LorMate

71741-301-30
Dietary Supplement
Dispensed by Prescription

LorMate is an orally administered dietary supplement intended for the clinical dietary management of suboptimal nutritional status in patients taking methotrexate to treat their chronic inflammatory diseases where advanced folate, Vitamin B-12 supplementation and maintenance of good health is needed under physician supervision.

LorMate has been formulated, manufactured and labeled in accordance with the requirements for Dietary Supplements. LorMate is to be used only under a physician's supervision.

LorMate consists of a mixture of L-5-methyltetrahydrofolic acid, Calcium salt – 1mg, Vitamin B-12 as methylcobalamin – 1 mg, and CurcuGen™ Turmeric Extract and Essential Oil Complex – 500mg. L-5-methyltetrahydrofolate provides the methotrexate-induced distinctive nutritional requirement for folate due to competitive inhibition of reduced folate production in certain individuals who may have a more pronounced genetic polymorphism in the folate metabolic pathway. Methylcobalamin provides adequate Vitamin B-12 stores to avoid masking borderline deficiency Vitamin B-12 with external folate supplementation. Curcumin provides an increased nutritional requirement for antioxidants associated with methotrexate induced oxidative stress.

OTHER GRAS INGREDIENTS: Vegetable Cellulose (Capsule), Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate.

All ingredients in LorMate are GRAS ingredients, approved food additives, or approved color additives.

Allergen: NONE

Methotrexate is the most widely used disease modifying drug in the treatment of inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis or psoriasis. Despite its therapeutic benefit as many as 30% of patients discontinue or reduce their dose due to its adverse effects caused by the failure to compensate for the increased need for folate acid. The increased requirement for folate results from the methotrexate induced reduction in the folate-mediated one-carbon metabolic pathway and other enzymatic processes for which reduced folate is a cofactor.

Methylcobalamin provides adequate Vitamin B-12 stores to avoid masking borderline deficiency of Vitamin B-12 with exogenous folate supplementation.

Methotrexate adverse events are thought to be caused by a disruption of cellular redox homeostasis (severe oxidative stress) with depletion of natural antioxidant mechanisms and marked rise in oxidative by-products. This creates increased nutritional requirement for supplemental dietary antioxidants (curcuminoids) thus reducing oxidative burden.

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

Folate may interfere with absorption of certain medications. Patients receiving both LorMate and tetracycline should take these medications at least one hour apart. The serum levels and the utilization of folate may be reduced when taken with sulfasalazine, phenytoin, statins and some birth control medications.

LorMate should only be used under the direction and supervision of a licensed medical practitioner.

LorMate use should be under the supervision of a physician when administered to patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking other medications.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B-12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Redmont Pharmaceuticals, LLC at 1-800-986-5909.

Adult dose is 1 capsule by mouth once daily, preferably with a meal or as directed by a physician.

Bottles of 30 capsules (71741-301-30²).
LorMate is supplied as a yellowish powder in a clear transparent capsule.

Store at 20°-25° C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light and moisture.

This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking Vitamin B-12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (64 FR 8760). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statues as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)

TAMPER EVIDENT: Do not use if seal is broken or missing.

MADE IN USA

Distributed by:
Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909

CurcuGen™ is a registered trademark of Dolcas BioTech LLC
CurcuGen™ Turmeric Extract - Patents Pending

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

301321

71741-301-30

LorMate

Dietary Supplement

30 CAPSULES

Dispensed by Prescription