Folive

• Prevention and treatment of folate deficiency:
  Used in individuals with dietary folate insufficiency, malabsorption disorders (such as celiac disease or inflammatory bowel disease), or increased physiological demand including pregnancy and lactation.
• Pregnancy and lactation:
  To reduce the risk of neural tube defects and other congenital anomalies associated with folate deficiency.
• Hyperhomocysteinemia:
  To lower elevated homocysteine levels, reducing cardiovascular risk, especially in patients with MTHFR gene mutations.
• Methylation disorders and MTHFR polymorphisms:
  For individuals with genetic variations impairing folic acid metabolism, providing bioavailable folate.
• Supportive treatment of folate-responsive megaloblastic anemia.
• Off-label uses:
• Adjunctive therapy in certain psychiatric disorders such as depression.
• Support of hair and skin health as part of combination supplements.
• Support during chemotherapy to reduce toxicity related to folate deficiency under medical supervision.

• Adults:
  Oral doses typically range from 400 mcg to 1 mg daily depending on indication. The standard dose for supplementation and pregnancy is 400 mcg per day.
• Pregnant and lactating women:
  400–800 mcg daily; up to 1 mg daily may be recommended for high-risk individuals.
• Pediatrics:
  Dose adjusted by age and clinical condition, generally 150–400 mcg daily.
• Elderly:
  Standard adult dosing; ensure concurrent vitamin B12 deficiency is ruled out.
• Renal or hepatic impairment:
  No specific dose adjustments usually required, but caution is advised in severe impairment.
• Route of administration:
  Oral tablets or capsules.
• Duration:
  Depends on clinical indication; continuous in pregnancy and until deficiency is corrected.

6S-5-Methyltetrahydrofolate is the biologically active form of folate that serves as a methyl donor in crucial cellular processes. It is essential for the synthesis of nucleotides required for DNA and RNA production, thus supporting cell division and repair. Additionally, it donates a methyl group in the remethylation of homocysteine to methionine, an important amino acid in methylation reactions affecting gene expression and neurotransmitter synthesis. Because it bypasses the enzymatic steps required to convert synthetic folic acid into the active form, 6S-5-MTHF ensures effective folate bioavailability, especially in individuals with impaired folate metabolism.

• Absorption:
  Rapidly absorbed from the proximal small intestine with higher bioavailability compared to synthetic folic acid.
• Distribution:
  Widely distributed in plasma and tissues; crosses the placenta to support fetal development.
• Metabolism:
  Active form itself with minimal further metabolism; some hepatic conjugation occurs.
• Elimination:
  Excreted mainly via the kidneys as folate metabolites; minor fecal excretion.
• Half-life:
  Approximately 4 to 6 hours in plasma; retained longer in tissue folate pools.

• Pregnancy:
  Considered safe and classified as FDA Pregnancy Category A. Recommended for preventing neural tube defects when taken at appropriate doses.
• Lactation:
  Excreted in small amounts in breast milk; supplementation is safe and supports infant health.
• Precautions:
  Excessive folate intake can mask vitamin B12 deficiency; monitoring is recommended during prolonged use.

• Primary class: Water-soluble vitamin
• Subclass: Bioactive folate derivative

• Known hypersensitivity to 6S-5-Methyltetrahydrofolate or any excipients.
• Untreated vitamin B12 deficiency (risk of masking neurological symptoms).
• Caution advised in severe renal impairment.

• Patients with undiagnosed vitamin B12 deficiency should be screened before starting folate supplementation.
• Regular monitoring of folate and B12 levels is recommended during long-term use.
• Folate supplementation may mask hematological signs of B12 deficiency, leading to irreversible neurological damage if untreated.
• Use cautiously in patients undergoing antifolate chemotherapy; coordination with oncology care is essential.
• Discontinue use if hypersensitivity reactions occur.

• Common:
  Mild gastrointestinal symptoms such as nausea, bloating, or gas may occur.
• Rare:
  Allergic reactions including rash or itching; serious anaphylaxis is very rare.
• Onset:
  Side effects typically appear shortly after starting supplementation.
• Dose-dependent:
  Adverse effects are rare at recommended doses; high doses may increase risk of masking B12 deficiency.

• Drugs reducing folate levels:
  Antiepileptics (phenytoin, phenobarbital, primidone), methotrexate, trimethoprim, and sulfonamides can interfere with folate metabolism.
• Drugs affected by folate:
  Folate may reduce the efficacy of certain antimalarial drugs (e.g., pyrimethamine).
• Food and alcohol:
  Alcohol may impair folate absorption and metabolism.
• Enzyme systems:
  Does not significantly affect or get metabolized by cytochrome P450 enzymes.

• Store at 20°C to 25°C (68°F to 77°F) in a dry environment.
• Protect from moisture, heat, and direct light.
• Keep containers tightly closed when not in use.
• Do not freeze.
• Suitable for solid oral dosage forms; no reconstitution required.
• Keep out of reach of children.