{"adverse_reactions":["ADVERSE REACTIONS None known."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Sodium thiosulfate is used as an antidote for cyanide poisoning. The primary mechanism of cyanide detoxification involves the conversion of cyanide to the thiocyanate ion, which is relatively nontoxic. This reaction involves the enzyme rhodanese (thiosulfate: cyanide sulfurtransferase) which is found in many body tissues, but with the major activity in the liver. The body has the capability to detoxify cyanide, however, the rhodanese enzyme system is slow to respond to large amounts of cyanide. The rhodanese enzyme reaction can be accelerated by supplying an exogenous source of sulfur. This is commonly accomplished by administering sodium thiosulfate. Sodium thiosulfate may be used alone or in combination with nitrite compounds such as amyl nitrite or sodium nitrite. Following intravenous injection, sodium thiosulfate is distributed throughout the extracellular fluid and is excreted unchanged in the urine. The biological half life is reported to be 0.65 hours."],"contraindications":["CONTRAINDICATIONS None known."],"description":["DESCRIPTION Sodium Thiosulfate Injection, USP is a preservative free, sterile solution for slow intravenous injection only. It is available as a 10% (100 mg/mL) solution and as a 25% (250 mg/mL) solution. Each mL contains: Sodium Thiosulfate Pentahydrate 100 mg or 250 mg, Water for Injection q.s. pH (range 6.0-9.5) adjusted with boric acid and/or sodium borate. Sodium thiosulfate is designated as Na 2 S 2 O 3 . The pentahydrate form, (Na 2 S 2 O 3 •5H 2 O; molecular weight 248.19) occurs as odorless granules or crystals that are soluble in water and insoluble in alcohol."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Death from cyanide poisoning occurs rapidly. Delays in administering the antidote should be avoided. Slow intravenous use only : The dose of sodium thiosulfate whether used alone or in combination with other cyanide antidotes is 12.5 grams given intravenously over approximately 10 minutes. The dosage for children is 7 grams per square meter of body surface area, with a maximum dose of 12.5 grams. Patients should be closely monitored for 24 to 48 hours for symptoms of cyanide poisoning to reappear. In the event symptoms return, sodium thiosulfate administration should be repeated at one half the original dose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. As a precautionary measure, a filter must be used for the withdrawal and administration of all lots of this product. The following procedure must be used for the compounding and administration of ALL lots of Sodium Thiosulfate Injection, USP. Perform a visual inspection on the vial prior to withdrawal of the contents. DO NOT USE IF PARTICULATES ARE PRESENT. USE A NEW VIAL. Use a 5 micron filter needle to withdraw the required calculated volume of Sodium Thiosulfate Injection, USP. NOTE: Sodium Thiosulfate Injection, USP is administered intravenously by either the IV push method or after further dilution in a larger volume of IV fluid. If the IV push method is used, withdraw contents of Sodium Thiosulfate Injection, USP vial with a 5 micron filter needle. Replace filter needle with appropriate needle for injection before administering to patients. If the IV infusion method is used, remove the filter needle and attach an appropriate needle to the syringe before adding to a larger volume of IV fluid and prior to patient administration. Visually inspect the final IV admixture solution. DO NOT USE IF PARTICULATES ARE PRESENT. DISCARD ADMIXTURE & USE A NEW VIAL. Use a 0.22 micron in-line filter when administering the final IV admixture to patients. If glass or other particulates are observed, or if you require additional information, please contact American Regent at 1-877-788-3232 then press 2 for the Professional Services Department (Monday-Friday: 9:00 am-5:00 pm ET) or via e-mail at: inquiry@americanregent.com."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE None known."],"effective_time":"20121128","how_supplied":["HOW SUPPLIED Sodium Thiosulfate Injection USP, for slow intravenous injection only, is available as follows: Product No. Size - Strength How Packaged NDC 0517-1019-05 10 mL single dose vials - 10% (100 mg/mL) Boxes of 5 NDC 0517-5019-01 50 mL single dose vials - 25% (250 mg/mL) Individually boxed Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15 o to 30 o C (59 o to 86 o F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN1019 Rev. 8/11"],"how_supplied_table":["
Product No. Size - Strength How Packaged
NDC 0517-1019-05 10 mL single dose vials - 10% (100 mg/mL) Boxes of 5
NDC 0517-5019-01 50 mL single dose vials - 25% (250 mg/mL) Individually boxed
"],"id":"c563faba-cd68-4358-8505-becb53e2c4bc","indications_and_usage":["INDICATIONS AND USAGE Sodium thiosulfate is indicated for the treatment of cyanide poisoning."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPLE DISPLAY PANEL – 10 mL Carton SODIUM THIOSULFATE INJECTION, USP 10% 100 mg/mL (1 g/10 mL) NDC 0517-1019-05 5 x 10 mL SINGLE DOSE VIALS FOR SLOW IV USE ONLY PRESERVATIVE FREE Rx Only Each mL contains: Sodium Thiosulfate Pentahydrate 100 mg, Water for Injection q.s. pH adjusted with Boric Acid and/or Sodium Borate. WARNING: DISCARD UNUSED PORTION. USE ONLY IF SOLUTION IS CLEAR. Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15 o to 30 o C (59 o to 86 o F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 PRINCIPLE DISPLAY PANEL – 50 mL Carton NDC 0517-5019-01 50 mL SINGLE DOSE VIAL SODIUM THIOSULFATE INJECTION, USP 25% 250 mg/mL (12.5 g/50 mL) Rx Only For Slow IV Use Only Preservative Free AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 11/05 c563faba-figure-01 c563faba-figure-02"],"precautions":["PRECAUTIONS Sodium thiosulfate is essentially nontoxic. However, studies conducted in dogs, with a constant infusion of sodium thiosulfate, showed hypovolemia which was considered to be due to an osmotic diuretic effect of sodium thiosulfate. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with sodium thiosulfate. It is also not known whether sodium thiosulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium thiosulfate should be given to a pregnant woman only if clearly needed."],"pregnancy":["Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with sodium thiosulfate. It is also not known whether sodium thiosulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium thiosulfate should be given to a pregnant woman only if clearly needed."],"set_id":"cfa4773c-ecfc-4d36-86d1-60aa50d8e527","spl_product_data_elements":["Sodum Thiosulfate Sodium Thiosulfate SODIUM THIOSULFATE THIOSULFATE ION BORIC ACID SODIUM BORATE WATER Sodum Thiosulfate Sodium Thiosulfate SODIUM THIOSULFATE THIOSULFATE ION BORIC ACID SODIUM BORATE WATER"],"spl_unclassified_section":["Rx Only"],"teratogenic_effects":["Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with sodium thiosulfate. It is also not known whether sodium thiosulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium thiosulfate should be given to a pregnant woman only if clearly needed."],"version":"2","warnings":["WARNINGS None known."]}