Product Summary

1.    Trade Name of the Medicinal Product Colomycm Tablets

2.    Qualitative and Quantitative Composition

Colistin Sulphate BP 1.5MU per tablet.

3.    Pharmaceutical Form

Tablet.

Clinical Particulars

4.1.    Therap euti c Indi cati ons

Indicated for use in adults, the elderly and children. For the treatment of gastrointestinal infections caused by sensitive Gram negative organisms. Also for bowel preparation.

Colistin sulphate is not absorbed from the gastro-intestinal 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 (15-30kg):

750.000    to 1,500,000 units every 8 hours.

Children (under 15kg):

Colomycin tablets are not suitable for children under 15kg, because an appropriate dose cannot be delivered from a 1,500,000 unit tablet presentation.

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.

4.3. Contra-indications

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 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 and in 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 curari-form agents or antibiotics with similar neurotoxic effects. Therapy need not be discontinued and reduction of dosage may alleviate symptoms.

An in vitro study with colistin sulphate found that it became markedly and irreversibly bound to sucralfate at the pH values found in the gut. This suggests that efficacy for gut decontamination or gastrointestinal infections might be decreased.

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 should only be used in pregnancy if the potenial benefit justifies the potenial risk

Colomcyin 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.

4.8. Undesirable Effects

As previously stated, no significant 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.

4.9. Overdose

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 ‘Side 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.

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.

5.3. Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Pharmaceutical Particulars

6.1.    List of Excipients

Microcrystalline cellulose, starch (maize), colloidal silicon dioxide, Cutina HR

6.2.    Incompatibilities

None stated.

6.3.    Shelf Life

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

Pack of 50 tablets in a plastic container with a plastic lid comprising: white or grey polypropylene body and white or grey low density polyethylene closure, or white or grey high density polyethylene body and white or grey low density polyethylene closure.

6.6. Instruction for Use/Handling

None stated.

7. Marketing Authorisation Holder

Riverbridge House Anchor Boulevard Crossways Business Park Dartford Kent

DA2 6SL.

8. Marketing Authorisation Number

PL 0108/5008R

9. Date of First Authorisation/Renewal of Authorisation

30 May 1986/11 July 1996

10 DATE OF REVISION OF THE TEXT

24/01/2012