DESCRIPTION

SULFZIX is an orally-administered medical food dispensed by prescription for the clinical dietary management of suboptimal hydrogen sulfide levels related to metabolic imbalances in endogenous hydrogen sulfide biochemistry. Use under medical supervision.

Each SULFZIX capsule contains:
      sodium polysulthionate†                 400 mg
      folic acid                                           1 mg

† Proprietary matrix of alpha sulfur, sodium sulfate, sodium thiosulfate obtained by reacting sodium hydrosulfide with sodium metabisulfite in an acidic medium

INDICATIONS AND USAGE

SULFZIX is indicated for the clinical dietary management of the metabolic processes of certain individuals with chronic hydrogen sulfide insufficiency that cannot be corrected through diet alone, with a particular emphasis in persons who have inborn errors of cystathionine beta-synthase (CBS), cystathione gamma-lyase (CSE), and/or 3-mercaptopyruvatesulfurtransferase (3-MST) hydrogen sulfide synthesizing enzymes. Clinical dietary management in patients who, as a result of a condition or disease, have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients associated with endogenous hydrogen sulfide biochemistry, with a particular emphasis in patients with heart failure and chronic wounds.1-8 Must be used under licensed medical supervision.

CONTRAINDICATIONS

SULZIX is contraindicated in patients with known hypersensitivity to sulfur containing products or any of the components contained in this product.

WARNINGS AND PRECAUTIONS

GENERAL:
Sulfur, by itself, is not toxic to our bodies. However, some people are allergic to relatives of sulfur such as sulfites and sulfa drugs. Certain sulfites can trigger asthma and other allergic reactions in people who are sensitive. Sulfa drugs can cause hypoglycemia (low blood sugar), skin rashes, high fever, headache, fatigue, and gastric problems for people with alpha drug allergies. Tell your health care provider if you think you may be allergic to sulfur-containing substances.

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). Folate therapy alone is inadequate for the treatment of a B12 deficiency.

INTERACTIONS WITH DRUGS:
Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. No decrease in effectiveness of drugs has been reported with the use of SULFZIX.
Hydrogen sulfide may induce cytochrome P450 2B67 and 2E18, therefore it may decrease the half-life of medications metabolized by these enzymes. Careful monitoring of concomitant medications metabolized by these enzymes is recommended.

ADVERSE REACTIONS:
Mild gastrointestinal (GI) issues such as flatulence and nausea were observed in sodium polysulthionate patients.1 All GI incidences were categorized as mild and no patients discontinued due to adverse events1. Allergic reactions have not been reported following the use of oral sodium polysulthionate.

USE IN SPECIFIC POPULATIONS:

• Pregnancy: SULFZIX has not been studied in pregnant women. The choice to administer SULFZIX during pregnancy is at the clinical discretion of the prescribing physician.
• Labor and Delivery/NursingMothers: SULFZIX has not been studied in labor and delivery. The choice to administer SULFZIX during labor and delivery is at the clinical discretion of the prescribing physician.
• Overdosage: No specific information is available on the treatment of overdosage with SULFZIX.

SULFZIX has been self-affirmed as Generally Recognized as Safe (GRAS). The highest level of sodium polysulthionate consumption has been 1,600MG per day in clinical studies although anecdotal reports of 3,000mg per day have used without adverse events.

DOSAGE AND ADMINISTRATION

The adult dose of SULFZIX is 1-2 capsules twice a day, or 400–800mg sodium polysulthionate and 1-2 mg folic acid twice per day (BID). For people who are sensitive to medications, a starting dose of 1 SULFZIX capsule twice daily is recommended for the first week prior to titrating to 800mg twice daily if warranted. One to two (1-2) capusles can be administered twice daily with or without food or as directed under medical supervision.

INSTRUCTIONS FOR USE

• Take 1-2 capsules twice a day or as directed by medical supervision, with or without meals

For persons with difficulty swallowing capsules, the capsule can be pulled apart and product can be mixed with foods such as pudding or yogurt

PATIENT INFORMATION:
SULFZIX is a prescription medical food to be used only under licensed medical supervision and direction. Your licensed medical practitioner may choose to prescribe SULFZIX along with other medications.

PHARMACOLOGY

Sodium polysulthionate: consists of a biologically active sulfur based nutrients in a proprietary matrix of alpha sulfur, sodium sulfate, and sodium thiosulfate derived from food sources. In a study of health controls and heart failure patients, oral sodium polysulthionate increased hydrogens sulfide and nitric oxide levels (p<0.05).1

Folate: folate is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. Through one-carbon metabolism folate plays an essential role in homocysteine metabolism. Homocysteine metabolizes in the body to produce hydrogen sulfied, which is a strong antioxidant and vasorelaxation factor. At an elevated level, homocysteine inactivates proteins by homocysteinylation including its endogenous metabolizing enzyme, cystathionine gamma-lyase. Thus, there is a reduced production of endogenous hydrogen sulfide during hyperhomocysteinemia.12 Folate along with methylcobolamin is an essential co-factor in the conversion of homocysteine to methionine.13

HOW SUPPLIED

SULFZIX is a is a medical food
SULFZIX 60 capsules per bottle……………………………….Product Code # 69597-904-60*
Use only  under medical/physician supervision.
A 30 day supply is typically 60-120 capsules

SULFZIX bottle contains 60 capsules that contains 400mg of sodium polysulthionate and 1 mg of folic acid. SULFZIX does not contain any milk products such as lactose, casein, or whey. SULFZIX is gluten-free, dye-free, and soy-free. SULFZIX is manufactured in accordance with current Good Manufacturing Practice (cGMP).

SULFZIX may- under certain circumstances, be dispensed through a certified mail-order program so long as there is confirmation that the patient is under licensed medical supervision.

*Basiem 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.
This product is a prescription-folate with or without other dietary ingredients that due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (38 FR 20750, 61 FR 8760, 45 FR 69043 at 69044).14-16. The ingredients, indication or claims of this product are not to be construed to be drug claims. This product is not intended to diagnose, treat, cure, or prevent disease.

STORAGE AND HANDLING

Store at controlled room temperature 15oC to 30oC (59oF to 86oF). Protect from heat, light and moisture.

REFERENCES

1. Polhemus DJ1, et al. Cardiovasc Ther. 2015 Apr 29. doi: 10.1111/1755-5922.12128
2. Martinez et al. Asian Pacific Journal, Volume 4, Issue 2, June 2015; 106–111
3. Kondo K. et al. Circulation. 2013 Mar 12;127(10):1116-27
4. Barr LA1, Nitric Oxide. 2015 Apr 30;46:145-56. doi: 10.1016/j.niox.2014.12.013
5. Lucock M et al. Genes Nutr. 2013 Mar;8(2):221-9.
6. Kruger WD et al. Mol Genet Metab. 2000.70:53-60.
7. Seneff S. et al. Theor Biol Med Model. 2015 May 27;12:9.
8. Seneff S. Wise Traditions in Food, Farming and the Healing Arts; Weston A. Price Foundation, Summer 2011.
9. Wang J, et al. Clin Genet. 2004 Jun;65(6):483-6.
10. Wang, X., et al., Biol Pharm Bull, 2013. 36(10): p. 1627-33.
11. Caro, A.A., S. Thompson, and J. Tackett,. Cell Biol Toxicol, 2011. 27(6): p. 439-53.
12. B Akoglu, et al. European Journal of Clinical Nutrition (2007), 1-6
13. Scott JM, et al.Lancet. 1981 2:337-340
14. Sen U., et al. Cell Biochem Biophys. 2010 Jul;57(2-3):49-58
15. Lumb M., et al. Biochem J. 1989 Mar 1;258(2):611-2.
16. Federal Register Notice of August 2, 1973 (38 FR 20750)
17. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
18. Federal Register Notice of March 5, 1996 (61 FR 8760)

PACKAGE LABEL