Ferrous Gluconate 324mg 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; Mineral supplement
Pharmacologic Class
Iron preparation
Pregnancy Category
Category A (when used for iron deficiency anemia)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ferrous gluconate is an 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 can take it with food. Be aware that certain 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.
When taking this medication, drink a full glass of water. If you use antacids, you may need to take them at a different time than your medication. Discuss this with your doctor or pharmacist to determine the best approach.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing 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 available 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'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 the 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 can take it with food. Be aware that certain 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.
When taking this medication, drink a full glass of water. If you use antacids, you may need to take them at a different time than your medication. Discuss this with your doctor or pharmacist to determine the best approach.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing 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 available 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'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 the missed one.
Lifestyle & Tips
- Take iron on an empty stomach (1 hour before or 2 hours after meals) for best absorption, if tolerated. If stomach upset occurs, take with food, but avoid dairy, tea, coffee, and high-fiber foods.
- Take with a glass of water or orange juice (Vitamin C enhances absorption).
- Do not lie down for at least 30 minutes after taking to prevent esophageal irritation.
- Avoid taking with antacids, calcium supplements, or certain medications (see interactions) within 2-4 hours.
- Maintain a balanced diet rich in iron (e.g., red meat, poultry, fish, beans, fortified cereals).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
324 mg (equivalent to 38 mg elemental iron) orally 1 to 3 times daily, or as directed by physician. Dosing should be based on elemental iron requirements.
Dose Range:
38 - 114 mg
Condition-Specific Dosing:
ironDeficiencyAnemia:
324 mg (38 mg elemental iron) orally 2-3 times daily, or 648 mg (76 mg elemental iron) orally once daily, adjusted based on elemental iron needs (typically 100-200 mg elemental iron daily in divided doses).
Pediatric Dosing
Neonatal:
Not established (use specific pediatric formulations and dosing based on elemental iron, e.g., 1-2 mg/kg/day for prophylaxis, 3-6 mg/kg/day for treatment)
Infant:
Not established (use specific pediatric formulations and dosing based on elemental iron, e.g., 1-2 mg/kg/day for prophylaxis, 3-6 mg/kg/day for treatment)
Child:
Not established (use specific pediatric formulations and dosing based on elemental iron, e.g., 3-6 mg/kg/day elemental iron in 1-3 divided doses for treatment of iron deficiency anemia, up to 150-200 mg elemental iron/day)
Adolescent:
Similar to adult dosing for iron deficiency anemia (e.g., 324 mg orally 1-3 times daily, based on elemental iron needs)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; avoid in patients with non-iron deficiency anemia (e.g., anemia of chronic kidney disease) without confirmed iron deficiency, due to risk of iron overload. Monitor iron parameters closely.
Dialysis:
No specific adjustment needed, but monitor iron parameters. IV iron may be preferred in some dialysis patients.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution in patients with severe liver disease, especially if associated with hemochromatosis or hemosiderosis. Monitor iron parameters closely.
Confidence:
Medium
Pharmacology
Mechanism of Action
Iron is an essential component in the formation of hemoglobin, myoglobin, and various enzymes (e.g., cytochromes, catalase, peroxidase). It functions as an oxygen carrier in hemoglobin and myoglobin, and is involved in electron transport and energy metabolism. Ferrous gluconate provides a source of iron to replenish depleted iron stores and correct iron deficiency anemia.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, typically 5-10% in healthy individuals, but can increase to 20-30% in iron-deficient states. Ferrous salts are generally better absorbed than ferric salts.
Tmax:
Approximately 2-4 hours (for serum iron concentration)
FoodEffect:
Food, especially dairy products, tea, coffee, and whole grains, can significantly decrease iron absorption. Ascorbic acid (Vitamin C) enhances absorption.
Distribution:
Vd:
Not directly applicable for iron as it's incorporated into various body components; primarily bound to transferrin in plasma, stored as ferritin and hemosiderin in reticuloendothelial cells (liver, spleen, bone marrow), and incorporated into hemoglobin.
ProteinBinding:
Bound to transferrin (a beta-globulin) for transport in plasma.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable for elemental iron; iron is conserved by the body.
Clearance:
Minimal excretion; primarily through desquamation of cells from skin, GI tract, and urinary tract, and via bile.
ExcretionRoute:
Feces (unabsorbed iron), minimal urine, sweat, and bile.
Unchanged:
Most absorbed iron is utilized; unabsorbed iron is excreted in feces.
Pharmacodynamics
OnsetOfAction:
Hematologic response (reticulocytosis) typically begins within 3-10 days; increase in hemoglobin concentration usually seen within 2-4 weeks.
PeakEffect:
Hemoglobin levels typically normalize within 1-3 months, but iron stores may take 3-6 months or longer to fully replenish.
DurationOfAction:
Effects persist as long as iron stores are maintained; treatment duration is typically 3-6 months after hemoglobin normalization to replenish stores.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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
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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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, don't hesitate to 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 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
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 minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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, don't hesitate to 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 pain, nausea, vomiting, or diarrhea (especially if severe or persistent)
- Black, tarry stools (normal with iron, but report if accompanied by other severe symptoms)
- Constipation or diarrhea that is unmanageable
- 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so in conjunction 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 symptoms you experienced as a result of the allergy.
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, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so in conjunction 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. Your doctor will instruct you to have regular blood tests, and it is crucial to discuss any concerns or questions you have with them.
This medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you have an allergy to tartrazine (FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient.
As this medication can prevent other drugs from being absorbed by the body, it is crucial to check with your doctor or pharmacist if you are taking other medications to determine if you need to take them at a different time.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
This medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you have an allergy to tartrazine (FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient.
As this medication can prevent other drugs from being absorbed by the body, it is crucial to check with your doctor or pharmacist if you are taking other medications to determine if you need to take them at a different time.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Initial symptoms (within 6 hours): Nausea, vomiting, abdominal pain, diarrhea (often bloody), lethargy, pallor, cyanosis, drowsiness, shock.
- Latent period (6-24 hours): Apparent recovery.
- Later symptoms (12-48 hours): Metabolic acidosis, shock, hepatic necrosis, renal failure, cardiovascular collapse, coma, death.
- Delayed complications (weeks): Pyloric stenosis, liver cirrhosis.
What to Do:
IMMEDIATELY call Poison Control (1-800-222-1222) or seek emergency medical attention. Treatment may involve gastric lavage, whole bowel irrigation, and chelation therapy (e.g., deferoxamine).
Drug Interactions
Contraindicated Interactions
- Hemochromatosis
- Hemosiderosis
- Hemolytic anemia (unless iron deficiency coexists)
- Parenteral iron preparations (concurrent use)
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Iron forms insoluble chelates, reducing absorption of both.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Iron forms insoluble chelates, reducing absorption of both.
- Levothyroxine: Iron can impair levothyroxine absorption, leading to hypothyroidism.
- Bisphosphonates (e.g., alendronate, risedronate): Iron can reduce bisphosphonate absorption.
- Mycophenolate mofetil: Iron can decrease mycophenolate absorption.
- Antacids (aluminum, magnesium, calcium-containing): Can decrease iron absorption by increasing gastric pH.
- Proton Pump Inhibitors (PPIs) (e.g., omeprazole, pantoprazole): Can decrease iron absorption by increasing gastric pH.
- H2-receptor antagonists (e.g., ranitidine, famotidine): Can decrease iron absorption by increasing gastric pH.
Moderate Interactions
- Penicillamine: Iron can decrease penicillamine absorption.
- Chloramphenicol: May delay response to iron therapy.
- Vitamin E: Large doses may impair iron utilization.
- Cholestyramine: May decrease iron absorption.
- Zinc supplements: High doses of zinc can interfere with iron absorption.
Minor Interactions
- Food (dairy products, eggs, tea, coffee, whole grains, high-fiber foods): Can decrease iron absorption.
- Ascorbic acid (Vitamin C): Enhances iron absorption.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess hemoglobin (Hb), hematocrit (Hct), mean corpuscular volume (MCV), and red blood cell indices to confirm iron deficiency anemia and rule out other causes.
Timing: Prior to initiation of therapy
Serum Ferritin
Rationale: To assess body iron stores; low ferritin is the most sensitive indicator of iron deficiency.
Timing: Prior to initiation of therapy
Serum Iron and Total Iron Binding Capacity (TIBC)
Rationale: To assess circulating iron levels and iron-binding capacity, aiding in diagnosis of iron deficiency.
Timing: Prior to initiation of therapy
Routine Monitoring
Hemoglobin (Hb) and Hematocrit (Hct)
Frequency: Every 3-4 weeks initially, then every 1-3 months until levels normalize.
Target: Age and gender-appropriate normal ranges (e.g., Hb >12 g/dL for adult females, >13 g/dL for adult males)
Action Threshold: If Hb does not increase by at least 1-2 g/dL after 3-4 weeks of therapy, re-evaluate diagnosis and adherence.
Reticulocyte Count
Frequency: Optional, 7-10 days after initiation of therapy.
Target: Increase from baseline (reticulocytosis indicates bone marrow response)
Action Threshold: Lack of reticulocytosis may indicate non-adherence or incorrect diagnosis.
Serum Ferritin
Frequency: Every 3-6 months after Hb normalization, or periodically to monitor repletion of iron stores.
Target: Typically >30-50 ng/mL to ensure adequate iron stores.
Action Threshold: If ferritin remains low after Hb normalization, continue therapy to replete stores.
Symptom Monitoring
- Improvement in fatigue, weakness, pallor, shortness of breath, pica, restless legs syndrome.
- Monitoring for gastrointestinal side effects: nausea, vomiting, constipation, diarrhea, abdominal pain, dark stools (expected and harmless).
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. It is classified as Pregnancy Category A when used for iron deficiency.
Trimester-Specific Risks:
First Trimester:
Generally safe and often recommended for prophylaxis or treatment of iron deficiency.
Second Trimester:
Safe and commonly used.
Third Trimester:
Safe and commonly used.
Lactation
Iron is excreted in breast milk in small amounts. Ferrous gluconate is considered compatible with breastfeeding and is often recommended for postpartum iron deficiency.
Infant Risk:
Low risk to the infant. No adverse effects reported with maternal use.
Pediatric Use
Used in pediatric populations for iron deficiency anemia, but dosing must be carefully calculated based on elemental iron per kg body weight. Liquid formulations are often preferred for younger children. Accidental overdose is a leading cause of poisoning fatalities in young children; keep out of reach.
Geriatric Use
No specific dose adjustments are typically needed. However, geriatric patients may be more susceptible to gastrointestinal side effects (constipation) and may have underlying conditions affecting iron absorption or metabolism. Monitor for interactions with polypharmacy.
Clinical Information
Clinical Pearls
- Ferrous gluconate contains approximately 12% elemental iron (324 mg tablet = ~38 mg elemental iron).
- Darkening of stools is a normal and harmless side effect of iron supplementation.
- Constipation is a common side effect; advise patients to increase fluid and fiber intake, or consider a stool softener.
- For optimal absorption, take iron on an empty stomach. If GI upset occurs, take with food, but avoid dairy, tea, coffee, and high-fiber foods.
- Vitamin C (ascorbic acid) enhances iron absorption; advise taking iron with orange juice or a Vitamin C supplement.
- Iron supplements should be continued for at least 3-6 months after hemoglobin levels normalize to replenish body iron stores.
Alternative Therapies
- Other oral iron salts: Ferrous sulfate (most common, ~20% elemental iron), Ferrous fumarate (~33% elemental iron), Polysaccharide iron complex.
- Intravenous (IV) iron preparations: Iron dextran, Iron sucrose, Ferric carboxymaltose, Ferumoxytol (used for severe deficiency, malabsorption, or intolerance to oral iron).
Cost & Coverage
Average Cost:
$5 - $20 per 100 tablets (approximate)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.