Integra 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 help growth and good health.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Iron supplement; Vitamin supplement
Pharmacologic Class
Mineral; Vitamin
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Integra Capsules are a supplement containing iron and vitamins. Iron is essential for making red blood cells that carry oxygen throughout your body. Vitamin C helps your body absorb the iron better. Vitamin B3 is important for overall body functions. This supplement is used to treat or prevent iron deficiency, which can cause tiredness and weakness.
How to Use This Medicine
Taking Your Medication
To get the most out of your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication at bedtime, but you can also take it between meals if needed. For optimal effectiveness, take this medication on an empty stomach. However, if it causes stomach upset, you can take it with food. Certain foods, such as eggs, whole grain breads, 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.
It's essential to note that this medication can interact with other medications, preventing them from being absorbed by the body. 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 explore local drug take-back programs.
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 dose, skip the missed dose and resume your regular 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 out of your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication at bedtime, but you can also take it between meals if needed. For optimal effectiveness, take this medication on an empty stomach. However, if it causes stomach upset, you can take it with food. Certain foods, such as eggs, whole grain breads, 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.
It's essential to note that this medication can interact with other medications, preventing them from being absorbed by the body. 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 explore local drug take-back programs.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the capsule 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 a small amount of food, but avoid dairy, tea, coffee, and whole grains around the time of dosing.
- Do not lie down for at least 10 minutes after taking the capsule to prevent esophageal irritation.
- Maintain a balanced diet rich in iron (e.g., red meat, poultry, fish, beans, spinach) and Vitamin C (e.g., citrus fruits, bell peppers).
- Keep 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:
1 capsule daily, or as directed by a physician
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
iron_deficiency_anemia:
1-2 capsules daily, depending on severity and physician's recommendation
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (consult physician for specific dosing based on weight and iron needs)
Adolescent:
Typically adult dosing, 1 capsule daily, or as directed by a physician
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically needed
Moderate:
No specific adjustment typically needed
Severe:
Use with caution; monitor iron levels to avoid overload, especially in patients on dialysis or with chronic kidney disease
Dialysis:
Monitor iron levels closely; iron supplementation may be necessary but risk of overload is higher. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment typically needed
Moderate:
No specific adjustment typically needed
Severe:
Use with caution; monitor iron levels, especially in conditions like hemochromatosis or liver disease where iron accumulation is a concern.
Pharmacology
Mechanism of Action
Ferrous Fumarate and Polysaccharide Iron Complex provide elemental iron, which is an essential component of hemoglobin, myoglobin, and various enzymes. Iron is crucial 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. Vitamin B3 (Niacin/Niacinamide) is a precursor to NAD and NADP, coenzymes involved in numerous metabolic processes, including energy production and DNA repair.
Pharmacokinetics
Absorption:
Bioavailability:
Iron: Highly variable (5-35%), depends on iron stores and form. Ferrous salts generally have higher bioavailability than ferric. Polysaccharide Iron Complex may have different absorption characteristics, potentially leading to less GI upset. Vitamin C: High (70-90% at low doses, decreases with higher doses). Vitamin B3: Readily absorbed.
Tmax:
Iron: 2-4 hours (for ferrous salts). Vitamin C: 2-3 hours. Vitamin B3: 0.5-1 hour.
FoodEffect:
Iron absorption is decreased by food (especially dairy, tea, coffee, whole grains, eggs) but taking with food can reduce GI upset. Vitamin C absorption is not significantly affected by food. Vitamin B3 absorption is not significantly affected by food.
Distribution:
Vd:
Iron: Not typically reported as it's incorporated into tissues. Vitamin C: 0.2-0.3 L/kg. Vitamin B3: Widely distributed.
ProteinBinding:
Iron: Binds to transferrin for transport. Vitamin C: Low (25%). Vitamin B3: Low.
CnssPenetration:
Limited for iron. Vitamin C: Yes. Vitamin B3: Yes.
Elimination:
HalfLife:
Iron: Not applicable (incorporated). Vitamin C: 8-40 hours (dose-dependent). Vitamin B3: 20-60 minutes (for nicotinic acid, longer for niacinamide).
Clearance:
Iron: Primarily through shedding of GI mucosal cells, skin, and menstrual blood. Vitamin C: Renal excretion. Vitamin B3: Renal excretion.
ExcretionRoute:
Iron: Feces (unabsorbed), small amounts in urine, sweat, bile. Vitamin C: Urine. Vitamin B3: Urine.
Unchanged:
Iron: Not applicable. Vitamin C: Significant portion excreted unchanged at high doses. Vitamin B3: Small amount excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Iron: Therapeutic effects (e.g., increase in hemoglobin) typically seen within 2-4 weeks. Vitamin C/B3: Immediate metabolic effects, but clinical benefits for deficiency take time.
PeakEffect:
Iron: Hemoglobin levels typically normalize within 2-3 months. Vitamin C/B3: Peak plasma levels within hours.
DurationOfAction:
Iron: Effects persist as long as iron stores are maintained. Vitamin C/B3: Daily intake required to maintain adequate levels.
Safety & Warnings
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
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:
Gastrointestinal symptoms:
+ Constipation
+ Diarrhea
+ Stomach pain
+ Upset stomach
+ Vomiting
+ Decreased appetite
Change in stool color to green
* Stomach cramps
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns 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.
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
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:
Gastrointestinal symptoms:
+ Constipation
+ Diarrhea
+ Stomach pain
+ Upset stomach
+ Vomiting
+ Decreased appetite
Change in stool color to green
* Stomach cramps
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns 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.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain
- Persistent nausea or vomiting
- Severe constipation or diarrhea
- Bloody or tarry stools (beyond the expected dark stools from iron)
- Allergic reaction symptoms (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 symptoms you experienced.
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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 this ingredient.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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 this ingredient.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe stomach pain
- Nausea
- Vomiting (may contain blood)
- Diarrhea (may be bloody)
- Drowsiness
- Pale or bluish skin
- Weak, rapid pulse
- Low blood pressure
- Fever
- Seizures
- Coma
What to Do:
Iron overdose is a medical emergency. Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US) immediately. Do NOT induce vomiting unless instructed by a healthcare professional.
Drug Interactions
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Iron can chelate tetracyclines, significantly reducing their absorption. Separate administration by at least 2-3 hours.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Iron can chelate fluoroquinolones, significantly reducing their absorption. Separate administration by at least 2-6 hours.
- Levothyroxine: Iron can impair levothyroxine absorption. Separate administration by at least 4 hours.
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide): Can decrease iron absorption. Separate administration by at least 2 hours.
- Proton Pump Inhibitors (PPIs) / H2 Blockers: Can reduce gastric acidity, potentially impairing iron absorption. Monitor iron levels.
- Bisphosphonates (e.g., alendronate): Iron can interfere with bisphosphonate absorption. Separate administration by at least 30 minutes to 2 hours.
- Mycophenolate mofetil: Iron can decrease its absorption. Avoid co-administration.
- Cholestyramine: Can bind iron and reduce absorption.
- Chloramphenicol: May delay response to iron therapy.
- Vitamin E: High doses may impair iron response.
- Statins (with high dose Niacin): Increased risk of myopathy/rhabdomyolysis. Monitor closely if Niacin is given at high doses (unlikely with supplement doses).
Minor Interactions
- Dairy products, tea, coffee, whole grains, eggs: Can reduce iron absorption. Advise taking iron supplement on an empty stomach or separating by 1-2 hours.
- Zinc supplements: High doses of iron can interfere with zinc absorption. Separate administration if possible.
- Antihypertensive drugs (with Niacin): Niacin can cause vasodilation and additive hypotensive effects. Monitor blood pressure.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differentials (Hemoglobin, Hematocrit, MCV)
Rationale: To assess baseline anemia status and red blood cell characteristics.
Timing: Prior to initiation of therapy
Iron studies (Serum Ferritin, Serum Iron, Total Iron Binding Capacity (TIBC), Transferrin Saturation)
Rationale: To confirm iron deficiency and assess iron stores.
Timing: Prior to initiation of therapy
Routine Monitoring
Complete Blood Count (CBC)
Frequency: Every 4-6 weeks initially, then every 3-6 months once stable
Target: Hemoglobin: Age/sex appropriate; MCV: Normal (80-100 fL)
Action Threshold: Lack of improvement in Hb/Hct after 4-6 weeks, or continued symptoms of anemia.
Serum Ferritin
Frequency: Every 3-6 months, or as clinically indicated
Target: >30-50 ng/mL (to replenish stores)
Action Threshold: Ferritin levels not increasing or remaining low despite therapy; very high levels (>1000 ng/mL) may indicate iron overload.
GI side effects (constipation, nausea, dark stools)
Frequency: Ongoing patient assessment
Target: Minimal to tolerable
Action Threshold: Severe or persistent GI upset requiring dose reduction or change in formulation.
Symptom Monitoring
- Fatigue
- Pallor (pale skin)
- Shortness of breath
- Dizziness
- Pica (craving non-food items like ice or dirt)
- Restless legs syndrome
- Brittle nails
- Hair loss
- Gastrointestinal upset (nausea, constipation, diarrhea, abdominal pain)
- Dark or black stools (expected due to unabsorbed iron)
Special Patient Groups
Pregnancy
Iron supplementation is often necessary and recommended during pregnancy to prevent and treat iron deficiency anemia, which is common due to increased iron demands. Integra Capsules, providing iron and essential vitamins, can be beneficial. Consult a healthcare provider for appropriate dosing.
Trimester-Specific Risks:
First Trimester:
Generally safe and often recommended to prevent iron deficiency.
Second Trimester:
Increased iron demands; supplementation is typically continued or initiated.
Third Trimester:
Highest iron demands; supplementation is crucial.
Lactation
Iron and vitamins are generally safe and often recommended during lactation to meet the mother's nutritional needs and prevent postpartum iron deficiency. Small amounts of iron are excreted in breast milk, but not enough to harm the infant. Consult a healthcare provider.
Infant Risk:
Low risk to infant; considered compatible with breastfeeding.
Pediatric Use
Not typically recommended for general use in young children without specific medical advice due to the risk of accidental iron overdose. Dosing must be carefully determined by a physician based on the child's weight and iron status. For adolescents, adult dosing may apply.
Geriatric Use
Generally safe for older adults. However, monitor for gastrointestinal side effects (constipation is common) and potential drug interactions. Older adults may have underlying conditions that affect iron absorption or increase risk of iron overload (e.g., hemochromatosis).
Clinical Information
Clinical Pearls
- Advise patients that iron supplements can cause dark or black stools, which is a normal and harmless side effect.
- Constipation is a common side effect; recommend increasing fluid intake and dietary fiber. Stool softeners may be considered if needed.
- Taking iron with Vitamin C (as included in this formulation) enhances absorption. Advise patients to take it with a glass of water, preferably orange juice, if not contraindicated.
- Emphasize the importance of keeping iron supplements out of reach of children due to the high risk of fatal poisoning.
- Therapeutic response to iron supplementation (e.g., increase in hemoglobin) is not immediate and typically takes several weeks. Patients should be advised to continue therapy as prescribed even if they don't feel immediate improvement.
Alternative Therapies
- Other oral iron preparations (e.g., ferrous sulfate, ferrous gluconate, ferrous biglycinate)
- Intravenous iron preparations (e.g., iron dextran, iron sucrose, ferric carboxymaltose) for severe deficiency, malabsorption, or intolerance to oral iron.
- Dietary modifications to increase iron intake.
Cost & Coverage
Average Cost:
$15 - $40 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC) or may be covered as a Tier 3/4 prescription by some insurance plans if medically necessary and prescribed.
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 medication taken, the amount, and the time it happened.