Ezfe 200mg Capsules
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 help growth and good health.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?
Ezfe is an iron supplement used to treat or prevent iron deficiency anemia. Iron is a mineral your body needs to make red blood cells, which carry oxygen throughout your body. This form of iron is often easier on the stomach than other types of iron.
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 you experience stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe 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 by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs 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 you experience stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe 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 by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs 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 as directed by your doctor or pharmacist. Do not take more than recommended.
- You may take this medicine with or without food. Taking it with food may help reduce stomach upset, but it might slightly reduce absorption. If stomach upset occurs, try taking it with a small amount of food.
- Avoid taking this iron supplement at the same time as antacids, calcium supplements, or certain antibiotics (like tetracyclines or fluoroquinolones). Separate doses by at least 2-4 hours.
- Vitamin C (ascorbic acid) can help your body absorb iron. You can take this supplement with a glass of orange juice or a vitamin C supplement.
- Dark or black stools are a normal and harmless side effect of iron supplements. Do not be alarmed.
- To prevent constipation, drink plenty of fluids and eat fiber-rich foods. A stool softener may also be recommended by your doctor.
- Store at room temperature, away from moisture and heat. Keep out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
150 mg elemental iron (e.g., one Ezfe 200mg capsule) orally once daily or as directed by physician.
Dose Range:
150 - 200 mg
Condition-Specific Dosing:
iron_deficiency_anemia:
150-200 mg elemental iron per day, in 1-2 divided doses, until iron stores are repleted (typically 3-6 months).
Pediatric Dosing
Neonatal:
Not established (consult specialist)
Infant:
3-6 mg/kg/day elemental iron in 1-3 divided doses for iron deficiency anemia (consult specialist)
Child:
3-6 mg/kg/day elemental iron in 1-3 divided doses for iron deficiency anemia (max 200 mg elemental iron/day); 1-2 mg/kg/day for prophylaxis.
Adolescent:
150-200 mg elemental iron per day for iron deficiency anemia; 60 mg elemental iron per day for prophylaxis.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed, but monitor iron levels carefully due to potential for iron accumulation in patients on dialysis or with chronic kidney disease not on dialysis who receive erythropoiesis-stimulating agents.
Dialysis:
Oral iron may be used, but IV iron is often preferred in hemodialysis patients due to poor oral absorption and high iron requirements. Monitor iron parameters closely.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment, but use with caution in severe liver disease due to potential for impaired iron metabolism and increased risk of iron overload.
Severe:
Use with caution; avoid if hemochromatosis or hemosiderosis is present or suspected.
Pharmacology
Mechanism of Action
Iron is an essential component of hemoglobin, myoglobin, and various enzymes. Polysaccharide-Iron Complex (PIC) provides a source of elemental iron, which is necessary for erythropoiesis (red blood cell formation) and oxygen transport. PIC is a non-ionic iron preparation, which is thought to lead to better gastrointestinal tolerability and potentially more consistent absorption compared to traditional ferrous salts.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (typically 10-30% of elemental iron, but can be higher in iron-deficient states). Polysaccharide-iron complex is designed for improved absorption and reduced GI side effects compared to ferrous salts.
Tmax:
Variable, generally 2-4 hours for peak serum iron.
FoodEffect:
Less affected by food than ferrous salts, but absorption can still be influenced by certain dietary components (e.g., phytates, oxalates, tannins).
Distribution:
Vd:
Iron is primarily bound to transferrin in plasma and distributed to bone marrow, liver, spleen, and muscle. Stored as ferritin and hemosiderin.
ProteinBinding:
>90% (bound to transferrin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable for elemental iron; iron is conserved by the body.
Clearance:
Minimal (primarily through shedding of GI mucosal cells, sweat, urine, and menstruation in females).
ExcretionRoute:
Fecal (unabsorbed iron), minor renal, sweat, skin desquamation.
Unchanged:
Most unabsorbed iron is excreted in feces.
Pharmacodynamics
OnsetOfAction:
Hematologic response (reticulocytosis) typically begins within 3-10 days. Hemoglobin increase 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 being repleted; therapy usually continues for 3-6 months after hemoglobin normalizes 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 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 coffee ground-like material
Stomach cramps
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 persist, contact your doctor for advice:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
* Change in stool color to green
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 reach out to 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 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 coffee ground-like material
Stomach cramps
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 persist, contact your doctor for advice:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
* Change in stool color to green
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 reach out to 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 (may indicate overdose or severe intolerance).
- Constipation that is severe or persistent.
- Allergic reaction symptoms: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing (seek immediate medical attention).
- Signs of iron overload (rare with oral supplements unless underlying condition): joint pain, fatigue, abdominal pain, dark skin, loss of libido.
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.
If you have an excessive amount of iron in your body (iron overload).
This medication may interact with other medications or health conditions. Therefore, it is crucial to 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 existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination 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.
If you have an excessive amount of iron in your body (iron overload).
This medication may interact with other medications or health conditions. Therefore, it is crucial to 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 existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication in combination 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. This drug may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor before taking this drug, as some formulations may contain tartrazine.
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 breast-feeding, it is crucial 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.
If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor before taking this drug, as some formulations may contain tartrazine.
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 breast-feeding, it is crucial 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): severe stomach pain, nausea, vomiting (may be bloody), diarrhea, lethargy, pallor, cyanosis, drowsiness, shock.
- Latent period (6-24 hours): apparent recovery.
- Later symptoms (12-48 hours): metabolic acidosis, shock, liver damage, renal failure, coma, seizures, death.
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 (e.g., deferoxamine) in severe cases.
Drug Interactions
Contraindicated Interactions
- Hemochromatosis
- Hemosiderosis
- Hemolytic anemia (unless iron deficiency is also present and confirmed)
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Iron can chelate tetracyclines, reducing their absorption. Separate administration by at least 2-3 hours.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Iron can chelate fluoroquinolones, reducing their absorption. Separate administration by at least 2-4 hours.
- Levothyroxine: Iron can reduce levothyroxine absorption. Separate administration by at least 4 hours.
- Mycophenolate mofetil: Iron can decrease mycophenolate absorption. Avoid co-administration.
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide): May reduce iron absorption by increasing gastric pH. Separate administration by 2 hours.
- H2-receptor antagonists (e.g., ranitidine, famotidine): May reduce iron absorption by increasing gastric pH. Separate administration by 2 hours.
- Proton pump inhibitors (e.g., omeprazole, pantoprazole): May reduce iron absorption by increasing gastric pH. Separate administration by 2 hours.
- Cholestyramine: May bind iron and reduce absorption. Separate administration by 2 hours.
- Bisphosphonates (e.g., alendronate): Iron may interfere with absorption. Separate administration by at least 30 minutes (or as directed by bisphosphonate label).
- Zinc supplements: High doses of iron can inhibit zinc absorption. Separate administration.
- Calcium supplements: May inhibit iron absorption. Separate administration by 2 hours.
- Vitamin E: May impair response to iron therapy in some cases.
Minor Interactions
- Dietary fiber, phytates (in cereals, legumes), oxalates (in spinach, rhubarb), tannins (in tea, coffee, wine): Can reduce iron absorption. Advise taking iron between meals or with vitamin C-rich foods.
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 anemia and characterize its type.
Timing: Prior to initiating therapy.
Serum Ferritin
Rationale: To assess body iron stores. Low ferritin is indicative of iron deficiency.
Timing: Prior to initiating therapy.
Serum Iron, Total Iron Binding Capacity (TIBC), Transferrin Saturation (TSAT)
Rationale: To further characterize iron status and confirm iron deficiency.
Timing: Prior to initiating therapy.
Routine Monitoring
Hemoglobin (Hb) and Hematocrit (Hct)
Frequency: Every 3-4 weeks initially, then every 1-3 months until normalized.
Target: Age and sex-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 4 weeks of therapy, re-evaluate diagnosis, adherence, and absorption.
Reticulocyte Count
Frequency: Optional, 7-10 days after starting therapy.
Target: Increase in reticulocyte count (reticulocytosis) is an early sign of bone marrow response.
Action Threshold: Lack of reticulocytosis may indicate non-response.
Serum Ferritin
Frequency: Every 3 months or after Hb normalizes.
Target: >50 ng/mL (to ensure repletion of iron stores).
Action Threshold: Continue therapy until ferritin levels are adequately repleted, typically for 3-6 months after Hb normalizes.
Symptom Monitoring
- Improvement in fatigue, weakness, pallor, shortness of breath, pica, restless legs syndrome.
- Monitoring for gastrointestinal side effects: constipation, diarrhea, nausea, abdominal pain, dark stools (expected and harmless).
Special Patient Groups
Pregnancy
Iron is essential during pregnancy for both maternal and fetal health. Iron deficiency anemia is common in pregnancy due to increased iron demands. Polysaccharide-Iron Complex is generally considered safe and effective for treating and preventing iron deficiency in pregnant women. Category A.
Trimester-Specific Risks:
First Trimester:
No known increased risk of birth defects. Iron is crucial for early fetal development.
Second Trimester:
Safe and commonly used to meet increased iron demands.
Third Trimester:
Safe and commonly used to meet increased iron demands and prepare for delivery.
Lactation
Iron is a normal component of breast milk. Oral iron supplements are considered safe for use during breastfeeding. The amount of iron transferred into breast milk is small and not expected to harm the nursing infant.
Infant Risk:
Low risk to infant. May benefit infant if mother is iron deficient.
Pediatric Use
Iron deficiency is common in children, especially infants and toddlers. Dosing must be carefully calculated based on weight and elemental iron content to avoid toxicity. Accidental iron overdose is a leading cause of poisoning fatalities in young children. Keep iron supplements out of reach.
Geriatric Use
Older adults may be at increased risk for iron deficiency due to dietary factors, malabsorption, or chronic blood loss. Oral iron supplements are generally safe and effective. Monitor for gastrointestinal side effects, which may be more pronounced in this population. Consider underlying causes of iron deficiency.
Clinical Information
Clinical Pearls
- Polysaccharide-Iron Complex (PIC) is often better tolerated gastrointestinally than ferrous salts (e.g., ferrous sulfate), making it a good option for patients who experience significant GI upset with other iron supplements.
- While PIC is less affected by food than ferrous salts, taking it with a source of Vitamin C (e.g., orange juice, Vitamin C tablet) can still enhance absorption.
- Educate patients that dark or black stools are a normal and expected side effect of oral iron therapy and do not indicate bleeding.
- Emphasize the importance of consistent daily dosing for several months (typically 3-6 months after hemoglobin normalizes) to fully replete iron stores.
- Always rule out underlying causes of iron deficiency (e.g., gastrointestinal bleeding) before initiating long-term iron supplementation.
Alternative Therapies
- Other oral iron salts (e.g., ferrous sulfate, ferrous gluconate, ferrous fumarate)
- Carbonyl iron
- Heme iron polypeptide
- Intravenous (IV) iron preparations (e.g., iron dextran, iron sucrose, ferric carboxymaltose, ferumoxytol) for severe deficiency, malabsorption, or intolerance to oral iron.
Cost & Coverage
Average Cost:
Typically $10-$50 per 30 capsules (for generic/OTC)
Generic Available:
Yes
Insurance Coverage:
Often covered by most insurance plans, especially generic forms. May be available OTC without prescription.
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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.