Orazinc 110mg Tablets
It is used to help growth and good health.
Drug Class
Mineral supplement, Trace element
Pharmacologic Class
Essential trace element
Pregnancy Category
Category C (for therapeutic doses exceeding RDA; Category A for doses within RDA)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zinc sulfate is a form of zinc, an essential mineral that your body needs for many important functions, including immune system health, wound healing, and proper growth and development. It's often used to treat or prevent zinc deficiency.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. 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
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are 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's 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 a missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. 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
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are 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's 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 a missed one.
Lifestyle & Tips
- Take with food if stomach upset occurs, but be aware that food (especially dairy, high-fiber foods, and certain grains/legumes) can reduce absorption. If possible, take 1 hour before or 2 hours after meals.
- Avoid taking at the same time as iron supplements, calcium supplements, or certain antibiotics (quinolones, tetracyclines). Separate doses by at least 2-6 hours.
- Do not exceed recommended doses, as excessive zinc can lead to side effects and copper deficiency.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
25-50 mg elemental zinc (equivalent to 110-220 mg zinc sulfate heptahydrate) once daily
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
zincDeficiency:
25-50 mg elemental zinc daily, adjusted based on serum zinc levels and clinical response.
acrodermatitisEnteropathica:
25-50 mg elemental zinc daily, lifelong therapy may be required.
woundHealing:
25-50 mg elemental zinc daily for specific deficiencies.
Pediatric Dosing
Neonatal:
Not established for routine supplementation; specific dosing for conditions like acrodermatitis enteropathica (e.g., 0.5-1 mg/kg elemental zinc daily).
Infant:
Not established for routine supplementation; specific dosing for conditions like acrodermatitis enteropathica (e.g., 0.5-1 mg/kg elemental zinc daily).
Child:
10-25 mg elemental zinc daily, depending on age, weight, and indication (e.g., diarrhea, deficiency).
Adolescent:
25-50 mg elemental zinc daily, depending on indication.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor zinc levels to avoid accumulation. May require dose reduction.
Dialysis:
Monitor zinc levels; supplementation may be needed due to losses, but avoid excessive accumulation.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment.
Severe:
No specific adjustment, but monitor for signs of toxicity if severe liver disease affects mineral metabolism.
Pharmacology
Mechanism of Action
Zinc is an essential trace element and cofactor for over 300 enzymes involved in various metabolic pathways, including DNA and RNA synthesis, protein synthesis, immune function, wound healing, cell division, and sensory functions (taste and smell). It plays a crucial role in maintaining structural integrity of proteins and regulating gene expression.
Pharmacokinetics
Absorption:
Bioavailability:
20-40% (highly variable, influenced by dietary factors and other minerals)
Tmax:
1-3 hours
FoodEffect:
Absorption is decreased by food, especially phytates (found in whole grains, legumes), fiber, dairy products, and iron. Best taken on an empty stomach, but can be taken with food to reduce GI upset.
Distribution:
Vd:
Not readily quantifiable for an essential nutrient; widely distributed throughout the body.
ProteinBinding:
Approximately 60-70% bound to albumin, 30-40% to alpha-2 macroglobulin, and a small percentage to amino acids.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable for an essential nutrient; whole-body turnover is slow.
Clearance:
Primarily regulated by intestinal excretion.
ExcretionRoute:
Mainly fecal (via bile and pancreatic secretions); small amounts excreted in urine and sweat.
Unchanged:
Not applicable (excreted as zinc ion)
Pharmacodynamics
OnsetOfAction:
Gradual (weeks to months for clinical effects in deficiency states)
PeakEffect:
Not applicable for a nutrient; effects are sustained with consistent intake.
DurationOfAction:
Dependent on continued intake and body stores.
Confidence:
Medium
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 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. Your doctor is available to provide medical advice about side effects.
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. Your doctor is available to provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Severe nausea, vomiting, or diarrhea (may indicate overdose or intolerance)
- Abdominal pain or cramps
- Metallic taste in mouth
- Headache, dizziness
- Unusual tiredness or weakness
- Signs of copper deficiency: pale skin, unusual bruising or bleeding, frequent infections, numbness or tingling in hands/feet, difficulty walking.
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 adjust the dosage of any medication without first consulting 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 adjust the dosage of any medication without first consulting your doctor.
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 consult with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute: Nausea, vomiting, diarrhea, abdominal pain, metallic taste, dizziness, headache, lethargy.
- Chronic: Copper deficiency (anemia, neutropenia, neurological symptoms), impaired immune function, reduced HDL cholesterol.
What to Do:
Discontinue zinc. For acute overdose, supportive care. For chronic toxicity, manage copper deficiency (e.g., copper supplementation). Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Major Interactions
- Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin): Zinc can chelate these antibiotics, significantly reducing their absorption. Separate administration by at least 2-6 hours.
- Tetracycline antibiotics (e.g., doxycycline, minocycline): Zinc can chelate these antibiotics, significantly reducing their absorption. Separate administration by at least 2-6 hours.
Moderate Interactions
- Penicillamine: Zinc can decrease the absorption of penicillamine. Separate administration by at least 2 hours.
- 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 and prevents its absorption. Monitor copper levels with long-term high-dose zinc.
- Calcium and Phosphorus: High dietary intake of calcium and phosphorus may slightly impair zinc absorption.
- Phytates (in whole grains, legumes, nuts): Reduce zinc absorption. Take zinc supplements away from meals rich in phytates.
Minor Interactions
- Folate: High doses of zinc may interfere with folate metabolism, though clinical significance is usually low.
- Chromium: May compete for absorption, but clinical significance is generally low.
Monitoring
Baseline Monitoring
Serum Zinc Level
Rationale: To confirm deficiency if suspected and establish a baseline for therapeutic monitoring.
Timing: Prior to initiation of therapy for deficiency.
Serum Copper Level
Rationale: To establish baseline, especially if high-dose or long-term zinc therapy is anticipated, due to risk of copper deficiency.
Timing: Prior to initiation of high-dose or long-term therapy.
Routine Monitoring
Serum Zinc Level
Frequency: Every 3-6 months for long-term therapy, or as clinically indicated.
Target: 70-120 mcg/dL (or laboratory specific reference range)
Action Threshold: Below target range indicates inadequate supplementation; above target range (especially >200 mcg/dL) indicates potential toxicity or excessive supplementation.
Serum Copper Level
Frequency: Every 6-12 months for long-term high-dose zinc therapy.
Target: 70-140 mcg/dL (or laboratory specific reference range)
Action Threshold: Below target range indicates potential copper deficiency induced by zinc; consider copper supplementation or zinc dose reduction.
Complete Blood Count (CBC)
Frequency: Annually for long-term high-dose zinc therapy.
Target: Normal ranges
Action Threshold: Anemia or neutropenia may indicate 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, peripheral neuropathy, myelopathy)
- Impaired immune function (paradoxical effect with excessive zinc)
Special Patient Groups
Pregnancy
Zinc is an essential nutrient during pregnancy. Adequate intake is crucial for fetal development. Therapeutic doses (above RDA) should only be used if a deficiency is confirmed and under medical supervision. Excessive intake can be harmful.
Trimester-Specific Risks:
First Trimester:
Essential for early organogenesis; deficiency can impact development. High doses should be avoided.
Second Trimester:
Continued need for fetal growth and development.
Third Trimester:
Important for rapid fetal growth and preparation for birth.
Lactation
Zinc is excreted in breast milk and is essential for infant growth and development. Generally considered compatible with breastfeeding at recommended doses. High doses should be avoided.
Infant Risk:
Low risk at appropriate maternal doses; high maternal doses could theoretically lead to infant toxicity or mineral imbalances.
Pediatric Use
Dosing must be carefully calculated based on age, weight, and specific indication to avoid toxicity. Infants and young children are more susceptible to adverse effects from excessive zinc. Essential for growth, immune function, and development.
Geriatric Use
Older adults may have altered zinc absorption or increased risk of deficiency due to dietary factors or comorbidities. Dosing generally similar to adults, but monitor for interactions with other medications and for signs of toxicity or deficiency.
Clinical Information
Clinical Pearls
- Orazinc 110mg typically contains 110mg of zinc sulfate heptahydrate, which provides approximately 25mg of elemental zinc. Always clarify the elemental zinc content when prescribing or dispensing.
- Advise patients to take zinc sulfate with food if they experience gastrointestinal upset, despite potential for reduced absorption.
- Emphasize the importance of separating zinc doses from quinolone and tetracycline antibiotics by several hours to prevent significant reduction in antibiotic efficacy.
- For long-term, high-dose zinc therapy (e.g., >50 mg elemental zinc/day), monitor serum copper levels to prevent induced copper deficiency, which can lead to anemia and neurological issues.
- Zinc supplementation is most effective when a deficiency is confirmed or highly suspected. Routine high-dose supplementation without indication is not recommended.
Alternative Therapies
- Other zinc salts (e.g., zinc gluconate, zinc picolinate, zinc acetate): These salts vary in elemental zinc content and absorption characteristics, but serve the same purpose.
- Dietary sources of zinc: Red meat, poultry, seafood (especially oysters), dairy products, nuts, beans, whole grains.
Cost & Coverage
Average Cost:
$5 - $30 per 30 tablets (for 25-50mg elemental zinc)
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance if prescribed for a medical condition (e.g., deficiency, acrodermatitis enteropathica); otherwise, typically out-of-pocket as an OTC supplement.
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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.