Colomycin® Tablets
Prescription Products
Colistin Sulphate
Summary of Product Characteristics
- Trade Name of the Medicinal Product
- Qualitative and Quantitative Composition
- Pharmaceutical Form
- Clinical Particulars
- Pharmacological Properties
- Pharmaceutical Particulars
- Marketing Authorisation Holder
- Marketing Authorisation Number
- Date of First Authorisation/Renewal of the Authorisation
- Date of (Partial) Revision of the Text
- Legal Category
4. Clinical Particulars
For the treatment of gastrointestinal infections caused by sensitive Gram negative organisms. Also for bowel preparation.
Colistin sulphate is not absorbed from the gastrointestinal tract and must not, therefore, be used for systemic infections.
4.2 Posology and Method of Administration
To be taken orally.
Adults (including the elderly) (over 30kg):
1,500,000 to 3,000,000 units every 8 hours.
Children (up to 15kg):
250,000 to 500,000 units every 8 hours.
Children (15-30kg):
750,000 to 1,500,000 units every 8 hours.
A minimum of five days treatment is recommended. Dosage may be increased when clinical or bacteriological response is slow.
For bowel preparation, a 24 hour course at the normal dosage above is given. Treatment should preferably finish 12 hours before surgery.
Contra-indicated in patients with known sensitivity to colistin and those with myasthenia gravis.
4.4 Special Warnings and Precautions for Use
Colistin is subject to limited and unpredictable absorption from the GI tract in infants under six months. Studies in older children and in adults have demonstrated no systemic absorption of colistin following oral administration.
Nevertheless, caution should be employed in the use of the preparation in patients with renal failure, patients receiving curari-form muscle relaxants and patients with porphyria.
4.5 Interactions with Other Medicaments and Other Forms of Interaction
Neurotoxicity has been reported in association with the concomitant use of either curariform agents or antibiotics with similar neurotoxic effects.
Therapy need not be discontinued and reduction of dosage may alleviate symptoms.
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 should only be used in pregnancy if the potential benefit justifies the potential risk.
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
No specific warnings
No significant systemic absorption has been found to occur in older children and adults following oral administration nor have any systemic side effects been reported.
However, since the use of colistin may be associated with unpredictable, albeit limited, absorption in infants under 6 months the potential adverse effects of systemic administration should be noted for this patient population. These adverse effects may include transient sensory disturbances such as perioral parasthesia and vertigo.
Neuro-toxicity and adverse effects on renal function have been reported in association with systemic over-dosage, failure to reduce dosage in patients with renal insufficiency and the concomitant use of either curariform 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.
No symptoms of overdosage have been reported following oral use of colistin. However, following systemic administration overdosage can result in renal insufficiency, muscle weakness and apnoea and this should be borne in mind in the oral therapy of infants under 6 months old (see 'Undesirable Effects' above).
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 polypeptide antibiotic derived from Bacillus polymyxa var. colistinus.
It possesses a rapid bactericidal activity against a number of Gram-negative organisms, including Pseudomonas aeruginosa and is largely free from the development or transference of resistance.
5.2 Pharmacokinetic Properties
Studies on the gastrointestinal absorption of colistin have shown no significant systemic absorption following oral administration in adults and older children.
Limited and unpredictable absorption is, however, evident in infants under 6 months.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
- Microcrystalline cellulose
- Starch (maize)
- Colloidal silicon dioxide
- Cutina HR.
None stated
5 years
6.4 Special Precautions for Storage
Do not store above 25°C. Store in the original container.
6.5 Nature and Contents of Container
Plastic container of 50 tablets
6.6 Instructions for Use/Handling
None stated
11. Legal Category
POM