DESCRIPTION

XaQuil  XR Extended-Release Tablets
53731-0003-03†

XaQuil XR is a medical food* that supplies 5-methyltetrahydrofolic acid (5-MTHF) for the dietary management of patients with a distinctive nutritional requirement associated with depression.

XaQuil XR is a medical food for use under the supervision of a physician.

CLINICAL PHARMACOLOGY
XaQuil XR is a medical food that consists of a patented biologically active folate (6S)-5-MTHF, glucosamine salt.

Each tablet delivers:

5-MTHF is the bioactive form of folate.¹ It is the form that crosses the blood-brain barrier and is important in the modulation of neurotransmitters such as serotonin, norepinephrine, and dopamine.^1,2 Low levels of these neurotransmitters have been associated with depression.³ Researchers have found that subjects with treatment-resistant depression commonly possess one or more gene variations that affect the activity of an enzyme(s) critically needed in the biochemical pathway that determines the availability of bioactive folate.^4,5

INDICATIONS AND USE
ADJUNCTIVE USE IN MAJOR DEPRESSIVE DISORDER
XaQuil XR is indicated for the dietary management of patients with a distinctive nutritional requirement associated with depression. These individuals may have suboptimal 5-MTHF levels in the cerebrospinal fluid, plasma, and/or red blood cells and have major depressive disorder (MDD). XaQuil XR is particularly used as adjunctive support for individuals who are on an antidepressant but are either not responding or only partially responding to medication therapy.

CONTRAINDICATIONS
XaQuil XR is contraindicated in anyone with a known prior hypersensitivity to its ingredients. Children, pregnant or nursing women, women of child-bearing age, and anyone at risk of vitamin B12 deficiency should consult with their physician before use.

PRECAUTIONS
Pernicious, aplastic, or normocytic anemias are caused by vitamin B12 deficiency. High-dose folic acid intake without concurrent vitamin B12 supplementation may correct hematological effects while masking neurological symptoms possibly delaying diagnosis of the deficiency.Compared to folic acid, (6S)-5-MTHF is less likely to mask a vitamin B12 deficiency.⁶ However, appropriate monitoring is recommended.

Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. XaQuil XR is not an antidepressant; however, 5-MTHF has been shown to enhance the antidepressant effects of known antidepressants.

INTERACTION WITH DRUGS
Before using this product, tell your physician or pharmacist of all the products you use. Keep a list of all of your medications with you, and share the list with your physician and pharmacist.

XaQuil XR contains folate, which may have interactions with the following:

• Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital, and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate.⁷ Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of this AED in the blood and allowing breakthrough seizures to occur.⁷
• Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.⁸

• Methotrexate competes with reduced folates for active transport across cell membranes.⁹
• Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.¹⁰
• Nonsteroidal anti-inflammatory drugs (NSAIDSs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin, and sulindac.¹¹
• Oral contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.¹²
• Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.¹³
• Metformin treatment in patients with type 2 diabetes decreases serum folate.¹⁴

Note: This list of interactions may not be complete and may not contain up-to-date information. Patients who are taking any medications and/or dietary supplements are advised to check interactions with a pharmacist or physician.

References available upon request

ADVERSE REACTIONS
Adverse reactions to forms of oral 5-MTHF have been reported. Talk to your physician about possible reactions prior to using this product.

DOSAGE AND ADMINISTRTION
The usual adult dose is 25,500 mcg DFE (one tablet, previously stated as 15 mg) given daily, with or without food, or as directed under medical supervision.

HOW SUPPLIED:

XaQuil XR is a coated, yellow, round, extended-release tablet designed to be given once daily.

STORAGE
Store at 20° to 25°C (68° to 77°F). Protect from heat, light, and moisture.

KEEP THIS MEDICAL FOOD OUT OF THE REACH OF CHILDREN.

INGREDIENTS: Dicalcium phosphate dihydrate, microcrystalline cellulose, coating (talc, shellac, vegetable glycerin, L-arginine, vegetable magnesium stearate, silica, sodium alginate, titanium dioxide, riboflavin 5’-phosphate sodium), vegetable stearic acid, (6S)-5-methyltetrahydrofolic acid glucosamine salt,^S1 vegetable magnesium stearate, and croscarmellose sodium.

FORMULATED TO EXCLUDE: Wheat, gluten, yeast, soy, dairy products, fish, shellfish, peanuts, tree nuts, egg, ingredients derived from genetically modified organisms (GMOs), artificial colors, artificial sweeteners, and artificial preservatives.

PharmaceutiX®
6900 Kingspointe Pkwy
Orlando, FL 32819
800-647-6100
info@pharmaceutixhealth.com

S1. Quatrefolic® is a registered trademark of Gnosis S.p.A. Produced under U.S. patent 7,947,662.

C.A.S.# 1181972-37-1

*A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

†PharmaceutiX® 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.

(30 Count)

REV. 050721