PETHIDINE Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Pethidine 50 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 50mg pethidine hydrochloride. Excipients with known effect: Each tablet also contains lactose (66.70 mg) and sucrose (4.30mg). For the full list of excipients, see section 6.1.
Pharmaceutical form
White or almost white tablet for oral use, with a score line on one side and an imprint of M50 on the reverse side. The score line is only to facilitate breaking for ease of swallowing and not to divide ...
Therapeutic indications
Obstetric analgesia. Moderate to severe pain. Premedication and analgesia during anaesthesia.
Posology and method of administration
Posology Adults The normal single dose, usually not to be repeated more often than four hourly, is as follows: Orally: 50-150 mg. Elderly and debilitated patients The initial dose should not exceed 50 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Not to be given to comatose patients or to patients with respiratory depression, obstructive airways disease ...
Special warnings and precautions for use
Pethidine should only be given with caution, and in reduced dosage, to neonates and premature infants, elderly or debilitated patients, hypotension, decreased respiratory reserve, biliary tract disorders, ...
Interaction with other medicinal products and other forms of interaction
Alcohol: Enhanced sedative and hypotensive effects. Antidepressants, SSRI and Tricyclic: The use of pethidine should be avoided in patients receiving monoamine oxidase inhibitors (including moclobemide), ...
Fertility, pregnancy and lactation
Pregnancy There is inadequate evidence of safety of pethidine in human pregnancy, but the drug has been widely used for many years without apparent ill-consequence, and animal studies have not shown any ...
Effects on ability to drive and use machines
Pethidine may modify the patients reactions to a varying extent, depending on dosage, administration and individual susceptibility. If affected or if you are in any doubt that you may be affected do not ...
Undesirable effects
The table below presents adverse drug reactions by System Organ Class. Within each System Organ Class, the adverse drug reactions are presented by incidence, using the following convention: Not known (cannot ...
Overdose
Symptoms In acute overdose the signs may be incoordination, tremors and convulsions followed by respiratory depression and coma. Management Gastric lavage should be performed soon after ingestion, and ...
Pharmacodynamic properties
Pharmacotherapeutic group: Phenylpiperidine derivatives ATC code: N02AB02 Pethidine binds to opioid receptors and exerts its chief pharmacological action on the CNS and the neural elements of the bowel. ...
Pharmacokinetic properties
Peak plasma concentrations are normally observed between 1 and 2 hours after oral administration. However, only about 50% of the drug escapes first pass metabolism to enter the circulation. About 60% is ...
Preclinical safety data
None stated.
List of excipients
Starch Lactose Sucrose Talc Magnesium stearate Acacia
Incompatibilities
Not applicable.
Shelf life
2 years (24 months).
Special precautions for storage
Store in the original packaging. Do not store above 25°C.
Nature and contents of container
A blister strip of 10 tablets, 5 strips per pack. Pack size of 50 tablets.
Special precautions for disposal and other handling
No special requirement.
Marketing authorization holder
Martindale Pharma, Bampton Road, Romford, RM3 8UG, England
Marketing authorization number(s)
PL 00156/0031
Date of first authorization / renewal of the authorization
Date of first authorisation: 07/08/2008
Date of revision of the text
20/05/2019
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