Nufol

Description

COMPOSITION:

Quatrefolic 0.555mg eq. to Foilc Acid (B.P.) ……………….0.3mg
Mfg. Specs: U.S.P.
Each tablet contains above mentioned quantity of vitamin before processing.

DESCRIPTION:

Nufol contains Quatrefolic, the glucosamine salt of (65)-5-methyltetrahydrofolate and is structurally analogous to the reduced and active form of folic acid. It represents the fourth generation folate endowed with long lasting stability as well as peculiarly high water solubility, improved bioavailability and well established safety.

MECHANISM OF ACTION:

The mechanism of action of Quatrefolic is related to the action of 5-methyltetrahydrofolate the active part of the proprietary ingredient. 5- methyl tetrahydrofolate derives from tetrahydrofolic acid, through a series of metabolic reactions. Tetrahydrofolic acid acts as a coenzyme in several vital metabolic reactions participating in the transfer as acceptors and donors of various one-carbon fragments, involved in the biosynthesis of nucleotides purines and pyrimidines and in the metabolism of several important amino acids. In concert with vitamin B12, folate coenzymes allow the conversion of the amino acid homocysteine to methionine, the lack of this conversion has been associated with various pathologies and diseases. Conversion of tetrahydrofolic acid to 5-methyltetrahydrofolate is mediated by the action of the enzyme methylenetetrahydrofolate reductase. In individuals with a genetic defect of methylenetetrahydrofolate reductase enzyme conversion is limited, predisposing these individuals for an increased risk for certain disease conditions. Supplementation with 5-methyltetrahydrofolate might be preferable to folic acid, being it is immediately available to react with homocysteine to avoid the possibility of hyperhomocysteinemia. 5-MTHF improves trimonoamine neurotransmitter synthesis and helps to maintain a sense of calmness and a healthy outlook.

PHARMACOKINETICS:

Absorption: Quatrefolic demonstrates a surprisingly high solubility in water — greater than 1 g/ml. High water solubility means the product may be better absorbed by mucosal cells which may facilitate access to the blood and circulation with the potential for improved bioavailability.

Bioavailability: Quatrefolic supplementation allows 5-methyltetrahydrofolate to be immediately bioavailable for its biological action without being metabolized in the body.

Metabolism: Quatrefolic is the glucosamine salt of (6S)-5-methyltetrahydrofolate and is structurally analogous to the reduced and active form of folic acid. So, Quatrefolic completely bypasses the “damaged” MTHFR conversion step and delivers a “finished” folate, that the body can immediately use without any kind of metabolization.

Elimination: Quatrefolic is excreted in urine, a majority of the metabolic products appeared in urine.

INDICATIONS:

Quatrefolic increases plasma folate more effectively than folic acid, and thus:

• Helps in the treatment and maintenance of anemia
• Supports Healthy Serum Folate
• Supports the Conversion of Homocysteine to Methionine
• Supports Methylation
• Supports Nervous System and Oral Health
• Supports Normal Cellular Proliferation (including red blood cells)
• Helps to treat Depression, Cognitive Impairment, Dementia and Alzheimer disease.
• Supports a Healthy Pregnancy Outcome

DOSAGE & ADMINISTRATION:

As directed by the Doctor, Children: Age 1-3 years: 1/2 tablet daily. Age 4-18 years: 1 tablet daily. Adults: Age 19 years and older: 1 tablet daily. Pregnancy: 2 tablets daily.

CONTRAINDICATIONS:

Nufol is contraindicated in patients with a known hypersensitivity to any of the ingredients of the formulation.

WARNINGS:

Consult your healthcare practitioner prior to use. Individuals taking medication should discuss potential interactions with their healthcare practitioner.

PRECAUTIONS:

Quatrefolic alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

PREGNANCY & LACTATION:

Quatrefolic, as a source of (6S)-5-methyltetrahydrofolate might be particularly useful to provide the nutritionally active form of folate during preconception, pregnancy and lactation.

DRUG-DRUG INTERACTIONS:

These medications may cause some risk when taken with Nufol; Fosphenytoin, Methotrexate, Phenobarbital, Phenytoin, Primidone and Pyrimethamine.

ADVERSE DRUG REACTIONS:

Allergic sensitization has been reported following oral administration of folic acid.

OVER DOSAGE:

Quatrefolic is not considered to be toxic and even high doses of Folic Acid are considered to be safe and non-toxic. However, high intakes of Folic Acid can make it difficult to detect a Vitamin B12 deficiency because Folic Acid also reduces Vitamin B12 deficiency symptoms but without correcting the neurological damage that also occurs.

STORAGE:

Protect from light, excessive heat and moisture. Store in a cool and dry place below 30°C. Keep out of reach of children.
PRESENTATION:

Nufol tablets are presented in a blister pack of 30’s.