Codeine Phosphate (Douglas)

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Codeine phosphate hemihydrate 60mg;  

Tillgänglig från:

Douglas Pharmaceuticals Limited

INN (International namn):

Codeine phosphate hemihydrate 60 mg

Dos:

60 mg

Läkemedelsform:

Tablet

Sammansättning:

Active: Codeine phosphate hemihydrate 60mg   Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Opadry white Y-1R-7000B Povidone Purified water   Sodium starch glycolate

Enheter i paketet:

Bottle, glass, 100, 100 tablets

Klass:

Class C2 Controlled Drug

Receptbelagda typ:

Class C2 Controlled Drug

Tillverkad av:

Tasmanian Alkaloids Pty Ltd

Produktsammanfattning:

Package - Contents - Shelf Life: Bottle, glass, 100 - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Tillstånd datum:

1993-11-24

Produktens egenskaper

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 14
1.
PRODUCT
NAME
Codeine Phosphate Tablets (Noumed) 15 mg, 30 mg & 60 mg tablets
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Name and strength of the active substance
Codeine Phosphate Hemihydrate BP 15 mg
Codeine Phosphate Hemihydrate BP 30 mg
Codeine Phosphate Hemihydrate BP 60 mg
Codeine phosphate hemihydrate is obtained from opium or made by
methylating
morphine. It occurs as odourless colourless crystals or white
crystalline powder.
The molecular formula of codeine phosphate is C
18
H
21
NO
3
,H
3
PO
4
.½H
2
O and the
molecular weight 406.4.
Excipient(s) with known effect
Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral – tablet, uncoated
Presentation
Codeine Phosphate Tablets (Noumed) are white to cream, biconvex
circular tablets.
4.
CLINICAL
PARTICULARS
4.1
Therapeutic indications
Codeine phosphate is indicated for:
•
the relief of mild to moderate pain (including pain associated with
terminal
illness, post-operative pain, headache),
•
the relief of symptoms of diarrhoea (except diarrhoea caused by
poisoning).
4.2
Dose and method of administration
_Adults _
Codeine phosphate may be given orally in doses of 15 mg – 60 mg
every 4 – 6 hours
as needed.
If these doses fail to relieve pain, larger doses rarely succeed and
may give rise to
restlessness and excitement.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 14
The maximum daily dose in adults should not exceed 300 mg.
_Paediatric _
Do not use in children aged less than 12 years (see sections 4.3 and
4.4).
The usual paediatric dose is 0.5 mg per kg of body weight, every 4 to
6 hours as needed.
The total dose should not exceed 240 mg in 24 hours. The duration of
treatment should
not normally exceed 3 days.
4.3
Contraindications
Codeine phosphate is contraindicated in:
•
Known hypersensitivity to codeine, other opioids, or any component of
the tablets
•
Acute respiratory depression, especially in the presence of cyanosis
a