ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B12. Allergic sensitization has been reported following both oral and parenteral administration of vitamin B9.

DESCRIPTION SECTION.

DESCRIPTION. PaxLyte is an orally administered prescription vitamin for therapeutic use formulated for patients who are under specific direction and monitoring of homocysteine (HCY) status by physician. It is specifically formulated for patients with deficiencies in folate and vitamin B12, including those with genetic polymorphisms affecting homocysteine metabolism. recent study+ suggested that PaxLyte was effective in lowering homocysteine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism). ClinicalTrials.gov identifier: NCT02709668, Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced Vitamins in Patients with MDD Who Are Positive for MTHFR C677T or A1298C Polymorphism.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. The normal dose, is one capsule daily OR as directed by licensed healthcare practioner; preferably on an empty stomach.

HOW SUPPLIED SECTION.

HOW SUPPLIED. PaxLyte is an oval, brownish orange softgel capsule with imprint 7N3 (NDC 64661-217-30). This product is prescription-folate with or without other dietary ingredients that due to increased folate levels (AUG 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Due to the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications.

INDICATIONS & USAGE SECTION.

INDICATION. PaxLyte is indicated in the TREATMENT of vitamin deficiency specifically vitamin B12 deficiency, and the PREVENTION of vitamin B12-cofactor deficiency, l-methylfolate.

MECHANISM OF ACTION SECTION.

MECHANISM OF ACTION. VITAMIN B12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION]; Vitamin B12 is essential for the synthesis of methionine from homocysteine a reaction which also requires l-methylfolate as necessary cofactor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

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SPL UNCLASSIFIED SECTION.

CONTAINS. Each PaxLyte Softgel Contains: Adenosylcobalamin1 (vitamin B12 .......................... 50 mcgFolinic Acid (B vitamer).......................................... 4.25 mg DFE (2.5 mg) Folic Acid (B9 vitamer)............................................ 1.7 mg DFE (1 mg)L-Methylfolate Magnesium (B9 vitamer)..................... 11.9 mg DFE (7 mg)OTHER INGREDIENTS: Olive oil, gelatin, glycerin, magnesium ascorbate, at least 20 mg Phosphatidylserine DHA Complex (Sharp-PS(R) Gold)2, yellow beeswax, sodium citrate, sunflower lecithin, citric acid, annatto extract, 1.5 mg elemental iron (as ferrous glycine cysteinate)3, zinc ascorbate, mg magnesium l-threonate, natural orange flavor, piperine, CoQ10 (ubidecarenone), betaine, 25 mcg flavin adenine dinucleotide (reduced vitamin B3), 25 mcg nicotinamide adenosine dinucleotide hydride (reduced vitamin B2), 25 mcg pyridoxal phosphate (reduced vitamin B6), 25 mcg thiamine pyrophosphate (reduced vitamin B1).1 Adenosylcobalamin is an active coenzyme form of Vitamin B12 found in the human body.2 Contains at least 12 mg phosphatidylserine (PS) of which approximately 6.4 mg as PS-DHA-Ca, and less than 1% EPA (<800 mcg PS-EPA-Ca).3 Pure amino acid, cysteinated iron chelate. CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.

WARNINGS AND PRECAUTIONS SECTION.

PRECAUTIONS. Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Daily doses of 0.1 mg or more of folic acid (vitamin B9) may obscure pernicious anemia. Hematologic improvement can occur while neurological damage progresses. Exclusive use of folic acid to treat vitamin B12-deficient macrocytic anemia can lead to progressive and irreversible neurological damage. Vitamin B12 deficiency allowed to progress for over months may cause permanent spinal cord lesions. Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with vitamin B9 deficiency. Indiscriminate administration may mask the true diagnosis.