L-Methyl Folate + Myo-Inositol + Vitamin D3

Usage

• This combination is primarily prescribed for the management of Polycystic Ovary Syndrome (PCOS) and to address nutritional deficiencies related to these components. It is also used to support reproductive health, improve egg quality, regulate menstrual cycles, and restore ovulation. It may also be used in patients with conditions related to insulin resistance and metabolic health.
• Pharmacological Classification: Nutritional Supplement, Vitamin, Hormone Regulator.
• Mechanism of Action: Myo-inositol improves insulin sensitivity and may influence hormonal balance. L-methylfolate, the active form of folic acid, is essential for cell growth and development, DNA synthesis, and red blood cell production. Vitamin D3 is crucial for calcium absorption, bone health, and potentially hormonal regulation.

Alternate Names

• No widely recognized alternate names exist for this specific combination. Individual components are sometimes referred to as:
  • L-Methylfolate: (6S)-5-methyltetrahydrofolic acid, levomefolic acid, 5-MTHF
  • Myo-inositol: inositol, cyclohexane-1,2,3,4,5,6-hexol
  • Vitamin D3: cholecalciferol, calciol
• Brand Names: A number of brand names exist for combinations containing these ingredients. Examples include: Ovasitol, Myo-Inositol & D-Chiro Inositol with L-Methylfolate, Follical, Confert Tablets. Brand names vary by region and manufacturer.

How It Works

• Pharmacodynamics: Myo-inositol acts as a secondary messenger in insulin signaling pathways, improving cellular glucose uptake. L-methylfolate is involved in one-carbon metabolism, critical for various biosynthetic processes. Vitamin D3 modulates gene expression, affecting calcium homeostasis and other physiological functions.
• Pharmacokinetics:
  • Absorption: Myo-inositol and L-methylfolate are absorbed from the gastrointestinal tract. Vitamin D3 can be absorbed from the diet or synthesized in the skin upon exposure to ultraviolet B (UVB) radiation.
  • Metabolism: L-methylfolate is converted to tetrahydrofolic acid, the biologically active form of folate. Vitamin D3 undergoes hydroxylation in the liver and kidneys to form calcitriol, its active form. Myo-inositol does not undergo significant metabolism.
  • Elimination: Myo-inositol is primarily excreted in the urine. L-methylfolate and its metabolites are excreted in urine and bile. Vitamin D metabolites are eliminated through bile and urine.
• Mode of Action: Myo-inositol influences intracellular calcium levels and signal transduction, impacting insulin sensitivity and hormone regulation. L-methylfolate acts as a cofactor for enzymes involved in DNA and RNA synthesis. Vitamin D3 binds to vitamin D receptors, influencing gene transcription related to calcium absorption, bone metabolism, and other functions.

Dosage

Dosage varies based on the specific formulation and the individual patient’s needs. It’s crucial to follow the healthcare provider’s recommendations.

Standard Dosage

Adults:

• Typical dosages of Myo-inositol range from 2-4 grams daily, often divided into two doses. L-Methylfolate is commonly prescribed in doses of 400-800 mcg daily. Vitamin D3 supplementation typically ranges from 600-4000 IU daily, depending on individual requirements.
• Administration: Oral, usually taken with food.

Children:

• Dosage should be determined by a pediatrician based on the child’s age, weight, and health condition.

Special Cases:

• Elderly Patients: Dosage adjustments may be necessary based on renal function.
• Patients with Renal Impairment: Dosage adjustments may be required based on the degree of renal impairment.
• Patients with Hepatic Dysfunction: Caution should be exercised, and dose adjustments might be necessary.
• Patients with Comorbid Conditions: Individualized dosage adjustments based on specific comorbid conditions are crucial.

Clinical Use Cases

The combination of L-Methyl Folate + Myo-Inositol + Vitamin D3 is generally not indicated for acute medical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.

Dosage Adjustments

• Dosage should be individualized based on patient-specific factors like renal/hepatic function and concurrent medications.

Side Effects

Common Side Effects

• Nausea
• Gas
• Bloating
• Dizziness
• Headache
• Fatigue

Rare but Serious Side Effects

• Allergic reactions (rash, itching, swelling, difficulty breathing)

Long-Term Effects

• Generally well-tolerated. Monitoring for potential vitamin D toxicity with high doses is advisable.

Contraindications

• Hypersensitivity to any of the components.
• Use with caution in patients with bipolar disorder, as inositol might exacerbate symptoms.

Drug Interactions

• Limited information is available on specific drug interactions. Consult with a healthcare professional regarding potential interactions with other medications, including those affecting folate metabolism or vitamin D levels.

Pregnancy and Breastfeeding

• Generally considered safe for use during pregnancy and breastfeeding, especially L-Methylfolate to support fetal development and prevent neural tube defects. However, consulting a doctor before use is crucial.

Drug Profile Summary

(See summary at the beginning of this section)

Popular Combinations

• Often combined with other vitamins and minerals to support overall reproductive health.

Precautions

(See precautions mentioned earlier)

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for L-Methyl Folate + Myo-Inositol + Vitamin D3?

A: Dosage varies depending on individual needs and product formulation. Typical ranges are Myo-inositol 2-4 grams daily, L-methylfolate 400-800 mcg daily, and Vitamin D3 600-4000 IU daily. A healthcare professional should determine the precise dosage.

Q2: What is the primary use of this combination?

A: Primarily used for managing PCOS and supporting reproductive health in women.

Q3: How does Myo-inositol help in PCOS?

A: It improves insulin sensitivity, which can help regulate hormonal imbalances often seen in PCOS.

Q4: What are the benefits of L-methylfolate in this combination?

A: Supports cell growth, DNA synthesis, and red blood cell production, essential for overall health and crucial during pregnancy.

Q5: Why is Vitamin D3 included in this combination?

A: Supports calcium absorption, bone health, and may play a role in hormonal regulation.

Q6: Are there any significant drug interactions I should be aware of?

A: Consult a healthcare professional regarding potential interactions with other medications, especially those metabolized by the same pathways or those affecting folate or vitamin D levels.

Q7: Can this combination be used during pregnancy?

A: Generally considered safe, but consulting a doctor before use during pregnancy or breastfeeding is essential.

Q8: What are the common side effects?

A: Common side effects include gastrointestinal issues like nausea, gas, and bloating, as well as dizziness, headache, and fatigue. These are usually mild and transient.

Q9. What is the role of melatonin, which is sometimes included in these combination products?

A: Melatonin helps regulate sleep and is believed to improve egg quality and maturation when used in combination with myo-inositol. It is thought to impact oocyte quality by acting as an antioxidant, reducing oxidative stress, and promoting mitochondrial function. Melatonin is used for improving sleep and can be combined with Myo-inositol, L-methylfolate, and vitamin D3. However, its inclusion does not impact the primary use of this drug combination.

Q10. Why is N-acetyl cysteine (NAC) sometimes included in the formulation?

A: NAC is a precursor to glutathione, a powerful antioxidant that can help reduce oxidative stress in the body. It’s added to formulations to enhance hormonal balance and protect the eggs from oxidative damage.