Package insert / product label
Dosage form: injection, solution
Drug class: Minerals and electrolytes

Medically reviewed by Drugs.com. Last updated on Jan 1, 2023.

Indications and Usage for Zinc Sulfate Injection

Zinc Sulfate Injection is 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.

Zinc Sulfate Injection Dosage and Administration

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 mOsmol/L or greater must be infused through a central catheter [see Warnings and Precautions (5.2)].

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.

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 Fresenius Kabi USA, LLC. 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:
  • Precipitates have not formed during mixing or addition on additives.
  • 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.
  • 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) (25ºC/77ºF) 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 2ºC to 8ºC (36ºF to 46ºF) and limited to a period of time no longer than 9 days. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Discard any remaining admixture.
• Protect the admixed parenteral nutrition solution from light.

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.

Recommended Dosage and Monitoring in Adult and Pediatric Patients

• Zinc Sulfate Injection provides 1 mg/mL, 3 mg/mL, or 5 mg/mL of zinc.
• Zinc Sulfate Injection in a concentration of 1 mg/mL is recommended for use in pediatric patients, particularly those weighing less than 12 kg.
• 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.

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.

Dosage Forms and Strengths

Zinc Sulfate Injection, USP:

• 10 mg per10 mL (1 mg per mL) of zinc as a clear, colorless solution in a 10 mL Pharmacy Bulk Package vial.
• 30 mg per 10 mL (3 mg per mL) of zinc as a clear, colorless solution in a 10 mL Pharmacy Bulk Package vial.
• 25 mg per 5 mL (5 mg per mL) of zinc as a clear, colorless solution in a 5 mL Pharmacy Bulk Package vial.

Contraindications

Zinc Sulfate Injection is contraindicated in patients with known hypersensitivity to zinc [see Warnings and Precautions (5.6)]

Warnings and Precautions

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.

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.

In addition, consider the osmolarity of the final parenteral nutrition solution in determining peripheral versus central administration. Solutions with an osmolarity of 900 mOsmol/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.

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)].

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)].

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.

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 insulin product. If hypersensitivity reactions occur, discontinue Zinc Sulfate Injection and initiate appropriate medical treatment [see Contraindications (4)].

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)]
• 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)]

USE IN SPECIFIC POPULATIONS

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.

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.

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)].

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.

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.

Zinc Sulfate Injection Description

Zinc Sulfate Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition.

10 mg per 10 mL Pharmacy Bulk Package vial:

Each mL contains 1 mg of zinc present as a 2.46 mg of zinc sulfate and water for injection, q.s.

30 mg per 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 per 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.

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, USP has a molecular weight of 287.54 g/mol and a formula of ZnSO4·7H2O.

Zinc Sulfate Injection - Clinical Pharmacology

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.

Pharmacodynamics

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

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.

How Supplied/Storage and Handling

Zinc Sulfate Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles supplied as:

The container closure is not made with natural rubber latex.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

For storage of admixed solution see Dosage and Administration (2.3).

Discard unused portion.

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)]

Lake Zurich, IL 60047
www.fresenius-kabi.com/us
451762A

PRINCIPAL DISPLAY PANEL - 1 mg/mL Vial Label

NDC 65219-401-00

Zinc Sulfate

Injection, USP STERILE

10 mg* per 10 mL

(1 mg* per mL) of zinc

For intravenous use after

dilution and admixing.

10 mL

PHARMACY BULK PACKAGE -

NOT FOR DIRECT INFUSION

Rx only

PRINCIPAL DISPLAY PANEL - 1 mg/mL Tray Label

NDC 65219-401-01 405001

Zinc Sulfate

Injection, USP STERILE

10 mg* per 10 mL

(1 mg* per mL) of zinc

For intravenous use after

dilution and admixing.

25 x 10 mL Vials

PHARMACY BULK PACKAGE -

NOT FOR DIRECT INFUSION

Rx only

PRINCIPAL DISPLAY PANEL - 3mg/mL Vial Label

NDC 65219-403-01

Zinc Sulfate

Injection, USP STERILE

30 mg* per 10 mL

(3 mg* per mL) of zinc

For intravenous use after

dilution and admixing.

10 mL

PHARMACY BULK PACKAGE -

NOT FOR DIRECT INFUSION

Rx only

PRINCIPAL DISPLAY PANEL – 3mg/mL Tray Label

NDC 65219-403-03 405003

Zinc Sulfate

Injection, USP STERILE

30 mg* per 10 mL

(3 mg* per mL) of zinc

For intravenous use after

dilution and admixing

25 x 10 mL Vials

PHARMACY BULK PACKAGE-

NOT FOR DIRECT INFUSION

Rx only

PRINCIPAL DISPLAY PANEL – 5mg/mL Vial Label

NDC 65219-405-02

Zinc Sulfate

Injection, USP STERILE

25 mg* per 5 mL

(5 mg* per mL) of zinc

For intravenous use after

dilution and admixing

5mL

PHARMACY BULK PACKAGE-

NOT FOR DIRECT INFUSION

Rx only

PRINCIPAL DISPLAY PANEL – 5mg/mL Tray Label

NDC 65219-405-05 405005

Zinc Sulfate

Injection, USP STERILE

25 mg* per 5 mL

(5 mg* per mL) of zinc

For intravenous use after

dilution and admixing

25 x 5 mL Vials

PHARMACY BULK PACKAGE-

NOT FOR DIRECT INFUSION

Rx only

Frequently asked questions

• What are the best zinc-rich foods to eat?

Medical Disclaimer

Zinc supplement

Commonly used brand name(s)

In the U.S.

• Galzin
• M2 Zinc 50
• Orazinc 110
• Orazinc 220
• Zinc-220
• Zinc Chelated
• Zn Plus Protein

In Canada

• Prostavan

Available Dosage Forms:

• Capsule
• Tablet
• Tablet, Chewable

Uses for zinc supplement

Zinc supplements are used to prevent or treat zinc deficiency.

The body needs zinc for normal growth and health. For patients who are unable to get enough zinc in their regular diet or who have a need for more zinc, zinc supplements may be necessary. They are generally taken by mouth but some patients may have to receive them by injection.

Zinc supplements may be used for other conditions as determined by your health care professional.

Lack of zinc may lead to poor night vision and wound-healing, a decrease in sense of taste and smell, a reduced ability to fight infections, and poor development of reproductive organs.

• Acrodermatitis enteropathica (a lack of absorption of zinc from the intestine)
• Alcoholism
• Burns
• Type 2 diabetes mellitus
• Down''s syndrome
• Eating disorders
• Intestine diseases
• Infections (continuing or chronic)
• Kidney disease
• Liver disease
• Pancreas disease
• Sickle cell disease
• Skin disorders
• Stomach removal
• Stress (continuing)
• Thalassemia
• Trauma (prolonged)

In addition, premature infants may need additional zinc.

Increased need for zinc should be determined by your health care professional.

Claims that zinc is effective in preventing vision loss in the elderly have not been proven. Zinc has not been proven effective in the treatment of porphyria.

Injectable zinc is given by or under the supervision of a health care professional. Other forms of zinc are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Zinc is found in various foods, including lean red meats, seafood (especially herring and oysters), peas, and beans. Zinc is also found in whole grains; however, large amounts of whole-grains have been found to decrease the amount of zinc that is absorbed. Additional zinc may be added to the diet through treated (galvanized) cookware. Foods stored in uncoated tin cans may cause less zinc to be available for absorption from food.

The daily amount of zinc needed is defined in several different ways.

For U.S.—
• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person''s age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for zinc are generally defined as follows:

Before using zinc supplement

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. There is some evidence that the elderly may be at risk of becoming deficient in zinc due to poor food selection, decreased absorption of zinc by the body, or medicines that decrease absorption of zinc or increase loss of zinc from the body.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. There is evidence that low blood levels of zinc may lead to problems in pregnancy or defects in the baby. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breastfeeding

It is important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amygdalin
• Baloxavir Marboxil
• Bictegravir
• Deferoxamine
• Dolutegravir
• Eltrombopag
• Elvitegravir
• Raltegravir

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Copper deficiency—Zinc supplements may make this condition worse.

Proper use of zinc supplement

Zinc supplements are most effective if they are taken at least 1 hour before or 2 hours after meals. However, if zinc supplements cause stomach upset, they may be taken with a meal. You should tell your health care professional if you are taking your zinc supplement with meals.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor''s orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, lozenges, tablets, extended-release tablets):
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes (Note that the normal daily recommended intakes are expressed as an actual amount of zinc. The dosage form [e.g., zinc gluconate, zinc sulfate] has a different strength):
    For the U.S
    • Adult and teenage males—15 milligrams (mg) per day.
    • Adult and teenage females—12 mg per day.
    • Pregnant females—15 mg per day.
    • Breast-feeding females—16 to 19 mg per day.
    • Children 4 to 10 years of age—10 mg per day.
    • Children birth to 3 years of age—5 to 10 mg per day.
    For Canada
    • Adult and teenage males—9 to 12 mg per day.
    • Adult and teenage females—9 mg per day.
    • Pregnant females—15 mg per day.
    • Breast-feeding females—15 mg per day.
    • Children 7 to 10 years of age—7 to 9 mg per day.
    • Children 4 to 6 years of age—5 mg per day.
    • Children birth to 3 years of age—2 to 4 mg per day.
  • To treat deficiency:
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.

Missed dose

If you miss a dose of zinc supplement, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss taking zinc supplements for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in zinc. However, if your health care professional has recommended that you take zinc, try to remember to take it as directed every day.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions while using zinc supplement

When zinc combines with certain foods it may not be absorbed into your body and it will do you no good. If you are taking zinc, the following foods should be avoided or taken 2 hours after you take zinc:

• Bran
• Fiber-containing foods
• Phosphorus-containing foods such as milk or poultry
• Whole-grain breads and cereals

Do not take zinc supplements and copper, iron, or phosphorus supplements at the same time. It is best to space doses of these products 2 hours apart, to get the full benefit from each dietary supplement.

Zinc supplement side effects

Along with its needed effects, a dietary supplement may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Chills
• continuing ulcers or sores in mouth or throat
• fever
• heartburn
• indigestion
• nausea
• sore throat
• unusual tiredness or weakness

Symptoms of overdose

• Chest pain
• dizziness
• fainting
• shortness of breath
• vomiting
• yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer