Ferrex 150mg Capsules

Manufacturer BRECKENRIDGE Active Ingredient Polysaccharide-Iron Complex Capsules and Tablets(pol i SAK a ride-EYE ern KOM pleks) Pronunciation pol-ee-SAK-a-ride EYE-ern KOM-pleks
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.
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Drug Class
Antianemic agent
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Pharmacologic Class
Iron preparation
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Pregnancy Category
Category A
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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 150mg Capsules contain a special form of iron that helps your body make healthy red blood cells. It's used to treat or prevent low iron levels (iron deficiency anemia) in your blood, which can make you feel tired and weak.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in bathrooms. Ensure all medications are stored safely and out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. Many areas have drug take-back programs that can help with safe disposal.

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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take with a full glass of water.
  • For best absorption, take on an empty stomach (1 hour before or 2 hours after meals). If stomach upset occurs, you may take it with food, but avoid dairy products, tea, coffee, and whole grains, as they can reduce iron absorption.
  • Taking with Vitamin C (e.g., orange juice or a Vitamin C supplement) can enhance iron absorption.
  • Do not lie down for at least 10 minutes after taking to prevent esophageal irritation.
  • Darkening of stools is a normal and harmless side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: 150 mg elemental iron (1 capsule) once daily
Dose Range: 150 - 300 mg

Condition-Specific Dosing:

ironDeficiencyAnemia: 150 mg elemental iron once daily, or as directed by physician. Doses up to 300 mg elemental iron daily may be used in severe cases, often divided.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (consult pediatrician; typically 3-6 mg/kg/day elemental iron for treatment, 1-2 mg/kg/day for prophylaxis)
Child: Not established (consult pediatrician; typically 3-6 mg/kg/day elemental iron for treatment, 1-2 mg/kg/day for prophylaxis)
Adolescent: 150 mg elemental iron once daily, or as directed by physician.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: Use with caution; monitor iron levels closely due to potential for iron overload in patients on dialysis or with chronic kidney disease not experiencing blood loss.
Dialysis: Consider IV iron if oral absorption is insufficient or not tolerated. Monitor iron parameters closely.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Use with caution; monitor iron levels closely, especially in conditions predisposing to iron overload.
Severe: Contraindicated in patients with hemochromatosis or hemosiderosis. Use with extreme caution in other severe hepatic impairments due to altered iron metabolism.

Pharmacology

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Mechanism of Action

Polysaccharide-iron complex provides elemental iron, an essential component of hemoglobin, myoglobin, and various enzymes. Iron is crucial for oxygen transport, cellular respiration, and numerous metabolic processes. Supplementation corrects iron deficiency, allowing for adequate erythropoiesis and restoration of iron stores.
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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 GI tolerability.
Tmax: Not typically reported for iron supplements in the same manner as drugs; peak serum iron levels may occur 2-4 hours post-ingestion.
FoodEffect: Food, especially dairy products, tea, coffee, and whole grains, can decrease iron absorption. However, polysaccharide-iron complex may be less affected by food than some other iron salts, and taking with food can reduce GI upset.

Distribution:

Vd: Not applicable (iron is incorporated into tissues and proteins)
ProteinBinding: High (binds to transferrin for transport)
CnssPenetration: Limited

Elimination:

HalfLife: Not applicable (iron is conserved by the body)
Clearance: Not applicable (iron is conserved by the body)
ExcretionRoute: Minimal excretion; primarily through shedding of cells (e.g., gastrointestinal tract, skin), and blood loss (e.g., menstruation).
Unchanged: Not applicable (absorbed iron is utilized or stored)
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Pharmacodynamics

OnsetOfAction: Hematologic response (e.g., reticulocytosis) typically seen within 7-10 days.
PeakEffect: Significant increase in hemoglobin levels usually observed within 2-4 weeks.
DurationOfAction: Therapy typically continues for 3-6 months after hemoglobin levels normalize to replenish iron stores.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Black, tarry, or bloody stools
Fever
Vomiting blood or coffee ground-like material
Stomach cramps

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. 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
* 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 about side effects, contact your doctor for medical advice. 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 or persistent stomach pain, nausea, vomiting, or diarrhea
  • Black, tarry stools (while common, report if accompanied by other severe symptoms or if you suspect bleeding)
  • Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing
  • Symptoms of iron overdose: severe vomiting, diarrhea, abdominal pain, lethargy, pale or bluish skin, shallow breathing, weak pulse, shock, coma (seek immediate medical attention)
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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 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, 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.
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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. This drug may interfere with certain laboratory tests, so 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 before taking this medication, 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 breastfeeding, 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.
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Overdose Information

Overdose Symptoms:

  • Initial symptoms (within 6 hours): Nausea, vomiting, abdominal pain, diarrhea (often bloody), lethargy, pallor, cyanosis, drowsiness, shock.
  • Latent period (6-24 hours): Apparent recovery.
  • Late symptoms (12-48 hours): Recurrence of symptoms, metabolic acidosis, shock, liver damage, coagulopathy, renal failure, cardiovascular collapse, coma, death.

What to Do:

IMMEDIATELY call a poison control center (1-800-222-1222) or emergency medical services (911). Iron overdose is a medical emergency, especially in children. Treatment may involve gastric lavage, whole bowel irrigation, and chelation therapy (e.g., deferoxamine).

Drug Interactions

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Contraindicated Interactions

  • Not applicable (no absolute contraindications with other drugs, but certain conditions are contraindications for iron use)
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Major Interactions

  • Antacids (aluminum, magnesium, calcium-containing): Decreased iron absorption. Separate by at least 2 hours.
  • Tetracyclines (e.g., doxycycline, minocycline): Decreased absorption of both iron and tetracycline. Separate by at least 2-3 hours.
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Decreased absorption of both iron and fluoroquinolone. Separate by at least 2-6 hours.
  • Levothyroxine: Decreased absorption of levothyroxine. Separate by at least 4 hours.
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Moderate Interactions

  • Bisphosphonates (e.g., alendronate): Decreased absorption of bisphosphonates. Separate by at least 30 minutes.
  • Penicillamine: Decreased absorption of penicillamine. Separate by at least 2 hours.
  • Mycophenolate mofetil: Decreased absorption of mycophenolate. Avoid concomitant use if possible.
  • Zinc supplements: High doses of zinc can inhibit iron absorption. Separate dosing.
  • Calcium supplements: Can inhibit iron absorption. Separate dosing.
  • Vitamin E: May interfere with iron utilization.
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Minor Interactions

  • Cholestyramine: May reduce iron absorption.
  • Chloramphenicol: May delay response to iron therapy.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differentials

Rationale: To assess baseline hemoglobin, hematocrit, MCV, and red blood cell indices to confirm anemia and characterize its type.

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, Total Iron Binding Capacity (TIBC), Transferrin Saturation

Rationale: To further characterize iron status and confirm iron deficiency.

Timing: Prior to initiation of therapy

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Routine Monitoring

Hemoglobin and Hematocrit

Frequency: Every 4-6 weeks initially, then every 3 months until target reached

Target: Within normal limits for age and sex

Action Threshold: If no improvement after 4-6 weeks, re-evaluate diagnosis and adherence; if levels drop, investigate cause.

Serum Ferritin

Frequency: Every 3-6 months, or after hemoglobin normalizes

Target: >50 ng/mL (to ensure repletion of iron stores)

Action Threshold: If ferritin remains low after hemoglobin normalizes, continue therapy; if ferritin becomes excessively high, consider reducing dose or discontinuing.

Adverse Effects (GI upset, constipation)

Frequency: Regularly during therapy

Target: Minimal to none

Action Threshold: If severe or persistent, consider dose reduction, alternative formulation, or symptomatic treatment.

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Symptom Monitoring

  • Improvement in fatigue, weakness, pallor, shortness of breath, pica, restless legs syndrome
  • Gastrointestinal side effects: nausea, vomiting, abdominal pain, constipation, diarrhea
  • Stool color (darkening of stools is common and expected)

Special Patient Groups

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Pregnancy

Category A. Iron supplementation is often necessary during pregnancy to prevent and treat iron deficiency anemia, which is common due to increased maternal blood volume and fetal iron demands. Polysaccharide-iron complex is considered safe and effective when used as directed.

Trimester-Specific Risks:

First Trimester: No known increased risk of congenital anomalies.
Second Trimester: Safe and commonly used.
Third Trimester: Safe and commonly used; essential for fetal iron stores.
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Lactation

L1 (Compatible). Iron is a normal component of breast milk. Supplementation is generally considered safe for nursing mothers and infants. No adverse effects on the breastfed infant are expected.

Infant Risk: Low risk; iron is naturally present in breast milk and supplementation is unlikely to cause adverse effects in the infant.
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Pediatric Use

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep out of reach of children. Dosing must be carefully calculated based on elemental iron and child's weight/age. Consult a pediatrician for appropriate dosing.

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Geriatric Use

Generally well-tolerated. May be at increased risk for constipation, which can be managed with dietary fiber and fluids. Monitor for potential drug interactions due to polypharmacy.

Clinical Information

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Clinical Pearls

  • Polysaccharide-iron complex is often better tolerated gastrointestinally than some other oral iron salts (e.g., ferrous sulfate), making it a good option for patients experiencing significant GI side effects.
  • Always emphasize the importance of keeping iron supplements out of reach of children due to the high risk of fatal overdose.
  • Educate patients that dark or black stools are a normal and expected side effect of oral iron supplementation and do not indicate bleeding.
  • Advise patients to separate iron doses from medications that interfere with absorption (e.g., antacids, tetracyclines, levothyroxine) by several hours.
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Alternative Therapies

  • Other oral iron salts: Ferrous sulfate, ferrous gluconate, ferrous fumarate (differ in elemental iron content and GI tolerability).
  • Intravenous (IV) iron preparations: Iron sucrose, ferric carboxymaltose, ferumoxytol, iron dextran (used for severe iron deficiency, malabsorption, or intolerance to oral iron).
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered by most insurance plans, especially generics)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not 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 seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.