Sodium nitrite

Based on human experience sodium nitrite is suspected to cause congenital malformations when administered during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Sodium nitrite should not be used during pregnancy unless the clinical condition of the woman requires treatment with sodium nitrite.

It is unknown whether sodium nitrite is excreted in human milk. A risk to the suckling child cannot be excluded.

Breast-feeding should be discontinued during treatment with sodium nitrite.

Fertility

There are no fertility data from the use of sodium nitrite in animals.

Not relevant.

There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium nitrite.

The medical literature has reported the following adverse events in association with sodium nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.

Cardiac and vascular disorders

Not known: Syncope, hypotension*, tachycardia, palpitations, dysrhythmia*

Blood and lymphatic system disorders

Not known: Methemoglobinemia*

Nervous system disorders

Not known: Headache, dizziness, blurred vision, seizures, confusion, coma*

Gastrointestinal disorders

Not known: Nausea, vomiting, abdominal pain

Respiratory, thoracic and mediastinal disorders

Not known: Tachypnea, dyspnea

Skin disorders

Not known: Urticaria

General disorders and administration site conditions

Not known: Anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, generalized numbness and tingling

^*Description of selected adverse reactions

Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of sodium nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.