Integra F 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 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.
Drug Class
Antianemic; Vitamin/Mineral Supplement
Pharmacologic Class
Iron supplement; Folic acid supplement; Vitamin C; Niacin
Pregnancy Category
Category A
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Integra F Capsules are a vitamin and mineral supplement containing iron, folic acid, Vitamin C, and Vitamin B3. It is primarily used to treat or prevent iron deficiency anemia and to provide essential vitamins, especially important during pregnancy for healthy red blood cell formation and fetal development.
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, reducing their absorption. 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 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.
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, reducing their absorption. 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 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.
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). However, if stomach upset occurs, take with food (avoiding dairy, tea, coffee, and whole grains).
- Avoid taking with antacids, dairy products, tea, or coffee, as these can reduce iron absorption. Separate by at least 2 hours.
- Maintain a balanced diet rich in iron (e.g., red meat, fortified cereals, leafy greens) and folate (e.g., leafy greens, legumes, fortified grains).
- Stay hydrated to help prevent constipation, a common side effect of iron.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Typically 1 capsule orally once daily, or as directed by a healthcare professional.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
ironDeficiencyAnemia:
1 capsule daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (consult pediatrician; iron overdose is a leading cause of poisoning in children)
Adolescent:
Typically 1 capsule orally once daily, or as directed by a healthcare professional.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; iron accumulation may occur in patients on dialysis or with severe chronic kidney disease. Monitor iron levels.
Dialysis:
Monitor iron status closely; avoid iron overload. Folic acid may be needed due to loss during dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed, but use with caution in conditions like hemochromatosis where iron accumulation is a concern.
Pharmacology
Mechanism of Action
Integra F Capsules provide essential micronutrients. Iron is a crucial component of hemoglobin, myoglobin, and various enzymes, vital for oxygen transport and cellular respiration. Folic acid (Vitamin B9) is essential for DNA synthesis, red blood cell maturation, and neural tube development. Vitamin C (Ascorbic Acid) enhances the absorption of non-heme iron by reducing ferric iron to ferrous iron and acts as an antioxidant. Vitamin B3 (Niacin) is a precursor to NAD and NADP, coenzymes involved in numerous metabolic processes, including energy production and DNA repair.
Pharmacokinetics
Absorption:
Bioavailability:
Iron: 10-30% (variable, enhanced by Vitamin C); Folic Acid: ~100%; Vitamin C: Dose-dependent (high doses lead to lower percentage absorption); Vitamin B3: High
Tmax:
Iron: 2-4 hours; Folic Acid: 1-2 hours; Vitamin C: 2-3 hours; Vitamin B3: 1-2 hours
FoodEffect:
Iron absorption is reduced by food (especially dairy, tea, coffee, whole grains), but taking with food can reduce GI upset. Vitamin C enhances iron absorption. Folic acid and B3 absorption are generally not significantly affected by food.
Distribution:
Vd:
Not specifically defined for combination; components distribute widely.
ProteinBinding:
Iron: Binds to transferrin; Folic Acid: High (to plasma proteins); Vitamin C: Low; Vitamin B3: Low
CnssPenetration:
Limited for iron; Folic acid and Vitamin B3 penetrate CNS; Vitamin C has limited penetration.
Elimination:
HalfLife:
Iron: Not applicable (recycled); Folic Acid: ~3-4 hours; Vitamin C: 2-3 hours (dose-dependent); Vitamin B3: ~1 hour
Clearance:
Not specifically defined for combination.
ExcretionRoute:
Iron: Minimal (primarily through feces, desquamation); Folic Acid: Renal; Vitamin C: Renal; Vitamin B3: Renal
Unchanged:
Iron: Not applicable; Folic Acid: Small amount; Vitamin C: Significant amount at high doses; Vitamin B3: Small amount
Pharmacodynamics
OnsetOfAction:
Gradual (weeks to months for correction of iron deficiency anemia)
PeakEffect:
Not applicable for acute effect; therapeutic effect on anemia seen over weeks.
DurationOfAction:
Sustained as long as supplementation continues and underlying deficiency is addressed.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, 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
- 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. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Decreased appetite
- Change in stool color
- Heartburn
Reporting Side Effects
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, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or through their website at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, 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
- 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. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Decreased appetite
- Change in stool color
- Heartburn
Reporting Side Effects
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, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or through their website at https://www.fda.gov/medwatch.
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)
- Black, tarry stools (expected, but report if accompanied by other severe symptoms)
- Signs of iron overdose (see overdose section)
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.
If you have an iron overload in your body.
If you have certain types of anemia, including pernicious anemia or hemolytic anemia.
If the patient is a child under 12 years of age, as this medication is not suitable for children younger than 12 years old.
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. Never start, stop, or adjust the dosage of any medication without first consulting 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.
If you have an iron overload in your body.
If you have certain types of anemia, including pernicious anemia or hemolytic anemia.
If the patient is a child under 12 years of age, as this medication is not suitable for children younger than 12 years old.
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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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.
Women who are pregnant, planning to become pregnant, or are breastfeeding should discuss the potential benefits and risks of this medication with their doctor to make an informed decision about its use.
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.
Women who are pregnant, planning to become pregnant, or are breastfeeding should discuss the potential benefits and risks of this medication with their doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Initial symptoms (within 6 hours): Severe stomach pain, nausea, vomiting (may be bloody), diarrhea, drowsiness, pale or bluish skin, weakness.
- Delayed symptoms (12-48 hours): Metabolic acidosis, shock, liver damage, kidney failure, coma, seizures.
What to Do:
IMMEDIATELY call Poison Control (1-800-222-1222) or seek emergency medical attention. 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
Contraindicated Interactions
- Hemochromatosis (iron overload disorder)
- Hemosiderosis
- Hypersensitivity to any component
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Iron can chelate and reduce absorption of tetracyclines. Separate administration by 2-3 hours.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Iron can chelate and reduce absorption of fluoroquinolones. Separate administration by 2-3 hours.
- Levothyroxine: Iron can reduce absorption of levothyroxine. Separate administration by at least 4 hours.
- Mycophenolate mofetil: Iron can decrease absorption. Avoid concomitant use.
- Methotrexate: Folic acid can antagonize the effects of methotrexate. Use with caution and monitor.
- Statins (e.g., simvastatin, atorvastatin): High doses of niacin (Vitamin B3) can increase the risk of myopathy/rhabdomyolysis when co-administered with statins.
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide): Can reduce iron absorption. Separate administration by 2-4 hours.
- Proton Pump Inhibitors (PPIs) (e.g., omeprazole, pantoprazole): Can reduce iron absorption by increasing gastric pH.
- H2-receptor antagonists (e.g., ranitidine, famotidine): Can reduce iron absorption by increasing gastric pH.
- Bisphosphonates (e.g., alendronate): Iron can reduce absorption. Separate administration by 30 minutes to 2 hours.
- Penicillamine: Iron can reduce absorption. Separate administration by 2 hours.
- Chloramphenicol: May delay response to iron therapy.
- Phenytoin, Phenobarbital, Primidone: Folic acid may decrease serum levels of these anticonvulsants, potentially increasing seizure frequency. Monitor levels.
- Sulfasalazine: May inhibit folic acid absorption.
- Cholestyramine, Colestipol: May reduce absorption of folic acid and niacin.
Minor Interactions
- Dairy products, tea, coffee, whole grains: Can reduce iron absorption. Advise taking iron on an empty stomach or separating by 1-2 hours.
- Alcohol: May impair folic acid absorption and metabolism.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differentials (Hemoglobin, Hematocrit, MCV)
Rationale: To assess baseline anemia status and red blood cell indices.
Timing: Prior to initiation of therapy, especially if treating iron deficiency anemia.
Serum Ferritin
Rationale: To assess body iron stores, crucial for diagnosing iron deficiency.
Timing: Prior to initiation of therapy if iron deficiency is suspected.
Serum Vitamin B12
Rationale: To rule out co-existing Vitamin B12 deficiency, as folic acid can mask megaloblastic anemia due to B12 deficiency.
Timing: Prior to initiation of folic acid supplementation.
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 of anemia, warrants further investigation.
Serum Ferritin
Frequency: Every 3-6 months, or as clinically indicated, until iron stores are repleted.
Target: Ferritin > 30-50 ng/mL (target may vary based on guidelines).
Action Threshold: Persistent low ferritin despite therapy, or excessively high ferritin (suggesting iron overload).
Liver function tests (LFTs)
Frequency: Periodically, especially with high doses of niacin or in patients with pre-existing liver conditions.
Target: Within normal limits.
Action Threshold: Significant elevation of transaminases (e.g., >3x ULN).
Symptom Monitoring
- Improvement in fatigue, pallor, shortness of breath, pica (if present)
- Gastrointestinal upset (nausea, constipation, diarrhea, abdominal pain)
- Darkening of stools (expected with iron supplementation)
- Allergic reactions (rash, itching, swelling)
- Flushing, itching, tingling (with niacin, usually transient)
Special Patient Groups
Pregnancy
Generally considered safe and often recommended during pregnancy to prevent and treat iron deficiency anemia and to ensure adequate folic acid intake for neural tube development. Folic acid is Category A. Iron and Vitamin C are commonly used and considered safe at recommended doses. Vitamin B3 is also generally safe.
Trimester-Specific Risks:
First Trimester:
Folic acid is critical during the first trimester to prevent neural tube defects. Iron and Vitamin C are also important.
Second Trimester:
Continued need for iron as blood volume expands; folic acid and other vitamins remain important.
Third Trimester:
Increased iron requirements continue; all components are beneficial.
Lactation
Generally considered safe and beneficial during lactation. Components are excreted in breast milk in small amounts that are not harmful to the infant and may even be beneficial.
Infant Risk:
L1 (Safest) - No known risk to the breastfed infant when used at recommended doses.
Pediatric Use
Use with extreme caution due to the high risk of accidental iron poisoning in children. Keep out of reach of children. Dosing must be carefully determined by a pediatrician based on weight and specific deficiency. Not typically recommended for routine use in young children without medical supervision.
Geriatric Use
Generally safe. Monitor for potential drug interactions, especially with polypharmacy. Gastrointestinal side effects (constipation) may be more pronounced. Iron absorption may be reduced in some elderly individuals due to achlorhydria or use of acid-reducing medications.
Clinical Information
Clinical Pearls
- Iron absorption is best on an empty stomach, but if GI upset occurs, take with a small amount of food (avoiding dairy, tea, coffee).
- Vitamin C in the formulation enhances iron absorption.
- Darkening of stools is a normal and expected side effect of iron supplementation.
- Constipation is a common side effect; advise patients to increase fluid and fiber intake.
- Folic acid supplementation is crucial for women of childbearing age to prevent neural tube defects, even before conception.
- Always rule out Vitamin B12 deficiency before initiating high-dose folic acid, as folic acid can mask the hematological symptoms of B12 deficiency while neurological damage progresses.
Alternative Therapies
- Dietary modifications (iron-rich foods, folate-rich foods)
- Oral iron supplements alone (e.g., ferrous sulfate, ferrous gluconate, ferrous fumarate)
- Folic acid supplements alone
- Intravenous iron (for severe iron deficiency or malabsorption)
- Blood transfusion (for severe, symptomatic anemia)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often OTC or Tier 3/4, may be covered by some insurance plans with a 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.