Ferrex Tablets 28s

Manufacturer BRECKENRIDGE Active Ingredient Iron, Succinic Acid, Vitamin C, Folic Acid, and Vitamin B12(EYE urn/sux IN ic AS id/ VYE ta min C/FOE lik AS id/VYE ta min B 12) Pronunciation EYE-urn / sux-IN-ik AS-id / VYE-tuh-min SEE / FOE-lik AS-id / VYE-tuh-min BEE TWELV
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 treat or prevent low iron in the body.It is used to help growth and good health.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antianemic, Nutritional Supplement, Hematopoietic Agent
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Pharmacologic Class
Iron supplement, Vitamin supplement (B-complex, C), Metabolic enhancer
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Pregnancy Category
Category A/B (Components are essential nutrients; Category A for recommended daily allowances, B for higher therapeutic doses if not monitored)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ferrex is a nutritional supplement containing iron, vitamin C, folic acid, vitamin B12, and succinic acid. It's primarily used to treat and prevent iron deficiency anemia, which is a condition where your body doesn't have enough iron to make healthy red blood cells. The other vitamins help your body absorb iron and make new red blood cells, while succinic acid supports energy production.
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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. Certain foods, such as eggs, whole grain bread, cereal, dairy products, coffee, and tea, may interfere with the medication's absorption. If you experience stomach upset, consult your doctor about the best way to take this medication with food.

It's essential to note that this medication can interact with other drugs, preventing them from being absorbed properly. If you're taking other medications, consult your doctor or pharmacist to determine if you should take them at a different time than this medication.

Storing and Disposing of Your Medication

To maintain the medication's potency, store it 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're unsure about the best way to dispose 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 the missed one.
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Lifestyle & Tips

  • Take Ferrex as directed by your doctor, usually once daily. It can be taken with or without food, but taking it with food may help reduce stomach upset. However, certain foods (like dairy, tea, coffee, whole grains) can reduce iron absorption, so try to avoid taking it with these.
  • For best absorption, avoid taking antacids, calcium supplements, or certain medications (like thyroid hormones, some antibiotics) within 2-4 hours of taking Ferrex.
  • Iron supplements can cause constipation. To help prevent this, drink plenty of fluids and increase fiber in your diet.
  • Iron can cause dark or black stools, which is normal and not a cause for concern unless accompanied by other symptoms like blood in stool or severe abdominal pain.
  • Store Ferrex in a cool, dry place, out of reach of children. Accidental iron overdose is a leading cause of poisoning deaths in young children.

Dosing & Administration

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Adult Dosing

Standard Dose: Typically 1 tablet orally once daily, or as directed by a healthcare professional.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

iron_deficiency_anemia: 1 tablet once or twice daily, depending on severity and specific product formulation (e.g., Ferrex 150 vs. Ferrex 150 Forte).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (Iron supplementation in infants should be specifically formulated and dosed for this age group)
Child: Not established (Consult pediatrician; iron overdose is a significant risk in children)
Adolescent: Dosing may be similar to adults for iron deficiency, but under medical supervision.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required, but monitor iron levels.
Moderate: No specific adjustment typically required, but monitor iron levels closely due to potential for iron accumulation.
Severe: Use with caution; monitor iron levels closely to avoid iron overload, especially in patients on dialysis who may receive IV iron. May require reduced frequency or dose.
Dialysis: Consideration of total iron load from oral and IV sources is crucial. Oral iron may be contraindicated if receiving IV iron or if iron overload is present.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution; monitor iron levels. Patients with hemochromatosis or other iron storage disorders should avoid iron supplementation.
Severe: Contraindicated in patients with severe liver disease associated with iron overload (e.g., hemochromatosis, porphyria cutanea tarda).
Confidence: Medium

Pharmacology

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Mechanism of Action

Ferrex provides essential nutrients for erythropoiesis and overall metabolic function. Iron is a crucial component of hemoglobin, myoglobin, and various enzymes, essential for oxygen transport and cellular respiration. Vitamin C (Ascorbic Acid) enhances the absorption of non-heme iron by reducing ferric iron (Fe3+) to ferrous iron (Fe2+) and forming a soluble chelate. Folic Acid (Vitamin B9) and Vitamin B12 (Cyanocobalamin) are coenzymes essential for DNA synthesis, particularly important for rapidly dividing cells like red blood cells. Succinic Acid is an intermediate in the Krebs cycle (citric acid cycle), involved in cellular respiration and energy production; it may also contribute to iron absorption or utilization, though its precise role in this combination for iron deficiency is less defined than the other components.
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Pharmacokinetics

Absorption:

Bioavailability: Iron: Highly variable (5-35%), influenced by iron stores, diet, and co-administration of Vitamin C. Vitamin C: Dose-dependent (70-90% at low doses, decreases at higher doses). Folic Acid: ~85-100%. Vitamin B12: ~1-5% (requires intrinsic factor for active absorption). Succinic Acid: Limited data as an oral supplement.
Tmax: Iron: 2-4 hours (for elemental iron). Vitamin C: 2-3 hours. Folic Acid: 1-6 hours. Vitamin B12: 8-12 hours.
FoodEffect: Iron: Absorption is reduced by phytates (grains, legumes), oxalates (spinach), tannins (tea, coffee), and calcium. Enhanced by Vitamin C. Best absorbed on an empty stomach, but often taken with food to minimize GI upset. Vitamin C: No significant food effect. Folic Acid: No significant food effect. Vitamin B12: Food can slightly delay absorption.

Distribution:

Vd: Iron: Not applicable (bound to transferrin, stored as ferritin/hemosiderin). Vitamin C: ~0.2-0.3 L/kg. Folic Acid: ~1.7 L/kg. Vitamin B12: ~60 L.
ProteinBinding: Iron: >90% (bound to transferrin). Vitamin C: ~25%. Folic Acid: ~60%. Vitamin B12: Highly bound to transcobalamins.
CnssPenetration: Iron: Limited. Vitamin C: Yes. Folic Acid: Yes. Vitamin B12: Yes.

Elimination:

HalfLife: Iron: Not applicable (recycled). Vitamin C: 8-40 hours (dose-dependent). Folic Acid: ~30 minutes (for folic acid itself, but active forms have longer half-lives). Vitamin B12: ~6 days (for total body stores, but plasma half-life is shorter). Succinic Acid: Rapidly metabolized.
Clearance: Iron: Minimal excretion. Vitamin C: Renal. Folic Acid: Renal. Vitamin B12: Renal (small amounts), enterohepatic recirculation.
ExcretionRoute: Iron: Primarily via shedding of cells (skin, GI tract), minor amounts in bile, urine, sweat. Vitamin C: Renal (unchanged or as metabolites). Folic Acid: Renal (unchanged or as metabolites). Vitamin B12: Biliary excretion with extensive enterohepatic recirculation; small amounts in urine. Succinic Acid: Excreted as CO2 and water.
Unchanged: Iron: Minimal. Vitamin C: Variable (dose-dependent). Folic Acid: Variable. Vitamin B12: Small amounts.
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Pharmacodynamics

OnsetOfAction: Correction of anemia symptoms: Weeks to months. Improvement in laboratory parameters (e.g., reticulocyte count): 3-7 days for iron, 2-3 days for B12/folate.
PeakEffect: Correction of anemia: 1-3 months of consistent therapy.
DurationOfAction: As long as supplementation continues and underlying cause of deficiency is addressed.
Confidence: Medium

Safety & Warnings

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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
- Black, tarry, or bloody stools
- Fever
- Vomiting blood or material that looks like coffee grounds
- Stomach cramps

Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Change in stool color to green

Reporting Side Effects
This list does not include all possible side effects. If you have questions about side effects, contact your doctor. For medical advice about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, nausea, vomiting, or diarrhea (may indicate overdose or severe intolerance).
  • Bloody or tarry stools (seek medical attention immediately).
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
  • Symptoms of iron overload (fatigue, joint pain, abdominal pain, heart problems, liver problems) - rare with typical dosing but possible with prolonged high doses or underlying conditions.
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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.
If you have an excessive amount of iron in your body (iron overload).
* If you have certain types of anemia, including pernicious anemia or hemolytic anemia.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a soy allergy, consult your doctor before taking this drug, as some products contain soy. Additionally, this medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are allergic to tartrazine (also known as FD&C Yellow No. 5), discuss this with your doctor, as some products may contain this ingredient. Furthermore, if you are pregnant, planning to become pregnant, or are breastfeeding, you should discuss the potential benefits and risks of this medication with your doctor to ensure the best decision for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Initial symptoms (within 6 hours): Nausea, vomiting (may be bloody), diarrhea (may be bloody), abdominal pain, lethargy, pallor, drowsiness.
  • Latent period (6-24 hours): Apparent recovery, but toxicity is progressing.
  • Later symptoms (12-48 hours): Metabolic acidosis, shock, liver damage, kidney failure, cardiovascular collapse, coma, seizures, death.

What to Do:

IMMEDIATELY call emergency services (e.g., 911 in the US) or a poison control center (1-800-222-1222). Do NOT induce vomiting unless instructed by medical personnel. Seek immediate medical attention. Treatment may involve gastric lavage, whole bowel irrigation, and chelation therapy (e.g., deferoxamine).

Drug Interactions

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Contraindicated Interactions

  • Iron: Hemochromatosis, hemosiderosis, hemolytic anemia (unless iron deficiency coexists), porphyria cutanea tarda.
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Major Interactions

  • Iron + Tetracyclines/Doxycycline: Iron can chelate tetracyclines, significantly reducing their absorption. Separate administration by at least 2-4 hours.
  • Iron + Fluoroquinolones (e.g., Ciprofloxacin, Levofloxacin): Iron can chelate fluoroquinolones, significantly reducing their absorption. Separate administration by at least 2-6 hours.
  • Iron + Levothyroxine: Iron can impair levothyroxine absorption. Separate administration by at least 4 hours.
  • Folic Acid + Methotrexate: Folic acid can reduce the efficacy of methotrexate (a folate antagonist). Careful monitoring and specific dosing regimens are required.
  • Vitamin B12 + Chloramphenicol: May antagonize the hematopoietic response to Vitamin B12 in patients with megaloblastic anemia.
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Moderate Interactions

  • Iron + Antacids/PPIs/H2 Blockers: May reduce iron absorption by increasing gastric pH. Separate administration by several hours.
  • Iron + Bisphosphonates (e.g., Alendronate): Iron can interfere with bisphosphonate absorption. Separate administration by at least 30 minutes to 2 hours.
  • Iron + Mycophenolate Mofetil: Iron may decrease mycophenolate absorption. Separate administration.
  • Iron + Zinc/Copper: High doses of iron can interfere with zinc and copper absorption. Administer at different times.
  • Folic Acid + Anticonvulsants (e.g., Phenytoin, Phenobarbital, Primidone): Folic acid may decrease serum levels of these drugs, potentially increasing seizure frequency. Anticonvulsants can also lower folate levels.
  • Vitamin B12 + Metformin: Metformin can reduce Vitamin B12 absorption.
  • Vitamin B12 + Colchicine: May reduce Vitamin B12 absorption.
  • Vitamin B12 + Nitrous Oxide: Can inactivate Vitamin B12, leading to functional deficiency.
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Minor Interactions

  • Vitamin C + Warfarin: High doses of Vitamin C may theoretically decrease warfarin effect, though clinical significance is generally low.
  • Iron + Dairy products/Calcium supplements: Calcium can inhibit iron absorption. Separate administration by at least 2 hours.
  • Iron + Tea/Coffee: Tannins can inhibit iron absorption. Avoid taking with meals.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To assess severity of anemia (hemoglobin, hematocrit, MCV) and rule out other causes.

Timing: Prior to initiation of therapy.

Serum Ferritin

Rationale: Primary indicator of body iron stores. Low ferritin confirms iron deficiency.

Timing: Prior to initiation of therapy.

Iron Studies (Serum Iron, Total Iron Binding Capacity (TIBC), Transferrin Saturation)

Rationale: To confirm iron deficiency and differentiate from other anemias.

Timing: Prior to initiation of therapy.

Serum Vitamin B12 and Folate levels

Rationale: To confirm deficiencies and rule out co-existing megaloblastic anemia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Complete Blood Count (CBC)

Frequency: Every 4-8 weeks initially, then every 3-6 months once stable.

Target: Hemoglobin and hematocrit within normal limits for age/sex; MCV normalizing.

Action Threshold: Lack of improvement in Hb/Hct after 4-6 weeks, or continued symptoms.

Reticulocyte Count

Frequency: 1-2 weeks after initiation (optional, to confirm bone marrow response).

Target: Increase in reticulocyte count.

Action Threshold: No increase in reticulocyte count.

Serum Ferritin

Frequency: Every 3-6 months, or once hemoglobin has normalized.

Target: Ferritin >50 ng/mL (or target >100 ng/mL for repletion).

Action Threshold: Ferritin not increasing or remaining low after 3-6 months of therapy.

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Symptom Monitoring

  • Fatigue
  • Pallor (pale skin)
  • Shortness of breath
  • Dizziness
  • Pica (craving for non-food items like ice, dirt)
  • Restless legs syndrome
  • Glossitis (sore tongue)
  • Cheilosis (cracks at corners of mouth)
  • Neurological symptoms (numbness, tingling, gait instability - for B12 deficiency)

Special Patient Groups

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Pregnancy

Iron, folic acid, and vitamin B12 are essential nutrients during pregnancy and are often recommended to prevent and treat anemia. Vitamin C is also safe and beneficial. Ferrex, providing these components, is generally considered safe and often prescribed during pregnancy for iron deficiency anemia. Close monitoring of iron levels is recommended.

Trimester-Specific Risks:

First Trimester: Generally safe and often recommended for adequate fetal development and maternal health.
Second Trimester: Safe and commonly used to meet increased iron demands.
Third Trimester: Safe and important for continued fetal growth and preparation for delivery.
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Lactation

Components of Ferrex (iron, vitamin C, folic acid, vitamin B12) are essential nutrients and are excreted in breast milk in small, physiologically normal amounts. They are generally considered safe for use during lactation and are often recommended to support maternal health and prevent postpartum anemia.

Infant Risk: L1 - No known risk to the breastfed infant when taken at recommended doses.
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Pediatric Use

Use with extreme caution. Accidental iron overdose is a leading cause of fatal poisoning in children under 6 years of age. Ferrex is not typically formulated for pediatric use; specific pediatric iron supplements with appropriate dosing should be used under medical supervision. Keep out of reach of children.

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Geriatric Use

Generally safe for use in geriatric patients. However, older adults may have underlying conditions affecting iron absorption (e.g., atrophic gastritis, use of acid-reducing medications) or may be at higher risk for B12 deficiency. Monitoring for iron overload is important if there are pre-existing conditions like hemochromatosis. Dosage adjustments are typically not required based on age alone, but individual patient factors should be considered.

Clinical Information

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Clinical Pearls

  • Advise patients to take iron supplements with a source of Vitamin C (like orange juice) to enhance absorption, but avoid taking with milk, tea, or coffee.
  • Warn patients about potential GI side effects (constipation, nausea, dark stools) and strategies to manage them.
  • Emphasize the critical importance of keeping iron supplements out of reach of children due to severe overdose risk.
  • Educate patients that correction of anemia takes time; hemoglobin levels typically rise by 1-2 g/dL every 3-4 weeks, and iron stores may take 3-6 months to replete after hemoglobin normalizes.
  • Always investigate the underlying cause of iron deficiency anemia, as supplementation alone may mask a more serious condition (e.g., GI bleeding).
  • For patients with difficulty swallowing tablets, some iron formulations are available in liquid or chewable forms, though Ferrex is typically a tablet.
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Alternative Therapies

  • Oral Iron Supplements (e.g., Ferrous Sulfate, Ferrous Gluconate, Ferrous Fumarate)
  • Intravenous Iron (e.g., Iron Dextran, Iron Sucrose, Ferric Carboxymaltose) for severe deficiency or intolerance to oral iron
  • Folic Acid supplements (e.g., Folic Acid tablets)
  • Vitamin B12 supplements (e.g., Cyanocobalamin tablets, injections)
  • Dietary modifications to increase iron, folate, and B12 intake.
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Cost & Coverage

Average Cost: Variable, typically $15-$40 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often covered as a Tier 1 or Tier 2 medication by most insurance plans, or available over-the-counter.
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.