Rx Item-Nithiodote 300/12.5 Vial By Hope Pharma Special Order item

NITHIODOTE: Package Insert and Label Information
By Hope Pharmaceuticals | Last revised: 26 January 2011
NITHIODOTE- sodium nitrite and sodium thiosulfate
Hope Pharmaceuticals

WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION

Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain.



Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite.

Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g. smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite. [See Warnings and Precautions (5.1 and 5.2)]

1 INDICATIONS AND USAGE

1.1 Indication
NITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with NITHIODOTE should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

1.2 Identifying Patients with Cyanide Poisoning
Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.

The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, NITHIODOTE should be administered without delay.

RX ITEM-Nithiodote 300/12.5 Vial By Hope
NDC 60267-0812-00 UPC/GTIN No.3-60267-81200-7 Mfg.Part No.81200

Nithiodote 300/12.5 Vial By Hope Pharma
BRAND: NITHIODOTE NDC: 60267-0812-00,60267081200 UPC: 3-60267-81200-7,360267812007

SODIUM NITRITE/SOD THIOSU
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