Aristofol Fe
Generic Name
Ferrous Fumarate + Folic Acid
Manufacturer
Aristopharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
aristofol fe 308 mg tablet | ৳ 0.47 | ৳ 4.70 |
Description
Overview of the medicine
Aristofol Fe 308 mg Tablet is a combination medication containing Ferrous Fumarate and Folic Acid, primarily used to treat and prevent various types of anemia, particularly iron deficiency anemia and megaloblastic anemia, especially during pregnancy and lactation.
Uses & Indications
Dosage
Adults
Usually 1 tablet daily, or as directed by the physician. In severe cases, dosage may be increased to 2 tablets daily.
Elderly
Similar to adult dosage, but caution should be exercised in patients with underlying conditions.
Renal_impairment
No specific dose adjustment for mild to moderate renal impairment. Use with caution in severe renal impairment and consult a physician.
How to Take
Take orally, preferably with or after meals to minimize gastrointestinal upset. Do not chew or crush the tablet. Avoid taking with antacids or dairy products, as they can interfere with iron absorption.
Mechanism of Action
Ferrous Fumarate provides elemental iron, which is an essential component of hemoglobin, myoglobin, and other iron-containing enzymes. It is crucial for oxygen transport and cellular respiration. Folic acid is a B vitamin necessary for DNA synthesis, red blood cell formation, and proper fetal development, particularly neural tube development.
Pharmacokinetics
Onset
Hematological response (reticulocytosis) can be seen within days; full hemoglobin restoration takes weeks to months.
Excretion
Iron is primarily excreted in small amounts via feces (unabsorbed iron), urine, and sweat. Folic acid is excreted via urine, largely as metabolites.
Half life
Iron has no true biological half-life as it's recycled. Folic acid has a plasma half-life of several hours.
Absorption
Iron is primarily absorbed in the duodenum and upper jejunum, influenced by iron stores and dietary factors. Folic acid is readily absorbed from the gastrointestinal tract, mainly from the proximal small intestine.
Metabolism
Iron is incorporated into various proteins (hemoglobin, myoglobin, ferritin). Folic acid is metabolized in the liver to its active form, tetrahydrofolate.
Side Effects
Contraindications
- Patients with known hypersensitivity to any component of the tablet.
- Patients with iron overload syndromes (e.g., hemochromatosis, hemosiderosis).
- Patients receiving repeated blood transfusions.
- Patients with active peptic ulcer, regional enteritis, or ulcerative colitis.
- Non-iron deficiency anemia (e.g., pernicious anemia unless used with vitamin B12).
Drug Interactions
Antacids/PPIs
May decrease iron absorption. Separate administration by at least 2 hours.
Levothyroxine
Iron may decrease the efficacy of levothyroxine. Separate administration by at least 4 hours.
Bisphosphonates
Iron may interfere with bisphosphonate absorption. Separate administration by at least 2 hours.
Chloramphenicol
May delay response to iron therapy.
Tetracycline antibiotics
Iron can decrease the absorption of tetracyclines. Separate administration by at least 2-3 hours.
Fluoroquinolone antibiotics
Iron can reduce the absorption of fluoroquinolones. Separate administration by at least 2 hours.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of iron overdose include severe gastrointestinal upset, vomiting, diarrhea, abdominal pain, pallor, cyanosis, and shock. Folic acid overdose is rare but may include stomach upset or rash. In case of suspected overdose, seek immediate medical attention. Management includes gastric lavage, supportive care, and chelation therapy for severe iron toxicity.
Pregnancy & Lactation
This medication is often indicated for iron and folic acid deficiency during pregnancy and lactation. It is generally considered safe and beneficial when used as directed by a healthcare professional. Folic acid is crucial for fetal development.
Side Effects
Contraindications
- Patients with known hypersensitivity to any component of the tablet.
- Patients with iron overload syndromes (e.g., hemochromatosis, hemosiderosis).
- Patients receiving repeated blood transfusions.
- Patients with active peptic ulcer, regional enteritis, or ulcerative colitis.
- Non-iron deficiency anemia (e.g., pernicious anemia unless used with vitamin B12).
Drug Interactions
Antacids/PPIs
May decrease iron absorption. Separate administration by at least 2 hours.
Levothyroxine
Iron may decrease the efficacy of levothyroxine. Separate administration by at least 4 hours.
Bisphosphonates
Iron may interfere with bisphosphonate absorption. Separate administration by at least 2 hours.
Chloramphenicol
May delay response to iron therapy.
Tetracycline antibiotics
Iron can decrease the absorption of tetracyclines. Separate administration by at least 2-3 hours.
Fluoroquinolone antibiotics
Iron can reduce the absorption of fluoroquinolones. Separate administration by at least 2 hours.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of iron overdose include severe gastrointestinal upset, vomiting, diarrhea, abdominal pain, pallor, cyanosis, and shock. Folic acid overdose is rare but may include stomach upset or rash. In case of suspected overdose, seek immediate medical attention. Management includes gastric lavage, supportive care, and chelation therapy for severe iron toxicity.
Pregnancy & Lactation
This medication is often indicated for iron and folic acid deficiency during pregnancy and lactation. It is generally considered safe and beneficial when used as directed by a healthcare professional. Folic acid is crucial for fetal development.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Generic, patent expired
WHO Essential Medicine
YesClinical Trials
Clinical trials have established the efficacy and safety of iron and folic acid supplementation in various populations, particularly pregnant women, for preventing and treating anemia. Specific trials for Aristofol Fe are not widely published as it's a generic formulation.
Lab Monitoring
- Complete Blood Count (CBC) with hemoglobin and hematocrit to monitor anemia response.
- Serum ferritin levels to assess iron stores.
- Folic acid levels (if deficiency suspected beyond general supplementation).
Doctor Notes
- Emphasize the importance of adherence, especially during pregnancy.
- Advise patients on dietary changes to enhance iron absorption and reduce gastrointestinal side effects.
- Regular monitoring of hemoglobin levels and iron stores is crucial for assessing treatment efficacy and preventing overload.
Patient Guidelines
- Take the tablet whole; do not chew, crush, or suck it.
- Take with food to reduce stomach upset.
- Do not take with antacids, calcium supplements, milk, tea, or coffee.
- Store in a cool, dry place away from direct sunlight and out of reach of children.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Aristofol Fe is not known to impair the ability to drive or operate machinery. However, if you experience any side effects that affect your concentration or coordination, avoid these activities.
Lifestyle Advice
- Maintain a balanced diet rich in iron (red meat, fortified cereals, beans) and folic acid (leafy green vegetables, fruits, nuts).
- Stay hydrated by drinking plenty of water.
- Regular exercise can improve overall well-being.
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