Consumer medicine information

Clindamycin Mylan Injection

Clindamycin

BRAND INFORMATION

Brand name

Clindamycin Mylan

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Clindamycin Mylan Injection.

What is in this leaflet

This leaflet answers some common questions about clindamycin injection.

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

All medicines have risks and benefits. Your doctor has weighed the risks of you taking clindamycin injection 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 MYLAN is used for

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

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

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

CLINDAMYCIN MYLAN injection is recommended for patients who are allergic to penicillin or patients for whom, in the judgment of the doctor, penicillin is inappropriate.

Your doctor may have prescribed CLINDAMYCIN MYLAN injection for another reason.

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

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

CLINDAMYCIN MYLAN is not addictive.

Before you are given CLINDAMYCIN MYLAN Injection

When you must not take it

You should not be given CLINDAMYCIN MYLAN injection if you have an allergy to:

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

Symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing and 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 it has expired or is damaged, return it to your pharmacist for disposal.

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

Before you are given it

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

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
  • bowel disease
  • any gastrointestinal (stomach or gut) problems

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor or pharmacist about any of the above, do so before you are given clindamycin injection.

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.

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

  • the antibiotics, erythromycin and rifampicin
  • medicines used for muscle relaxation in anaesthesia

These medicines may be affected by clindamycin or may affect how well it works. 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 this medicine.

How CLINDAMYCIN MYLAN is given

Usually clindamycin injection will be given to you intramuscularly (into a muscle) or intravenously (into the vein by drip) in a hospital by a healthcare professional.

Your dose and how it should be given to you will be determined by your doctor or your pharmacist. If given intravenously, clindamycin injection will be mixed with the appropriate amount of diluent before use. This will be prepared by your pharmacist or health care professional.

It is important that you complete the full course prescribed by your doctor so that all of the bacteria causing your infection will be killed. If the course is not completed, these bacteria may continue to grow and multiply so that your infection may not clear completely or may return.

In case of overdose (if you are given too much)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have been given or has self-injected too much of this medicine.

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

You may need urgent medical attention. Keep the telephone numbers for these services handy. Have the CLINDAMYCIN MYLAN Injection box or this leaflet available to give details if needed.

While you are being given this medicine

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 the clindamycin injection has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

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

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

If you get a sore, white mouth or tongue while being given this medicine or soon after clindamycin injection has been stopped, 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 allows fungi/yeast to grow and the above symptoms to occur.

Clindamycin does not work against fungi/yeast.

If you become pregnant while you are being given clindamycin, tell your doctor.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are being given clindamycin.

Tell all doctors, dentists and pharmacists who are treating you that you are being given CLINDAMYCIN MYLAN injection.

Things you must not do

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

Clindamycin should not be given to treat any other complaints unless instructed by your doctor.

Do not stop using your medicine without checking with your doctor. If you stop CLINDAMYCIN MYLAN too soon, the infection may not clear completely or your symptoms may return.

Side effects

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

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.

It can be difficult to tell whether side effects are the result of taking CLINDAMYCIN MYLAN, effects of your condition or side effects of other medicines you may be taking. For this reason it is important to tell your doctor of any change in your condition.

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

Do not be alarmed by the following list of side effects. You may not experience any of them.

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

  • stomach pain, cramps or discomfort
  • nausea and/or vomiting
  • diarrhoea
  • skin rash; severe irritation of the skin
  • vaginal thrush - sore and itchy vagina and/or discharge
  • low blood pressure (feeling of dizziness or light-headedness)
  • joint pain and swelling
  • pain, swelling, redness or formation of an abscess at the site of the injection
  • loss or distorted sense of taste

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you experience 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
  • pain, swelling, redness and tenderness in vein or pain and swelling in leg
  • chest pain, shortness of breath and/or fainting

These are very serious side effects.

You may need urgent medical attention or hospitalisation.

After finishing it

Tell your doctor immediately if you notice any of the following side effects while you are being given clindamycin injection or several weeks after treatment has stopped:

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

CLINDAMYCIN MYLAN injection can cause some bacteria, which are normally present in the bowel and normally harmless to multiply and therefore cause the above symptoms.

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.

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 liver conditions) can only be found when your doctor does tests from time to time to check on your progress.

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

After using this medicine

Storage

CLINDAMYCIN MYLAN Injection will normally be stored in a hospital. It should be stored below 25°C.

Product description

What this medicine looks like

CLINDAMYCIN MYLAN injection appears as a clear colourless solution and comes in 2 mL or 4 mL glass vials with rubber stopper and aluminium flip off seal.

Ingredients

The active ingredient in CLINDAMYCIN MYLAN injection is clindamycin-2-phosphate.

It also contains, disodium edetate, sodium hydroxide, hydrochloric acid and water for injections.

It does not contain benzyl alcohol.

Sponsor

Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

CLINDAMYCIN MYLAN
300 mg/2 mL: AUST R 189176

CLINDAMYCIN MYLAN
600 mg/4 mL: AUST R 191745

This leaflet was prepared in January 2020.

CLINDAMYCIN_MYLAN cmi\0519/01

Published by MIMS April 2020

BRAND INFORMATION

Brand name

Clindamycin Mylan

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin phosphate.

6.7 Physicochemical Properties

Chemical name: Methyl 7-chloro-6,7,8-trideoxy-6-[[[(2S,4R)-1-methyl-4- propylpyrrolidin-2-yl]carbonyl]amino]-1-thio-L-threo-α-D-galacto- octopyranoside 2-(dihydrogen phosphate).
Molecular formula: C18H34ClN2O8PS.
Molecular weight: 504.96.

Chemical structure.


CAS number.

24729-96-2.

2 Qualitative and Quantitative Composition

The active ingredient is clindamycin phosphate.
Each 1 mL of Clindamycin Mylan solution for injection contains clindamycin phosphate equivalent to 150 mg clindamycin base; 0.5 mg disodium edetate; and Water for Injections q.s. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the injection is 5.5-7.0. This preparation is preservative free.
Clindamycin is a semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

Excipients with known effect.

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

3 Pharmaceutical Form

Solution for Injection.
Clindamycin phosphate injection is a sterile solution of a water soluble ester of clindamycin and phosphoric acid.

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.

Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.
Clindamycin has been shown to have in vitro activity against most isolates of the following organisms.

Aerobic bacteria.

Gram-positive bacteria, including: 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; Viridians group streptococci; Corynebacterium spp.
Gram-negative bacteria: Chlamydia trachomatis.

Anaerobic bacteria.

Gram-negative bacteria: Bacteroides species; Fusobacterium species; Gardnerella vaginalis; Prevotella spp.
Gram-positive bacteria: Propionibacterium acnes; Actinomyces species; 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 3.
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" 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 4. For the disk diffusion technique using the 2 microgram clindamycin disk the criteria provided in Table 4 should be achieved.
The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints are presented in Table 5.
EUCAST QC ranges for MIC and disk zone determinations are in Table 6.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Biologically inactive clindamycin phosphate is rapidly converted to active clindamycin.
By the end of short-term intravenous infusion, peak serum levels of active clindamycin are reached.
In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominately oxidized by CYP3A4, with minor contribution for CYP3A5, to from clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin.
Biologically-inactive clindamycin phosphate disappears rapidly from the serum, the average disappearance half-life is 6 minutes; however, the serum disappearance half-life of active clindamycin is about 3 hours in adults and 2.5 hours in children.
After intramuscular injection of clindamycin phosphate, peak levels of active clindamycin are reached within 3 hours in adults and 1 hour in children. Serum level curves may be constructed from IV peak serum levels as given in Table 7 by application of the disappearance half-lives listed above.
Serum levels of clindamycin can be maintained above the in vitro minimum inhibitory concentrations for most indicated organisms by administration of clindamycin phosphate every 8-12 hours in adults and every 6-8 hours in children, or by continuous intravenous infusion. An equilibrium state is reached by the third dose.
The disappearance half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function; dosage schedules need not be modified in the presence of mild to moderate renal or hepatic disease. No significant levels of clindamycin are attained in the cerebrospinal fluid even in the presence of inflamed meninges.
Serum assays for active clindamycin require an inhibitor to prevent in vitro hydrolysis of clindamycin phosphate.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Clindamycin Mylan is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin Mylan is 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) and infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection, all when given in conjunction with an antibiotic of appropriate Gram-negative aerobic spectrum.

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

This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients listed, see Section 6.1 List of Excipients.

4.4 Special Warnings and Precautions for Use

Serious anaphylactoid reactions require immediate emergency treatment with adrenaline (epinephrine). Oxygen, colloid infusion, antihistamines and intravenous corticosteroids should also be administered as indicated.
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, clindamycin should be discontinued and appropriate therapy should be initiated (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)).
The use of clindamycin can lead to the development of severe colitis. Fatalities have been reported. Therefore, clindamycin should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described, see Section 4.1 Therapeutic Indications. It should not be used in patients with non-bacterial infections such as most upper respiratory tract infections.
A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with the use of antibiotics, including parenteral clindamycin. Symptoms may occur up to several weeks after cessation of antibiotic therapy.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone, however in moderate to severe cases appropriate therapy with suitable oral antibacterial agents effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
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.
Clindamycin should be used with caution in patients with a history of regional enteritis, ulcerative colitis or antibiotic associated colitis.
Clindamycin should be prescribed with caution in atopic individuals.
During prolonged therapy periodic liver and kidney function tests and blood counts should be performed.
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.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy. The use of clindamycin may result in overgrowth of non-susceptible organisms - particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
Clindamycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 10-60 minutes as directed, see Section 4.2 Dose and Method of Administration. Drugs which delay peristalsis (e.g. opiates and diphenoxylate with atropine) may prolong and/or worsen the condition and should not be used.
Rare instances of cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration (see Section 4.2 Dose and Method of Administration).
Local irritation, pain, induration and sterile abscess have been reported after intramuscular injection and thrombophlebitis after intravenous infusion (see Section 4.8 Adverse Effects (Undesirable Effects)). Reactions can be minimised by giving deep intramuscular injections and avoiding prolonged use of indwelling intravenous catheters.

Usage in meningitis.

Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

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.

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, it 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 predominately 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.
See Section 4.2 Dose and Method of Administration; Section 6.2 Incompatibilities for physicochemical interactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(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 human breast milk in ranges from < 0.5 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, it 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 2 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 www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

For Intramuscular and Intravenous Use.
Dosage and route of administration should be determined by the severity of the infection, the condition of the patient and the susceptibility of the causative micro-organism.
Clindamycin Mylan IM administration should be used undiluted.
Clindamycin Mylan IV administration should be diluted (see Dilution for IV use and IV infusion rates below).
Product is for single use in one patient only. Discard any residue.

Adults (IM or IV administration).

The usual daily adult dosage of clindamycin phosphate for infections of the intra-abdominal area, female pelvis and other complicated or serious infections is 1200-2700 mg given in 2, 3 or 4 equal doses. Doses of up to 4800 mg daily have been used successfully. Less complicated infections due to more susceptible organisms may respond to lower doses such as 600-1200 mg/day administered in 3 or 4 equal doses.
Single IM doses of greater than 600 mg are not recommended.

Children over one month of age (IM or IV administration).

Serious infections.

15-25 mg/kg/day in 3 or 4 equal doses.

More severe infections.

25-40 mg/kg/day in 3 or 4 equal doses.
As an alternative to dosing on a body weight basis, children may be dosed on the basis of square metres of body surface.

Serious infections.

350 mg/m2/day.

More severe infections.

450 mg/m2/day.
In severe infections it is recommended that children be given no less than 300 mg per day regardless of body weight.
Parenteral therapy may be changed to oral clindamycin when the condition warrants and at the discretion of the physician.
In cases of β-haemolytic streptococcal infections, treatment should be continued for at least 10 days.

Dilution for IV use and IV infusion rates.

Clindamycin Mylan must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 12 mg per mL and infused at a rate of not more than 30 mg per minute as indicated in Table 1.
To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2° to 8°C for not more than 24 hours.

Compatibility/incompatibility.

Clindamycin has been known to be physically and chemically compatible for at least 24 hours in glucose 5% water and sodium chloride injection solutions containing the following antibiotics in usually administered concentrations: amikacin sulfate, aztreonam, cephamandole nafate, cephazolin sodium, cefotaxime sodium, cefoxitin sodium, ceftazidime sodium, ceftizoxime sodium, gentamicin sulfate, netilmicin sulfate, piperacillin and tobramycin. The compatibility and duration of stability of drug mixtures will vary depending on concentration and other conditions.
No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

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.

The minimal toxic or lethal dose is not well established. At therapeutic doses, the primary toxic effects may involve the gastrointestinal tract and may include severe diarrhoea and pseudomembranous colitis that may result in death. Rapid administration of large doses has resulted in ventricular dysrhythmias, hypotension and cardiac arrest. Dermatitis, nephrotoxicity, hepatotoxicity, and various haematological abnormalities are toxic effects that occur less frequently.

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 Poison Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Disodium edetate, water for injections, hydrochloric acid and sodium hydroxide, for pH adjustment, when necessary.

6.2 Incompatibilities

The following drugs are physically incompatible with clindamycin: ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, magnesium sulfate, ceftriaxone sodium and ciprofloxacin.

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. Do not freeze.
To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2° to 8°C for not more than 24 hours.

6.5 Nature and Contents of Container

Container type.

Clear glass vial.

Pack sizes.

Clindamycin Mylan 300 mg/2 mL: Pack size 10 x 2 mL vials per carton.
Each clear glass vial contains 300 mg of clindamycin as the active ingredient, presented as a solution for injection.
Clindamycin Mylan 600 mg/4 mL: Pack size 10 x 4 mL vials per carton.
Each clear glass vial contains 600 mg of clindamycin as the active ingredient, presented as a solution for injection.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes