Galzin 50mg Capsules
It is used to treat Wilson's disease.
Drug Class
Agent for Wilson's Disease
Pharmacologic Class
Trace element; Metallothionein inducer
Pregnancy Category
Category C
FDA Approved
Mar 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Galzin is a medication used to treat Wilson's disease, a rare genetic disorder where too much copper builds up in the body, especially in the liver and brain. Galzin works by blocking the absorption of copper from the food you eat, helping your body get rid of the excess copper and preventing further damage.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication on an empty stomach, either at least 1 hour before or at least 2 hours after a meal.
Swallow the tablet whole with plain water only. Do not chew, open, or crush the tablet. Avoid taking it with mineral water, milk, or any other drinks.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication on an empty stomach, either at least 1 hour before or at least 2 hours after a meal.
Swallow the tablet whole with plain water only. Do not chew, open, or crush the tablet. Avoid taking it with mineral water, milk, or any other drinks.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take Galzin on an empty stomach, at least 1 hour before or 2-3 hours after meals, to ensure proper absorption. Food can significantly reduce how much zinc your body absorbs.
- Avoid taking Galzin at the same time as other medications, especially certain antibiotics (like tetracyclines or quinolones) or other metal-binding drugs (like penicillamine), as they can interfere with each other's absorption. Separate doses by at least 2-3 hours.
- Report any new or worsening symptoms, especially severe stomach upset, nausea, vomiting, or signs of anemia (unusual tiredness, pale skin).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg three times daily
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
maintenance_therapy_wilson_disease:
50 mg three times daily. May reduce to 25 mg three times daily if copper balance is stable. Administer at least 1 hour before or 2-3 hours after meals.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
25 mg three times daily for children under 10 years of age. Administer at least 1 hour before or 2-3 hours after meals.
Adolescent:
50 mg three times daily for adolescents 10 years of age and older. Administer at least 1 hour before or 2-3 hours after meals.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for zinc accumulation.
Moderate:
No specific adjustment recommended, monitor for zinc accumulation.
Severe:
Use with caution; monitor zinc levels and clinical status due to potential for zinc accumulation.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, as the drug is used to treat hepatic copper accumulation in Wilson's disease. Monitor liver function as part of disease management.
Pharmacology
Mechanism of Action
Zinc acetate acts by inducing the synthesis of metallothionein in the intestinal mucosa. Metallothionein has a high affinity for copper, binding dietary copper and preventing its absorption into the bloodstream. The copper-metallothionein complex is then excreted in the feces when the intestinal cells are sloughed off. This mechanism reduces copper absorption and promotes a negative copper balance, which is beneficial in Wilson's disease.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (reduced by food)
Tmax:
1-3 hours
FoodEffect:
Food, especially high-fiber foods, phytates, dairy products, coffee, and tea, significantly reduces the absorption of zinc. Should be taken on an empty stomach.
Distribution:
Vd:
Not precisely quantified for therapeutic zinc, widely distributed in tissues (bone, muscle, liver, kidney, prostate, eye).
ProteinBinding:
Approximately 60% bound to albumin, 30% to alpha-2 macroglobulin, and 10% to amino acids.
CnssPenetration:
Limited (zinc is present in CSF, but therapeutic levels for CNS effects are not well-defined for this mechanism).
Elimination:
HalfLife:
Plasma half-life is short (hours), but whole-body turnover is much longer (weeks to months).
Clearance:
Not precisely quantified for therapeutic zinc.
ExcretionRoute:
Primarily fecal (unabsorbed zinc and zinc bound to metallothionein), with a small amount excreted renally.
Unchanged:
Not applicable (zinc is an element)
Pharmacodynamics
OnsetOfAction:
Weeks to months (for significant reduction in copper absorption and improvement in copper balance)
PeakEffect:
Months (for stabilization of copper balance and clinical improvement in Wilson's disease)
DurationOfAction:
Continuous as long as therapy is maintained.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Low copper levels in the body, which may cause:
+ Fever
+ Chills
+ Sore throat
+ Unexplained bruising or bleeding
+ Feeling very tired or weak
+ Burning, numbness, or tingling sensations that are not normal
+ Changes in balance
Stomach ulcers, which may cause:
+ Severe stomach or back pain
+ Black, tarry, or bloody stools
+ Vomiting blood or material that looks like coffee grounds
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Upset stomach
Stomach pain
Reporting Side Effects
This is not a complete list of 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Low copper levels in the body, which may cause:
+ Fever
+ Chills
+ Sore throat
+ Unexplained bruising or bleeding
+ Feeling very tired or weak
+ Burning, numbness, or tingling sensations that are not normal
+ Changes in balance
Stomach ulcers, which may cause:
+ Severe stomach or back pain
+ Black, tarry, or bloody stools
+ Vomiting blood or material that looks like coffee grounds
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Upset stomach
Stomach pain
Reporting Side Effects
This is not a complete list of 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.
Seek Immediate Medical Attention If You Experience:
- Severe nausea, vomiting, or abdominal pain (especially if persistent)
- Signs of anemia: unusual tiredness, weakness, pale skin, shortness of breath, dizziness
- Worsening neurological symptoms (tremors, difficulty walking, speech problems)
- Yellowing of skin or eyes (jaundice)
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.
If you are breastfeeding, as you should not breastfeed while taking this medication.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, you must consult with your doctor to confirm that it is safe to do so.
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.
If you are breastfeeding, as you should not breastfeed while taking this medication.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, you must consult with your doctor to confirm that it is safe to do so.
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 and other laboratory assessments should be performed as directed by your doctor to monitor your condition. To minimize the risk of adverse effects, including life-threatening complications, do not exceed the prescribed dosage. If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy, as this will enable you to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Severe gastrointestinal irritation (nausea, vomiting, diarrhea, abdominal pain, gastric erosion)
- Lethargy, dizziness
- Anemia (due to copper deficiency induced by excessive zinc)
- Pancreatitis (rare)
- Renal dysfunction (rare)
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and may involve gastric lavage or chelation therapy if severe and indicated.
Drug Interactions
Major Interactions
- Penicillamine (reduced absorption of both zinc and penicillamine)
- Tetracyclines (e.g., doxycycline, minocycline - reduced absorption of tetracyclines)
- Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin - reduced absorption of quinolones)
Moderate Interactions
- Iron supplements (compete for absorption)
- Calcium supplements (compete for absorption)
- Phosphate supplements (may reduce zinc absorption)
- Diuretics (thiazides, loop diuretics - may increase urinary zinc excretion)
Monitoring
Baseline Monitoring
Serum copper
Rationale: To assess baseline copper status.
Timing: Prior to initiation of therapy.
Serum ceruloplasmin
Rationale: To assess baseline copper binding protein status.
Timing: Prior to initiation of therapy.
24-hour urinary copper excretion
Rationale: To assess baseline copper excretion and overall copper balance.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin, albumin, INR)
Rationale: To assess baseline hepatic function and monitor for disease progression/improvement.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess for baseline anemia or other hematological abnormalities.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum non-ceruloplasmin bound copper (NCC) or 'free' copper
Frequency: Every 1-3 months initially, then every 3-6 months once stable.
Target: <10-15 mcg/dL (or as per clinical guidelines for Wilson's disease)
Action Threshold: Persistently elevated levels may indicate inadequate therapy; consider dose adjustment or adherence issues.
24-hour urinary copper excretion
Frequency: Every 3-6 months, or as clinically indicated.
Target: Typically 200-500 mcg/24 hours (for patients on zinc therapy, indicating effective copper excretion).
Action Threshold: Persistently high levels may indicate inadequate therapy; very low levels may suggest over-treatment or zinc toxicity.
Liver function tests (ALT, AST, bilirubin)
Frequency: Every 3-6 months, or as clinically indicated.
Target: Within normal limits or improving towards baseline.
Action Threshold: Worsening LFTs may indicate disease progression or other liver pathology.
Complete Blood Count (CBC)
Frequency: Every 3-6 months, or as clinically indicated.
Target: Within normal limits.
Action Threshold: Anemia (especially microcytic) may indicate copper deficiency (over-treatment with zinc) or other issues.
Serum zinc levels
Frequency: Periodically, especially if concerns about adherence or toxicity.
Target: 150-250 mcg/dL (therapeutic range for Wilson's disease)
Action Threshold: Very high levels (>300 mcg/dL) may indicate zinc toxicity; very low levels may indicate non-adherence.
Symptom Monitoring
- Gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea)
- Anemia (fatigue, pallor, shortness of breath)
- Neurological symptoms (tremors, dystonia, ataxia - to monitor Wilson's disease progression/control)
- Psychiatric symptoms (depression, anxiety, psychosis - to monitor Wilson's disease progression/control)
- Signs of copper deficiency (e.g., neutropenia, sideroblastic anemia, neurological symptoms like ataxia or myelopathy, especially with excessive zinc dosing)
Special Patient Groups
Pregnancy
Zinc is an essential nutrient, and zinc acetate is considered a first-line therapy for pregnant women with Wilson's disease due to its relatively favorable safety profile compared to chelating agents. However, careful monitoring of maternal copper status (e.g., non-ceruloplasmin bound copper) is crucial to ensure adequate copper control without inducing copper deficiency in the fetus.
Trimester-Specific Risks:
First Trimester:
Generally considered safe and often continued. Close monitoring of copper levels is essential.
Second Trimester:
Continued with close monitoring. Risk of copper deficiency in the fetus if maternal zinc levels are too high or copper levels too low.
Third Trimester:
Continued with close monitoring. Risk of copper deficiency in the fetus if maternal zinc levels are too high or copper levels too low.
Lactation
Zinc is excreted in breast milk. While zinc is an essential nutrient for infants, the therapeutic doses used for Wilson's disease may lead to higher than normal zinc levels in breast milk. The decision to breastfeed should be made considering the potential benefits of breastfeeding for the infant and the potential risk of excess zinc exposure. Monitoring of infant zinc levels may be considered.
Infant Risk:
L3 (Moderate risk) - While zinc is essential, high therapeutic doses could theoretically lead to excessive infant exposure. However, the benefits of breastfeeding often outweigh the theoretical risks, especially if maternal copper is well-controlled. Close monitoring of the infant for any adverse effects is prudent.
Pediatric Use
Zinc acetate is a first-line therapy for children with Wilson's disease, particularly for maintenance therapy or in asymptomatic patients. Dosing is weight-based or age-based. Close monitoring of copper status and growth is essential to prevent copper deficiency, which can impair development.
Geriatric Use
No specific dose adjustments are generally required for geriatric patients. However, as with all medications in this population, monitor for potential age-related changes in renal function and overall tolerance. The incidence of Wilson's disease is rare in this age group, but treatment principles remain similar.
Clinical Information
Clinical Pearls
- Zinc acetate is primarily used for maintenance therapy in Wilson's disease, especially in asymptomatic patients or those who have been decoppered with chelators.
- Strict adherence to taking the medication on an empty stomach (at least 1 hour before or 2-3 hours after meals) is critical for optimal absorption and efficacy.
- Monitor non-ceruloplasmin bound copper (NCC) as the primary marker of copper control, rather than total serum copper or ceruloplasmin, which can be misleading in Wilson's disease.
- Be vigilant for signs of copper deficiency (e.g., anemia, neutropenia, neurological symptoms) which can occur with over-treatment, especially in children.
- Separate administration of zinc acetate from other medications, particularly antibiotics (tetracyclines, quinolones) and other chelating agents (penicillamine), by several hours to prevent drug interactions.
Alternative Therapies
- Penicillamine (e.g., Cuprimine, Depen Titratabs) - copper chelating agent
- Trientine (e.g., Syprine, Trika) - copper chelating agent
- Ammonium tetrathiomolybdate (investigational/compassionate use in some regions) - copper chelating agent
Cost & Coverage
Average Cost:
$1,500 - $3,000+ per 100 capsules (50mg)
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.