Zinc Sulfate 10mg/10ml Inj, 10ml

Manufacturer ZYDUS PHARMACEUTICALS (USA) Active Ingredient Zinc Sulfate Injection(zink SUL fate) Pronunciation ZINK SUL-fayt
It is used to help growth and good health.
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Drug Class
Trace Element; Nutritional Supplement
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Pharmacologic Class
Essential Mineral
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Zinc sulfate injection is a medicine that provides zinc, an essential mineral your body needs to stay healthy. It's especially important for people who can't get enough zinc from their diet, often those receiving nutrition through an IV (like TPN). Zinc helps your body heal wounds, fight off infections, and grow properly.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time, after being mixed with fluids.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Follow your healthcare provider's instructions regarding diet and other supplements.
  • Report any new or worsening symptoms to your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: For stable adults on total parenteral nutrition (TPN): 2.5 to 4 mg elemental zinc per day. (Note: 10mg Zinc Sulfate Heptahydrate contains approximately 2.27mg elemental zinc. Thus, 10ml of this solution contains 2.27mg elemental zinc.)
Dose Range: 2.5 - 17 mg

Condition-Specific Dosing:

acuteCatabolicStates: 4.5 to 6 mg elemental zinc per day
highOutputGIlosses: Up to 12 to 17 mg elemental zinc per day
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Pediatric Dosing

Neonatal: Preterm infants up to 3 kg: 300 mcg elemental zinc/kg/day. Full-term infants: 100 mcg elemental zinc/kg/day.
Infant: 100 mcg elemental zinc/kg/day (up to 5 years of age).
Child: 100 mcg elemental zinc/kg/day (up to 5 years of age); Children > 5 years: 2.5 to 5 mg elemental zinc/day.
Adolescent: 2.5 to 5 mg elemental zinc/day.
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Dose Adjustments

Renal Impairment:

Mild: Monitor zinc levels; dose adjustment may be needed based on levels.
Moderate: Monitor zinc levels closely; dose reduction may be necessary.
Severe: Monitor zinc levels closely; significant dose reduction may be necessary due to decreased renal excretion.
Dialysis: Zinc is not significantly removed by dialysis. Monitor zinc levels and adjust dose as needed, typically lower doses.

Hepatic Impairment:

Mild: No specific adjustment recommended; monitor zinc levels.
Moderate: No specific adjustment recommended; monitor zinc levels.
Severe: No specific adjustment recommended; monitor zinc levels.

Pharmacology

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Mechanism of Action

Zinc is an essential trace element and a cofactor for over 300 enzymes involved in various metabolic pathways, including protein and nucleic acid synthesis, carbohydrate metabolism, and lipid metabolism. It plays a crucial role in immune function, wound healing, cell division, growth, and development. Zinc also contributes to the structural integrity of proteins and cell membranes and is involved in taste and smell perception.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous administration)
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 2.9 L/kg (widely distributed throughout the body, with high concentrations in bone, muscle, skin, hair, prostate, and eye)
ProteinBinding: Highly protein-bound (primarily to albumin and alpha-2 macroglobulin)
CnssPenetration: Limited

Elimination:

HalfLife: Variable; long-term turnover is slow (e.g., 280 days for whole body zinc). Acute half-life after IV administration is rapid distribution phase followed by slower elimination.
Clearance: Not readily quantifiable as a typical drug clearance; primarily eliminated via excretion.
ExcretionRoute: Primarily fecal (approximately 90%), with a small amount excreted renally.
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Rapid (correction of biochemical parameters may be seen within days to weeks, clinical improvement over weeks to months depending on severity of deficiency)
PeakEffect: Not applicable in the typical sense for a trace element; sustained physiological effect with continued administration.
DurationOfAction: Dependent on continued administration to maintain adequate zinc levels and correct deficiency.

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you notice any of the following symptoms, which could be signs of a serious reaction:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat

Vein Irritation and Other Local Reactions

This medication may cause irritation at the injection site. If the medication leaks from the vein, it can also cause irritation around the affected area. Inform your nurse immediately if you experience:

Redness
Burning
Pain
Swelling
Leaking of fluid at the injection site

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you have side effects that bother you or do not go away.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe nausea or vomiting
  • Diarrhea
  • Stomach pain
  • Unusual tiredness or weakness
  • Signs of copper deficiency (e.g., pale skin, unusual bruising, frequent infections, numbness or tingling in hands/feet)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.

This medication may contain aluminum, which can lead to aluminum toxicity with long-term use. The risk of aluminum toxicity is higher if you have kidney problems or if you are a premature infant. It is crucial to discuss this potential risk with your doctor.

As this medication is mixed into parenteral nutrition (PN), it is important to be aware that blood clots in the lungs have occurred in some individuals receiving PN, and in rare cases, this has been fatal. If you have any questions or concerns, be sure to discuss them with your doctor.

If you are pregnant, planning to become pregnant, or are breast-feeding, it is essential to inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Lethargy
  • Dizziness
  • Metallic taste in mouth
  • Fever
  • Chills
  • Hypotension
  • Pulmonary edema (rare, with massive overdose)
  • Copper deficiency (with chronic excessive intake)

What to Do:

Seek immediate medical attention. Treatment is supportive and symptomatic. Discontinue zinc administration. For acute overdose, gastric lavage may be considered if oral ingestion. For IV overdose, manage symptoms and monitor vital signs. Chelation therapy may be considered in severe cases of symptomatic zinc toxicity, but is rarely needed for IV overdose.

Drug Interactions

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Moderate Interactions

  • Copper (high doses of zinc can induce copper deficiency by interfering with copper absorption and increasing metallothionein synthesis)
  • Tetracyclines (e.g., doxycycline, minocycline - oral zinc can chelate, reducing absorption; less relevant for IV zinc but consider if oral forms are co-administered)
  • Quinolones (e.g., ciprofloxacin, levofloxacin - oral zinc can chelate, reducing absorption; less relevant for IV zinc but consider if oral forms are co-administered)
  • Iron supplements (high doses of oral iron can interfere with oral zinc absorption; less relevant for IV zinc)
  • Chelating agents (e.g., penicillamine, EDTA - can increase urinary excretion of zinc)

Monitoring

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Baseline Monitoring

Serum Zinc Levels

Rationale: To assess baseline zinc status and confirm deficiency if suspected.

Timing: Prior to initiation of therapy.

Clinical Signs of Zinc Deficiency

Rationale: To document symptoms such as dermatitis, alopecia, impaired wound healing, diarrhea, immune dysfunction, or growth retardation.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Zinc Levels

Frequency: Periodically (e.g., weekly initially, then monthly or every 3 months for long-term TPN patients)

Target: 70-120 mcg/dL (or 10.7-18.4 micromol/L)

Action Threshold: Below target range: Consider increasing dose. Above target range or signs of toxicity: Consider decreasing dose.

Serum Copper Levels

Frequency: Periodically (especially with higher zinc doses or long-term therapy)

Target: 70-140 mcg/dL

Action Threshold: Low copper levels: May indicate zinc-induced copper deficiency; consider reducing zinc dose or supplementing copper.

Clinical Response

Frequency: Ongoing

Target: Resolution of deficiency symptoms (e.g., improved wound healing, skin integrity, immune function)

Action Threshold: Lack of improvement or worsening symptoms: Re-evaluate dose or consider other causes.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Lethargy
  • Copper deficiency symptoms (e.g., anemia, neutropenia, neurological symptoms)
  • Fever
  • Chills
  • Metallic taste

Special Patient Groups

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Pregnancy

Zinc is an essential nutrient during pregnancy. Deficiency can lead to adverse pregnancy outcomes. Zinc sulfate injection is generally considered safe when used to treat or prevent deficiency at recommended doses. However, excessive doses should be avoided. Category C (risk cannot be ruled out, but benefits may outweigh risks).

Trimester-Specific Risks:

First Trimester: Essential for early fetal development; deficiency can be detrimental.
Second Trimester: Continued need for fetal growth and development.
Third Trimester: Continued need for fetal growth and development.
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Lactation

Zinc is naturally present in breast milk and is essential for infant growth and development. Zinc sulfate injection is generally considered compatible with breastfeeding when used at recommended doses to treat maternal deficiency or provide nutritional support. Monitor infant for any adverse effects, though unlikely.

Infant Risk: Low risk at therapeutic doses; essential nutrient.
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Pediatric Use

Crucial for normal growth, development, and immune function in infants and children. Dosing is weight-based for younger children. Close monitoring of zinc levels is important to prevent both deficiency and toxicity.

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Geriatric Use

Elderly patients may be at higher risk for zinc deficiency due to decreased dietary intake, malabsorption, or chronic diseases. Dosing generally follows adult guidelines, but careful monitoring of zinc levels and renal function is advised.

Clinical Information

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Clinical Pearls

  • Zinc sulfate injection is commonly used as a component of total parenteral nutrition (TPN) to prevent or treat zinc deficiency.
  • Ensure accurate calculation of elemental zinc content, as product labeling may refer to the salt form (Zinc Sulfate) rather than elemental zinc.
  • Rapid intravenous infusion of concentrated zinc solutions can cause local irritation or phlebitis; administer slowly or as part of a TPN admixture.
  • Long-term or high-dose zinc supplementation can induce copper deficiency; monitor serum copper levels periodically.
  • Clinical signs of zinc deficiency include dermatitis (especially around orifices), alopecia, impaired wound healing, growth retardation, and immune dysfunction.
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Alternative Therapies

  • Oral zinc supplements (e.g., zinc gluconate, zinc acetate, zinc picolinate) for patients with intact GI function and less severe deficiency.
  • Dietary sources rich in zinc (e.g., red meat, poultry, seafood, nuts, beans, dairy products) for prevention or mild deficiency.
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Cost & Coverage

Generic Available: Yes
Insurance Coverage: Generally covered by most insurance plans as a necessary medical supply/medication for TPN or deficiency.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.