Usage
- Medical Conditions: Escitalopram Oxalate + L-Methyl Folate is primarily prescribed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). It may also be used in cases of depression with comorbid folate deficiency, or to enhance the effects of other antidepressant medications. L-Methylfolate itself is a medical food used for conditions related to folate deficiency.
- Pharmacological Classification: Escitalopram is a selective serotonin reuptake inhibitor (SSRI), and L-methylfolate is the biologically active form of folic acid (vitamin B9). Thus, the combination acts as an antidepressant and folate supplement.
- Mechanism of Action: Escitalopram increases serotonin levels in the brain by inhibiting its reuptake. L-Methylfolate acts as a cofactor in the synthesis of serotonin, norepinephrine, and dopamine, further supporting mood regulation.
Alternate Names
- While “Escitalopram Oxalate + L-Methyl Folate” is the generic name, several brand names exist depending on the manufacturer and region.
- Brand Names: Escirise-LMF, Escepam LMF, Escitafol, Remfolet Plus, Lefodapplus.
How It Works
- Pharmacodynamics: Escitalopram’s primary effect is the enhancement of serotonergic neurotransmission. This is achieved by selectively blocking the serotonin transporter (SERT), preventing serotonin reuptake into presynaptic neurons. Consequently, serotonin concentrations increase in the synaptic cleft, potentiating its effects on postsynaptic receptors. L-Methylfolate is essential for various metabolic processes, including the synthesis of neurotransmitters like serotonin, norepinephrine, and dopamine, important for mood regulation.
- Pharmacokinetics: Escitalopram is well-absorbed orally and extensively metabolized in the liver, primarily by CYP2C19 and, to a lesser extent, CYP3A4 and CYP2D6 enzymes. Elimination occurs primarily through renal excretion. L-Methylfolate is also absorbed orally and converted to tetrahydrofolic acid, the active form of folate. It is excreted primarily in the urine.
- Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation: Escitalopram binds to and inhibits SERT, increasing extracellular serotonin levels. L-Methylfolate acts as a cofactor for enzymes involved in neurotransmitter synthesis.
- Elimination Pathways: Escitalopram undergoes hepatic metabolism and is excreted mainly through the kidneys. L-Methylfolate is also primarily eliminated renally.
Dosage
Standard Dosage
Adults:
- Initial dose: Escitalopram 10 mg orally once daily, L-Methylfolate 7.5-15 mg orally once daily.
- The escitalopram dose may be increased to a maximum of 20 mg/day after at least one week, depending on individual response and tolerability.
- L-Methylfolate dosage is based on the level of deficiency.
Children:
- For adolescents (12-17 years old) with MDD: Escitalopram 10 mg orally once daily. The maximum dose is 20 mg daily.
- The safety and efficacy of this combination have not been established in children younger than 12 years.
Special Cases:
- Elderly Patients: Start with Escitalopram 10 mg once daily. Close monitoring is necessary due to potential age-related changes in drug metabolism.
- Patients with Renal Impairment: For mild to moderate renal impairment, no dose adjustment is usually needed. Caution is recommended in severe renal impairment.
- Patients with Hepatic Dysfunction: Start with Escitalopram 10 mg once daily due to reduced clearance.
- Patients with Comorbid Conditions: Caution is advised in patients with a history of seizures, bipolar disorder, bleeding disorders, glaucoma, hyponatremia, diabetes, cardiovascular disease, or those taking medications that can interact with escitalopram or L-methylfolate.
Clinical Use Cases
Escitalopram + L-Methylfolate is not indicated for specific clinical use cases such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary use is in the management of MDD and GAD.
Dosage Adjustments
Dose adjustments may be necessary based on individual response, tolerability, comorbid conditions, concomitant medications, and hepatic or renal impairment. Genetic polymorphisms affecting drug metabolism may also warrant dose adjustments. Consult a clinical pharmacist or other drug information resources for specific guidance.
Side Effects
Common Side Effects:
- Nausea
- Headache
- Insomnia
- Somnolence (sleepiness)
- Dry mouth
- Diarrhea
- Decreased libido
- Sweating
- Dizziness
- Fatigue
- Weight changes (gain or loss)
Rare but Serious Side Effects:
- Serotonin syndrome
- Suicidal thoughts or behavior
- Seizures
- Hyponatremia
- Allergic reactions
- Mania
- Abnormal bleeding
- QT interval prolongation
Long-Term Effects:
- Sexual dysfunction
- Weight gain
- Dependence
Adverse Drug Reactions (ADR):
- Serotonin syndrome
- Severe allergic reactions
- Suicidal ideation or behavior
Contraindications
- Hypersensitivity to escitalopram or L-methylfolate
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs
- Bipolar disorder (monitor closely)
Drug Interactions
- MAOIs
- Serotonergic drugs (e.g., triptans, tramadol)
- NSAIDs
- Anticoagulants (e.g., warfarin)
- Tricyclic antidepressants
- Lithium
- St. John’s Wort
- Alcohol
- CYP2C19 inhibitors and inducers
- CYP3A4 inhibitors and inducers
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Citalopram (racemic mixture of escitalopram) is classified as Pregnancy Category C by the FDA. While escitalopram can be used during pregnancy if necessary, potential risks to the fetus should be weighed against the benefits to the mother.
- There might be a slight increase in the risk of persistent pulmonary hypertension of the newborn (PPHN).
- Breastfeeding: Escitalopram is present in breast milk. Monitor infants for adverse effects, such as drowsiness, irritability, poor feeding, and weight changes.
Drug Profile Summary
- Mechanism of Action: Escitalopram inhibits serotonin reuptake, while L-methylfolate aids in the synthesis of neurotransmitters involved in mood regulation.
- Side Effects: Nausea, headache, insomnia, somnolence, dry mouth, decreased libido, sexual dysfunction.
- Contraindications: Hypersensitivity, concurrent MAOI use.
- Drug Interactions: MAOIs, serotonergic drugs, NSAIDs, anticoagulants, alcohol, CYP2C19/3A4 inhibitors/inducers.
- Pregnancy & Breastfeeding: Use with caution during pregnancy and breastfeeding; monitor infant for side effects.
- Dosage: Adults: Escitalopram 10-20 mg/day, L-Methylfolate 7.5-15mg/day. Adolescents (MDD): Escitalopram 10-20 mg/day.
- Monitoring Parameters: Mood, suicidal ideation, weight, blood pressure, heart rate, liver function tests, electrolytes (sodium), sleep pattern.
Popular Combinations
L-Methylfolate is sometimes combined with escitalopram to potentially improve treatment outcomes in some individuals.
Precautions
- Monitor for worsening of depression, suicidal thoughts, and serotonin syndrome.
- Pre-existing conditions: Evaluate patients for liver/kidney disease, seizure disorders, glaucoma, bleeding problems, hyponatremia, and bipolar disorder.
- Special populations: Monitor pregnant women, breastfeeding mothers, children, and the elderly for adverse effects.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Escitalopram Oxalate + L-Methyl Folate?
A: Adults: Escitalopram 10-20 mg/day, L-methylfolate 7.5-15mg/day. Adolescents (12-17 years, MDD): Escitalopram 10-20 mg/day. Dosages should be adjusted according to individual response and tolerance.
Q2: Can this combination be used during pregnancy?
A: It can be used if the benefits outweigh the risks, but it is important to consult an obstetrician and psychiatrist and discuss the potential risks.
Q3: What are the signs of serotonin syndrome?
A: Agitation, confusion, tachycardia, hypertension, muscle rigidity, hyperthermia, sweating, tremor, diarrhea.
Q4: Can patients drink alcohol while taking this medication?
A: Alcohol consumption should be limited or avoided as it can interact with escitalopram and worsen side effects.
Q5: What are the common side effects of this drug combination?
A: Nausea, headache, insomnia, dry mouth, decreased libido, and sexual dysfunction are common side effects.
Q6: How long does it take for this medication to work?
A: It can take 4-6 weeks for the full therapeutic effects to be observed.
Q7: What should be done if a dose is missed?
A: Take the missed dose as soon as possible unless it is close to the time for the next dose. Do not double the dose.
Q8: What are the withdrawal symptoms associated with escitalopram discontinuation?
A: Dizziness, nausea, headache, irritability, anxiety, insomnia, paresthesia (“pins and needles” sensation). Tapering the dose gradually is recommended to minimize withdrawal symptoms.
Q9: What are the drug interactions to be aware of when prescribing this medication?
A: Significant interactions can occur with MAOIs, other serotonergic drugs, NSAIDs, anticoagulants, and alcohol. It’s essential to review a patient’s full medication list before prescribing this combination.
