L-Methyl-mc Tablets
It is used to help growth and good health.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Nutritional Supplement; Antianemic; Adjunctive Therapy
Pharmacologic Class
Folic Acid Derivative; B Vitamin Complex
Pregnancy Category
Not applicable (Medical Food/Dietary Supplement); Folate is essential in pregnancy.
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This product contains L-methylfolate, which is the active form of a B vitamin called folate, along with other essential B vitamins (B6 and B12). These nutrients are crucial for many body functions, including brain health, nerve function, and the production of important chemicals that affect mood. It's often used to support overall well-being, improve mood, help with nerve pain, and manage certain metabolic conditions.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry location, away from bathrooms. Protect it from heat and light. Store all medications in a safe place, out of the reach of children and pets.
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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry location, away from bathrooms. Protect it from heat and light. Store all medications in a safe place, out of the reach of children and pets.
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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Maintain a balanced diet rich in fruits, vegetables, and whole grains to support overall nutrient intake.
- Engage in regular physical activity to promote general health and well-being.
- Limit or avoid excessive alcohol intake, as it can interfere with folate metabolism and absorption.
- Follow your healthcare provider's recommendations for any underlying conditions.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
7.5 mg to 15 mg L-methylfolate once daily, often with co-formulated B6 and B12.
Dose Range:
7.5 - 15 mg
Condition-Specific Dosing:
Depression (adjunctive):
7.5 mg to 15 mg L-methylfolate once daily.
Diabetic Neuropathy:
15 mg L-methylfolate once daily.
Hyperhomocysteinemia:
7.5 mg to 15 mg L-methylfolate once daily.
Folate Deficiency:
7.5 mg to 15 mg L-methylfolate once daily.
Pediatric Dosing
Neonatal:
Not established; individual component dosing based on specific deficiency or metabolic disorder under medical supervision.
Infant:
Not established; individual component dosing based on specific deficiency or metabolic disorder under medical supervision.
Child:
Not established; individual component dosing based on specific deficiency or metabolic disorder under medical supervision.
Adolescent:
Not established; individual component dosing based on specific deficiency or metabolic disorder under medical supervision.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment typically required.
Moderate:
No specific dose adjustment typically required; consult physician for severe impairment.
Severe:
No specific dose adjustment typically required; consult physician for severe impairment.
Dialysis:
No specific dose adjustment typically required; consult physician.
Hepatic Impairment:
Mild:
No specific dose adjustment typically required.
Moderate:
No specific dose adjustment typically required.
Severe:
No specific dose adjustment typically required.
Pharmacology
Mechanism of Action
L-methylfolate (5-MTHF) is the primary biologically active form of folate and the only form that can cross the blood-brain barrier. It serves as a critical coenzyme in the one-carbon metabolism cycle, which is essential for DNA synthesis and repair, amino acid metabolism, and the synthesis of monoamine neurotransmitters (e.g., serotonin, dopamine, norepinephrine) and phospholipids. It acts as a methyl donor in the conversion of homocysteine to methionine, which is subsequently converted to S-adenosylmethionine (SAMe), a universal methyl donor. Pyridoxal 5'-phosphate (active B6) and methylcobalamin (active B12) are cofactors in these metabolic pathways, particularly in the methylation cycle and homocysteine metabolism, facilitating the conversion of homocysteine to methionine.
Pharmacokinetics
Absorption:
Bioavailability:
High (nearly 100% for oral L-methylfolate).
Tmax:
1-3 hours for L-methylfolate.
FoodEffect:
Minimal effect on absorption.
Distribution:
Vd:
Not specifically quantified; widely distributed throughout body tissues.
ProteinBinding:
Low.
CnssPenetration:
Yes (L-methylfolate readily crosses the blood-brain barrier).
Elimination:
HalfLife:
Approximately 3 hours for L-methylfolate.
Clearance:
Primarily renal excretion.
ExcretionRoute:
Renal; some biliary.
Unchanged:
Minimal.
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical effects (e.g., mood improvement, neuropathy symptom relief).
PeakEffect:
Weeks to months of consistent use.
DurationOfAction:
Maintained with continued daily dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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
A burning or tingling sensation that is not normal
Swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While 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:
Upset stomach or vomiting
Stomach pain or diarrhea
Decreased appetite
Feeling sleepy
Headache
* Pimples (acne)
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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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
A burning or tingling sensation that is not normal
Swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While 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:
Upset stomach or vomiting
Stomach pain or diarrhea
Decreased appetite
Feeling sleepy
Headache
* Pimples (acne)
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:
- Signs of an allergic reaction (rare): rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- Unusual or severe gastrointestinal upset (e.g., nausea, bloating, diarrhea) - generally rare.
- Worsening of existing symptoms or development of new, concerning symptoms.
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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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 formulations may contain this ingredient.
This medication can increase your susceptibility to sunburn. Exercise caution when spending time outdoors, especially in sunny conditions, and notify your doctor if you experience excessive sunburn while taking this drug.
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 you make an informed decision regarding your treatment and the well-being of 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 formulations may contain this ingredient.
This medication can increase your susceptibility to sunburn. Exercise caution when spending time outdoors, especially in sunny conditions, and notify your doctor if you experience excessive sunburn while taking this drug.
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 you make an informed decision regarding your treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- L-methylfolate and B vitamins are generally considered to have low toxicity. Very high doses may rarely cause mild gastrointestinal upset, irritability, or sleep disturbances. No severe toxicity has been reported with folate overdose.
What to Do:
Discontinue use. Symptomatic and supportive care. Contact a poison control center or seek medical attention if symptoms are severe or persistent. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Methotrexate (high doses of L-methylfolate can theoretically reduce methotrexate efficacy, though low doses are used for rescue in cancer therapy).
- Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital - can decrease folate levels and increase folate requirements).
- Pyrimethamine (folate antagonist, L-methylfolate may reduce its efficacy).
- Sulfasalazine (inhibits folate absorption).
Minor Interactions
- Cholestyramine (may impair folate absorption).
- Oral contraceptives (may affect folate metabolism and increase folate requirements).
Monitoring
Baseline Monitoring
Serum Folate/Red Blood Cell Folate
Rationale: To assess baseline folate status, especially if deficiency is suspected or for specific conditions like depression or neuropathy.
Timing: Prior to initiation, if deficiency is suspected or for specific indications.
Homocysteine levels
Rationale: To assess methylation status, particularly in individuals with cardiovascular risk factors or cognitive impairment.
Timing: Prior to initiation, if indicated.
Vitamin B12 levels (serum cobalamin)
Rationale: To rule out B12 deficiency, as high folate intake can mask the hematological symptoms of B12 deficiency while neurological damage may progress.
Timing: Prior to initiation.
Routine Monitoring
Clinical symptom improvement (e.g., mood, neuropathic symptoms, energy levels)
Frequency: Ongoing assessment by patient and clinician.
Target: Not applicable (subjective improvement).
Action Threshold: Lack of improvement or worsening symptoms may indicate a need for dose adjustment, re-evaluation of diagnosis, or alternative therapy.
Homocysteine levels (if elevated at baseline)
Frequency: 3-6 months after initiation, then annually if stable and indicated.
Target: <10-12 µmol/L
Action Threshold: Persistent elevation may require dose adjustment or further investigation.
Symptom Monitoring
- Mood changes (e.g., reduction in depressive or anxious symptoms)
- Neuropathic symptoms (e.g., reduction in numbness, tingling, pain)
- Fatigue levels
- Cognitive function (e.g., memory, concentration)
- Gastrointestinal upset (rare)
Special Patient Groups
Pregnancy
Folate (including L-methylfolate) is essential during pregnancy for proper fetal development, particularly to prevent neural tube defects. Supplementation is highly recommended for all women of childbearing age and throughout pregnancy. L-methylfolate may be preferred in individuals with MTHFR gene variations who may have impaired conversion of folic acid.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development; deficiency risk is highest during this period.
Second Trimester:
Continued need for fetal growth and maternal health.
Third Trimester:
Continued need for fetal growth and maternal health.
Lactation
Folate and B vitamins are excreted into breast milk and are essential for infant growth and development. Supplementation is generally considered safe and beneficial for lactating mothers to ensure adequate maternal and infant nutritional status.
Infant Risk:
L1 (Safest) - No known risk to the infant; considered beneficial.
Pediatric Use
Not typically used in this specific combination for general pediatric populations unless a specific deficiency or condition (e.g., MTHFR polymorphism, certain metabolic disorders, or specific types of epilepsy) is diagnosed and under strict medical supervision. Dosing should be individualized based on age, weight, and specific medical needs.
Geriatric Use
Generally safe and often beneficial, especially given the potential for malabsorption, increased nutritional needs, or polypharmacy in older adults. No specific dose adjustment typically required, but monitor for potential drug interactions and assess overall nutritional status.
Clinical Information
Clinical Pearls
- L-methylfolate is the active, bioavailable form of folate, bypassing the need for enzymatic conversion by the MTHFR enzyme, which can be impaired in individuals with common MTHFR gene polymorphisms (e.g., C677T, A1298C).
- Often used as an adjunctive therapy in major depressive disorder, particularly in patients who do not respond adequately to antidepressant monotherapy, due to its role in neurotransmitter synthesis and methylation pathways.
- Important for reducing elevated homocysteine levels, a recognized risk factor for cardiovascular disease, stroke, and cognitive decline.
- Always assess Vitamin B12 levels (serum cobalamin) before initiating high-dose folate supplementation, as folate can mask the hematological symptoms of B12 deficiency (macrocytic anemia) while allowing neurological damage to progress unchecked.
- Marketed as a medical food, meaning it is intended for the dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
Alternative Therapies
- For depression: Antidepressants (SSRIs, SNRIs, TCAs), psychotherapy (CBT, DBT), electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS).
- For neuropathy: Other neuropathic pain medications (e.g., gabapentin, pregabalin, duloxetine), lifestyle modifications, physical therapy.
- For hyperhomocysteinemia: Other B vitamin supplements (e.g., standalone B6, B12), dietary modifications.
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often not covered by standard prescription drug insurance plans; may be covered as a medical food or through Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA). Coverage varies significantly by insurance plan and specific product.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.