Galzin 25mg Capsules
It is used to treat Wilson's disease.
Drug Class
Trace element, Chelating agent (indirect)
Pharmacologic Class
Zinc salt
Pregnancy Category
Category C
FDA Approved
Mar 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Galzin is a medication containing zinc acetate, which is used to treat Wilson's disease. Wilson's disease is a rare genetic disorder where your body cannot properly remove excess copper, leading to copper buildup in organs like the liver and brain. Galzin works by blocking the absorption of copper from your food and helping your body get rid of extra copper, preventing it from causing harm.
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 have access to drug take-back programs 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 return to your regular 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 have access to drug take-back programs 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 return to your regular 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. Taking it with food, especially dairy, high-fiber foods, or certain grains, can reduce its effectiveness.
- Avoid taking other medications like tetracycline or fluoroquinolone antibiotics, or iron supplements, at the same time as Galzin. Separate them by at least 2-3 hours.
- Follow a low-copper diet as advised by your doctor or dietitian. This typically involves avoiding foods high in copper like liver, shellfish, nuts, chocolate, and mushrooms.
- Do not stop taking Galzin without consulting your doctor, even if you feel well. Wilson's disease is a lifelong condition requiring continuous treatment.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg (elemental zinc) three times daily or 25 mg four times daily, taken at least 1 hour before or 2-3 hours after meals.
Dose Range:
75 - 250 mg
Condition-Specific Dosing:
Wilson's Disease Maintenance:
50 mg (elemental zinc) two to three times daily, adjusted based on copper levels and clinical response.
Initial Therapy (Decompensated Wilson's Disease):
50 mg (elemental zinc) three times daily, often used in conjunction with a chelator initially.
Pediatric Dosing
Neonatal:
Not established (use in infants with Wilson's disease is typically based on weight and clinical response, often 25 mg two to three times daily).
Infant:
25 mg (elemental zinc) two to three times daily, adjusted based on weight and clinical response.
Child:
For children <10 years or <50 kg: 25 mg (elemental zinc) two to three times daily. For children >10 years or >50 kg: 50 mg (elemental zinc) two to three times daily.
Adolescent:
50 mg (elemental zinc) two to three times daily, adjusted based on copper levels and clinical response.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but monitor for zinc accumulation if severe renal impairment is present, as some zinc is renally excreted.
Dialysis:
Consider monitoring zinc levels; no specific dose adjustment guidelines, but zinc is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, often used in patients with severe hepatic impairment due to Wilson's disease.
Pharmacology
Mechanism of Action
Zinc acetate works by inducing the synthesis of metallothionein in the intestinal mucosal cells. Metallothionein has a high affinity for copper, binding dietary copper within the enterocytes and preventing its absorption into the bloodstream. The copper-metallothionein complex is then excreted in the feces when the enterocytes are sloughed off. Zinc also promotes the fecal excretion of endogenous copper.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (20-60%)
Tmax:
2-4 hours
FoodEffect:
Food, especially high-fiber foods, phytates, and dairy products, significantly reduces zinc absorption. Should be taken on an empty stomach.
Distribution:
Vd:
Not readily quantifiable, 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 its direct penetration across the blood-brain barrier is not extensive for therapeutic purposes).
Elimination:
HalfLife:
Plasma half-life is short (minutes to hours), but whole-body turnover is slow (days to weeks).
Clearance:
Not readily quantifiable; primarily eliminated via fecal excretion (unabsorbed zinc) and some renal excretion.
ExcretionRoute:
Fecal (major), Renal (minor)
Unchanged:
Not applicable (zinc is an element, not metabolized)
Pharmacodynamics
OnsetOfAction:
Weeks to months (for full therapeutic effect in reducing copper burden).
PeakEffect:
Several months (as metallothionein levels build up and copper stores are depleted).
DurationOfAction:
Continuous administration is required to maintain therapeutic effect.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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 sensation that is 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience 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 an exhaustive 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.
Although rare, some people may experience severe and potentially life-threatening side effects while 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 sensation that is 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience 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 an exhaustive 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 stomach upset, nausea, vomiting, or diarrhea (especially if persistent or severe)
- Unusual tiredness, weakness, or pale skin (signs of anemia, which can be caused by too much zinc leading to copper deficiency)
- New or worsening neurological symptoms (e.g., tremors, difficulty speaking, coordination problems)
- New or worsening liver problems (e.g., yellowing of skin/eyes, dark urine, severe abdominal pain)
- Hair loss, skin rash, or impaired wound healing (can be signs of zinc deficiency if dose is too low or absorption is poor)
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 allergic reaction you experienced, including any symptoms that occurred.
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 (OTC) 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, consult with your doctor to confirm that it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions.
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 allergic reaction you experienced, including any symptoms that occurred.
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 (OTC) 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, consult with your doctor to confirm that it is safe to:
Start taking a new medication
Stop taking a medication
* Change the dosage of any medication
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions.
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 work and laboratory tests should be conducted as directed by your doctor to ensure safe and effective treatment. To minimize the risk of adverse effects, including death, 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.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Lethargy
- Dizziness
- Anemia (due to induced copper deficiency)
- Fever
- Chills
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and may involve gastric lavage or chelation if severe.
Drug Interactions
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Zinc can chelate tetracyclines, significantly reducing their absorption. Separate administration by at least 2-3 hours.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Zinc can chelate fluoroquinolones, significantly reducing their absorption. Separate administration by at least 2-3 hours.
Moderate Interactions
- Iron supplements: Zinc and iron compete for absorption. Separate administration by at least 2-3 hours.
- Penicillamine: If used concurrently (e.g., during initial therapy for Wilson's disease), separate administration by at least 1 hour to avoid chelation and reduced absorption of both agents.
- Calcium supplements: High doses of calcium may interfere with zinc absorption.
- Phytates (found in whole grains, legumes): Can reduce zinc absorption. Advise patients to take zinc on an empty stomach.
Minor Interactions
- Dairy products: Can reduce zinc absorption. Advise patients to take zinc on an empty stomach.
Monitoring
Baseline Monitoring
24-hour urine copper excretion
Rationale: To assess baseline copper overload and monitor therapeutic response.
Timing: Prior to initiation of therapy
Serum copper (total and non-ceruloplasmin bound copper [NCC])
Rationale: To assess baseline copper status and monitor therapeutic response. NCC is a more accurate reflection of toxic copper.
Timing: Prior to initiation of therapy
Serum ceruloplasmin
Rationale: Typically low in Wilson's disease, used for diagnosis and monitoring.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin, albumin, INR)
Rationale: To assess baseline hepatic damage and monitor for improvement or worsening.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline anemia or other hematologic abnormalities, and monitor for potential copper deficiency (anemia, leukopenia) or zinc toxicity.
Timing: Prior to initiation of therapy
Serum zinc levels
Rationale: To ensure adequate zinc levels are achieved and to monitor for excessive zinc accumulation.
Timing: Prior to initiation of therapy
Routine Monitoring
24-hour urine copper excretion
Frequency: Every 3-6 months initially, then annually once stable.
Target: <100 mcg/24 hours (ideally <50 mcg/24 hours for maintenance)
Action Threshold: If >100 mcg/24 hours, consider dose adjustment or adherence issues. If <25 mcg/24 hours, consider zinc deficiency or over-treatment.
Non-ceruloplasmin bound copper (NCC)
Frequency: Every 3-6 months initially, then annually once stable.
Target: <10-15 mcg/dL
Action Threshold: If persistently elevated, consider dose adjustment or adherence issues.
Serum zinc levels (fasting)
Frequency: Every 3-6 months initially, then annually once stable.
Target: 150-250 mcg/dL (therapeutic range for Wilson's disease)
Action Threshold: If <150 mcg/dL, consider dose increase or adherence. If >300 mcg/dL, consider dose reduction due to potential toxicity.
Liver function tests (ALT, AST, bilirubin)
Frequency: Every 6-12 months, or as clinically indicated.
Target: Within normal limits or improving from baseline.
Action Threshold: Significant worsening may indicate inadequate copper control or other liver pathology.
Complete Blood Count (CBC)
Frequency: Annually, or as clinically indicated.
Target: Within normal limits.
Action Threshold: Anemia or leukopenia may indicate copper deficiency (over-treatment with zinc) or other issues.
Symptom Monitoring
- Symptoms of copper toxicity (e.g., worsening neurological symptoms, liver dysfunction, Kayser-Fleischer rings)
- Symptoms of zinc deficiency (e.g., anemia, leukopenia, hair loss, skin rash, impaired wound healing, impaired taste/smell)
- Symptoms of zinc toxicity (e.g., nausea, vomiting, abdominal pain, diarrhea, lethargy, dizziness, copper deficiency anemia)
Special Patient Groups
Pregnancy
Zinc acetate is generally considered safe and is often the preferred treatment for Wilson's disease during pregnancy. Untreated Wilson's disease poses significant risks to both mother and fetus. Close monitoring of copper and zinc levels is essential throughout pregnancy.
Trimester-Specific Risks:
First Trimester:
Generally considered safe and necessary to continue treatment to prevent maternal and fetal complications from untreated Wilson's disease.
Second Trimester:
Continue treatment; monitor copper and zinc levels.
Third Trimester:
Continue treatment; monitor copper and zinc levels. Some sources suggest a slight dose reduction in the third trimester to avoid neonatal copper deficiency, but this should be individualized.
Lactation
Zinc is naturally present in breast milk and is essential for infant growth. Therapeutic doses of zinc acetate for Wilson's disease are generally considered compatible with breastfeeding. Monitor the infant for signs of copper deficiency, though this is rare.
Infant Risk:
Low risk. Zinc is an essential nutrient. The amount transferred into breast milk is not expected to cause harm to the infant. Monitor infant for signs of copper deficiency (e.g., anemia, neutropenia) if concerns arise.
Pediatric Use
Zinc acetate is a first-line treatment for Wilson's disease in children, including asymptomatic siblings of affected patients. Dosing is weight-based. Regular monitoring of copper and zinc levels is crucial to ensure efficacy and prevent over-treatment (copper deficiency) or under-treatment (copper toxicity).
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, age-related decline in renal function should be considered, and monitoring for potential zinc accumulation or interactions with other medications is important.
Clinical Information
Clinical Pearls
- Galzin is a maintenance therapy for Wilson's disease and is often preferred for asymptomatic patients or those in remission due to its excellent safety profile.
- It is crucial to take Galzin on an empty stomach (at least 1 hour before or 2-3 hours after meals) to maximize absorption and efficacy.
- Patients should be educated on dietary copper restriction, as zinc therapy alone may not be sufficient if dietary copper intake is high.
- Regular monitoring of 24-hour urine copper, non-ceruloplasmin bound copper (NCC), and serum zinc levels is essential to guide therapy and prevent both copper toxicity and zinc-induced copper deficiency.
- Zinc acetate can cause gastric irritation, especially when initiating therapy or if taken without food. Splitting the dose or taking it with a small amount of protein-free food (e.g., a cracker) might help, but this can reduce absorption.
- Unlike chelating agents (e.g., penicillamine, trientine), zinc acetate does not cause an initial worsening of neurological symptoms (paradoxical worsening) and is often preferred for patients with neurological presentations after initial chelation.
Alternative Therapies
- Penicillamine (Cuprimine, Depen): A chelating agent that binds copper and promotes its excretion. Often used for initial treatment of symptomatic Wilson's disease.
- Trientine (Syprine, Cuvrior): Another chelating agent, often used for patients intolerant to penicillamine or as initial therapy.
- Ammonium tetrathiomolybdate: An investigational agent that binds copper in the gut and bloodstream, preventing its absorption and promoting excretion.
Cost & Coverage
Average Cost:
$100 - $500+ per 100 capsules (25mg or 50mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty drug, may require prior authorization)
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 medication taken, the amount, and the time it occurred.