Dalacin C Phosphate

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Clindamycin phosphate 178.22 mg/mL Equivalent to clindamycin base 150 mg/mL;  ;  ;  ;  
Available from:
Pfizer New Zealand Limited
INN (International Name):
Clindamycin phosphate 178.22 mg/mL (Equivalent to clindamycin base 150 mg/mL)
Dosage:
600mg/4mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Clindamycin phosphate 178.22 mg/mL Equivalent to clindamycin base 150 mg/mL         Excipient: Benzyl alcohol Disodium edetate dihydrate Hydrochloric acid Sodium hydroxide Water for injection
Units in package:
Ampoule, 4mL, 1 dose unit
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Zhejiang Hisoar Pharmaceutical Co. Ltd
Therapeutic indications:
Clindamycin phosphate has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as streptococci, staphylococci and pneumococci: 1. Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever.
Product summary:
Package - Contents - Shelf Life: Ampoule, 4mL - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, 4mL - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-1532/1
Authorization date:
1974-07-12

DALACIN

C PHOSPHATE INJECTION

DALACIN

®

C

PHOSPHATE Injection

Clindamycin phosphate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Dalacin C Phosphate

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 Phosphate injection against the

benefits this medicine is expected to

have for you.

Dalacin C Phosphate 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

PHOSPHATE Injection

is used for

Dalacin C Phosphate 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 Phosphate injection is

recommended for patients who are

allergic to penicillin or patients for

whom, in the judgment of the doctor,

penicillin is inappropriate.

Ask your doctor if you have any

questions about why Dalacin C

Phosphate injection has been

prescribed for you.

Your doctor may have prescribed

Dalacin C Phosphate injection for

another reason.

This medicine is available only with

a doctor's prescription.

Dalacin C Phosphate is not addictive.

Before you are given

DALACIN C

PHOSPHATE Injection

When you must not be given

it

You must not be given Dalacin C

Phosphate 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

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 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 Phosphate Injection.

Children

Dalacin C Phosphate injection

contains benzyl alcohol. Benzyl

alcohol has been associated with a

DALACIN

C PHOSPHATE INJECTION

rare but serious side effect in infants.

Your doctor will decide if treatment

is appropriate.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Dalacin C Phosphate 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 or pharmacist may have

more information on medicines to be

careful with or avoid while being

given this medicine.

How DALACIN C

PHOSPHATE 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 Phosphate 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

How it is given

Dalacin C Phosphate 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 Phosphate injection will

be diluted if given as injection into a

vein.

If too much is given

(overdose)

As Dalacin C Phosphate 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 Phosphate 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 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

been given too much Dalacin C

Phosphate injection.

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 Dalacin C Phosphate

Injection box or this leaflet

available to give details if needed.

.

While you are being

given DALACIN C

PHOSPHATE 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 Phosphate 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 Phosphate Injection has

been stopped.

A severe skin rash may mean you are

having an allergic reaction to Dalacin

C Phosphate Injection. You may

need urgent medical care.

If you get a sore, white mouth or

tongue while being given Dalacin C

Phosphate or soon after Dalacin C

Phosphate 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

Phosphate does not work against

fungi/yeast.

If you become pregnant while you

are being given Dalacin C

Phosphate, tell your doctor.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

DALACIN

C PHOSPHATE INJECTION

are being given Dalacin C

Phosphate.

Tell all doctors, dentists and

pharmacists who are treating you

that you are being given Dalacin C

Phosphate Injection.

Things you must not do

Dalacin C Phosphate 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

Phosphate 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

Phosphate injection.

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 Phosphate, 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:

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 lightheadedness)

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, particularly if they occur

several weeks after stopping

treatment with Dalacin C

Phosphate 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 Phosphate 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 liver conditions) can only

be found when your doctor does tests

from time to time to check on your

progress.

After using DALACIN

C PHOSPHATE

Injection

Storage

Dalacin C Phosphate 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 Phosphate

Injection.

Product description

What it looks like

Dalacin C Phosphate injection

appears as a clear colourless solution

DALACIN

C PHOSPHATE INJECTION

and comes in 2 mL or 4 mL glass

ampoules.

Ingredients

Dalacin C Phosphate 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 Phosphate injection is

supplied in Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia

Toll Free number: 1800 675 229

Dalacin C Phosphate injection is

supplied in New Zealand by:

Pfizer New Zealand Limited.

PO Box 3998

Auckland, New Zealand

Toll Free Number: 0800 736 363

Australian registration

numbers

300 mg/2 mL injection: AUST R

12294 (Not marketed in New

Zealand)

600 mg/4 mL injection: AUST R

47636

Date of preparation

This leaflet was prepared in April

2016.

© Pfizer Australia Pty Ltd

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NEW ZEALAND DATA SHEET

1. PRODUCT NAME

DALACIN

C Phosphate 600 mg/4 mL solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 mL of DALACIN C Phosphate solution contains 178.22 mg/mL clindamycin phosphate

equivalent to 150 mg clindamycin.

Excipients with known effect:

Each 1 mL of solution contains 9.45 mg benzyl alcohol.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless, sterile solution.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Clindamycin phosphate has been shown to be effective in the treatment of the following

infections when caused by susceptible anaerobic bacteria or susceptible strains of Gram-

positive bacteria such as Streptococci, Staphylococci and Pneumococci:

Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and

scarlet fever.

Lower respiratory infections including bronchitis, pneumonia, empyema and lung abscess.

Skin and soft tissue infections including acne, furuncles, cellulitis, impetigo, abscesses,

and wound infections. For specific skin and soft tissue infections like erysipelas and

paronychia (panaritium).

Bone and joint infections including osteomyelitis and septic arthritis.

Pelvic infections including endometritis, cellulitis, vaginal cuff infection tubo-ovarian

abscesses salpingitis and pelvic inflammatory disease when given in conjunction with an

antibiotic of appropriate Gram-negative aerobic spectrum. In cases of cervicitis due to

Chlamydia trachomatis, monotherapy with clindamycin has been shown to be effective in

eradicating the organism.

Intra-abdominal infections including peritonitis and abdominal abscess when given in

conjunction with an antibiotic of appropriate Gram-negative aerobic spectrum.

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Septicaemia and endocarditis - the effectiveness of clindamycin in the treatment of

selected cases of endocarditis has been documented when clindamycin is determined to be

bactericidal to the infecting organism by in vitro testing of appropriate achievable serum

concentrations.

Dental infections such as periodontal abscess and periodontitis.

Toxoplasmic encephalitis in patients with AIDS. In patients who are intolerant to

conventional treatment, clindamycin in combination with pyrimethamine has been shown

to be efficacious.

Pneumocystis jirovici pneumonia in patients with AIDS. In patients who are intolerant to

or do not respond to conventional treatment, clindamycin in combination with primaquine

has been shown to be efficacious.

4.2 Dose and method of administration

Dose

DALACIN C Phosphate IM administration should be used undiluted.

DALACIN C Phosphate IV administration should be diluted (see Dilution for IV use and IV

infusion rates below).

If significant diarrhoea occurs during therapy, this antibiotic should be discontinued

(see section 4.4).

Adults:

Serious Infections: 150 mg – 300 mg every six hours.

More severe infections: 300 mg – 450 mg every six hours.

Children:

Serious Infections: 8 – 16 mg/kg/day divided into three or four equal doses.

More severe infections: 16 – 25 mg/kg/day divided into three or four equal

doses.

For the treatment of Pelvic Inflammatory Disease - Inpatient treatment

Clindamycin phosphate 900 mg (IV) q8h daily plus an antibiotic with an appropriate Gram-

negative aerobic spectrum administered IV; e.g. gentamicin in patients with normal renal

function. Continue (IV) drugs for at least 4 days and at least 48 hours after the patient

improves. Then continue oral clindamycin hydrochloride 450 mg q6h daily to complete 10-

14 days total therapy.

For the treatment of Cervicitis due to Chlamydia trachomatis:

Clindamycin hydrochloride by mouth 450 mg 4 times daily for 10-14 days.

For the treatment of β-haemolytic Streptococcal infections

In cases of β-haemolytic Streptococcal infections, treatment should continue for at least ten

days.

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For the treatment of Toxoplasmic encephalitis in patients with AIDS

Clindamycin phosphate IV or clindamycin hydrochloride by mouth 600-1200 mg every 6 hours

for two weeks followed by 300-600 mg by mouth every 6 hours. The usual total duration of

therapy is 8 to 10 weeks. The dose of pyrimethamine is 25-75 mg by mouth daily for 8-

10 weeks. Folinic acid 10-20 mg/day should be given with higher doses of pyrimethamine.

For the treatment of Pneumocystis jiroveci pneumonia in patients with AIDS

Clindamycin phosphate IV 600-900 mg every 6 hours or 900 mg IV every 8 hours or

clindamycin hydrochloride 300-450 mg by mouth every 6 hours for 21 days. Primaquine 15-

30 mg dose by mouth once daily for 21 days.

Method of administration

Dilution for IV Use and IV Infusion Rates

DALACIN C Phosphate must be diluted prior to IV administration. The concentration of

clindamycin in diluent for infusion should not exceed 18 mg per mL AND INFUSED AT A

RATE OF NOT MORE THAN 30 MG PER MINUTE AS INDICATED BELOW:

When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

Table 2: Dilution and Infusion Rates in Relation to Total Infusion Dose

Dose

Diluent

Minimum Time

300 mg

50 mL

10 min

600 mg

50 mL

20 min

900 mg

50-100 mL

30 min

1200 mg

100 mL

40 min

Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

Directions for use

The neck of the ampoule is pre-scored 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.

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.

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4.4 Special warnings and precautions for use

SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY

TREATMENT WITH ADRENALINE. 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 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 and section 4.8).

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 birth weight infants may be more likely to develop toxicity.

The use of clindamycin can lead to the development of severe colitis. Fatalities have been

reported. Therefore, DALACIN C Phosphate should be reserved for serious infections where

less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS section. 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. Cholestyramine and colestipol resins have been shown to bind the toxin in vitro. The

colitis is usually characterised by mild watery diarrhoea to severe, persistent diarrhoea,

leukocytosis, fever, severe abdominal cramps which may be associated with the passage of

blood and mucous and if allowed to progress may produce peritonitis, shock and toxic

megacolon. Endoscopic examination may reveal pseudomembranous colitis.

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.

When significant diarrhoea occurs, the drug should be discontinued or, if necessary, continued

only with close observation of the patient. Large bowel endoscopy has been recommended.

Vancomycin has been found to be effective in the treatment of antibiotic associated

pseudomembranous colitis produced by Clostridium difficile. The usual adult dose is 500 mg

to 2 g of vancomycin orally per day in three to four divided doses administered for seven to ten

days.

If both a resin and vancomycin are to be administered con-currently, it may be advisable to

separate the time of administration of each drug.

Diarrhoea, colitis, and pseudomembranous colitis have been observed to begin up to several

weeks following cessation of therapy with clindamycin.

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Systemic corticoids and corticoid retention enemas may help relieve the colitis. Other causes

of colitis should also be considered.

A careful inquiry should be made concerning previous sensitivities to medicines and other

allergens.

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 Phosphate should be prescribed with caution in individuals with a history of

gastrointestinal disease, particularly colitis.

DALACIN C Phosphate 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 DALACIN C Phosphate may result in overgrowth of non-susceptible

organisms - particularly yeasts. Should superinfections occur, appropriate measures should be

taken as indicated by the clinical situation.

DALACIN C Phosphate should not be injected intravenously undiluted as a bolus, but should

be infused over at least 10-60 minutes as directed in the DOSAGE AND ADMINISTRATION

section.

Drugs which delay peristalsis (e.g., opiates and diphenoxylate with atropine [Lomotil

LOMOTIL

]) may prolong and/or worsen the condition and should not be used.

DALACIN C Phosphate should be used with caution in patients with a history of regional

enteritis, ulcerative colitis or antibiotic associated colitis.

Stool culture for Clostridium difficile and stool assay for C. difficile toxin maybe helpful

diagnostically.

Rare instances of cardiopulmonary arrest and hypotension have been reported following too

rapid intravenous administration (see section 4.2).

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Local irritation, pain, induration and sterile abscess have been reported after intramuscular

injection and thrombophlebitis after intravenous infusion (see section 4.8). Reactions can be

minimised by giving deep intramuscular injections and avoiding prolonged use of indwelling

intravenous catheters.

Usage in the Newborn and Infants

When DALACIN C Phosphate is administered to newborns and infants, appropriate

monitoring of organ system functions is desirable.

Usage in Meningitis

Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not

be used in the treatment of meningitis.

4.5 Interaction with other medicines and other forms of interaction

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.

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. Therefore, clinically important

interactions between clindamycin and co-administered drugs metabolised by these CYP

enzymes are unlikely.

4.6 Fertility, pregnancy and lactation

Pregnancy

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).

Breast-feeding

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.

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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 effect of clindamycin on the ability to drive or operate machinery has not been

systematically evaluated.

4.8 Undesirable effects

The adverse effects listed in the table below 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.

System Organ

Class

Common

(≥ 1/100 to < 1/10)

Uncommon

(≥1/1000 to

<1/100)

Rare

(≥1/10000 to

<1/1000)

Frequency not known (cannot

be estimated from available

data)

Infections and

infestations

Pseudomembranous

colitis

Vaginal infection

Blood and

lymphatic

system

disorders

Eosinophilia

Agranulocytosis, neutropenia,

thrombocytopenia, leucopenia

Immune system

disorders

Anaphylactoid reaction

Nervous system

disorders

Dysgeusia

Cardiac

disorders

Cardio-

respiratory

arrest§†

Vascular

disorders

Thrombophlebitis†

Hypotension§†

Gastrointestinal

disorders

Diarrhoea, abdominal

pain

Vomiting, nausea

Hepatobiliary

disorders

Jaundice

Skin and

subcutaneous

tissue disorders

Rash maculo-papular

Urticaria

Erythema

multiforme,

pruritus

Toxic epidermal necrolysis

(TEN), Steven Johnson syndrome

(SJS), drug reaction with

eosinophilia and systemic

symptoms (DRESS), acute

generalised exanthematous

pustulosis (AGEP), dermatitis

exfoliative, dermatitis bullous,

rash morbilliform

Musculoskeletal

and connective

tissue disorders

Polyarthritis

General

disorders and

administration

site conditions

Pain†, injection

site abscess†

Injection site irritation†

Investigations

Liver function test

abnormal

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CIOMS III categories: Very Common

1/10 (

10%); Common

1/100 to

1/10 (

1% and <10%); Uncommon

1/1000 to

1/100 (

0.1% and <1%); Rare

1/10,000 to

1/1000 (

0.01% and <0.1%); Very Rare

1/10,000

(<0.01%)

† Adverse reactions apply only to injectable formulations.

§ Rare instances have been reported following too rapid intravenous administration (see section 4.2).

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 of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions

https://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

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.

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.

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For advice on the management of overdose please contact the National Poisons Centre on 0800

POISON (0800 764766).

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamics effects

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 (MLS

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)

Streptococci groups A, B, C, and G

Viridans group Streptococci

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Corynebacterium spp.

Atypical 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. CLSI or EUCAST).

Standardised susceptibility testing procedures require the use of laboratory control

microorganisms to control the technical aspects of laboratory procedures.

The prevalence of acquired resistance may vary geographically and with time for selected

species and local information on resistance is desirable, particularly when treating severe

infections. As necessary, expert advice should be sought when the local prevalence of

resistance is such that the utility of the agent in at least some types of infections is

questionable. Particularly in severe infections or therapy failure microbiological diagnosis

with verification of the pathogen and its susceptibility to clindamycin is recommended.

Resistance is usually defined by susceptibility interpretive criteria (breakpoints) established by

Clinical and Laboratory Standards Institute (CLSI) or European Committee on Antimicrobial

Susceptibility Testing (EUCAST) for systemically administered antibiotics.

Clinical and Laboratory Standards Institute (CLSI) breakpoints for relevant organisms are

listed below.

Table 1. CLSI Susceptibility Interpretive Criteria for Clindamycin

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Pathogen

Minimal Inhibitory

Concentrations (mcg/mL)

Disk Diffusion

(Zone Diameters in mm)

a

S

I

R

S

I

R

Staphylococcus spp.

≤0.5

1–2

≥4

≥21

15–20

≤14

Streptococcus spp.

≤0.25

≥1

≥19

16–18

≤15

Anaerobic bacteria

≤2

≥8

NA=not applicable; S=susceptible; I=intermediate; R=resistant.

Disk content 2 micrograms of clindamycin

MIC ranges for anaerobes are based on agar dilution methodology.

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 2. For the disk diffusion technique using the 2 mcg

clindamycin disk the criteria provided in Table 2 should be achieved.

Table 2. CLSI Acceptable Quality Control (QC) Ranges for Clindamycin to

be Used in Validation of Susceptibility Test Results

QC Strain

Minimum Inhibitory

Concentration Range

(mcg/mL)

Disk Diffusion Range

(Zone Diameters

in mm)

Staphylococcus aureus

ATCC 29213

0.06–0.25

Staphylococcus aureus

ATCC 25923

24–30

Streptococcus

pneumoniae

ATCC 49619

0.03–0.12

19–25

Bacteroides fragilis

ATCC 25285

0.5–2

Bacteroides

thetaiotaomicron

ATCC 29741

2–8

Eggerthella lenta

ATCC 43055

0.06–0.25

NA=Not applicable.

ATCC

is a registered trademark of the American Type Culture Collection

MIC ranges for anaerobes are based on agar dilution methodology.

The European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints are

presented below.

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Table 3. EUCAST Susceptibility Interpretive Criteria for Clindamycin

MIC breakpoints

(mg/L)

Zone diameter breakpoints

(mm)

a

Organism

S ≤

R >

S ≥

R <

Staphylococcus spp.

0.25

Streptococcus

Groups A, B, C and G

Streptococcus

pneumoniae

Viridans group

Streptococci

Gram-positive

anaerobes

Gram-negative

anaerobes

Corynebacterium spp.

Disk content 2 µg of clindamycin

NA=not applicable; S=susceptible; R=resistant

EUCAST QC ranges for MIC and disk zone determinations are in the table below.

Table 4. EUCAST Acceptable Quality Control (QC) Ranges for Clindamycin

to be Used in Validation of Susceptibility Test Results

QC Strain

Minimum Inhibitory

Concentration Range (mcg/mL)

Disk Diffusion Range

(Zone Diameters

in mm)

Staphylococcus aureus

ATCC 29213

0.06–0.25

23-29

Streptococcus

pneumoniae

ATCC 49619

0.03–0.125

22-28

ATCC

is a registered trademark of the American Type Culture Collection

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 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 1 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 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.

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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.

Table 1: Average Peak Serum Concentrations after Dosing with DALACIN® C Phosphate

Dosage Regimen

Clindamycin

(micrograms/mL)

Clindamycin

Phosphate

(micrograms/mL)

Healthy Adult Males (Post Equilibrium)

300 mg IV in 10 min q 8h

600 mg IV in 20 min q 8h

900 mg IV in 30 min q 12h

1200 mg IV in 45 min q 12h

300 mg IM q 8h

600 mg IM q 12h

Children (first dose)

*

5-7 mg/kg in 1 h

3-5 mg/kg IM

5-7 mg/kg IM

Data in this group from patients being treated for infection

5.3 Preclinical safety data

None stated.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol (9.45 mg),

Disodium edetate (0.5 mg),

Water for Injections.

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6.2 Incompatibilities

DALACIN C Phosphate 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, 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 cephalothin, kanamycin,

gentamicin, penicillin or carbenicillin.

The following drugs are physically incompatible with DALACIN C Phosphate:

ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, magnesium

sulphate, ceftriaxone sodium and ciprofloxacin.

6.3 Shelf life

24 months

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:

4 mL ampoule (600 mg) - 1s

Also available for oral administration:

DALACIN C Capsules 150 mg - Each capsule contains clindamycin hydrochloride hydrate

equivalent to 150 mg clindamycin base.

Please consult prescribing information on oral formulations for further details.

6.6 Special precautions for disposal

None stated.

7. MEDICINE SCHEDULE

Prescription medicine.

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8. SPONSOR

Pfizer New Zealand Ltd

PO Box 3998

Auckland, New Zealand

Toll Free number: 0800 736 363

9. DATE OF FIRST APPROVAL

12 July 1974

10. DATE OF REVISION OF THE TEXT

12 September 2018

Summary of updates

Section

Update

Section 4.6

To update the text related to recommendation for nursing mothers.

® Registered Trademark

Document Approval Record

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