Integra Plus Capsules

Manufacturer U S PHARMACEUTICAL Active Ingredient Vitamin B Complex and Iron Combinations Tablets and Capsules(VYE ta min bee KOM pleks kom bi NAY shuns) Pronunciation IN-teh-gruh PLUS KAP-soolz (VYE-tuh-min BEE KOM-pleks and EYE-urn KOM-bi-NAY-shuns)
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 may be given to you for other reasons. Talk with the doctor.It is used to treat or prevent low iron in the body.
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Drug Class
Nutritional Supplement, Antianemic
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Pharmacologic Class
Vitamin/Mineral Combination
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Pregnancy Category
Category A (for typical doses of essential vitamins/minerals)
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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?

Integra Plus Capsules are a nutritional supplement containing a combination of B vitamins and iron. B vitamins are essential for energy production, nerve function, and healthy red blood cells. Iron is vital for making hemoglobin, which carries oxygen in your blood. This supplement helps prevent or treat deficiencies of these nutrients, especially iron-deficiency anemia.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Protect it from heat and light to prevent degradation. Keep all medications in a secure location, out of the reach of children and pets, to avoid accidental ingestion or overdose.

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, as this can increase the risk of adverse effects.
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Lifestyle & Tips

  • Take with food to minimize stomach upset, but be aware that some foods (like dairy, tea, coffee) can reduce iron absorption.
  • Consider taking with a source of Vitamin C (e.g., orange juice) to enhance iron absorption.
  • Avoid taking with antacids, calcium supplements, or certain medications (like tetracyclines, fluoroquinolones, levothyroxine) at the same time. Separate doses by at least 2-4 hours.
  • Store in a cool, dry place, out of reach of children. Iron overdose is dangerous for children.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One capsule daily, or as directed by a healthcare professional.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

ironDeficiencyAnemia: May require higher doses initially, as directed by physician, often 1-2 capsules daily.
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Pediatric Dosing

Neonatal: Not established, consult pediatrician
Infant: Not established, consult pediatrician
Child: Not established, consult pediatrician due to risk of iron overdose
Adolescent: One capsule daily, or as directed by a healthcare professional, especially for adolescent females with iron deficiency.
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Dose Adjustments

Renal Impairment:

Mild: Generally no specific adjustment for typical doses.
Moderate: Generally no specific adjustment for typical doses; monitor iron levels if prolonged use.
Severe: Use with caution; monitor iron levels and B vitamin levels (especially B6) as accumulation can occur. Consult nephrologist.
Dialysis: Consult nephrologist; specific iron and vitamin supplementation may be required based on individual needs and dialysis type.

Hepatic Impairment:

Mild: Generally no specific adjustment.
Moderate: Generally no specific adjustment.
Severe: Generally no specific adjustment, but monitor for signs of iron overload if underlying liver disease.

Pharmacology

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Mechanism of Action

Vitamin B Complex components (e.g., B1, B2, B3, B5, B6, B7, B9, B12) act as coenzymes in various metabolic processes, including energy production, DNA synthesis, and red blood cell formation. Iron is an essential mineral component of hemoglobin, myoglobin, and various enzymes; it is crucial for oxygen transport, cellular respiration, and energy metabolism. The combination supports overall nutritional status and addresses deficiencies leading to conditions like iron-deficiency anemia.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (Iron: 5-35% depending on iron status, form, and dietary factors; B vitamins: generally high, but varies by specific vitamin)
Tmax: Not precisely defined for combination; Iron: 2-4 hours; B vitamins: generally rapid absorption, peak levels within hours.
FoodEffect: Iron absorption is reduced by certain foods (e.g., dairy, tea, coffee, high-fiber foods) but enhanced by Vitamin C. B vitamins are generally well absorbed with or without food, though some may be better absorbed with food.

Distribution:

Vd: Not applicable for combination; Iron: primarily bound to transferrin, distributed to bone marrow, liver, spleen; B vitamins: widely distributed to tissues.
ProteinBinding: Iron: >90% bound to transferrin; B vitamins: variable, some bound to plasma proteins.
CnssPenetration: Limited for iron; some B vitamins (e.g., B1, B6, B12) can cross the blood-brain barrier.

Elimination:

HalfLife: Not applicable for combination; Iron: long biological half-life due to recycling; B vitamins: variable, from hours to days.
Clearance: Not applicable for combination; Iron: minimal renal excretion; B vitamins: primarily renal excretion.
ExcretionRoute: Iron: primarily fecal (unabsorbed iron), minimal urinary/biliary; B vitamins: primarily renal (excess excreted in urine).
Unchanged: Not applicable for combination; Iron: minimal; B vitamins: variable, excess amounts excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Gradual, as part of nutritional repletion; clinical improvement in symptoms of deficiency (e.g., anemia) may take weeks to months.
PeakEffect: Not applicable for nutritional supplements in the same way as drugs; sustained effect with consistent daily intake.
DurationOfAction: Dependent on continued supplementation and body stores; effects persist as long as adequate levels are maintained.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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. Although 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 persist, contact your doctor:

Stomach pain or diarrhea
Upset stomach or vomiting
Decreased appetite
Gas
Bad taste in your mouth
Constipation
Green-colored stool

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, nausea, vomiting, or diarrhea (especially if black or bloody)
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Persistent constipation or dark, tarry stools (common side effect, but report if severe or concerning)
  • Signs of iron overload (fatigue, joint pain, abdominal pain, heart problems, liver problems - rare with typical doses but possible with excessive intake or genetic predisposition)
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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 allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking levodopa, as this may interact with the medication.
If you have an iron overload condition, where your body has excessive levels of iron.
If you have certain types of anemia, including pernicious anemia or hemolytic anemia, as these conditions may be affected by the medication.

This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and supplements with your doctor. This includes:

All prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor and pharmacist need to be aware of all your medications and health conditions to ensure safe treatment. Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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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 your healthcare providers and lab 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 products may contain this ingredient.

Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Discuss any concerns or questions you have with your doctor.

Taking this medication may affect the absorption of other oral medications. If you are taking other drugs by mouth, your doctor may advise you to take them at a different time than this medication to ensure proper absorption.

Not all formulations of this medication are suitable for children, so it is crucial to consult with your doctor before administering it to a child.

If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Initial symptoms (within 6 hours): severe stomach pain, nausea, vomiting (may be bloody), diarrhea, lethargy, pallor.
  • Latent phase (6-24 hours): apparent recovery.
  • Late symptoms (12-48 hours): metabolic acidosis, shock, liver failure, coma, death.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222) immediately. Iron overdose is a medical emergency, especially in children.

Drug Interactions

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Major Interactions

  • Tetracyclines (e.g., doxycycline, minocycline): Iron can chelate tetracyclines, reducing absorption of both. Separate administration by at least 2-3 hours.
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Iron can chelate fluoroquinolones, reducing absorption. Separate administration by at least 2-4 hours.
  • Levothyroxine: Iron can impair levothyroxine absorption. Separate administration by at least 4 hours.
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Moderate Interactions

  • Antacids (e.g., aluminum hydroxide, magnesium hydroxide): Can reduce iron absorption. Separate administration by 2 hours.
  • H2-receptor antagonists (e.g., ranitidine, famotidine) & Proton Pump Inhibitors (e.g., omeprazole, pantoprazole): Reduce gastric acid, which can impair iron absorption. Monitor iron status.
  • Bisphosphonates (e.g., alendronate): Iron can interfere with absorption. Separate administration by at least 30 minutes (preferably longer).
  • Penicillamine: Iron can reduce penicillamine absorption. Separate administration by at least 2 hours.
  • Chloramphenicol: May delay response to iron therapy in iron deficiency anemia.
  • Vitamin E: High doses may impair iron absorption.
  • Alcohol: Chronic heavy alcohol use can impair absorption and utilization of B vitamins (especially folate, B1, B6, B12).
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Minor Interactions

  • Calcium supplements: Can reduce iron absorption. Take iron at a different time of day.
  • Dietary fiber (e.g., bran): Can reduce iron absorption.
  • Tea/Coffee: Tannins can reduce iron absorption. Avoid taking with meals containing iron.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To assess for anemia (hemoglobin, hematocrit, MCV) and other blood cell abnormalities.

Timing: Prior to initiation, especially if treating suspected deficiency.

Iron studies (serum iron, ferritin, TIBC, transferrin saturation)

Rationale: To confirm iron deficiency and assess severity.

Timing: Prior to initiation if iron deficiency is suspected.

Serum Vitamin B12 and Folate levels

Rationale: To confirm specific B vitamin deficiencies if suspected, and to rule out pernicious anemia before high-dose folate supplementation.

Timing: Prior to initiation if B vitamin deficiency is suspected.

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Routine Monitoring

Complete Blood Count (CBC)

Frequency: Every 1-3 months initially, then every 3-6 months once stable, or as clinically indicated.

Target: Hemoglobin: within normal limits for age/sex; MCV: within normal limits (or increasing if microcytic anemia was present).

Action Threshold: Failure to improve hemoglobin/MCV, or worsening anemia; consider re-evaluation of diagnosis or compliance.

Iron studies (ferritin)

Frequency: Every 3-6 months, or as clinically indicated, especially if treating iron deficiency.

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

Action Threshold: Ferritin levels not increasing or remaining low; consider re-evaluation of absorption, compliance, or ongoing blood loss.

Clinical symptoms (fatigue, pallor, pica)

Frequency: Ongoing patient self-monitoring and clinician assessment at follow-up visits.

Target: Improvement or resolution of deficiency symptoms.

Action Threshold: Persistent or worsening symptoms; investigate other causes or adjust therapy.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, constipation, diarrhea, dark stools)
  • Fatigue, weakness, pallor (signs of anemia)
  • Neurological symptoms (e.g., tingling, numbness, gait instability - if B12 deficiency is severe and unaddressed)
  • Allergic reactions (rare: rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Iron and B vitamins (especially folate) are crucial during pregnancy for maternal health and fetal development. This combination is often recommended to prevent or treat iron-deficiency anemia and neural tube defects. Dosing should be guided by a healthcare provider.

Trimester-Specific Risks:

First Trimester: Folate is critical for neural tube development; iron needs increase.
Second Trimester: Iron needs continue to increase significantly.
Third Trimester: Iron needs remain high; continued supplementation is often necessary.
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Lactation

Iron and B vitamins are important for lactating mothers and are generally considered safe and beneficial. They are excreted in breast milk in small amounts, providing essential nutrients to the infant. Dosing should be guided by a healthcare provider.

Infant Risk: Low risk at typical doses; provides essential nutrients to the infant.
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Pediatric Use

Use with extreme caution in children due to the high risk of accidental iron overdose, which can be fatal. Keep out of reach of children. Dosing must be precise and determined by a pediatrician based on age, weight, and specific deficiency.

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Geriatric Use

Older adults may have increased risk of iron deficiency due to reduced absorption or chronic conditions. They may also have B vitamin deficiencies (especially B12 due to malabsorption). This combination can be beneficial, but monitor for potential drug interactions and underlying conditions. Start with lower doses if sensitive to GI upset.

Clinical Information

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Clinical Pearls

  • Advise patients that iron supplements can cause dark or black stools, which is a normal and harmless side effect.
  • To minimize GI upset, advise patients to take the supplement with food, but be mindful of food interactions that reduce iron absorption.
  • Emphasize the importance of consistent daily dosing for effective repletion of iron and vitamin stores.
  • Educate patients on the critical danger of iron overdose in children and the need for secure storage.
  • For patients with ongoing blood loss (e.g., heavy menstruation), continuous supplementation may be necessary.
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Alternative Therapies

  • Oral iron supplements (e.g., ferrous sulfate, ferrous gluconate, ferrous fumarate) as single agents
  • Individual B vitamin supplements (e.g., folic acid, vitamin B12, B complex)
  • Dietary modifications (iron-rich foods, folate-rich foods)
  • Intravenous iron (for severe iron deficiency or malabsorption)
  • Parenteral B12 (for severe B12 deficiency or malabsorption)
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Cost & Coverage

Average Cost: Highly variable, typically $10-$50 per 30-100 capsules
Generic Available: Yes
Insurance Coverage: Often Over-The-Counter (OTC) and not covered by insurance unless prescribed for a specific medical condition (e.g., severe anemia) and deemed medically necessary.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.