Consumer medicine information

Hope Pharmaceuticals Sodium Thiosulfate Injection

Sodium thiosulfate pentahydrate

BRAND INFORMATION

Brand name

Hope Pharmaceuticals Sodium Thiosulfate Injection

Active ingredient

Sodium thiosulfate pentahydrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Hope Pharmaceuticals Sodium Thiosulfate Injection.

What is in this leaflet

This leaflet answers some common questions about HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given sodium thiosulfate against the benefits they expect it will have for you.

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

Keep this leaflet. You may need to read it again.

What HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection is used for

This medicine is used:

  • in the emergency treatment of cyanide poisoning
  • to prevent cyanide poisoning when sodium nitroprusside is given.

This medicine works by helping the body to convert cyanide to a less dangerous chemical called thiocyanate.

Ask your doctor if you have any questions about why this medicine has been prescribed for your. Your doctor may have prescribed it for another reason.

Before you are given HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection

Before you are given it

Tell your doctor if you have an allergy to:

  • any medicine containing sodium thiosulfate
  • any of the ingredients listed at the end of this leaflet
  • any other medicines, foods, preservatives or dyes.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Tell your doctor if you have any of the following medical conditions:

  • high blood pressure
  • conditions that cause fluid retention, such as liver disease, heart failure, kidney disease or toxaemia of pregnancy.

Tell your doctor if you are pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given sodium thiosulfate.

How HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition.

How it is given

HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection is given as a slow injection into a vein. It must only be given by a doctor, nurse or other trained person.

If you receive too much (overdose)

As HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection is given to you under close supervision, it is very unlikely that you will receive an overdose. However, if you experience severe side effects, tell your doctor or nurse immediately. Symptoms of an overdose may include joint pain, blurred vision, muscle cramps, nausea and vomiting, strange or disturbing thoughts or behaviour, and ringing or other persistent noises in the ears.

In case of overdose, immediately contact the Poisons Information Centre for advice. (In Australia, call 13 11 26.)

This medicine is not addictive.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given sodium thiosulfate.

This medicine 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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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

Tell your doctor or nurse if you notice any of the following and they worry you:

  • headache
  • disorientation
  • diarrhoea
  • increased urge to urinate.

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

  • dizziness
  • nausea and vomiting
  • muscle cramps or joint pain
  • blurred vision
  • strange or disturbing thoughts or behaviour, including feeling agitated or seeing, feeling, or hearing things that are not there
  • buzzing, hissing, whistling, ringing another persistent noise in the ears.

The above list includes serious side effects. You may need urgent medical attention.

Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After being given HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection

Storage

HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection will generally 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.

Product description

What it looks like

HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection is a clear, colourless solution in a glass vial. It is available in single packs.

Ingredients

Each 50 mL vial of HOPE PHARMACEUTICALS™ Sodium Thiosulfate Injection contains 12.5 g of sodium thiosulfate as the active ingredient. The vials also contain:

  • boric acid
  • potassium chloride
  • water for injections
  • sodium hydroxide and boric acid are added as necessary to adjust the pH.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Hope Pharmaceuticals, Pty. Ltd.
Level 12, Castlereagh Street
Sydney NSW 2000
Australia

AUST R number: 50 mL vial 276773

This leaflet was prepared in May 2017.

Published by MIMS December 2022

BRAND INFORMATION

Brand name

Hope Pharmaceuticals Sodium Thiosulfate Injection

Active ingredient

Sodium thiosulfate pentahydrate

Schedule

Unscheduled

 

1 Name of Medicine

Sodium thiosulfate pentahydrate.

2 Qualitative and Quantitative Composition

Each vial contains 12.5 grams of sodium thiosulfate pentahydrate in 50 mL solution (250 mg/mL).
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Hope Pharmaceuticals Sodium Thiosulfate Injection is a sterile aqueous solution and is intended for intravenous injection. Hope Pharmaceuticals Sodium Thiosulfate Injection is a clear and colourless solution, practically free from visual particles, with a pH between 7.5 and 9.0.

4 Clinical Particulars

4.1 Therapeutic Indications

Hope Pharmaceuticals Sodium Thiosulfate Injection is indicated as an antidote in the treatment of cyanide poisoning. It is frequently used in conjunction with sodium nitrite.
Sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

4.2 Dose and Method of Administration

Hope Pharmaceuticals Sodium Thiosulfate Injection is for single use in one patient only. Discard any residue.
Hope Pharmaceuticals Sodium Thiosulfate Injection is administered by slow intravenous injection. If sodium nitrite is administered in the treatment of cyanide poisoning, sodium thiosulfate should be administered immediately following the sodium nitrite infusion.
Therapy should be administered 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.

Cyanide poisoning.

Adult dose.

The usual adult dose is 12.5 g (50 mL of a 25% solution) administered intravenously at a rate of 1.25 g/min (5 mL/min). If signs of cyanide toxicity are still present 30 minutes to 2 hours after administration, both sodium nitrite and sodium thiosulfate may be repeated at half the original dose.

Paediatric dose.

The usual paediatric dose is 412.5 mg/kg (1.65 mL/kg of a 25% solution) or 7 g/m2 (28 mL/m2) administered at a rate of 0.625 to 1.25 g/min (2.5 to 5 mL/min). A maximum dose of 12.5 g (50 mL of a 25% solution) is recommended.
Alternatively, a paediatric dose based on haemoglobin concentration has been recommended (see Table 1).

Prevention of sodium nitroprusside induced cyanide toxicity.

Adult dose.

Administer intravenously concurrently with sodium nitroprusside at 5 to 10 times the dose rate of sodium nitroprusside.

4.3 Contraindications

There are no specific contraindications to sodium thiosulfate administration.

4.4 Special Warnings and Precautions for Use

Sodium thiosulfate should be administered with caution in patients sensitive to sodium thiosulfate.
Sodium thiosulfate should also be administered with caution in patients with hypertension, since sodium thiosulfate may exacerbate the condition.
Sodium thiosulfate should be administered with caution in patients with oedematous sodium retaining conditions, such as cirrhosis of the liver, congestive heart failure, renal function impairment, and toxaemia of pregnancy, since sodium thiosulfate may also exacerbate these conditions.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available. Also 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 thiosulfate 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.
 It is not known whether sodium thiosulfate is distributed into breast milk. Concerns about adverse effects on the breastfed infant may have little relevance in the context of life threatening cyanide poisoning in the mother.

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 a part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Sodium thiosulfate has low toxicity, and adverse reactions at the recommended doses are usually mild.

Cardiovascular system.

Hypotension.

Central nervous system.

Headache, disorientation, psychotic behaviour, including agitation, delusions and hallucinations may result from excess thiocyanate production.

Gastrointestinal system.

Diarrhoea (usually from oral doses), osmotic disturbances. Nausea and vomiting may result from excess thiocyanate production.

Genitourinary system.

Diuretic effects are possible.

Musculoskeletal system.

Arthralgia, hyperreflexia and muscle cramps may result from excess thiocyanate production.

Ocular system.

Blurred vision may result from excess thiocyanate production.

Ototoxicity.

Tinnitus may occur from excess thiocyanate production.

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 thiosulfate during treatment of cyanide poisoning results in thiocyanate toxicity. Symptoms of thiocyanate toxicity may be seen at serum thiocyanate concentrations above 10 mg/100 mL (1.72 mmol/L). Thiocyanate toxicity becomes life threatening at serum concentrations of 20 mg/100 mL (3.44 mmol/L). The symptoms of thiocyanate toxicity include arthralgias, blurred vision, hyperreflexia, muscle cramps, nausea and vomiting, psychotic behaviour and tinnitus.

Treatment.

Treatment of overdose involves the following measures:
enhancing thiocyanate elimination using haemodialysis;
supportive treatment as required.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Sodium thiosulfate is an antidote for cyanide poisoning. Cyanide poisoning can be rapidly fatal. When hydrogen cyanide gas is inhaled or large doses of cyanide are taken, toxicity occurs within a few seconds, and death occurs within minutes. The potentially lethal dose of potassium or sodium cyanide is 200 to 300 mg and of hydrocyanic acid is 50 mg. 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 thiosulfate is generally used in conjunction with sodium 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. Sodium thiosulfate acts as a sulfur donor for rhodanese. The lack of a suitable sulfur donor is the rate limiting step for this reaction, and thus provision of sulfur by sodium thiosulfate administration enhances the endogenous cyanide detoxification capacity of the body.

5.2 Pharmacokinetic Properties

Sodium thiosulfate is poorly absorbed orally, but is rapidly distributed throughout extracellular fluid after IV administration. The volume of distribution of sodium thiosulfate is 150 mL/kg. Sodium thiosulfate is excreted in the urine, with a clearance half life of 0.25 to 3 hours being reported when a single bolus dose of 1 g of sodium thiosulfate is given.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Boric acid, potassium chloride, sodium hydroxide, water for injections.
Each mL also contains 2.8 mg boric acid, 4.4 mg of potassium chloride, and water for injections. The pH of the solution is adjusted with boric acid and/or sodium hydroxide.

6.2 Incompatibilities

Chemical incompatibility has been reported between sodium thiosulfate and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between sodium thiosulfate and sodium nitrite, when administered sequentially through the same IV line as described in Section 4.2 Dose and Method of Administration.

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 direct light. Do not freeze.

6.5 Nature and Contents of Container

1 x 50 mL glass vial.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The molecular formula of sodium thiosulfate pentahydrate is Na2S2O3.5H2O. It has a molecular weight of 248.2.

CAS number.

10102-17-7.

Chemical structure.


7 Medicine Schedule (Poisons Standard)

Not scheduled. Not considered by committee.

Summary Table of Changes