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
This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin. It is not indicated in the treatment of minor bacterial infections or viral infections.
Lincomycin is not indicated in the newborn.
Lincomycin should not be injected IV as a bolus but should be infused as described in the DOSAGE AND ADMINISTRATION section.
The use of lincomycin can lead to the development of severe colitis. Fatalities have been reported. Therefore LINCOCIN should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS section. It should not be used in patients with non-bacterial infections such as most upper respiratory tract infections.
A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with the use of antibiotics, including parenteral lincomycin. Symptoms may occur up to several weeks after cessation of antibiotic therapy.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone, however, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis (e.g. opiates and diphenoxylate with atropine [LOMOTIL]) may prolong and/or worsen the condition and should not be used.
Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhoea less well. When LINCOCIN is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including lincomycin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
LINCOCIN should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
LINCOCIN, like any drug, should be used with caution in patients with a history of asthma or significant allergies.
Hypersensitivity reactions (such anaphylactic reaction, angioedema and serum sickness) have been reported, some of these in patients known to be sensitive to penicillin. If an allergic reaction should occur, the drug should be discontinued and the usual agents (adrenalin, corticosteroids, antihistamines) should be available for emergency treatment.
Severe hypersensitivity reactions, including anaphylactic reactions and severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP), and erythema multiforme (EM) have been reported in patients receiving lincomycin therapy. If an anaphylactic reaction or severe skin reaction occurs, lincomycin should be discontinued and appropriate therapy should be initiated (see section 4.8 Adverse Effects (Undesirable Effects)).
The use of antibiotics occasionally results in overgrowth of non-susceptible organisms-particularly yeasts. Should superinfections occur, appropriate measures should be taken. When patients with pre-existing monilial infections require LINCOCIN therapy, concomitant antimonilial treatment should be given.
Although lincomycin appears to diffuse into cerebrospinal fluid, levels of lincomycin in the CSF may be inadequate for the treatment of meningitis. Thus, the drug should not be used in the treatment of meningitis.
In patients with impaired hepatic or renal function, the serum half-life of lincomycin is increased. Consideration should be given to decreasing the frequency and dose of lincomycin administered in patients with impaired hepatic or liver function.
Since adequate data are not yet available in patients with pre-existing liver disease, its use in such patients is not recommended at this time unless special clinical circumstances so indicate.
See section 4.4, Special Warnings and Precautions for Use, Use in hepatic impairment)
No data available.
LINCOCIN Injection contains benzyl alcohol which is associated with severe adverse effects, including fatal “Gasping Syndrome”, in paediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is unknown. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low birth weight infants may be more likely to develop toxicity.
No data available.
LINCOCIN has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
No data available.
Category A.
In humans, lincomycin crosses the placenta and results in cord serum levels about 25% of the maternal serum levels. No significant accumulation occurs in the amniotic fluid. There are limited data on the use of lincomycin in pregnant women. The progeny of 302 patients treated with lincomycin at various stages of pregnancy showed no increases in congenital anomalies or delayed development compared to a control group for up to 7 years after birth. Lincomycin should be used during pregnancy only if clearly needed. Lincomycin is not indicated in the newborn (see section 4.3, Contraindications). Benzyl alcohol can cross the placenta (see section 4.4, Special Warnings and Precautions for Use, Paediatric Use).
No embryo fetal toxicity was observed in rats dosed with 10% lincomycin in the diet (equivalent to 5000 mg/kg/day) during organogenesis.
LINCOCIN has been reported to appear in breast milk in ranges of 0.5 to 2.4 micrograms/mL. It should not, therefore, be used during lactation unless alternative arrangements can be made for feeding the baby.
No studies were conducted to determine the effect of LINCOCIN on ability to drive and use machines.
Adverse reactions are listed according to the following categories: Very common: ≥1/10, Common: ≥1/100 to <1/10, Uncommon: ≥1/1,000 to <1/100, Rare: ≥1/10,000 to <1/1,000, Very rare: <1/10,000, Not known: cannot be estimated from available data
Uncommon: Vaginal infection.
Not known: Pseudomembranous colitis, Clostridium difficile colitis.
Common: Diarrhoea, vomiting, nausea.
Rare: Stomatitis.
Not known: Enterocolitis (see section 4.4, Special Warnings and Precautions for Use), oesophagitisa, glossitis, abdominal discomfort.
Not known: Pancytopenia, agranulocytosis, aplastic anaemia, leukopenia, neutropenia, thrombocytopenic purpura.
Not known: Anaphylactic reaction, angioedema, serum sickness (see section 4.4, Special Warnings and Precautions for Use).
Uncommon: Rash, urticaria.
Rare: Pruritus.
Not known: Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute-generalised exanthematous pustulosis, erythema multiforme, dermatitis bullous, dermatitis exfoliative, anal pruritus.
Not known: Jaundice, liver function test abnormal, transaminases increased.
Not known: Renal impairment, oliguria, proteinuria, azotaemia.
Not known: Cardio-respiratory arrestc.
Not known: Hypotensiond, thrombophlebitise.
Not known: Vertigo, tinnitus.
Not known: Injection site abscess sterilef, injection site indurationf, injection site painf, injection site irritationf.
a Reported with oral preparations.
b No direct relationship of lincomycin to renal damage has been established.
c Rare instances have been reported after too rapid intravenous administration.
d Following parenteral administration, particularly after too rapid administration.
e Reported with intravenous injection. This reaction can be minimised by avoidance of indwelling intravenous catheters.
f Reported with intramuscular injection. These reactions can be minimised by deep intramuscular injection.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.
LINCOCIN is incompatible with novobiocin, kanamycin and phenytoin.
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