1. Name Of The Medicinal Product
COLOMYCIN STERILE POWDER
2. Qualitative And Quantitative Composition
Each vial contains 1g equivalent to approximately 19,500,000 units of Colistin Sulphate BP.
3. Pharmaceutical Form
A white to cream coloured powder.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of topical infections caused by sensitive Gram negative organisms.
4.2 Posology And Method Of Administration
For adults, children and the elderly:
Colomycin Sterile Powder is applied topically as a 1% solution, dispersed powder or ointment according to the site of infection, as follows:-
- 1% solution in water or saline for use as eye and ear drops, in wound irrigation, and for application to dressings.
- 1% dispersed powder in lactose or biosorb for application for infected leg ulcers and in other skin infections.
Undiluted powder should NOT be applied topically.
- 1% ointment in simple cream BP, simple cream plus hydrous lanolin (90:10), hydrous ointment BP, macrogel ointment BPC, for use in skin infections.
Colomycin Sterile Powder must not be used for the preparation of injectable solutions.
4.3 Contraindications
The preparation is contra-indicated in patients with known sensitivity to colistin. Colomycin Sterile Powder should not be used for the treatment of otitis externa if the tympanic membrane is perforated.
4.4 Special Warnings And Precautions For Use
Colistin absorption has not been detected following limited topical application. Absorption may, however, increase with prolonged use and absorption may be enhanced if colistin is applied to large areas of broken skin.
Caution should be employed in the use of the preparation in patients with renal failure and in patients receiving curari-form muscle relaxants.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Neurotoxicity has been reported with concomitant use of either curari-form agents or antibiotics with similar neurotoxic effects and systemic administration of colistin.
Therapy need not be discontinued and reduction of dosage may alleviate symptoms.
4.6 Pregnancy And Lactation
Safety in human pregnancy has not been established. Animal studies do not indicate teratogenic properties; however, parenteral single dose studies in human pregnancy show that colomycin crosses the placental barrier and there is a risk of foetal toxicity if repeated doses are given to pregnant patients.
Colomycin is secreted in breast milk and patients to whom the drug is administered should not breast-feed an infant.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
Topical therapy is well tolerated. Transient irritation at the site of application has been reported infrequently. Allergic sensitisation has not been reported.
Systemic side effects have not been reported following topical administration. Following systemic therapy with colistin, adverse effects on renal function have been reported, usually following use of higher than recommended dose in patients with normal renal function, or failure to reduce the dosage in patients with renal impairment or during concomitant use of nephrotoxic antibiotics. The effects are usually reversible on discontinuation of therapy.
Other adverse effects following systemic administration may include transient sensory disturbances such as perioral paraesthesia and vertigo. Neurotoxicity has been reported in association with overdosage, failure to reduce dosage in patients with renal insufficiency and a concomitant use of either curari-form agents or antibiotics with similar neurotoxic effects. Therapy need not be discontinued and reduction of dosage may alleviate symptoms. Permanent nerve damage such as deafness or vestibular damage has not been reported.
4.9 Overdose
No symptoms of overdosage have been reported following topical use of colistin. However, use of the undiluted powder causes stinging and is not recommended. Following systemic administration overdosage can result in renal insufficiency, muscle weakness and apnoea.
There is no specific antidote. Manage by supportive treatment and measures to increase the rate of elimination of colistin, e.g. mannitol diuresis, prolonged haemodialysis or peritoneal dialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Colistin is a polymyxin antibiotic derived from Bacillus polymyxin var. colistinus. It has a bactericidal action on most Gram negative bacilli, including Pseudomonas aeruginosa, and use is largely free from the development or transference of resistance. It is not recommended for Proteus spp.
5.2 Pharmacokinetic Properties
There is almost complete lack of absorption when colistin is applied to intact or denuded skin; it is poorly absorbed from mucus membranes and the surface of large burns.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber that might add to the safety data provided in other sections of this SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
None
6.2 Incompatibilities
None stated.
6.3 Shelf Life
Unopened product as packaged for sale: 60 months.
Colomycin Sterile Powder solutions should be used within 24 hours of preparation, and stored at 2o - 8oC. Ointments or dispersed powders may be stored for up to 1 month at room temp. (25oC), as may preserved solutions.
6.4 Special Precautions For Storage
Unopened product should be stored below 25oC, protected from light.
6.5 Nature And Contents Of Container
Neutral glass vial closed with an aluminium crimp ring. Each vial is individually packed in a cardboard carton.
6.6 Special Precautions For Disposal And Other Handling
Colomycin Sterile Powder should be formulated as a 1% solution, 1% dispersed powder or 1% ointment, according to the site of infection. Suitable formulations include:
- 1% solution prepared by dissolving 1g of powder in 100ml water or saline.
- 1% dispersed powder in lactose or Biosorb.
- a 1% ointment prepared by the addition of 1g of powder to 100ml of either Simple Cream BP, Simple Cream plus hydrous lanolin (90:10), Hydrous Ointment BP or Macrogel Ointment BPC.
Colomycin Sterile Powder may be given orally as an alternative to Colomycin Tablets or Syrup by dissolving in a suitable vehicle.
7. Marketing Authorisation Holder
Forest Laboratories UK Limited |
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8. Marketing Authorisation Number(S)
PL 0108/5010R
9. Date Of First Authorisation/Renewal Of The Authorisation
25 February 1991 / 25 March 1996
10. Date Of Revision Of The Text
November 1995
11. Legal Category
POM
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