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DALACIN C CAPSULES 150MG

Active substance(s): CLINDAMYCIN HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dalacin C Capsules 150 mg or Clindamycin 150mg capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
One Dalacin C capsule contains 150mg clindamycin (as hydrochloride).
For excipients, see section 6.1 (List of excipients).

3

PHARMACEUTICAL FORM
Capsule
Hard capsule (white/white) with markings ‘CLIN 150 and Pfizer’ On cap and body

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Antibacterial. Serious infections caused by susceptible Gram-positive organisms,
staphylococci (both penicillinase- and non-penicillinase-producing), streptococci
(except Streptococcus faecalis) and pneumococci. It is also indicated in serious
infections caused by susceptible anaerobic pathogens.
Clindamycin does not penetrate the blood/brain barrier in therapeutically effective
quantities.

4.2

Posology and method of administration
Oral. Dalacin C Capsules should always be taken with a glass of water. Absorption
of Dalacin C is not appreciably modified by the presence of food.
Adults: Moderately severe infection, 150 - 300 mg every six hours; severe infection,
300 - 450 mg every six hours.
Elderly patients: The half-life, volume of distribution and clearance, and extent of
absorption after administration of clindamycin hydrochloride are not altered by
increased age. Analysis of data from clinical studies has not revealed any age-related
increase in toxicity. Dosage requirements in elderly patients, therefore, should not be
influenced by age alone. See Precautions for other factors which should be taken
into consideration.
Children: 3 - 6 mg/kg every six hours depending on the severity of the infection.
Note: In cases of beta-haemolytic streptococcal infection, treatment with Dalacin C
should continue for at least 10 days to diminish the likelihood of subsequent
rheumatic fever or glomerulonephritis.

4.3

Contraindications
Dalacin C is contra-indicated in patients previously found to be sensitive to
clindamycin, lincomycin, or to any component of the formulation.

4.4

Special warnings and precautions for use
Warnings: Dalacin C should only be used in the treatment of serious
infections. In considering the use of the product, the practitioner should bear
in mind the type of infection and the potential hazard of the diarrhoea which
may develop, since cases of colitis have been reported during, or even two or
three weeks following, the administration of clindamycin.
Studies indicate a toxin(s) produced by clostridia (especially Clostridium
difficile) is the principal direct cause of antibiotic-associated colitis. These
studies also indicate that this toxigenic clostridium is usually sensitive in vitro
to vancomycin. When 125 mg to 500 mg of vancomycin are administered
orally four times a day for 7 - 10 days, there is a rapid observed disappearance

of the toxin from faecal samples and a coincident clinical recovery from the
diarrhoea. (Where the patient is receiving cholestyramine in addition to
vancomycin, consideration should be given to separating the times of
administration).
Colitis is a disease which has a clinical spectrum from mild, watery diarrhoea
to severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps,
which may be associated with the passage of blood and mucus. If allowed to
progress, it may produce peritonitis, shock and toxic megacolon. This may be
fatal.
The appearance of marked diarrhoea should be regarded as an indication that
the product should be discontinued immediately. The disease is likely to
follow a more severe course in older patients or patients who are debilitated.
Diagnosis is usually made by the recognition of the clinical symptoms, but can
be substantiated by endoscopic demonstration of pseudomembranous colitis.
The presence of the disease may be further confirmed by culture of the stool
for Clostridium difficile on selective media and assay of the stool specimen for
the toxin(s) of C. difficile.
Clostridium difficile associated diarrhea (CDAD) has been reported with use
of nearly all antibacterial agents, including clindamycin, and may range in
severity from mild diarrhea 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 diarrhea following antibiotic use. Careful medical history is
necessary since CDAD has been reported to occur over two months after the
administration of antibacterial agents.

Precautions: Caution should be used when prescribing Dalacin C to
individuals with a history of gastro-intestinal disease, especially colitis.
Periodic liver and kidney function tests should be carried out during prolonged
therapy. Such monitoring is also recommended in neonates and infants.

Prolonged administration of Dalacin C, as with any anti-infective, may result
in super-infection due to organisms resistant to clindamycin.
Care should be observed in the use of Dalacin C in atopic individuals

4.5

Interaction with other medicaments and other forms of interaction
Clindamycin has been shown to have neuromuscular blocking properties that
may enhance the action of other neuromuscular blocking agents. It should be
used with caution, therefore, in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin in
vitro. Because of possible clinical significance the two drugs should not be
administered concurrently.
Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding have been reported in
patients treated with clindamycin in combination with a vitamin K antagonist
(e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore,
should be frequently monitored in patients treated with vitamin K antagonists.

4.6

Fertility, Pregnancy and lactation
Safety for use in pregnancy has not yet been established.
Clindamycin is excreted in human milk. Caution should be exercised when Dalacin C
is administered to a nursing mother. It is unlikely that a nursing infant can absorb a
significant amount of clindamycin from its gastro-intestinal tract.

4.7

Effects on ability to drive and use machines
Not applicable

4.8.

Undesirable Effects
Blood and the Lymphatic System Disorders: Transient neutropenia
(leucopenia), eosinophilia, agranulocytosis and thrombocytopenia have been
reported. No direct aetiologic relationship to concurrent clindamycin therapy
could be made in any of the foregoing.
Immune System Disorders: A few cases of anaphylactoid reactions have
been reported.
Gastro-intestinal Disorders: Oesophageal ulcers have been reported as
serious adverse events; oesophagitis with oral preparations, nausea, vomiting,

abdominal pain, and diarrhoea (see Section 4.4 Special Warnings and Special
Precautions for Use, Warnings).
Hepatobiliary Disorders: Jaundice and abnormalities in liver function tests
have been observed during clindamycin therapy.
Skin and Subcutaneous Tissue Disorders: Maculopapular rash and urticaria
have been observed during drug therapy. Generalised mild to moderate
morbilliform-like skin rashes are the most frequently reported reactions. Rare
instances of erythema multiforme, some resembling Stevens-Johnson
syndrome, have been associated with clindamycin. Pruritus, vaginitis and rare
instances of exfoliative and vesiculobullous dermatitis have been reported.
Serious cutaneous adverse reaction (SCAR) and rare cases of toxic epidermal
necrolysis have been reported during post-marketing surveillance.
Nervous System Disorders: Frequent cases of Dysgeusia have been observed
upon systemic administration of clindamycin using injectables (IM or IV),
capsules, or oral granulate solutions, which include a few (non-frequent)
serious adverse events.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

4.9

Overdose
In cases of overdosage no specific treatment is indicated.
The serum biological half-life of clindamycin is 2.4 hours. Clindamycin cannot
readily be removed from the blood by dialysis or peritoneal dialysis.
If an allergic adverse reaction occurs, therapy should be with the usual emergency
treatments, including corticosteroids, adrenaline and antihistamines

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Antibacterials for Systemic Use. ATC Code: J01 F F

Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against
Gram-positive aerobes and a wide range of anaerobic bacteria. Most Gram-negative
aerobic bacteria, including the Enterobacteriaceae, are resistant to clindamycin.
Lincosamides such as clindamycin bind to the 50S subunit of the bacterial ribosome
similarly to macrolides such as erythromycin and inhibit the early stages of protein
synthesis. The action of clindamycin is predominantly bacteriostatic although high
concentrations may be slowly bactericidal against sensitive strains.

5.2

Pharmacokinetic properties
General characteristics of active substance
About 90% of a dose of clindamycin hydrochloride is absorbed from the gastrointestinal tract; concentrations of 2 to 3 micrograms per ml occur within one hour
after a 150 mg dose of clindamycin, with average concentrations of about 0.7
micrograms per ml after 6 hours. After doses of 300 and 600 mg peak plasma
concentrations of 4 and 8 micrograms per ml, respectively, have been reported.
Absorption is not significantly diminished by food in the stomach but the rate of
absorption may be reduced.
Clindamycin is widely distributed in body fluids and tissues including bone, but it
does not reach the csf in significant concentrations. It diffuses across the placenta
into the fetal circulation and has been reported to appear in breast milk. High
concentrations occur in bile. It accumulates in leucocytes and macrophages. Over
90% of clindamycin in the circulation is bound to plasma proteins. The half-life is 2
to 3 hours, although this may be prolonged in pre-term neonates and patients with
severe renal impairment.
Clindamycin undergoes metabolism, presumably in the liver, to the active Ndemethyl and sulphoxide metabolites, and also some inactive metabolites. About
10% of a dose is excreted in the urine as active drug or metabolites and about 4% in
the faeces; the remainder is excreted as inactive metabolites. Excretion is slow, and
takes place over several days. It is not effectively removed from the blood by
dialysis.
Characteristics in patients
No special characteristics. See section 4.4 "Special warnings and special precautions
for use" for further information.

5.3

Preclinical safety data
None stated

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Maize starch
Talc
Magnesium stearate
Capsule shell:
Gelatin
Capsule cap:
Indigo carmine (E132)
Erythrosine (E127)
Titanium dioxide
Capsule body:
Indigo carmine (E132)
Erythrosine (E127)
Printing ink:
Shellac
Soya lecithin
Dimeticone (Antifoam DC 1510)
Titanium dioxide (E171)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Bottles: 60 months
Blisters: 60 months

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
Dalacin C Capsules 150 mg are available in blister packs (aluminium
foil/PVC) of 24 and 100 capsules and bottle packs (high density polyethylene
or amber glass) of 24, 100 or 500 capsules.
Not all pack sizes may be marketed

6.6

Special precautions for disposal
None stated

7

MARKETING AUTHORISATION HOLDER

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00057/0957

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/02/1989 / 11/03/2002

10

DATE OF REVISION OF THE TEXT
23/07/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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