SODIUM THIOSULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Thiosulfate (UNII: HX1032V43M) (THIOSULFATE ION - UNII:LLT6XV39PY)

Available from:

Hope Pharmaceuticals

INN (International Name):

Sodium Thiosulfate

Composition:

Sodium Thiosulfate 250 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. None Risk Summary There are no available data on Sodium Thiosulfate Injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the pregnant woman and fetus associated with untreated cyanide poisoning (see Clinical Considerations). Therefore, if a pregnant woman has known or suspected cyanide poisoning, Sodium Thiosulfate Injection for sequential use with sodium nitrite is recommended [see Indications and Usage (1)] . In published animal studies, no evidence of embryotoxicity or malformations was reported when sodium thiosulfate was administered during organogenesis to pregnant mice, rats, hamsters, or rats at 0.2 to 0.9 times the human daily dose of 12.5 g for cyanide poisoning. The studies did not test doses that were comparable to the human dose for cyanide poisoning (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Cyanide readily crosses the placenta. Cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated. Life-sustaining therapy should not be withheld due to pregnancy. Data Animal Data: No malformations or evidence of embryo-fetal toxicity were noted when pregnant mice, rats, hamsters, or rabbits were administered oral doses of sodium thiosulfate of up to 550, 400, 400, or 580 mg/kg, respectively during organogenesis (0.2, 0.3, 0.26, and 0.9 times the human dose of 12.5 g/60 kg person for cyanide poisoning based on body surface area). Published studies suggest that treatment with sodium thiosulfate ameliorates the teratogenic effects of maternal cyanide poisoning in hamsters. Risk Summary There are no data on the presence of sodium thiosulfate in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Cyanide and thiocyanate (which is formed when sodium thiosulfate combines with cyanide) are present in human milk. Because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment with Sodium Thiosulfate Injection. There are no data to determine when breastfeeding may be safely restarted following the administration of Sodium Thiosulfate Injection. There are case reports in the medical literature of sodium nitrite in conjunction with sodium thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of sodium thiosulfate in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports. Sodium thiosulfate is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Sodium thiosulfate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Product summary:

Each Sodium Thiosulfate carton (NDC 60267-705-50) consists of the following: Storage Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze. (Note: Sodium Nitrite must be obtained separately.)

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM THIOSULFATE- SODIUM THIOSULFATE INJECTION, SOLUTION
HOPE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE THE
SODIUM THIOSULFATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SODIUM THIOSULFATE
INJECTION.
SODIUM THIOSULFATE INJECTION, USP
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sodium Thiosulfate Injection, an antidote, is indicated for sequential
use with sodium nitrite for treatment
of acute cyanide poisoning that is judged to be serious or
life-threatening. (1)
Use with caution if the diagnosis of cyanide poisoning is uncertain.
(1)
DOSAGE AND ADMINISTRATION
If clinical suspicion of cyanide poisoning is high, administer Sodium
Thiosulfate Injection without delay
and in conjunction with appropriate airway, ventilatory, and
circulatory support. (2.1)
The expert advice of a regional poison control center may be obtained
by calling 1-800-222-1222. (2.1)
Dosing:
AGE
INTRAVENOUS DOSE OF SODIUM NITRITE AND SODIUM THIOSULFATE
ADULTS
1.)
2.)
CHILDREN
1.)
2.)
Redosing: If signs of cyanide poisoning reappear, repeat treatment
using one-half the original dose of
both sodium nitrite and sodium thiosulfate. (2.2)
Monitoring: Blood pressure must be monitored during treatment. (2.2)
Sodium thiosulfate is chemically incompatible with hydroxocobalamin
and should not be administered
via the same intravenous line. (2.4)
DOSAGE FORMS AND STRENGTHS
Sodium Thiosulfate Injection consists of:
One vial of sodium thiosulfate injection USP 12.5 grams/50 mL (250
mg/mL) (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Sulfites: Sodium thiosulfate may contain trace impurities of sodium
sulfite (5.1)
ADVERSE REACTIONS
Most common adverse reactions are:
Hypotension, headache, disorientation (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HOPE PHARMACEUTICALS AT
1-800-755-
SODIUM NITRITE -10 mL of sodium nitrite at the rate of 2.5 to 5
mL/minute
SODIUM THIOSULFATE - 50 mL of sodium thiosulfate immediately follo