Integra Plus Capsules
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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.
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).
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
Baseline Monitoring
Rationale: To assess for anemia (hemoglobin, hematocrit, MCV) and other blood cell abnormalities.
Timing: Prior to initiation, especially if treating suspected deficiency.
Rationale: To confirm iron deficiency and assess severity.
Timing: Prior to initiation if iron deficiency is suspected.
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.
Routine Monitoring
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.
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.
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.
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
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:
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.
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.
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
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.
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)