Pethidine (PSM)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pethidine hydrochloride 100mg;  

Available from:

Noumed Pharmaceuticals Limited

INN (International Name):

Pethidine hydrochloride 100 mg

Dosage:

100 mg

Pharmaceutical form:

Tablet

Composition:

Active: Pethidine hydrochloride 100mg   Excipient: Acacia Lactose monohydrate Magnesium stearate Maize starch

Units in package:

Bottle, glass, 10 tablets

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Union Quimico Farmaceutica SA (Uquifa SA)

Therapeutic indications:

For the relief of most types of moderate to severe pain. As it has some antispasmodic activity it may be the analgesic of choice in renal colic, bilary colic and acute pancreatitis.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, - 10 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-30

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 14
1.
PRODUCT NAME (strength pharmaceutical form)
Pethidine, Tablet, 50 mg (NOUMED) Pethidine, Tablet, 100 mg (NOUMED)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Pethidine Hydrochloride 50 mg
Pethidine Hydrochloride 100 mg
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral – tablet
Presentation
Pethidine Hydrochloride 50 mg tablets are: round, white, normal
biconvex tablets, 8.0
mm diameter.
Pethidine Hydrochloride 100 mg Tablets are: round, white, normal
biconvex tablets,
9.5 mm diameter.
_Note: Not all product strengths may be marketed. _
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Pethidine Tablets given orally are indicated for the relief of most
types of moderate to
severe pain. As it has some antispasmodic activity, it may be the
analgesic of choice in
renal colic, biliary colic and acute pancreatitis.
4.2
Dose and method of administration
_Adults: _
For the relief of pain, Pethidine Tablets given in oral doses of 50 to
150 mg by mouth
every 4 hours if necessary.
_Children_:
For the relief of pain, 1.1 to 1.76 mg per kg of body weight, not to
exceed 100 mg
every 3 to 4 hours as needed. (See Section 4.4 Special Warnings and
Precautions for
use).
Opioid agonist analgesics may suppress respiration, especially in the
very young,
NEW ZEALAND DATA SHEET
Page 2 of 14
elderly, very ill or debilitated patients and those with respiratory
problems. Lower
doses may be required for these patients.
Neonates (see also Pharmacology section 5 and Use in Pregnancy section
4.6)
Excretion and metabolism of Pethidine in the neonate is reduced
compared with
adults. Safety has not been established in neonates and due to lack of
data, no dosage
regimen can be recommended.
Geriatric patients
Dose reduction to half normal adult dose is recommended in geriatric
patients (over
70 years).
Liver impairment
Dosage reduction and/or increased dosage intervals are recommended.
Renal impairment
Due t