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.

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