1. Name Of The Medicinal Product
Naseptin Nasal Cream
2. Qualitative And Quantitative Composition
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Excipients: Contains 8% w/w (80mg/g) cetostearyl alcohol
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
A smooth white cream with a fatty odour.
4. Clinical Particulars
4.1 Therapeutic Indications
Eradication of nasal infection with, and carriage of, Staphylococci.
4.2 Posology And Method Of Administration
For nasal application only.
A small amount of Naseptin is placed on the little finger and applied to the inside of each nostril.
For prophylaxis: Naseptin is applied as above, twice daily, to prevent patients from becoming carriers and to inhibit the dispersion of Staphylococci.
For eradication of infection: Naseptin is applied four times daily for 10 days to eliminate organisms from the nares.
Children and elderly patients: There are no special dosage recommendations for either children or elderly patients.
4.3 Contraindications
Patients who have previously shown a hypersensitivity reaction to neomycin or chlorhexidine, although such reactions are extremely rare.
4.4 Special Warnings And Precautions For Use
For nasal application only. Keep out of the eyes and ears.
Naseptin contains Arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Naseptin.
Irritative skin reactions can occasionally occur. Prolonged use of neomycin can lead to skin sensitisation, ototoxicity and nephrotoxicity.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Chlorhexidine and neomycin cannot be detected in the blood following application of Naseptin and its use is unlikely to have any effect on the foetus or on breast feeding.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Irritative skin reactions can occasionally occur.
Topical application of neomycin preparations can lead to skin sensitisation in a small number of patients. Prolonged use of neomycin can lead to ototoxicity and nephrotoxicity. Therefore, use with caution in children, elderly patients and patients with impaired hearing.
Anaphylaxis to chlorhexidine has been reported rarely.
4.9 Overdose
Accidental ingestion of the contents of a Naseptin tube is unlikely to have any adverse effects on the patient.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is inactive against bacterial spores except at elevated temperatures.
Neomycin is a rapidly bactericidal aminoglycoside antibiotic effective against Gram positive organisms including staphylococci and a wide range of Gram negative organisms. Strains of Pseudomonas aeruginosa are resistant to neomycin, as are fungi and viruses.
5.2 Pharmacokinetic Properties
Because of its cationic nature, chlorhexidine binds strongly to the skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found in man following oral use and percutaneous absorption, if it occurs at all, is insignificant.
Neomycin is either not absorbed or is absorbed only minimally through intact skin. Any neomycin which is absorbed will be rapidly excreted by the kidneys in an unchanged state.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Arachis oil, cetostearyl alcohol, cetostearyl alcohol/ethylene oxide condensate, purified water.
6.2 Incompatibilities
Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with preparations containing chlorhexidine.
Chlorhexidine is incompatible with soap and other anionic agents.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store below 30°C.
6.5 Nature And Contents Of Container
Collapsible, internally lacquered aluminium tubes of 15g with white food-grade polypropylene screw caps.
6.6 Special Precautions For Disposal And Other Handling
For nasal application only.
Administrative Data
7. Marketing Authorisation Holder
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
8. Marketing Authorisation Number(S)
PL16853/0024
9. Date Of First Authorisation/Renewal Of The Authorisation
August 1999
10. Date Of Revision Of The Text
30th June 2010
Legal Status
POM
Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks of Alliance Pharmaceuticals Ltd.
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