Qfol 1000 mcg

Indication:

Qfol 1000 mcg is indicated for the treatment of-

• Treatment and Prevention of Folate Deficiency Anemia: Specifically Megaloblastic and Macrocytic anemia, where red blood cells are abnormally large and dysfunctional.
• Adjuvant Therapy for Major Depressive Disorder (MDD): Prescribed to augment the therapeutic efficacy of traditional antidepressants (SSRIs/SNRIs) in patients who show poor or partial response due to low CNS folate or MTHFR genetic mutations.
• Hyperhomocysteinemia Management: To reduce elevated serum homocysteine levels, thereby lowering the risk of coronary artery disease, deep vein thrombosis (DVT), and stroke.
• Periconceptional & Prenatal Care: Crucial for pregnant women to prevent Neural Tube Defects (NTDs) such as spina bifida and anencephaly in developing fetuses. Highly recommended for expectant mothers with known MTHFR mutations who cannot process regular folic acid.
• Cognitive Decline & Dementia Prevention: To preserve brain volume, protect cortical neurons from oxidative stress, and manage age-related cognitive impairment.
• Diabetic Peripheral Neuropathy: To support vascular endothelial health and nerve repair mechanisms in diabetic patients.

Dogase & Adminstration:

Dosage must be tailored according to the clinical indication and the specific age group.

Adult Dose (Ages 18 and older):

• For General Health Maintenance & Prenatal Support: Take 400 mcg to 800 mcg orally once daily, or as directed by an obstetrician/physician.
• For Adjuvant Treatment in Depression (MDD) & High Homocysteine: The recommended therapeutic dose ranges from 7.5 mg to 15 mg orally once daily. Note: High-dose therapies must be supervised by a medical specialist.
• For MTHFR Mutation Carriers: 800 mcg to 1000 mcg (1 mg) daily is typically recommended to maintain optimal cellular folate pools.

Pediatric Dose (Children & Adolescents):

• Infants (0 to 12 months): 60 mcg to 80 mcg daily (strictly via fortified foods or specialized pediatric drops under a pediatrician’s direct guidance).
• Children (1 to 3 years): 150 mcg orally once daily.
• Children (4 to 8 years): 200 mcg orally once daily.
• Children (9 to 13 years): 300 mcg orally once daily.
• Adolescents (14 to 17 years): 400 mcg orally once daily.

Administration Guidelines:

• Can be taken with or without food. However, taking it with a meal improves gastrointestinal tolerance for sensitive individuals.
• Administer with a full glass of water. Do not crush or chew capsules if they are extended-release or specially coated. Consistent daily intake at the same time is vital for establishing stable plasma levels.

”রেজিস্ট্রার চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন”

Pharmacology:

The pharmacological superiority of 6S-5-Methyltetrahydrofolate (6S-5-MTHF) over synthetic folic acid relies entirely on its nature as a fully metabolized, active coenzyme that operates directly at the cellular level without requiring activation.

                                                                                  [Dietary Folate / Folic Acid] 

                                                                                    (Requires DHFR Enzyme)

                                                                                                            ▼

                                                                                               [Dihydrofolate] 

                                                              (Requires MTHFR Enzyme – Often impaired by genetic mutations)

                                                                                                              ▼

                                             [6S-5-Methyltetrahydrofolate (L-Methylfolate)] <─── (OUR PRODUCT BYPASSES ALL STEPS)

                                              ─► Crosses Blood-Brain Barrier (BBB) ──► BH4 Cycle ──► Synthesizes Serotonin, Dopamine, NE

                                            ─► Homocysteine Remethylation Cycle ──► Converts Homocysteine to Methionine (Cardioprotection)

 Absorption and Metabolic Bypass-

When standard synthetic folic acid is ingested, it must undergo a multi-step enzymatic reduction process involving Dihydrofolate Reductase (DHFR) and ultimately Methylenetetrahydrofolate Reductase (MTHFR) to be converted into 5-MTHF. Up to 40-60% of the global population possesses genetic variants/polymorphisms of the MTHFR gene (such as 677C→T or 1298A→C), which severely impairs this conversion, leading to folic acid accumulation and cellular folate deficiency. 6S-5-MTHF requires no conversion. Upon oral administration, it is rapidly absorbed via the proton-coupled folate transporter (PCFT) in the small intestine, directly entering systemic circulation as the dominant, ready-to-use plasma folate.

Blood-Brain Barrier (BBB) Permeability & Neurotransmitter Synthesis-

Unlike folic acid, 6S-5-MTHF is the only form of folate capable of readily crossing the blood-brain barrier via specific receptor-mediated transport mechanisms. Within the central nervous system, 6S-5-MTHF acts as a mandatory regulatory cofactor for the synthesis of Tetrahydrobiopterin (BH4). BH4 is the rate-limiting cofactor for the enzymes tyrosine hydroxylase and tryptophan hydroxylase, which are responsible for converting amino acids into core monoamine neurotransmitters:

• Serotonin (regulates mood, sleep, and anxiety)
• Dopamine (governs reward, focus, and motor control)
• Norepinephrine (modulates stress response and alertness) By maximizing this pathway, 6S-5-MTHF exerts powerful natural antidepressant and cognitive-enhancing effects.

Homocysteine Remethylation and Cardiovascular Protection-

In the methionine cycle, 6S-5-MTHF acts as a crucial methyl donor. It transfers its methyl group to cobalamin (Vitamin B12), forming methylcobalamin, which then transfers it to toxic Homocysteine, converting it back into the essential amino acid Methionine via the enzyme methionine synthase. High levels of homocysteine are heavily linked to endothelial dysfunction, arterial plaque formation, and blood clots. By keeping homocysteine at a safe biochemical level, 6S-5-MTHF protects blood vessels, prevents stroke, and preserves cardiovascular health.

Side Effects:

6S-5-Methyltetrahydrofolate is exceptionally safe and classified as non-toxic even at high doses. However, rare side effects may include:

• Mild gastrointestinal symptoms (Abdominal distension, flatulence, nausea, or altered taste).
• Central Nervous System mild reactions (Altered sleep patterns, vivid dreams, mild hyperactivity, or temporary irritability).
• Hypersensitivity reactions (Rare skin rash, pruritus, or flushing).

Drug Interaction:

• Anticonvulsants/Antiepileptic Drugs (Phenytoin, Fosphenytoin, Phenobarbital, Primidone): High doses of active folate can stimulate the metabolism of these drugs, significantly lowering their plasma concentration and increasing the risk of breakthrough seizures.
• Folate Antagonists (Methotrexate, Pyrimethamine, Triamterene): These drugs inhibit dihydrofolate reductase. While 6S-5-MTHF bypasses this enzyme, concurrent high doses can alter the therapeutic efficacy of chemotherapy or anti-parasitic protocols.
• Fluorouracil (5-FU): Folate compounds structurally stabilize the binding of 5-FU to its target enzyme, dramatically potentiating the cytotoxicity and adverse side effects of 5-FU.
• Proton Pump Inhibitors (Omeprazole, Lansoprazole) & H2 Blockers: Prolonged use alters gastric pH, which may slightly decrease the baseline absorption rate of folates.

Pregnancy & Lactation:

• Pregnancy: Category A. This is the optimal, safest, and most effective form of folate during pregnancy. It is absolutely essential for embryonic cellular division, organogenesis, and the total prevention of congenital neural tube defects.
• Lactation (Breastfeeding): Fully recommended and safe. Active folate is a natural component of human breast milk. Supplementation ensures the nursing infant receives adequate folate levels necessary for rapid neurological and physical growth.

Over Dosage:

• Symptoms: Folate is a water-soluble vitamin; hence, any excess amount is readily excreted via the kidneys. True acute toxic overdose is highly improbable. However, massive sustained excess may mask the symptoms of Vitamin B12 deficiency (pernicious anemia) while neurological damage continues, or cause temporary neurological excitation (irritability/sleep disturbances).
• Management: Discontinue the supplement. Maintain high fluid intake to accelerate renal clearance. Symptomatic care is sufficient.

Therapeutic Class:

Bio-Active Vitamin B9 Coenzyme / Neurological and Hematological Nutritional Agent.

Storage Conditions:

Store below at 30°C  temperature in a dry place. Away from light and out of reach of children. Do not use the medication after its expiration date.