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SODIUM NITRITE 30 MG/ML SOLUTION FOR INJECTION

Active substance(s): SODIUM NITRITE

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Patient Information Leaflet

NITHIODOTE
(Co-Packaged Sodium Nitrite 30 mg/mL
Solution for Injection and
Sodium Thiosulfate 250 mg/mL
Solution for Injection)
Read all of this leaflet carefully
• This leaflet contains information about
Nithiodote, which will have already
been given to you by injection into one
of your veins.
• Although you will not be taking this
medicine yourself, this leaflet contains
important information to help you
understand how Nithiodote is used.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or nurse.
• If you get any side effects talk to your
doctor or nurse. This includes any
possible side effects not listed in this
leaflet. See section 4.

In this leaflet:

1. What Nithiodote is and what it is used for
2. Before you are given Nithiodote
3. How Nithiodote is given
4. Possible side effects
5. How to store Nithiodote Injection
6. Further information

1. What Nithiodote is and what
it is used for
Nithiodote is a kit that contains two separate
medications: Sodium Nitrite Solution for
Injection and Sodium Thiosulfate Solution
for Injection.
Nithiodote is used as an antidote for cyanide
poisoning. Cyanide poisoning is a condition
that develops when you inhale, touch, or
swallow cyanide. Cyanide is a poisonous
chemical that prevents your body from
absorbing oxygen. The lack of oxygen can
damage your organs and be life-threatening.

2. Before you are given Nithiodote
Take special care with Nithiodote if you:
• are pregnant or breast-feeding (See
Pregnancy and breast-feeding);
• have low blood pressure;
• have a condition called anaemia (This is a
reduction in number of red blood cells in
the bloodstream. Anaemia can make the
skin appear pale and can cause weakness
or breathlessness);
• suffer from Glucose-6-Phosphate
Dehydrogenase (G6PD) deficiency
(This may result in anaemia.);
• have a history of elevated levels of
methemoglobin (This is a modified form
of hemoglobin that reduces the amount of

oxygen in the bloodstream and can cause
weakness or breathlessness.);
• have inhaled smoke from a fire;
• have had allergic reactions to sulfites.
You will be monitored during use with
Nithiodote, and the dose of the medication
will be adjusted if necessary.

pregnancy or while breast-feeding. Tell your
doctor right away if you are pregnant or
breast feeding.

3. How Nithiodote will be given

Nithiodote will be given by injection into a
vein by a doctor or nurse. Your doctor will
choose the dose that is right for you.
Using other medicines
If signs of cyanide poisoning reappear, your
Tell your doctor or pharmacist if you are doctor will decide if you should receive
taking or have recently taken any other more Nithiodote.
medicines, including medicines obtained If you have any further questions on the use
without a prescription.
of Nithiodote, ask your doctor or nurse.
The following medicines have side effects
that are similar to the side effects that may 4. Possible side effects
occur with Nithiodote.
Like all medicines, this medicine can cause side
• Medicines used to treat high blood
pressure such as beta blockers, diuretics,
and nitrates;

effects, although not everybody gets them.
The side effects of sodium nitrite include:

• Medicines that can increase
• Cardiovascular: reduced blood pressure,
methemoglobin levels such as procaine
rapid heart rate, irregular pulse, transient
(used as a local anaesthetic) and
loss of consciousness, palpitations
nitroprusside (used to reduce blood
• Hematological: blood disorder resulting
pressure)
in oxygen deprivation in tissues
It may be necessary for your doctor to adjust
(methemoglobinemia)
the dose of Nithiodote or one of your other
• Central nervous system: headache,
medications.
dizziness, blurred vision, seizures,
Do not take Nithiodote concurrently with
confusion, coma
hydroxocobalamin.
• Psychiatric: anxiety

Pregnancy and breast-feeding

Nithiodote should not be used during

• Gastrointestinal: nausea, vomiting,
abdominal pain

• Respiratory: rapid breathing, shortness
of breath
• Skin: urticaria (skin rash notable for pale,
red, raised, itchy bumps)
• Body as a whole: sweating, light
headedness, injection site tingling, fatigue,
weakness, generalized numbness and
tingling, blue or purple coloured skin
The side effects of sodium thiosulfate
include:
• Cardiovascular: reduced blood pressure
• Hematological: cuts take longer to stop
bleeding than normal
• Central nervous system: headache,
disorientation
• Gastrointestinal: nausea, vomiting
• Body as a whole: salty taste in mouth,
warm sensation over body
The frequencies at which the above reactions
occur are not known yet.

Reporting of side effects:

If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
help make sure that medicines remain as
safe as possible by reporting any unwanted
side effects directly via www.mhra.gov.uk/
yellowcard.

5. How to store Nithiodote
Keep this medicine out of the sight and reach
of children.
Do not use Nithiodote after the expiry date
which is stated on the vial label and carton.
The expiry date refers to the last day of that
month.
Store below 25°C.
Store in the original package in order to
protect from light.
Sodium nitrite and sodium thiosulfate
solutions for injection must be clear
and colourless. If particulate matter or
discolouration is present, the solution
must not be used and should be discarded.
For single use only. Sodium nitrite and
sodium thiosulfate solutions should be
used immediately after opening. Discard
any unused portions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

6. Further information
What Nithiodote contains
Each 10 mL vial of Sodium Nitrite Solution
for Injection contains 300 mg of the active
ingredient sodium nitrite (30 mg/mL).

The other ingredient is water for injections.
Each 50 mL vial of Sodium Thiosulfate
Solution for Injection contains 12.5 g of the
active ingredient sodium thiosulfate (250
mg/mL). The other ingredients are boric
acid, potassium chloride, and water for
injections. Sodium hydroxide may also be
used to adjust the pH of the solution.

What Nithiodote looks like and
contents of the pack
Each carton of Nithiodote contains one 10
mL glass vial of Sodium Nitrite Solution for
Injection and one 50 mL glass vial of Sodium
Thiosulfate Solution for Injection.
Nithiodote is a kit that contains a single vial
of Sodium Nitrite PL 42589/0001 and a single
vial of Sodium Thiosulfate PL 42589/0002.

Marketing Authorisation Holder
Hope Pharmaceuticals, Ltd.
120 Baker Street
London W1U 6TU
United Kingdom
Manufacturer
Cangene bioPharma, Inc.
Baltimore MD 21230
USA
This leaflet was last revised on August 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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