Ferrous Gluconate 324mg U/d Tablets
WARNING: Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away. @ COMMON USES: It is used to aid diet needs.It is used to treat or prevent low iron in the body.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antianemic agent; Iron supplement
Pharmacologic Class
Iron preparation
Pregnancy Category
Category A
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ferrous gluconate is a type of iron supplement used to treat or prevent iron deficiency anemia, a condition where your body doesn't have enough iron to make healthy red blood cells. Iron is essential for carrying oxygen throughout your body.
How to Use This Medicine
Taking Your Medication Correctly
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. For optimal effectiveness, take this medication on an empty stomach. However, if it causes stomach upset, you may take it with food.
Some foods, such as eggs, whole grain breads, cereal, dairy products, coffee, and tea, may interfere with the medication's effectiveness. If you experience stomach upset, consult your doctor about the best way to take this medication with food. Always take your medication with a full glass of water.
If you need to take antacids, discuss with your doctor or pharmacist whether you should take them at a different time than your medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a 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 in your area.
What to Do If You Miss 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 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. For optimal effectiveness, take this medication on an empty stomach. However, if it causes stomach upset, you may take it with food.
Some foods, such as eggs, whole grain breads, cereal, dairy products, coffee, and tea, may interfere with the medication's effectiveness. If you experience stomach upset, consult your doctor about the best way to take this medication with food. Always take your medication with a full glass of water.
If you need to take antacids, discuss with your doctor or pharmacist whether you should take them at a different time than your medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a 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 in your area.
What to Do If You Miss 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 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 on an empty stomach (1 hour before or 2 hours after meals) for best absorption, unless stomach upset occurs. If stomach upset is a problem, take with food, but avoid dairy, tea, coffee, or high-fiber foods.
- Avoid taking with antacids, calcium supplements, or certain medications (e.g., tetracyclines, fluoroquinolones, levothyroxine) within 2-4 hours of your iron dose.
- Taking with Vitamin C (e.g., orange juice) can enhance iron absorption.
- Maintain a balanced diet rich in iron (e.g., red meat, poultry, fish, beans, fortified cereals, leafy greens).
- Do not lie down for at least 30 minutes after taking to prevent esophageal irritation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For iron deficiency anemia: 324 mg ferrous gluconate (approx. 38 mg elemental iron) 2-3 times daily. For iron deficiency prophylaxis: 324 mg ferrous gluconate (approx. 38 mg elemental iron) once daily.
Dose Range:
38 - 114 mg
Condition-Specific Dosing:
ironDeficiencyAnemia:
324 mg ferrous gluconate (approx. 38 mg elemental iron) 2-3 times daily, adjusted based on response and tolerability.
ironDeficiencyProphylaxis:
324 mg ferrous gluconate (approx. 38 mg elemental iron) once daily.
Pediatric Dosing
Neonatal:
Not established for routine use; consult specialist for specific conditions.
Infant:
Elemental iron: Prophylaxis: 1-2 mg/kg/day. Mild-moderate deficiency: 3 mg/kg/day. Severe deficiency: 4-6 mg/kg/day, divided 2-3 times daily. Max 200 mg elemental iron/day.
Child:
Elemental iron: Prophylaxis: 1-2 mg/kg/day. Mild-moderate deficiency: 3 mg/kg/day. Severe deficiency: 4-6 mg/kg/day, divided 2-3 times daily. Max 200 mg elemental iron/day.
Adolescent:
Elemental iron: Prophylaxis: 1-2 mg/kg/day. Mild-moderate deficiency: 3 mg/kg/day. Severe deficiency: 4-6 mg/kg/day, divided 2-3 times daily. Max 200 mg elemental iron/day. For iron deficiency anemia, adult dosing may apply.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required, but use with caution in patients on dialysis due to potential for iron overload if receiving IV iron. Monitor iron parameters closely.
Dialysis:
Monitor iron parameters (ferritin, transferrin saturation) closely. Oral iron may be used, but IV iron is often preferred in hemodialysis patients.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Use with caution in severe hepatic impairment, especially if associated with conditions like hemochromatosis or hemosiderosis, as iron accumulation can worsen liver damage. Monitor iron parameters.
Pharmacology
Mechanism of Action
Iron is an essential component in the formation of hemoglobin, myoglobin, and various enzymes (e.g., cytochromes, catalase, peroxidase). It plays a crucial role in oxygen transport, cellular respiration, and numerous metabolic processes. Ferrous gluconate provides a readily absorbable form of iron to replenish depleted iron stores and support erythropoiesis.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (10-30% in iron-deficient individuals; 5-10% in iron-replete individuals), inversely proportional to body iron stores.
Tmax:
Peak serum iron levels typically occur 2-4 hours after oral administration.
FoodEffect:
Food significantly decreases iron absorption (by 40-50% or more), but may reduce gastrointestinal upset.
Distribution:
Vd:
Iron does not distribute into a specific volume in the classical sense; it is transported in plasma bound to transferrin and stored primarily in the liver, spleen, and bone marrow as ferritin or hemosiderin.
ProteinBinding:
Extensively bound to transferrin in plasma.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable (iron is conserved in the body).
Clearance:
Minimal excretion; small amounts are lost via desquamation of skin and mucosal cells, sweat, urine, and bile. Unabsorbed iron is excreted in feces.
ExcretionRoute:
Primarily fecal (unabsorbed iron); minimal renal and biliary excretion.
Unchanged:
Most absorbed iron is utilized; unabsorbed iron is excreted in feces.
Pharmacodynamics
OnsetOfAction:
Hemoglobin levels typically begin to rise within 1-2 weeks of initiating therapy.
PeakEffect:
Maximum increase in hemoglobin usually observed after 4-6 weeks of therapy.
DurationOfAction:
Therapy typically continues for 3-6 months after hemoglobin levels normalize to replenish iron stores.
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 immediately or seek emergency 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
Black, tarry, or bloody stools
Fever
Vomiting blood or material that looks like coffee grounds
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Change in stool color to green
Stomach cramps
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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 can provide medical advice about side effects and help you manage any concerns.
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 immediately or seek emergency 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
Black, tarry, or bloody stools
Fever
Vomiting blood or material that looks like coffee grounds
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Change in stool color to green
Stomach cramps
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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 can provide medical advice about side effects and help you manage any concerns.
Seek Immediate Medical Attention If You Experience:
- Severe constipation or diarrhea that does not resolve.
- Persistent nausea or vomiting.
- Severe abdominal pain.
- Black, tarry stools (expected, but report if accompanied by other severe symptoms).
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Having too much iron in your body
+ Anemia caused by a factor other than low iron levels
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Having too much iron in your body
+ Anemia caused by a factor other than low iron levels
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm 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 will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
As this medication may interfere with certain laboratory tests, it is crucial to notify all healthcare providers and laboratory personnel that you are taking this drug. If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult with your doctor, as some formulations of this medication may contain this ingredient.
Additionally, this medication can affect the absorption of other drugs. If you are taking other medications, consult with your doctor or pharmacist to determine if you need to take them at a different time than this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
As this medication may interfere with certain laboratory tests, it is crucial to notify all healthcare providers and laboratory personnel that you are taking this drug. If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult with your doctor, as some formulations of this medication may contain this ingredient.
Additionally, this medication can affect the absorption of other drugs. If you are taking other medications, consult with your doctor or pharmacist to determine if you need to take them at a different time than this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe stomach pain
- Nausea
- Vomiting (may be bloody or contain dark material)
- Diarrhea (may be bloody)
- Drowsiness
- Pale or bluish lips/skin
- Weak, rapid pulse
- Low blood pressure
- Shallow breathing
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Iron overdose can be fatal, especially in children.
Drug Interactions
Major Interactions
- Dimercaprol (increased risk of nephrotoxicity)
- Oral tetracyclines (decreased absorption of both iron and tetracycline)
- Oral fluoroquinolones (decreased absorption of fluoroquinolones)
Moderate Interactions
- Antacids (decreased iron absorption)
- Proton pump inhibitors (decreased iron absorption)
- H2-receptor antagonists (decreased iron absorption)
- Levothyroxine (decreased levothyroxine absorption)
- Penicillamine (decreased penicillamine absorption)
- Mycophenolate mofetil (decreased mycophenolate absorption)
- Bisphosphonates (decreased bisphosphonate absorption)
- Cholestyramine (decreased iron absorption)
- Zinc supplements (decreased absorption of both iron and zinc if taken together)
- Vitamin E (may impair iron utilization)
- Chloramphenicol (may delay response to iron therapy)
Minor Interactions
- Ascorbic acid (Vitamin C) (enhances iron absorption)
- Dairy products (decreased iron absorption)
- Tea, coffee (decreased iron absorption)
- Eggs (decreased iron absorption)
- Phytates (e.g., whole grains, legumes) (decreased iron absorption)
- Oxalates (e.g., spinach, rhubarb) (decreased iron absorption)
- Phosphates (e.g., in cola drinks) (decreased iron absorption)
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To establish baseline severity of anemia.
Timing: Prior to initiation of therapy.
Hematocrit (Hct)
Rationale: To establish baseline severity of anemia.
Timing: Prior to initiation of therapy.
Serum Ferritin
Rationale: To assess body iron stores and confirm iron deficiency.
Timing: Prior to initiation of therapy.
Transferrin Saturation (TSAT)
Rationale: To assess functional iron deficiency and iron transport.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with Red Blood Cell Indices (MCV, MCH)
Rationale: To characterize anemia (e.g., microcytic, hypochromic).
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Every 2-4 weeks initially, then every 1-3 months until normalized.
Target: Age and sex-appropriate normal range.
Action Threshold: If Hb does not increase by 1-2 g/dL after 4 weeks, re-evaluate diagnosis and adherence.
Hematocrit (Hct)
Frequency: Every 2-4 weeks initially, then every 1-3 months until normalized.
Target: Age and sex-appropriate normal range.
Action Threshold: If Hct does not show expected increase, re-evaluate.
Serum Ferritin
Frequency: Every 3-6 months after Hb normalization, or as needed.
Target: >30-50 ng/mL (to ensure repletion of iron stores).
Action Threshold: If ferritin remains low after Hb normalization, continue therapy. If ferritin is excessively high, consider iron overload.
Reticulocyte Count
Frequency: 1-2 weeks after initiation (optional).
Target: Expected increase (reticulocytosis).
Action Threshold: Lack of reticulocytosis may indicate non-response.
Symptom Monitoring
- Gastrointestinal upset (nausea, vomiting, abdominal pain, constipation, diarrhea)
- Darkening of stools (expected and harmless)
- Heartburn
- Metallic taste
- Symptoms of iron deficiency (fatigue, pallor, shortness of breath, pica, restless legs syndrome) should improve.
Special Patient Groups
Pregnancy
Iron requirements increase significantly during pregnancy. Ferrous gluconate is commonly used and considered safe and effective for treating or preventing iron deficiency anemia in pregnant women when indicated. Category A indicates adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester (and there is no evidence of risk in later trimesters).
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of fetal abnormalities.
Second Trimester:
No evidence of increased risk.
Third Trimester:
No evidence of increased risk.
Lactation
Iron is a normal component of breast milk. Supplemental iron is generally considered compatible with breastfeeding and is often recommended for lactating women with iron deficiency. Infant exposure is minimal and not expected to cause adverse effects.
Infant Risk:
L1 (Safest) - No increase in adverse effects on the infant.
Pediatric Use
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep out of reach of children. Dosing must be carefully calculated based on elemental iron per kg body weight. Use liquid formulations for infants and young children if tablets are not appropriate.
Geriatric Use
No specific dose adjustments are typically required for elderly patients, but they may be more susceptible to gastrointestinal side effects. Monitor for constipation. Ensure adequate fluid and fiber intake. Consider underlying causes of iron deficiency.
Clinical Information
Clinical Pearls
- Advise patients that stools may become dark or black, which is a normal and harmless effect of iron supplementation.
- To minimize GI side effects, start with a lower dose and gradually increase, or take with a small amount of food (though this reduces absorption).
- Emphasize the importance of consistent daily dosing for several months to fully replenish iron stores, even after hemoglobin levels normalize.
- Educate patients about common drug and food interactions that can reduce iron absorption.
- Liquid iron preparations can stain teeth; advise patients to dilute with water or juice and drink through a straw, then brush teeth immediately.
Alternative Therapies
- Ferrous sulfate (most common and cost-effective oral iron salt)
- Ferrous fumarate
- Polysaccharide iron complex
- Carbonyl iron
- Iron protein succinylate
- Intravenous iron preparations (e.g., iron dextran, iron sucrose, ferric carboxymaltose) for severe deficiency, malabsorption, or intolerance to oral iron.
Cost & Coverage
Average Cost:
Varies widely, typically $5-$30 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often covered as a Tier 1 or Tier 2 generic by most insurance plans. May be available OTC without prescription coverage.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about your 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.