PTU propylthiouracil 50mg tablet bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

propylthiouracil, Quantity: 50.75 mg

Commercializzato da:

Phebra Pty Ltd

Forma farmaceutica:

Tablet, uncoated

Composizione:

Excipient Ingredients: povidone; lactose monohydrate; sodium lauryl sulfate; maize starch; magnesium stearate

Via di somministrazione:

Oral

Confezione:

100

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Propylthiouracil is an antithyroid drug indicated for the total treatment of hyperthyroidism or in the treatment of the thyrotoxic patient piror to surgery or radioactive-iodine therapy

Dettagli prodotto:

Visual Identification: White, round, biconvex and uncoated. One side debossed 'PRESTAB' and other side is plain.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

1991-08-28

Foglio illustrativo

PTU
TM
50 mg Tablets
V09
1
PTU
TM 50 MG TABLETS
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 PTU
TM 50 MG TABLETS?
PTU
contains the active ingredient propylthiouracil. PTU is used to treat
an overactive thyroid gland.
For more information, see Section 1. Why am I using PTU
TM
50 mg Tablets? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PTU
TM 50 MG TABLETS?
Do not use if you have ever had an allergic reaction to PTU
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 use
PTU
TM
50 mg Tablets? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PTU 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 USE PTU
TM 50 MG TABLETS?
•
Your doctor will tell you how many tablets to take, and when to take
them each day.
•
Follow all directions given to you by your doctor or pharmacist
carefully.
•
If you do not understand the instructions on the bottle, ask your
doctor or pharmacist for help.
More instructions can be found in Section 4. How do I use PTU
TM
50 mg Tablets? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PTU
TM 50 MG TABLETS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or nurse you visit that you are
using PTU.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking PTU.
•
If you become pregnant while taking PTU, tell your doctor immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take PTU 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

Scheda tecnica

PRODUCT INFORMATION
Australian Product Information - PTU
TM
Page 1 of 8
_ _
Version 12
PTU™ 50 MG TABLETS
(PROPYLTHIOURACIL)
1
NAME OF THE MEDICINE
Propylthiouracil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propylthiouracil is a thioamide derivative which occurs as a white
crystalline powder, odourless with a bitter taste,
very slightly soluble in water, sparingly soluble in ethanol and
soluble in solutions of alkali hydroxides or ammonia.
PTU
TM
50 mg Tablets contain 50 mg of the active ingredient propylthiouracil.
Excipients with known effect: lactose monohydrate. The tablet is
gluten free.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
PTU
TM
50 mg Tablets are white, round, biconvex and uncoated. One side is
debossed 'PRESTAB' and other side
is plain.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Propylthiouracil is an antithyroid drug indicated for the total
treatment of hyperthyroidism or in the treatment of the
thyrotoxic patient prior to surgery or radioactive iodine therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Propylthiouracil is administered orally, usually in 2 to 4 equal doses
at 12 to 6 hourly intervals respectively.
DOSAGE IN ADULTS
The usual initial controlling dose of propylthiouracil is 200-400 mg
daily (range 100-1200 mg) in divided doses
(three doses at eight-hour intervals or four doses at six-hour
intervals) until the patient becomes euthyroid.
NB: Patients with severe hyperthyroidism may require up to 1,200 mg a
day.
Maintenance Dose:
50-800 mg daily in two to four divided doses.
Thyrotoxic Crisis:
Concomitant with the administration of other agents, e.g. iodine,
adrenergic blocking
agents, and general supportive measures, the recommended dose of
propylthiouracil
is 800-1200 mg daily in divided doses administered orally or by
naso-gastric tube.
PRODUCT INFORMATION
PTU
TM
Australian Product Information - PTU
TM
Page 2 of 8
Version 12
_ _
DOSAGE IN CHILDREN
Propylthiouracil use should be avoided in children, except in rare
circumstances in