Consumer medicine information

Clindamycin Lu Capsules

Clindamycin

BRAND INFORMATION

Brand name

Clindamycin Lu

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Clindamycin Lu Capsules.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about CLINDAMYCIN LU 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 risks and benefits. Your doctor has weighed the risks of you taking CLINDAMYCIN LU capsules against the benefits this medicine is expected to have for you.

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 CLINDAMYCIN LU CAPSULES ARE USED FOR

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

CLINDAMYCIN LU capsules works by killing or stopping the growth of the bacteria causing your infection.

CLINDAMYCIN LU capsules will not work against viral infections such as colds or flu.

CLINDAMYCIN LU capsules are recommended for patients who are allergic to penicillin or patients for whom penicillin is not suitable.

Your doctor may have prescribed CLINDAMYCIN LU capsules for another reason. Ask your doctor if you have any questions about why CLINDAMYCIN LU capsules have been prescribed for you.

This medicine is available only with a doctor's prescription. CLINDAMYCIN LU capsule is not addictive.

BEFORE TAKING CLINDAMYCIN LU CAPSULES

When you must not take CLINDAMYCIN LU capsulesDo not take CLINDAMYCIN LU capsules:

  1. if you have an allergy to:
  • clindamycin or lincomycin
  • lactose or any of the other ingredients listed at the end of this leaflet
Symptoms of an allergic reaction may include swelling of the face, lips, tongue or other parts of the body, skin rash, itching or wheezing or difficulty in breathing.
  1. if the packaging is torn or shows signs of tampering
  2. after the expiry date (EXP) printed on the label.
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 CLINDAMYCIN LU capsules, talk to your doctor.

Before you start to take CLINDAMYCIN LU capsules

You must tell your doctor about all of the following before you start to take CLINDAMYCIN LU capsules:

  1. if you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
  2. if you are pregnant or intend to become pregnant.
Clindamycin crosses the placenta therefore CLINDAMYCIN LU capsules should only be used in pregnancy if clearly needed. Your doctor will discuss the risks and benefits of taking CLINDAMYCIN LU capsules during pregnancy.
  1. if you are breastfeeding or plan to breastfeed.
CLINDAMYCIN LU capsules are not recommended during breastfeeding.
  1. if you have or have ever had:
  • severe diarrhoea associated with the use of antibiotics
  • severe liver disease
  • severe kidney disease
  • bowel disease, a medicine used to treat bacterial infections
  • any gastrointestinal (stomach or gut) problems
  1. if you have had any other health problems or medical conditions
  2. if you are taking erythromycin, a medicine used to treat bacterial infections

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

Taking other medicines

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

There may be interference between CLINDAMYCIN LU capsules and some other medicines including:

  • the antibiotic, erythromycin
  • rifampicin, a medicine used to treat bacterial infections
  • medicines used for muscle relaxation in anaesthesia

These medicines may be affected by CLINDAMYCIN LU capsules or may affect how well CLINDAMYCIN LU capsules work. You may need different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking CLINDAMYCIN LU capsules.

HOW TO TAKE CLINDAMYCIN LU CAPSULES

Your doctor or pharmacist will tell you how to take your CLINDAMYCIN LU capsules. Follow all directions given to you by your doctor and pharmacist carefully.

Their directions 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. The directions your doctor or pharmacist gives you should be strictly followed.

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

How much to take and how long to take it

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: CLINDAMYCIN LU capsules are not recommended in children for formulation reasons.

Continue taking CLINDAMYCIN LU capsules 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 CLINDAMYCIN LU capsules or change the dose because you are feeling better. If you stop taking CLINDAMYCIN LU suddenly, the infection may not clear completely or your symptoms may return.

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.

How to take it and when to take it

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

Space the doses of CLINDAMYCIN LU capsules evenly apart and take them at about the same time each day. This will allow the medicine to have its best effect. It will also help you remember when to take it.

CLINDAMYCIN LU capsules can be taken with or without food, it does not matter.

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 double a dose to make up for the dose you have missed.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 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 taken too much CLINDAMYCIN LU.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places/services handy. Have the CLINDAMYCIN LU box or this leaflet available to give details if needed.

WHILE YOU ARE TAKING CLINDAMYCIN LU 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 CLINDAMYCIN LU capsules. 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 CLINDAMYCIN LU capsules, 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 CLINDAMYCIN LU allows fungi/yeast to grow, and the above symptoms to occur. CLINDAMYCIN LU does not work against fungi/yeast.

If you become pregnant while taking CLINDAMYCIN LU, tell your doctor immediately.

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

Tell all doctors, dentists and pharmacists who are treating you that you are taking CLINDAMYCIN LU.

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

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

If you get a severe skin rash tell your doctor immediately. Do this even if the rash occurs after CLINDAMYCIN LU has been stopped. A severe skin rash may mean you are having an allergic reaction to CLINDAMYCIN LU. You may need urgent medical care.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

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

Do not use CLINDAMYCIN LU to treat any other medical complaints unless your doctor tells you to.

SIDE EFFECTS

Check with your doctor or pharmacist as soon as possible if you have any problems while taking CLINDAMYCIN LU, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, CLINDAMYCIN LU can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor 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

Tell your doctor immediately if you notice any of the following side effects while you are taking CLINDAMYCIN LU capsules or several weeks after stopping treatment:

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

These are rare, but serious side effects. You may need urgent medical attention.

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

CLINDAMYCIN LU can cause some bacteria, which are normally present in the bowel and normally harmless to multiply and therefore cause the above symptoms. You may need urgent medical attention. However this side effect is rare.

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.

Some of these side effects (for example, abnormal blood test results and certain kidney and liver conditions) can only be found when your doctor does tests from time to time to check on your progress.

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

  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
  • moderate or severe skin rash or blisters often with flu-like symptoms
  • enlarged lymph glands and/or fever
  • diarrhoea, usually with blood and mucus, stomach pain and fever
  • yellowing of the eyes or skin, also called jaundice
  • swelling of the legs, ankles, or feet, passing less urine, irregular heartbeat, confusion, shortness of breath, weakness, fatigue and nausea
  • chest pain, and/or shortness of breath.

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

Do not be alarmed by this list of possible side effects. You may not experience any of them.

AFTER USING CLINDAMYCIN LU CAPSULES

Storage

Keep your CLINDAMYCIN LU capsules in their original container where the temperature stays below 30°C and protected from light, heat and moisture. If you take the capsules out of their original container, they may not keep as well.

Do not store your CLINDAMYCIN LU capsules, or any other medicine, in a bathroom or near a sink. Do not leave them in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep your CLINDAMYCIN LU capsules where children cannot reach them. 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 using CLINDAMYCIN LU capsules or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules left over.

PRODUCT DESCRIPTION

What it looks like

CLINDAMYCIN LU capsules with a strength of 150 mg are available in packs of 24 capsules, 50 capsules and 100 capsules. The No. 2 Apple Green capsules are marked with "CLD 150".

Ingredients

The active ingredient in CLINDAMYCIN LU is clindamycin hydrochloride. CLINDAMYCIN LU also contains Microcrystalline Cellulose, Lactose, Povidone, Sodium Starch Glycolate, Talc and Magnesium Stearate.

The capsule is a Hard Gelatin Capsules size 2 P Lt Green Op / Plt Green Op (proprietary ingredient number: 109543) imprinted with the text CLD 150 using the ink TekPrint SB-0007P White Ink (proprietary ingredient number: 2216).

Supplier

CLINDAMYCIN LU capsules are supplied in Australia by:

Luminarie Pty Ltd
Baulkham Hills
NSW 2153
Australia
http://www.luminarie.com.au

Australian Register Number(s)
150 mg Capsules
AUST R 214526

This leaflet was prepared in January 2024

Published by MIMS March 2024

BRAND INFORMATION

Brand name

Clindamycin Lu

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin hydrochloride.

2 Qualitative and Quantitative Composition

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

Excipient(s) with known effect.

Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Capsule, hard. The capsules are No. 2 apple green in color and imprinted with CLD 150.

4 Clinical Particulars

4.1 Therapeutic Indications

Clindamycin Lu (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin Lu 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 hydrochloride is not appreciably modified by ingestion of food, and Clindamycin Lu may be taken with meals with no significant reduction of the serum level. To avoid the possibility of oesophageal irritation, clindamycin hydrochloride 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 β-haemolytic streptococcal infections, treatment should continue for at least 10 days.

Children.

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

4.3 Contraindications

Clindamycin hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients as listed under 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. If a hypersensitivity or severe skin reaction occurs, clindamycin 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, corticosteroids, antihistamines, colloid infusion) should be available for emergency treatment of serious reactions.
The use of clindamycin hydrochloride capsules can lead to the development of severe colitis. Fatalities have been reported. Most of these patients have been found to be colonised with Clostridium 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 C. 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.
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 hydrochloride should not be used in patients with nonbacterial infections.
Clindamycin hydrochloride 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 over growth of nonsusceptible organisms, particularly yeasts. Should superinfection occur, appropriate measures should be taken as indicated by the clinical situation.

Use in hepatic impairment.

Patients with 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 renal impairment.

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.

Use in the elderly.

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.

Paediatric use.

When clindamycin is administered to newborns and infants, appropriate monitoring of organ system functions is desirable. For formulation reasons, clindamycin hydrochloride 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 hydrochloride 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.
Clindamycin may be less effective in the presence of strong CYP3A4 inducers such as rifampicin.

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 hydrochloride should be used in pregnancy only if clearly needed.
Clindamycin hydrochloride has been reported to appear in breast milk in ranges of 0.7 to 3.8 microgram/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.

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.

Frequency not known: C. difficile colitis.

Immune system disorders.

Frequency not known: anaphylactic shock, anaphylactic reaction, hypersensitivity.

Skin and subcutaneous tissue disorders.

Frequency 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. Oxygen and intravenous corticosteroids should also be administered as indicated.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

Clindamycin has been shown to have in vitro activity against isolates of the following organisms.
Aerobic Gram positive cocci including Staphylococcus aureus, Staphylococcus epidermidis (penicillinase and nonpenicillinase producing strains).
When tested by in vitro methods some staphylococcal strains originally resistant to erythromycin rapidly develop resistance to clindamycin.
Streptococci (except S. faecalis), Pneumococci.
Anaerobic Gram negative bacilli including Bacteroides species, Fusobacterium species.
Anaerobic Gram positive nonspore forming bacilli including Propionibacterium species, Eubacterium species, Actinomyces species.
Anaerobic and microaerophilic Gram positive cocci including Peptococcus species, Peptostreptococcus species, microaerophilic Streptococci, Clostridia. Clostridia are more resistant than most anaerobes to clindamycin. Most C. perfringens are susceptible, but other species, e.g. C. sporogenes and C. tertium are frequently resistant to clindamycin.
Susceptibility testing should be done.
Cross resistance has been demonstrated between clindamycin and lincomycin.

Disc susceptibility tests.

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.
A report of 'susceptible' 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' 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' 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.
The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

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 microgram/mL was reached in 45 minutes; serum levels averaged 1.51 microgram/mL at 3 hours and 0.70 microgram/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.

Distribution.

Clindamycin is widely distributed in body fluids and tissues, including bones. 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

Microcrystalline cellulose, lactose, povidone, sodium starch glycolate, purified talc and magnesium stearate. Hard gelatin capsule size 2 P Lt Green Op/ Plt Green Op (proprietary ingredient number: 109543), TekPrint SB-0007P White Ink (proprietary ingredient number: 2216).

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 30°C. Protect from light, heat and moisture.

6.5 Nature and Contents of Container

Clindamycin capsules, are available in PVC/Al blister packs of 24 capsules, 50 capsules, and 100 capsules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy (or) any unused medicine or waste material should be disposed of in accordance with local requirements.

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 semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Molecular formula is C18H33ClN2O5S,HCl and Molecular weight is 461.5 for clindamycin hydrochloride.
Clindamycin hydrochloride is a white or almost white crystalline powder that is very soluble in water and slightly soluble in ethanol (96%).

Chemical structure.


CAS number.

21462-39-5.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes