Usage
This combination medication is primarily prescribed for the management of Polycystic Ovary Syndrome (PCOS). It addresses several PCOS features, including insulin resistance, hyperandrogenism, and menstrual irregularities. It is classified as a nutritional supplement and insulin sensitizer.
The components work synergistically: Myo-inositol and D-chiro-inositol improve insulin sensitivity and glucose uptake; Metformin lowers blood glucose; L-methylfolate (the active form of folate) reduces homocysteine levels; and Methylcobalamin (vitamin B12) supports nerve function and homocysteine metabolism.
Alternate Names
While there isn’t a universally recognized alternate name, this combination may be referred to as a “PCOS management supplement.” Some brand names marketing similar combinations include Met-PCO Care and Mysofert-M. Myofolin-D is another brand name which contains this combination. Regional or international variations exist with slight differences in formulations.
How It Works
Pharmacodynamics: Myo-inositol and D-chiro-inositol are insulin-sensitizing agents, improving cellular glucose uptake and utilization. Metformin enhances insulin action, reduces hepatic glucose production, and improves peripheral glucose uptake. L-methylfolate participates in one-carbon metabolism, lowering homocysteine levels. Methylcobalamin is involved in various metabolic pathways, including homocysteine metabolism and myelin synthesis.
Pharmacokinetics: Myo-inositol and D-chiro-inositol are absorbed in the gut, with peak plasma concentrations reached within hours. Metformin absorption is incomplete and occurs in the small intestine. L-methylfolate is actively transported across the gut, and its bioavailability is high. Methylcobalamin is absorbed via intrinsic factor-mediated transport. Metformin undergoes negligible metabolism and is renally cleared. Inositol isomers, folate, and methylcobalamin undergo hepatic metabolism, followed by renal excretion.
Mode of Action: Myo-inositol and D-chiro-inositol influence insulin signaling pathways. Metformin activates AMP-activated protein kinase (AMPK), affecting glucose and lipid metabolism. L-methylfolate is a cofactor for enzymes involved in nucleotide synthesis and homocysteine remethylation. Methylcobalamin acts as a coenzyme in various metabolic reactions.
Elimination Pathways: Metformin is eliminated primarily by the kidneys. Myo-inositol, D-chiro-inositol, L-methylfolate, and Methylcobalamin are metabolized in the liver and subsequently excreted by the kidneys.
Dosage
Dosage is determined by a physician based on individual patient needs.
Standard Dosage
Children: This combination is generally not recommended for children due to limited safety and efficacy data.
Special Cases:
- Elderly Patients: Start with a lower dose and titrate based on renal function and tolerability.
- Patients with Renal Impairment: Dose adjustment, particularly for metformin, is crucial. Contraindicated in severe renal impairment.
- Patients with Hepatic Dysfunction: Use cautiously; dose adjustment might be required. Metformin is contraindicated in severe hepatic dysfunction.
- Patients with Comorbid Conditions: Careful consideration of diabetes, cardiovascular disease, or other conditions is essential.
Clinical Use Cases
This combination is not typically used for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Adjustments should be made for renal/hepatic impairment, metabolic disorders, drug interactions, and patient response.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, stomach pain, loss of appetite, changes in taste, headache, tiredness.
Rare but Serious Side Effects:
Lactic acidosis (metformin), megaloblastic anemia (methylcobalamin or L-methylfolate deficiency).
Long-Term Effects:
Long-term effects are not comprehensively documented, but vitamin B12 deficiency or folate deficiency could develop with inadequate intake or absorption issues. Long-term metformin use may affect vitamin B12 absorption.
Adverse Drug Reactions (ADR):
Severe gastrointestinal effects, lactic acidosis, allergic reactions.
Contraindications
Hypersensitivity to any component, severe kidney/liver impairment, metabolic acidosis, vitamin B12 deficiency, uncontrolled heart failure, acute myocardial infarction.
Drug Interactions
Sulfonylureas, insulin, diuretics, beta-2 agonists, corticosteroids, antihypertensives, cationic drugs, carbonic anhydrase inhibitors, thyroid medications, alcohol.
Pregnancy and Breastfeeding
Consult a doctor before use during pregnancy or breastfeeding. While L-methylfolate and Methylcobalamin are generally safe during pregnancy, metformin use requires careful risk-benefit assessment.
Drug Profile Summary
- Mechanism of Action: Improves insulin sensitivity, regulates ovarian function, reduces homocysteine.
- Side Effects: Nausea, vomiting, diarrhea, stomach pain, rarely lactic acidosis.
- Contraindications: Hypersensitivity, severe kidney/liver disease, metabolic acidosis.
- Drug Interactions: Several; consult a physician.
- Pregnancy & Breastfeeding: Consult physician.
- Dosage: Adult dosage varies; pediatric use not recommended.
- Monitoring Parameters: Blood glucose, insulin levels, lipids, renal/liver function, homocysteine, vitamin B12.
Popular Combinations
This combination often includes additional supplements like vitamin D or omega-3 fatty acids.
Precautions
Monitor renal/liver function, blood glucose, and vitamin B12 levels. Assess for pre-existing medical conditions, allergies, or concomitant medications. Caution advised with alcohol use.
FAQs (Frequently Asked Questions)
Q1: What is the standard dosage of this combination?
A: A common regimen is Myo-inositol 550mg + D-chiro-inositol 13.8mg + Metformin 500mg + L-methylfolate calcium 0.5mg + Methylcobalamin 750mcg. Dosage should be individualized based on patient needs.
Q2: What are the primary uses of this combination?
A: Primarily used for managing PCOS and associated symptoms like insulin resistance, menstrual irregularities, and hyperandrogenism.
Q3: What are the common side effects?
A: Nausea, vomiting, diarrhea, stomach pain, and loss of appetite are commonly reported.
Q4: Are there any serious side effects?
A: Rarely, lactic acidosis (associated with metformin) and megaloblastic anemia can occur.
Q5: Can this combination be used during pregnancy?
A: Consult a physician before use during pregnancy or breastfeeding.
Q6: What are the contraindications to using this medication?
A: Contraindicated in severe renal or hepatic impairment, hypersensitivity to any component, and metabolic acidosis.
Q7: Does this drug interact with other medications?
A: Yes, it interacts with several medications, including antidiabetic drugs, diuretics, and certain cardiovascular medications. Consult a physician regarding potential drug interactions.
Q8: What monitoring is recommended while taking this combination?
A: Monitor blood glucose levels, renal and hepatic function, lipid profile, and vitamin B12 status.
Q9: Can this combination be used in children?
A: Safety and efficacy in pediatric patients haven’t been established, hence generally not recommended.
Q10: Is it safe to take this combination if I have diabetes?
A: Consult your physician as the combination contains metformin, which is also used to treat diabetes. Careful monitoring of blood glucose is essential, and dose adjustment of other antidiabetic medications might be required.
