Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2018 Publisher: Pfizer Australia Pty Ltd, 38-42 Wharf Road, West Ryde NSW 2114, Toll Free Number: 1800 675 229, www.pfizer.com.au
LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of gram-positive aerobes such as streptococci, pneumococci and staphylococci.
Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate. Because of the risk of colitis (see section 4.4, Special Warnings and Precautions for Use), before selecting lincomycin the physician should consider the nature of infection and the suitability of less toxic alternatives (e.g. erythromycin).
LINCOCIN has been demonstrated to be effective in the treatment of staphylococcal infections resistant to other antibiotics and susceptible to lincomycin. Staphylococcal strains resistant to LINCOCIN have been recovered; culture and susceptibility studies should be done in conjunction with LINCOCIN therapy. In the case of macrolides, partial but not complete cross resistance may occur. The drug may be administered concomitantly with other antimicrobial agents with which it is compatible when indicated (see section 4.4, Special Warnings and Precautions for Use).
The specific infections for which LINCOCIN is indicated are as follows:
Note: If significant diarrhoea occurs during therapy, this antibiotic should be discontinued (see section 4.4, Special Warnings and Precautions for Use).
LINCOCIN is incompatible with novobiocin, kanamycin and phenytoin.
With beta-haemolytic streptococcal infections, treatment should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis.
Serious infections – 600 mg (2 mL) intramuscularly every 24 hours.
More serious infections – 600 mg (2 mL) intramuscularly every 12 hours or more often, as determined by the severity of the infection.
Serious infections – one intramuscular injection of 10 mg/kg/day.
More serious infections – one intramuscular injection of 10 mg/kg every 12 hours or more often.
Intravenous doses are given on the basis of 1 g LINCOCIN diluted in not less than 100 mL of appropriate solution and infused over a period of not less than one hour. Note: Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate.
Serious infections – 600 mg to 1 g given every 8-12 hours.
More severe infections – the above doses may be increased. In life-threatening situations, daily intravenous doses of as much as 8 g have been given.
Depending on the severity of the infection, 10-20 mg/kg/day may be infused in divided doses as described below.
Dilution and Infusion Rates:
| Dose | Vol. Diluent | Time |
|---|---|---|
| 600 mg | 100 mL | 1 hr |
| 1 g | 100 mL | 1 hr |
| 2 g | 200 mL | 2 hr |
| 3 g | 300 mL | 3 hr |
| 4 g | 400 mL | 4 hr |
These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 g.
The following infusion solutions have been found to be physically compatible with LINCOCIN: Glucose Intravenous Infusion 5%, Glucose Intravenous Infusion 10%, Sodium Chloride 0.9% and Glucose 5% Intravenous Infusion, Sodium Chloride 0.9% and Glucose 10% Intravenous Infusion, Compound Sodium Lactate Intravenous Infusion, Sodium Lactate 1/6 Molar and Dextran 70 Intravenous Infusion.
Please note that these compatibility determinations are physical observations only, not chemical determinations. Adequate clinical evaluation of the safety and efficacy of these combinations has not been performed.
Patients with diminished renal function: When LINCOCIN therapy is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normal renal function.
During prolonged LINCOCIN therapy, periodic liver function and renal studies and blood counts should be performed.
The minimal toxic or lethal dose is not well established. At therapeutic doses, the primary toxic effects may involve the gastrointestinal tract and may include severe diarrhoea and pseudomembranous colitis that may result in death. Rapid administration of large doses has resulted in ventricular dysrhythmias, hypotension and cardiac arrest. Dermatitis, nephrotoxicity, hepatotoxicity, and various haematological abnormalities are toxic effects that occur less frequently.
No specific antidote is known. Support respiratory and cardiac function. In cases of overdose, drug levels of lincomycin are not clinically useful. However, monitoring serum concentrations in patients with markedly reduced renal and hepatic function may be indicated during high-dose therapy. Monitor full blood count in patients with significant exposure as lincomycin may produce abnormalities of the haematopoietic system. Because lincomycin may cause hepatotoxicity, monitor liver function tests in patients with significant exposure.
Haemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Store below 25oC. Protect from light. Do not freeze.
LINCOCIN Injection is available as 5 × 2 mL vials.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
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