Consumer medicine information

Cystagon 50 mg Capsules

Mercaptamine (cysteamine)

BRAND INFORMATION

Brand name

Cystagon

Active ingredient

Mercaptamine (cysteamine)

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cystagon 50 mg Capsules.

1. Why am I taking CYSTAGON?


CYSTAGON contains the active ingredient mercaptamine (cysteamine) bitartrate. CYSTAGON is used to manage nephropathic cystinosis, in children and adults.
For more information, see Section 1. Why am I taking CYSTAGON? in the full CMI.

2. What should I know before I take CYSTAGON?


Do not take if you have ever had an allergic reaction to mercaptamine, penicillamine, 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.
For more information, see Section 2. What should I know before I take CYSTAGON? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with CYSTAGON and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take CYSTAGON?

  • The dose of CYSTAGON is based on your weight.

More instructions can be found in Section 4. How do I take CYSTAGON? in the full CMI.

5. What should I know while taking CYSTAGON?

Things you or your child should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking CYSTAGON.
  • Take adequate precautions when using this medicine in children, especially those at risk of the medicine entering their airways or lungs.
  • Keep all of your doctor's appointments so that your progress can be checked.
  • Follow your doctor's advice about tests that are needed to find out if any unwanted serious side effects are occurring. The tests are very important because serious side effects can occur.
Things you should not do
  • Do not take CYSTAGON to treat any other complaints unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not stop taking your medicine or change the dosage without checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how CYSTAGON affects you.
  • This medicine may cause drowsiness or tiredness in some people.
Looking after your medicine
  • Store below 25°C in a cool dry place away from moisture, heat or sunlight.
  • Keep your capsules in the bottle until it is time to take them.
  • Keep CYSTAGON where young children cannot reach it.

For more information, see Section 5. What should I know while taking CYSTAGON? in the full CMI.

6. Are there any side effects?


Less serious side effects include nausea, vomiting, loss of appetite, diarrhoea, drowsiness, rash, unpleasant breath odour, fever or feel tired or fatigued.
Serious side effects include stomach pain, loss of appetite, throwing up blood, seizures, depression, excessive sleepiness, low white blood cell count, abnormal liver function headache, dizziness, double vision, blurry vision, loss of vision, pain behind the eye or pain with eye movement, skin lesions, bone lesions or joint problems.
Please note this is not a complete list of possible side effects.
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.

BRAND INFORMATION

Brand name

Cystagon

Active ingredient

Mercaptamine (cysteamine)

Schedule

S4

 

1 Name of Medicine

Mercaptamine (cysteamine) bitartrate.

2 Qualitative and Quantitative Composition

Each Cystagon capsule contains either 50 mg or 150 mg of mercaptamine free base as mercaptamine bitartrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cystagon capsules for oral administration, contain mercaptamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis, an inherited defect of lysosomal transport.
Cystagon 50 mg are white, opaque capsules printed with CYSTA 50 on the body and MYLAN on the cap.
Cystagon 150 mg are white, opaque capsules printed with CYSTAGON 150 on the body and MYLAN on the cap.

4 Clinical Particulars

4.9 Overdose

Overdoses of up to 250 mg/kg have been reported. Symptoms of overdose include vomiting, dehydration, progressive lethargy and cardiac arrest. There is no specific antidote. Respiratory and cardiovascular support may be required.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Mercaptamine showed no evidence of mutagenic potential in assays for gene mutations (bacteria). In assays of chromosomal damage and interactions with DNA, mercaptamine was clastogenic (rat liver cells and human lymphocytes in vitro) and caused sister chromatid exchanges in vitro (Chinese hamster cells but not human lymphocytes).
Mercaptamine was negative in a mouse micronucleus test.
Carcinogenicity. Mercaptamine has not been tested for carcinogenic potential in long-term animal studies.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Cystagon is the bitartrate salt of mercaptamine, an aminothiol, beta-mercaptoethylamine. Mercaptamine bitartrate is a highly water soluble white powder.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMERBIT.gif Chemical name: Ethanethiol, 2-amino, [R-(R*, R*)]2,3- dihydroxybutanedioate (1:1) (salt) (9CI).
Molecular formula: C2H7NS.C4H6O6.
Molecular weight: 227.
CAS number. 27761-19-9.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CYSTAGST.gif