Consumer medicine information

Clindamycin BNM

Clindamycin

BRAND INFORMATION

Brand name

Clindamycin BNM Capsules

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Clindamycin BNM.

What is in this leaflet

Please read this leaflet carefully before you start taking Clindamycin BNM.

This leaflet answers some common questions about Clindamycin BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au.

Reading this leaflet 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 taking Clindamycin BNM against the benefits this medicine is expected to have for you.

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

Keep this leaflet with the medicine.

You may want to read it again.

What Clindamycin BNM is used for

Clindamycin BNM contains clindamycin, an antibiotic. Clindamycin is used to treat bacterial infections in different parts of the body.

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

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

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

Your doctor may have prescribed this medicine for another reason.

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

Clindamycin BNM is available only with a doctor's prescription.

Clindamycin BNM is not addictive.

Before you take Clindamycin BNM

Clindamycin BNM is not suitable for everyone.

When you must not take it

Do not take Clindamycin BNM if you are allergic to any medicine containing clindamycin, lincomycin (a very similar antibiotic), or any of the ingredients listed at the end of this leaflet.

Do not take it after the expiry date (‘EXP’) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is torn or shows signs of tampering.

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

Before you start to take it

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

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

  • diarrhoea, especially severe diarrhoea associated with fever, stomach pain or cramps, or passage of blood and mucous
  • a history of gastrointestinal (stomach or gut) problems, particularly colitis (inflammation of the large bowel)
  • severe liver or kidney problems
  • a history of allergies (e.g. asthma, hay fever or eczema)
  • lactose intolerance.

Tell your doctor if you are over 60 years old.

Diarrhoea and inflammation of the large bowel occur more frequently and may be more severe if you are over 60 years old.

Tell your doctor if you are pregnant or intend to become pregnant.

Since the active ingredient in Clindamycin BNM crosses the placenta, it should be used in pregnancy only if clearly needed. Your doctor will discuss the risks and benefits of using it if you are pregnant.

Do not breast-feed if you are taking this medicine.

The active ingredient in Clindamycin BNM passes into breast milk and there is a possibility that your baby may be affected.

Do not give Clindamycin BNM to children.

Clindamycin BNM is not recommended in children for formulation reasons.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Clindamycin BNM.

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.

Tell any healthcare professional who is prescribing a new medicine for you that you are taking Clindamycin BNM.

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

  • medicines used to relax muscles
  • erythromycin or rifampicin, an antibiotic (medicine used to treat infections).

If you have bowel problems, do not take opioid pain medicines or medicines for diarrhoea without first checking with your doctor.

These medicines may make your bowel problems worse.

The above medicines may be affected by Clindamycin BNM, or may affect how well it works. You may need different amounts of Clindamycin BNM, 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 Clindamycin BNM.

How to take Clindamycin BNM

Read the label carefully and follow all directions given to you by your doctor and pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

The standard adult dose is one capsule every six hours (i.e. 4 times a day). Your doctor may increase this dosage for more serious infections.

Clindamycin BNM is not recommended in children for formulation reasons.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take. This depends on your condition and the type of infection.

If you take the wrong dose, Clindamycin BNM may not work as well and your problem may not improve.

Swallow the capsules whole with a full glass of water and in an upright position.

The content of Clindamycin BNM capsules may irritate your food pipe, therefore it is important they are swallowed without getting stuck.

When to take it

Take Clindamycin BNM with or without food (it does not matter), every six hours or as advised by your doctor.

How long to take it

Continue taking the capsules until you finish the pack or until your doctor tells you to stop. Check with your doctor if you are not sure how long you should be taking it.

Do not stop taking Clindamycin BNM because you are feeling better.

If you do not complete the full course prescribed by your doctor, some of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply, so your infection may not clear up completely or it may return.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If there is still a long time to go before your next dose, take it as soon as you remember, and then go back to taking it as you would normally.

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 hints.

While you are taking Clindamycin BNM

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Clindamycin BNM. Likewise, tell any other doctors, dentists and pharmacists who are treating you that you are taking this medicine.

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

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

If you develop severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking Clindamycin BNM. Do not take any medicines for diarrhoea without first checking with your doctor.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

Tell your doctor if you get a sore, white mouth or tongue while taking or soon after stopping Clindamycin BNM. 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 antibiotics allows fungi/yeast to grow and the above symptoms to occur. Clindamycin BNM does not work against fungi/yeast.

Your doctor may want to carry out liver and kidney function tests or blood counts during long-term treatment.

Things you must not do

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

This medicine is only intended for the use of the person it has been prescribed for.

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

Things to be careful of

Be careful driving or operating machinery until you know how Clindamycin BNM affects you.

Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous.

In case of overdose

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Clindamycin BNM.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too many capsules, you may notice some of the following signs and symptoms of overdose:

  • severe diarrhoea, usually with blood and mucous, stomach pain, fever (symptoms of pseudomembranous colitis, an inflammation of the large bowel)
  • skin rash.

Side effects

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

Like all medicines, Clindamycin BNM may occasionally cause side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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:

  • nausea and/or vomiting
  • itching of the skin
  • taste disturbance or loss of taste.

These side effects are usually mild.

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

  • stomach pain or cramping
  • diarrhoea
  • inflammation of the food pipe, or ulcers and/or pain in the food pipe
  • heartburn
  • skin rash, hives, irritation of the skin
  • jaundice (yellowing of the skin)
  • oral thrush (white, furry, sore tongue and/or mouth)
  • vaginal thrush (discharge and itching in the vagina)
  • painful or swollen joints.

These may be serious side effects. You may need urgent medical attention.

Tell your doctor immediately if you develop the following symptoms while you are taking Clindamycin BNM, or several weeks after you have finished taking it:

  • severe stomach cramps
  • severe diarrhoea (sometimes with blood and mucous)
  • fever, in combination with one or both of the above.

These are symptoms of pseudomembranous colitis, an inflammation of the large bowel, which may require urgent medical care.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • serious allergic reaction (swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing)
  • severe skin reactions accompanied by fever and chills, aching muscles and generally feeling unwell.

These are very serious side effects; you may need urgent medical attention or hospitalisation.

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

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

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking Clindamycin BNM

Storage

Keep your capsules in the pack until it is time to take them.

If you take the capsules out of the pack they may not keep well.

Keep Clindamycin BNM in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window sill. Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it and any other medicine 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.

Do not keep Clindamycin BNM past its expiry date.

Disposal

Return any unused medicine and any medicine past its expiry date (as shown on the labelling) to your pharmacy.

Product description

What it looks like

Clindamycin BNM is available in blister packs of 24 or 100 capsules. The capsules have a powder blue opaque cap and a purple transparent body.

Ingredients

Active ingredient:

  • Clindamycin hydrochloride, equivalent to 150 mg of clindamycin per capsule

Inactive ingredients:

  • Lactose monohydrate
  • magnesium stearate
  • maize starch
  • purified talc
  • gelatin
  • titanium dioxide
  • carmoisine
  • indigo carmine
  • patent blue V.

Clindamycin BNM contains lactose.

Clindamycin BNM does not contain sucrose, tartrazine or any other azo dyes.

Date of preparation

This leaflet was prepared on 15 December 2017.

BRAND INFORMATION

Brand name

Clindamycin BNM Capsules

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin hydrochloride.

6.7 Physicochemical Properties

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.
Molecular formula: C18H33ClN2O5S.HCl.
Molecular weight: 461.5.

Chemical structure.


CAS number.

21462-39-5.
Clindamycin hydrochloride is a white or almost white, crystalline powder. It is very soluble in water, slightly soluble in ethanol (96%).

2 Qualitative and Quantitative Composition

Clindamycin BNM capsules contain clindamycin hydrochloride, equivalent to 150 mg of clindamycin.

Excipients with known effect.

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

3 Pharmaceutical Form

Capsules.
The capsules have a powder blue opaque cap and a purple transparent body.

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 streptogramins 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 test) 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 most isolates of the following organisms.

Aerobic bacteria.

Gram-positive bacteria.

Staphylococcus aureus (methicillin-susceptible isolates), Coagulase-negative staphylococci (methicillin-susceptible isolates), Streptococcus pneumoniae (penicillin-susceptible isolates), Beta-haemolytic streptococci groups A, B, C, and G, Viridans group streptococci, Corynebacterium spp.

Gram-negative bacteria.

Chlamydia trachomatis.

Anaerobic bacteria.

Gram-negative bacteria.

Bacteroides spp., Fusobacterium spp., Gardnerella vaginalis, 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 below. See 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 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 usually achievable concentrations 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.

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. 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. In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly oxidised by CYP3A4, with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin.

Distribution.

Clindamycin is widely distributed in body fluids and tissues, including bones. The average biological half-life is 2.4 hours.
No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.

Excretion.

Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the faeces; the remainder is excreted as bio-inactive 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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Clindamycin BNM (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin BNM 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, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical 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.

4.3 Contraindications

Clindamycin BNM capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients as listed (see 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 generalised exanthematous pustulosis (AGEP), have been reported in patients receiving clindamycin therapy (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)). If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued, and appropriate therapy should be initiated. The usual agents (adrenaline, corticosteroids, antihistamines, colloid infusion) should be available for emergency treatment of serious reactions.
The use of clindamycin 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 (see Section 4.1 Therapeutic Indications). It should not be used in patients with non-bacterial 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, 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.
Clostridium 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 non-bacterial 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.
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 non-susceptible organisms - particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Use in hepatic and renal impairment.

Patients with very severe renal 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 metabolised 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 from < 0.5 to 3.8 micrograms/mL. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora such as diarrhoea 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 need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

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 by decreasing medical seriousness.

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.

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

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 BNM may be taken with meals with no significant reduction of the serum level. To avoid the possibility of oesophageal irritation, Clindamycin BNM 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 (the injection dosage form is available from other brands). This may be followed by oral therapy with Clindamycin BNM (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.

4.7 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.

4.9 Overdose

Signs and symptoms.

For overdose in general, the mainstay of treatment is supportive and symptomatic care.
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. Oxygen and intravenous corticosteroids should also be administered as indicated.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Clindamycin BNM contains lactose monohydrate, magnesium stearate, maize starch, purified talc, gelatin, titanium dioxide, carmoisine, indigo carmine and patent blue V.

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.

6.5 Nature and Contents of Container

Clindamycin BNM is supplied in blister packs of 100 capsules and 24 capsules in cardboard cartons.

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