Ferrous Gluc 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
Pharmacologic Class
Mineral supplement; Iron preparation
Pregnancy Category
Category B
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. Iron is a vital mineral that your body needs to make red blood cells, which carry 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.
Some foods, such as eggs, whole grain bread, cereal, dairy products, coffee, and tea, may interfere with the medication's effectiveness. If you experience stomach upset, consult your doctor for guidance on taking the 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 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 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 can take it with food.
Some foods, such as eggs, whole grain bread, cereal, dairy products, coffee, and tea, may interfere with the medication's effectiveness. If you experience stomach upset, consult your doctor for guidance on taking the 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 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 a missed one.
Lifestyle & Tips
- Take on an empty stomach (1 hour before or 2 hours after meals) for best absorption, unless it causes stomach upset. If stomach upset occurs, take with food.
- Avoid taking with milk, dairy products, coffee, tea, or antacids, as these can reduce iron absorption. Separate by at least 2 hours.
- Consider taking with Vitamin C (e.g., orange juice) to enhance absorption.
- Expect stools to become dark or black; this is a normal and harmless effect of iron.
- Increase fluid and fiber intake to help prevent constipation, a common side effect.
- Store iron supplements out of reach of children, as accidental overdose can be fatal.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For iron deficiency anemia: 324 mg (38 mg elemental iron) to 648 mg (76 mg elemental iron) orally 1 to 3 times daily.
Dose Range:
324 - 648 mg
Condition-Specific Dosing:
prophylaxis:
324 mg (38 mg elemental iron) orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for this formulation; elemental iron dosing typically 1-2 mg/kg/day for prophylaxis, 3-6 mg/kg/day for treatment.
Child:
For iron deficiency anemia: 3-6 mg elemental iron/kg/day in 1-3 divided doses. Ferrous gluconate 324 mg contains 38 mg elemental iron.
Adolescent:
For iron deficiency anemia: 324 mg (38 mg elemental iron) to 648 mg (76 mg elemental iron) orally 1 to 3 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but monitor iron levels to avoid overload.
Severe:
Use with caution; monitor iron levels closely due to potential for iron accumulation, especially in patients on dialysis.
Dialysis:
Monitor iron levels closely. Oral iron may be used, but IV iron is often preferred in ESRD due to poor absorption and need for higher doses.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
Use with caution; monitor iron levels. Impaired liver function can affect iron metabolism and storage.
Severe:
Contraindicated in hemochromatosis and hemosiderosis. Use with extreme caution; monitor iron levels closely.
Pharmacology
Mechanism of Action
Iron is an essential component in the formation of hemoglobin, myoglobin, and various enzymes (e.g., cytochrome oxidases, catalase, peroxidase). It functions as an oxygen carrier in hemoglobin and myoglobin, and is involved in various metabolic processes, including electron transport, DNA synthesis, and energy metabolism. Ferrous gluconate provides a readily absorbable form of iron to replenish depleted iron stores and support erythropoiesis.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, typically 10-30% of elemental iron, inversely proportional to body iron stores. Absorption is highest when iron stores are low.
Tmax:
Approximately 2-4 hours (for elemental iron from oral preparations).
FoodEffect:
Food, especially dairy products, tea, coffee, and whole grains, can decrease absorption. Ascorbic acid (Vitamin C) can enhance absorption.
Distribution:
Vd:
Not applicable (iron is incorporated into various body components).
ProteinBinding:
Binds to transferrin for transport in plasma; stored as ferritin and hemosiderin.
CnssPenetration:
Limited (does not readily cross the blood-brain barrier in significant amounts).
Elimination:
HalfLife:
Not applicable (iron is conserved and recycled in the body).
Clearance:
Minimal excretion; primarily lost through shedding of cells (skin, GI tract), menstruation, and minor bleeding.
ExcretionRoute:
Feces (unabsorbed iron), urine (trace amounts), sweat, desquamation of skin and GI cells, menstruation.
Unchanged:
Not applicable (iron is utilized).
Pharmacodynamics
OnsetOfAction:
Reticulocytosis typically begins within 3-10 days; increase in hemoglobin concentration usually seen within 2-4 weeks.
PeakEffect:
Maximum hemoglobin response typically achieved after 1-2 months of therapy.
DurationOfAction:
Effects persist as long as iron stores are maintained; therapy usually continued for 3-6 months after hemoglobin normalizes to replenish 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 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
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. 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, 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.
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 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
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. 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, 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.
Seek Immediate Medical Attention If You Experience:
- Severe abdominal pain
- Vomiting (especially if bloody or coffee-ground like)
- Diarrhea (especially if bloody)
- Dizziness or fainting
- Rapid or shallow breathing
- Bluish lips or fingernails
- Unusual tiredness or weakness (signs of severe overdose)
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.
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, tell 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, consult with your doctor to confirm it is safe for you to do so.
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.
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, tell 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, consult with your doctor to confirm it is safe for you 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. Your doctor will likely recommend regular blood tests to monitor your condition, and it is crucial to discuss the details with them.
As this medication may interfere with certain laboratory tests, be sure to notify all your healthcare providers and laboratory personnel that you are taking it.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor, as some formulations of this medication may contain this ingredient.
This medication can affect the absorption of other drugs, potentially reducing their effectiveness. If you are taking other medications, consult with your doctor or pharmacist to determine if you should take them at a different time than this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they will need to weigh the advantages and disadvantages for both you and your baby.
As this medication may interfere with certain laboratory tests, be sure to notify all your healthcare providers and laboratory personnel that you are taking it.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor, as some formulations of this medication may contain this ingredient.
This medication can affect the absorption of other drugs, potentially reducing their effectiveness. If you are taking other medications, consult with your doctor or pharmacist to determine if you should take them at a different time than this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they will need to weigh the advantages and disadvantages for both you and your baby.
Overdose Information
Overdose Symptoms:
- Initial symptoms (within 6 hours): Nausea, vomiting, diarrhea, abdominal pain, lethargy, pallor, cyanosis, drowsiness, shock.
- Latent period (6-24 hours): Apparent recovery.
- Relapse (12-48 hours): Metabolic acidosis, shock, hepatic necrosis, renal failure, coagulopathy, cardiovascular collapse, coma, death.
- Delayed complications (weeks): Gastric scarring, pyloric stenosis.
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment may involve gastric lavage, whole bowel irrigation, and chelation therapy with deferoxamine.
Drug Interactions
Major Interactions
- Dimercaprol (increased risk of nephrotoxicity)
- Levodopa (reduced levodopa efficacy)
- Methyldopa (reduced methyldopa efficacy)
- Mycophenolate mofetil (reduced mycophenolate efficacy)
Moderate Interactions
- Antacids (reduced iron absorption)
- Tetracyclines (reduced absorption of both iron and tetracycline)
- Fluoroquinolones (reduced absorption of both iron and fluoroquinolone)
- Levothyroxine (reduced levothyroxine efficacy)
- Bisphosphonates (reduced bisphosphonate absorption)
- Penicillamine (reduced penicillamine absorption)
- Zinc supplements (reduced absorption of both iron and zinc)
- Calcium supplements (reduced iron absorption)
- Proton pump inhibitors (PPIs) / H2 blockers (reduced iron absorption due to increased gastric pH)
- Cholestyramine (reduced iron absorption)
- Chloramphenicol (may delay response to iron therapy)
Minor Interactions
- Vitamin C (ascorbic acid) (enhances iron absorption)
- Coffee/Tea (reduced iron absorption)
- Dairy products (reduced iron absorption)
- Whole grains/Fiber (reduced iron absorption)
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To assess severity of anemia.
Timing: Prior to initiation of therapy.
Hematocrit (Hct)
Rationale: To assess severity of anemia.
Timing: Prior to initiation of therapy.
Serum Ferritin
Rationale: To assess body iron stores.
Timing: Prior to initiation of therapy.
Serum Iron
Rationale: To assess circulating iron levels.
Timing: Prior to initiation of therapy.
Total Iron Binding Capacity (TIBC)
Rationale: To assess iron transport capacity.
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 (e.g., 12-16 g/dL for adult females, 13.5-17.5 g/dL for adult males).
Action Threshold: If Hb does not increase by 1-2 g/dL after 4 weeks of therapy, re-evaluate diagnosis or 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 increase appropriately, re-evaluate.
Reticulocyte count
Frequency: 1-2 weeks after initiation (optional).
Target: Increase indicates bone marrow response.
Action Threshold: Lack of increase may indicate non-response.
Serum Ferritin
Frequency: Every 3-6 months, or after Hb normalizes.
Target: Typically >50 ng/mL to replenish stores.
Action Threshold: Continue therapy until ferritin levels are adequate.
Symptom Monitoring
- Gastrointestinal upset (nausea, vomiting, abdominal pain)
- Constipation or diarrhea
- Darkening of stools (expected and harmless)
- Heartburn
- Metallic taste
Special Patient Groups
Pregnancy
Iron is essential during pregnancy to support increased maternal blood volume and fetal development. Iron deficiency anemia is common in pregnancy. Ferrous gluconate is generally considered safe and effective for treating or preventing iron deficiency anemia in pregnant women.
Trimester-Specific Risks:
First Trimester:
No known increased risk of birth defects.
Second Trimester:
Safe and commonly used.
Third Trimester:
Safe and commonly used.
Lactation
Iron is a normal component of breast milk. Oral iron supplements are generally considered safe for use during breastfeeding and are not expected to cause adverse effects in breastfed infants. It may be necessary to treat maternal iron deficiency.
Infant Risk:
Low risk; no adverse effects expected in breastfed infants at therapeutic maternal doses.
Pediatric Use
Iron deficiency is common in children, especially infants and toddlers. Oral iron supplements are widely used. However, accidental overdose of iron is a leading cause of poisoning fatalities in young children. Dosing must be precise based on elemental iron content and child's weight. Keep out of reach of children.
Geriatric Use
Elderly patients may be more susceptible to gastrointestinal side effects (constipation). Absorption may be reduced due to achlorhydria or use of acid-reducing medications. Monitor for interactions with polypharmacy. Iron deficiency in the elderly should prompt investigation for underlying causes (e.g., GI bleeding).
Clinical Information
Clinical Pearls
- Ferrous gluconate contains approximately 12% elemental iron (e.g., 324 mg tablet contains 38 mg elemental iron). Dosing should always be based on elemental iron.
- Oral iron therapy should be continued for at least 3-6 months after hemoglobin levels normalize to replenish body iron stores (ferritin).
- Constipation is a common side effect; advise patients to increase fluid and fiber intake, and consider stool softeners if needed.
- Advise patients that stools will turn dark or black, which is a harmless effect of iron.
- For optimal absorption, iron should be taken on an empty stomach, but if GI upset occurs, it can be taken with food (though absorption may be reduced).
- Educate patients about potential drug and food interactions that can reduce iron absorption (e.g., antacids, dairy, coffee, tea, certain antibiotics). Separate doses by at least 2 hours.
Alternative Therapies
- Dietary iron intake (red meat, fortified cereals, leafy greens)
- Intravenous (IV) 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-$20 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 this medication, don't hesitate to discuss them with 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.