Deplin 7.5mg Capsules
It is used to aid diet needs.
Drug Class
Medical Food; Nutritional Supplement; Antidepressant Augmentation
Pharmacologic Class
Folate derivative; Vitamin
Pregnancy Category
Not assigned (Medical Food)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Deplin is a medical food that provides a special form of the vitamin folate (L-methylfolate). This form is important for brain health and helps your body make chemicals that affect mood. It's often used along with antidepressant medications to help them work better, especially if your body has trouble processing regular folate.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider advises you to stop.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. Ensure all medications are stored in a safe location, out of 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 have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider advises you to stop.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. Ensure all medications are stored in a safe location, out of 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 have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Maintain a balanced diet.
- Follow your doctor's instructions for all medications.
- Do not stop taking other prescribed medications without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
7.5 mg once daily
Dose Range:
7.5 - 15 mg
Condition-Specific Dosing:
Major Depressive Disorder (adjunctive therapy):
7.5 mg or 15 mg once daily
Hyperhomocysteinemia (dietary management):
7.5 mg or 15 mg once daily
Pediatric Dosing
Neonatal:
Not established for this specific formulation/indication
Infant:
Not established for this specific formulation/indication
Child:
Not established for this specific formulation/indication
Adolescent:
Not established for this specific formulation/indication
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Dialysis:
No specific considerations; water-soluble vitamin
Hepatic Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Pharmacology
Mechanism of Action
L-methylfolate is the primary biologically active form of folate and the only form that can cross the blood-brain barrier. It is a critical cofactor in the synthesis of monoamines (serotonin, norepinephrine, dopamine) and other neurotransmitters (e.g., tetrahydrobiopterin, S-adenosylmethionine) in the brain. It facilitates the methylation cycle, which is essential for DNA synthesis, repair, and regulation of homocysteine levels. In depression, it is thought to enhance the response to antidepressants by increasing neurotransmitter synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
High (well-absorbed)
Tmax:
1-3 hours
FoodEffect:
Minimal effect, can be taken with or without food.
Distribution:
Vd:
Not readily quantifiable for a vitamin; widely distributed in tissues.
ProteinBinding:
Not extensively protein bound.
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 3 hours (for L-methylfolate in plasma)
Clearance:
Renal excretion of excess and metabolites.
ExcretionRoute:
Renal (primarily), also biliary.
Unchanged:
Small amounts of unchanged L-methylfolate excreted.
Pharmacodynamics
OnsetOfAction:
Weeks to months for clinical effect in depression augmentation.
PeakEffect:
Weeks to months.
DurationOfAction:
Sustained with daily dosing.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice about side effects, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice about side effects, contact 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:
- Unusual mood changes (e.g., increased anxiety, agitation, mania - though rare with methylfolate alone)
- Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
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 assess 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 current medications and health conditions. Do not initiate, discontinue, or modify the dosage 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 assess 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 current medications and health conditions. Do not initiate, discontinue, or modify the dosage 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. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. If you have any concerns or questions, be sure to discuss them with your doctor.
If you are allergic to tartrazine, also known as FD&C Yellow No. 5, consult with your doctor before taking this medication, as some products may contain this ingredient.
When taking cholestyramine or colestipol, it is crucial to consult with your pharmacist to determine the best way to take these medications in conjunction with this drug to ensure safe and effective use.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision about your treatment.
If you are allergic to tartrazine, also known as FD&C Yellow No. 5, consult with your doctor before taking this medication, as some products may contain this ingredient.
When taking cholestyramine or colestipol, it is crucial to consult with your pharmacist to determine the best way to take these medications in conjunction with this drug to ensure safe and effective use.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
What to Do:
Discontinue use and contact a healthcare professional or poison control. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- Folic acid antagonists (e.g., methotrexate, pyrimethamine, trimethoprim) - may reduce efficacy of methylfolate or require higher doses of methylfolate to overcome antagonism.
Moderate Interactions
- Anticonvulsants (e.g., phenytoin, phenobarbital, primidone) - may reduce serum folate levels, potentially requiring higher methylfolate doses.
- Sulfasalazine - may inhibit folate absorption.
Monitoring
Baseline Monitoring
Baseline depressive symptoms (e.g., HAM-D, MADRS scores)
Rationale: To assess initial severity and track response to therapy.
Timing: Prior to initiation.
Homocysteine levels (if indicated for hyperhomocysteinemia)
Rationale: To assess folate status and monitor treatment efficacy.
Timing: Prior to initiation.
Routine Monitoring
Depressive symptoms
Frequency: Regularly (e.g., weekly to monthly initially, then periodically)
Target: Reduction in symptom scores, clinical improvement.
Action Threshold: Lack of improvement after adequate trial, worsening symptoms.
Homocysteine levels (if indicated)
Frequency: Periodically (e.g., every 3-6 months) until stable, then annually.
Target: <15 µmol/L (or as per clinical guidelines)
Action Threshold: Persistently elevated levels.
Symptom Monitoring
- Mood changes
- Energy levels
- Sleep patterns
- Appetite changes
- Anxiety
- Irritability
Special Patient Groups
Pregnancy
Folate (including L-methylfolate) is essential during pregnancy for fetal development, particularly to prevent neural tube defects. Supplementation is generally recommended for all pregnant women. Deplin is a medical food, not a drug, and its use should be discussed with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development; adequate folate intake is vital.
Second Trimester:
Continued importance for fetal growth and development.
Third Trimester:
Continued importance for fetal growth and maternal health.
Lactation
L-methylfolate is naturally present in breast milk and is considered compatible with breastfeeding. It is essential for infant growth and development.
Infant Risk:
L1 (Safest) - No known risk to the infant; beneficial.
Pediatric Use
Not specifically indicated for pediatric depression augmentation, but folate supplementation is common in children for deficiency or specific metabolic conditions. Use under medical supervision.
Geriatric Use
No specific dose adjustments needed. May be beneficial in elderly patients with folate deficiency or depression, as absorption of folic acid can be impaired in this population.
Clinical Information
Clinical Pearls
- Deplin (L-methylfolate) is a medical food, not an FDA-approved drug, which impacts its regulatory status, prescribing, and insurance coverage.
- It is the active, bioavailable form of folate, bypassing the need for the MTHFR enzyme, which can be deficient in some individuals.
- Primarily used as an adjunctive therapy for major depressive disorder, particularly in patients who are partial responders to standard antidepressants.
- May be beneficial in patients with genetic polymorphisms (e.g., MTHFR C677T or A1298C) that impair folate metabolism, although routine genetic testing is not universally recommended.
- Generally well-tolerated with a low side effect profile.
Alternative Therapies
- Other antidepressant augmentation strategies (e.g., lithium, thyroid hormone, atypical antipsychotics, psychotherapy)
- Other forms of folate supplementation (e.g., folic acid, folinic acid)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$150 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as a medical food; may require prior authorization or be out-of-pocket.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 this 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.