Ferralet 90 Tabs (new Formula)
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 is used to prevent constipation.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antianemic, Vitamin/Mineral Supplement, Stool Softener
Pharmacologic Class
Mineral (Iron), Vitamin (Folic Acid, Cyanocobalamin, Ascorbic Acid), Surfactant Laxative (Docusate)
Pregnancy Category
Not assigned (Components generally safe, often used in pregnancy)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ferralet 90 is a supplement that provides iron, folic acid, and vitamins B12 and C, along with a stool softener called docusate. It's used to treat or prevent certain types of anemia (low red blood cells) and to ensure you get enough of these important nutrients, especially during pregnancy. The docusate helps prevent constipation, which can be a common side effect of iron supplements.
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 breads, cereal, dairy products, coffee, and tea, may interfere with the medication's effectiveness. If you experience stomach upset, consult your doctor for guidance on taking the medication with food.
It's essential to note that this medication can interact with other medications, reducing their absorption into 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 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.
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 breads, cereal, dairy products, coffee, and tea, may interfere with the medication's effectiveness. If you experience stomach upset, consult your doctor for guidance on taking the medication with food.
It's essential to note that this medication can interact with other medications, reducing their absorption into 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 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.
Lifestyle & Tips
- Take with a glass of water, preferably on an empty stomach (1 hour before or 2 hours after meals) for best absorption. If stomach upset occurs, take with food, but avoid dairy, tea, coffee, and whole grains within 2 hours of taking iron.
- Do not lie down for at least 10 minutes after taking to prevent esophageal irritation.
- Maintain a diet rich in fiber and fluids to further aid in preventing constipation.
- Avoid taking antacids, calcium supplements, or certain medications (like tetracyclines or fluoroquinolones) within 2-4 hours of taking Ferralet 90, as they can interfere with iron absorption.
- Store in a cool, dry place, out of reach of children. Iron overdose can be fatal in young children.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 tablet orally daily
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
iron_deficiency_anemia:
1 tablet orally daily, or as directed by a healthcare professional.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Use of this specific combination product is generally not recommended for routine pediatric use; individual components may be used under medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; monitor iron levels due to potential for accumulation in chronic kidney disease. Docusate generally safe.
Dialysis:
Use with caution; monitor iron levels. Docusate generally safe. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution, especially with iron, as liver is central to iron metabolism. Docusate generally safe.
Confidence:
Medium
Pharmacology
Mechanism of Action
Ferralet 90 provides essential nutrients for erythropoiesis and overall health, combined with a stool softener to mitigate iron-induced constipation.
- **Iron (Ferrous Fumarate)**: Essential component of hemoglobin, myoglobin, and various enzymes. Required for oxygen transport and cellular respiration.
- **Folic Acid (Vitamin B9)**: Coenzyme essential for DNA synthesis, cell division, and red blood cell maturation. Crucial for neural tube development during pregnancy.
- **Cyanocobalamin (Vitamin B12)**: Coenzyme involved in DNA synthesis, fatty acid and amino acid metabolism, and myelin formation. Essential for red blood cell production and nervous system function.
- **Vitamin C (Ascorbic Acid)**: Enhances the absorption of non-heme iron by reducing ferric iron (Fe3+) to ferrous iron (Fe2+), which is more readily absorbed. Also an antioxidant.
- **Docusate Sodium**: A surfactant laxative that lowers the surface tension of stool, allowing water and fats to penetrate and soften the fecal mass, facilitating easier bowel movements.
- **Iron (Ferrous Fumarate)**: Essential component of hemoglobin, myoglobin, and various enzymes. Required for oxygen transport and cellular respiration.
- **Folic Acid (Vitamin B9)**: Coenzyme essential for DNA synthesis, cell division, and red blood cell maturation. Crucial for neural tube development during pregnancy.
- **Cyanocobalamin (Vitamin B12)**: Coenzyme involved in DNA synthesis, fatty acid and amino acid metabolism, and myelin formation. Essential for red blood cell production and nervous system function.
- **Vitamin C (Ascorbic Acid)**: Enhances the absorption of non-heme iron by reducing ferric iron (Fe3+) to ferrous iron (Fe2+), which is more readily absorbed. Also an antioxidant.
- **Docusate Sodium**: A surfactant laxative that lowers the surface tension of stool, allowing water and fats to penetrate and soften the fecal mass, facilitating easier bowel movements.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (Iron: 10-30% from diet, enhanced by Vit C; Folic Acid: ~100% from supplements; B12: ~1-5% from oral doses, requires intrinsic factor; Vit C: Dose-dependent, ~70-90% at lower doses; Docusate: Minimal systemic absorption, primarily acts locally in GI tract)
Tmax:
Iron: 2-4 hours; Folic Acid: 1-6 hours; B12: 8-12 hours; Vit C: 2-3 hours; Docusate: 1-3 days for laxative effect
FoodEffect:
Iron absorption is decreased by food (especially dairy, tea, coffee, whole grains) but taking with food can reduce GI upset. Vitamin C enhances iron absorption. Docusate effect not significantly altered by food.
Distribution:
Vd:
Iron: ~0.6 L/kg (bound to transferrin); Folic Acid: Widely distributed, stored in liver; B12: Stored in liver; Vit C: Widely distributed; Docusate: Primarily acts in GI lumen, minimal systemic distribution.
ProteinBinding:
Iron: High (to transferrin); Folic Acid: High; B12: High (to transcobalamins); Vit C: Low; Docusate: Not extensively protein bound systemically.
CnssPenetration:
Limited (Iron, Folic Acid, B12, Vit C can cross BBB to varying degrees; Docusate: No significant CNS penetration)
Elimination:
HalfLife:
Iron: Not applicable (recycled); Folic Acid: ~30 minutes (unmetabolized), longer for active forms; B12: ~6 days (body stores last years); Vit C: 8-40 days (dose-dependent); Docusate: Not well-defined due to minimal systemic absorption, but laxative effect lasts 1-3 days.
Clearance:
Iron: Minimal excretion, primarily regulated by absorption; Folic Acid: Renal; B12: Renal, enterohepatic recirculation; Vit C: Renal; Docusate: Fecal/renal (minimal systemic)
ExcretionRoute:
Iron: Feces (unabsorbed), minimal urine/sweat/desquamation; Folic Acid: Urine, feces (biliary); B12: Urine, feces (biliary); Vit C: Urine; Docusate: Feces (primary), urine (minimal systemic)
Unchanged:
Iron: Not applicable; Folic Acid: Small amount; B12: Small amount; Vit C: Significant amount at high doses; Docusate: Minimal systemic unchanged excretion.
Pharmacodynamics
OnsetOfAction:
Iron: Weeks to months for anemia correction; Folic Acid/B12: Days to weeks for hematologic response; Vit C: Immediate (absorption enhancement); Docusate: 12-72 hours (1-3 days) for stool softening effect.
PeakEffect:
Iron: Varies with anemia severity; Docusate: 1-3 days.
DurationOfAction:
Iron: Sustained as long as supplementation continues; Docusate: As long as therapy continues, effect persists for a few days after discontinuation.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 medical attention 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or 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 do not go away, contact your doctor for advice:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Change in stool color to green
Reporting Side Effects
This list does not include all possible 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.
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 medical attention 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or 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 do not go away, contact your doctor for advice:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Change in stool color to green
Reporting Side Effects
This list does not include all possible 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 or persistent constipation or diarrhea
- Black, tarry stools (expected with iron, but report if accompanied by other symptoms of GI bleeding)
- Severe abdominal pain or cramping
- Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- 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 conditions to ensure safe treatment:
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.
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.
If you are experiencing any of the following health issues:
+ Bowel obstruction
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that have lasted for more than 2 weeks
* If you are currently taking mineral oil.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. 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 conditions to ensure safe treatment:
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.
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.
If you are experiencing any of the following health issues:
+ Bowel obstruction
+ Abdominal pain
+ Upset stomach
+ Rectal bleeding
+ Vomiting
+ Changes in bowel habits that have lasted for more than 2 weeks
* If you are currently taking mineral oil.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments. 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 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 products may contain this ingredient.
Unless advised by your doctor, do not use any other laxatives or stool softeners in conjunction with this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for both you and your baby.
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.
Unless advised by your doctor, do not use any other laxatives or stool softeners in conjunction with this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as this will help determine the best course of treatment for both you and your baby.
Overdose Information
Overdose Symptoms:
- Initial symptoms (within 6 hours): Nausea, vomiting (may be bloody), diarrhea, abdominal pain, lethargy, pallor, drowsiness.
- Latent period (6-24 hours): Apparent recovery, but toxicity is progressing.
- Later symptoms (12-48 hours): Metabolic acidosis, shock, liver damage (jaundice, dark urine), kidney failure, seizures, coma, death.
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222) immediately. Do NOT induce vomiting unless instructed by a healthcare professional. Management may include gastric lavage, whole bowel irrigation, and chelation therapy (e.g., deferoxamine) for severe iron toxicity.
Drug Interactions
Contraindicated Interactions
- Mineral oil (with Docusate: increased absorption of mineral oil, leading to potential systemic toxicity like lipid pneumonia)
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Iron forms insoluble chelates, reducing absorption of both.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Iron forms insoluble chelates, reducing absorption of both.
- Levothyroxine: Iron can impair absorption of levothyroxine.
- Mycophenolate mofetil: Iron can decrease absorption of mycophenolate.
Moderate Interactions
- Antacids (e.g., calcium carbonate, aluminum hydroxide): Decrease iron absorption.
- Proton Pump Inhibitors (PPIs) / H2 Blockers: Reduce gastric acidity, impairing iron absorption.
- Bisphosphonates (e.g., alendronate): Iron can reduce bisphosphonate absorption.
- Penicillamine: Iron can reduce penicillamine absorption.
- Methotrexate: Folic acid can interfere with methotrexate's antineoplastic effect (by providing substrate for dihydrofolate reductase, reducing methotrexate's efficacy).
- Anticonvulsants (e.g., phenytoin, phenobarbital, primidone): Folic acid can decrease serum levels of these drugs, potentially increasing seizure frequency. These drugs can also decrease folate levels.
- Metformin: Can decrease vitamin B12 absorption.
- Chloramphenicol: Can antagonize the hematologic response to iron, folic acid, and B12.
Minor Interactions
- Cholestyramine: Can decrease absorption of folic acid and B12.
- Oral Contraceptives: May affect folate metabolism.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differentials
Rationale: To assess for anemia (hemoglobin, hematocrit, MCV) and other blood cell abnormalities, especially if iron/folate/B12 deficiency is suspected.
Timing: Prior to initiation, if deficiency is suspected or for routine prenatal care.
Serum Ferritin, Iron, TIBC, Transferrin Saturation
Rationale: To assess iron stores and confirm iron deficiency anemia.
Timing: Prior to initiation, if iron deficiency is suspected.
Serum Folate and Vitamin B12 levels
Rationale: To confirm deficiency if megaloblastic anemia is suspected, and to rule out B12 deficiency before initiating high-dose folic acid (to prevent masking B12 deficiency).
Timing: Prior to initiation, if deficiency is suspected.
Routine Monitoring
Symptom improvement (e.g., fatigue, pallor, pica)
Frequency: Ongoing, patient self-report
Target: Resolution or significant improvement of deficiency symptoms
Action Threshold: Lack of improvement or worsening symptoms warrants re-evaluation.
Stool consistency and frequency
Frequency: Daily, patient self-report
Target: Soft, formed stools, regular bowel movements (e.g., 1-3 times per day or every other day)
Action Threshold: Persistent constipation or diarrhea; adjust docusate or other laxatives if needed.
Complete Blood Count (CBC)
Frequency: 4-6 weeks after initiation for anemia, then as clinically indicated (e.g., every 3-6 months)
Target: Hemoglobin and hematocrit within normal limits for age/sex; MCV normalizing.
Action Threshold: No improvement in Hgb/Hct, or continued microcytosis/macrocytosis; investigate non-response.
Serum Ferritin
Frequency: 3-6 months after initiation, then as clinically indicated
Target: Ferritin > 30-50 ng/mL (or target for specific condition)
Action Threshold: Persistent low ferritin or signs of iron overload; adjust dose or investigate.
Symptom Monitoring
- Constipation
- Abdominal discomfort
- Nausea
- Dark stools (expected with iron)
- Fatigue
- Pallor
- Shortness of breath
- Pica (craving non-food items)
- Neurological symptoms (for B12 deficiency)
Special Patient Groups
Pregnancy
Ferralet 90 is commonly prescribed during pregnancy to prevent and treat iron deficiency anemia and to ensure adequate folic acid intake for fetal neural tube development. The components (iron, folic acid, B12, Vit C, docusate) are generally considered safe and beneficial when used at recommended doses during pregnancy.
Trimester-Specific Risks:
First Trimester:
Folic acid is critical during the first trimester to prevent neural tube defects. Iron and other vitamins are also important for maternal and fetal health.
Second Trimester:
Continued need for iron as maternal blood volume expands and fetal iron demands increase. Folic acid and B12 remain important.
Third Trimester:
High demand for iron as fetal iron stores are accumulated. Docusate helps manage iron-induced constipation.
Lactation
The components of Ferralet 90 are generally considered compatible with breastfeeding. Iron, folic acid, B12, and Vitamin C are naturally present in breast milk and are essential for infant growth. Docusate is minimally absorbed systemically and is considered safe for use during lactation.
Infant Risk:
Low risk of adverse effects to the breastfed infant at recommended maternal doses. Monitor infant for any unusual symptoms like diarrhea, though unlikely.
Pediatric Use
This specific combination product (Ferralet 90) is generally not indicated for routine pediatric use. Iron, folic acid, B12, and Vitamin C are used in pediatric populations for specific deficiencies, but usually as single agents or in pediatric-specific formulations. Docusate can be used in children for constipation, but dosage must be carefully adjusted by weight. Accidental iron overdose is a leading cause of fatal poisoning in children.
Geriatric Use
Generally safe for use in geriatric patients. However, older adults may be more susceptible to constipation or gastrointestinal side effects from iron. Docusate can be beneficial. Monitor for potential drug interactions, especially with polypharmacy. Renal and hepatic function should be considered for severe impairment.
Clinical Information
Clinical Pearls
- Iron absorption is best on an empty stomach, but if GI upset occurs, taking it with a small amount of food (avoiding dairy, tea, coffee) is acceptable.
- Vitamin C in the formulation enhances iron absorption; avoid taking with calcium or antacids which can inhibit iron absorption.
- Darkening of stools is a normal and expected side effect of iron supplementation.
- The docusate component helps mitigate the common side effect of constipation associated with iron supplements, improving patient adherence.
- Always rule out Vitamin B12 deficiency before initiating high-dose folic acid supplementation, as folic acid can mask the hematological symptoms of B12 deficiency while neurological damage progresses.
- Educate patients on the importance of keeping iron-containing products out of reach of children due to the risk of accidental poisoning.
Alternative Therapies
- Oral iron supplements (e.g., ferrous sulfate, ferrous gluconate, polysaccharide iron complex)
- Folic acid supplements
- Vitamin B12 supplements (oral or injectable)
- Vitamin C supplements
- Other stool softeners (e.g., docusate calcium, docusate potassium)
- Bulk-forming laxatives (e.g., psyllium, methylcellulose)
- Osmotic laxatives (e.g., polyethylene glycol, lactulose)
Cost & Coverage
Average Cost:
$30 - $60 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often covered under prescription drug plans as a medical food or supplement, but coverage varies widely by insurer and plan. May require prior authorization or be covered under a specific benefit category.
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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.