Hematinic/ FA Tablets

Manufacturer CYPRESS Active Ingredient Iron and Folic Acid(EYE urn & FOE lik AS id) Pronunciation EYE-urn and FOE-lik AS-id
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 treat low folate levels.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
Hematinic; Antianemic Agent
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Pharmacologic Class
Iron Supplement; Vitamin (B9)
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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?

This medication combines iron and folic acid, two important nutrients your body needs to make healthy red blood cells. Iron helps carry oxygen in your blood, and folic acid helps your body make new cells, including red blood cells. It's often used to treat or prevent certain types of anemia, especially during pregnancy.
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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

Store your medication at room temperature in a dry place, avoiding the 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 available 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 with a full glass of water.
  • Avoid taking with milk, tea, coffee, or antacids, as these can reduce iron absorption. Separate by at least 2 hours.
  • Taking with Vitamin C (e.g., orange juice) can enhance iron absorption.
  • Take with food if stomach upset occurs, but be aware it may slightly reduce absorption.
  • Maintain a balanced diet rich in iron (red meat, poultry, fish, beans, fortified cereals) and folate (leafy green vegetables, fruits, nuts, fortified grains).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Typically 1 tablet daily (e.g., 60 mg elemental iron, 400 mcg folic acid)
Dose Range: 30 - 100 mg

Condition-Specific Dosing:

ironDeficiencyAnemia: 1-2 tablets daily, depending on elemental iron content and severity
pregnancyProphylaxis: 1 tablet daily (e.g., 27 mg elemental iron, 400-800 mcg folic acid)
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Pediatric Dosing

Neonatal: Not established (specific formulations/doses for neonates are different)
Infant: Dosing based on weight and elemental iron needs (e.g., 1-2 mg/kg/day elemental iron for prophylaxis, 3-6 mg/kg/day for treatment of anemia). Folic acid 0.1-0.5 mg/day.
Child: Dosing based on weight and elemental iron needs (e.g., 3-6 mg/kg/day elemental iron for treatment of anemia, up to 200 mg/day). Folic acid 0.1-1 mg/day.
Adolescent: Similar to adult dosing for iron deficiency anemia (e.g., 60-120 mg elemental iron daily). Folic acid 400-800 mcg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor iron levels to avoid overload, especially in patients on dialysis.
Severe: No specific adjustment needed, but monitor iron levels closely. Oral iron may be less effective in patients on hemodialysis due to inflammation and hepcidin effects; IV iron may be preferred.
Dialysis: Oral iron may be used, but IV iron is often preferred for iron deficiency in dialysis patients. Folic acid supplementation is often recommended due to loss during dialysis.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: No specific adjustment.
Severe: No specific adjustment, but caution in conditions like hemochromatosis where iron accumulation is a concern.

Pharmacology

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Mechanism of Action

Iron is an essential component in the formation of hemoglobin, myoglobin, and various enzymes. It is crucial for oxygen transport and cellular respiration. Folic acid (Vitamin B9) is a coenzyme essential for DNA synthesis, cell division, and erythropoiesis (red blood cell formation). It is particularly important for the maturation of red blood cells and prevention of megaloblastic anemia.
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Pharmacokinetics

Absorption:

Bioavailability: Iron: Highly variable (5-35% for ferrous salts), influenced by diet and iron stores. Folic Acid: High (85-100%)
Tmax: Iron: 2-4 hours. Folic Acid: 1-6 hours.
FoodEffect: Iron: Decreased absorption with food (especially dairy, tea, coffee, whole grains), but taking with food can reduce GI upset. Folic Acid: Minimal effect.

Distribution:

Vd: Iron: Not applicable (bound to transferrin). Folic Acid: Approximately 1.7 L/kg.
ProteinBinding: Iron: >90% (bound to transferrin). Folic Acid: Approximately 50% (to plasma proteins).
CnssPenetration: Iron: Limited. Folic Acid: Yes (crosses blood-brain barrier).

Elimination:

HalfLife: Iron: Not applicable (recycled). Folic Acid: Approximately 3-10 hours.
Clearance: Iron: Minimal excretion (primarily through desquamation of cells, sweat, bile). Folic Acid: Renal clearance.
ExcretionRoute: Iron: Feces (unabsorbed iron), minimal renal. Folic Acid: Urine (excess and metabolites).
Unchanged: Iron: Not applicable. Folic Acid: Up to 90% of absorbed dose excreted unchanged in urine at high doses.
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Pharmacodynamics

OnsetOfAction: Correction of anemia symptoms: Weeks to months. Hematologic response (reticulocytosis): 3-10 days.
PeakEffect: Correction of anemia: 1-2 months.
DurationOfAction: As long as supplementation continues and underlying cause is addressed.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent 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
Fever
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material

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
Heartburn
Stomach cramps

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 constipation or diarrhea
  • Persistent nausea or vomiting
  • Severe abdominal pain
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing) - seek immediate medical attention
  • Black, tarry stools (expected due to iron, but report if accompanied by other severe symptoms)
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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 health conditions and medications with your doctor. Please disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
All your health problems, including any medical conditions or diseases.

To ensure your safety, it is vital to verify that this medication is compatible with all your other medications and health conditions. Never start, stop, or modify 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. 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.

Additionally, this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

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.

Before taking this medication, women who are pregnant, planning to become pregnant, or are breastfeeding should discuss the potential benefits and risks with their doctor, as this medication may affect the baby. Your doctor will help you weigh the advantages and disadvantages of taking this medication during this time.
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Overdose Information

Overdose Symptoms:

  • Initial phase (30 min - 6 hours post-ingestion): Nausea, vomiting (often bloody), diarrhea, abdominal pain, lethargy, pallor, cyanosis.
  • Latent phase (6-24 hours): Apparent recovery.
  • Systemic toxicity phase (12-48 hours): Metabolic acidosis, shock, hepatic necrosis, coagulopathy, renal failure, cardiovascular collapse, coma, seizures.
  • Delayed complications (weeks): Gastric scarring, pyloric stenosis.

What to Do:

Iron overdose is a medical emergency, especially in children. Call 911 or Poison Control (1-800-222-1222) immediately. Treatment may involve gastric lavage, whole bowel irrigation, and chelation therapy (e.g., deferoxamine).

Drug Interactions

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Major Interactions

  • Dimercaprol (with iron, increases nephrotoxicity)
  • Methotrexate (folic acid can interfere with its antineoplastic action, though often given as 'rescue')
  • Phenytoin (folic acid can decrease phenytoin levels)
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Moderate Interactions

  • Antacids (decrease iron absorption)
  • Tetracyclines (decrease absorption of both iron and tetracycline)
  • Fluoroquinolones (decrease absorption of both iron and fluoroquinolone)
  • Levothyroxine (decreased levothyroxine absorption)
  • Mycophenolate mofetil (decreased mycophenolate absorption)
  • Bisphosphonates (decreased bisphosphonate absorption)
  • Penicillamine (decreased penicillamine absorption)
  • Cholestyramine (decreased folic acid absorption)
  • Sulfasalazine (decreased folic acid absorption)
  • Oral contraceptives (may decrease folic acid levels)
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Minor Interactions

  • Vitamin C (enhances iron absorption)
  • Calcium (decreases iron absorption)
  • Zinc (decreases iron absorption at high doses)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hemoglobin, hematocrit, red blood cell indices (MCV, MCH), and identify anemia type.

Timing: Prior to initiation of therapy.

Serum Ferritin

Rationale: To assess body iron stores and confirm iron deficiency.

Timing: Prior to initiation of therapy.

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

Rationale: To further characterize iron status.

Timing: Prior to initiation of therapy.

Serum Folate or Red Blood Cell Folate

Rationale: To confirm folate deficiency and rule out other causes of macrocytic anemia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Complete Blood Count (CBC) with differential

Frequency: Every 2-4 weeks initially, then every 3-6 months once stable.

Target: Hemoglobin: Age and sex-appropriate normal range; MCV: Normal range.

Action Threshold: Lack of improvement in hemoglobin after 4-6 weeks, or worsening anemia.

Reticulocyte Count

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

Target: Increase from baseline.

Action Threshold: No reticulocyte response.

Serum Ferritin

Frequency: Every 3-6 months, or as clinically indicated.

Target: >30-50 ng/mL (to replenish stores).

Action Threshold: Ferritin remains low despite therapy, or excessively high (risk of overload).

Serum Folate

Frequency: Not routinely needed once levels are normalized, unless new symptoms or concerns arise.

Target: Normal range.

Action Threshold: Persistent low levels or signs of folate deficiency.

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Symptom Monitoring

  • Improvement in fatigue, weakness, pallor, shortness of breath, pica (iron deficiency symptoms)
  • Resolution of glossitis, cheilosis (folate deficiency symptoms)
  • Gastrointestinal side effects (nausea, constipation, diarrhea, abdominal pain, dark stools)
  • Allergic reactions (rare)

Special Patient Groups

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Pregnancy

Category A. Both iron and folic acid are essential during pregnancy for maternal and fetal health. Folic acid supplementation is crucial to prevent neural tube defects, and iron is needed to meet increased maternal red blood cell mass and fetal iron demands, preventing iron deficiency anemia.

Trimester-Specific Risks:

First Trimester: Folic acid is critical during the first trimester (and preconception) for neural tube development. Iron needs increase throughout pregnancy.
Second Trimester: Iron needs continue to increase as blood volume expands and fetal development progresses.
Third Trimester: Highest iron demands due to rapid fetal growth and preparation for delivery. Continued folic acid is important.
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Lactation

L1 (safest). Both iron and folic acid are safe and often recommended during lactation to support maternal recovery and ensure adequate nutrient levels in breast milk. Minimal amounts are excreted into breast milk.

Infant Risk: Low risk to infant; considered compatible with breastfeeding.
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Pediatric Use

Iron overdose is a leading cause of poisoning fatalities in children under 6. Keep iron-containing products out of reach. Dosing must be carefully calculated based on weight and elemental iron content. Folic acid is generally safe in pediatric populations.

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Geriatric Use

Older adults may have reduced gastric acid, which can impair iron absorption. Polypharmacy increases the risk of drug interactions with iron. Monitor for constipation. Folic acid is generally well-tolerated.

Clinical Information

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Clinical Pearls

  • Advise patients that iron supplements can cause dark or black stools, which is harmless but can be alarming.
  • Constipation is a common side effect; recommend increased fluid intake and dietary fiber.
  • For best absorption, iron should be taken on an empty stomach, but if GI upset occurs, it can be taken with a small amount of food (avoiding dairy, tea, coffee).
  • Emphasize the importance of consistent daily dosing for effective treatment of anemia.
  • Folic acid supplementation is crucial for all women of childbearing potential to prevent neural tube defects, regardless of pregnancy status.
  • Iron deficiency anemia should always be investigated to determine the underlying cause, not just treated symptomatically.
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Alternative Therapies

  • Dietary modifications (iron-rich foods, folate-rich foods)
  • Iron-only supplements (if only iron deficiency is present)
  • Folic acid-only supplements (if only folate deficiency is present)
  • Intravenous iron (for severe iron deficiency, malabsorption, or intolerance to oral iron)
  • Blood transfusion (for severe, symptomatic anemia requiring rapid correction)
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Cost & Coverage

Average Cost: $5 - $30 per 30 tablets
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 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.