Active substance(s): CETRIMIDE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide 0.5% w/w
Cetavlex is an antiseptic cream for skin disorders such as minor wounds,
minor burns and abrasions and napkin rash.
Posology and Method of Administration
Apply liberally to the affected area. In some cases it may be necessary to
cover the wound or bum with a clean dressing.
Cetavlex is contra-indicated for patients who have previously shown a
hypersensitivity reaction to cetrimide preparations.
Special warnings and precautions for use
If no improvement or there is aggravation, use should be discontinued and a
For topical application only. Keep out of the eyes and ears.
Interaction with other medicinal products and other forms of interaction
See section 6.2.
Pregnancy and Lactation
No special precautions are necessary.
Effects on Ability to Drive and Use Machines
It is unlikely that Cetavlex cream would effect the ability to drive or operate
Side effects include allergic reactions and local irritation.
The toxicity of Cetavlex arises from the cetrimide content. It seems unlikely
that systemic toxicity will occur from accidental ingestion of the cream.
However, in the event of large quantities being swallowed, carry out gastric
lavage with milk, raw egg, gelatin or mild soap. Do not induce vomiting.
Central paralysis cannot be countered by curare antagonists or CNS stimulants
but sympathomimetic drugs have been given.
Mechanically assisted ventilation with oxygen may be necessary. Persistent
convulsions may be controlled with cautious doses of diazepam or a shortacting barbiturate. Do not give alcohol in any form.
Studies with cetrimide have shown it to be active against a wide range of
vegetative bacteria, both Gram positive and Gram negative, including Staph.
aureus the commonest cause of infection in wounds and burns. Certain Gram
negative bacteria, particularly strains of Pseudomonas and Proteus remain the
least susceptible of the pathogenic bacteria to cetrimide, requiring a higher
concentration than other species to produce an effective kill. There are no
general pharmacological studies available on topically administered cetrimide
Cetrimide is strongly cationic in nature, binding strongly to skin and other
tissue, and thus absorption is negligible.
Preclinical Safety Data
Cetrimide is a drug on which extensive clinical experience has been obtained.
All relevant information for the prescriber is provided elsewhere in the
Summary of Product Characteristics.
List of Excipients
Industrial Methylated Spirits
Propyl Parahydroxybenzoate (E216)
Cetrimide is incompatible with soap and other anionic agents.
Special Precautions for Storage
Store below 30 C.
Nature and Contents of Container
Internally lacquered aluminium tubes (50g).
Instructions for Use/Handling
MARKETING AUTHORISATION HOLDER
28 30 Wolverhampton Street
MARKETING AUTHORISATION NUMBERS
DATE OF FIRST AUTHORISATION/RENEWAL OF
30 April 2004
DATE OF REVISION OF THE TEXT