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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Folixate
Generic Name
Folate, Vitamin D3
Active Ingredient
LevomefolateCategory
Vitamin C [EPC]
Salt Form
Calcium
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 1000 ug/1 | TABLET | ORAL | 59088-301 |
Detailed information about Folixate
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Folixate, you must consult a qualified healthcare professional.
Levomefolate (L-5-methyltetrahydrofolate) is the primary biologically active form of folate used as a medical food for major depressive disorder and as a supplement for folate deficiency. It belongs to the folate analog class and bypasses critical enzymatic steps in the one-carbon cycle.
The dosage of levomefolate varies significantly depending on the underlying condition being treated.
Levomefolate is generally considered safe for pediatric use when used as a nutritional supplement, but specific dosing for psychiatric conditions in children has not been extensively established in large-scale clinical trials.
Because levomefolate is primarily excreted by the kidneys, patients with significant renal impairment (kidney disease) should be monitored closely. While specific dose reduction protocols are not standardized, a lower starting dose may be prudent to prevent accumulation.
Since levomefolate does not require hepatic activation, it is generally well-tolerated in patients with liver disease. No specific dosage adjustments are typically required for hepatic impairment, though the overall nutritional status of the patient should be considered.
Geriatric patients should start at the lower end of the dosing spectrum (e.g., 7.5 mg for depression). It is crucial to screen elderly patients for Vitamin B12 deficiency before starting high-dose levomefolate, as folate can mask the hematological signs of B12 deficiency while neurological damage continues.
To ensure maximum benefit and safety, follow these administration guidelines:
If you miss a dose of levomefolate, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular routine. Do not double the dose to catch up, as this can increase the risk of side effects like agitation or insomnia.
Levomefolate is a water-soluble vitamin, and the body typically excretes excess amounts. However, acute ingestion of very high doses (overdose) may lead to symptoms such as:
In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. While not typically life-threatening, supportive care may be necessary to manage neurological or gastrointestinal symptoms.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking Levomefolate without medical guidance, especially when using it as an adjunct for depression.
Levomefolate is generally very well-tolerated, as it is a naturally occurring nutrient. However, some patients may experience mild side effects, particularly when starting high-dose therapy (7.5 mg to 15 mg). Common side effects include:
These side effects are less frequent but may require a dosage adjustment:
Rarely, patients may experience more distinct reactions:
While extremely rare, serious reactions can occur. You should contact a healthcare provider immediately if you experience:
> Warning: Stop taking Levomefolate and call your doctor immediately if you experience any signs of a severe allergic reaction or sudden, drastic changes in mood or behavior.
Research into the long-term use of levomefolate is ongoing. To date, no significant toxicities have been identified with prolonged use at recommended doses. However, the primary concern with long-term high-dose folate supplementation is the potential to mask a Vitamin B12 deficiency. Over years, if B12 levels are not monitored, this could lead to permanent nerve damage (subacute combined degeneration of the spinal cord).
There is also theoretical discussion regarding 'methyl trapping' or imbalances in the one-carbon cycle, but these are typically managed by ensuring a balanced intake of other B-vitamins (B6 and B12). Regular blood work is recommended for anyone on long-term high-dose therapy.
No FDA black box warnings currently exist for Levomefolate. Unlike many psychiatric medications, it has a high safety profile and is categorized as a medical food or supplement rather than a potent pharmaceutical drug with high toxicity risks. However, its use as an adjunct in depression should always be monitored by a physician due to the complexities of mental health treatment.
Report any unusual symptoms or persistent side effects to your healthcare provider. Keeping a daily log of symptoms when you first start the medication can help your doctor determine if the dosage is correct for you.
Levomefolate is a potent bioactive compound. While it is a vitamin, at the doses used for medical purposes (7.5 mg to 15 mg), it functions more like a pharmaceutical agent. It is essential that patients do not self-treat with high doses without a clinical diagnosis. The most significant safety concern is the interaction between folate and Vitamin B12. High levels of folate can correct the anemia (low red blood cell count) caused by B12 deficiency, but it does not fix the underlying B12-related nerve damage. This can lead to a situation where the patient feels fine physically while their nervous system is suffering irreversible damage.
There are no FDA black box warnings for Levomefolate. It is generally recognized as safe (GRAS) by the FDA when used according to labeling instructions.
If you are taking levomefolate for a medical condition, your healthcare provider may require the following tests:
Levomefolate does not typically cause sedation or cognitive impairment. Most patients can safely drive or operate machinery. However, if you experience jitteriness or agitation during the initial phase of treatment, use caution until you know how the medication affects you.
Alcohol interferes with the absorption and metabolism of folate. Chronic alcohol consumption can deplete the body's folate stores and reduce the effectiveness of levomefolate therapy. While a single drink is unlikely to cause a severe reaction, it is best to limit alcohol intake to ensure the medication works as intended.
Levomefolate does not cause physical dependence or a traditional withdrawal syndrome. However, if you are taking it for depression, stopping it suddenly may cause a return of depressive symptoms. It is always best to taper off under a doctor's guidance to monitor for mood changes.
> Important: Discuss all your medical conditions, especially any history of anemia or bipolar disorder, with your healthcare provider before starting Levomefolate.
There are no absolute contraindications where levomefolate must never be used with another drug, but there are combinations that require extreme caution:
For each major interaction, the management strategy usually involves either monitoring blood levels of the affected drug (like phenytoin) or adjusting the timing of the dose. Because levomefolate is a natural metabolite, it lacks the complex liver enzyme interactions (CYP450) that plague most pharmaceutical drugs.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter vitamins.
Levomefolate should NOT be used in the following circumstances:
Conditions requiring careful risk-benefit analysis include:
Patients who are sensitive to folic acid or folinic acid (leucovorin) may also be sensitive to levomefolate, as they share a similar pteridine ring structure. If you have had a mild rash from other B-vitamins, proceed with caution under medical supervision.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of anemia or psychiatric conditions, before prescribing Levomefolate.
Levomefolate is considered Pregnancy Category A (or the equivalent under the new FDA Pregnancy and Lactation Labeling Rule). It is not only safe but is considered essential for a healthy pregnancy.
Folate is a natural component of human breast milk.
In patients with chronic kidney disease (CKD), levomefolate levels may be elevated due to decreased clearance. While it is not toxic, the dose should be kept at the minimum necessary to achieve clinical goals. It is not removed significantly by hemodialysis.
Levomefolate is an excellent choice for patients with liver impairment who need folate, as it does not require the liver to 'activate' it. However, patients with cirrhosis often have complex nutritional deficiencies and should be managed with a comprehensive vitamin plan.
> Important: Special populations, particularly the elderly and those with kidney disease, require individualized medical assessment and regular monitoring of vitamin levels.
Levomefolate acts as the primary source of the methyl group in the one-carbon transfer cycle. Its most critical molecular action is serving as a co-substrate for the enzyme methionine synthase. In this reaction, levomefolate transfers a methyl group to homocysteine, converting it into the essential amino acid methionine. This process is also dependent on methylcobalamin (Vitamin B12).
Once methionine is formed, it is converted into S-adenosylmethionine (SAMe). SAMe is the 'master methylator' that provides the carbon units necessary for the synthesis of DNA, RNA, and neurotransmitters. Specifically, in the central nervous system, this cycle is required for the production of tetrahydrobiopterin (BH4), which is a mandatory co-factor for the enzymes that create serotonin, dopamine, and norepinephrine.
| Parameter | Value |
|---|---|
| Bioavailability | High (>85%) |
| Protein Binding | 70% to 90% (Albumin) |
| Half-life | ~3 hours (Plasma) |
| Tmax | 1 to 3 hours |
| Metabolism | None (Directly enters one-carbon cycle) |
| Excretion | Renal (primarily), Fecal (minor) |
Levomefolate is classified as a folate analog and a methylating agent. Within the therapeutic area of psychiatry, it is considered an antidepressant adjunct. It is distinct from folic acid (synthetic) and folinic acid (5-formyl-THF) because it is the only form that does not require the MTHFR enzyme for its final activation step.
Common questions about Folixate
Levomefolate is primarily used as an add-on treatment for Major Depressive Disorder to help antidepressants work more effectively. It is also used to treat folate deficiency and is a key ingredient in many prenatal vitamins to prevent birth defects. Because it is the active form of Vitamin B9, it is especially useful for people who have trouble processing standard folic acid due to genetic factors like the MTHFR mutation. Your doctor may also prescribe it to lower high homocysteine levels, which can be a risk factor for heart disease. It is available both as a high-dose medical food and in lower doses as a nutritional supplement.
Most people tolerate Levomefolate very well since it is a form of a natural vitamin. The most common side effects include mild nausea, gas, or bloating when first starting the supplement. Some people may also experience a bit of trouble sleeping (insomnia) or feel slightly more irritable or 'jittery' if the dose is high. These effects are usually mild and often go away as your body gets used to the medication. If you experience a rash, itching, or severe agitation, you should contact your healthcare provider immediately.
While there is no dangerous 'reaction' between alcohol and Levomefolate, alcohol is known to interfere with how your body absorbs and uses folate. Drinking alcohol can deplete your body's folate stores and may make the Levomefolate supplement less effective at treating your condition. For the best results, especially if you are taking it for depression, it is recommended to limit your alcohol consumption. Always discuss your alcohol use with your doctor to ensure it doesn't interfere with your treatment plan.
Yes, Levomefolate is not only safe but often recommended during pregnancy. It is the active form of folate, which is essential for the development of the baby's brain and spine (the neural tube). Many doctors prefer Levomefolate over folic acid for pregnant women, particularly those with MTHFR genetic variations, to ensure the baby gets the nutrients it needs. However, if you are taking the high-dose version (15 mg) for depression, you should confirm the dosage with your obstetrician. It is a critical component of modern prenatal care.
If you are taking Levomefolate for depression, it typically takes about 2 to 4 weeks to notice a significant improvement in your mood. While the vitamin enters your bloodstream within hours, it takes time for it to influence the production of neurotransmitters like serotonin and dopamine in the brain. For treating a folate deficiency, your blood levels will begin to improve within a few days, though it may take several weeks for symptoms like fatigue to fully resolve. Consistency is key to seeing the full benefits.
Levomefolate is not an addictive medication, and stopping it suddenly does not cause a physical withdrawal like some other drugs. However, if you are taking it to help manage depression, stopping it abruptly could lead to a return of your depressive symptoms. It is always best to talk to your doctor before stopping any medication. They can help you decide if it is the right time to stop and how to do so safely while monitoring your mental health.
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, simply skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for the one you missed, as this could lead to temporary side effects like jitteriness or trouble sleeping. To help you remember, try taking your Levomefolate at the same time every day, such as with your morning meal.
There is no clinical evidence to suggest that Levomefolate causes weight gain. In fact, because it is used to help treat depression, some patients find that as their mood improves, they are better able to maintain a healthy diet and exercise routine. Unlike some traditional antidepressant medications that are associated with weight changes, Levomefolate is a vitamin-based supplement and does not typically affect metabolism or appetite in a way that leads to weight gain.
Levomefolate can be taken with most medications, but there are a few important exceptions. It can interact with certain seizure medications (like phenytoin) and some cancer treatments (like methotrexate). It is also important to ensure you aren't taking other high-dose folate supplements at the same time. Always provide your doctor and pharmacist with a full list of all the medications, vitamins, and herbal supplements you are taking to avoid any potential interactions.
Yes, Levomefolate is available in both brand-name versions (like Deplin) and as generic levomefolate calcium. Generic versions are typically more cost-effective and contain the same active ingredient. You can find it in various strengths, ranging from low-dose over-the-counter supplements to high-dose prescription-strength tablets. When choosing a generic, ensure it is from a reputable manufacturer and discuss with your pharmacist to ensure it matches the specific form your doctor recommended.