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CEFOTAXIME 1000MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Cefotaxime Copharma 500mg and 1000mg
Powder for Solution for Injection or infusion
Cefotaxime (as Cefotaxime sodium)
Cefotaxime Copharma 500mg and 1000mg Powder for Solution for Injection or infusion referred
to as Cefotaxime in this leaflet
Read all this leaflet carefully before you are given Cefotaxime Copharma
Keep this leaflet. You may need to read it again
If you any have further questions, please ask your doctor or nurse
If any of the side effects become serious or if you notice any side effects not listed in this
tell your doctor or nurse.
In this leaflet:
1. What Cefotaxime Copharma is and what it is used for
2. Before you are given Cefotaxime
3. How Cefotaxime Copharma is given
4. Possible side-effects
5. How to store Cefotaxime Copharma
6. Further information
1. WHAT CEFOTAXIME IS AND WHAT IT IS USED FOR
Cefotaxime belongs to a group of antibiotics called cephalosporins.
Antibiotics are used to kill the bacteria or “germs” that cause infections.
Cefotaxime Copharma is used to treat infections of the:
chest (respiratory tract infections)
kidneys and urinary tract
skin and soft tissues
genitals caused by gonococci such as gonorrhoea, a sexually transmitted disease
abdomen such as peritonitis (inflammation of the peritoneum, the thin membrane that lines
the abdominal wall and covers the organs within)
the membranes covering the brain (meningitis)
2. BEFORE YOU ARE GIVEN CEFOTAXIME COPHARMA
You should not be given Cefotaxime Copharma if:
you are allergic (hypersensitive) to cefotaxime, or to any of the cephalosporin type antibiotics.
you are allergic to other antibiotics such as penicillin
Take special care with Cefotaxime Copharma if:
you have kidney problems
you are pregnant and breast-feeding
you ever had colitis
you are on a low sodium diet
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Tell your doctor before you are given Cefotaxime Copharma if you are taking any
of the following medicines:
medicines that make you pass more urine (diuretics) such as furosemide
medicines that may cause kidney damage such as amphotericin and aminoglycosides.
other medicines used to treat bacterial infections such as tetracyclines, macrolides and
probenecid, a medicine used to treat gout.
If you require any test on blood, urine or diagnostic, whilst taking this medicine please tell
your doctor or nurse
If you have any doubts about whether Cefotaxime Copharma is suitable for you speak to your
doctor before starting your treatment with this medicine.
Pregnancy and breast-feeding
Please inform your doctor if you are pregnant, planning on becoming pregnant or breastfeeding.
Cefotaxime Copharma should not be used during pregnancy or breastfeeding unless advised by
Driving and using machines
If you have an attack of cramps or muscle spasms or you are feeling giddy, your ability to drive
or operate machinery will be affected after being given Cefotaxime Copharma. Do not drive or
Important information about some of the ingredients of Cefotaxime Copharma
Cefotaxime Copharma 500mg Powder for Solution for Injection or Infusion contains 25.3 mg and
of sodium per gram and Cefotaxime Copharma 1000mg Powder for Solution for Injection or
Infusion contains 50.6mg. If you are on a low sodium diet you should speak to your doctor before
being given this medicine.
3. HOW CEFOTAXIME IS GIVEN
Cefotaxime Copharma will usually be given by a doctor or nurse either directly into a vein
(intravenously) or into a muscle (intramuscularly). In some cases, it may be given as an infusion
(a drip). Cefotaxime Copharma is supplied as a powder, so before it can be given it must be
diluted and made into a solution. This is normally done by your doctor or nurse.
Your doctor will determine the dose you require. The usual doses are given below, however your
doctor may decide to give you less or more cefotaxime than this and given more often depending
on the severity and types of infection, your weight, age and kidney function. The duration of
treatment depends on the type of infection.
Adults and the Elderly:
The usual adult dose is 1000mg given twice a day. Bigger or more frequent doses are sometimes
needed. The duration of treatment depends on the type of infection.
Infants and children from the age of 1 month to 12 years:
For infants and children <50kg the usual dose is 50 mg to 150mg per kilogram of body weight
daily divided into two to four separate doses.
For infants and children >50kg the dose for adults should be used.
For newborn children the dose is usually 50mg per kilogram of body weight given daily divided
into two to four separate doses. Bigger or more frequent doses are sometimes needed.
Adults with moderate to severe kidney problems
For patients with moderate to severe kidney problems the dose of Cefotaxime Copharma will be
If you are given too much, or too little, Cefotaxime Copharma
Your medication will usually be given to you by the health professional, if you think you may
have missed a dose or have received too much medicine please tell your doctor or nurse.
If you stop taking Cefotaxime Copharma
It is important that the course of treatment your doctor has prescribed is taken. You may start to
feel better but it is important not to stop taking this medicine, until the doctor advices, otherwise
your condition may get worse again.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefotaxime Copharma can cause side effects, although not everybody gets
Serious side effects:
As with other antibiotics, some people find they have an allergy to Cefotaxime
Tell your doctor immediately if any of the following symptoms occur:
sudden wheeziness and tightness of chest
swelling of neck, face or lips
skin rash (red spots), itchiness, fever
Other side effects:
Very common side effects:
These may affect more than 1 in
10 people treated with Cefotaxime
oral thrush – white furry, sore tongue and mouth
vaginal thrush – sore and itchy vagina sometimes
with a white discharge
unusual bruising or bleeding caused by low levels
of a type of blood cell called platelets
inflammation of the vein under the skin
nausea, vomiting, stomach pain
rash, hives or itching of skin
pain at the site of injection
headache or dizziness
abnormal levels of certain blood cells in the body
loss of appetite
inflammation of the kidney, which may cause pain
in your kidney area
Rare side effects:
These may affect up to 1 in
10,000 people treated with
symptoms of anaemia such as pale skin and
feelings of tiredness
fever, shivering, headache and joint pains
a spontaneous swelling up of areas of skin or
bacterial infection of the colon, the symptoms of
which include fever, diarrhoea and stomach pain
damage to the liver, this may make you feel tired
in patients with kidney problems, loss of
consciousness, abnormal movements and
Common side effects:
These may affect up to 1 in
1000 people treated with
Very rare side effects:
These may affect more than 1
in 100,000 people treated with
an illness which can affect the skin, and in some
people, the nervous system, joints, heart or other
failure of the bone marrow to make enough white
blood cells (neutrophils)
a severe, potentially fatal allergic reaction
fast or irregular heart beat
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or nurse.
5. HOW TO STORE CEFOTAXIME COPHARMA
Keep out of the reach and sight of children.
Unopened: Do not store vials above 25°C.
This product has an expiry date on the vial and carton label (EXP). The doctor or nurse will check
that the product has not passed this date.
Reconstituted solutions for injection/infusion should be used immediately.
6. FURTHER INFORMATION
What Cefotaxime Copharma contains
The active ingredient is cefotaxime sodium equivalent to 500mg or 1000mg of cefotaxime. The
sodium content is 25.3mg per 500mg and 50.6g per 1000mg of Cefotaxime.
There are no other ingredients.
What Cefotaxime Copharma looks like and contents of the pack
Cefotaxime 500mg Powder for Solution for Injection or Infusion is a white to slightly yellow
powder supplied in 10ml moulded colourless glass vial EP type I with 20 mm grey bromobutyl
rubber plugs and blue coloured flip off aluminium seal 20 mm lacquered on both sides
Cefotaxime 1000mg Powder for Solution for Injection or Infusion is a white to slightly yellow
powder supplied in 15ml moulded colourless glass vial EP type I with 20 mm grey bromobutyl
rubber plugs and green coloured flip off aluminium seal 20 mm lacquered on both sides
Marketing Authorisation Holder:
COPHARMA ApS, Jægersborg Allé 164, DK-2820 Gentofte, Denmark
This leaflet was last approved in xx/yyyy
Product Licence Nos.: 500 mg: PL 40386/0014, 1000 mg: 40386/0015
If this leaflet is difficult to see or read, please contact the marketing authorisation
holder for help.
NAME OF THE MEDICINAL PRODUCT
Cefotaxime Copharma 500mg or 1000mg Powder for Solution for Injection or Infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefotaxime sodium equivalent to 500 mg cefotaxime base.
Each gram of Cefotaxime Copharma 500 mg Powder for Solution for Injection or Infusion
contains 25.3 mg (1.1mmol) of sodium.
Each vial contains cefotaxime sodium equivalent to 1000 mg cefotaxime base.
Each gram of Cefotaxime Copharma 1000 mg Powder for Solution for Injection or
Infusion contains 50.6 mg (2.2 mmol) of sodium.
Powder for solution for injection or Infusion.
White or slightly yellow powder.
For the treatment of the following severe infections when known or thought very likely to be due
to organisms that are susceptible to cefotaxime.
Bacterial infections of the lower respiratory tract (bacterial pneumonia, infected
bronchiectasis, lung abscess and post-operative chest infections)
Complicated infections of the kidneys and upper urinary tract
Severe infections of the skin and soft tissue
Genital infections caused by gonococci
Intra-abdominal infections ( including peritonitis) Cefotaxime should be used in
combination with another antibiotic that can provide anaerobic cover in the treatment of
Acute bacterial meningitis
Consideration should be given to official local guidance on appropriate use of antibiotics when
Posology and method of administration
Cefotaxime Copharma can be administered as an intravenous bolus injection as an intravenous
infusion or as an intramuscularly injection.
The intramuscular method of administration is reserved for exceptional clinical situations and
should undergo a risk-benefit assessment. It is recommended that no more than 4 ml is injected
unilaterally. If the daily dose exceeds 2 g cefotaxime or if cefotaxime is injected more than twice
per day, the i.v. route is recommended. Intramuscular administration of cefotaxime reconstituted
with lidocaine should not be administered to children in the first year of age.
Dosage with individual and daily administration
Dosage and type of administration depends on the severity of the infection, the sensitivity of the
bacterium and the condition of the patient.
For the dosages and routes of administration which are not possible with this strength, other
strengths are available.
The duration of the treatment depends on the course of disease.
In general receive 1 g cefotaxime every 12 hours. In severe cases, the daily dose can be increased
up to 12 g. Daily doses up to 6 g can be divided into at least two individual administrations at 12
hour intervals. Higher daily doses must be divided into at least 3 to 4 individual administrations
at 8 or 6-hour intervals, respectively. For bacterial meningitis, daily doses of 6 to 12g divided into
equal doses every 6 to 8 hours are recommended.
The following table may serve as a guide to dosages:
Type of infection
Typical infections, in which a sensitive
bacterium is proven or suspected
Infections, in which various bacteria with high 1-2 g
to medium sensitivity are demonstrated or
Infants and children from the age of 1 month to 12 years:
The usual dosage range for infants and children <50Kg is 50-150mg/kg/day in 2 to 4 divided
doses. However, in very severe infections doses of up to 200mg/kg/day may be required. For
infants and children in the age range weighing > 50Kg the adult dosage should be used, but the
daily dosage should not exceed 12g.
Premature Neonates: The recommended dosage of 50 mg cefotaxime per kilogram of body
weight per day (in 2-4 divided doses) should not be exceeded for premature neonates because
kidney clearance is not fully matured.
The recommended dosage is 50 mg cefotaxime per kilogram of body weight per day (in 2-4
In cases of life-threatening situations it may be necessary to increase the daily dose. In severe
infections 150-200 mg/kg/day, in divided doses have been given. The following table may serve
as a guide, since there are differences in kidney maturation.
Daily dose of cefotaxime
8 days – 1 month
50 mg/kg every 12 hours i.v.
50 mg/kg every 8 hours i.v.
A single injection of 1 gram may be administered intramuscularly or intravenously. For
complicated infections consideration should be given to available official guidelines. . The
possibility of syphilis needs to be ruled out before starting cefotaxime therapy.
Special dosage recommendations
Dosage in impaired renal function
For adult patients with a creatinine clearance of 5 ml/minute or less, after an initial loading dose
of 1 g, the daily dose should be halved without change in the frequency of dosing i.e. 1 g 12
hourly becomes 0.5 g 12 hourly, 1 g 8 hourly becomes 0.5 g 8 hourly, 2 g 8 hourly becomes 1 g 8
hourly etc. As in all other patients, dosage may require further adjustment according to the
course of the infection and the general condition of the patient.
In patients on haemodialysis, 0.5-2 g is given by i.v. injection at the end of every dialysis. This
dose is repeated every 24 hours.
No dosage adjustments are needed in patients with normal renal function.
Method of administration
See also “Special precautions for disposal of a used medicinal product or waste materials derived
from such medicinal product and other handling of the product”
Hypersensitivity to cefotaxime or to any of the cephalosporins.
Previous immediate and/or severe hypersensitivity reaction to penicillin or to any other type of
Special warnings and special precautions for use
Cefotaxime should be given with caution to patients who have had any other type of
hypersensitivity reaction to penicillin or any other beta-lactam drug. Before therapy with
cefotaxime is instituted, careful inquiry should be made to determine whether the patient had any
previous hypersensitivity reactions to cefotaxime, any other cephalosporin, or to any penicillin or
other beta-lactam drug.
Cefotaxime should be used with caution in patients with allergic diatheses and asthma.
Antibiotic-associated diarrhoea, colitis and pseudomembranous colitis have all been reported with
the use of cefotaxime. These diagnoses should be considered in any patient who develops severe,
persistent diarrhoea during or shortly after treatment.
The presence of Clostridium difficile should be investigated and cefotaxime should be
discontinued immediately. Appropriate treatment measures should be initiated including specific
antibiotic therapy if considered necessary. Antiperistaltics are contraindicated.
Cefotaxime should be used with caution in individuals with a previous history of gastro-intestinal
disease, particularly colitis.
As with other cephalosporins, prolonged use of cefotaxime may result in overgrowth of nonsusceptible organisms, such as enterococci and Candida spp.
Since haematological abnormalities may develop during treatment with cefotaxime, blood count
should be monitored if treatment lasts for longer than 7 days. In cases of neutropenia (<1400
neutrophils/mm3), treatment should be interrupted.
Fast infusion into a central vein can cause arrhythmia.
Patients with severe renal dysfunction (creatinine clearance of 5 ml/minute or less) require dose
If cefotaxime is intramuscularly administered after reconstitution with lidocaine, the SPC of
lidocaine should be checked for the necessary product information.
The product contains sodium, which should be taken into account when prescribing to patients
requiring sodium restriction.
Each gram of Cefotaxime Copharma 500 mg Powder for Solution for Injection or Infusion
contains 25.3 mg (1.1mmol) of sodium.
Each gram of Cefotaxime Copharma 1000 mg Powder for Solution for Injection or Infusion
contains 50.6 mg (2.2 mmol) of sodium.
Interaction with other medicinal products and other forms of Interaction
As far as possible, cefotaxime should not be combined with substances having a bacteriostatic
action (e.g. tetracycline, erythromycin, chloramphenicol or sulfonamides), since an antagonistic
effect has been observed regarding the anti-bacterial effect in vitro. A synergistic effect can result
when combined with aminoglycosides.
An increased risk of oto- and nephrotoxicity have been reputed when high doses of
cephalosporins have been used concomitantly with aminoglycosides. A dose adjustment may be
necessary, and the kidney function must be monitored (see 4.2 Posology and method of
The simultaneous administration of probenecid leads to higher, more prolonged concentrations of
cefotaxime in the serum by inhibiting renal clearance.
Cefotaxime/potentially nephrotoxic drugs and loop diurectics
Kidney function should be monitored when used in combination with potentially nephrotoxic
drugs (for example, aminoglycoside antibiotics, polymyxin B and colistin) and with loop
diuretics, since the nephrotoxicity of these substances may be accentuated.
Influence on laboratory diagnostic tests
False positives may occur in the Coombs-test in rare cases during treatment with cefotaxime.
In glucose determinations in urine and blood, false positive results may be obtained with reducing
substances (Benedict’s or Fehling’s solution or with Clinitest tablets), these may be avoided by
the use of enzymatic methods.
Fertility, pregnancy and lactation
Cefotaxime crosses the placenta. Although reproduction studies in animals have not revealed any
evidence of harm to the foetus, cefotaxime should not be used during pregnancy especially during
the first trimester, without carefully weighing the expected benefit against possible risks.
Cefotaxime is excreted in human milk in small amounts and is usually compatible with breast
feeding, but carefully monitoring of the infant is recommended. Consequently caution should be
exercised when cefotaxime is administered to a nursing mother.
Cefotaxime does not have any known effect on fertility.
Effects on ability to drive and use machines
No studies on the effect to drive and use machines have been performed.
In individual cases, in administration of high doses and particularly with simultaneous kidney
function impairment, attacks of cramp (tonic/clonic), muscle spasms (myoclonias) and giddiness
have been reported. The indicated activities should therefore be discontinued under these
The following frequencies have been used:
Very common (1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to <1/100)
Rare (≥ 1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data).
Frequency Very Common
(>1/100 and < 1/10)
Long-term use may
result in vigorous
growth of resistant
increase in liver
(treatment over long
anaemia (the blood
count should be
monitored if treatment
lasts more than 10
reaction (may result in
headache and joint
patients with impaired
Loss of appetite.
Liver and Bile duct
Moderate or transient
increase in bilirubin,
liver transaminase and
other enzymes (SGOT,
SGPT, LDH, GammaGT, alkaline
such as rash,
Renal and urinary
transient increase in
creatinine and urea
Transient, local pain
and induration after
transient increase in
and other enzymes
(SGPT, LDH, GT).
Coomb’s test (false
for glucose in the
In the event of overdose, it may be necessary, in addition to removing the drug, to take steps to
Cefotaxime is haemodialysable.
a) Symptoms of overdosing
In predisposed patients and with the administration of very high dose, central nervous system
excitation conditions, myoclonia and cramp can occur, as have been described for other βlactams. The risk of the appearance of these undesirable effects is increased in patients with
severely restricted kidney function, epilepsy and meningitis.
b) Emergency measures
Centrally initiated cramps can be treated with diazepam or phenobarbital, but not with phenytoin.
With anaphylactic reactions the usual emergency measures must be commenced, preferably at the
first sign of shock.
In the event of overdose, it may be necessary in addition to removing the drug, to take steps to
List of excipients
Cefotaxime should not be mixed in alkaline solutions such as sodium bicarbonate injection.
Cefotaxime should also not be admixed with aminoglycosides. However, they may be
administered separately to same patient.
Unopened: 2 years
Reconstituted Solution: Should be used immediately
Opened and reconstituted product
From a microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Special precautions for storage
Unopened: Do not Store above 25°C.
Reconstituted product: Should be used immediately
Nature and contents of container
Cefotaxime Copharma 500 mg Powder for Solution for Injection or Infusion is supplied in 10ml
moulded colourless glass vials EP type I with a 20mm grey bromobutyl rubber plugs and blue
coloured flip off aluminum seal 20 mm both sides lacquered. The vials are packed in a carton
containing 1 vial.
Cefotaxime Copharma 1000 mg Powder for Solution for Injection or Infusion is supplied in
15ml moulded colourless glass vials EP type I with a 20mm grey bromobutyl rubber plugs and
dark green coloured flip off aluminum seal 20 mm both sides lacquered. The vials are packed in a
carton containing 1 vial.
Special precautions for disposal of a used medicinal product or waste materials derived
from such medicinal product and other handling of the product
Reconstituted Solution: Cefotaxime Copharma should be reconstituted with water for injections.
When reconstituted with water, a pale yellow colour is formed. The reconstituted product should
be used immediately.
For intravenous injection, Cefotaxime Copharma 500mg Powder for Solution for Injection or
Infusion is dissolved in at least 2 ml water for injections and Cefotaxime Copharma 1000mg
Powder for Solution for Injection or Infusion in at least 4 ml water for injections and
subsequently injected directly into the vein over 3 to 5 minutes or after clamping of the infusion
tube into the distal end of the tube.
For intramuscular injection, Cefotaxime Copharma 500mg Powder for Solution for Injection or
Infusion and Cefotaxime Copharma 1000mg Powder for Solution for Injection or Infusion should
be dissolved in 2 and 4 ml water for injections, respectively. Afterwards, the injection should
take place deep into the gluteal muscle.
Intravenous Infusion: Cefotaxime Copharma may be administered by intravenous infusion. 12g are dissolved in 40-100ml of Water for Injections. The prepared infusion may be administered
over 20-60 minutes.
For single use only. The solution is to be inspected visually for particulate matter prior to
administration. The solution should only be used if the solution is free from particles. Any unused
product or waste material should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Jægersborg Allé 164
MARKETING AUTHORISATION NUMBER(S)
500 mg: PL 40386/0014, 1000 mg: 40386/0015