CYSTAGON mercaptamine (cysteamine) (as bitartrate) 150mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mercaptamine (cysteamine) bitartrate, Quantity: 441.72 mg (Equivalent: mercaptamine (cysteamine), Qty 150 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; sodium lauryl sulfate; silicon dioxide; croscarmellose sodium; titanium dioxide; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

500

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the management of nephropathic cystinosis in children and adults.

Product summary:

Visual Identification: white opaque capsule printed with CYSTA 150 on the body and MYLAN on the cap; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1997-08-05

Patient Information leaflet

CYSTAGON
®
_Mercaptamine (cysteamine) (as bitartrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CYSTAGON. 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 taking CYSTAGON
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CYSTAGON IS
USED FOR
CYSTAGON contains a medicine
called mercaptamine (cysteamine)
that is used to manage nephropathic
cystinosis, in children and adults.
Nephropathic cystinosis is a rare
inherited disorder characterised by
the build-up of cystine in organs such
as kidneys.
Cystine build up causes kidney
damage and excretion of excess
amounts of glucose, proteins and
electrolytes.
Cystinosis can be detected by
measuring the amount of cystine in
while blood cells and other body
cells. The results of cystinosis are
slow body growth, weak bones and
progressive kidney failure.
Mercaptamine works by reacting
with cystine so that the cystine level
in cells is decreased.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
CYSTAGON is only available with a
doctor's prescription.
BEFORE YOU TAKE
CYSTAGON
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CYSTAGON IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
mercaptamine, penicillamine
•
any of the ingredients listed at the
end of this leaflet
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
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If i

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CYSTAGON
®
_mercaptamine (cysteamine) (as bitartrate) capsule _
1
NAME OF THE 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
4.1
THERAPEUTIC INDICATIONS
CYSTAGON is indicated for the management of nephropathic cystinosis in
children and adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
The initial dose is 0.2 to 0.3 g/m
2
/day, given in four divided doses, increasing over 4 to 6 weeks to a
maintenance dose of 1.3 g/m
2
/day given in four divided doses for children up to 12 years. The
maintenance
dose of 1.3 g/m
2
/day can be calculated from the following table which is based on
weight and surface area.
WEIGHT IN KG
MG OF MERCAPTAMINE
FREE BASE
EVERY 6 HOURS
0 – 2
100
2.5 – 5
150
5 – 6.5
200
6.5 – 9
250
9 – 10.5
300
10.5 – 14.5
350
14.5 – 19
400
19 – 23
450
> 23
500
Patients over 12 years old and 50 kg body weight should receive 2
g/day in four divided doses. This dose
should be reached after 4 to 6 weeks as stated above.
If the patient cannot tolerate a specific dose, therapy should be
stopped temporarily and restarted at a lower
dose.
Intact capsules should not be administered to children under the age
of approximately 6 years due to the risk
of aspiration. The contents of the capsules may be sprinkled over food
for children of this age.
CYSTAGON
®
– PRODUCT INFORMATION
2
Leukocyte Cystine Concent