Consumer medicine information

HYDROXO-B12 Injection

Hydroxocobalamin

BRAND INFORMATION

Brand name

Hydroxo-B12

Active ingredient

Hydroxocobalamin

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using HYDROXO-B12 Injection.

SUMMARY CMI

HYDROXO-B12 Injection

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Hydroxo-B12 Injection?

Hydroxo-B12 contains the active ingredient Hydroxocobalamin chloride which is a form of vitamin B12. Hydroxo-B12 is used for the prevention and treatment of anemia's associated with vitamin B12 deficiency. It is also used to treat diseases of nerves in the eyes.

For more information, see Section 1. Why am I using Hydroxo-B12? in the full CMI.

2. What should I know before I use Hydroxo-B12?

Do not use if you have ever had an allergic reaction to Hydroxo-B12 or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

If you are about to have any blood tests, tell your doctor that you are being given this medicine.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent any unwanted side effects.

For more information, see Section 2. What should I know before I use Hydroxo-B12? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Hydroxo-B12 and affect how it works. Tell your doctor or pharmacist if you are using any other medicines, including any that you buy without a prescription for your pharmacy, supermarket or health food shop.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Hydroxo-B12?

  • Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.
  • Hydroxo-B12 Injection is given as an injection into a muscle. It must be only given by a nurse or doctor.

More instructions can be found in Section 4. How do I use Hydroxo-B12? in the full CMI.

5. What should I know while using Hydroxo-B12?

Things you should do
  • Remind any doctor or pharmacist that you visit that you are using Hydroxo-B12.
  • If you are going to have surgery, tell the surgeon or anesthetist that you are being given Hydroxo-B12 as it may affect other medicines used during surgery.
Looking after your medicine
  • Hydroxo-B12 Injection must be kept in a cool, dry place where the temperature stays below 25°C
  • If you need to store Hyrdroxo-B12 Injection, keep it in the original pack until it is time for it to be given.

For more information, see Section 5. What should I know while using Hydroxo-B12? in the full CMI.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being treated with Hydroxo-B12 Injection. This medicine helps most people with vitamin B12 deficiency, but it may have unwanted side effects in a few people. Tell your doctor or pharmacist if you notice any of the following and they are worrying you: diarrhoea, nausea, headache, vomiting, dizziness, acne, skin rash, pain or redness at the injection site. If any of the following happen, tell your doctor immediately or go to the Accident and Emergency Department at your nearest hospital: Signs of allergic reaction, which 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, breathlessness, changes to heart rate, chest tightness or pain.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

HYDROXO-B12 Injection

Active ingredient(s): [Hydroxocobalamin chloride] (hye-drox-oh-koe-BAL-a-min)


Consumer Medicine Information (CMI)

This leaflet provides important information about using Hydroxo B-12. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Hydroxo-B12.

Where to find information in this leaflet:

1. Why am I using Hydroxo-B12?
2. What should I know before I use Hydroxo-B12?
3. What if I am taking other medicines?
4. How do I use Hydroxo-B12?
5. What should I know while using Hydroxo-B12?
6. Are there any side effects?
7. Product details

1. Why am I using Hydroxo-B12

Hydroxo-B12 contains the active ingredient Hydroxocobalamin chloride which is a form of vitamin B12.

Hydroxo-B12 is used for the prevention and treatment of anaemias associated with vitamin B12 deficiency. It is also used to treat diseases of nerves in the eyes.

2. What should I know before I use Hydroxo-B12?

Warnings

Do not use Hydroxo-B12 if:

  • you are allergic to Hydroxocobalamin, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • Do not use Hydroxo-B12 if you have an allergy to cobalt

Check with your doctor if you:

  • have any other medical conditions such as, a disease of the spinal cord, folate-deficiency megaloblastic anaemia (a type of anaemia caused by the deficiency of another vitamin called folic acid).
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

Medicines that may reduce the effect of Hydroxo-B12 include:

  • Chloramphenicol, a medicine used to treat infections
  • The contraceptive pill (birth control pill)
  • Folic acid

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Hydroxo-B12.

4. How do I use Hydroxo-B12?

How much to take / use

  • Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

If you use too much Hydroxo-B12

As Hydroxo-B12 Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However if you experience severe side effects,

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Hydroxo-B12?

Things you should do

If you are to be started on any new medicine, remind your doctor and pharmacist that you are being given Hydroxo-B12 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 or anesthetist that you are being given this medicine.

It may affect other medicines used during the surgery.

Looking after your medicine

  • Hydroxo-B12 Injection is usually stored in the doctor's surgery or clinic, or at the pharmacy. The injection is kept in a cool, dry place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

If you need to store Hydroxy-B12 Injection, keep it in the original pack until it is time for it to be given.

Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days, or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • Diarrhoea
  • Nausea
  • Headache
  • Vomiting
  • Dizziness
  • Acne
  • Skin rash
  • Pain or redness at the injection site. This side effect is usually mild
  • Loss of pigmentation of the skin
  • Bowel motions may have a reddish colour
  • Urine may take on a pink or reddish tinge
  • Feeling tired, lacking energy
  • Sensation of feeling hot and cold
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Allergic Reactions
  • Shortness of breath
  • Wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body.
  • Skin rash
  • Itching or hives
  • Chest pain or chest discomfort
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Hydroxo-B12 contains

Active ingredient
(main ingredient)
Hydroxocobalamin as Hydroxocobalamin chloride
Other ingredients
(inactive ingredients)
Sodium Chloride
Water for Injections

Do not take this medicine if you are allergic to any of these ingredients.

What Hydroxo-B12 looks like

Hydroxo-B12 Injection is a clear dark red solution in a glass ampoule, it is available in packs of 3 ampoules.

Who distributes Hydroxo-B12

Aspen Pharmacare Australia Pty Limited
34-36 Chandos Street
St Leonards 2065
NSW Australia

Australian Registration Number:
AUST R 161606

This leaflet was prepared in November 2022.

Published by MIMS January 2023

BRAND INFORMATION

Brand name

Hydroxo-B12

Active ingredient

Hydroxocobalamin

Schedule

Unscheduled

 

1 Name of Medicine

Hydroxocobalamin chloride (vitamin B12).

2 Qualitative and Quantitative Composition

Hydroxocobalamin is a dark red, odourless crystalline powder or crystals. It is soluble in water and alcohol, sparingly soluble in methyl alcohol and practically insoluble in acetone, chloroform and ether.
Hydroxocobalamin (as chloride) and hydroxocobalamin chloride 1.027 mg/mL equivalent to 1.0 mg/mL hydroxocobalamin.
Hydroxo-B12 also contains sodium chloride 9.0 mg and hydrochloric acid for pH adjustment and water for injections. The pH of the solution is approximately 4.6.

3 Pharmaceutical Form

Solution for injection in ampoules, 1 mg/mL (1000 microgram/mL) (clear dark red solution) in a pack of 3 ampoules.

4 Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis and treatment of pernicious (Addisonian) anaemia and other macrocytic anaemias associated with vitamin B12 deficiency. Treatment of optic neuropathies such as tobacco amblyopia and Leber's optic atrophy.

4.2 Dose and Method of Administration

This product contains no antimicrobial agent. It is for single use in one patient only. Discard any residue. Hydroxo-B12 injection is to be administered intramuscularly.
The following dosage schemes are suitable for adults and children.

Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement.

Initially.

250 to 1,000 micrograms intramuscularly on alternate days for one to two weeks, then 250 micrograms weekly until the blood count is normal.

Maintenance.

1,000 micrograms every two or three months.

Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement.

Initially.

1,000 micrograms on alternate days for one to two weeks.

Maintenance.

1,000 micrograms every two months.

Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes and nutritional deficiencies.

1,000 micrograms every two or three months.

Tobacco amblyopia and Leber's optic atrophy.

Initially.

1,000 microgram daily by intramuscular injection for two weeks then twice weekly for four weeks.

Maintenance.

1,000 microgram monthly.

4.3 Contraindications

Known sensitivity to hydroxocobalamin or any other ingredient in Hydroxo-B12. Known sensitivity to cobalt. Hydroxocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).

4.4 Special Warnings and Precautions for Use

Do not use intravenously. A sensitivity history should be obtained from the patient prior to administration of vitamin B12. An intradermal test dose is recommended before vitamin B12 is administered to patients who may be sensitive to cobalamins.
Hypokalaemia and cardiac arrest have been reported when megaloblastic anaemia is treated intensively.
Serum potassium is to be carefully monitored during the initial phase of treatment in pernicious anaemia.
Diagnosis of vitamin B12 deficiency should be confirmed by laboratory investigation before institution of hydroxocobalamin (vitamin B12) therapy.
Do not use hydroxocobalamin until diagnosis is fully established, as it may mask symptoms of subacute degeneration of the spinal cord, or of the true diagnosis of pernicious anaemia. Folic acid may potentiate the neurological complications of vitamin B12 deficiency, so it should not be administered to patients with pernicious anaemia (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Regular blood tests to determine vitamin B12 levels are advisable during treatment. Administration of hydroxocobalamin doses in excess of 10 microgram daily may improve folate deficient megaloblastic anaemia and obscure the true diagnosis.
The platelet count should be monitored during the first weeks of treatment of megaloblastic anaemia because of the possibility of reactive thrombocytosis. Longterm parenteral administration can increase the risk of aluminium toxicity in patients with renal impairment and in preterm infants.
The therapeutic response to hydroxocobalamin may be impaired by concurrent infection, uraemia, folic acid or iron deficiency, or by drugs with bone marrow suppressing effects, such as chloramphenicol (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Treatment with hydroxocobalamin may unmask polycythaemia vera, because vitamin B12 deficiency may suppress the symptoms of this condition.
The administration of hydroxocobalamin may impart a pink, red/reddish colour to blood, urine, body fluids and discoloured faeces.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Most antibiotics, methotrexate and pyrimethamine invalidate folic acid and vitamin B12 microbiological blood assays.
The administration of hydroxocobalamin may affect blood homocysteine levels.
The administration of hydroxocobalamin may affect various clinical chemistry laboratory tests due to its characteristic of absorbing light. The chief laboratory tests that may be affected by the administration of hydroxocobalamin are those that involve the use of colorimetric methods or that require the use of nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP).
An artifactual increase has been observed in the levels of creatinine, bilirubin, triglycerides, cholesterol, total proteins, glucose, albumin and alkaline phosphatase and a decrease in alanine aminotransferase (ALT) and amylase. Unpredictable results have been observed in the levels of phosphatase, uric acid, aspartate aminotransferase (AST), creatine phosphokinase (CPK), creatine phosphokinase isoenzymes (CK-MB) and lactate dehydrogenase (LDH). The effects on the various laboratory tests are summarised in Table 1.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent administration of chloramphenicol and hydroxocobalamin may impair the therapeutic response to hydroxocobalamin in vitamin B12 deficient patients. The haematological response should be carefully monitored in patients receiving both these drugs. Serum concentrations of hydroxocobalamin may be lowered by oral contraceptives. Vitamin B12 concentrations in the blood may be reduced following administration of large and continuous doses of folic acid. Folic acid administration may impair the therapeutic response to hydroxocobalamin.
Hydroxocobalamin may antagonise the toxic effects of cyanide poisoning.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Problems in humans have not been documented with intake of normal daily amounts. Vitamin B12 crosses the placental barrier. There are no studies establishing the safety of this drug during pregnancy. It is not recommended for pregnancy unless the expected benefits outweigh any potential risk to the infant. Megaloblastic anaemia occurring during pregnancy is usually due to folic acid deficiency rather than vitamin B12 deficiency.
Hydroxocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy caused by folic acid deficiency.
Hydroxocobalamin is distributed into breast milk. Therefore it is not recommended for breastfeeding mothers unless the expected benefits to the mother outweigh any potential risk to the 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)

Sensitisation to hydroxocobalamin is rare, but may manifest itself as itching exanthema and rarely, anaphylaxis. Antibodies to hydroxocobalamin transcobalamin II complex may develop during hydroxocobalamin therapy.
Typical adverse events include transitory hypertension, hypokalaemia at the start of the treatment and loss of pigmentation of the skin and mucosa All these skin reactions tend typically to regress after 1 or 2 days.
Other reported adverse effects include diarrhoea, faeces may have a reddish colour, urine may take on a pink or reddish tinge, nausea, vomiting, headache, dizziness, peripheral vascular thrombosis, chest pain/ discomfort, cardiac arrest, injection site reactions, allergic reactions, generalised itching, redding of the skin, bronchospasm, dyspnoea, sensation of heat and cold, malaise, urticaria or a feeling of swelling of the whole body, angioedema, oropharyngeal oedema, cardiocirculatory collapse, eczematous skin lesions, acne and folliculitis. Exceptionally anaphylactic shock has been reported.
Pulmonary oedema and congestive heart failure have been reported during early vitamin B12 treatment, possibly as a result of an increase in blood volume induced by the drug.
Polycythaemia vera may occur (see Section 4.4 Special Warnings and Precautions for Use).
Arrhythmias secondary to hypokalaemia have appeared at the beginning of parenteral treatment with hydroxocobalamin.

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

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Several chemically related forms of vitamin B12, differing in slight modification of a side chain attached to the cobalamin nucleus have been isolated. Two such variants of vitamin B12 are cyanocobalamin and hydroxocobalamin. Vitamin B12 is essential for normal growth, haemopoiesis, production of all epithelial cells and maintenance of myelin throughout the nervous system. Whenever nucleic acid synthesis occurs and therefore whenever cell reproduction occurs, vitamin B12 is required.
The amounts of vitamin B12 needed to maintain normal blood forming functions are small and low doses are sufficient to correct the usual symptoms of vitamin B12 deficiency. Vitamin B12 acts as an enzyme or coenzyme in a number of metabolic processes and is transformed in the body to at least two compounds which possess enzymatic properties.
i) Coenzyme B12 is required for conversion of propionate to succinate, thus involving vitamin B12 in both fat and carbohydrate metabolism.
ii) Methylcobalamin acts in a transmethylation process converting homocysteine to methionine, thus involving vitamin B12 in fat and protein metabolism. In some cases of vitamin B deficiency, severe neurological symptoms develop, as vitamin B12 is necessary for the formation of protein structures required for the integrity of the nerve cell and myelin sheath.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Hydroxocobalamin produces higher and more prolonged serum levels of vitamin B12 than cyanocobalamin when given by intramuscular injection in the same dosage. Hydroxocobalamin disperses more slowly from the site of injection than cyanocobalamin, is more strongly bound to plasma proteins and accumulates in the liver to a greater extent. Hydroxocobalamin is excreted in the bile and urine, but more slowly than cyanocobalamin. Hydroxocobalamin combines with cyanide and thus acts as a cyanide antagonist in vivo resulting in the formation of cyanocobalamin.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

2 years.

6.4 Special Precautions for Storage

Store below 25°C.
Protect from light.

6.5 Nature and Contents of Container

Coloured glass ampoule.
Pack size 3.

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

Molecular formula: C62H90ClCoN13O15P.
Molecular weight is 1,383 g/mol.

Chemical structure.


CAS number.

58288-50-9.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes