate vial closure only one time with a suitable sterile transfer device or dispensing set
`that allows measured dispensing of the contents.
`
`• Use Zinc Sulfate Injection for admixing promptly once the sterile transfer set has been
`inserted into the Pharmacy Bulk Package container or not more than 4 hours at room
`temperature 20°C to 25°C (68°F to 77°F) (25°C/77°F) after the container closure has been
`penetrated. Discard any remaining drug.
`
`• Use parenteral nutrition solutions containing Zinc Sulfate Injection promptly after mixing. Any
`storage of the admixture should be under refrigeration from 2°C to 8°C (36°F to 46°F) and
`limited to a brief period of time, no longer than 24 hours. After removal from refrigeration, use
`promptly and complete the infusion within 24 hours. Discard any remaining admixture.
`
`• Protect the parenteral nutrition solution from light during storage.
`
`2.4 Dosing Considerations
`
`• The dosage of the final parenteral nutrition solution containing Zinc Sulfate Injection must
`be based on the concentrations of all components in the solution and the recommended
`daily nutritional requirements [see Dosage and Administration (2.5)]. Consult the prescribing
`information of all added components
`to determine
`the
`recommended nutritional
`requirements for dextrose and lipid emulsion, as applicable.
`
`• Prior to administration of parenteral nutrition solution containing Zinc Sulfate Injection,
`correct severe fluid, electrolyte and acid-base disorders.
`
`2.5 Recommended Dosage and Monitoring in Adult and Pediatric Patients
`
`• Zinc Sulfate Injection provides 3 mg/ml or 5 mg/ml of zinc.
`
`• The dosage of Zinc Sulfate Injection should be individualized based on the patient's clinical
`condition, nutritional requirements, and the contribution of oral or enteral zinc intake.
`
`Adults
`
`The recommended adult dosage is 3 mg/day for metabolically stable patients, with potential
`need for a higher daily dosage in monitored patients with small bowel fluid loss or excess stool
`or ileostomy output.
`
`Pediatric Patients
`
`The recommended pediatric dosage is shown in Table 1 by age and estimated weight. The
`dosages in Table 1 are general recommendations intended for most pediatric patients. However,
`based on clinical requirements, some patients may require a higher dosage.
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`Table 1: Recommended Dosage of Zinc Sulfate Injection for Pediatric Patients by Age
`and Estimated Weight
`
`Population
`Pediatric patients
`
`Estimated Weight for Age Recommended Daily Dosage
`10 kg and above
`50 mcg/kg (up to 3 mg/day)
`
`5 kg to less than 1 0 kg
`3 kg to less than 5 kg
`Less than 3 kg
`
`100 mcg/kg
`
`250 mcg/kg*
`
`400 mcg/kg
`
`Term neonates
`
`Preterm neonates
`*Term
`
`neonates have higher requirements in the first 3 months of life
`
`Monitoring
`Monitor zinc concentrations during treatment. Also monitor patients clinically for signs and symptoms
`of zinc deficiency, especially in pediatrics. Zinc concentrations may vary depending on the assay
`used and the laboratory reference range. The collection, processing, and storage of the blood
`samples for zinc analysis should be performed according to the laboratory's sample requirements.
`Zinc concentrations in hemolyzed samples are falsely elevated due to release of zinc from
`erythrocytes. The lower end of the reported range in healthy adults in serum is 60 mcg/dl.
`
`3 DOSAGE FORMS AND STRENGTHS
`
`Zinc Sulfate Injection, USP:
`
`• 30 mg/10 ml (3 mg/ml) of zinc as a clear, colorless solution in a 10 ml Pharmacy Bulk
`Package vial.
`• 25 mg/5 ml (5 mg/ml) of zinc as a clear, colorless solution in a 5 ml Pharmacy Bulk
`Package vial.
`
`4 CONTRAINDICATIONS
`
`Zinc Sulfate Injection is contraindicated in patients with known hypersensitivity to zinc [see
`Warnings and Precautions (5.6)].
`
`5 WARNINGS AND PRECAUTIONS
`
`5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates
`
`Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have
`been reported in patients receiving parenteral nutrition. The cause of precipitate formation has not
`been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result
`of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line
`filter; in vivo precipitate formation may also have occurred. If signs of pulmonary distress occur, stop
`the parenteral nutrition infusion and initiate a medical evaluation. In addition to inspection of the
`solution [see Dosage and Administration (2.2, 2.3)], the infusion set and catheter should also
`periodically be checked for precipitates.
`
`5.2 Vein Damage and Thrombosis
`
`Zinc Sulfate Injection has a low pH and must be prepared and used as an admixture in parenteral
`nutrition solutions. It is not for direct intravenous infusion.
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`In addition, consider the osmolarity of the final parenteral nutrition solution in determining peripheral
`versus central administration. Solutions with an osmolarity of 900 mOsm/L or greater must be infused
`through a central catheter [see Dosage and Administration (2. 1 )]. The infusion of hypertonic nutrient
`solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The
`primary complication of peripheral access is venous thrombophlebitis, which manifests as pain,
`erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis
`develops.
`
`5.3 Aluminum Toxicity
`
`Zinc Sulfate Injection contains aluminum that may be toxic.
`
`Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is
`impaired. Preterm infants are particularly at risk for aluminum toxicity because the kidneys are
`immature, and they require large amounts of calcium and phosphate solutions, which also contain
`aluminum.
`
`Patients with impaired kidney function, including preterm infants, who receive greater than 4 to 5
`mcg/kg/day of parenteral aluminum can accumulate aluminum at levels associated with central
`nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
`
`Exposure to aluminum from Zinc Sulfate Injection is not more than 0.6 mcg/kg/day. When
`prescribing Zinc Sulfate Injection for use in parenteral nutrition containing other small volume
`parenteral products, the total daily patient exposure to aluminum from the admixture should be
`considered and maintained at no more than 5 mcg/kg/day [see Use in Specific Populations (8.4)].
`
`5.4 Monitoring and Laboratory Tests
`
`Monitor zinc concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and
`kidney function, blood count and coagulation parameters throughout treatment [see Dosage and
`Administration (2.4)].
`
`5.5 Copper Deficiency
`
`Several post-marketing cases have reported that high doses of supplemental zinc (approximately
`10 times the recommended dosage of 3 mg/day Zinc Sulfate Injection in adults) taken over extended
`periods of time (i.e., months to years) may result in decreased enteral copper absorption and copper
`deficiency. The cases reported the following complications of copper deficiency: anemia,
`leukopenia, thrombocytopenia, myeloneuropathy, and nephrotic-range proteinuria [see Adverse
`Reactions (6)].
`
`If a patient develops signs and symptoms of copper deficiency during treatment with Zinc Sulfate
`Injection, interrupt zinc treatment and check zinc, copper, and ceruloplasmin levels. Copper
`deficiency should be treated with supplemental copper administration and discontinuation of zinc
`supplementation.
`
`5.6 Hypersensitivity Reactions
`
`Hypersensitivity reactions to subcutaneously administered zinc-containing insulin products were
`identified in postmarketing case reports. Reported reactions included injection site induration,
`erythema, pruritus, papular rash, generalized urticaria, facial swelling, and dyspnea. Patients did
`not manifest symptoms after changing to zinc-free insulin or another insulin product with a reduced
`amount of zinc. In some cases, allergy testing confirmed the allergy to the zinc component of the
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`If hypersensitivity reactions occur, discontinue Zinc Sulfate Injection and initiate
`insulin product.
`appropriate medical treatment [see Contraindications (4)].
`
`6 ADVERSE REACTIONS
`
`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)1
`• 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)]
`
`8 USE IN SPECIFIC POPULATIONS
`
`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
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`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
`In general, dose selection should be
`requirements between elderly and younger patients.
`individualized based on the patient's clinical condition, nutritional requirements, and additional
`nutritional intake provided orally or enterally to the patient.
`
`10 OVERDOSAGE
`
`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 to 60 days; 6 of the 7 patients developed
`hyperamylasemia (peak amylase values of 557 to 1850 Klein units; normal: 130 to 310).
`Amylase was not reported in one patient. Serum zinc concentrations ranged from 310 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.
`
`11 DESCRIPTION
`
`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.
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`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 12.32 mg of zinc sulfate and Water for Injection q.s.
`
`Both presentations do not contain preservatives free.
`
`The pH range is 2 to 4; pH may be adjusted with sulfuric acid.
`
`Zinc Sulfate Injection contains no more than 2,500 mcg/l of aluminum and has a calculated
`osmolarity of 96.5 mOsmol/l for 3 mg/ml and 157 .2 mOsmol/l for 5 mg/ml.
`
`Zinc sulfate heptahydrate has a molecular weight of 287.56 g/mol and a formula of ZnSO4• 7H2O.
`
`H
`' -o
`
`H~O
`H
`I
`H
`'
`zn•
`,0
`-o O H
`,,
`,s'o-
`H 0 1
`I Q
`H
`H
`0 - H:
`
`\
`
`12 CLINICAL PHARMACOLOGY
`
`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
`c finger” motif that interacts with a
`coordinator of protein structural folding, such as folding of "Zin
`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.
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`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.
`
`16 HOW SUPPLIED/STORAGE AND HANDLING
`
`Zinc Sulfate Injection, USP is a clear, colorless solution supplied as:
`
`• 30 mg/10 ml (3 mg/ml) of zinc in a 10 ml Pharmacy Bulk Package vial. Cartons of 25 vials
`(NOC 0517-6103-25)
`• 25 mg/5 ml (5 mg/ml) of zinc in a 5 ml Pharmacy Bulk Package vial. Cartons of 25 vials
`(NOC 0517-8005-25)
`
`Vial closure is not made with natural rubber latex.
`Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F)
`[see USP
`Controlled Room Temperature]
`
`For storage of admixed solution see Dosage and Administration (2.3)
`
`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)]
`
`AMERICAN
`REGENT, INC.
`SHIRLEY, NY 11967
`
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