Zinc Chloride 10mg/10ml Inj, 10ml

Manufacturer EXELA PHARMA SCIENCES Active Ingredient Zinc Chloride(zink KLOR ide) Pronunciation ZINK KLOR-ide
It is used to help growth and good health.
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Drug Class
Trace Element Supplement
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Pharmacologic Class
Essential Micronutrient
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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 chloride injection is a medicine that provides your body with zinc, which is a very important mineral. Zinc is essential for many body functions, including healing wounds, fighting off infections, and helping your body grow and develop properly. This medicine is given intravenously (into a vein), usually as part of a complete nutritional solution, when you cannot get enough zinc from food or other oral supplements.
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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, 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

  • Maintain good hygiene to prevent infections, especially if immune function is compromised.
  • Report any new or worsening skin rashes, hair loss, or problems with wound healing.
  • Follow all dietary recommendations provided by your healthcare team.

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 to 4 mg zinc/day (equivalent to 5.5 to 8.8 mg zinc chloride) for stable patients receiving parenteral nutrition.
Dose Range: 2.5 - 4 mg

Condition-Specific Dosing:

acutecatabolicStates: Up to 12 mg zinc/day (26.4 mg zinc chloride) may be required.
gastrointestinalLosses: Additional 2 mg zinc/day (4.4 mg zinc chloride) for moderate losses, 4-6 mg zinc/day (8.8-13.2 mg zinc chloride) for severe losses.
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Pediatric Dosing

Neonatal: Premature infants: 300 mcg zinc/kg/day (0.66 mg zinc chloride/kg/day). Term infants up to 3 months: 250 mcg zinc/kg/day (0.55 mg zinc chloride/kg/day).
Infant: Term infants 3 months to 5 years: 100 mcg zinc/kg/day (0.22 mg zinc chloride/kg/day).
Child: Children > 5 years: 2.5 to 4 mg zinc/day (5.5 to 8.8 mg zinc chloride/day).
Adolescent: 2.5 to 4 mg zinc/day (5.5 to 8.8 mg zinc chloride/day).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor zinc levels.
Moderate: Consider reducing dose to 1-2 mg zinc/day (2.2-4.4 mg zinc chloride/day) if not on dialysis, monitor zinc levels.
Severe: 1-2 mg zinc/day (2.2-4.4 mg zinc chloride/day) if not on dialysis, monitor zinc levels closely. May not be needed if on hemodialysis.
Dialysis: Patients on hemodialysis may not require zinc supplementation or require reduced doses due to decreased excretion. Monitor plasma zinc levels.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: No specific adjustment, monitor zinc levels.
Severe: No specific adjustment, monitor zinc levels. Zinc excretion may be altered in severe liver disease.

Pharmacology

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Mechanism of Action

Zinc is an essential trace element and a cofactor for over 300 enzymes involved in major metabolic pathways, including nucleic acid synthesis, protein synthesis, carbohydrate metabolism, and lipid metabolism. It plays a crucial role in immune function, wound healing, cell growth and differentiation, and maintenance of normal taste and smell acuity. As an injectable, it provides a direct source of zinc for patients unable to obtain adequate amounts orally, typically in the context of parenteral nutrition.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not typically reported for trace elements; widely distributed throughout the body, with highest concentrations in bone, muscle, liver, kidney, and prostate.
ProteinBinding: Approximately 60-70% bound to albumin, 30-40% to alpha-2 macroglobulin, and a small percentage to amino acids.
CnssPenetration: Limited, but essential for normal brain function and development.

Elimination:

HalfLife: Plasma half-life is short (minutes to hours), but whole-body turnover is slow, with a biological half-life of 100-300 days due to tissue storage.
Clearance: Primarily via fecal excretion (endogenous secretion into the intestine), with a smaller amount excreted renally.
ExcretionRoute: Fecal (major), Renal (minor)
Unchanged: Not applicable (elemental form)
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Pharmacodynamics

OnsetOfAction: Immediate (upon IV administration, for distribution to tissues). Clinical effects (e.g., wound healing, resolution of deficiency symptoms) may take days to weeks.
PeakEffect: Not applicable for a nutritional supplement in terms of a single peak effect; continuous supply maintains physiological levels.
DurationOfAction: Dependent on continuous administration to maintain adequate body stores and prevent deficiency.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
- 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

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, discuss them with 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:

  • Signs of zinc deficiency (e.g., new or worsening skin rash, hair loss, poor wound healing, frequent infections, changes in taste or smell).
  • Signs of zinc toxicity (rare with appropriate dosing, but may include nausea, vomiting, abdominal pain, diarrhea, lethargy, copper deficiency).
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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 dosage 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. Discuss the details of these tests 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 if you are a premature infant. It is crucial to discuss this potential risk with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Lethargy
  • Dizziness
  • Anemia (due to induced copper deficiency with chronic excessive intake)
  • Fever
  • Chills

What to Do:

Discontinue zinc administration. Symptomatic and supportive care. In cases of severe acute overdose, chelation therapy may be considered, but is rarely necessary for IV zinc chloride. Monitor copper levels if chronic overdose is suspected. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

Plasma Zinc Levels

Rationale: To assess baseline zinc status and guide initial dosing, especially in patients with suspected deficiency or conditions predisposing to deficiency (e.g., malabsorption, high output fistulas).

Timing: Prior to initiation of parenteral nutrition or zinc supplementation.

Clinical Signs of Zinc Deficiency

Rationale: To identify symptoms such as dermatitis, alopecia, impaired wound healing, immune dysfunction, or altered taste/smell.

Timing: Prior to initiation and throughout therapy.

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Routine Monitoring

Plasma Zinc Levels

Frequency: Weekly initially, then every 2-4 weeks once stable, or as clinically indicated.

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

Action Threshold: Levels below target may indicate need for increased supplementation; levels significantly above target may indicate toxicity or need for dose reduction.

Alkaline Phosphatase (ALP)

Frequency: Periodically, as part of routine chemistry panel.

Target: Normal range (varies by lab)

Action Threshold: Low ALP levels can be an indicator of zinc deficiency, as ALP is a zinc-dependent enzyme.

Clinical Status (e.g., wound healing, skin integrity, immune function)

Frequency: Daily assessment during hospitalization, periodically in outpatient settings.

Target: Improvement or maintenance of normal function.

Action Threshold: Worsening or lack of improvement in zinc-related symptoms may indicate inadequate supplementation.

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Symptom Monitoring

  • Dermatitis (especially acral, periorificial)
  • Alopecia (hair loss)
  • Impaired wound healing
  • Diarrhea
  • Immune dysfunction (increased infections)
  • Anorexia
  • Dysgeusia (altered taste)
  • Night blindness
  • Growth retardation (in children)
  • Lethargy
  • Anemia (microcytic, hypochromic)

Special Patient Groups

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Pregnancy

Zinc is an essential nutrient during pregnancy for fetal growth and development. Adequate zinc intake is crucial. While high doses should be avoided, supplementation at recommended levels is generally considered safe and necessary if deficiency is present or anticipated. Category C is assigned due to lack of adequate, well-controlled studies in pregnant women, but benefits may outweigh risks in deficiency.

Trimester-Specific Risks:

First Trimester: Essential for early embryonic development; deficiency can lead to adverse outcomes.
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 an essential component of breast milk. Supplementation at recommended doses is generally considered safe and necessary for lactating women with deficiency or inadequate intake. It is rated L1 (safest) by some sources.

Infant Risk: Low risk to infant at recommended maternal doses, as zinc is a natural component of breast milk and essential for infant growth.
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Pediatric Use

Essential for growth and development. Dosing is weight-based and adjusted for age. Premature infants and those with significant GI losses may have higher requirements. Close monitoring of zinc levels is crucial to prevent both deficiency and toxicity.

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Geriatric Use

No specific dose adjustments are typically required beyond standard adult dosing, but elderly patients may be at higher risk for zinc deficiency due to decreased dietary intake, malabsorption, or chronic diseases. Monitor zinc levels and clinical status.

Clinical Information

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Clinical Pearls

  • Zinc chloride injection is primarily used as a component of parenteral nutrition (PN) to prevent or correct zinc deficiency.
  • Monitor plasma zinc levels regularly, especially in patients on long-term PN, those with significant GI losses, or renal impairment.
  • Be aware of potential physical incompatibilities in PN solutions, particularly with high concentrations of phosphate, which can lead to precipitation.
  • Clinical signs of zinc deficiency (e.g., dermatitis, alopecia, impaired wound healing) are important indicators for assessing zinc status.
  • Excessive zinc supplementation can lead to copper deficiency due to competitive absorption; monitor copper levels if high zinc doses are used or toxicity is suspected.
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Alternative Therapies

  • Oral zinc supplements (e.g., zinc sulfate, zinc gluconate, zinc acetate) for patients with intact GI function and ability to absorb oral zinc.
  • Dietary sources of zinc (e.g., red meat, poultry, seafood, nuts, beans, dairy products).
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Cost & Coverage

Average Cost: Inexpensive per 10ml vial
Generic Available: Yes
Insurance Coverage: Typically covered as part of parenteral nutrition or trace element formulations.
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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 guidance. To ensure safe use, never share your medication with others or 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 dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. 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 information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate care.