Consumer medicine information

Clindamyk

Clindamycin

BRAND INFORMATION

Brand name

Clindamyk

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Clindamyk.

What is in this leaflet

This leaflet answers some common questions about CLINDAMYK capsules.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking CLINDAMYK against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

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

What CLINDAMYK capsules is used for

CLINDAMYK is an antibiotic. It is used to treat infections in different parts of the body caused by bacteria.

CLINDAMYK works by killing or stopping the growth of the bacteria causing your infection.

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

CLINDAMYK is recommended for patients who are allergic to penicillin or patients for whom penicillin is not suitable.

Your doctor may have prescribed CLINDAMYK for another reason. Ask your doctor if you have any questions about why CLINDAMYK has been prescribed for you.

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

CLINDAMYK is not addictive.

Before you take CLINDAMYK capsules

When you must not take it

Do not take CLINDAMYK capsules:

If you have an allergy to:

  • clindamycin or lincomycin
  • lactose or any of the other ingredients listed at the end of this leaflet (see 'Product Description').

Some of the symptoms of an allergic reaction may include

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you take it after the expiry date, it may have no effect at all, or worse, an entirely unexpected effect.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

You must tell your doctor about all of the following before you start to take CLINDAMYK.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you pregnant or intend to become pregnant. Clindamycin crosses the placenta therefore CLINDAMYK capsules should only be used in pregnancy if clearly needed. Your doctor will discuss the risks and benefits of taking CLINDAMYK during pregnancy.

Tell your doctor if you breast-feeding or intend to breast-feed. CLINDAMYK capsules are not recommended during breastfeeding.

Tell your doctor if you have or have had any of the following medical conditions:

  • severe diarrhoea associated with the use of antibiotics
  • severe liver disease
  • severe kidney disease
  • any gastrointestinal (stomach or gut) problems

Tell your doctor if you have had any other health problems or medical conditions.

If you have not told your doctor or pharmacist about any of the above, do so before you start taking CLINDAMYK capsules.

Taking other medicines

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

Some medicines and CLINDAMYK may interfere with each other. These include:

  • erythromycin, an antibiotic
  • medicines used for muscle relaxation in anaesthesia

These medicines may be affected by CLINDAMYK or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take CLINDAMYK capsules

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

You may be given a different dosage depending on your condition and how you react to the medicine.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much to take

Adults
One (1) capsule (150 mg) every six hours is the usual dose. The number of capsules may increase with more serious infections. Your doctor will tell you how long to take your capsules.

Children
CLINDAMYK capsules are not recommended in children for formulation reasons.

How to take it

CLINDAMYK capsules should be taken by mouth, with a full glass of water.

When to take it

CLINDAMYK can be taken with or without food, it does not matter.

How long to take it

Your doctor will tell you how long to take your capsules.

Continue taking CLINDAMYK until you finish the box or until your doctor recommends.

Check with your doctor if you are not sure how long you should be taking it.

Do not stop taking CLINDAMYK capsules because you are feeling better. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or may return.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking your capsules as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much CLINDAMYK. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking CLINDAMYK capsules

Things you must do

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 you have stopped taking CLINDAMYK. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medicines for diarrhoea without first checking with your doctor.

If you get a sore, white mouth or tongue while taking or soon after stopping CLINDAMYK, 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 CLINDAMYK allows fungi/yeast to grow and the above symptoms to occur. CLINDAMYK does not work against fungi/yeast.

If you become pregnant while taking this medicine, tell your doctor immediately.

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

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you feel that CLINDAMYK is not helping your condition, tell your doctor.

Tell your doctor if, for any reason, you have not used CLINDAMYK exactly as prescribed.

Things you must not do

Do not take CLINDAMYK to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Side effects

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

This medicine helps most people with treating their infections but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of 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 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
  • stomach cramping
  • stomach discomfort
  • inflammation of the food pipe; discomfort or/and pain of the food pipe
  • loss or distorted sense of taste
  • nausea and/or vomiting
  • heartburn
  • diarrhoea
  • loss of appetite
  • skin rash; severe irritation of the skin
  • jaundice (yellowing of the skin)
  • joint pain and swelling

If any of the following happen while you are taking CLINDAMYK capsules or several weeks after stopping treatment, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • severe stomach cramps;
  • watery and severe diarrhoea which may also be bloody;
  • fever, in combination with one or both of the above.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

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

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

After taking CLINDAMYK capsules

Storage

Keep your CLINDAMYK capsules in a cool, dry place where the temperature stays below 25°C. If you take the capsules out of their original container, they may not keep as well.

Do not store CLINDAMYK capsules or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

CLINDAMYK capsules consist of a white cap and white body imprinted with 'Clin 150' in black printing ink.

Ingredients

CLINDAMYK capsules contain 150 mg of clindamycin (as hydrochloride).

Also contains the following inactive ingredients:

  • lactose
  • magnesium stearate
  • maize starch
  • purified talc
  • titanium dioxide
  • gelatin
  • black printing ink (shellac, iron oxide black)

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15 - 17 Chapel Street
Cremorne VIC 3121
Australia

Distributor

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

Australian registration numbers:
CLINDAMYK 150 mg: AUST R 214371

CLINDAMYK® is a Viatris company trade mark

This leaflet was prepared on May 2023.

CLINDAMYK_cmi\May23/00

Published by MIMS July 2023

BRAND INFORMATION

Brand name

Clindamyk

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

Active ingredient: Clindamycin hydrochloride, equivalent to 150 mg of clindamycin. Clindamycin hydrochloride is white or almost white, crystalline powder, very soluble in water, slightly soluble in ethanol (96 per cent).
Clindamycin is methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-α-L-threo-D-galacto-octapyranoside (CAS 18323-44-9). It is a semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Each [dosage form] contains xx mg of [active ingredient] as the active ingredient.

Excipients with known effect.

Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clindamyk capsules 150 mg: The capsules consist of a white cap and white body imprinted with 'CLIN 150' in black printing ink.

4 Clinical Particulars

4.1 Therapeutic Indications

Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin capsules are also indicated in the treatment of serious infections due to susceptible strains of 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.

Anaerobes.

Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection.

Streptococci.

Serious respiratory tract infections; serious skin and skin structure infections, septicaemia.

Staphylococci.

Serious respiratory tract infections; serious skin and skin structure infections; septicaemia; acute haematogenous osteomyelitis.

Pneumococci.

Serious respiratory tract infections.

Adjunctive therapy.

In the surgical treatment of chronic bone and joint infections due to susceptible organisms. Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
Bacteriological studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

4.2 Dose and Method of Administration

Adults.

150 mg every six hours;
300 mg every six hours - more serious infections;
450 mg every six hours - severe infections.
Absorption of clindamycin is not appreciably modified by ingestion of food, and clindamycin may be taken with meals with no significant reduction of the serum level. To avoid the possibility of oesophageal irritation, clindamycin capsules should be taken with a full glass of water.
In the treatment of anaerobic infections (see Section 4.1 Therapeutic Indications), clindamycin phosphate injection should be used initially. This may be followed by oral therapy with clindamycin hydrochloride capsules at the discretion of the physician.
In cases of beta-haemolytic streptococcal infections, treatment should continue for at least 10 days.

Children.

For formulation reasons, clindamycin capsules are not recommended in newborns, infants and children.

4.3 Contraindications

Clindamycin capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients as listed in Section 6.1 List of Excipients.

4.4 Special Warnings and Precautions for Use

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy. If a hypersensitivity or severe skin reaction occurs, the drug should be discontinued and appropriate therapy should be initiated (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)). The usual agents (adrenaline (epinephrine), corticosteroids, antihistamines, colloid infusion) should be available for emergency treatment of serious reactions.
The use of clindamycin capsules can lead to the development of severe colitis. Fatalities have been reported. Most of these patients have been found to be colonised with C. difficile. Therefore, the drug should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in Section 4.1 Therapeutic Indications. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
It is important to consider the diagnosis of antibiotic associated colitis in patients who develop diarrhoea or colitis associated with antibiotic use. Antibiotic associated colitis appears to result from a toxin produced by Clostridium difficile in the alimentary tract. The severity of the colitis may range from mild watery diarrhoea to severe, persistent, life threatening bloody diarrhoea. The diagnosis is usually made by recognition of the clinical symptoms. The symptoms may occur during therapy or up to several weeks after cessation of therapy. Additional confirmatory signs of antibiotic associated colitis include pseudomembrane formation seen with colonoscopy, C. difficile culture from the stool, or assay of the stool for C. difficile toxin.
Mild cases 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 hydrochloride with atropine sulfate monohydrate (Lomotil), may prolong and/or worsen the condition and should not be used.
Antibiotic associated colitis and diarrhoea (due to C. difficile) occur more frequently and may be more severe in debilitated and/or elderly patients (> 60 years). When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
C. difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, 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.
Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
Clindamycin should not be used in patients with nonbacterial infections.
Clindamycin should be prescribed with caution in atopic individuals.
During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

Use in renal impairment.

Clindamycin is potentially nephrotoxic. Acute kidney injury including acute renal failure has been reported. Therefore, monitoring of renal function should be considered during therapy of patients with pre-existing renal dysfunction or taking concomitant nephrotoxic drugs and monitoring of renal function should be performed if therapy is prolonged.
Patients with very severe renal disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high-dose therapy.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy. The use of clindamycin occasionally results in overgrowth of nonsusceptible organisms - particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Use in hepatic impairment.

Patients with very severe hepatic disease and/or very severe hepatic disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high-dose therapy.

Use in the elderly.

No data available.

Paediatric use.

When clindamycin is administered to newborns and infants, appropriate monitoring of organ system functions is desirable. For formulation reasons, clindamycin capsules are not recommended in newborns, infants and children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, clindamycin should be used with caution in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
In vitro studies of human liver and intestinal microsomes showed that clindamycin is metabolized predominantly by CYP3A4 and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore, inhibitors of CYP3A4 and CYP3A5 may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility was not impaired in rats given 300 mg/kg/day in the diet.
(Category A)
Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed.
Clindamycin has been reported to appear in breast milk in ranges of < 0.5 to 3.8 micrograms/mL. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora such as diarrhea or blood in the stool, or rash. Therefore, clindamycin is not recommended for nursing mothers.
If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical needs for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The adverse effects listed in Table 1 are presented by system organ class. Within each frequency category, the adverse effects are presented in the order of frequency and then of clinical importance.

Post-marketing experience.

The following additional adverse reactions have been reported during post-marketing experience.

Infections and infestations.

Not known: Clostridium difficile colitis.

Immune system disorders.

Not known: anaphylactic shock, anaphylactic reaction, hypersensitivity.

Skin and subcutaneous tissue disorders.

Not known: angioedema.

Renal and urinary disorders.

Frequency not known: acute kidney injury.

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 www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur (see Section 4.8 Adverse Effects ((Undesirable Effects)).
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. Dermatitis, nephrotoxicity, hepatotoxicity, and various haematological abnormalities are toxic effects that occur less frequently. Rapid administration of large doses intravenously has resulted in ventricular dysrhythmias, hypotension and cardiac arrest.

Recommended treatment.

No specific antidote is known. Support respiratory and cardiac function. In cases of overdose, drug levels of clindamycin 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 clindamycin may produce abnormalities of the haematopoietic system. Because clindamycin may cause hepatotoxicity, monitor liver function tests in patients with significant exposure.
Neither haemodialysis nor peritoneal dialysis appear to be effective in reducing clindamycin levels significantly.
Serious anaphylactoid reactions require immediate emergency treatment with adrenaline (epinephrine). Oxygen and intravenous corticosteroids should also be administered as indicated.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis. It binds to the 50S ribosomal subunit and affects both ribosome assembly and the translation process. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. At usual doses, clindamycin exhibits bacteriostatic activity in vitro.

Pharmacodynamic effects.

Efficacy is related to the time period over which the agent level is above the minimum inhibitory concentration (MIC) of the pathogen (%T/MIC).

Resistance.

Resistance to clindamycin is most often due to mutations at the rRNA antibiotic binding site or methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit. These alterations can determine in vitro cross resistance to macrolides and streptogrammins B (MLSB phenotype). Resistance is occasionally due to alterations in ribosomal proteins. Resistance to clindamycin may be inducible by macrolides in macrolide-resistant bacterial isolates. Inducible resistance can be demonstrated with a disk test (D-zone) or in broth. Less frequently encountered resistance mechanisms involve modification of the antibiotic and active efflux. There is complete cross resistance between clindamycin and lincomycin. As with many antibiotics, the incidence of resistance varies with the bacterial species and the geographical area. The incidence of resistance to clindamycin is higher among methicillin-resistant staphylococcal isolates and penicillin-resistant pneumococcal isolates than among organisms susceptible to these agents.

Antimicrobial activity.

Clindamycin has been shown to have in vitro activity against isolates of the following organisms:

Aerobic bacteria.

Gram-positive bacteria: Staphylococcus aureus (methicillin-susceptible isolates); Coagulase-negative staphylococcus (methicillin-susceptible isolates); Streptococcus pneumoniae (penicillin-susceptible isolates); Beta-haemolytic streptococci; Viridans group streptococci; Corynebacterium spp.
Gram-negative bacteria: Chlamydia trachomatis.

Anaerobic bacteria.

Gram-negative bacteria: Bacteroides spp.; Fusobacterium spp.; Prevotella spp.
Gram-positive bacteria: Propionibacterium acnes; Actinomyces spp.; Eggerthella (Eubacterium spp.); Peptococcus spp.; Peptostreptococcus spp. (Finegoldia magna, Micromonas micros); Clostridium spp. (except Clostridium difficile).

Fungi.

Pneumocystis jirovecii.

Protozoans.

Toxoplasma gondii; Plasmodium falciparum.

Breakpoints.

Dilution or diffusion techniques - either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility testing procedures require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures.
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. Particularly in severe infections or therapy failure microbiological diagnosis with verification of the pathogen and its susceptibility to clindamycin is recommended.
Resistance is usually defined by susceptibility interpretive criteria (breakpoints) established by Clinical and Laboratory Standards Institute (CLSI) or European Committee on Antimicrobial Susceptibility Testing (EUCAST) for systemically administered antibiotics.
Clinical and Laboratory Standards Institute (CLSI) breakpoints for relevant organisms are listed in Table 2.
A report of 'Susceptible' (S) indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of 'Intermediate' (I) indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small, uncontrolled technical factors from causing major discrepancies in interpretation. A report of 'Resistant' (R) indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable and other therapy should be selected.
Standardised susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test. Standard clindamycin powder should provide the MIC ranges in Table 3. For the disk diffusion technique using the 2 microgram clindamycin disk, the criteria provided in Table 3 should be achieved.
The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints are presented in Table 4.
EUCAST QC ranges for MIC and disk zone determinations are in Table 5.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Serum level studies with a 150 mg oral dose of clindamycin in 24 normal adult volunteers showed that clindamycin was rapidly absorbed after oral administration. An average peak serum level of 2.5 micrograms/mL was reached in 45 minutes; serum levels averaged 1.51 micrograms/mL at 3 hours and 0.70 micrograms/mL at 6 hours. Absorption of an oral dose is virtually complete (90%). Concomitant administration of food does not appreciably modify the serum concentrations; serum levels have been uniform and predictable from person to person and dose to dose.

Distribution.

Serum level studies following multiple doses of clindamycin for up to 14 days show no evidence of accumulation or altered metabolism of drug. Multiple dose studies in newborns and infants up to 6 months of age show that the drug does not accumulate in the serum and is excreted rapidly.
Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
Concentrations of clindamycin in the serum increased linearly with increased dose. Serum levels exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. Clindamycin is widely distributed in body fluids and tissues, including bones.

Metabolism.

In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly oxidized by CPY3A4, with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin.

Excretion.

The average biological half-life is 2.4 hours. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the faeces; the remainder is excreted as bioinactive metabolites.
Doses of up to 2 g of clindamycin per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses.
No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients are lactose monohydrate, magnesium stearate, maize starch, purified talc, titanium dioxide and gelatin with black printing ink (shellac, iron oxide black).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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.

6.5 Nature and Contents of Container

Available in PVC/Al blister packs of 100 capsules and 24 capsules.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

The structural formula of clindamycin hydrochloride is:
Molecular formula: C18H33ClN2O5S,HCl.
Molecular weight: 461.5.
pKa value: 7.6.

CAS number.

21462-39-5.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes