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CEFOTAXIME SODIUM FOR INJECTION 500MG 1G

Active substance(s): CEFOTAXIME

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Cefotaxime Sodium for Injection 500mg, 1g
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• 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 your pharmacist.








In this leaflet:
1. What Cefotaxime Injection is and what it is used for.
2. Before you are given Cefotaxime Injection.
3. How Cefotaxime Injection is given.
4. Possible side effects.
5. How to store Cefotaxime Injection
6. Further information.

The name of your medicine is “Cefotaxime sodium for injection”
(referred to as Cefotaxime Injection throughout this leaflet).
1. WHAT CEFOTAXIME INJECTION IS AND WHAT IT IS USED FOR
Cefotaxime is an antibiotic. It belongs to a group of antibiotics that
are called cephalosporins. These types of antibiotic are similar to
penicillin.
Cefotaxime kills bacteria and it can be used to treat infections of the:

• Kidneys and bladder

• Blood (septicaemia)

• Skin and flesh immediately under the skin

• Bones

• Heart valves

• Brain (meningitis)

• Abdomen (peritonitis)

• Some sexually transmitted infections (gonorrhoea)
It can also be used to prevent and treat infections following surgical
operations.
2. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION
You should not be given Cefotaxime injection if:
• you are allergic (hypersensitive) to cefotaxime
• you are allergic to any similar antibiotics (known as “cephalosporins”)
• you have ever had a serious allergic reaction when given penicillin
or similar antibiotics
• you are allergic to lidocaine
Tell your doctor or nurse if any of the above apply to you.
Before you are given Cefotaxime injection
You must tell the doctor or nurse if any of the following apply to you:
• you have a history of allergies or asthma
• you are on a low sodium diet
• you have a heart or kidney disorder
• you are having any blood or urine tests
• you have a history of gastro-intestinal problems e.g. colitis, which
causes diarrhoea containing blood.

Taking other medicines
Tell the doctor or nurse if you are taking any of the following medicines:
• the contraceptive pill (in which case you will need to take extra
contraceptive precautions such as using a condom)
• any diuretic medicine (“water tablets”) e.g. furosemide
• another antibiotic e.g. chloramphenicol or aminoglycoside
antibiotics
• probenecid (for gout)
Please tell your doctor if you are taking, or have recently taken, any
other medicines including any that you may have bought without a
prescription.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are breastfeeding, you
must tell your doctor before you are given this medicine.
Driving and using machines
If you are given high doses of cefotaxime, you may feel dizzy/drowsy or
fall asleep or experience convulsions (fits) or unusual body movements.
If this happens, you should not drive or operate machinery.
Important information about some of the ingredients of Cefotaxime
injection
Cefotaxime Injection contains approximately 50mg (2.2 mmol)
of sodium per 1g dose. This should be taken into consideration by
patients on a controlled sodium diet. Tell your doctor or nurse if you
are on a low sodium diet.
3. HOW CEFOTAXIME INJECTION IS GIVEN
Cefotaxime Injection is supplied as a powder so before it can be
given it must be diluted and made into a solution. Your doctor or
nurse normally does this. They will inject this directly into a vein
(intravenous) or muscle (intramuscular). It may also be given by an
intravenous infusion (“drip”).
Your doctor will decide how much you need and how often the
injections should be given.
The usual doses are given below but doctors may prescribe different
doses depending on the severity and type of your infection, your
weight, your age and how well your kidneys are working.
Treatment with Cefotaxime injection is usually continued for
2-3 days after you start to recover from your illness or after your
operation.
Adults and children over 12 years old:
The usual dose is 1 g every twelve hours. In some patients where
infections are severe, the doctor may give a higher dose up to 12g
every day.

Cefotaxime Sodium for Injection
500mg, 1g

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefotaxime Sodium for Injection
500mg, 1g

For the treatment of gonorrhoea, a single 500mg dose is usually given.
To prevent an infection after surgery, 1 -2 g is given before the
operation. A second dose may be needed after the operation.

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical
or healthcare professionals only.
Storage precautions:
Unopened vial: Do not store above 25°C. Keep container in the
outer carton.
Following reconstitution: 2°C - 8°C.
Instructions for use and handling
Following reconstitution: Cefotaxime sodium is compatible with the
following diluents:
Water for Injections
Sodium Chloride 0.9%
Dextrose 5 and 10%
Ringer’s Solution
Ringer-Lactate Solution
Lidocaine 1% (only freshly prepared solutions should be used)
Chemical and physical in-use stability has been demonstrated for 24
hours at 2°C-8°C. However, 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 and should not exceed 24 hours at 2°C-8°C.
After 24 hours any unused solution should be discarded.
Preparation and administration of Cefotaxime Injection
Cefotaxime
(as Cefotaxime sodium)
per vial
500mg
1g

Diluent to be
added

Final
concentration
of solution

2ml
4ml

500mg/ 2.2ml
1g/ 4.4ml

Intravenous Injection
Cefotaxime Sodium for Injection 500mg is dissolved in at least 2 ml
water for injections, Cefotaxime Sodium for Injection 1 g in at least 4 ml
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.
During post-marketing surveillance, potentially life-threatening
arrhythmia has been reported in a very few patients who received
rapid intravenous administration of cefotaxime through a central
venous catheter.
Intravenous Infusion
For brief infusion 2g of Cefotaxime Sodium for Injection is dissolved
in 100 ml of isotonic sodium chloride or glucose solution and
subsequently IV infused over 50 to 60 minutes. Another compatible
infusion solution can also be used for the solution.

Intramuscular Injection
For intramuscular injection. Cefotaxime Sodium for Injection 500mg
is dissolved in 2 ml and Cefotaxime Sodium for Injection 1 g in 4 ml
water for injections respectively. Afterwards the injection should take
place deep into the gluteal muscle. Pain with the IM injection can
be avoided by dissolving Cefotaxime Sodium for Injection 500mg
in 2ml or Cefotaxime Sodium for Injection 1 g in 4 ml 1% lidocaine
solution. An intravascular injection is to be avoided in this case, since
with intravascular administration lidocaine may lead to unrest,
tachycardia, disturbances of cardiac conduction as well as vomiting
and cramp. Cefotaxime reconstituted with lidocaine should not be
administered in children under 30 months.
It is recommended that no more than 4 ml be injected unilaterally. If
the daily dose exceeds 2 g Cefotaxime or if Cefotaxime is injected
more frequently than twice per day, the IV route is recommended.
Combination Therapy
Combination therapy of Cefotaxime with aminoglycosides is
indicated without availability of an antibiogram in the case of severe,
life-threatening infections. Kidney function must be watched in such
combination usage.
Cefotaxime and aminoglycosides should not be mixed in the same
syringe or infusion fluid.
In cases of infections with Pseudomonas aeruginosa combination
with other antibiotics effective against Pseudomonas can also be
indicated.
For infection prophylaxis (peri-operative prophylaxis in surgical
procedures such as colorectal, gastrointestinal, prostatic, urogenital,
obstetric and gynaecological surgery) in patients with weakened
defence mechanisms, combination can also be indicated with other
suitable antibiotics.
Posology
Cefotaxime sodium may be administered intravenously, by bolus
injection or infusion, or intramuscularly. The dosage, route and
frequency of administration should be determined by the severity of
infection, the sensitivity of causative organisms and condition of the
patient. Therapy may be initiated before the results of sensitivity tests
are known.
The clinician should consult published protocols for information
on dosage regimens in specific conditions such as gonorrhoea,
Pseudomonas infections and CNS infections.
Dosage and type of administration depend on the severity of the
infection, the sensitivity of the bacterium and the condition of the
patient.
The duration of the treatment depends on the course of the disease. As
a general rule Cefotaxime is administered for a further 3 to 4 days after
improvement/regression of the symptoms.

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Infants and children up to 12 years old:
The usual daily dose is 50 mg to 100 mg Cefotaxime per kilogram of
their bodyweight. This is usually split into 2 doses each day. Severely
ill children may receive up to 200 mg per kg bodyweight daily (to a
maximum of 6 g daily), split into 3 separate doses.
Young babies (newborn):
The daily dose should not normally exceed 50 mg Cefotaxime per kg
of their bodyweight.
Patients with kidney problems:
Lower doses may be given if you have severe kidney problems.
Patients on dialysis machines will be monitored for the correct dose.
If you think you have missed an injection
This is unlikely as you will probably receive this medicine in hospital. If
you think you have missed a dose, speak to your doctor or nurse.

If you have been given more of this medicine than you should
This is unlikely to happen but if it does, the doctor will treat any
symptoms that follow.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefotaxime Injection can cause side effects,
although not everybody gets them.
As with other antibiotics, some people find they have an allergy to it. Tell
your doctor immediately if any of the following rare symptoms occur:
• Sudden wheeziness and tightness of chest
• Swelling of eyelids, face, lips or throat
• Skin lumps or “hives” (nettle rash)
• Severe skin rashes with itching
• Serious illness with blistering of the skin, mouth, eyes and genitals
• Loss of consciousness, abnormal movements or convulsions (fits)
Antibiotic treatment can affect the normal bacteria in the
gut, causing new infection (colitis). You should tell your doctor
immediately if you develop diarrhoea.
The following side effects may occur in some patients treated with
Cefotaxime injection. Tell your doctor if any become troublesome:
Very common side effects (probably affecting more than 1 in 10 people)
• pain at the injection site
Uncommon side effects (probably affecting less than 1 in 100 patients)
• reduction in blood platelets which increases risk of bruising or
bleeding
• reduction in number of white blood cells which makes infections
more likely
• increase in number of white blood cells
• fever
• increase in liver enzymes and/or bilirubin
• kidney problems
• skin rash, itching, ‘hives’ (nettle rash)
• difficulty breathing
• convulsions (fits)
• diarrhoea
• redness and swelling at injection site

Side effects occurring with unknown frequency
• secondary infections
• serious allergic reactions which may cause difficulty in breathing or
dizziness
• serious allergic reaction which causes swelling of the face or throat
• difficulty in breathing or wheezing
• headache
• dizziness
• loss of consciousness, abnormal movements
• feeling sick (nausea)
• being sick (vomiting)
• stomach pains
• diarrhoea containing blood
• inflammation of the liver (hepatitis)
• skin and whites of the eyes turn yellow (jaundice)
• painful joints
• irregular heart rhythm
• inflammation of the kidneys which may cause dark discolouration
of urine, cloudy/bloody urine, or any change in your urine output.
Treatment with high doses of Cefotaxime, particularly in patients with
kidney problems, has been known to cause loss of consciousness,
abnormal movements and convulsions (“fits”).
Reporting of side effects If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible 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. By reporting side effects
you can help provide more information on the safety of this medicine.
5. HOW TO STORE CEFOTAXIME INJECTION
Keep out of the reach and sight of children.
Do not use Cefotaxime injection after the expiry date which is
printed on the label and carton.
Do not store above 25°C. Keep the vial in the outer carton.
Your doctor, pharmacist or nurse will know how to store Cefotaxime
injection properly.
6. FURTHER INFORMATION
What Cefotaxime injection contains:
Each vial contains 500mg or 1g Cefotaxime (as Cefotaxime sodium).
There are no other ingredients.
What Cefotaxime injection looks like and contents of the pack:
Cefotaxime injection is a white to slightly yellow powder in a glass vial.
Each carton contains 1, 10, 25 or 50 vials. Not all pack sizes may be
marketed
Marketing Authorisation Holder:
Villerton Invest SA
40, Avenue Monterey
L-2163 Luxembourg
Manufacturers:
Anfarm Hellas S.A.,
Shimatari Viotias,
320 09 Greece
Facta Farmaceutici S.p.A,
Nucleo Industriale S. Atto,
San Nicolò a Tordino, 64100 Teramo - Italy
This leaflet was last revised in January 2015
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Adults and children over 12 years 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 hourly intervals. Higher daily doses must be
divided into at least 3 to 4 individual administrations at 8 or 6 hour
intervals respectively.
The following table may serve as a guide to dosages:
Type of Infection

Single Dose
Cefotaxime

Typical infections, in which
sensitivity is demonstrated and
bacterium is proven or
suspected
Infections, in which various
bacteria with high to medium
sensitivity are demonstrated or
suspected
Unclear bacterial illness which
cannot be localised and where
the patient is critically ill

1g

Dose
Interval
12 h

Daily Dose
Cefotaxime
2g

In case of life-threatening situations it may be necessary to increase
the daily dose.
In those situations the following table is recommended.





Age
0 - 7 days
7 days - 1 month
> 1 month

Daily Dose of Cefotaxime
50 mg/kg every 12 hours IV
50 mg/kg every 8 hours IV
75 mg/kg every 8 hours IV

It is not necessary to differentiate between premature and normalgestational age infants.
Dosage in the Case of Impaired Renal Function

2g

12 h

4g

2- 3 g

8h
up to 6 h
up to 6 h

6g
up to 8 g
up to 12 g

For the treatment of gonorrhoea in adults, 1 vial of Cefotaxime
Sodium for Injection 500mg administered as a single administration.

With patients with a creatinine clearance of 20ml/minute or less,
the maintenance dose is reduced to half the normal dose. With
patients with a creatinine clearance of 5ml/minute or less, a
reduction of the maintenance dose to 1 g Cefotaxime (divided
into two individual administrations at 12 hour intervals), seems to be
appropriate. The stated recommendations are based on experience
with adults.
Since Cefotaxime is to a large extent eliminated by haemodialysis, an
additional dose should be administered to patients who are dialysed,
after the dialysis procedure.

In most cases due to less sensitive infective bacteria, an increase
may be necessary, i.e. 1 g Cefotaxime. Examination for syphilis
needs to be carried out before commencing therapy.

Elderly Patients

Perioperative Infection Prophylaxis

Other Advice

For peri-operative infection prophylaxis the administration of a single
dose of 1 to 2 g Cefotaxime 30 to 60 minutes prior to the operation is
recommended. Another antibiotic to cover anaerobic organisms is
necessary. A repeat dose is required if the duration of the operation
exceeds 90 minutes.
Special Dose Recommendations
Lyme borrelisosis: A daily dose of 6 g Cefotaxime (14 to 21 days
duration). The daily dose was generally administered divided into 3
parts (2 g Cefotaxime 3 times daily).

Electrolyte content of the injection solutions: Since Cefotaxime is
available as the sodium salt, the sodium content per dose should be
taken into account within the framework of the overall therapy and
with special balance checks.

No dosage adjustments are needed in patients with normal function.

Basis for calculation: 1 g Cefotaxime (equivalent to 1.04 g Cefotaxime
sodium) should be calculated as 48 mg sodium equivalent to
2.1 mmol sodium.

Infants and children up to 12 years receive 50 to 100 mg Cefotaxime
according to the severity of the infection (up to 150 mg) per Kilogram
of body weight per day, divided into equal doses, administered
at 12 (up to 6) hour intervals. In individual cases - particularly in life
threatening situations - it may be necessary to increase the daily dose
to 200 mg Cefotaxime per kilogram of body weight.
In neonates and infants doses of 50 mg Cefotaxime per kilogram of
body weight per day should not be exceeded in view of not fully
matured kidney clearance.
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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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