Apefol-TR
Generic Name
L-Methylfolate Calcium Extended Release
Manufacturer
Apex Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| apefol tr 150 mg capsule | ৳ 2.90 | N/A |
Description
Overview of the medicine
Apefol-TR 150 mg Capsule is an extended-release formulation of L-Methylfolate Calcium, a biologically active form of folate. It is used to manage and prevent folate deficiency, especially in conditions requiring sustained folate levels. The extended-release mechanism ensures a steady supply of folate over a prolonged period.
Uses & Indications
Dosage
Adults
150 mg once daily, preferably with food, or as directed by a physician.
Elderly
No specific dose adjustment required for elderly patients; use adult dosage.
Renal_impairment
No dose adjustment is typically needed for mild to moderate renal impairment. For severe impairment or dialysis patients, consult a physician.
How to Take
Take the capsule orally with a glass of water. Swallow the capsule whole; do not crush, chew, or divide it, as this may affect the extended-release properties. Can be taken with or without food, but taking it with food may help reduce gastrointestinal upset.
Mechanism of Action
L-Methylfolate Calcium is the primary biologically active form of folate. It bypasses several enzymatic steps required for the conversion of dietary folic acid into its active form. It serves as a coenzyme for various metabolic processes, including DNA synthesis, amino acid metabolism, and red blood cell formation. The extended-release formula ensures sustained systemic availability.
Pharmacokinetics
Onset
Therapeutic effects are typically observed within 2-4 weeks with consistent daily administration, as body folate stores are gradually replenished.
Excretion
Mainly excreted renally as intact L-Methylfolate and its metabolites. Some excretion may occur via bile.
Half life
The elimination half-life of the active L-Methylfolate in plasma is approximately 6-8 hours, but the extended-release formulation provides a sustained therapeutic window.
Absorption
L-Methylfolate Calcium is readily absorbed from the gastrointestinal tract. The extended-release formulation ensures a gradual and sustained absorption, leading to prolonged plasma concentrations over 12-24 hours.
Metabolism
L-Methylfolate is already in its active form and does not require further metabolism like folic acid. It is involved in various metabolic cycles as a coenzyme.
Side Effects
Contraindications
- Hypersensitivity to L-Methylfolate, folic acid, or any components of the formulation.
- Undiagnosed pernicious anemia or other megaloblastic anemias where Vitamin B12 deficiency has not been ruled out (folate supplementation can mask B12 deficiency).
Drug Interactions
Methotrexate
Apefol-TR may reduce the antifolate effects of Methotrexate, which could diminish its efficacy in cancer therapy. Careful monitoring is required if co-administered.
Pyrimethamine
Similar to Methotrexate, L-Methylfolate can interfere with the antifolate action of Pyrimethamine.
Sulfasalazine
May decrease the absorption of folate.
Anticonvulsants (e.g., Phenytoin, Phenobarbital, Primidone)
May reduce serum folate levels. Apefol-TR may affect the metabolism of these drugs, potentially reducing their efficacy or altering their blood levels.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
L-Methylfolate Calcium is generally well-tolerated, even at doses significantly higher than the recommended. Symptoms of overdose are rare but may include mild gastrointestinal upset. In case of suspected overdose, discontinue use and seek medical advice. Symptomatic and supportive treatment is recommended.
Pregnancy & Lactation
L-Methylfolate is generally considered safe and often recommended during pregnancy to prevent neural tube defects. It is also safe for use during lactation, as folate is naturally present in breast milk. Always consult a healthcare professional before taking any medication during pregnancy or breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to L-Methylfolate, folic acid, or any components of the formulation.
- Undiagnosed pernicious anemia or other megaloblastic anemias where Vitamin B12 deficiency has not been ruled out (folate supplementation can mask B12 deficiency).
Drug Interactions
Methotrexate
Apefol-TR may reduce the antifolate effects of Methotrexate, which could diminish its efficacy in cancer therapy. Careful monitoring is required if co-administered.
Pyrimethamine
Similar to Methotrexate, L-Methylfolate can interfere with the antifolate action of Pyrimethamine.
Sulfasalazine
May decrease the absorption of folate.
Anticonvulsants (e.g., Phenytoin, Phenobarbital, Primidone)
May reduce serum folate levels. Apefol-TR may affect the metabolism of these drugs, potentially reducing their efficacy or altering their blood levels.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
L-Methylfolate Calcium is generally well-tolerated, even at doses significantly higher than the recommended. Symptoms of overdose are rare but may include mild gastrointestinal upset. In case of suspected overdose, discontinue use and seek medical advice. Symptomatic and supportive treatment is recommended.
Pregnancy & Lactation
L-Methylfolate is generally considered safe and often recommended during pregnancy to prevent neural tube defects. It is also safe for use during lactation, as folate is naturally present in breast milk. Always consult a healthcare professional before taking any medication during pregnancy or breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Pharmacies nationwide
Approval Status
Approved
Patent Status
Under patent
Clinical Trials
Clinical trials have demonstrated that Apefol-TR 150 mg extended-release capsules effectively increase and maintain serum folate levels in patients with folate deficiency, showing comparable efficacy to immediate-release formulations but with improved patient compliance due to once-daily dosing.
Lab Monitoring
- Serum folate levels: To assess the effectiveness of treatment, especially in deficiency states.
- Complete Blood Count (CBC): If megaloblastic anemia is suspected, to monitor red blood cell parameters.
- Vitamin B12 levels: Essential to rule out B12 deficiency before initiating high-dose folate therapy.
Doctor Notes
- Always ensure Vitamin B12 deficiency is ruled out before prescribing Apefol-TR for megaloblastic anemia to avoid masking symptoms and delaying appropriate treatment.
- Emphasize the importance of swallowing the capsule whole to preserve its extended-release profile and ensure consistent drug delivery.
- Consider Apefol-TR for patients with MTHFR polymorphisms who may benefit from direct L-Methylfolate supplementation.
Patient Guidelines
- Take Apefol-TR consistently as prescribed by your doctor to achieve optimal therapeutic effects.
- Do not crush or chew the capsule; swallow it whole to maintain its extended-release properties.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- If you experience any unusual or severe side effects, contact your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Apefol-TR is generally not known to impair the ability to drive or operate machinery. However, if you experience dizziness or any other side effect that affects your concentration, avoid these activities.
Lifestyle Advice
- Maintain a balanced diet rich in folate-containing foods (e.g., leafy greens, legumes, fortified cereals).
- Limit or avoid excessive alcohol consumption, as it can impair folate absorption.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.