Pethidine Hydrochloride (Douglas)

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

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Ladda ner Produktens egenskaper (SPC)
06-01-1992

Aktiva substanser:

Pethidine hydrochloride 100mg;  

Tillgänglig från:

Douglas Pharmaceuticals Limited

INN (International namn):

Pethidine hydrochloride 100 mg

Dos:

100 mg

Läkemedelsform:

Tablet

Sammansättning:

Active: Pethidine hydrochloride 100mg   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, 10 tablets

Klass:

Class B3 Controlled Drug

Receptbelagda typ:

Class B3 Controlled Drug

Tillverkad av:

Sanofi-Aventis Deutschland GmbH

Produktsammanfattning:

Package - Contents - Shelf Life: Bottle, glass, - 10 tablets - 60 months from date of manufacture stored at or below 25°C

Tillstånd datum:

1992-01-06

Produktens egenskaper

                                DATA SHEET 
PETHIDINE HYDROCHLORIDE 
Pethidine Hydrochloride 50mg and 100mg Tablets. 
PRESENTATION 
 
PETHIDINE HYDROCHLORIDE 50MG AND 100MG TABLETS are white, circular,
film-coated tablets 
embossed with DP on one side and '50' or '100' respectively on the
other. 
USES 
_ACTIONS _
 
Pethidine is a synthetic narcotic pharmacologically similar to
morphine and may be used 
clinically in place of morphine. It exerts agonist activity at the
opioid receptors located in the 
central and peripheral nervous systems. Its main effects are on the
central nervous system 
resulting in analgesia, sedation, euphoria and respiratory
depression. Pethidine also increases 
smooth muscle tone, causing spasm. Clinically pethidine is used for
the relief of moderate to 
severe pain (including the pain of labour) and in other dosage forms
as a pre-operative 
medication and as an adjunct to anaesthesia. It has little effect on
cough or diarrhoea. 
 
The analgesic effect of pethidine hydrochloride is shorter than
for morphine and usually lasts for 
2 to 4 hours with a rapid onset of action at 15 minutes. Peak effect
is obtained orally within 60 to 
90 minutes. 
 
10mg of morphine is equivalent in analgesic effect to approximately
100mg of pethidine. 
_PHARMACOKINETICS _
 
Pethidine hydrochloride is absorbed from the
gastro-intestinal tract, but availability is less with 
the oral than the parenteral routes. It is highly bound to plasma
proteins. 
 
Pethidine is metabolised in the liver, by hydrolysis to pethidinic
acid or by demethylation to 
norpethidine and hydrolysis to norpethidinic acid followed by
conjugation with glucuronic acid. 
Norpethidine is both active and toxic. The half life of pethidine is
2.4 to 4 hours. 
 
Elimination is renal and negligible unchanged pethidine is excreted
into the urine (5%). 
Acidification of the urine enhances excretion of both pethidine and
norpethidine. In subjects with 
cirrhosis, excretion of pethidine is delayed. 
 
Pethidine 
                                
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