Consumer medicine information

Dalacin C Injection

Clindamycin

BRAND INFORMATION

Brand name

Dalacin C Injection

Active ingredient

Clindamycin

Schedule

What is in this leaflet

This leaflet answers some common questions about Dalacin C 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 being given Dalacin C Injection against the benefits this medicine is expected to have for you.

Dalacin C Injection should only be given to you by a health professional.

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 DALACIN C Injection is used for

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

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

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

Dalacin C Injection is recommended for patients who are allergic to penicillin.

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

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

Dalacin C Injection is not addictive.

Before you are given DALACIN C Injection

When you must not be given it

You must not be given Dalacin C 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').

Some of the symptoms of an allergic reaction may include:

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

You should not be given this medicine if the expiry date printed on the pack has passed 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 be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other 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
kidney disease
bowel disease
any gastrointestinal (stomach or gut) problems.

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

If you have not told your doctor about any of the above, tell him/her before you are given Dalacin C Injection.

Children

Dalacin C Injection contains benzyl alcohol. Benzyl alcohol has been associated with a rare but serious side effect in infants. Your doctor will decide if treatment is appropriate.

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.

Some medicines and Dalacin C Injection may interfere with each other. These include:

erythromycin, a medicine used to treat bacterial infections
rifampicin, a medicine used to treat bacterial infections
some medicines that may be used during surgery.

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

erythromycin, a medicine used to treat bacterial infections.

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

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

How DALACIN C Injection is given

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

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

How much is given

Your doctor will decide what dose of Dalacin C Injection you should receive and for how long you should receive it for. This depends on your condition, the infection being treated and how severe it is.

For children, the doctor will work out the dose based on their age, body weight and how severe the infection is.

How it is given

Dalacin C Injection is usually given as an injection into a vein (intravenous drip) or into a muscle (intramuscular). It is given by a doctor or trained nurse.

Dalacin C Injection will be diluted if given as injection into a vein.

If you take too much (overdose)

As Dalacin C Injection is usually given to you in hospital under the close supervision of your doctor, it is unlikely that you will receive too much.

However, if you experience severe side effects after being given Dalacin C Injection, tell your doctor or nurse immediately.

Symptoms of an overdose are the same as those listed under the "Side effects" section but are usually of a more severe nature.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Emergency at the nearest hospital if you think that you or anyone else may have been given too much Dalacin C Injection.

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

While you are being given DALACIN C Injection

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 Dalacin C 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 Dalacin C Injection has been stopped. A severe skin rash may mean you are having an allergic reaction to DALACIN C Injection. You may need urgent medical care.

If you get a sore, white mouth or tongue while being given Dalacin C Injection or soon after Dalacin C 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 this medicine allows fungi/yeast to grow and the above symptoms to occur. Dalacin C Injection does not work against fungi/yeast.

If you become pregnant while you are being given Dalacin C Injection, tell your doctor immediately.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Dalacin C Injection.

Tell all doctors, dentists and pharmacists who are treating you that you are being given Dalacin C Injection.

Things you must not do

Dalacin C Injection should not be given to treat any other complaints unless your doctor tells you.

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

Do not stop using your medicine without checking with your doctor.

If you stop using Dalacin C Injection 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 given Dalacin C Injection.

This medicine helps most people with bacterial infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the list of side effects.

You may not experience any of them.

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

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

stomach pain, cramps or discomfort
nausea and/or vomiting
diarrhoea
skin rash; 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 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
swelling of the legs, ankles, or feet, passing less urine, irregular heartbeat, confusion, shortness of breath, weakness, fatigue and nausea
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, particularly if they occur several weeks after stopping treatment with Dalacin C Injection:

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

Dalacin C Injection 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.

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

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

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

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.

After using DALACIN C Injection

Storage

Dalacin C Injection will normally be stored in a hospital. It should be stored at 2°C to 8°C (Refrigerate. Do not freeze).

Disposal

The hospital staff will dispose of any leftover Dalacin C Injection.

Product description

What it looks like

Dalacin C Injection appears as a clear colourless solution and comes in 2 mL or 4 mL glass ampoules.

Ingredients

Dalacin C Injection contains clindamycin 2-phosphate as the active ingredient

It also contains:

benzyl alcohol
disodium edetate
sodium hydroxide
hydrochloric acid
water for injections.

Supplier

Dalacin C Injection is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW 2000
Toll Free number: 1800 675 229
www.pfizer.com.au

® = Registered Trademark

This leaflet was prepared in February 2022.

Australian registration numbers

300 mg/2 mL injection: AUST R 12294

600 mg/4 mL injection: AUST R 47636

Published by MIMS March 2022

BRAND INFORMATION

Brand name

Dalacin C Injection

Active ingredient

Clindamycin

Schedule

1 Name of Medicine

Clindamycin phosphate.

2 Qualitative and Quantitative Composition

Each 1 mL of Dalacin C contains clindamycin phosphate equivalent to 150 mg clindamycin base; 9.45 mg benzyl alcohol; 0.5 mg disodium edetate; and water for injections q.s. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.
Clindamycin is a semi synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for Injection.
Dalacin C (clindamycin phosphate injection) is a sterile solution of a water soluble ester of clindamycin and phosphoric acid.

4 Clinical Particulars

4.1 Therapeutic Indications

Dalacin C is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Dalacin C 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.

4.2 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 microorganism.
Dalacin C IM administration should be used undiluted.
Dalacin C IV administration should be diluted (see Dilution for IV use and IV infusion rates below).

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).

Clindamycin should be dosed based on total body weight regardless of obesity.

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 bodyweight 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 bodyweight.
Parenteral therapy may be changed to oral clindamycin (Dalacin C Capsules) 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.

Dalacin C 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/minute as indicated in Table 1.

Directions for use.

The neck of the ampoule is prescored at the point of constriction (no ampoule file is needed to open the ampoules). A coloured dot on the ampoule head helps to orientate the ampoule. Take the ampoule and face the coloured dot. The ampoule opens easily by placing the thumb on the coloured dot and gently pressing downwards.

Compatibility.

Dalacin C 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, cefamandole nafate, cefazolin 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 cefalotin, kanamycin, gentamicin, penicillin or carbenicillin.

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 under Section 6.1 List of Excipients.

4.4 Special Warnings and Precautions for Use

Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, colloidal 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 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 use of clindamycin can lead to the development of severe colitis. Fatalities have been reported. Therefore, Dalacin C 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.
A toxin produced by Clostridioides 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 C. 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.
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.
Dalacin C should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Dalacin C should be used with caution in patients with a history of regional enteritis, ulcerative colitis or antibiotic associated colitis.
Dalacin C should be prescribed with caution in atopic individuals.
During prolonged therapy, periodic liver function tests and blood counts should be performed.
Clindamycin is potentially nephrotoxic. Acute kidney injury including acute renal failure has been reported. Therefore, monitoring of renal function should be considered during therapy of patients with pre-existing renal dysfunction or taking concomitant nephrotoxic drugs and monitoring of renal function should be performed if therapy is prolonged.
Patients with very severe renal disease 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 Dalacin C may result in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfection occur, appropriate measures should be taken as indicated by the clinical situation.
Dalacin C should not be injected intravenously undiluted as a bolus, but should be infused over at least 10-60 minutes as directed in Section 4.2 Dose and Method of Administration. Drugs which delay peristalsis (e.g. opiates and diphenoxylate with atropine (Lomotil)) 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 Dalacin C is administered to newborns and infants, appropriate monitoring of organ system functions is desirable.
This product contains benzyl alcohol which is associated with severe adverse effects, including fatal "gasping syndrome", in paediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is unknown. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low birthweight infants may be more likely to develop toxicity.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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 Dalacin C 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.
See Section 4.2 Dose and Method of Administration, Compatibility; 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.
Benzyl alcohol can cross the placenta (see Section 4.4 Special Warnings and Precautions for Use).
Clindamycin has been reported to appear in human 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.

4.7 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 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.

Postmarketing experience.

The following additional adverse reactions have been reported during postmarketing 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

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. 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.

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.

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), Clostridioides spp. (except C. 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" (R) indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the usually achievable concentrations, 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 mcg 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.

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 predominantly oxidised by CYP3A4, with minor contribution from CYP3A5, to form 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 Dalacin C, 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 Dalacin C 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.

Obese paediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years.

An analysis of pharmacokinetic data in obese paediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution normalised by total body weight are comparable regardless of obesity.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl alcohol, disodium edetate, hydrochloric acid, sodium hydroxide, water for injections.

6.2 Incompatibilities

The following drugs are physically incompatible with Dalacin C: 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 at 2°C to 8°C (Refrigerate. Do not freeze.)

6.5 Nature and Contents of Container

The following sizes are available:
2 mL ampoule (300 mg): 10's.
4 mL ampoule (600 mg): 10's.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

The MW of clindamycin phosphate is 504.96.

CAS number.

CAS Number: 24729-96-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

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Dalacin C Injection

Clindamycin

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