Consumer medicine information

Lincocin

Lincomycin

BRAND INFORMATION

Brand name

Lincocin

Active ingredient

Lincomycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Lincocin.

What is in this leaflet

Please read this leaflet carefully before you start using LINCOCIN Injection. This leaflet answers some common questions about LINCOCIN Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using LINCOCIN against the benefits it is expected to have for you. Use LINCOCIN as instructed and follow the advice given in this leaflet.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What LINCOCIN is used for

LINCOCIN is an antibiotic used to treat serious infections in different parts of the body caused by certain bacteria. LINCOCIN works by killing or stopping the growth of bacteria causing your infection.

The specific infections for which LINCOCIN is used include: ear, throat and lung infections; skin infections; bone and joint infections; and infections of the blood.

LINCOCIN will not work against viral infections such as colds or flu.

Your doctor may have prescribed LINCOCIN for another reason.

Ask your doctor if you have any questions about why LINCOCIN has been prescribed for you.

This medicine is available only with a doctor's prescription.

LINCOCIN is not addictive.

Before you use LINCOCIN

Some information is provided below. However, always talk to your doctor if you have concerns or questions about your treatment.

When you must not take it

Do not take LINCOCIN if you have an allergy to:

  • clindamycin or lincomycin
  • any of the other ingredients listed at the end of this leaflet
    (see 'Product Description')
    Symptoms of an allergic reaction may include:
    Symptoms of an allergic reaction may include skin rash, itching or difficulty in breathing, wheezing or coughing (anaphylactic reactions). If you are not sure if you have or have had an allergic reaction to LINCOCIN, check with your doctor.

The packaging is torn or shows signs of tampering

The expiry date (EXP) printed on the label has passed.

You are breast-feeding LINCOCIN may pass into the breast-milk so alternatives should be discussed with your doctor.

LINCOCIN is not to be given to a newborn baby.

If you are not sure about the use of LINCOCIN Injection, talk to your doctor.

Before you start to take it

Tell your doctor if:

  • you are pregnant or intend to become pregnant.
  • Your child who is to be treated was born prematurely or was of low birth weight.
  • You have any of the following conditions:
    - asthma
    - any gastrointestinal (stomach or gut) problems
    - any liver or kidney disease.
  • You have ever had any other health problems or medical conditions.
  • You have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.

If you have not told your doctor or pharmacist about any of the above, do so before you start using LINCOCIN Injection.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

  • LINCOCIN should not be given with certain medicines due to physical incompatibility with LINCOCIN. These include kanamycin, novobiocin and phenytoin.
  • Interference between LINCOCIN and neuromuscular blocking medicines (muscle-relaxing medicines) may occur.

Your doctor or pharmacist can tell you what to do if you are already taking any of these medicines. They also have a more complete list of medicines to be careful with or avoid while using LINCOCIN.

Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.

How to use LINCOCIN

LINCOCIN is administered by an infusion into a vein or an injection into a muscle. This will be done by a doctor or nurse.

How much to use

The dose and frequency of LINCOCIN that your doctor prescribes for you depends on your medical condition.

How long to use LINCOCIN

Your doctor will continue giving you LINCOCIN for as long as your condition requires.

If you a dose is missed

If a dose of LINCOCIN is missed, the next dose should be given at the normal time it is due.

If you are given too much (overdose)

Your doctor will ensure that you receive the correct dose of LINCOCIN.

Never administer this medicine to yourself.

Immediately telephone your doctor or Poisons Information Centre on the numbers listed below:

In Australia 13 11 26 for advice or go to Accident and Emergency (Casualty) at your nearest hospital if you think that you or anyone else may have been given too much LINCOCIN Injection.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep the telephone numbers for these services handy. Have the LINCOCIN Injection box or this leaflet available to give details if needed.

While using LINCOCIN

Things you must do

Advise your doctor immediately if you notice any unusual symptoms.

If you are about to start taking any new medicines, tell your doctor or pharmacist that you are taking LINCOCIN.

Tell all doctors, dentists and pharmacists who are treating you that you are being treated with LINCOCIN.

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea, tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after LINCOCIN has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.

If you get sore, white mouth or tongue while taking or soon after stopping LINCOCIN, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal/yeast infection called thrush. Sometimes the use of LINCOCIN allows fungi/yeast to grow and the above symptoms to occur. LINCOCIN does not work against fungi/yeast.

If you become pregnant while you are using LINCOCIN, tell your doctor.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are on LINCOCIN.

Tell all doctors, dentists and pharmacists who are treating you that you are on LINCOCIN.

Side effects

Check with your doctor as soon as possible if you have any concerns while using LINCOCIN, even if you do not think your concerns are connected with the medicine or are not listed in this leaflet.

All medicines can have side effects and LINCOCIN may have unwanted side effects in a few people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using LINCOCIN.

While being treated with LINCOCIN

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • sore mouth or tongue
  • nausea and/or vomiting
  • diarrhoea
  • abdominal cramps
  • skin rash
  • ringing in the ears
  • dizziness
  • pain or swelling at the Injection site

If these effects do not go away or they are worrying to you, tell your doctor.

Tell your doctor immediately or go to Accident and Emergency (Casualty) at your nearest hospital if you experience any of the following:

  • allergic type reactions e.g. skin rash, itching and difficulty breathing, wheezing or coughing (anaphylactic reactions)
  • severe diarrhoea (with blood or pus).
  • severe stomach pains

LINCOCIN can also cause changes in blood cells, lowering of blood pressure.

After finishing treatment with LINCOCIN

  • Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with LINCOCIN. severe abdominal cramps or stomach cramps.
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above.

LINCOCIN can cause bacteria which is normally present in the bowel and normally harmless, to multiply and cause the above symptoms. These are rare but serious side effects of LINCOCIN and you may need urgent medical attention.

Do not take any diarrhoea medicine without first checking with your doctor.

Tell your doctor if you notice any other effects.

This is not a complete list of all possible side effects. Some people may get other side effects while being treated with LINCOCIN.

After treatment with LINCOCIN

Storage

Normally your doctor will get your LINCOCIN from the hospital pharmacy or their consulting rooms. If however, you do take your LINCOCIN from the pharmacy to your doctor, it is important to store your LINCOCIN in a safe place away from light and away from heat (below 25°C).

Do not leave your LINCOCIN in a car.

If for any reason you take your LINCOCIN home, always ensure that it is stored in a place where children cannot reach it. Do not freeze LINCOCIN.

Disposal

If your doctor stops treating you with LINCOCIN, your hospital pharmacist will dispose of any unused medicine.

The expiry date is printed on the carton. Do not use LINCOCIN after this date has passed.

Product description

What LINCOCIN looks like

LINCOCIN is a clear, colourless or almost colourless solution in a glass vial. LINCOCIN is supplied in cartons containing 5 vials.

Identification

LINCOCIN can be identified by the Australian Register Number:

600 mg/2 mL vial: AUST R 12281.

Ingredients

The active ingredient in LINCOCIN is lincomycin hydrochloride monohydrate. Each 2 mL vial contains lincomycin hydrochloride monohydrate equivalent to 600 mg of lincomycin.

LINCOCIN also contains benzyl alcohol and Water for Injections.

Supplier

LINCOCIN is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW 2000
Toll free number: 1800 675 229

This leaflet was revised in March 2020

® Registered trademark.

© Pfizer Australia Pty Ltd 2015.

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Lincocin

Active ingredient

Lincomycin

Schedule

S4

 

1 Name of Medicine

Lincomycin hydrochloride monohydrate.

6.7 Physicochemical Properties

Chemical structure.

Chemical Name: Lincomycin hydrochloride consists mainly of the monohydrate of methyl 6,8-dideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-D-erythro-α-D-galacto-octopyranoside hydrochloride.
The structure of lincomycin hydrochloride monohydrate is:
Lincocin (lincomycin hydrochloride) is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (fam. Streptomycetaceae). It is a white, or practically white, crystalline powder and is odourless or has a faint odour. Its solutions are acid and are dextrorotatory. Lincocin is freely soluble in water, soluble in dimethylformamide and very slightly soluble in acetone.

CAS number.

7179-49-9.

2 Qualitative and Quantitative Composition

Each mL contains lincomycin hydrochloride monohydrate equivalent to lincomycin base 300 mg.

Excipients with known effect.

Benzyl alcohol, 9.45 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Lincocin injection is a clear, colourless or almost colourless solution, practically free from particles.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Lincocin is an antibiotic produced by fermentation of Streptomyces lincolnensis. Lincocin inhibits bacterial protein synthesis by binding to the 50S subunit of the bacterial ribosome. Lincocin is predominantly bacteriostatic in vitro. The antibacterial activity of Lincocin appears to best correlate with the length of time the concentration of active ingredient remains above the minimum inhibitory concentration (MIC) of the infecting organism.

Mechanism of resistance.

Cross resistance between Lincocin and clindamycin is complete. Resistance in staphylococci and streptococci is most often due to methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit, which can determine cross resistance to macrolides and streptogramins B (MLSB phenotype). Macrolide-resistant isolates of these organisms should be tested for inducible resistance to lincomycin/clindamycin using the D zone test.

Antibacterial spectrum.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Lincocin is cross-resistant with clindamycin. A decrease in clindamycin/lincomycin susceptibility over time has been noted in particular among methicillin-resistant Staphylococcus aureus and in some species of Clostridium.
In vitro studies indicate that the following organisms are usually sensitive to concentrations achieved normally in the serum following recommended doses:

Aerobic and facultative gram-bacteria.

Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pyogenes, Viridans group streptococci, Streptococcus pneumoniae, Corynebacterium diphtheriae.

Anaerobic and microaerophilic bacteria.

Clostridium tetani, Clostridium perfringens, Propionibacterium acnes.

Note.

The drug is not active against most strains of Enterococcus faecalis nor against Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, or other Gram-negative organisms or yeasts. Some strains of Clostridium perfringens and strains of some less common human pathogens of Clostridia may be lincomycin-resistant. Depending on the sensitivity of the organism and concentration of the antibiotic, it may be either bactericidal or bacteriostatic. Cross resistance has not been demonstrated with penicillin, chloramphenicol, ampicillin, cephalosporins or the tetracyclines. Despite chemical differences, Lincocin exhibits antibacterial activity similar but not identical to the macrolide antibiotics (e.g. erythromycin). Some cross-resistance (with erythromycin) including a phenomenon known as dissociated cross-resistance or macrolide effect has been reported. Microorganisms have not developed resistance to Lincocin rapidly when tested by in vitro or in vivo methods. Staphylococci develop resistance to Lincocin in a slow, step-wise manner based on in vitro serial subculture experiments. Studies indicated that Lincocin does not share antigenicity with penicillin compounds.

Methodology for determining in vitro susceptibility to lincomycin.

Susceptibility testing should be conducted using standardized laboratory methods, such as those described by the Clinical and Laboratory Standards Institute (CLSI) or the European Committee on Antimicrobial Susceptibility Testing (EUCAST). Because CLSI and EUCAST have not established susceptibility breakpoints for Lincocin, clindamycin should be tested instead. Resistance to lincosamides may be inducible by macrolides in macrolide-resistant staphylococci, Streptococcus pneumoniae, and beta-hemolytic streptococci. Macrolide-resistant isolates of these organisms should be screened for inducible clindamycin resistance using the D-zone test or other standard methodology. See Table 2.
The validity of both the dilution and disk diffusion test methods should be verified using quality control (QC) strains, as indicated by CLSI. Acceptable limits when testing clindamycin against these organisms are listed in Tables 3-5.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Lincocin is absorbed rapidly after a 500 mg oral dose in the fasting state, producing an average peak serum level of 5.3 microgram/mL at 2 hours post dose. Doubling the dose increases but does not double the peak serum levels. Food in the stomach reduces total absorption as well as peak serum levels.

Distribution.

Significant levels have been demonstrated in the majority of body tissues. Although lincomycin appears to diffuse into cerebrospinal fluid (CSF), levels of lincomycin in the CSF appear inadequate for the treatment of meningitis.

Metabolism.

Tissue level studies indicate that bile is an important route of excretion. The excretion of lincomycin in urine and bile does not account for all of the administered dose and a substantial proportion of the drug appears to be inactivated in the body, presumably in the liver.
The biological half-life, after intramuscular administration is approximately 5 hours.

Excretion.

Urinary recovery of drug in a 24-hour period ranges from 1.0% to 31% (mean: 4.0%) after a single oral dose of 500 mg. Bile is an important route of excretion.
Intramuscular administration of a single dose of 600 mg of lincomycin produces an average peak serum level of 11.6 microgram/mL at 60 minutes and maintains therapeutic levels for 17 to 20 hours for most susceptible Gram-positive organisms. Urinary excretion after this dose ranges from 1.8% to 24.8% (mean: 10.3%).
The intravenous infusion over a 2-hour interval of 600 mg of lincomycin achieves average peak serum levels of 15.9 microgram/mL and yields therapeutic levels for 14 hours for most susceptible Gram-positive organisms. Urinary excretion ranges from 4.9% to 23.3% (mean: 15.1%).
Haemodialysis and peritoneal dialysis do not effectively remove lincomycin from the blood.

Special populations.

Patients with renal impairment.

The serum half-life of Lincocin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function.

Patients with hepatic impairment.

In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function.

5.3 Preclinical Safety Data

Genotoxicity.

Lincomycin was not genotoxic in various in vitro and in vivo genotoxicity studies including bacterial reverse mutation assays, gene mutation assays in mammalian cells and Drosophila melanogaster germ cells, chromosomal aberration assays in human lymphocytes, and in vivo micronucleus assays. It induced DNA damage in one unscheduled DNA synthesis (UDS) assay in primary rat hepatocytes, but it was negative in another UDS assay in rat hepatocytes and in a UDS assay in Chinese hamster lung fibroblasts.

Carcinogenicity.

Lincomycin was not carcinogenic in rats at up to 100 mg/kg/day administered in the diet for 26 months.

Effects on fertility.

No effects on fertility were observed in rats administered lincomycin at oral doses up to 1000 mg/kg/day.

4 Clinical Particulars

4.1 Therapeutic Indications

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:

Upper respiratory infections.

Including tonsillitis, pharyngitis, otitis media, sinusitis, scarlet fever and as adjuvant therapy for diphtheria. Effectiveness in the treatment of mastoiditis would be anticipated.

Lower respiratory infections.

Including acute and chronic bronchitis and pneumonia.

Skin and skin structure infections.

Including cellulitis, furuncles, abscesses, impetigo, acne and wound infections. Conditions such as erysipelas, lymphadenitis, paronychia (panaritium), mastitis and cutaneous gangrene should, if caused by susceptible organisms, respond to lincomycin therapy.

Bone and joint infections.

Including osteomyelitis and septic arthritis.

Septicaemia and endocarditis.

Selected cases of septicaemia and/or endocarditis due to susceptible organisms have responded well to lincomycin. However, bactericidal drugs are often preferred for these infections.

Bacillary dysentery.

Although Shigella is resistant to lincomycin in vitro (MIC approximately 200-400 microgram/mL), lincomycin has been effective in its treatment due to the very high levels of lincomycin attained in the bowel (approximately 3000-7000 microgram/gram of stool).

4.3 Contraindications

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.

4.4 Special Warnings and Precautions for Use

Lincomycin should not be injected IV as a bolus but should be infused as described (see Section 4.2 Dose and Method of Administration).

Risk of colitis.

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 (see Section 4.1 Therapeutic Indications). 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.

Allergies.

Lincocin, like any drug, should be used with caution in patients with a history of asthma or significant allergies.

Hypersensitivity reactions.

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 (adrenaline, 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)).

Superinfections.

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.

Meningitis.

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.

Use in hepatic impairment.

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.

Use in renal impairment.

See Section 4.4 Special Warnings and Precautions for Use, Use in hepatic impairment.

Use in the elderly.

No data available.

Paediatric use.

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 birthweight infants may be more likely to develop toxicity.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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 microgram/mL. It should not, therefore, be used during lactation unless alternative arrangements can be made for feeding the baby.

4.8 Adverse Effects (Undesirable Effects)

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.

Infections and infestations.

Uncommon: vaginal infection. Not known: pseudomembranous colitis, Clostridium difficile colitis.

Gastrointestinal disorders.

Common: diarrhoea, vomiting, nausea. Rare: stomatitis. Not known: enterocolitis (see Section 4.4 Special Warnings and Precautions for Use), oesophagitisa, glossitis, abdominal discomfort.

Blood and lymphatic system disorders.

Not known: pancytopenia, agranulocytosis, aplastic anaemia, leukopenia, neutropenia, thrombocytopenic purpura.

Immune system disorders.

Not known: anaphylactic reaction, angioedema, serum sickness (see Section 4.4 Special Warnings and Precautions for Use).

Skin and subcutaneous tissue disorders.

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.

Hepatobiliary disorders.

Not known: jaundice, liver function test abnormal, transaminases increased.

Renal and urinary disordersb.

Not known: renal impairment, oliguria, proteinuria, azotaemia.

Cardiac disorders.

Not known: cardio-respiratory arrestc.

Vascular disorders.

Not known: hypotensiond, thrombophlebitise.

Ear and labyrinth disorders.

Not known: vertigo, tinnitus.

General disorders and administration site conditions.

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 effects.

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.

4.2 Dose and Method of Administration

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.

Intramuscular.

Adults.

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.

Children over 1 month of age.

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.

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.

Adults.

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.

Children over 1 month of age.

Depending on the severity of the infection, 10-20 mg/kg/day may be infused in divided doses as described in Table 1.
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.

Monitoring.

During prolonged Lincocin therapy, periodic liver function and renal studies and blood counts should be performed.

4.7 Effects on Ability to Drive and Use Machines

No studies were conducted to determine the effect of Lincocin on ability to drive and use machines.

4.9 Overdose

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).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl alcohol, water for injections, q.s.

6.2 Incompatibilities

Lincocin is incompatible with novobiocin, kanamycin and phenytoin.

6.3 Shelf Life

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.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light. Do not freeze.

6.5 Nature and Contents of Container

Lincocin injection is available as 5 x 2 mL vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes