Orazinc 220mg Capsules
It is used to help growth and good health.
Drug Class
Mineral supplement; Trace element
Pharmacologic Class
Essential trace element
Pregnancy Category
Category A (for recommended daily allowance); Category C (for doses exceeding RDA)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Orazinc 220mg Capsules contain zinc sulfate, a form of zinc. Zinc is an essential mineral that your body needs for many important functions, including your immune system, wound healing, and proper growth. This medication is used to treat or prevent zinc deficiency.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Ensure that all medications are stored in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled 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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Ensure that all medications are stored in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled 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 the missed one.
Lifestyle & Tips
- Take with food if stomach upset occurs, but be aware that some foods (like dairy, high-fiber foods, or whole grains) can reduce zinc absorption. If possible, take zinc at least 1 hour before or 2 hours after meals for best absorption, unless stomach upset is an issue.
- Avoid taking zinc at the same time as iron supplements, calcium supplements, or certain antibiotics (like tetracyclines or fluoroquinolones). Separate doses by at least 2-4 hours.
- Do not exceed the recommended dose, as too much zinc can be harmful and may lead to copper deficiency.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For zinc deficiency: 220 mg zinc sulfate (equivalent to 50 mg elemental zinc) 1 to 3 times daily.
Dose Range:
50 - 150 mg
Condition-Specific Dosing:
Dietary Supplementation:
11-22 mg elemental zinc daily (e.g., 50-100 mg zinc sulfate)
Wilson's Disease (maintenance):
50 mg elemental zinc 2-3 times daily
Pediatric Dosing
Neonatal:
Not established (consult specialist for deficiency)
Infant:
For deficiency: 0.5-1 mg elemental zinc/kg/day (e.g., 2.2-4.4 mg zinc sulfate/kg/day), max 10 mg elemental zinc/day.
Child:
For deficiency: 0.5-1 mg elemental zinc/kg/day (e.g., 2.2-4.4 mg zinc sulfate/kg/day), max 50 mg elemental zinc/day.
Adolescent:
For deficiency: 220 mg zinc sulfate (50 mg elemental zinc) 1-2 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
No specific adjustment typically needed.
Severe:
Use with caution; monitor zinc levels. Accumulation possible in severe renal failure.
Dialysis:
Supplemental zinc may be required due to losses during dialysis; monitor levels.
Hepatic Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
No specific adjustment typically needed.
Severe:
Use with caution; monitor zinc levels, especially in cholestatic liver disease.
Pharmacology
Mechanism of Action
Zinc is an essential trace element and a cofactor for over 300 enzymes involved in various metabolic processes, including DNA and RNA synthesis, cell division, immune function, wound healing, and sensory functions (taste and smell). It plays a crucial role in protein synthesis, carbohydrate metabolism, and maintaining cell membrane integrity. In Wilson's disease, zinc induces metallothionein in enterocytes, which binds dietary copper, preventing its absorption and promoting its fecal excretion.
Pharmacokinetics
Absorption:
Bioavailability:
10-60% (highly variable, influenced by dietary factors)
Tmax:
1-3 hours
FoodEffect:
Decreased absorption when taken with food, especially foods high in phytates (e.g., whole grains, legumes), fiber, or dairy products. Taking with protein-rich meals may improve absorption slightly.
Distribution:
Vd:
Not readily quantifiable as it's widely distributed in tissues (muscle, bone, skin, hair, liver, kidney, prostate).
ProteinBinding:
>90% (primarily to albumin and alpha-2 macroglobulin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma half-life: Approximately 2-3 hours (for acute changes); Tissue half-life: Much longer (days to months) reflecting storage.
Clearance:
Not readily quantifiable as it's primarily excreted.
ExcretionRoute:
Primarily fecal (via pancreatic and biliary secretions); minor renal excretion.
Unchanged:
Not applicable (excreted as the ion)
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement in deficiency states.
PeakEffect:
Weeks to months for repletion of body stores.
DurationOfAction:
Dependent on continued intake and underlying deficiency.
Safety & Warnings
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 any side effects that bother you or do not go away, contact your doctor or seek medical help.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 any side effects that bother you or do not go away, contact your doctor or seek medical help.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. 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, diarrhea, or abdominal pain (may indicate overdose or intolerance)
- Unusual tiredness or weakness
- Pale skin, shortness of breath, or frequent infections (could be signs of copper deficiency from prolonged high-dose zinc)
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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. If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. This will allow you to have a thorough discussion about the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Diarrhea
- Abdominal pain/cramps
- Metallic taste in mouth
- Headache
- Dizziness
- Lethargy
- Irritability
- Long-term high-dose overdose can lead to copper deficiency, characterized by anemia, neutropenia, and neurological symptoms (e.g., ataxia, peripheral neuropathy).
What to Do:
If you suspect an overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive; gastric lavage may be considered if ingestion is recent. Chelation therapy is generally not recommended for zinc overdose unless severe and specific indications are present.
Drug Interactions
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Zinc can chelate tetracyclines, significantly reducing their absorption. Separate administration by at least 2-4 hours.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Zinc can chelate fluoroquinolones, significantly reducing their absorption. Separate administration by at least 2-4 hours.
- Penicillamine: Zinc can reduce the absorption of penicillamine, and penicillamine can reduce zinc absorption. Separate administration by at least 2 hours.
Moderate Interactions
- Iron supplements: High doses of iron can interfere with zinc absorption. Separate administration by at least 2 hours.
- Copper supplements: High doses of zinc can induce copper deficiency by increasing metallothionein synthesis, which binds copper in the gut. Monitor copper levels with long-term high-dose zinc.
- Calcium supplements: High doses of calcium may interfere with zinc absorption.
- Diuretics (thiazide and loop): May increase urinary excretion of zinc, potentially leading to deficiency with long-term use.
- Phytates (in whole grains, legumes, nuts): Reduce zinc absorption. Take zinc supplements away from high-phytate meals.
- Fiber: High fiber intake can reduce zinc absorption.
Minor Interactions
- Dairy products: Calcium in dairy can slightly reduce zinc absorption. Separate administration if possible.
Monitoring
Baseline Monitoring
Plasma Zinc Levels
Rationale: To confirm deficiency before initiating therapy and establish a baseline.
Timing: Before starting treatment for suspected deficiency.
Plasma Copper Levels (and Ceruloplasmin)
Rationale: To assess baseline copper status, especially if high-dose or long-term zinc therapy is anticipated, as zinc can induce copper deficiency.
Timing: Before starting high-dose or long-term zinc therapy.
Routine Monitoring
Plasma Zinc Levels
Frequency: Every 3-6 months for long-term therapy, or as clinically indicated.
Target: 70-120 mcg/dL (normal range, may vary by lab)
Action Threshold: If levels remain low despite therapy, reassess adherence or absorption. If levels become excessively high, consider dose reduction.
Plasma Copper Levels (and Ceruloplasmin)
Frequency: Every 6-12 months for long-term high-dose zinc therapy (e.g., >50 mg elemental zinc/day).
Target: Copper: 70-140 mcg/dL; Ceruloplasmin: 20-60 mg/dL (normal ranges, may vary by lab)
Action Threshold: If copper levels fall below normal, consider reducing zinc dose or supplementing with copper (under medical supervision).
Complete Blood Count (CBC)
Frequency: Annually for long-term high-dose zinc therapy.
Target: Normal
Action Threshold: Monitor for signs of anemia or neutropenia, which can be indicative of copper deficiency.
Symptom Monitoring
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal pain)
- Metallic taste in mouth
- Headache
- Dizziness
- Signs of copper deficiency (e.g., anemia, neutropenia, neurological symptoms like ataxia or peripheral neuropathy - rare with typical supplementation doses but possible with very high or prolonged doses)
Special Patient Groups
Pregnancy
Zinc is an essential nutrient during pregnancy. The recommended daily allowance (RDA) for pregnant women is 11-13 mg elemental zinc. Doses within the RDA are considered safe (Category A). However, high doses exceeding the RDA should be used with caution and only if clearly needed, as excessive intake may be harmful (Category C).
Trimester-Specific Risks:
First Trimester:
Essential for early fetal development; ensure adequate intake within RDA.
Second Trimester:
Continued importance for fetal growth.
Third Trimester:
Important for continued fetal growth and maternal health.
Lactation
Zinc is an essential nutrient for lactating women and infants. It is excreted in breast milk. Doses within the recommended daily allowance (RDA) are considered safe and compatible with breastfeeding (L1). High doses should be used with caution and only if medically indicated, as excessive intake could potentially affect the infant.
Infant Risk:
Low risk at recommended doses; potential for adverse effects (e.g., copper deficiency) with excessive maternal intake.
Pediatric Use
Zinc is essential for growth and development in children. Dosing must be carefully calculated based on age, weight, and the severity of deficiency. Overdosing can lead to toxicity and copper deficiency. Always consult a pediatrician for appropriate dosing.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, elderly individuals may have reduced zinc absorption or increased risk of deficiency due to dietary factors, comorbidities, or polypharmacy. Monitor zinc levels if deficiency is suspected or treated.
Clinical Information
Clinical Pearls
- Orazinc 220mg contains 220 mg of zinc sulfate, which is equivalent to 50 mg of elemental zinc. Always clarify the elemental zinc content when comparing products or dosing.
- For best absorption, zinc supplements are often recommended to be taken on an empty stomach, but if gastrointestinal upset occurs, taking it with a small, non-dairy, low-phytate meal (e.g., lean protein) can help.
- Long-term high-dose zinc supplementation (e.g., >50 mg elemental zinc/day) can induce copper deficiency, leading to anemia and neutropenia. Regular monitoring of copper levels is crucial in such cases.
- Zinc is commonly used for zinc deficiency, but its efficacy for common cold prevention/treatment is debated and requires specific formulations (e.g., lozenges) and timing.
- Patients with Wilson's disease use zinc to block copper absorption, but this is a specific, high-dose, long-term therapy requiring close medical supervision.
Alternative Therapies
- Dietary modification to increase zinc-rich foods (e.g., red meat, poultry, seafood, nuts, legumes, dairy products).
- For specific conditions like Wilson's disease, other copper-chelating agents (e.g., penicillamine, trientine) are alternatives to zinc.
Cost & Coverage
Average Cost:
$5 - $30 per 100 capsules (220mg)
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC) or covered as a Tier 1/2 generic prescription if prescribed for a medical condition (e.g., deficiency).
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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.