Slow FE 45mg 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 B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Slow FE is an iron supplement used to prevent or treat low iron levels in the body, which can lead to a condition called iron deficiency anemia. Iron is essential for making red blood cells that 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 may 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 about the best way to take this medication with food. Additionally, if you take antacids, your doctor or pharmacist may recommend taking them at a different time than your medication.
Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
Take the medication with a full glass of water.
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.
Missing 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 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 bread, 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. Additionally, if you take antacids, your doctor or pharmacist may recommend taking them at a different time than your medication.
Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
Take the medication with a full glass of water.
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.
Missing 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.
Lifestyle & Tips
- Take Slow FE with a full glass of water. If stomach upset occurs, you may take it with food, but be aware that food can reduce iron absorption. Avoid taking it with milk, coffee, or tea.
- Taking Slow FE with Vitamin C (e.g., orange juice or a Vitamin C supplement) can help your body absorb iron better.
- Do not lie down for at least 30 minutes after taking the tablet to prevent irritation of the esophagus.
- Iron supplements can cause dark or black stools, which is a normal and harmless side effect. It can also cause constipation; increasing fiber and water intake may help.
- Store iron supplements 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:
For iron supplementation/prophylaxis: 1 tablet (45 mg elemental iron) orally once daily. For treatment of iron deficiency anemia, higher elemental iron doses (e.g., 150-200 mg/day) are typically used, often with immediate-release formulations.
Dose Range:
45 - 45 mg
Condition-Specific Dosing:
ironDeficiencyProphylaxis:
45 mg elemental iron (1 tablet) orally once daily.
ironDeficiencyAnemia:
While Slow FE 45mg can be used, higher doses of elemental iron (e.g., 150-200 mg/day) are generally required for treatment of established iron deficiency anemia, often given as 2-3 doses per day using other ferrous sulfate formulations. Slow FE 45mg may be used for maintenance after repletion.
Pediatric Dosing
Neonatal:
Not established (specific dosing for neonates typically requires careful calculation based on weight and condition, often using liquid formulations).
Infant:
Not established (specific dosing for infants typically requires careful calculation based on weight and condition, often using liquid formulations).
Child:
Not established for Slow FE 45mg tablets. Dosing for children with iron deficiency varies by age, weight, and severity of deficiency (e.g., 3-6 mg elemental iron/kg/day in 1-3 divided doses). Consult a pediatrician.
Adolescent:
For iron deficiency prophylaxis: 45 mg elemental iron (1 tablet) orally once daily. For treatment of iron deficiency anemia, higher elemental iron doses may be required, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed. Use with caution in patients with chronic kidney disease not on dialysis, as iron overload can occur if not monitored.
Severe:
No specific adjustment needed. Use with caution in patients with chronic kidney disease not on dialysis, as iron overload can occur if not monitored. IV iron may be preferred in dialysis patients.
Dialysis:
Oral iron may be used, but IV iron is often preferred in hemodialysis patients due to poor oral absorption and higher iron requirements. Monitor iron parameters closely to avoid overload.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment. Use with caution in patients with liver disease due to potential for iron accumulation.
Severe:
No specific adjustment. Use with caution in patients with severe liver disease (e.g., cirrhosis) due to potential for iron accumulation and exacerbation of liver damage. Avoid in hemochromatosis.
Pharmacology
Mechanism of Action
Iron is an essential component 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 sulfate provides elemental iron, which is absorbed and incorporated into these vital compounds, thereby correcting iron deficiency and supporting erythropoiesis.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (5-35%), inversely proportional to body iron stores. Absorption is highest when iron stores are depleted. Slow-release formulations like Slow FE may have slightly different absorption profiles compared to immediate-release, potentially leading to sustained absorption and reduced peak concentrations.
Tmax:
Approximately 2-4 hours for immediate-release ferrous sulfate. For slow-release formulations, Tmax may be delayed and prolonged.
FoodEffect:
Food, especially dairy products, tea, coffee, and whole grains, can significantly decrease iron absorption. Ascorbic acid (Vitamin C) enhances absorption. Slow FE's slow-release formulation may mitigate some food effects, but it's generally recommended to take iron on an empty stomach if tolerated, or with food to reduce GI upset.
Distribution:
Vd:
Not readily quantifiable as iron is primarily bound to proteins and incorporated into cells.
ProteinBinding:
Primarily bound to transferrin in plasma; stored as ferritin and hemosiderin in tissues.
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. The body has no regulated mechanism for iron excretion.
ExcretionRoute:
Primarily through shedding of gastrointestinal mucosal cells, skin, and urine (trace amounts). Small amounts are lost in sweat, hair, and nails.
Unchanged:
Not applicable (iron is an element).
Pharmacodynamics
OnsetOfAction:
Correction of iron deficiency anemia is gradual. Reticulocytosis typically begins within 3-10 days, and hemoglobin levels start to rise within 2-4 weeks.
PeakEffect:
Hemoglobin levels usually normalize within 1-3 months of consistent therapy, depending on the severity of deficiency.
DurationOfAction:
Effects persist as long as iron stores are being repleted and maintained. Therapy typically continues for 3-6 months after hemoglobin normalization to replenish iron stores.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Fever
- Black, tarry, or bloody stools
- Vomiting blood or material that looks like coffee grounds
Other Possible Side Effects
Like all medications, this drug can cause side effects. While 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 bother you or do not go away:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Decreased appetite
- Change in stool color to green
- Stomach cramps
Additional Information
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, 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.
Although rare, some people may experience severe and potentially life-threatening side effects while 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Fever
- Black, tarry, or bloody stools
- Vomiting blood or material that looks like coffee grounds
Other Possible Side Effects
Like all medications, this drug can cause side effects. While 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 bother you or do not go away:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Decreased appetite
- Change in stool color to green
- Stomach cramps
Additional Information
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, 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
- Vomiting (especially if it contains blood or looks like coffee grounds)
- Diarrhea (especially if it contains blood)
- Fever
- Unusual tiredness or weakness
- Pale skin (worsening)
- Shortness of breath (worsening)
- Chest pain
- 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Having too much iron in your body (iron overload)
+ Anemia caused by a condition other than low iron levels
If you are currently taking another medication that contains iron
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please 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, including any medical conditions or concerns
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 vital to verify that it is safe to take this medication with all 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Having too much iron in your body (iron overload)
+ Anemia caused by a condition other than low iron levels
If you are currently taking another medication that contains iron
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please 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, including any medical conditions or concerns
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 vital to verify that it is safe to take this medication with all 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. 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.
Please note that this medication may interfere with certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
To ensure safe use, do not exceed the recommended dosage or frequency of this medication. Taking more than prescribed or taking it more often than directed can be harmful.
If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult with your doctor before taking this medication, as some products may contain this ingredient.
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.
Please note that this medication may interfere with certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
To ensure safe use, do not exceed the recommended dosage or frequency of this medication. Taking more than prescribed or taking it more often than directed can be harmful.
If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult with your doctor before taking this medication, as some products may contain this ingredient.
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 coffee-ground like)
- Diarrhea (may be bloody)
- Drowsiness
- Pale or bluish lips/nails/palms
- Rapid, shallow breathing
- Weak, rapid pulse
- Cold, clammy skin
- Convulsions
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Iron overdose is a medical emergency.
Drug Interactions
Contraindicated Interactions
- Hemochromatosis
- Hemosiderosis
- Hemolytic anemia (unless iron deficiency coexists)
Major Interactions
- Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin): Decreased absorption of both iron and quinolone. Separate administration by at least 2-6 hours.
- Tetracycline antibiotics (e.g., doxycycline, minocycline): Decreased absorption of both iron and tetracycline. Separate administration by at least 2-4 hours.
- Levothyroxine: Decreased absorption of levothyroxine. Separate administration by at least 4 hours.
- Bisphosphonates (e.g., alendronate, risedronate): Decreased absorption of bisphosphonates. Separate administration by at least 30 minutes to 2 hours.
- Mycophenolate mofetil: Decreased absorption of mycophenolate. Avoid co-administration.
- Antacids (aluminum, magnesium, calcium-containing): Decreased iron absorption. Separate administration by at least 2 hours.
- Proton pump inhibitors (PPIs) and H2-receptor antagonists: May decrease iron absorption due to increased gastric pH.
Moderate Interactions
- Cholestyramine: May decrease iron absorption.
- Chloramphenicol: May delay response to iron therapy.
- Vitamin E: May impair response to iron therapy in some cases.
- Zinc supplements: High doses of zinc may interfere with iron absorption. Separate administration.
- Calcium supplements: May decrease iron absorption. Separate administration by at least 2 hours.
- Coffee, tea, dairy products, eggs, whole grains, dietary fiber: May decrease iron absorption. Advise patients to avoid taking iron with these foods.
Minor Interactions
- Ascorbic acid (Vitamin C): Enhances iron absorption. Often recommended to take together.
Monitoring
Baseline Monitoring
Hemoglobin (Hb) and Hematocrit (Hct)
Rationale: To assess the severity of anemia and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Serum Ferritin
Rationale: To assess body iron stores. Low ferritin is indicative of iron deficiency.
Timing: Prior to initiation of therapy.
Serum Iron and Total Iron Binding Capacity (TIBC)
Rationale: To calculate transferrin saturation, providing further insight into iron status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb) and Hematocrit (Hct)
Frequency: Every 2-4 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 rise by at least 1-2 g/dL after 4-6 weeks of therapy, investigate non-compliance, malabsorption, ongoing blood loss, or alternative diagnoses.
Serum Ferritin
Frequency: Every 3-6 months, or once Hb has normalized.
Target: Typically >30-50 ng/mL to indicate repletion of iron stores.
Action Threshold: Continue therapy until ferritin levels are within the desired range, usually for 3-6 months after Hb normalization.
Adverse Effects (GI upset, constipation)
Frequency: Routinely at follow-up visits.
Target: Minimal to tolerable.
Action Threshold: If severe or persistent, consider dose reduction, alternative formulation (e.g., liquid, different salt), or alternative iron source (e.g., IV iron).
Symptom Monitoring
- Fatigue
- Pallor (pale skin)
- Dyspnea (shortness of breath)
- Pica (craving for non-food items like ice, dirt)
- Restless legs syndrome
- Brittle nails
- Glossitis (sore tongue)
- Constipation
- Nausea
- Abdominal pain
- Dark or black stools (expected and harmless)
Special Patient Groups
Pregnancy
Iron requirements increase significantly during pregnancy. Ferrous sulfate is commonly used and considered safe and effective for preventing and treating iron deficiency anemia in pregnant women. It is a Category B drug.
Trimester-Specific Risks:
First Trimester:
Generally considered safe and often recommended for prophylaxis or treatment of iron deficiency.
Second Trimester:
Increased iron needs; continued use is common and safe.
Third Trimester:
Highest iron needs; continued use is common and safe.
Lactation
Ferrous sulfate is considered safe for use during lactation. Iron is naturally present in breast milk, and supplementation in the mother does not significantly increase iron levels in breast milk to a harmful extent for the infant. It is an L1 (safest) drug.
Infant Risk:
Low risk to the infant. No adverse effects are expected.
Pediatric Use
Iron deficiency is common in children, especially infants and adolescents. Slow FE 45mg tablets may not be suitable for very young children due to tablet form and specific dosing requirements. Liquid iron formulations are often preferred for infants and young children. Dosing must be carefully calculated based on weight and severity of deficiency. Accidental iron overdose is a leading cause of poisoning fatalities in children; strict storage precautions are essential.
Geriatric Use
Iron deficiency is common in older adults, often due to chronic blood loss or malabsorption. Ferrous sulfate is generally well-tolerated, but older adults may be more susceptible to gastrointestinal side effects (constipation, nausea). Start with a lower dose if necessary and monitor for tolerance. Ensure adequate fluid and fiber intake to manage constipation.
Clinical Information
Clinical Pearls
- Slow FE is a slow-release formulation of ferrous sulfate, designed to reduce gastrointestinal side effects compared to immediate-release forms. However, absorption might be slightly less efficient for some individuals.
- Advise patients that dark or black stools are a normal and expected side effect of iron supplementation and do not indicate bleeding.
- To maximize absorption, advise patients to take iron on an empty stomach if tolerated, or with a source of Vitamin C (e.g., orange juice).
- Educate patients about common drug interactions, especially with antibiotics (quinolones, tetracyclines), thyroid hormones, and antacids, and the importance of separating administration times.
- Emphasize the critical importance of keeping all iron supplements out of reach of children due to the high risk of fatal overdose.
- Iron therapy for anemia typically requires 3-6 months of treatment after hemoglobin normalization to fully replenish iron stores.
Alternative Therapies
- Dietary iron-rich foods (red meat, poultry, fish, beans, lentils, spinach, fortified cereals)
- Intravenous (IV) iron preparations (e.g., iron dextran, iron sucrose, ferric carboxymaltose) for severe deficiency, malabsorption, or intolerance to oral iron.
- Blood transfusion (for severe, symptomatic anemia requiring rapid correction).
Cost & Coverage
Average Cost:
$5 - $20 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC). May be covered by some prescription drug plans with a prescription, typically as a Tier 1 or preferred 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.