Usage
- This combination is primarily prescribed as a nutritional supplement to address deficiencies and support overall health, especially in women with Polycystic Ovary Syndrome (PCOS). It helps regulate menstrual cycles, improve insulin sensitivity, and enhance egg quality. It may also be used in women undergoing intra-cytoplasmic sperm injection (ICSI) procedures.
- Pharmacological Classification: Nutritional Supplement, Hormone Regulator
- Mechanism of Action: This combination works by improving insulin sensitivity, regulating hormone levels, promoting egg maturation and quality, and supporting regular menstruation. Melatonin component helps with sleep regulation.
Alternate Names
- Myo-Inositol + L-Methylfolate Calcium + Vitamin D3 + Melatonin
- Myo-inositol,l-methylfolate,vitamind3, melatonin tablets
- Follical
- Mynosit
- Nixha.
- Some formulations may also include additional ingredients.
How It Works
- Pharmacodynamics: Myo-inositol improves insulin sensitivity and ovarian function. L-Methylfolate, the active form of folate, is crucial for DNA/RNA synthesis and cell growth, lowering homocysteine levels. Vitamin D3 aids calcium absorption and bone health. Melatonin regulates sleep-wake cycles.
- Pharmacokinetics: Absorption, metabolism, and elimination pathways are similar to individual components. Myo-inositol is readily absorbed and distributed. L-methylfolate undergoes hepatic metabolism. Vitamin D3 is absorbed in the gut and stored in the liver and adipose tissues and it is converted into its active form in the kidneys. It is excreted in bile and feces. Melatonin is rapidly absorbed from the GI tract and is metabolized in the liver by CYP1A enzymes. Most of the melatonin is excreted in urine as metabolites. Specific pharmacokinetic data for this combination product are limited.
- Mode of Action: Myo-inositol may influence cellular signal transduction pathways and improve insulin signaling, potentially by activating specific enzymes like PI3K. L-methylfolate acts as a substrate for enzymatic reactions and is involved in one-carbon metabolism. Vitamin D3 acts by binding to vitamin D receptors and influencing gene transcription and calcium absorption. Melatonin binds to its receptors in the brain, regulating circadian rhythm and sleep.
Dosage
Dosage information for this specific combination product is limited and varies by brand formulation. Always follow the dosage prescribed by the physician or as directed on the product packaging.
Standard Dosage
Adults:
- Specific dosage recommendations are lacking for this combination product. Dosages mentioned in various studies vary depending on the condition being treated and the specific formulation used. For example, some studies for PCOS treatment used 2 g of myo-inositol, 200 mcg of L-methylfolate, and 1 mg of melatonin daily.
- As always, it is essential to follow the dosage advised by the physician.
Children: Safety and efficacy have not been established. Use only under the direction of a physician.
Special Cases: Dosage adjustments for elderly patients, patients with renal/hepatic impairment, or other comorbid conditions should be determined by a physician.
Clinical Use Cases
This combination is not typically indicated for use in acute medical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary use is for nutritional support and management of PCOS.
Dosage Adjustments
Adjustments should be made based on individual patient needs and response to therapy, as determined by the treating physician. Considerations include renal/hepatic function, other medical conditions, and concomitant medications.
Side Effects
Common Side Effects
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dizziness
- Sleep disturbances
- Irritability
- Digestive issues (constipation, upset stomach)
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling, difficulty breathing)
Long-Term Effects
Long-term effects are not well-established.
Adverse Drug Reactions (ADR)
Serious ADRs are rare. Any signs of an allergic reaction warrant immediate medical attention.
Contraindications
- Hypersensitivity to any of the components.
- Use with caution in patients with bipolar disorder, hormone-sensitive cancers, liver or kidney disease, autoimmune conditions.
Drug Interactions
- Potential interactions exist with blood thinners, diabetes medications, sedatives, antidiabetic drugs, immunosuppressants (methotrexate), certain antibiotics (nitrofurantoin, tetracycline), antiparasitics (pyrimethamine), anticonvulsants (phenytoin, primidone, pregabalin), antihistamines (diphenhydramine), benzodiazepines (alprazolam), and antidepressants (duloxetine, escitalopram, sertraline).
- Always consult a physician about potential drug interactions.
Pregnancy and Breastfeeding
Consult a physician before use during pregnancy or breastfeeding. While folate and vitamin D are essential during pregnancy, the safety of melatonin in pregnant or breastfeeding women has not been definitively established.
Drug Profile Summary
- Mechanism of Action: Improves insulin sensitivity, regulates hormone levels, supports egg quality and maturation, promotes regular menstrual cycles, aids calcium absorption, improves sleep.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness, sleep disturbances, irritability, digestive issues. Rarely, allergic reactions.
- Contraindications: Hypersensitivity, caution in patients with bipolar disorder, hormone-sensitive cancers, liver/kidney disease, autoimmune conditions.
- Drug Interactions: Potential interactions with various medications including blood thinners, diabetes medications, sedatives, and antidepressants; consult a physician.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: Varies depending on the brand and indication; follow physician’s advice or product label.
- Monitoring Parameters: Monitor for PCOS symptom improvement, adverse effects, and potential drug interactions.
Popular Combinations
May be combined with D-chiro-inositol, N-acetyl cysteine, L-arginine, and other vitamins/minerals related to female reproductive health.
Precautions
- General Precautions: Consult a healthcare professional before use, especially with pre-existing conditions. Monitor for adverse reactions. Follow recommended dosage guidelines.
- Specific Populations: Pregnant Women - Assess risks and benefits with a physician. Breastfeeding Mothers - Assess risk of neonatal exposure. Children & Elderly - Safety and efficacy not established. Consult a physician. Menstruating Individuals - Especially relevant for PCOS management.
- Lifestyle Considerations: Caution with alcohol consumption as it may worsen side effects. Avoid driving or operating machinery if melatonin causes drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for L-Methyl Folate Calcium + Melatonin + Myo-Inositol + Vitamin D3?
A: Dosage varies by brand and individual patient needs. Always follow the physician’s recommendation or product label instructions. There is no standardized dosage for this combination product.
Q2: What are the primary uses of this combination?
A: Primarily used as a nutritional supplement for general health, and specifically for managing PCOS symptoms. It is also being studied for potential use in women undergoing ICSI.
Q3: Can this combination be used during pregnancy?
A: Consult a physician before use during pregnancy or breastfeeding. Folate and Vitamin D3 are generally recommended during pregnancy, but melatonin’s safety is not fully established.
Q4: Are there any drug interactions I should be aware of?
A: Yes, potential interactions exist with several medications, including blood thinners, diabetes medications, sedatives, and antidepressants. Always discuss current medications and supplements with a physician before starting this combination.
Q5: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, headache, dizziness, sleep disturbances, irritability, and digestive issues.
Q6: Is this combination effective for all women with PCOS?
A: While it shows promise in managing PCOS symptoms, individual responses vary. A physician can determine if this combination is suitable for a specific patient.
Q7: How long does it take to see results?
A: The timeframe for observable effects varies among individuals. Consult with a physician to discuss expectations and treatment duration.
Q8: Can men take this combination?
A: While primarily used for female reproductive health, some components (like myo-inositol, vitamin D3, and melatonin) can benefit men’s health as well. However, consult a physician for appropriate dosage and usage.
Q9: Can this combination replace prescribed medications for PCOS or other conditions?
A: This combination is generally used as a supplement, not a replacement for prescribed medication. Discuss with a physician about managing existing medical conditions and treatments.
