Colomycin Syrup

1. Name Of The Medicinal Product

COLOMYCIN SYRUP

2. Qualitative And Quantitative Composition

Each bottle contains 4,000,000 units Colistin Sulphate, equivalent to 250,000 units/5ml when dispensed.

3. Pharmaceutical Form

Powder for syrup.

4. Clinical Particulars

4.1 Therapeutic Indications

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 except in infants under the age of 6 months, and must not be given orally for the treatment of systemic infections in any age group.

4.2 Posology And Method Of Administration

After reconstitution, the following doses are taken orally:

Adults over 30kg (including the elderly):

1,500,000 to 3,000,000 units every 8 hours.

Colomycin Tablets may be more suitable for adults.

Children (up to 15kg):

250,000 to 500,000 units (i.e. 5-10ml syrup) every 8 hours.

Children (15-30kg):

750,000 to 1,500,000 units (i.e. 15-30ml syrup) every 8 hours.

A minimum of 5 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 Contraindications

The preparation is 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 gastrointestinal 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 Interaction With Other Medicinal Products 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 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.

4.8 Undesirable Effects

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 paraesthesia and vertigo.

Neurotoxicity 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 '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 polymyxin antibiotic derived from Bacillus polymyxa 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

In adults and older children, colistin sulphate taken orally is not absorbed from the G.I. tract. However, in small infants less than 6 months old, some very limited and unpredictable absorption may occur.

Following oral administration of colistin sulphate, excretion is through faecal matter in both children and adults. Assuming minimal absorption in the intestine, only 1 to 10% of colistin is found in faeces, to that estimated from the dose administered and stool volume. Colistin faecal levels in man average 128µg/g when daily oral doses of 5-20mg/kg are administered (1mg colistin sulphate contains approx. 19,500 units).

Control studies have indicated that colistin is bound by the stool. When greater concentrations of colistin were assayed, significantly less activity, percentage-wise, was lost. This suggests that the 'binding sites' in the stool were saturated.

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

Sucrose

Sodium Citrate

Benzoic Acid

Sodium Methylhydroxybenzoate (E219)

6.2 Incompatibilities

None stated.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in a dry place, protected from light.

6.5 Nature And Contents Of Container

Colomycin Syrup powder is presented in a 4oz amber glass Winchester bottle fitted with a white polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

Colomycin Syrup powder is reconstituted by adding 58ml of water, and shaking the bottle until the powder is dissolved.

7. Marketing Authorisation Holder

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent

U.K.

8. Marketing Authorisation Number(S)

PL 0108/5009R

9. Date Of First Authorisation/Renewal Of The Authorisation

21 March 1991 / 07 November 2001

10. Date Of Revision Of The Text

March 2010

11. Legal Category

POM