Deplin 15mg Capsules
It is used to aid diet needs.
Drug Class
Medical food; Nutritional supplement; Antidepressant augmentation
Pharmacologic Class
Folate derivative; Vitamin
Pregnancy Category
Category A
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Deplin is a medical food that provides a special form of folate (a B vitamin) that your body can easily use. It's often prescribed to help manage certain conditions like depression or nerve pain, especially if your body has trouble processing regular folic acid.
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 in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a 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 in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Maintain a balanced diet
- Follow healthcare provider's recommendations for underlying conditions
- Do not stop other prescribed medications unless advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
15 mg once daily
Dose Range:
7.5 - 15 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD) augmentation:
7.5 mg or 15 mg once daily
Diabetic Peripheral Neuropathy:
15 mg once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Dialysis:
No specific adjustment recommended
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Pharmacology
Mechanism of Action
L-methylfolate is the primary active form of folate and the only form that can cross the blood-brain barrier. It serves as a cofactor in the synthesis of monoamines (serotonin, norepinephrine, dopamine) and nitric oxide. It bypasses the MTHFR enzyme, which can be deficient in some individuals, leading to impaired folate metabolism and reduced neurotransmitter synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
High (as it is the active form)
Tmax:
1-3 hours
FoodEffect:
Minimal effect
Distribution:
Vd:
Not available
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 3 hours (plasma elimination)
Clearance:
Not precisely quantified
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Weeks (for clinical effect in depression/neuropathy)
PeakEffect:
Weeks to months
DurationOfAction:
Sustained with daily dosing
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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. 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 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, consult 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.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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. 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 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, consult 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:
- Allergic reaction (rare: rash, itching, swelling)
- Mania/hypomania (rare, especially in bipolar patients)
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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems you have, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to ensure that you can take this medication safely and effectively.
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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems you have, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to ensure that you can take this medication safely and effectively.
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 your doctor before taking this medication, as some products may contain this ingredient.
When taking cholestyramine or colestipol, consult your pharmacist for guidance on how 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, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as they will help you weigh the advantages and disadvantages for both you and your baby.
If you are allergic to tartrazine, also known as FD&C Yellow No. 5, consult your doctor before taking this medication, as some products may contain this ingredient.
When taking cholestyramine or colestipol, consult your pharmacist for guidance on how 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, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as they will help you weigh the advantages and disadvantages for both you and your baby.
Overdose Information
Overdose Symptoms:
- Generally considered non-toxic even at high doses, but theoretical symptoms could include gastrointestinal upset, irritability, or sleep disturbances.
What to Do:
Call 1-800-222-1222 (Poison Control). Seek medical attention if symptoms are severe or persistent.
Drug Interactions
Moderate Interactions
- Folic acid antagonists (e.g., methotrexate, pyrimethamine, trimethoprim) - may reduce efficacy of methylfolate.
- Anticonvulsants (e.g., phenytoin, phenobarbital, primidone) - may lower folate levels, but methylfolate may not interfere with their efficacy as much as folic acid.
Monitoring
Baseline Monitoring
Baseline folate levels (serum or red blood cell folate)
Rationale: To confirm deficiency or insufficiency, especially in patients with MTHFR polymorphisms.
Timing: Prior to initiation
Routine Monitoring
Clinical response (e.g., mood, neuropathy symptoms)
Frequency: Regularly during treatment
Target: Improved symptoms
Action Threshold: Lack of improvement after 4-8 weeks may warrant re-evaluation.
Symptom Monitoring
- Mood changes
- Neuropathic pain
- Cognitive function
- Energy levels
Special Patient Groups
Pregnancy
Folate is essential during pregnancy for fetal development, especially neural tube formation. L-methylfolate is generally considered safe and beneficial, particularly for those with MTHFR polymorphisms.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development; supplementation is highly recommended.
Second Trimester:
Continued importance for fetal growth.
Third Trimester:
Continued importance for fetal growth.
Lactation
Folate is naturally present in breast milk and is essential for infant growth. L-methylfolate is considered safe during lactation.
Infant Risk:
Low risk; beneficial.
Pediatric Use
Not typically indicated for children for the specific uses of Deplin (MDD augmentation, neuropathy), but folate supplementation is essential for pediatric growth and development. Dosing would be different for general folate deficiency.
Geriatric Use
No specific dose adjustment needed. May be particularly beneficial in elderly patients with depression or cognitive decline who may have impaired folate metabolism.
Clinical Information
Clinical Pearls
- Deplin (L-methylfolate) is a medical food, not a prescription drug, and is intended for the dietary management of specific conditions where there is a distinct nutritional requirement for L-methylfolate.
- It is particularly useful in patients with genetic polymorphisms (e.g., MTHFR C677T or A1298C) that impair the conversion of folic acid to its active form, L-methylfolate.
- Often used as an adjunctive therapy in Major Depressive Disorder (MDD) to augment antidepressant response, especially in partial responders.
- May also be used for neuropathic pain, particularly diabetic peripheral neuropathy, due to its role in nitric oxide synthesis and nerve health.
- Patients should be advised that it is not an antidepressant itself and should not replace prescribed antidepressant medications.
Alternative Therapies
- For MDD augmentation: Other augmentation strategies (e.g., atypical antipsychotics, lithium, thyroid hormone, bupropion, buspirone)
- For Neuropathy: Gabapentin, pregabalin, duloxetine, tricyclic antidepressants, topical agents
Cost & Coverage
Average Cost:
Approximately $100-$200 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it's a medical food/supplement, or may require prior authorization. Coverage varies widely by plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.