Cerefolin NAC

Description CerefolinNAC is a prescription medical food for use only under the supervision of a physician for the clinical dietary management of mild cognitive impairment and is specially formulated to meet the distinctive nutritional requirements for this condition.

CAS# 151533-22-1

Contains milk and soy

Contains milk and soy

CerefolinNAC caplets do not contain lactose, yeast or gluten.

CerefolinNAC is a prescription medical food for use only under the supervision of a physician.

Medical foods are intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.

This product is not an orange book product.

Indications and usage CerefolinNAC is indicated for the distinct nutritional requirements of individuals with mild to moderate cognitive impairment who present with an increased risk for neurovascular oxidative stress and/or hyperhomocysteinemia; and/or suboptimal L-methylfolate and/or vitamin B12 levels in the cerebrospinal fluid, plasma, and/or red blood cells.

Contraindications CerefolinNAC is contraindicated in patients with known hypersensitivity to any of the components contained in this product.

Precautions General Folic acid, when administered in daily doses above 0.1mg, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). L-methylfolate Calcium may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of a B12 deficiency.

N-acetyl-L-cysteine should be avoided by nursing mothers.

N-acetyl-L-cysteine clearance is reduced in those with chronic liver disease as well as in pre-term newborns.

Headaches may be intensified in those taking N-acetyl-L-cysteine and nitrates for the treatment of angina.24 While the incidence of renal stones is low, those that do form renal stones, particularly cysteine stones should avoid CerefolinNAC. Do not administer CerefolinNAC to critically ill patients. N-acetyl-L-cysteine and its sulfhydryl metabolites could produce a false-positive result in the nitroprusside test for ketone bodies used in diabetes.24 N-acetyl-L-cysteine should be used with caution in those with a history of peptic ulcer disease since N-acetyl-L-cysteine may disrupt the gastric mucosal barrier.

Adverse reactions Allergic reactions have been reported following the use of oral L-methylfolate Calcium. Mild transient diarrhea, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with methylcobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with N-acetyl-L-cysteine.

Allergic reactions have been reported following the use of oral L-methylfolate Calcium. Mild transient diarrhea, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with methylcobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with N-acetyl-L-cysteine.

Recommended use The usual adult dose is one caplet daily or as directed under medical supervision.

CerefolinNAC bottle of 90 Product Code # 00525-0555-90.

Use under medical supervision.

Each CerefolinNAC caplet is an oval coated beige colored caplet. Debossed with “PAL” on one side and “600” on the other.

Alfasigma USA, Inc. does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirements of pharmacy and health insurance computer systems.

Storage Store at controlled room temperature 15(0)C to 30(0)C (59(0)F to 86(0)F) (See USP). Protect from heat, light and moisture.

Patents Some or all of the following patents may apply: U.S. Patent No. 5,997,915 U.S. Patent No. 6,008,221 U.S. Patent No. 6,011,040 U.S. Patent No. 6,127,370 U.S. Patent No. 6,254,904 U.S. Patent No. 6,441,168B1 U.S. Patent No. 7,172,778 U.S. Patent No. 7,674,490 U.S. Patent No. 7,709,460B2

Metafolin is a registered trademark of Merck KGaA, Darmstadt, Germany.