Skip to Content

KEMICETINE SUCCINATE INJECTION

Active substance(s): CHLORAMPHENICOL SODIUM SUCCINATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Page 1

Page 3

Kemicetine

®

Succinate Injection

Chloramphenicol sodium succinate equivalent to 1 g
chloramphenicol Powder for Solution for Injection

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:

This medicine contains chloramphenicol sodium succinate,
which is an antibiotic used to treat severe infections such as
typhoid and meningitis, and should only be used when other
antibiotics do not help or are unsuitable. It is also used when
oral chloramphenicol cannot be used or when higher amounts
of the medicine is needed in the blood.
Chloramphenicol prevents bacteria making an essential nutrient
required for growth and multiplication. In time, the number of
bacteria are reduced and the infection is controlled, so that
treatment can be continued using a more gentle antibiotic.
You must talk to a doctor if you do not feel better or if you feel
worse.

2. What you need to know before you are
given Kemicetine Succinate Injection

Do not use Kemicetine Succinate Injection:
• If you have had an allergic reaction (e.g. rash, wheezing)
to chloramphenicol before.
• If you are pregnant, or are breast-feeding.

Warnings and precautions:

Talk to your doctor or pharmacist:
• If you have a history of kidney or liver disease.
• If you are already taking any other medicines which may also
cause bone marrow depression.
• If you have a cold, viral influenza, throat infection and before
using this medicine to prevent bacterial infections.
• If you have recently been or are about to be vaccinated.
This medicine is associated with various forms of anaemia

(a decrease in red blood cells, white blood cells and platelets),
which in turn leads to a loss of immunity and can progress into
leukaemia. It should only be prescribed if less toxic antibiotics
are not available.
New born babies should be treated with care to avoid Grey
Syndrome, which is a serious condition arising from excessive
toxic chloramphenicol metabolites. Treatment should be
terminated as soon as symptoms are identified.
There is a risk of over-growth of non-susceptible organisms,
which can lead to severe diarrhoea up to a few months after
this medicine is given to the patient.

Healthcare Professional Information Leaflet

Kemicetine® Succinate Injection

Other medicines and Kemicetine Succinate Injection:

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
The following medicines interact with Kemicetine Succinate
Injection, which affects the way that one or the other medicine
works:
• anticoagulants of the coumarin-type (to thin your blood
or stop it clotting), antidiabetic agents (e.g. tolbutamide),
anti-epileptic agents (e.g. phenytoin and phenobarbital) or
rifampicin (an antibiotic).

Pregnancy and breast-feeding

If you are pregnant, breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice
before being given this medicine.

FPO

1. What Kemicetine Succinate Injection is and what it is used
for
2. What you need to know before you are given Kemicetine
Succinate Injection
3. How Kemicetine Succinate Injection is given to you
4. Possible side effects
5. How to store Kemicetine Succinate Injection
6. Contents of the pack and other information

1. What Kemicetine Succinate Injection is and
what is it used for

FPO

Package leaflet: Information for the patient

Driving and using machines

No effect on the ability to drive or use machinery is expected
with Kemicetine Succinate Injection.

N. KEM-GB-01

Chloramphenicol sodium succinate
Equivalent to 1 g chloramphenicol
Powder for Solution for Injection

After parenteral administration chloramphenicol is rapidly released from
chloramphenicol sodium succinate. Kemicetine (chloramphenicol) is
a broad spectrum antibiotic and is active against many gram-positive
organisms and gram-negative organisms, spirillae and rickettsia. It acts
by interfering with bacterial protein synthesis. Chloramphenicol is widely
distributed in body tissues and fluids and enters the cerebrospinal fluid.
Chloramphenicol sodium succinate, free chloramphenicol and metabolites
are excreted in the urine.
After intravenous administration of chloramphenicol succinate every 6 hours
elimination half lives were 4.03 hours for chloramphenicol and 2.65 hours
for chloramphenicol succinate. After intravenous chloramphenicol sodium
succinate, steady state peak concentrations were reached on average 18.0
minutes after cessation of the infusion. In infants and children aged 3 days to
16 years the apparent half-life was extremely variable ranging from 1.7
to 12.0 hours.
Indications
Kemicetine Succinate should not be used for trivial infections due to the
possibility of severe blood dyscrasias which may prove fatal. Kemicetine
succinate is indicated for typhoid, meningitis caused by H. influenzae and
other serious infections caused by bacteria susceptible to chloramphenicol. It
is also indicated wherever chloramphenicol is deemed the antibiotic of choice
and oral administration is not possible, or where higher than usual blood
concentrations are required.
Dosage and administration
Posology
The dose administered and the concentration used is dependent on the
severity of the infection. The recommended standard dosage is as follows:

Adults:
The equivalent of 1 g of chloramphenicol every 6-8 hours.
Elderly: The usual adult dosage should be given subject to normal hepatic
and renal function.
Children: The equivalent of 50 mg/kg chloramphenicol, according to
body weight, daily in divided doses every 6 hours (this dose should not be
exceeded). The patient should be carefully observed for signs of toxicity.
Premature Infants and Neonates: 25 mg/kg in divided doses.
In exceptional cases, such as patients with septicaemia or meningitis,
dosage schedule up to 100 mg/kg/day may be prescribed. However, these
high doses should be decreased as soon as clinically indicated. To prevent
relapses, treatment should be continued after the temperature has returned
to normal for 4 days in rickettsial diseases and for 8-10 days in typhoid fever.
The 10 % solution should be given by intravenous injection over a period of
about a minute, or in a large volume of fluid, by slow intravenous infusion.
The concurrent administration of intravenous Kemicetine succinate with
topical treatment has been found to be very effective in the treatment of
osteomyelitic foci, abscesses, empyema and skin and urinary infections.
Method of administration
To be given by intravenous or intramuscular injection.
In order to ensure rapid attainment of high blood levels, Kemicetine
Succinate Injection is best administered by intravenous injection. Where
this is not possible, however, intramuscular administration may be used,
although it should be borne in mind that absorption may be slow and
unpredictable.
The injection should be reconstituted with water for injections, sodium
chloride injection, or dextrose injection 5 %.
The following dilution table may be useful for the administration of a
proportion of the contents of a vial:
Concentration
Solution Volume of diluent to Total volume
strength
be added
after dilution
40%
400 mg/ml
1.7 ml
2.5 ml
25%
250 mg/ml
3.2 ml
4.0 ml
20%
200 mg/ml
4.2 ml
5.0 ml

Contraindications and warnings
Kemicetine Succinate is contraindicated in patients with a previous history of
sensitivity and/or toxic reactions to chloramphenicol. It is also contraindicated
in pregnancy and whilst breast feeding. Kemicetine Succinate is to be
administered only under the direction of a medical practitioner. It should
be reserved for serious infections caused by organisms susceptible
to its antimicrobial effects when less toxic antibiotics are ineffective or
contraindicated. However, chloramphenicol may be chosen to initiate
antibiotic therapy based on the clinical impression. In vitro sensitivity tests
should be performed concurrently so that the drug may be discontinued
as soon as possible if a less toxic antibiotic is indicated by the results of
such tests. The decision to continue use of chloramphenicol, rather than
another antibiotic when both are suggested by in vitro studies to be effective
against a specific pathogen, should be based upon severity of the infection,
susceptibility of the pathogen to the various antimicrobial drugs, and the
efficacy of the various drugs in the infection.
Bone marrow depression and blood disorders
Serious and fatal blood dyscrasias (aplastic anaemia, hypoplastic anaemia,
thrombocytopenia, granulocytopenia, and bone marrow depression) are known
to occur after the administration of chloramphenicol. In addition, there have
been reports of aplastic anaemia attributed to chloramphenicol, which later
resulted in leukaemia. Blood dyscrasias have occurred after both short-term
and prolonged therapy with this drug. Chloramphenicol must not be used in
the treatment of any infection for which a less toxic antibiotic is available.
Patient monitoring
Because of its toxic nature it is important to monitor serum levels of this
antibiotic particularly in new-born and premature infants, in the elderly, in
patients with renal or hepatic disease and in those receiving other drugs with
which chloramphenicol may interact.
It is essential that adequate haematologic functions be closely monitored
during treatment with chloramphenicol. While haematologic determinations
may detect early peripheral haematologic changes, such as leucopoenia,
reticulocytopenia, or granulocytopenia, before they become irreversible, such
determinations cannot be relied on to detect bone marrow depression prior
to the development of aplastic anaemia.

N. KEM-GB-01

Page 4

Page 2

It is desirable that patients be hospitalized during therapy, so that appropriate
laboratory determinations and clinical observations can be made.
Baseline haematologic determinations should be made and determinations
repeated approximately every two days during therapy. The drug should
be discontinued upon appearance of reticulocytopenia, leucopoenia,
thrombocytopenia, anaemia, or any other haematologic findings attributable
to chloramphenicol. However, such determinations do not exclude the
possible later appearance of the irreversible type of bone marrow depression.
Repeated courses of the drug should be avoided if at all possible. Treatment
should not be continued longer than required to produce a cure with little or
no risk of relapse of the disease. Concurrent therapy with other drugs that
may cause bone marrow depression should be avoided.
The following may become apparent after chloramphenicol treatment:
dryness of the mouth, nausea and vomiting, diarrhoea, urticaria, optic neuritis
with blurring or temporary loss of vision, peripheral neuritis, headache and
depression. Chloramphenicol has been shown to interact with, and enhance
the effects of coumarin anticoagulants, some hypoglycaemic agents (e.g.
tolbutamide) and phenytoin. When given concurrently, a dose reduction
of these agents may, therefore, be necessary. Plasma concentration of
chloramphenicol may be reduced with concomitant usage of phenobarbital
and rifampicin. Chloramphenicol may impede the development of immunity
and should therefore not be given during active immunisation.
Hepatic or Renal Impairment
Excessive chloramphenicol serum levels may result from administration of
the recommended dose to patients with impaired liver or kidney function,
including that due to immature metabolic processes in the infant. Dosage
should be adjusted accordingly or, preferably, the serum concentration
should be determined at appropriate intervals.
Grey syndrome in infants and neonates
Precaution should be used in therapy of premature and full-term neonates
to avoid “Grey Syndrome” toxicity. Serum drug levels should be carefully
monitored during therapy of the neonate (newborn infant).
Toxic reactions, including fatalities, have occurred in premature infants
and neonates. The signs and symptoms associated with these reactions

have been referred to as the “Grey Syndrome”. Although “Grey Syndrome”
has been reported in neonates born to mothers after having received
chloramphenicol during labour, in most cases therapy with chloramphenicol
has been instituted within the first 48 hours of life. The following
summarizes the clinical and laboratory determinations that have been made
on these patients.
Symptoms first appeared after 3 to 4 days of continued treatment with high
doses of chloramphenicol. The symptoms appeared in the following order:
abdominal distension with or without emesis, progressive pallid cyanosis,
vasomotor collapse, frequently accompanied by irregular respiration, death
within a few hours of onset of these symptoms.
The progression of symptoms from onset to death was accelerated
with higher dose schedules. Serum drug levels revealed unusually high
concentrations of chloramphenicol (over 90 mcg/mL after repeated doses).
Termination of therapy upon early evidence of the associated symptomatology
frequently reversed the process with complete recovery following.
General
Chloramphenicol must not be used in the treatment of trivial infections or
where it is not indicated, as in colds, viral influenza, infections of the throat
or as a prophylactic agent to prevent bacterial infections.
Superinfections
The use of chloramphenicol, as with other antibiotics, may result in an
overgrowth of nonsusceptible organisms, including fungi. If infections
caused by nonsusceptible organisms appear during therapy, appropriate
measures should be taken.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use
of nearly all antibacterial agents, including chloramphenicol, 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

3. How Kemicetine Succinate Injection is
given to you

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.
Pharmaceutical precautions
Keep container in the outer carton.
Package quantities
Individual vials containing Kemicetine Succinate equivalent to 1 g
chloramphenicol.
POM PL 00057/1001
Keep all medicines out of the sight and reach of children.
Manufactured by:
Actavis Italy S.p.A,
10 Via Pasteur,
Nerviano,
Milan,
Italy.
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road,
Sandwich,
Kent,
CT13 9NJ,
UK
Further information is available to the medical and allied professions on
request from:
Medical Information at Pfizer Limited, Walton Oaks, Tadworth, Surrey,
KT20 7NS, UK.
Tel: 01304 616161
This leaflet was last revised in 05/2014
Ref: KM 14_0

Kemicetine Succinate will be made into a solution and be
given to you by injection into a vein, or into a muscle under
the direction of a medical practitioner. Your doctor will
prescribe the required amount (the dose). The dose is decided
by taking into account the severity of your condition.

Adults:

The usual dosage for adults is; 1g of chloramphenicol every
6-8 hours.

Use in children and adolescents:

The usual dose for children is; 50 mg/kg of chloramphenicol
daily in divided doses every 6 hours (no more than this should
be given); and 25 mg/kg daily in divided equal doses every
6 hours in new-born and premature infants.
The doctor may give you more in certain cases e.g. if you
have septicaemia or meningitis (100 mg/kg/day), but should
then be decreased as soon as appropriate. Your doctor will
decide how long you need to be treated for.
During treatment your doctor will carry out blood tests to
check that:
• Your blood is functioning properly as Kemicetine Succinate
Injection can damage your blood cells.
• Your liver and kidneys are functioning properly as
Kemicetine Succinate Injection may affect these organs.

If you are given more Kemicetine Succinate Injection
than you should

In the case of serious overdosage, charcoal haemoperfusion
may be effective in removing chloramphenicol from your blood.

N. KEM-GB-01

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor immediately if any of the following side
effects occur:
• Severe allergic reaction e.g. red raised areas on your skin
which may look like spots or be several inches across,
which cause itchiness.
• Grey Syndrome – usually in new-born or premature infants,
where the skin appears grey, and the infant is listless and
weak.
• White blood cell counts (which fight infection) can also drop, increasing
the chance of infections, bruising and fever. Anaemia (a low red blood
cell count) that can leave you feeling tired and lethargic.
Other side effects may occur, but, the frequency cannot be
estimated from the available data:
• Dry mouth.
• Nausea (feeling sick), vomiting (being sick) and diarrhoea.
• Headache.
• Depression.
• Inflammation or damage to the nerves causing numbness,
tingling, pain or muscle weakness.
• Blurring, inflammation or temporary loss of vision.
• Chloramphenicol may slow down development of immunity,
and you may develop infections more frequently, which are
difficult to fight off.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.

N. KEM-GB-01

13 May 2014

REASON FOR REVISION: Change of name to Pfizer on
leaflet - this replaces the leaflet component on PAR 3020 which
has now been removed due to the EC now superceded by
changes approved on PAR 3502. this PAR contains the most
recent approved leaflet with annotated changes to Pfizer name.
Mock up is required by 25th May 2014 to submit. expected
approval will be July 2014 and once approved by UK agency
one production PAR will be created for all components

Description KEMICETINE
Market UK
Supplier No KEM-GB-01
Perigord No 229374
Barcode No N/A
Pages 1 of 1

Proof No 01
Component Leaflet
Colour Bar Positions 1, 6, 10
Drawing No N/A
ITF Code (23%) FPO

Dimensions 124 x 480 mm - Image Prints @ 100%
Notes N/A
Colours 01
Supplier Actavis - Nerviano
Smallest Font Used Body Text: 8.5 pt
PAR Number PAR-2014-0004498

14:50

Black

By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Kemicetine Succinate Injection

Your medicine should not be used after the expiry date given on the
vial after EXP. The expiry date refers to the last day of that month
Keep container in the outer carton. Keep this medicine out of
the sight and reach of children.

6. Contents of the pack and other information
What Kemicetine Succinate Injection contains:

The active substance is Chloramphenicol Sodium Succinate.
There are no other ingredients found in Kemicetine Succinate Injection.

What Kemicetine Succinate Injection looks like and
contents of the pack

Kemicetine Succinate Injection is available as single glass
vials. Each vial contains a freeze-dried powder containing the
equivalent of 1 g chloramphenicol.
Marketing Authorisation Pfizer Limited
Holder:
Ramsgate Road, Sandwich,
Kent, CT13 9NJ, UK
Manufacturer:

Actavis Italy S.p.A,
10 Via Pasteur,
Nerviano, Milan, Italy.
For further information on your medicine, contact Medical
Information at Pfizer Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey, KT20 7NS. Tel: 01304 616161.
This leaflet was last revised in 05/2014
Ref: KM 14_0

Expand view ⇕

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.

Hide