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Sodium Polysulthionate and Folic Acid

Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Sodium Polysulthionate and Folic Acid Description

Sodium Polysulthionate and Folic Acid is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and management of suboptimal hydrogen sulfide metabolic imbalance.

Sodium Polysulthionate and Folic Acid should be administered under the supervision of a licensed medical practitioner.

Indications and Usage for Sodium Polysulthionate and Folic Acid

Sodium Polysulthionate and Folic Acid is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and/or hydrogen sulfide deficiency.

The ingredients, indication or claims of this product are not to be construed to be drug claims.

Contraindications

Sodium Polysulthionate and Folic Acid is contraindicated in patients with known hypersensitivity to any of the components contained in this product.

WARNINGS AND PRECAUTIONS:

Sodium Polysulthionate and Folic Acid should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

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

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. 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 Sodium Polysulthionate and Folic Acid.
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. All GI incidences were categorized as mild and no patients discontinued due to adverse events. Allergic reactions have not been reported following the use of oral sodium polysulthionate.

SODIUM POLYSULTHIONATE 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 & ADMINISTRATION:

The adult dose of SODIUM POLYSULTHIONATE, FOLIC ACID is 1-2 capsules twice a day, or 400–800mg sodium polysulthionate and 1-2 mg folic acid twice per day (BID) or as prescribed by a medical practictioner. For people who are sensitive to medications, a starting dose of 1 capsule twice daily is recommended for the first week prior to titrating to a target dose of 2 capsules twice daily if warranted. SODIUM POLYSULTHIONATE, FOLIC ACID can be taken with or without food.

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

  • Pull capsule apart over a container or plate being careful not to lose any of the contents.
  • Add at least 4 oz of water (or other liquid as preferred)
  • Stir until fully mixed
  • Consume all of the contents immediately
  • Alternatively, product can be mixed with foods such as pudding or yogurt

PATIENT INFORMATION:
SODIUM POLYSULTHIONATE, FOLIC ACID is a dietary management / prescription (Rx)† nutritional product to be used only under licensed medical supervision and direction. Your licensed medical practitioner may choose to prescribe SODIUM POLYSULTHIONATE, FOLIC ACID along with other medications.

CLINICAL 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).

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. Folate along with methylcobolamin is an essential co-factor in the conversion of homocysteine to methionine.

How is Sodium Polysulthionate and Folic Acid Supplied

SODIUM POLYSULTHIONATE, FOLIC ACID is a is a dietary management / folate prescription (Rx)† nutritional product

SODIUM POLYSULTHIONATE, FOLIC ACID Bottle contains 60 capsules Product Code # 69499-904-60*
Use under medical/physician supervision.

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

This product is not Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to State statues as applicable.

†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 (61 FR 8760). The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). The ingredients, indication or claims of this product are not to be construed to be drug claims.

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

STORAGE AND HANDLING:

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

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident: Do not use if seal is broken or missing.

DISTRIBUTED BY:
Solubiomix
Madisonville, LA 704447

BOTTLE LABEL

Sodium Polysulthionate and Folic Acid 
Sodium Polysulthionate and Folic Acid capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69499-904
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
SULFUR (SULFUR) SULFUR 388 mg
SODIUM SULFATE (SODIUM SULFATE ANHYDROUS) SODIUM SULFATE 8 mg
SODIUM THIOSULFATE (THIOSULFATE ION) SODIUM THIOSULFATE 1.8 mg
Inactive Ingredients
Ingredient Name Strength
METHYLCOBALAMIN  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
Product Characteristics
Color white Score no score
Shape capsule Size 16mm
Flavor Imprint Code SG1002
Contains         
Packaging
# Item Code Package Description
1 NDC:69499-904-60 60 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2016
Labeler - Solubiomix (079640556)
Revised: 08/2016
 
Solubiomix



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