Consumer medicine information

DBL Sodium Nitrite Injection

Sodium nitrite

BRAND INFORMATION

Brand name

DBL Sodium Nitrite Injection

Active ingredient

Sodium nitrite

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Sodium Nitrite Injection.

What is in this leaflet

This leaflet answers some common questions about DBL™ Sodium Nitrite Injection.

It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL™ Sodium Nitrite Injection against the benefits this medicine is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet in a safe place. You may need to read it again.

What DBL™ Sodium Nitrite Injection is used for

DBL™ Sodium Nitrite Injection is used in the emergency treatment of cyanide poisoning.

DBL™ Sodium Nitrite Injection works by helping to prevent cyanide from binding to important enzymes in the cells of your body.

Your doctor may have prescribed DBL™ Sodium Nitrite Injection for another reason. Ask your doctor if you have any questions about why DBL™ Sodium Nitrite Injection has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you are given DBL™ Sodium Nitrite Injection

When you must not be given it

DBL™ Sodium Nitrite Injection should not be given to you if:

  • you are suffering from smoke inhalation and combined carbon monoxide and cyanide poisoning
  • you have an allergy to sodium nitrite or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction to sodium nitrite may include skin rash, itching, difficulty breathing and swelling, especially of the face and throat.
  • the packaging is torn or shows signs of tampering
  • the expiry date on the pack has passed.
    If you are given this medicine after the expiry date has passed, it may not work as well.

Before you are given it

Your doctor should know about all the following before you are given DBL™ Sodium Nitrite Injection:

  1. if you have or have ever had any other health problems/medical conditions, including:
  • a condition called methaemoglobinaemia, which is a condition of the blood,
  • hypotension or low blood pressure,
  • a deficiency of glucose-6-phospate dehydrogenase
  1. if you are pregnant or intend to become pregnant
    Your doctor will discuss the risks and benefits of using Sodium Nitrite Injection during pregnancy.
  2. if you are breast-feeding or plan to breast-feed
    Your doctor will discuss the risks and benefits of using Sodium Nitrite Injection when breast-feeding.

If you have not told your doctor about any of the above, tell them before you are given DBL™ Sodium Nitrite Injection.

How DBL™ Sodium Nitrite Injection is given

DBL™ Sodium Nitrite Injection is given as an injection into a vein.

DBL™ Sodium Nitrite Injection should only be given by a doctor or nurse or other trained person.

In emergency situations it may be necessary for the injection to be given by a health professional other than a doctor or nurse (such as an ambulance officer).

Your doctor will decide what dose of DBL™ Sodium Nitrite Injection you will require and how long you will receive it. This depends on your medical condition and other factors, such as your weight.

If you take too much (overdose)

As DBL™ Sodium Nitrite for Injection is given to you under the supervision of a health care professional, it is very unlikely that you will receive too much. However, if you experience any severe side effects after being given DBL™ Sodium Nitrite for Injection, tell your doctor immediately or go to Accident and Emergency at the nearest hospital. You may need urgent medical attention.

In case of overdose, immediately contact the Poisons Information Centre for advice (telephone 13 11 26 in Australia, or call 0800 764 766 in New Zealand)

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given DBL™ Sodium Nitrite Injection.

DBL™ Sodium Nitrite Injection may have unwanted side-effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side-effects.

Ask your doctor or pharmacist to answer any questions you may have.

While being given it

Tell your doctor immediately if you notice any of the following:

  • nausea, vomiting or abdominal pain
  • headache or dizziness
  • fast heart beat
  • fast or distressed breathing
  • blue finger nails or lips

Some people may get other side effects while being given DBL™ Sodium Nitrite Injection.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After being given DBL™ Sodium Nitrite Injection

Storage

DBL™ Sodium Nitrite Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 25°C, and it is protected from light.

After use, any unused portion of the ampoule should be discarded.

Product description

What it looks like

DBL™ Sodium Nitrite Injection is a clear, colourless solution.

Ingredients

DBL™ Sodium Nitrite Injection contains 300mg sodium nitrite as the active ingredient.

It also contains:

  • water for injection.

DBL™ Sodium Nitrite Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

DBL™ Sodium Nitrite Injection is supplied by:

Australian Sponsor:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

DBL™ Sodium Nitrite Injection is available in the following strength:

  • 300 mg/10 mL, x5 ampoules.
    AUST R 16290

This leaflet was prepared in September 1998 and reviewed in April 2019

Published by MIMS July 2019

BRAND INFORMATION

Brand name

DBL Sodium Nitrite Injection

Active ingredient

Sodium nitrite

Schedule

S2

 

1 Name of Medicine

Sodium nitrite.

2 Qualitative and Quantitative Composition

DBL Sodium Nitrite Injection is a clear, colourless, sterile solution of sodium nitrite in water for injections. Each 10 mL ampoule contains 300 mg of sodium nitrite. The pH of the solution is between 7.0 and 9.0.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DBL Sodium Nitrite Injection is a clear, colourless, sterile solution of sodium nitrite in water for injections.

4 Clinical Particulars

4.1 Therapeutic Indications

DBL Sodium Nitrite Injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.

4.2 Dose and Method of Administration

Dosage.

Adult dose.

The usual adult dose is 300 mg (10 mL of a 3% solution) administered intravenously at a rate of 75 to 150 mg/min (2.5 to 5 mL/min).

Paediatric dose.

The usual paediatric dose is 4 mg/kg bodyweight (0.13 mL of a 3% solution/kg bodyweight) [range 4.0 to 10 mg/kg bodyweight, 0.13 to 0.33 mL/kg bodyweight] or 180 to 240 mg/m2 (6 to 8 mL of a 3% solution/m2) administered at a rate of 75 to 150 mg/min (2.5 to 5 mL of a 3% solution/min). It is advisable to begin with doses at the lower end of the recommended range and increase to the desired effect. A maximum dose of 300 mg (10 mL of a 3% solution) is recommended.

Method of administration.

Therapy should be instituted immediately based upon reasonable suspicion of cyanide toxicity. The characteristic smell of bitter almonds may not be obvious, and is not detectable by all individuals. Sodium nitrite should only be administered in severe cases.
DBL Sodium Nitrite Injection is administered by intravenous injection. Sodium thiosulfate should be administered immediately following the sodium nitrite dosage. Methaemoglobin concentration should be monitored and must not exceed 40%.

Dosage adjustments.

For children under 25 kg, where anaemia is suspected, it is recommended that the dose of sodium nitrite be reduced relative to the haemoglobin measurement. Table 1 outlines a dosage regimen as a function of haemoglobin concentration.
In both adults and children, if symptoms of cyanide toxicity recur, treatment with half the original dose of sodium nitrite and sodium thiosulfate treatment may be repeated 30 minutes after the initial dose.

4.3 Contraindications

DBL Sodium Nitrite Injection should not be administered to asymptomatic patients who have been exposed to cyanide. Use should be reserved for patients with definite indications of severe poisoning, such as loss of consciousness and deteriorating vital functions.
DBL Sodium Nitrite Injection should not be administered to patients with smoke inhalation and combined carbon monoxide and cyanide poisoning unless hyperbaric oxygen therapy is available and such therapy has been initiated, since such patients may develop further hypoxia from methaemoglobin induction.

4.4 Special Warnings and Precautions for Use

Sodium nitrite should be administered with caution in patients sensitive to sodium nitrite.
Sodium nitrite should also be administered with caution in patients with acquired or congenital methaemoglobinaemia, since sodium nitrite will exacerbate this condition.
Hypotension may occur following rapid administration of sodium nitrite. Blood pressure should be monitored carefully during sodium nitrite administration, and the infusion rate slowed if hypotension occurs.
Patients with glucose-6-phosphate dehydrogenase deficiency are theoretically at great risk from sodium nitrite therapy because of the likelihood of haemolysis, although no such cases have been reported.

Patient monitoring.

Methaemoglobin levels should be monitored during sodium nitrite treatment to avoid excessive methaemoglobin induction and should not exceed 40%.
Blood pressure should be monitored carefully during sodium nitrite administration, since hypotension may result if the rate of administration is too fast.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.
See Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Little is known about the effects of sodium nitrite on pregnancy and the foetus, however, problems in pregnancy have not been documented. Concerns about adverse effects on the foetus may have little relevance in the context of life threatening cyanide poisoning in the pregnant woman. Animal experiments indicate that some sodium nitrite crosses the placenta and that foetal methaemoglobinaemia may be induced. The risk to the foetus from severe maternal cyanide poisoning should be evaluated against the risk of foetal methaemoglobinaemia.
 It is not known whether sodium nitrite is distributed into breastmilk. Concerns about adverse effects on the breastfed infant may have little relevance in the context of life threatening cyanide poisoning in the mother. No animal studies have addressed the question of sodium nitrite excretion in breastmilk or its possible effects on the nursing infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Cardiovascular system.

Vasodilation resulting in syncope, hypotension and tachycardia, methaemoglobinaemia.

Central nervous system.

Headache, dizziness.

Gastrointestinal system.

Nausea, vomiting, abdominal pain.

Respiratory system.

Tachypnoea, dyspnoea, cyanosis.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Clinical features.

Overdose of sodium nitrite results in methaemoglobinaemia. Symptoms of methaemoglobinaemia may be seen at blood methaemoglobin concentrations of 15%, but symptoms do not usually appear until the blood methaemoglobin concentration reaches 30 to 40%. The symptoms of methaemoglobinaemia include cyanosis, headache, unusual tiredness or weakness, tachycardia, shortness of breath, extreme dizziness or fainting and coma. Cardiovascular collapse, convulsions and death may occur after sodium nitrite overdose. The mean lethal oral dose of sodium nitrite in adults is approximately 1 g if no treatment is received, although survival after this dose has been reported.

Treatment.

Treatment of overdose involves the following measures.
Supportive and symptomatic treatment.
Intravenous administration of methylene blue (1 to 2 mg/kg bodyweight) over 5 to 10 minutes. The dose may be repeated after one hour if necessary, but the total dose should not exceed 7 mg/kg. Extreme caution should be exercised when administering methylene blue to patients likely to have substantial amounts of cyanide bound to methaemoglobin because methylene blue will increase the cyanide release.
Oxygen and exchange transfusion should be considered when methaemoglobinaemia is severe.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia), 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sodium nitrite is an antidote for cyanide poisoning. Cyanide poisoning can be rapidly fatal. When hydrogen cyanide gas or large doses are taken, toxicity occurs within a few seconds and death occurs within minutes. With smaller doses, toxicity occurs within minutes, and may include the following symptoms: constriction of the throat, nausea, vomiting, giddiness, headache, palpitations, hyperpnoea, then dyspnoea, bradycardia (which may be preceded by tachycardia), unconsciousness, violent convulsions followed by death.
Sodium nitrite is generally used in conjunction with sodium thiosulfate, and often amyl nitrite, in the treatment of cyanide poisoning. Cyanide has a high affinity for ferric ions, and reacts readily with the ferric ion of mitochondrial cytochrome oxidase. Sodium nitrite reacts with haemoglobin to form methaemoglobin, and cyanide preferentially binds to methaemoglobin, restoring cytochrome oxidase activity. As cyanide dissociates from methaemoglobin, it is converted to the relatively non-toxic thiocyanate by the enzyme rhodanese (EC 2.8.1.1). Sodium thiosulfate acts as a sulfur donor for rhodanese.
Sodium nitrite also produces vasodilation by relaxing vascular smooth muscle.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Sodium nitrite is rapidly absorbed following oral administration. After intravenous administration the time to peak effect of sodium nitrite is 30 to 70 minutes. An injection of 1 mg/kg sodium nitrite produces a peak methaemoglobin concentration of approximately 6%.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

Sodium nitrite is reported to be incompatible with the following: acetanilide, antipyrine, caffeine, citrate, chlorates, hypophosphites, iodides, mercury salts, morphine, oxidizing agents, permanganate, phenazone, sulfites, tannic acid and vegetable astringent decoctions, infusions or tinctures.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Strength.

300 mg in 10 mL.

Pack size.

5 x 10 mL ampoule.

AUST R.

16290.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

The molecular formula of sodium nitrite is NaNO2. It has a molecular weight of 69.0.

CAS number.

7632-00-0.

7 Medicine Schedule (Poisons Standard)

S2.

Summary Table of Changes