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Zinc Supplements (Systemic)

This monograph includes information on the following:

1) Zinc Chloride 
2) Zinc Gluconate
3) Zinc Sulfate

VA CLASSIFICATION
Primary: TN405
Secondary: AD300

Commonly used brand name(s): Orazinc2; PMS Egozinc3; Verazinc3; Zinc 153; Zinc-2203; Zinca-Pak3; Zincate3.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Nutritional supplement (mineral)—

copper absorption inhibitor—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Zinc deficiency (prophylaxis and treatment)—Zinc supplements are indicated in the prevention and treatment of zinc deficiency, which may result from inadequate nutrition or intestinal malabsorption and other conditions that interfere with zinc utilization or increase zinc losses from the body, {96} but does not occur in healthy individuals receiving an adequate balanced diet. For prophylaxis of zinc deficiency, dietary improvement, rather than supplementation, is advisable. For treatment of zinc deficiency, supplementation is preferred. {107}
—Deficiency of zinc may lead to growth retardation, hypogonadism in males, anorexia (possibly due to changes in taste and smell), depressed mental function, dermatitis, impaired wound-healing, suppressed immune function, diarrhea, and abnormal vitamin A metabolism with impaired night vision. {06} {17} {18} {23} {53}
—Recommended intakes may be increased and/or supplementation may be necessary in the following conditions (based on documented zinc deficiency):

• Alcoholism {06} {23} {24}


• Burns {05} {06} {18}


• Cirrhosis of the liver {06} {18} {23}


• Diabetes mellitus {06} {22}


• Eating disorders—anorexia nervosa, {25} {27} bulimia {27}


• Gastrectomy


• Genetic disorders {05} {06}—acrodermatitis enteropathica, Down's syndrome, sickle cell anemia, {35} thalassemia


• Hemodialysis {05} {37}


• Infants—premature {05} {06} {50}


• Infections, chronic, due to decreased immune responses {17} {18}


• Intestinal diseases—celiac, {20} Crohn's, {05} diarrhea, {17} {21} sprue, {34} ulcerative colitis {05}


• Intestinal parasitism {05} {06}


• Malabsorption syndromes associated with pancreatic insufficiency—pancreatic disease, cystic fibrosis {05} {38}


• Renal diseases—nephrotic syndrome, {05} {52} renal failure, {06} uremia {37}


• Short bowel syndrome {05} {06}


• Skin disorders—exfoliative dermatoses, psoriasis {05} {06}


• Stress, prolonged {51}


• Trauma, prolonged {18}

—Some unusual diets (e.g., reducing diets that drastically restrict food selection) may not supply minimum daily requirements of zinc. Supplementation may be necessary in patients receiving total parenteral nutrition (TPN) {33} or undergoing rapid weight loss or in those with malnutrition, because of inadequate dietary intake.
—Recommended intakes for all vitamins and most minerals are increased during pregnancy. Many physicians recommend that pregnant women receive multivitamin and mineral supplements, especially those pregnant women who do not consume an adequate diet and those in high-risk categories (i.e., women carrying more than one fetus, heavy cigarette smokers, and alcohol and drug abusers). However, taking excessive amounts of multivitamin and mineral supplements may be harmful to the mother and/or fetus and should be avoided. {60}
—There is some evidence that low serum zinc levels may lead to complications of pregnancy {70} {71} or congenital malformations. {73}
—Recommended intakes for all vitamins and most minerals are increased during breast-feeding. {02}
—Recommended intakes may be increased by the following: Folic acid, {66} {87} {88} penicillamine, {06} {45} {77} iron supplements, {28} {29} {30} {31} {32} or thiazide diuretics. {82} {89}

[Wilson's disease (treatment adjunct)]1—Zinc supplements have been used along with a reduced copper diet in the treatment of Wilson's disease in patients who are unable to tolerate penicillamine. {07} {63} {64} {65} {66} {67}

Unaccepted
A potential role for zinc in retarding the progression of age-related macular degeneration has not been proven. {61} {62} Zinc salts have not been found to be beneficial in the treatment of acute intermittent porphyria. {44}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Elemental zinc: 65.37 {49}
    Zinc chloride: 136.3 {68} {69}
    Zinc gluconate: 455.68 {69}
    Zinc sulfate: 287.5 {68}

Mechanism of action/Effect:

Nutritional supplement—Zinc is necessary for the proper functioning of over 200 metalloenzymes, including carbonic anhydrase, carboxypeptidase A, alcohol dehydrogenase, alkaline phosphatase, and RNA polymerase. {45} {47} {48} It is also required to maintain structure in nucleic acids, proteins, and cell membranes. {33} {44} Physiological functions that are zinc dependent include cell growth and division, {49} sexual maturation and reproduction, {45} {49} dark adaptation and night vision, {47} {49} wound-healing, {49} host immunity, {45} {49} taste acuity, {46} {49} and possibly olfactory acuity. {46}

Copper absorption inhibitor—Large doses of zinc inhibit the absorption of copper. {63} {75} {76}

Absorption:

Approximately 20 to 30% of dietary zinc is absorbed, {06} primarily from the duodenum and ileum. {43} {96} The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. {96}

After absorption, zinc is bound in the intestine to the protein metallothionein. {43}

Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc. {41} {43} {78}

Protein binding:

Zinc is 60% bound to albumin; 30 to 40% bound to alpha-2 macroglobulin or transferrin; and 1% bound to amino acids, primarily histidine and cysteine. {23}


Storage

Zinc is stored primarily in red and white blood cells, but also in the muscle, bone, skin, kidney, liver, pancreas, retina, and prostate. {01} {06}

Time to peak concentration:

Approximately 2 hours. {43}

Elimination:
    Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration. {01} {06}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented with intake of normal daily recommended amounts. However, adequate and well controlled studies in humans have not been done.

Studies have not been done in animals.

FDA Pregnancy Category C (parenteral zinc). {01}

Breast-feeding

Problems in humans have not been documented with intake of normal daily recommended amounts.

Pediatrics

Problems in pediatrics have not been documented with intake of normal daily recommended amounts.

Zinc injection that contains benzyl alcohol as a preservative should not be used in newborn and immature infants. The use of benzyl alcohol in neonates has been associated with a fatal toxic syndrome consisting of metabolic acidosis and CNS, respiratory, circulatory, and renal function impairment.


Geriatrics


Problems in geriatrics have not been documented with intake of normal daily recommended amounts. The elderly may be at risk of zinc deficiency due to poor food selection, decreased intestinal absorption of zinc, or medications which may decrease absorption or increase urinary loss of zinc. {79} {82} {83}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following, depending on the amount present, may also interact with zinc supplements.

» Copper supplements    (large doses of zinc may inhibit copper absorption in the intestine; zinc supplements should be taken at least 2 hours after the administration of copper supplements {07})


Diuretics, thiazide    (thiazide diuretics have been found to increase urinary zinc excretion {82} {89})


Fiber, found in bran, whole-grain breads and cereals or
Phosphorus-containing foods, such as milk or poultry or{08}{76}{84}{85}
Phytates, found in bran and whole-grain breads and cereals    (concurrent use of large amounts of fiber, phosphorus, or phytates with zinc supplements may reduce zinc absorption by formation of nonabsorbable complexes; foods containing fiber, phosphorus, or phytates should be taken at least 2 hours after zinc supplements {02} {05} {06} {08})


Folic acid    (some studies have found that folate can decrease the absorption of zinc, but not in the presence of excessive zinc; other studies have found no inhibition {76} {87} {88})


Iron supplements, oral    (large doses of iron supplements can inhibit the intestinal absorption of zinc; {28} {29} {30} {31} {32} this, at one time, was a problem in individuals taking commercial multivitamin-mineral preparations or infant formulas that had a high iron to zinc ratio {29} {31}; however, most firms in the U.S. have reformulated their products; zinc supplements should be taken at least 2 hours after iron supplements)


Penicillamine, and possibly other heavy metal chelators{77}    (concurrent use may decrease the absorption of zinc; a period of 2 hours should elapse between administration of penicillamine and zinc {06} {45})


Phosphorus-containing preparations    (concurrent use of phosphorus-containing preparations with zinc supplements may reduce zinc absorption by formation of nonabsorbable complexes; phosphorus-containing preparations should be taken 2 hours after zinc supplements {08} {76} {84} {85})


» Tetracycline, oral    (zinc salts may decrease the absorption of tetracycline by forming insoluble chelates; zinc supplements should be given 2 hours after the administration of tetracycline {41} {42})


Zinc-containing medications, other    (concurrent use with zinc supplements may increase serum zinc concentration)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Copper    (serum concentrations may be reduced with long-term, high-dose therapy with zinc)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
» Copper deficiency{01}    (zinc supplementation may induce copper deficiency or further decrease serum copper concentrations {01})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Alkaline phosphatase    (monthly monitoring in patients with zinc deficiency is recommended; {90} serum concentrations have been found to increase with zinc therapy {39} {40})


Copper    (serum copper concentrations may be decreased with prolonged zinc therapy; monthly {90} monitoring of copper may be required with long-term use {01})


High-density lipoprotein (HDL)    (serum concentrations may be decreased; monthly {90} monitoring is recommended for patients receiving high doses of zinc for long periods of time {09} {10} {11} {19})


Zinc, plasma or serum or urinary    (monthly monitoring is recommended; {90} {91} however, concentrations may not accurately reflect zinc status since plasma, serum, or urinary zinc concentrations are subject to many variables; zinc concentrations may be subject to a renal regulatory mechanism to conserve zinc; these factors should be considered when monitoring zinc status {39} {40} {41} {54})




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
—with large doses    
Gastrointestinal abnormalities, specifically dyspepsia{05} (indigestion), epigastric pain (heartburn){01}{05}, or nausea {05}
    
hematologic abnormalities, secondary to zinc-induced copper deficiency, specifically leukopenia (fever, chills, or sore throat){09}{12}{13}, neutropenia (continuing ulcers or sores in mouth or throat){09}{12}{13}, sideroblastic anemia (unusual tiredness or weakness){09}{12}{13}





Overdose
For specific information on the agents used in the management of zinc overdose, see:    • Edetate Calcium Disodium (Systemic) monograph.


For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (See Poison Control Center Listing ).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Hypotension (dizziness or fainting){55}

jaundice {55}(yellow eyes or skin)

pulmonary edema {55}(chest pain or shortness of breath)

vomiting{55}

Treatment of overdose
Dilute with milk or water. {15}



Specific treatment:
Intramuscular or intravenous edetate calcium disodium at a dose of 50 to 75 mg per kg (mg/kg) of body weight per day, in 3 to 6 divided doses, for up to 5 days. {16}



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Zinc Supplements (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Description should include function in the body, signs of deficiency, conditions that may cause zinc deficiency, and unproven uses


Importance of diet
Importance of proper nutrition; supplement may be needed because of inadequate dietary intake

Food sources of zinc; effects of processing

Recommended daily intake for zinc

Before using this dietary supplement
»   Conditions affecting use, especially:

Pregnancy—Low serum zinc levels may be associated with pregnancy complications or congenital malformations





Use in the elderly—May be at risk for zinc deficiency
Other medications or dietary supplements, especially oral copper supplements and oral tetracycline
Other medical problems, especially copper deficiency

Proper use of this dietary supplement

» Proper dosing
Taking at least 1 hour before or 2 hours after meals, unless gastrointestinal irritation develops
Missed dose: No cause for concern because of length of time necessary for depletion; remembering to take as directed

» Proper storage

Precautions while using this dietary supplement
Taking zinc supplements 2 hours before eating fiber-containing foods, such as bran or whole-grain breads and cereals or phosphorus-containing foods such as milk, or poultry

Not taking zinc supplements within 2 hours of iron, copper, or phosphorus supplements


Side/adverse effects
Signs of potential side effects, especially gastrointestinal or hematologic abnormalities


General Dosing Information
Because of the infrequency of zinc deficiency alone, combinations of several vitamins and/or minerals are commonly administered. Many commercial vitamin-mineral complexes are available.

For parenteral dosage forms only
In most cases, parenteral administration is indicated only when oral administration is not acceptable (for example, in nausea, vomiting, preoperative and postoperative conditions) or possible (for example, in malabsorption syndromes or following gastric resection).

Diet/Nutrition
Zinc supplements should be taken at least 1 hour before or 2 hours after meals, since many foods may impair the absorption of zinc. {79} {91} If gastric irritation occurs, then zinc supplements may be taken with meals; however, the zinc will be less bioavailable. {92}

Recommended dietary intakes for zinc are defined differently worldwide.


For U.S:
The Recommended Dietary Allowances (RDAs) for vitamins and minerals are determined by the Food and Nutrition Board of the National Research Council and are intended to provide adequate nutrition in most healthy persons under usual environmental stresses. In addition, a different designation may be used by the FDA for food and dietary supplement labeling purposes, as with Daily Value (DV). DVs replace the previous labeling terminology United States Recommended Daily Allowances (USRDAs). {02} {98}



For Canada:
Recommended Nutrient Intakes (RNIs) for vitamins, minerals, and protein are determined by Health and Welfare Canada and provide recommended amounts of a specific nutrient while minimizing the risk of chronic diseases. {99}

Daily recommended intakes for elemental zinc {02} are generally defined as follows:

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
5–10
2–4
4 to 6 years of age
10
5
7 to 10 years of age
10
7–9
Adolescent and adult males
15
9–12
Adolescent and adult females
12
9
Pregnant females
15
15
Breast-feeding females
16–19
15


The best sources of zinc include lean red meats, seafoods (especially herring and oysters), peas, and beans. {02} {03} {04} Zinc is found in whole-grains; however, large amounts of whole-grain foods have been found to reduce zinc absorption. {02} {05} {06} {08} Zinc has been reported to leach from galvanized cookware or storage containers in the presence of acidic foods, causing toxicity. {09} Foods stored in unlacquered tin containers may cause a decrease in zinc available for absorption. {28} {29} {36}


ZINC CHLORIDE


Parenteral Dosage Forms

Note: Injectable zinc products must be diluted prior to intravenous administration.


ZINC CHLORIDE INJECTION USP

Usual adult and adolescent dose
Deficiency (prophylaxis or treatment)
Intravenous infusion, 2.5 to 4 mg of elemental zinc a day, added to total parenteral nutrition (TPN). {01} {93}


Note: Some clinicians recommend doses as high as 12 mg per day to allow for excessive zinc losses that may occur with conditions such as diarrhea. {97}


Usual pediatric dose
Deficiency (prophylaxis or treatment)
Intravenous infusion: For full term infants and children up to 5 years of age—100 mcg of elemental zinc per kg of body weight a day, added to TPN.

For premature infants (up to 3 kg of body weight)—300 mcg of elemental zinc per kg of body weight a day, added to TPN. {01} {93}


Note: Zinc injection that contains benzyl alcohol as a preservative should not be used in newborn and immature infants. The use of benzyl alcohol in neonates has been associated with a fatal toxic syndrome consisting of metabolic acidosis and CNS, respiratory, circulatory, and renal function impairment.


Strength(s) usually available
U.S.—


1 mg of elemental zinc (2.09 mg zinc chloride) per mL (Rx)

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Preparation of dosage form:
Zinc chloride is physically compatible with amino acid solutions, dextrose solutions, and injectable vitamin preparations. {01}


ZINC GLUCONATE


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

ZINC GLUCONATE LOZENGES

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental zinc:

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
15
9–12
Adolescent and adult females
12
9
Pregnant females
15
15
Breast-feeding females
16–19
15


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.

[Copper absorption inhibitor]1
Oral, 50 mg of elemental zinc three times a day. {64} {95}


Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental zinc:

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
5–10
2–4
4 to 6 years of age
10
5
7 to 10 years of age
10
7–9


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.

[Copper absorption inhibitor]1
Oral, 22.5 to 34 mg of elemental zinc three times a day. {63} {76}


Strength(s) usually available
U.S.—


1.4 mg elemental zinc (10 mg zinc gluconate) (OTC) [Orazinc{100}{105}]

Canada—
Not commercially available.

Note: The strength of this zinc preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.


ZINC GLUCONATE TABLETS

Usual adult and adolescent dose
See Zinc Gluconate Lozenges.

Usual pediatric dose
See Zinc Gluconate Lozenges.

Strength(s) usually available
U.S.—


1.4 mg of elemental zinc (10 mg zinc gluconate) (OTC)


2 mg of elemental zinc (15 mg zinc gluconate) (OTC)


4 mg of elemental zinc (30 mg zinc gluconate) (OTC){103}


7 mg of elemental zinc (50 mg zinc gluconate) (OTC)


8 mg of elemental zinc (60 mg zinc gluconate) (OTC){103}{104}


11 mg of elemental zinc (78 mg zinc gluconate) (OTC){98}


13 mg of elemental zinc (100 mg zinc gluconate) (OTC){103}


31 mg of elemental zinc (235 mg zinc gluconate) (OTC){104}


52 mg of elemental zinc (390 mg zinc gluconate) (OTC){103}

Canada—
{57}

10 mg of elemental zinc (70 mg zinc gluconate) (OTC)


50 mg of elemental zinc (350 mg zinc gluconate) (OTC)

Note: The strength of these zinc preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.


ZINC SULFATE


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.


ZINC SULFATE CAPSULES

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental zinc:

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
15
9–12
Adolescent and adult females
12
9
Pregnant females
15
15
Breast-feeding females
16–19
15


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.

[Copper absorption inhibitor]1
Oral, 50 mg elemental zinc three times a day. {64} {95}


Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental zinc:

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
5–10
2–4
4 to 6 years of age
10
5
7 to 10 years of age
10
7–9


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.

[Copper absorption inhibitor]1
Oral, 22.5 to 34 mg elemental zinc three times a day. {63} {76}


Strength(s) usually available
U.S.—


25 mg elemental zinc (110 mg zinc sulfate) (OTC) [Orazinc]


50 mg elemental zinc (220 mg zinc sulfate) [Orazinc (OTC) (OTC)] [Verazinc (OTC) (OTC)] [Zinc-220 (OTC) (OTC)] [Zincate{98} (Rx) (Rx)][Generic] (Rx/OTC){98}

Canada—
Not commercially available.

Note: The strength of these zinc preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.


ZINC SULFATE TABLETS

Usual adult and adolescent dose
See Zinc Sulfate Capsules.

Usual pediatric dose
See Zinc Sulfate Capsules.

Strength(s) usually available
U.S.—


15 mg elemental zinc (66 mg zinc sulfate) (OTC) [Zinc 15{98}{100}]


25 mg elemental zinc (110 mg zinc sulfate) (OTC) [Orazinc{98}{100}]


45 mg elemental zinc (200 mg zinc sulfate) (Rx/OTC){98}{101}


50 mg elemental zinc (220 mg zinc sulfate) (Rx){101}

Canada—


50 mg elemental zinc (220 mg zinc sulfate) (OTC) [PMS Egozinc{99}]

Note: The strength of these zinc preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.


ZINC SULFATE EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
See Zinc Sulfate Capsules.

Usual pediatric dose
See Zinc Sulfate Capsules.

Strength(s) usually available
U.S.—


50 mg elemental zinc (220 mg zinc sulfate) (OTC){103}{106}

Canada—
Not commercially available.

Note: The strength of this zinc preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.



Parenteral Dosage Forms

ZINC SULFATE INJECTION USP

Note: Injectable zinc products must be diluted prior to intravenous administration.


Usual adult and adolescent dose
Deficiency (prophylaxis or treatment)
Intravenous infusion, 2.5 to 4 mg of elemental zinc a day, added to total parenteral nutrition (TPN). {01} {93}


Note: Some clinicians recommend doses as high as 12 mg per day to allow for excessive zinc losses that may occur with conditions such as diarrhea. {97}


Usual pediatric dose
Deficiency (prophylaxis or treatment)
Intravenous infusion: For full term infants and children up to 5 years of age: 100 mcg of elemental zinc per kg of body weight a day, added to TPN.

For premature infants (up to 3 kg of body weight): 300 mcg of elemental zinc per kg of body weight a day added to TPN. {01} {93}


Note: Zinc injection that contains benzyl alcohol as a preservative should not be used in newborn and immature infants. The use of benzyl alcohol in neonates has been associated with a fatal toxic syndrome consisting of metabolic acidosis and CNS, respiratory, circulatory, and renal function impairment.


Strength(s) usually available
U.S.—


1 mg of elemental zinc (4.39 mg zinc sulfate) per mL (Rx) [Zinca-Pak (0.9% benzyl alcohol){102}]


5 mg of elemental zinc (21.95 mg zinc sulfate) per mL (Rx) [Zinca-Pak]{102}

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Preparation of dosage form:
Zinc sulfate is physically compatible with amino acid solutions, dextrose solutions, and injectable vitamin preparations. {01}



Revised: 09/08/2000



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  1. Committee on Nutritional Status during Pregnancy, National Academy of Sciences. Washington DC: National Academy Press, 1990: 1-23.
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  1. Sandstead H. Trace element interactions. J Lab Clin Med 1981; 98(4): 457-62.
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  1. Solomons N, Jacob R. Studies on the bioavailability of zinc in humans: effects of heme and nonheme iron on the absorption of zinc. Am J Clin Nutr 1981; 34: 475-82.
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  1. McClain C. Trace metal abnormalities in adults during hyperalimentation. JPEN 1981; 5(5): 4244-9.
  1. McClain C, Kasarskis E, Allen J. Functional consequences of zinc deficiency. Prog Food Nutri Sci 1985; 9(1-2): 185-226.
  1. Prasad A and Cossack Z. Zinc supplementation and growth in sickle cell disease. Ann Int Med 1984; 100: 367-71.
  1. Johnson M, Baier M, Greyer J. Effects of dietary tin on zinc, copper, iron, manganese, and magnesium metabolism of adult males. Am J Clin Nutr 1983; 35: 1332-8.
  1. Mahajan S, Prasad A, Rabbani P, et al. Zinc deficiency: a reversible complication of uremia. Am J Clin Nutr 1982; 36: 1177-83.
  1. Boosalis M, Erans G, McClain C. Impaired handling of orally administered zinc in pancreatic insufficiency. Am J Clin Nutr 1983; 37: 268-71.
  1. Kasarski E, Schuna A. Serum alkaline phosphatase after treatment of zinc deficiency in humans. Am J Clin Nutr 1980; 33: 2609-12.
  1. Weismann K, Henrik H. Serum alkaline phosphatase and serum zinc levels in the diagnosis and exclusion of zinc deficiency in man. Am J Clin Nutr 1985; 41: 1214-9.
  1. Hansten PD, Horn JR. Drug interactions. 6th ed. Philadelphia: Lea & Febiger, 1989.
  1. Andersson K, Bratt L, Dencker H, et al. Inhibition of tetracycline absorption by zinc. Eur J Clin Pharmacol 1976; 10: 59-62.
  1. Solomons N. Biological availability of zinc in humans. Am J Clin Nutr 1983; 35: 1048-75.
  1. Kappas A, Sassa S, Anderson K. The porphyrias. In: Stanbury J, Wyngaarden J, Frederickson D, Goldstein J, Brown M. The metabolic basis of inherited disease. New York: McGraw-Hill, 1983, p 1351.
  1. Prasad A. Discovery of human zinc deficiency and studies in an experimental human model. Am J Clin Nutr 1991; 53: 403-12.
  1. Russell R, Cox M, Solomons N. Zinc and the special senses. Ann Int Med 1983; 99: 227-39.
  1. Riordan J. Biochemistry of zinc. Med Clin N Am 1976; 60(4): 661-75.
  1. Sandstead H. Zinc: essentiality for brain development and function. Nutr Rev 1985; 43(5): 129-37.
  1. Solomons N. Zinc, clinical guide to parenteral micronutrition, First Edition, 1984.
  1. Higashi A, Ikeda T, Iribe K, Matsuda I. Zinc balance in premature infants given the minimal dietary zinc requirement. J Pediatr 1988; 112: 262-6.
  1. Singh A, Smoak B, Patterson K, et al. Biochemical indices of selected trace minerals in men: effect of stress. Am J Clin Nutr 1991; 53: 126-31.
  1. Stec J, Podracha L, Pavkovcekova O, Kolla J. Zinc and copper metabolism in nephrotic syndrome. Nephron 1990; 56: 186-7.
  1. Solomons N, Russell R. The interaction of vitamin A and zinc: implications for human nutrition. Am J Clin Nutr 1980; 33: 2031-40.
  1. Solomons N. On the assessment of zinc and copper nutriture in man. Am J Clin Nutr 1979; 32: 856-71.
  1. Zinc chloride product information (Abbott—US) Rev 4/80, Rec 3/87.
  1. Zinc gluconate label information (Nature Made—US).
  1. Zinc gluconate label information (Jamieson–Canada).
  1. Zinc sulfate capsules label information (Mericon—US).
  1. Benitz W and Tatro D. Pediatric Drug Handbook, 2nd Edition, p 378.
  1. Institute of Medicine, Nutrition during Pregnancy, National Academy Press, 1990.
  1. Newsome D, Swartz M, Leone N, Elston R, Miller E. Oral zinc in macular degeneration. Arch Ophthamol 1988; 106(2): 192-8.
  1. Frambach D, Bendel R. Zinc supplementation and anemia. JAMA 1991; 265(7): 869.
  1. Caillie-Bertrand M, Degenhart H, Visser H, et al. Oral zinc sulphate for Wilson's disease. Arch Dis Child 1985; 60: 656-9.
  1. Hill G, Brewer G, Prasad A, Hydrick C, Hartmann D. Treatment of Wilson's disease with zinc. I. oral zinc therapy regimens. Hepatol 1987; 7(3): 522-8.
  1. Mayet I. Low-dose zinc therapy for maintenance treatment of Wilson's disease. Clin Pharm 1990; 9: 951-3.
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  1. Brewer G, Hill G, Pradad A, Cossack Z, Rabbani P. Oral zinc therapy for Wilson's disease. Ann Int Med 1983; 99: 314-20.
  1. Martindale's The Extrapharmacopeia, 28th Edition, 1982, p 945.
  1. Fleeger CA, editor. USAN 1993. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1992.
  1. Cherry F, Bennett E, Bazzano G, et al. Plasma zinc in hypertension/toxemia and other reproductive variables in adolescent pregnancy. Am J Clin Nutr 1981; 34: 2367-75.
  1. Sikorski R, Juszkiewicz T, Paszkowski T. Zinc status in women with premature rupture of membranes at term. Obstetrics and Gynecology 1990; 76(4): 675-7.
  1. Mahomed K, James D, Golding J, McCabe R. Zinc supplementation during pregnancy: a double blind randomized controlled trial. Br Med J 1989; 299: 826-30.
  1. Jameson S. Variations in maternal serum zinc supplementation during pregnancy and correlation to congenital malformations, dysmaturity, and abnormal parturition. Acta Medica Scandinavia 1976; 593(suppl): 5-20, 21-37.
  1. Swanson C and King J. Zinc and pregnancy outcome. Am J Clin Nutr 1987; 46: 763-71.
  1. Panelist comment, 1991.
  1. Panelist comment, 1991.
  1. Panel consensus, 1991.
  1. Lee H, Hill G, Sikha V, et al. Pancreaticobiliary secretion of zinc and copper in normal persons and patients with Wilson's disease. J Lab Clin Med 1990; 116: 283-8.
  1. Panelist comment, 1991.
  1. Sahyoun N, Otradovec C, Hartz S, Jacob R, Peters H, Russell R. Dietary intakes and biochemical indicators of nutritional status in an elderly, institutionalized population. Am J Clin Nutr 1988; 47: 524-33.
  1. Sandstead H, Henriksen L, Greger J, Prasad A. Good R. Zinc nutriture in the elderly in relation to taste acuity, immune responses, and wound healing. Am J Clin Nutr 1982; 36: 1046-59.
  1. Golik A, Modai D, Weissgarten J, Cohen N, Averbulch Z, Sigler E, Zaidenstein R, Shaked U. Hydrochlorothiazide-amiloride causes excessive urinary zinc excretion. Clin Pharmacol Ther 1987; 42: 42-4.
  1. Sweeney J, Ziegler P, Pruet C, Spaulding M. Hyperzincuria and hypozincemia in patients treated with cisplatin. Cancer 1989; 63: 2093-5.
  1. Panelist comment, 1991.
  1. Greger J, S Snedeker. Effect of dietary protein and phosphorus levels on the utilization of zinc, copper, and manganese by adult males. J Nutr 1980; 110: 2243-53.
  1. Mukheree M, Sandstead H, Ratnaporkhi M, et al. Maternal zinc, iron, folic acid and protein nutriture and outcome of human pregnancy. Am J Clin Nutr 1984; 40: 496-507.
  1. Milne D, Canfield W, Mahalko J, Sandstead H. Effect of oral folic acid supplements on zinc, copper, and iron absorption and excretion. Am J Clin Nutr 1984; 39: 535-9.
  1. Butterworth C, Hatch K, Cole P, et al. Zinc concentration in plasma and erythrocytes of subjects receiving folic acid supplementation. Am J Clin Nutr 1988; 47: 484-6.
  1. Wester P. Urinary zinc excretion during treatment with different diuretics. Acta Med Scand 1980; 208(3): 209-12.
  1. Panelist comment, 1991.
  1. Panelist comment, 1991.
  1. Panelist comment, 1991.
  1. Panel consensus, 1991.
  1. Panelist comment, 1991.
  1. Panel consensus, 1991.
  1. Panelist comment, 1991.
  1. Panelist comment, 1991.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, July 1992: 13c.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 952.
  1. Per phone call (Mericon—US), 1/24/94.
  1. Red book 1993. Montvale, NJ: Medical Economics Data, 1993: 609.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, September 1992: 49d.
  1. Red book 1993. Montvale, NJ: Medical Economics Data, 1993: 608.
  1. Freeda vitamins catalog.
  1. Red book 1993. Montvale, NJ: Medical Economics Data, 1993: 417.
  1. Per phone call (Vitaline—US), 1/25/94.
  1. Consensus from Nutrition and Electrolytes Panel meeting, 1995.
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