Consumer medicine information

Dalacin C Capsules

Clindamycin

BRAND INFORMATION

Brand name

Dalacin C Capsules

Active ingredient

Clindamycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dalacin C Capsules.

What is in this leaflet

This leaflet answers some common questions about Dalacin C 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 Dalacin C 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 DALACIN C capsules are used for

Dalacin C 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 the bacteria causing your infection.

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

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

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

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

Dalacin C is not addictive.

Before you take DALACIN C capsules

When you must not take it

Do not take Dalacin C capsules if you have an allergy to:

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

Some of the symptoms of an allergic reaction may include:

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

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If 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 start to take 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
  • severe kidney disease
  • any gastrointestinal (stomach or gut) problems

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Clindamycin crosses the placenta therefore Dalacin C capsules should only be used in pregnancy if clearly needed.

Dalacin C capsules are not recommended during breastfeeding.

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 start taking Dalacin C capsules.

Taking other medicines

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

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

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

Some 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 will advise you.

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

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

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

How to take DALACIN C capsules

Follow all directions given to you by your doctor or 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 to take

Your doctor will tell you how many capsules you need to take each day. This may depend on your condition and whether or not you are taking any other medicines.

The usual adult dose of Dalacin C is one capsule of 150 mg taken four times a day. The number of capsules may increase with more serious infections. Your doctor will tell you how long to take your capsules.

Dalacin C capsules are not recommended in children for formulation reasons.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Space the doses of Dalacin C 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.

It does not matter if you take this medicine before or after food.

How long to take it

Continue taking Dalacin C 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.

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.

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

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

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 at the nearest hospital, if you think that you or anyone else may have taken too much Dalacin C.

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 Dalacin C box or this leaflet available to give details if needed.

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

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

If you become pregnant while taking Dalacin C, tell your doctor immediately.

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

Tell all doctors, dentists and pharmacists who are treating you that you are taking Dalacin C.

Things you must not do

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

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

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking Dalacin C 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 Dalacin C.

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 Dalacin C, 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 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:

  • 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; irritation of the skin
  • joint pain and swelling

Tell your doctor immediately or go to Accident and 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

The above list includes 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:

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

Dalacin C 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 capsules

Storage

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

Do not store your Dalacin C 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 Dalacin C 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 taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Dalacin C capsules with a strength of 150 mg are available in blister packs of 100 capsules or 24 capsules. The opaque, white capsules are marked with "Clin 150" and "Pfizer" in black.

Ingredients

Dalacin C capsules contain 150 mg of clindamycin hydrochloride as the active ingredient.

It also contains:

  • lactose monohydrate
  • magnesium stearate
  • maize starch
  • purified talc
  • gelatin
  • titanium dioxide
  • edible black ink

Supplier

Dalacin C capsules are supplied in Australia by:

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

Australian registration numbers

150 mg capsule: AUST R 12275

This leaflet was prepared in February 2019

® = Registered Trademark

© Pfizer Australia Pty Ltd

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Dalacin C Capsules

Active ingredient

Clindamycin

Schedule

S4

 

1 Name of Medicine

Clindamycin hydrochloride.

6.7 Physicochemical Properties

C18H33ClN2O5S.HCl. MW: 461.5.
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).

Chemical structure.


CAS number.

21462-39-5.

2 Qualitative and Quantitative Composition

Each Dalacin C capsule contains clindamycin hydrochloride, equivalent to 150 mg of clindamycin.
It is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

Excipient(s) with known effect.

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

3 Pharmaceutical Form

Capsules.

The capsules consist of a white cap and white body imprinted with 'Clin 150' and 'Pfizer' in edible black ink.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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

Pharmacodynamic effects.

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

Resistance.

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

Antimicrobial activity.

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

Aerobic bacteria.

Gram-positive bacteria.

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

Gram-negative bacteria.

Chlamydia trachomatis.

Anaerobic bacteria.

Gram-negative bacteria.

Bacteroides spp., Fusobacterium spp., Gardnerella vaginalis, Prevotella spp.

Gram-positive bacteria.

Propionibacterium acnes, Actinomyces spp., Eggerthella (Eubacterium) spp., Peptococcus spp., Peptostreptococcus spp. (Finegoldia magna, Micromonas micros), Clostridium spp. (except Clostridium difficile).

Fungi.

Pneumocystis jirovecii.

Protozoans.

Toxoplasma gondii, Plasmodium falciparum.

Breakpoints.

Dilution or diffusion techniques, either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility testing procedures require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Particularly in severe infections or therapy failure microbiological diagnosis with verification of the pathogen and its susceptibility to clindamycin is recommended.
Resistance is usually defined by susceptibility interpretive criteria (breakpoints) established by Clinical and Laboratory Standards Institute (CLSI) or European Committee on Antimicrobial Susceptibility Testing (EUCAST) for systemically administered antibiotics.
Clinical and Laboratory Standards Institute (CLSI) breakpoints for relevant organisms are listed in Table 2.
A report of "Susceptible" (S) indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" (I) indicates that the result should be considered equivocal and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where 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.

Clinical trials.

Standardised susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test. Standard clindamycin powder should provide the MIC ranges in Table 3. For the disk diffusion technique using the 2 mcg clindamycin disk the criteria provided in Table 3 should be achieved.
The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints are presented in Table 4.
EUCAST QC ranges for MIC and disk zone determinations are in the Table 5.

5.2 Pharmacokinetic Properties

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. Clindamycin is widely distributed in body fluids and tissues, including bones. 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. 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 bio-inactive metabolites.
Doses of up to 2 g of clindamycin per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses.
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.

4 Clinical Particulars

4.1 Therapeutic Indications

Dalacin C (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Dalacin C 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 judgment 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.

4.3 Contraindications

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

4.4 Special Warnings and Precautions for Use

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients receiving clindamycin therapy. 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 Dalacin C capsules can lead to the development of severe colitis. Fatalities have been reported. Most of these patients have been found to be colonised with C. difficile. Therefore, the drug should be reserved for serious infections where less toxic antimicrobial agents are inappropriate as described, see Section 4.1 Therapeutic Indications. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
It is important to consider the diagnosis of antibiotic associated colitis in patients who develop diarrhoea or colitis associated with antibiotic use. Antibiotic associated colitis appears to result from a toxin produced by Clostridium difficile in the alimentary tract. The severity of the colitis may range from mild watery diarrhoea to severe, persistent, life threatening bloody diarrhoea. The diagnosis is usually made by recognition of the clinical symptoms. The symptoms may occur during therapy or up to several weeks after cessation of therapy. Additional confirmatory signs of antibiotic associated colitis include pseudomembrane formation seen with colonoscopy, C. difficile culture from the stool, or assay of the stool for C. difficile toxin.
Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate hydrochloride with atropine sulfate (Lomotil), may prolong and/or worsen the condition and should not be used. Antibiotic associated colitis and diarrhoea (due to C. difficile), occur more frequently and may be more severe in debilitated and/or elderly patients (> 60 years). When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
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.
Dalacin C 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.
Dalacin C should not be used in patients with nonbacterial infections.
Dalacin C should be prescribed with caution in atopic individuals.
During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibiotic therapy. The use of clindamycin occasionally results in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
Patients with very severe renal disease and/or very severe hepatic disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high dose therapy.

Use in the elderly.

No data available.

Paediatric use.

When clindamycin is administered to newborns and infants, appropriate monitoring of organ system functions is desirable. For formulation reasons, Dalacin C 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, Dalacin C should be used with caution in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
In vitro studies of human liver and intestinal microsomes showed that clindamycin is metabolised predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may reduce clindamycin clearance and inducers of these isoenzymes may increase clindamycin clearance. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness.
In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility was not impaired in rats given 300 mg/kg/day in the diet.
(Category A)
Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations.
Dalacin C 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, clindamycin is not recommended for nursing mothers.
If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

4.8 Adverse Effects (Undesirable Effects)

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

Post-marketing experience.

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

Infections and infestations.

Not known: Clostridium difficile colitis.

Immune system disorders.

Not known: anaphylactic shock, anaphylactic reaction, hypersensitivity.

Skin and subcutaneous tissue disorders.

Not known: angioedema.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Adults.

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

Children.

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

4.7 Effects on Ability to Drive and Use Machines

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

4.9 Overdose

Signs and symptoms.

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).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, magnesium stearate, maize starch, purified talc, titanium dioxide, gelatin with traces of edible black ink.

6.2 Incompatibilities

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

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Available in blister packs of 100 capsules and 24 capsules.

6.6 Special Precautions for Disposal

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

Summary Table of Changes