Zinc Sulfate 5mg/ml Inj, 5ml

Manufacturer ZYDUS PHARMACEUTICALS (USA) Active Ingredient Zinc Sulfate Injection(zink SUL fate) Pronunciation Zink SUL-fate
It is used to help growth and good health.
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Drug Class
Trace Element Supplement
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Pharmacologic Class
Mineral Supplement
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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 given into a vein (intravenously) to provide your body with zinc, which is an essential mineral. It's used when your body isn't getting enough zinc, often because you're receiving nutrition through an IV (like TPN) or have certain medical conditions that cause zinc loss. Zinc is vital for many body functions, including healing wounds, supporting your immune system, and proper growth.
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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 to you. 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 method.

Missing a Dose

If you miss a dose, contact your doctor to find out what steps to take next.
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Lifestyle & Tips

  • Not applicable for IV administration in terms of lifestyle changes, but maintaining a balanced diet (if able to eat) is important for overall nutritional health.

Dosing & Administration

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Adult Dosing

Standard Dose: For stable adults on TPN: 2.5 to 4 mg elemental zinc/day. (Note: 5mg Zinc Sulfate contains approx. 1.1 mg elemental zinc).
Dose Range: 2.5 - 17 mg

Condition-Specific Dosing:

stable_tpn: 2.5 to 4 mg elemental zinc/day
acute_catabolic_states: Up to 12.5 mg elemental zinc/day
severe_gastrointestinal_losses: Up to 17 mg elemental zinc/day
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Pediatric Dosing

Neonatal: Full-term: 100 mcg elemental zinc/kg/day; Preterm: 300 mcg elemental zinc/kg/day
Infant: 100 mcg elemental zinc/kg/day
Child: 50 mcg elemental zinc/kg/day
Adolescent: Similar to adult dosing, 2.5 to 4 mg elemental zinc/day
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor zinc levels.
Moderate: No specific adjustment, monitor zinc levels.
Severe: Reduce dose, monitor zinc levels closely due to potential accumulation.
Dialysis: Reduce dose, monitor zinc levels closely.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: No specific adjustment.
Severe: No specific adjustment, but monitor zinc levels as liver disease can affect zinc metabolism.

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 processes, including protein and nucleic acid synthesis, cell division, immune function, wound healing, and sensory functions (taste and smell). It plays a crucial role in maintaining structural integrity of proteins and regulating gene expression.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (Intravenous)
Tmax: Not applicable (IV)
FoodEffect: Not applicable (IV)

Distribution:

Vd: Not precisely defined; widely distributed in tissues such as muscle, bone, skin, hair, prostate, and eye. Plasma zinc is primarily bound to albumin and alpha-2 macroglobulin.
ProteinBinding: Highly protein-bound (approximately 60% to albumin, 30% to alpha-2 macroglobulin, 10% to amino acids).
CnssPenetration: Limited, but present.

Elimination:

HalfLife: Variable; plasma half-life is relatively short, but tissue half-life (e.g., bone, muscle) can be up to 120 days.
Clearance: Primarily via fecal excretion.
ExcretionRoute: Fecal (major route), urinary (minor route), sweat.
Unchanged: Not applicable (incorporated into body structures).
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Pharmacodynamics

OnsetOfAction: Immediate (replenishment of plasma levels); clinical effects (e.g., wound healing, immune function) may take days to weeks depending on the severity and duration of deficiency.
PeakEffect: Variable, dependent on repletion of body stores and resolution of deficiency symptoms.
DurationOfAction: Sustained as long as adequate supplementation is maintained and body stores are repleted.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

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

Injection Site 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. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, contact 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:

  • Symptoms of too much zinc (rare with appropriate IV dosing): nausea, vomiting, abdominal pain, lethargy, dizziness, metallic taste.
  • Symptoms of copper deficiency (can be induced by high zinc doses): fatigue, pale skin, frequent infections, numbness or tingling in hands/feet, problems with walking.
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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 assess 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 increase the risk of aluminum toxicity with long-term use. This risk is particularly higher if you have kidney problems or 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 been reported in patients receiving PN, and in some 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
  • Copper deficiency (anemia, neutropenia, neurological symptoms)

What to Do:

If you suspect an overdose, seek immediate medical attention. Discontinue zinc administration, provide supportive care, and monitor zinc and copper levels. In severe cases of toxicity, chelation therapy may be considered, but this is rare with therapeutic IV use.

Drug Interactions

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Moderate Interactions

  • Copper (high zinc doses can induce copper deficiency by interfering with absorption and metabolism)
  • Tetracyclines (oral zinc can chelate and reduce absorption, not directly relevant for IV)
  • Quinolones (oral zinc can chelate and reduce absorption, not directly relevant for IV)
  • Iron supplements (oral zinc can interfere with iron absorption, not directly relevant for IV)

Monitoring

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Baseline Monitoring

Plasma Zinc Levels

Rationale: To assess baseline deficiency and guide initial dosing.

Timing: Prior to initiation of therapy.

Plasma Copper Levels

Rationale: To assess for pre-existing copper deficiency and monitor for zinc-induced copper deficiency, especially with prolonged or high-dose therapy.

Timing: Prior to initiation of therapy.

Clinical signs of zinc deficiency (e.g., skin lesions, impaired wound healing, immune function, taste/smell disturbances)

Rationale: To establish clinical need and monitor response to therapy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Plasma Zinc Levels

Frequency: Weekly initially, then monthly or as clinically indicated (e.g., every 1-3 months for stable patients).

Target: 70-120 mcg/dL (adults); pediatric ranges vary by age.

Action Threshold: Adjust dose if levels are persistently outside target range or if clinical signs of deficiency/toxicity are present.

Plasma Copper Levels

Frequency: Monthly or every 3 months, especially with high zinc doses or prolonged therapy.

Target: 70-140 mcg/dL (adults); pediatric ranges vary by age.

Action Threshold: Consider copper supplementation if levels drop below target range or signs of copper deficiency appear.

Clinical status (e.g., wound healing, skin integrity, immune function, growth in children)

Frequency: Ongoing, at each clinical assessment.

Target: Improvement in deficiency symptoms.

Action Threshold: Re-evaluate therapy if no improvement or worsening symptoms.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Abdominal pain (rare with IV unless rapid infusion)
  • Lethargy
  • Copper deficiency symptoms (e.g., anemia, neutropenia, neurological symptoms like ataxia or peripheral neuropathy)

Special Patient Groups

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Pregnancy

Zinc is an essential nutrient during pregnancy for proper fetal development. Deficiency should be treated. Zinc sulfate injection is Pregnancy Category C, meaning it should be used only if the potential benefit justifies the potential risk to the fetus. Close monitoring of zinc levels is recommended.

Trimester-Specific Risks:

First Trimester: Essential for early fetal development, but excessive doses should be avoided.
Second Trimester: Continued need for fetal growth and development.
Third Trimester: Continued need for fetal growth and preparation for birth.
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Lactation

Zinc is excreted in breast milk and is essential for infant growth and development. Use of zinc sulfate injection at recommended doses for maternal deficiency is generally considered safe during lactation. Monitor the infant for any signs of adverse effects, though unlikely with appropriate dosing.

Infant Risk: Low risk at therapeutic doses. High maternal doses could potentially lead to adverse effects in the infant, but this is rare with appropriate clinical management.
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Pediatric Use

Zinc is critical for growth, development, and immune function in pediatric patients. Dosing is weight-based and highly individualized to prevent both deficiency and toxicity. Close monitoring of zinc levels is essential.

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Geriatric Use

No specific dose adjustments are typically needed based on age alone. However, age-related decline in renal function or the presence of co-morbidities may necessitate careful monitoring of zinc levels and overall nutritional status.

Clinical Information

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Clinical Pearls

  • Zinc sulfate injection is typically administered as part of a total parenteral nutrition (TPN) solution or as a separate IV infusion, diluted appropriately.
  • Dosing is based on elemental zinc content, not the salt form. 5 mg Zinc Sulfate heptahydrate contains approximately 1.1 mg elemental zinc.
  • Long-term high-dose zinc supplementation can induce copper deficiency; therefore, copper levels should be monitored, especially in patients receiving prolonged zinc therapy.
  • Clinical signs of zinc deficiency include acrodermatitis enteropathica-like skin lesions, impaired wound healing, alopecia, immune dysfunction, and taste/smell disturbances.
  • Ensure proper dilution and compatibility when adding to TPN or other IV solutions to prevent precipitation.
  • Zinc levels can be affected by acute phase reactions, making interpretation challenging in acutely ill patients; clinical assessment is crucial.
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Alternative Therapies

  • Oral zinc supplements (e.g., zinc gluconate, zinc acetate, zinc sulfate) for patients who can absorb zinc adequately via the gastrointestinal tract.
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Cost & Coverage

Average Cost: Variable, typically low cost for generic vials. per 5ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered by medical benefit for patients requiring parenteral nutrition or specific deficiency treatment).
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless explicitly instructed to do so by a healthcare professional or the medication's instructions. If you are unsure about the best disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which can be an effective way to dispose of medications safely.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to 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 emergency medical attention. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.