Leucovorin, Folic Acid, Levomefolate Magnesium, Ferrous Cysteine Glycinate, 1,2-Docosahexanoyl-Sn-Glycero-3-Phosphoserine Calcium, 1,2-Icosapentoyl-Sn-Glycero-3-Phosphoserine Calcium, Phosphatidyl Serine, Pyridoxal 5-Phosphate, Flavin Adenine Dinucleotide, Nadh, Cobamamide, Cocarboxylase (Thiamine Pyrophosphate), Magnesium Ascorbate, Zinc Ascorbate, Magnesium L-Threonate And Betaine Capsule
FDA Drug Information • Also known as: PaxLyte
- Brand Names
- PaxLyte
- Drug Class
- Methylating Agent [EPC], Folate Analog [EPC]
- Route
- ORAL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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 a physician. It is specifically formulated for patients with deficiencies in folate and vitamin B 12 , including those with genetic polymorphisms affecting homocysteine metabolism. A 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 B Vitamins in Patients with MDD Who Are Positive for MTHFR C677T or A1298C Polymorphism.
What Is Leucovorin, Folic Acid, Levomefolate Magnesium, Ferrous Cysteine Glycinate, 1,2-Docosahexanoyl-Sn-Glycero-3-Phosphoserine Calcium, 1,2-Icosapentoyl-Sn-Glycero-3-Phosphoserine Calcium, Phosphatidyl Serine, Pyridoxal 5-Phosphate, Flavin Adenine Dinucleotide, Nadh, Cobamamide, Cocarboxylase (Thiamine Pyrophosphate), Magnesium Ascorbate, Zinc Ascorbate, Magnesium L-Threonate And Betaine Capsule Used For?
INDICATION PaxLyte is indicated in the TREATMENT of vitamin deficiency – specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate.
Dosage and Administration
DOSAGE AND ADMINISTRATION The normal dose, is one capsule daily OR as directed by a licensed healthcare practioner; preferably on an empty stomach.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B 12 . Allergic sensitization has been reported following both oral and parenteral administration of vitamin B 9 .
How Supplied
HOW SUPPLIED PaxLyte is an oval, brownish orange softgel capsule with imprint 7N3 (NDC 64661-217-30*). * This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2 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 a 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.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.