Cupric Chloride Injection for Copper Deficiency: A Comprehensive Overview

Overview:

Animals and humans both require copper, an essential micronutrient, for healthy organ function and metabolic processes like hemoglobin synthesis, neurotransmission, iron oxidation, cellular respiration, antioxidant defense peptide amidation, pigment formation, and connective tissue formation. Both genetic and acquired variables have contributed to the rise in clinical cases of copper deficiency in recent decades. Oral or intravenous copper supplementation in the form of copper gluconate, copper sulfate, or copper chloride is used to treat copper deficiency anemia. Within four to twelve weeks, hematological symptoms can be completely reversed with copper supplementation. However, supplementing with copper only partially reverses neurological symptoms. Cupric chloride is approved by ANDA (Abbreviated New Drug Application). It is a request for approval of a generic medication in the United States presented to the Food and Drug Administration (FDA) on October 31, 2022, for use in cases of copper deficiency and as a supplement to intravenous solutions given for total parenteral nutrition.

Drug Group:

Cupric chloride is not classified into a specific drug group as it is not a common medication and has a very specific use.

Available Doses and Dosage Forms:

Doses Available: The usual concentration of Cupric chloride for TPN is 0.4 milligrams per milliliter (mg/ml).

Dosage Form: 10-milliliter vials containing a sterile, nonpyrogenic solution are supplied.

For Patients:

What Is Copper Deficiency?

When the body does not have enough copper, a trace mineral needed for several processes, it is said to be copper deficiency. Although rare, it can be caused by certain medical conditions, drugs, and restricted food consumption. There is a wide range of symptoms that might include anemia (reduced red blood cell count), exhaustion, weakness, changes in skin and hair, and mood swings. For an accurate diagnosis and course of therapy, speak with a healthcare provider.

How Does Cupric Chloride Work?

Cupric chloride acts by supplying copper, an essential trace mineral required for several body processes, such as:

1. Cupric chloride helps in energy production. Enzymes essential to cells' ability to produce energy include copper.

2. Copper is involved in the production of collagen and elastin. These are two connective tissues that are necessary for the health of blood vessels, joints, and skin.

3. Copper plays a role in the body's absorption and use of iron during iron metabolism.

4. Copper helps shield cells from harm by strengthening the body's defensive mechanisms against free radicals, which helps in antioxidant activity.

What Is the Dosage of Cupric Chloride?

A healthcare provider will establish the precise dosage of Cupric chloride in TPN depending on individual factors.

• Suggested Dose - The recommended daily intake of Cupric chloride addition is between 0.5 and 1.5 mg (1.25 and 3.75 mL). The recommended Cupric chloride addition dosage for pediatric patients is 20 mcg (microgram) copper per kg (kilogram) per day (0.05 mL/kg/day).

How Effective Is Cupric Chloride?

When administered correctly and under medical supervision, Cupric chloride can effectively treat copper deficiency in people on TPN. Research has demonstrated that it has a favorable effect on TPN patients' copper levels. However, it is important to remember that Cupric chloride should only be taken as a supplement in addition to other critical minerals because it cannot treat the underlying disease that calls for TPN.

What Are the Things to Inform the Doctor Before Taking the Drug?

• Allergies: Any allergies to foods, medicines, or other things should be mentioned. Allergies to copper or any of the TPN solution's ingredients, including stabilizers and preservatives, fall under this category.

• Supplements and Medication: Please provide a detailed list of all the current drugs and supplements. Prescription pharmaceuticals, over-the-counter medications, vitamins, herbal items, and recreational drugs are all included in this.

• Medications: The doctor can check for possible interactions between Cupric chloride and other drugs if they are aware of all of them. Certain drugs may alter the way the body absorbs or uses copper, which may raise the possibility of harmful side effects.

• Health Background: Please disclose any current medical issues, particularly those about the kidneys or liver. Diseases like renal failure (kidney impairment) or liver illness might alter how the body functions.

How Is Cupric Chloride Administered?

• Intravenous administration of copper 0.4 mg/mL (Cupric chloride injection) is contingent upon dilution before administration.

• The additive has to be diluted with at least 100 milliliters of liquid. The recommended daily copper supplement dosage for an adult on TPN is between 0.5 and 1.5 mg (1.25 and 3.75 mL).

• The recommended additional dose for pediatric patients is 20 mcg copper/kg/day (0.05 mL/kg/day). Due to their limited body reserves and higher development requirements, infants weighing less than 1500 grams (g) may have higher requirements.

• When the solution and container allow, parenteral medication preparations should be visually scrutinized for discoloration and particle debris before being administered.

What Are the Side Effects of Cupric Chloride?

Although Cupric chloride is typically well-tolerated when used as directed by a doctor, certain negative effects can occur, such as:

• Digestive: Upset stomach, vomiting, diarrhea, and discomfort in the abdomen.

• General: Headache, fever, chills, hypotension, or low blood pressure.

Rarely, more severe adverse effects may manifest, including:

• Liver damage.

• Kidney damage.

• Dangerous levels of copper (weakness, tiredness, jaundice).

Dietary Considerations:

As previously indicated, Cupric chloride is not taken orally as a dietary supplement; rather, it is usually employed within total parenteral nutrition (TPN) intravenously. As such, its usage in this context is not directly affected by dietary considerations. However, eating a well-balanced and healthy diet is important for general well-being and can help the body use copper more efficiently.

Missed Dose:

Cupric chloride is usually given constantly through a catheter, therefore, the idea of a "missed dose" is not applicable. Notify the healthcare provider right away if there is a break in the infusion for any reason so that it may be properly evaluated and resumed as directed.

Overdose:

Cupric chloride overdose is a possible risk, especially if doses are given excessively or improperly. Overdosage symptoms might include:

• Vomiting and nausea.

• Diarrhea.

• Stomach ache.

• Chills with fever.

• Hypotension (low blood pressure).

• Jaundice (yellowing of the skin and eyes).

• Weakness and exhaustion.

• Kidney or liver damage.

Get immediate professional attention if experiencing any of the above overdose symptoms. It has been reported that D-penicillamine works well as an antidote.

Storage:

Healthcare workers usually handle and store Cupric chloride in a sterile medical setting. They follow particular guidelines and make sure the right storage conditions are met to preserve sterility and avoid infection. Store at 68 to 77 degrees Fahrenheit or 20 to 25 degrees Celsius.

For Doctors:

Indication:

It is recommended to add copper 0.4 mg/mL (Cupric chloride injection) to intravenous solutions administered for TPN. Administration aids in maintaining serum copper levels in cases of copper deficiency.

Dose:

When treating adult copper insufficiency, the standard dosage of Cupric chloride injection is 0.5 to four mg of copper administered intravenously per day. The patient's reaction to therapy and copper levels may require adjusting the dosage.

Dosing Considerations:

The following are some general dosage guidelines for injecting Cupric chloride in cases of copper deficiency:

• Administration: In a therapeutic context, a healthcare professional normally gives a Cupric chloride injection. To guarantee the safe and efficient administration of the drug, it is crucial to adhere to the advised administration instructions.

• Monitoring: Medical practitioners should keep a careful eye on patients getting Cupric chloride injections for copper deficiency to evaluate how well they are responding to therapy and to watch for any possible problems or side effects.

• Individualized Dosing: Depending on the patient's age, weight, underlying medical issues, and the degree of their copper shortage, the dosage of Cupric chloride injection may need to be customized.

• Consultation: For individualized dose recommendations catered to particular circumstances, one must visit a healthcare specialist for nutritional deficiencies.

Recall that when it comes to the dosage and dosing considerations of Cupric chloride injection for the treatment of copper insufficiency, the advice of a healthcare provider is needed.

What Are the Pharmacological Aspects of Cupric Chloride?

Pharmacodynamics: As a cofactor for serum ceruloplasmin, an oxidase required for the correct synthesis of the iron carrier protein transferrin, copper is an important nutrient. Additionally, copper supports the maintenance of normal red and white blood cell production rates. The development of leukopenia, neutropenia, anemia, low ceruloplasmin levels, poor transferrin production, secondary iron insufficiency, and osteoporosis can all be avoided by giving copper during total parenteral nutrition.

Mechanism:

For those on TPN who cannot absorb enough copper through their digestive tract, Cupric chloride is a copper supplement. The body uses copper, a vital trace mineral, in several metabolic processes, such as:

1. Energy Generation: The electron transport chain, which is essential for cell energy production, is mediated by enzymes that are reliant on copper.

2. Collagen and Elastin Synthesis: Copper facilitates the development of collagen and elastin, two connective tissues necessary for healthy blood vessels, joints, and skin.

3. Iron Metabolism: Copper plays a role in the body's absorption and use of iron during iron metabolism.

4. Antioxidant Activity: Copper helps shield cells from harm by strengthening the body's defensive mechanisms against free radicals.

Pharmacokinetics

1. Absorption: The gastrointestinal system is capable of absorbing Cupric chloride, albeit at a variable pace. For therapeutic purposes, it can also be injected intravenously or intramuscularly.

2. Distribution: After being absorbed, Cupric chloride's copper is spread throughout the body, with the liver, brain, kidneys, and bones having the highest amounts.

3. Metabolism: The liver is where copper is processed and mostly eliminated into the stool through bile. Urine also contains some copper discharged in it.

4. Elimination: The majority of copper is expelled through feces, with a lesser quantity exiting the body through urine.

Toxicity:

• Non-Clinical Toxicity:

Mutagenesis, Carcinogenesis, and Fertility Impairment- There have been no long-term animal studies to determine whether Cupric chloride injection is carcinogenic, nor has there been any research to determine whether mutagenesis or reproductive impairment is affected.

• Clinical Toxicity: Signs of poisoning from copper chloride include:

1. Vomiting and nausea.

2. Diarrhea.

3. Stomach ache.

4. Chills with fever

5. Hypotension, or low blood pressure.

6. Jaundice (yellowing of the skin and eyes).

7. Weakness and exhaustion.

8. Harm to the kidneys or liver.

Contributing Elements to Toxicity:

1. Overdosage.

2. Underlying illnesses.

3. Interactions between drugs.

Clinical Studies:

Cupric chloride has been the subject of clinical trials to assess its safety and effectiveness in a range of medical disorders. Although the main application for Cupric chloride is the treatment of copper deficiency, other uses have also been investigated. Here are a few instances of Cupric chloride-related clinical studies:

• Copper Deficiency: Clinical research has looked into using Cupric chloride as a treatment for copper deficiency, which can result in several health issues. The goal of these investigations has been to establish the ideal treatment plan, dose, and delivery method for addressing copper deficiency.

• Wilson's Disease: Wilson's disease is a hereditary ailment resulting in copper accumulation in the body. Cupric chloride is also used to treat this condition. Clinical research has looked at how well Cupric chloride works to control copper levels in Wilson's disease patients, as well as how it affects the symptoms and course of the illness.

• Antimicrobial Properties: Studies have looked at the antimicrobial qualities of Cupric chloride and how it may be used to prevent the development of microorganisms in a variety of contexts, including water treatment and disinfection.

• Toxicity Studies: To evaluate the toxicity profile of Cupric chloride, including possible side effects and adverse responses when administered at various dosages and durations, clinical studies have also been carried out.

Overall, clinical research is essential to expanding our knowledge of Cupric chloride's pharmacological properties, safety, and effectiveness in treating a range of illnesses.

What Are the Contraindications of Cupric Chloride?

Because there is a significant chance of negative side effects, Cupric chloride should not be taken in several circumstances. The primary contraindications are as follows:

• Hypersensitivity: Cupric chloride should not be used if having a history of allergic reactions to copper or any of the ingredients in the TPN solution.

• Wilson's Disease: The body accumulates copper as a result of this hereditary illness. Cupric chloride is strictly prohibited since it would worsen this disease.

• Uncontrolled Liver Disease: People who have serious liver issues may not be able to process and excrete copper in a safe way, which raises the possibility of toxicity.

• Uncontrolled Kidney Disease: Severe renal failure can impede the excretion of copper, similar to liver problems, which may make Cupric chloride hazardous.

Warnings and Precautions:

• There may be hazardous aluminum in this product. If renal function is compromised, prolonged parenteral injections of aluminum may result in hazardous amounts of the metal. Because their kidneys are still developing and they need a lot of aluminum-containing calcium and phosphate solutions, premature newborns are especially vulnerable.

• Studies reveal that individuals with reduced renal function, such as preterm newborns, who are administered parenteral aluminum at doses exceeding four to five mcg/kg/day, amass aluminum at levels linked to toxicity to the central nervous system and bones. Even lower administration rates have the potential to cause tissue loading.

• Cupric chloride injection should only be administered as part of a pharmacy-directed admixture program in a laminar flow environment, utilizing an aseptic technique; it should also be utilized as soon as possible, in a single operation, and without repeat penetrations. There are no preservatives in the solution, so as soon as the mixing process is over, throw away any leftovers.

• Patients suffering from Wilson's disease, a hereditary disorder affecting copper metabolism, should not use copper supplements.

What Are the Drug Interactions of Cupric Chloride?

Several drugs may interact with Cupric chloride, influencing the medication's metabolism or absorption. Here are a few noteworthy instances:

• Penicillamine: Used to treat Wilson's disease, it can combine with copper and maybe reduce the amount of copper that is absorbed from Cupric chloride.

• Trientine: Another treatment for Wilson's disease is Trientine, which may similarly have an impact on the absorption of copper from Cupric chloride.

• Supplemental Iron: Consuming too much iron might impede the absorption of copper.

• Supplemental Zinc: Excessive zinc intake may potentially impact the absorption of copper.

Specific Considerations:

• Nursing Women: It is unknown if this medication is eliminated in human milk. When giving a Cupric chloride injection to a nursing woman, care should be taken because a lot of medications are excreted in human milk.

• Use in Pediatrics: Data on babies weighing less than 1500 grams are scarce. The specific use and dosage of Cupric chloride in children may differ from adults.

• Pregnant Women: Studies on animal reproduction with Cupric chloride have not been carried out. Furthermore, it is unknown if Cupric chloride administration to a pregnant woman can damage the fetus or impair the woman's ability to conceive. A pregnant lady should only be administered Cupric chloride if specifically required.

• Senior Usage: Since reduced hepatic, renal, or cardiac function is more common in older patients, as well as concurrent diseases or other pharmacological therapies, dose selection for these patients should generally be careful and begin at the low end of the dosing range.