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🏅 FDA Orphan Designation

Nithiodote

sodium nitrite and sodium thiosulfate

Manufacturer: Hope Pharmaceuticals

Indicated for:
Cyanide poisoningOrphan
⚠️

Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (1)

Cyanide poisoningOrphan Designation

For sequential use for the treatment of cyanide poisoning that is judged to be life-threatening

Indications & Usage

1 INDICATIONS AND USAGE NITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, carefully weigh the potentially life-threatening risks associated with NITHIODOTE against the potential benefits, especially if the patient is not in extremis. NITHIODOTE, an antidote, is indicated for the 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 )

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.