Consumer medicine information

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection

Thiamine hydrochloride

BRAND INFORMATION

Brand name

Biological Therapies Thiamine Hydrochloride

Active ingredient

Thiamine hydrochloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection.

What is in this leaflet

This leaflet answers some common questions about Biological Therapies Thiamine Hydrochloride 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 giving you Thiamine Hydrochloride Injection against the benefits they expect it will have for you.

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

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

What Biological Therapies Thiamine Hydrochloride Injection is used for

Thiamine is used for the prevention and treatment of vitamin B1 deficiency.

Thiamine hydrochloride is a form of Vitamin B1.

This medicine works by increasing the amount of thiamine in your body.

Vitamin B1 deficiencies:
Thiamine deficiencies may occur as a result of a diet deficient in B vitamins, malnutrition, or changes to the gastrointestinal tract which slow or prevent the absorption of B vitamins (e.g. abdominal surgery or some diseases of the gastro-intestinal tract).

A specific deficiency of vitamin B1 (thiamine) may cause the disease beriberi and cause the condition Wernicke’s encephalopathy.

Extra vitamin B1 may be needed during pregnancy, with increased carbohydrate intake, increased physical activity, infection and with some diseases relating to the liver.

Your doctor may prescribe this medicine to treat vitamin B1 deficiency, to supplement vitamin B1 missing in your diet or to raise the level of Thiamine in your body.

Your doctor may decide that Thiamine Hydrochloride Injection is the best way for you to take Vitamin B1.

Malnutrition resulting from alcoholism:
Alcoholism can lead to a diet deficient in B vitamins. The normal metabolism of alcohol in your liver also requires B vitamins, especially thiamine.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

This medicine is not addictive.

This medicine is only available from a medical practitioner or from a pharmacy with a prescription from a medical practitioner.

This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you are given Biological Therapies Thiamine Hydrochloride Injection

When you must not be given it:

You must not be given this medicine if you have an allergy to:

  • any medicine containing thiamine
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • Coughing or 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

You must not be given this medicine if you are taking high dose B vitamins This medicine should not be given to you if you have high levels of B vitamins in your body from other sources, such as high dose vitamin supplements.

This medicine must not be given to a child under 2 years. This medicine should not be given to Children under the age of 2 years because it contains benzyl alcohol which may be harmful.

You must not be given this medicine if the solution in the vial is not clear or contains particles.

You must not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are given this medicine after the expiry date has passed, it may not work and it may be harmful to you.

If it is expired or damaged, return it to your pharmacist for disposal.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given this medicine:

Tell your doctor or pharmacist if you have had an allergy to any of the ingredients listed at the end of this leaflet Your doctor may test if you have an allergy to this medicine by injecting a small amount under your skin

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

  • Memory problems

Tell your doctor if you have allergies to any other medicines or any other substances, such as foods, preservatives or dyes

Tell your doctor if you are pregnant or plan to become pregnant. There is an increased need for some B vitamins during pregnancy. It is recommended that you and your doctor discuss your requirements during pregnancy and the possible risks and benefits of having this medicine during pregnancy.

Tell your doctor if you are breastfeeding or are intending to breastfeed. There is an increased need for some B vitamins during breastfeeding. It is recommended that you and your doctor discuss your requirements during breastfeeding and the possible risks and benefits of having this medicine during breastfeeding.

If you have not told your doctor about any of the above, tell them before you are given Thiamine Hydrochloride Injection.

Taking Other Medicines:

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Thiamine Hydrochloride Injection may interfere with each other. These include:

  • Vitamin and Mineral Supplements
  • Medicines used to relax muscles
  • Some antibiotic drugs such as kanamycin sulfate and streptomycin sulfate

These medicines may be affected by Thiamine Hydrochloride Injection, or affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information about medicines to be careful with, or avoid while you are being treated with this medicine.

How Biological Therapies Thiamine Hydrochloride Injection is given

Thiamine Hydrochloride Injection is given as an injection, usually into a large muscle, or it may be given by infusion (slow injection) into a vein in your arm.

This medicine must only be given by a doctor or nurse.

How much is given:

Your doctor will decide how much Thiamine Hydrochloride Injection will need to be given and for how long it will need to be given. This is determined by many factors including your body weight and your medical condition. The usual dose of thiamine hydrochloride is 5mg to 100 mg under normal circumstances or much higher amounts in critically ill patients.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

How long to be treated with it:

Each person will respond differently to Thiamine Hydrochloride Injection.

Treatment times will differ depending on the reason for prescribing this medicine.

Your doctor will tell you know how long you will need to be treated with this medicine.

If you miss an appointment:

If you miss an appointment, talk to your doctor and arrange another appointment as soon as possible.

If you are not sure what to do, contact your doctor or pharmacist as soon as possible.

If too much is given (overdose):

Your doctor or nurse should be the only person to inject Thiamine Hydrochloride Injection, so an overdose is not likely to occur.

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have been given too much Thiamine Hydrochloride Injection. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are being given Biological Therapies Thiamine Hydrochloride Injection

Things you must do:

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with Thiamine Hydrochloride Injection.

Tell any other doctors, dentists and pharmacists who treat you that you are being given this medicine.

If you are going to have surgery, tell the surgeon and anaesthetist that you are being treated with this medicine. It may affect other medicines used during surgery.

If you are about to have any urine or blood tests tell your doctor that you are being treated with this medicine. It may interfere with the results of some tests.

If you become pregnant while being treated with Thiamine Hydrochloride Injection, tell your doctor immediately.

Tell your doctor if you feel that giving Thiamine Hydrochloride Injection is not helping your condition.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do:

Do not attempt to inject this medicine yourself.

Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting a pharmacist.

Do not give your medicine to anyone else, even if they have the same condition as you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given or treated with Thiamine Hydrochloride Injection.

This medicine helps most people with Vitamin B1 deficiency conditions, but it 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 attention if you get some of the side effects.

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

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

Tell your doctor, nurse or pharmacist as soon as possible if you notice any of the following and they worry you:

  • Tenderness or a hard lump around the injection site

The above list includes the more common side effects of this medicine. They are usually mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

  • Allergic reaction such as nausea, sweating, a feeling of warmth, tingling, weakness, tightness of the throat, pain in the chest, fast heart beat, difficulty breathing, faintness

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately, or go to Accident and Emergency Department at your nearest hospital:

  • severe allergic reaction which may include sudden signs of allergy such as rash, itching or hives on the skin, or swelling of the face, lips, tongue, throat or other parts of the body.
  • sneezing
  • severe rash
  • temporary itchiness
  • blue discolouration of the skin
  • bleeding
  • prolonged stomach pain
  • severe dizziness or drowsiness
  • muscular paralysis
  • low blood pressure
  • prolonged nausea or vomiting
  • Restlessness
  • Scaling of the facial skin
  • Inability to focus eyes

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

These side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell, even if it is not on this list. This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects.

You should not experience any of them.

After being given Biological Therapies Thiamine Hydrochloride Injection

Storage

Thiamine Hydrochloride Injection is usually stored in the doctor’s surgery or clinic, or at the pharmacy.

If you need to store Thiamine Hydrochloride Injection keep it in the original pack until it is time for it to be given. If you take the vials out of the pack they may not keep well.

Keep this medicine in a cool dry place, where the temperature stays below 25°C.

Do not store Thiamine Hydrochloride Injection or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

This product is for SINGLE USE in one patient on one occasion only. It will be used once only and then it will be discarded. It must never be stored after it is opened or used for more than one person.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any vials that are left over.

Product Description

What it looks like:

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection is a clear and colourless solution contained in an amber glass vial sealed with a rubber stopper and aluminium seal with polypropylene flip-off insert. It is packed in an outer carton.

This medicine may be available in 4 pack sizes:

1 x 1 mL vials
5 x 1 mL vials.
6 x 1 mL vials.
10 x 1 mL vials.

Ingredients per vial:

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection contains the following ingredients:

Active Ingredient:

Thiamine Hydrochloride 100mg

It also contains:

  • Benzyl alcohol
  • Disodium edetate
  • Water for injections

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

Supplier

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL Injection is supplied and manufactured in Australia by:

Biological Therapies
A Division of Orthomolecular Medisearch Laboratories Pty Ltd.
Suite 5, 20-30 Malcolm Road
Braeside VIC 3195
AUSTRALIA
Tel. +61 3 9587 3948
Fax +61 3 9587 1720
Website:
Email: [email protected]

Australian Registration Number:

AUST R: 218622

This leaflet was amended on 18 July 2019.

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Biological Therapies Thiamine Hydrochloride

Active ingredient

Thiamine hydrochloride

Schedule

Unscheduled

 

1 Name of Medicine

Thiamine hydrochloride.

2 Qualitative and Quantitative Composition

Each 1 mL Injection contains 100 mg of thiamine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection for intravenous or intramuscular use.
The injection is a clear and colourless solution.
The pH of the solution is 2.5 to 3.5.

4 Clinical Particulars

4.1 Therapeutic Indications

Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL injection is used for the prevention and treatment of vitamin B1 deficiency.

4.2 Dose and Method of Administration

Use in one patient on one occasion only and discard any residue.
Biological Therapies Thiamine Hydrochloride 100 mg in 1 mL injection is administered by IM injection or slow IV injection over a period of at least 10 minutes.
Due to the potential for serious anaphylactic reactions, parenteral administration of thiamine is only indicated when oral administration of thiamine is not acceptable or possible. Facilities for treating anaphylaxis should be available when administering thiamine injection.
If the thiamine hydrochloride solution is cloudy or contains visually detectable particles, please contact the Quality Assurance Manager at Biological Therapies.

Thiamine deficiency.

Simple thiamine deficiency is rare and as a result multiple vitamin deficiencies should be suspected either in those patients exhibiting signs consistent with thiamine deficiency, or those considered to be at risk of developing thiamine deficiency. Consideration should be given to administering other water soluble vitamins in conjunction with thiamine.
In critically ill thiamine deficient adults and in patients with malabsorption syndromes, the usual IM or IV dosage of thiamine hydrochloride is 5 to 100 mg three times daily. In patients with beriberi, the dose should then be reduced according to response and followed by oral therapy for one month.
In patients with Wernicke's encephalopathy, thiamine hydrochloride therapy is usually initiated with an IV dose of 100 mg over at least 30 minutes, followed by IM or IV doses of 50-100 mg daily until the patient is consuming a regular, well balanced diet. High carbohydrate diets or IV glucose solutions increase thiamine requirements and may worsen symptoms in thiamine deficient patients. Thiamine should be administered parentally before giving glucose solutions to the patient with Wernicke's encephalopathy.
In alcohol withdrawal syndrome to prevent Wernicke's encephalopathy, 100 mg of thiamine should be given IM or IV followed by 100 mg orally, IM or IV for up to 5 days.

Dietary supplementation.

Dietary improvement is preferred over supplementation wherever possible. The Australian recommended daily intake (RDI) of thiamine for adults is shown in Table 1.

Use in infants and children.

This product contains benzyl alcohol and should not be used in children less than 2 years of age. Critically ill children who are thiamine deficient receive a usual IM or IV dose of thiamine hydrochloride of 10-25 mg daily. The Australian recommended daily intake (RDI) of thiamine for children is shown in Table 2.

Compatibility.

Thiamine Hydrochloride 100 mg in 1 mL Injection is reported to be compatible with 100 mL of diluent; glucose 5%, glucose 10%, sodium chloride 0.9% or compound sodium lactate (Hartmann's solution).

4.3 Contraindications

Known hypersensitivity to any of the ingredients.
Do not use thiamine hydrochloride 100 mg in 1 mL Injection in children less than 2 years of age due to the benzyl alcohol content.

4.4 Special Warnings and Precautions for Use

Serious hypersensitivity reactions to thiamine have been reported following parenteral administration (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions include feelings of warmth, tingling, pruritus, pain, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioedema, respiratory distress, cyanosis, pulmonary oedema, gastrointestinal bleeding, transient vasodilatation and hypotension, vascular collapse, and death.
A sensitivity history should be obtained from the patient prior to administration of thiamine.
An intradermal diluted test dose of thiamine should be administered to patients with suspected sensitivity (e.g. a history of an allergic response such as itching, sneezing, wheezing or frank anaphylactic shock with a previous injection) before parenteral administration.
Simple thiamine deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.
Intravenous glucose loading may precipitate or worsen the condition of Wernicke's encephalopathy in thiamine deficient patients. Thiamine hydrochloride should be administered prior to glucose.

Use in the elderly.

Problems in geriatrics have not been documented with intake of normal daily recommended amounts.
The elderly may have impaired thiamine status, thereby requiring thiamine supplementation.
Information on large doses is not available.

Paediatric use.

Do not use thiamine hydrochloride 100 mg in 1 mL injection in children under 2 years due to the benzyl alcohol content.
Information on large doses in children over 2 years is not available.

Effects on laboratory tests.

Thiamine reportedly causes false-positive results in the urine spot test with Erlich's reagent for urobilinogen and may also interfere with the phosphotungstate method for determination of uric acid concentrations. Large doses of thiamine have reportedly interfered with the Schack and Waxler spectrophotometric determination of serum theophylline concentrations, giving falsely raised results.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although the clinical importance is unknown, thiamine reportedly may enhance the effect of neuromuscular blocking agents.
In vitro thiamine hydrochloride at a concentration of 0.1% significantly reduces the activity of kanamycin sulfate and streptomycin sulfate at 25°C.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is no information available on the effects of thiamine injection on fertility.
Exempt from classification in the Australian categorisation system for prescribing medicines in pregnancy.
There is an increasing demand for thiamine throughout pregnancy due to the increased energy requirement plus the amount needed to meet the foetal requirement. Thiamine is required by the newborn for normal growth and development. Problems in humans have not been documented with intake of normal daily recommended amounts.
There is limited information in humans that large doses in the second or third trimester have no apparent effect.
Embryonic and foetal death have been reported in pregnant women who have severe thiamine deficiency as a result of hyperemesis gravidarum.
 There is an increasing metabolic requirement for thiamine to produce milk, and additional thiamine is also needed to compensate for that lost in the milk and also for the increased maternal energy requirement. About 100-200 microgram of thiamine is distributed daily into the milk of lactating women receiving a normal diet (see Section 5.2 Pharmacokinetic Properties). Problems in humans have not been documented with intake of normal daily recommended amounts.
Information on large doses is not available.

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)

Anaphylactic reactions.

Rare: these reactions can be preceded by sneezing or transient pruritus.
Symptoms and signs of hypersensitivity and other adverse reactions to thiamine may include any one or more of the following: feelings of warmth, tingling, pruritus, pain, urticaria, erythema, scaling of the facial skin, severe rash, weakness, sweating, nausea, vomiting, restlessness, tightness of the throat, angioedema, respiratory distress, cyanosis, pulmonary oedema, dyspnoea, respiratory failure, gastrointestinal bleeding, abdominal pain, precordial pain, palpitations, tachycardia, transient vasodilation and hypotension, shock, vascular collapse, semicomatose state and death have occurred (see Section 4.4 Special Warnings and Precautions for Use).

Metabolic and nutritional disorders.

Very rare: fatty degeneration of the liver resulting in hyaline necrosis and ascites.

Skin and appendages.

Common: pain on injection, local irritation. Tenderness and induration have been reported following IM injection.
Rare: contact dermatitis, chronic pigment purpura.

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

In animals, very large parenteral doses have produced neuromuscular and ganglionic blockade. Parenteral doses of 100 mg to 500 mg, as single or repeated doses have been administered without toxic effects. In cases of overdose, withdraw thiamine and give supportive treatment for symptoms and respiratory and cardiac function.
For information on the management of overdose please contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

In humans, an exogenous source of thiamine (or Vitamin B1) is required for carbohydrate metabolism. Thiamine combines with adenosine triphosphate (ATP) in the liver, kidneys, and leukocytes to form thiamine diphosphate (thiamine pyrophosphate) also known as cocarboxylase. Thiamine diphosphate is a coenzyme in carbohydrate metabolism (in the decarboxylation of pyruvic acid and α-ketoglutaric acids) and in transketolase reactions. Thiamine diphosphate is also a coenzyme in the utilization of pentose in the hexose monophosphate shunt. Even large doses of thiamine have no effect on blood glucose concentrations. Thiamine deficiency leads to decreased transketolase activity in erythrocytes and to increased pyruvic acid concentration in the blood. In the absence of thiamine as thiamine pyrophosphate, pyruvic acid is not converted to acetyl-COA and therefore is unable to enter the usual aerobic oxidative pathway (Krebs citric acid cycle), resulting in accumulation of pyruvic acid and subsequent conversion to lactic acid. In addition, the resultant decreased production of NADH within the Krebs cycle stimulates anaerobic glycolysis and further lactic acid production. Therefore, lactic acidosis may occur in thiamine deficiency. The normal mean level of thiamine in whole blood is 28 microgram/L, and of free thiamine is 6.5 to 11.4 microgram/L.
Thiamine is used in the prevention or treatment of vitamin B1 deficiency syndromes including beriberi, Wernicke's encephalopathy and peripheral neuritis associated with pellagra or neuritis of pregnancy (if associated with severe vomiting). Dietary improvement is preferred over supplementation whenever possible to the administration of vitamin supplements.
Thiamine deficiency results in beriberi and Wernicke's encephalopathy syndrome. Clinical signs of thiamine deficiency become evident after 2-3 weeks of inadequate thiamine intake. The organ systems principally affected by thiamine deficiency are the peripheral nervous system, cardiovascular system and the gastrointestinal tract. Administration of thiamine completely reverses the cardiovascular and gastrointestinal symptoms of thiamine deficiency, however the degree of improvement in neurological symptoms depends on the duration and severity of the lesions. Fatal deficiency can develop as rapidly as within 3-4 weeks in the absence of thiamine intake. Several cases of fatal, acute beriberi developed within 5 weeks in patients receiving thiamine deficient total parenteral nutrition solutions during a US shortage of parenteral multivitamin preparations.
Thiamine supplementation is useful in preventing deficiency in malabsorption syndromes such as alcoholism, cirrhosis and gastrointestinal diseases. Increased thiamine requirements are also associated with pregnancy, increased carbohydrate intake, increased physical activity, hyperthyroidism, infection and hepatic disease. Dietary improvement is preferred over supplementation whenever possible to the administration of vitamin supplements.
Thiamine requirement is directly related to the carbohydrate content of the diet. The minimum daily requirement is estimated to be 0.33 mg/4,200 kJ (1,000 kcal). Vitamin B1 depletion can occur after approximately 3 weeks of total absence of thiamine in the diet. Deficiency may occur in alcoholics and food faddists or in special situations such as haemodialysis or chronic peritoneal dialysis. Requirements may be increased due to burns, chronic fever, gastrectomy, intestinal disease, liver disease and hyperthyroidism. Symptoms of deficiency include mental confusion, anorexia, muscle wasting, oedema and heart failure.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following oral administration of small doses, thiamine hydrochloride is readily absorbed; however absorption is an active process and the total amount absorbed after oral administration of a large dose is limited to about 4-8 mg.
GI absorption of thiamine is decreased in alcoholics and in patients with cirrhosis or malabsorption. The rate, but not the extent, of GI absorption of thiamine is decreased when the drug is administered with meals.
Thiamine is completely and rapidly absorbed after IM and IV administration.
In chronic alcohol mis-users, malnutrition can reduce intestinal thiamine absorption by ~70%, decreasing serum levels from 30 to 98% below the lower level established for normal subjects. Alcohol itself alone can also decrease absorption by 50% in one third of patients who are not malnourished.

Distribution.

Thiamine is widely distributed into body tissues, including the brain, liver, heart, kidneys, muscle, cerebrospinal fluid and blood cells. Thiamine is not stored to any appreciable extent in the body. Body stores of thiamine have been estimated to be about 30 mg with about a 1 mg daily turnover. About 100-200 microgram of thiamine is distributed daily into the milk of nursing women receiving a normal diet.

Metabolism.

Thiamine is metabolised in the liver in animals. Several urinary metabolites of thiamine have been identified in humans.

Excretion.

Little or no unchanged thiamine is excreted in urine following administration of physiologic doses; however, dosages exceeding 30 mg three times daily are not utilised effectively. When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine. As the intake of thiamine is further increased, thiamine appears unchanged in the urine in amounts exceeding 100 microgram/24 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl alcohol, disodium edetate, water for injections.

6.2 Incompatibilities

Thiamine is unstable in neutral or alkaline solutions; therefore, administration with carbonates, citrates, barbiturates, or copper ions is not recommended. In addition, stability is poor in intravenous solutions containing sodium bisulfite as an antioxidant or preservative; if these solutions must be given, they should be given separately from a thiamine hydrochloride injection.
Oxidation of thiamine hydrochloride results in the formation of the highly blue-coloured and biologically inactive compound - thiochrome.

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.
Keep out of reach of children.

6.5 Nature and Contents of Container

Container type.

Amber coloured Type 1 glass vial with a grey chlorobutyl rubber stopper and aluminium seal with red polypropylene flip-off insert packed in an outer carton. Vial stopper is not made with natural rubber latex.

Pack sizes.

Thiamine hydrochloride 100 mg in 1 mL injection has four pack sizes:
1 x 1 mL vial per carton;
5 x 1 mL vials per carton;
6 x 1 mL vials per carton;
10 x 1 mL vials per carton.
AUST R: 218622.

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

Chemical structure.


Molecular formula: C12H17ClN4OS.HCl.

CAS number.

67-03-8.
Thiamine hydrochloride occurs as a white or almost white, crystalline powder or colourless crystals. It is freely soluble in water, soluble in glycerol, slightly soluble in alcohol.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes