Leaflet:Information for the user

Cefotaxime Sodium 2 g powder for injection and for infusion EFG

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Cefotaxime Sodium and what it is used for

1. What you need to know before you start using Cefotaxime Sodium

3.How to use Cefotaxime Sodium

1. Possible side effects

5.Storage of Cefotaxime Sodium

6.Contents of the pack and additional information

Cefotaxime(an antibiotic that belongs to the group of medications known as cephalosporins) is a medication used to combat bacteria.

It is indicated for infections caused by bacteria sensitive to cefotaxime:

- respiratory infections,

- otolaryngological infections,

- renal and urinary tract infections,

- skin and soft tissue infections,

- bone and joint infections,

- gynecological infections, including gonorrhea,

- abdominal infections (including peritonitis),

- meningitis,

- blood poisoning (sepsis),

- heart inflammation (endocarditis),

- Lyme disease (especially in stages II and III) (infection mainly caused by tick bites).

Additionally, for the prevention of infections after surgical interventions in patients at higher risk of infections.

Do not use Cefotaxime Sal:

-If you are allergic to cefotaxime or to other cephalosporins, or to any of the components of this medication (listed in section 6).

- If you have had a previous acute or severe hypersensitivity reaction to penicillin or to other beta-lactam antibiotics. Penicillin with cephalosporins can cause cross-reactions.

-If you have ever had a severe skin rash or peeling of the skin, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to use cefotaxime:

• If you are allergic to penicillin or to other beta-lactam antibiotics in any form (for known hypersensitivity reactions, see earlier in the section «Do not use Cefotaxime Sal»).
• If you have an allergic reaction (e.g., hay fever, asthma, hives) or if it is known from your medical history. In this case, you have a higher risk of more severe hypersensitivity reactions (fatal in exceptional cases). If you experience a feeling of chest tightness, or feel dizzy, sick, or weak, these may be signs of a hypersensitivity reaction (see section 4).
• If a hypersensitivity reaction occurs, treatment should be interrupted.
• If you experience severe or persistent diarrhea during treatment or several weeks after its completion. Inform your doctor immediately, as diarrhea in its most severe form (called pseudomembranous colitis) could be fatal and should be treated. Do not take any medication that limits intestinal activity.
• If you know you have kidney insufficiency. Inform your doctor in this case; if necessary, your dose may be adjusted. Your kidney function must be monitored.
• If you are receiving concomitant or subsequent treatment with aminoglycosides (other antibiotics), probenecid (for gout) or other medications that can cause kidney damage. A doctor should monitor your kidney function, as these substances may increase the harmful effects on the kidneys and caution is needed.
• If you experience a movement disorder, seizures, confusion, or altered consciousness. These may be signs of what is called encephalopathy. There is a risk of these adverse effects occurring when high doses are administered, in cases of overdose, or if you have kidney insufficiency. If these reactions occur, consult your doctor immediately.
• If your treatment lasts more than 7 to 10 days. In this case, blood control tests should be performed because changes in the blood may occur (see also section 4).
• If you experience signs of a new infection (e.g., fungal membrane infections with redness and a white surface). The use of antibiotics can increase the amount of pathogens that are not sensitive to the medication used. Be vigilant to detect signs of a new infection and inform your doctor if necessary.

Be especially careful with Cefotaxime Sal

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute pustular exanthema (PEGA), have been associated with cefotaxime treatment. Stop taking cefotaxime and seek medical attention immediately if you observe any of the symptoms described in section 4 related to these severe skin reactions.

Other medications and Cefotaxime Sal

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Other antibiotics

The concomitant use of some antibiotics may reduce the effect of cefotaxime. Inform your doctor if you are taking or have taken recently other antibiotics.

Diuretics and potentially nephrotoxic medications

When cefotaxime is used concomitantly with medications that may have a nephrotoxic effect, such as aminoglycosides (other antibiotics) or medications with a high potential for dehydration (diuretics, such as furosemide), the nephrotoxic effect of these medications may be increased. If they are administered concomitantly, kidney function should be monitored (see section 2 «Warnings and Precautions»).

Probenecid

The simultaneous administration of probenecid results in an increase in cefotaxime serum concentration and, therefore, an extension of its effect because probenecid limits the renal elimination of cefotaxime. Inform your doctor if you are taking probenecid, especially if you have kidney insufficiency, so that, if necessary, your dose may be adjusted.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

There are insufficient data on the use of cefotaxime in pregnant women. Animal experiments did not show any teratogenic properties of cefotaxime.

However, cefotaxime should only be used during pregnancy, especially in the first trimester, after a strict evaluation of the risks and benefits of treatment by a specialist.

Lactation:

Cefotaxime is excreted in breast milk in small amounts. If you receive cefotaxime during breastfeeding, it may cause intestinal flora alterations with diarrhea, fungal growth, and may also cause sensitization. Your doctor will decide whether to interrupt breastfeeding or interrupt cefotaxime treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machines

According to previous experience, cefotaxime at low and medium doses has no effect on concentration or reaction capacity.

If you experience adverse effects such as dizziness or encephalopathy, which may be associated with seizures, confusion, altered consciousness, and movement disorders, you should not drive or operate machines.

Cefotaxime Sal contains sodium

This medicationcontains 101.2 mg (4.40 mmol) of sodium per dose, which is equivalent to 5.1% of the maximum daily recommended sodium intake in the diet for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist. Cefotaxime will be administered intravenously. Remember to use your medication.

Your doctor will indicate the appropriate dose and determine the duration of your treatment and the administration method, do not suspend or prolong it.

The dose, administration method, and time intervals between injections depend on the dose, pathogen sensitivity, infection severity, and patient condition.

Unless your doctor indicates otherwise, the recommended dose is:

Adults and children over 12 years old:the usual dosing regimen is 1 g of cefotaxime every 12 hours. In severe cases, the daily dose can be increased to 12 g. Daily doses up to 6 g can be divided into at least two fractional doses administered at 12-hour intervals. Higher daily doses should be divided into at least 3-4 fractional doses with 6 or 8-hour administration intervals.

The following table can be considered a dosing regimen:

For the treatment of gonorrhea in adults, a single dose of 0.5 g of cefotaxime should be administered intramuscularly. In less sensitive pathogens, a higher dose may be required. Before starting treatment, check for syphilis.

For perioperative prophylaxis of infections, it is recommended to administer 1-2 g of cefotaxime 30-60 minutes before surgery. Less sensitive pathogens may require a higher dose. Before starting treatment, check for syphilis.

For Lyme disease, the daily dose is 6 g of cefotaxime (14-21 days). In most cases, the daily dose is divided into 3 fractional doses (2 g of cefotaxime 3 times a day), but in some cases, it has been administered in 2 fractional doses (3 g of cefotaxime 2 times a day). The dosing recommendations are not based on comparative clinical trials, but on observations of individual patients.

Combined treatment

In severe infections that pose a vital risk, combined treatment with cefotaxime and aminoglycosides without an antibiogram is indicated. When combined with aminoglycosides, renal function should be monitored.

In cases of Pseudomonas aeruginosa infection, combined treatment with other effective antibiotics against Pseudomonas may also be indicated.

For prophylaxis of infections in patients with a weakened immune system, combined treatment with other appropriate antibiotics may also be indicated.

Children under 12 years old and infants receive 50-100 mg of cefotaxime (up to 150 mg) per kilogram of body weight daily, depending on the severity of the infection. The daily dose should be divided into 2 or more identical fractional doses, administered at 12 (6) hour intervals. In individual cases, especially in life-threatening situations, the daily dose can be increased to 200 mg of cefotaxime per kilogram of body weight.

In premature babies, renal function is not yet fully developed, and the daily dose should not exceed 50 mg of cefotaxime per kilogram of body weight.

In patients with severe renal insufficiency (creatinine clearance less than 10 ml/min), after the initial normal dose (the first dose at the start of treatment), the maintenance dose can be reduced to half the normal dose, maintaining the administration interval.

Patients on hemodialysis receive 1-2 g of cefotaxime daily, depending on the severity of the infection. Cefotaxime should be administered after dialysis on the day of dialysis.

Patients on peritoneal dialysis receive 1-2 g of cefotaxime daily, depending on the severity of the infection. Cefotaxime is not eliminated by peritoneal dialysis.

Cefotaxime 2g is administeredintravenously (in a vein).

Older patients

In older patients, renal function should be closely monitored, and if necessary, the dose should be adjusted.

Intravenous injection

To administer intravenously, dissolve 2 g of cefotaxime in at least 10 ml of injectable solution and administer directlyintravenously slowly over a period of 3 to 5 minutes.

Intravenous infusion

To administer an intravenous infusion, reconstitute the contents of the vial in 10 ml of injectable solution.

To administer a rapid intravenous infusion, dissolve 2 g of cefotaxime in 40 ml of injectable solution or isotonic sodium chloride solution and infuse over 20 minutes.

To administer a slow intravenous infusion, dissolve 2 g of cefotaxime in 100 ml of isotonic sodium chloride solution or glucose solution and infuse over 50 to 60 minutes.

Intramuscular injection

Cefotaxime 2g should not be administered intramuscularly. Use Cefotaxime 1g.

Compatibility

Unless physical-chemical compatibility with other infusion solutions is demonstrated, the cefotaxime solution should be administered separately from them.

Cefotaxime is not compatible with:

- sodium bicarbonate solution,

- infusion solutions with a pH greater than 7,

- aminoglycosides.

In general, cefotaxime should not be mixed or administered with other antibiotics or medications in the same syringe. Cefotaxime should not be mixed with aminoglycoside antibiotics in the infusion equipment or syringe.

The duration of treatment depends on the evolution of the disease.

If you use more Cefotaxime than you should

Betalactam antibiotics, including cefotaxime, can cause encephalopathies, accompanied by central nervous system excitation, myoclonus, seizures, confusion, altered consciousness, and movement disorders. This risk exists when higher doses are used, in cases of overdose, and in patients with renal impairment or epilepsy or meningitis.

If cefotaxime is injected through a central venous catheter (CVC) too quickly (in less than 1 minute), it can cause a severe cardiac arrhythmia.

If you think you have received too much cefotaxime, talk to your doctor or medical staff immediately.You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Cefotaxime

Your doctor or nurse will have instructions on when to administer the medication, so it is unlikely that they will not administer the medication according to the instructions. If you think you have forgotten a dose, talk to your doctor or nurse.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking cefotaxime and inform your doctor immediately if you observe any of the following symptoms:

• Seizures (rare, may affect up to 1 in 100 people)

- Unknown frequency (cannot be estimated from available data)

• Severe acute hypersensitivity reactions and life-threatening allergic reactions, as well as Quincke's edema and bronchospasm. If you experience chest tightness, or feel dizzy, sick, or weak, these may be signs of a hypersensitivity reaction.
• Flat red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Generalized red and scaly skin eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).
• Severe persistent diarrhea or blood in the stool due to possible life-threatening intestinal inflammation.
• Decreased red blood cells (hemolytic anemia), change in urine color (to a brownish-red color).
• Acute kidney failure.

Inform your doctor or nurse if you experience any of the following side effects with an unknown frequency (cannot be estimated from available data):

- Jaundice as a sign of possible hepatitis.

- Severe decrease in white blood cells (agranulocytosis), which may be detected by the appearance of acute infection signs, as well as inflammation of the oral, nasal, pharyngeal, genital, and anal areas.

- Significant decrease in the number of all blood cells and bone marrow insufficiency. You may also experience acute infection signs and inflammation (see above), bleeding, bruising (decreased platelets), fatigue, paleness, or difficulty breathing (decreased red blood cells).

Inform your doctor or nurse if any of the following side effects worsen or last more than a few days:

Very common(may affect more than 1 in 10 people)

- Pain at the injection site, also hardening due to intramuscular administration.

Common(may affect up to 1 in 10 people)

- Joint problems (e.g., swelling).

Rare(may affect up to 1 in 100 people)

- Increased eosinophils (eosinophilia).

- Decreased platelets (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia).

- Jarisch-Herxheimer reaction (see explanation below).

- Diarrhea.

- Loss of appetite.

- Increased bilirubin (bile pigment in the blood) and liver enzymes in serum (SGOT, SGPT, γ-GT, alkaline phosphatase, LDH).

- Allergic reactions in the form of rashes, itching, hives.

- Renal function limitation, e.g., increased serum creatinine and urea concentrations.

- Fever.

- Inflammatory reactions in the injection area and vein inflammation (phlebitis/thrombophlebitis).

Unknown frequency(cannot be estimated from available data)

- Secondary infections caused by bacteria or fungi (e.g., in the mouth or vagina).

- Decreased number of certain white blood cells (neutropenia).

- Tachycardia, cardiac arrhythmia (after rapid administration through a central venous access).

- Central nervous system stimulation, altered consciousness, confusion, movement disorders, muscle spasms (encephalopathy symptoms, especially with high doses, in cases of overdose or renal function deterioration).

- Headache.

- Dizziness.

- Nausea, vomiting, abdominal pain.

- Interstitial nephritis.

- Intolerance reactions in the form of heat sensation or nausea with rapid intravenous administration.

Jarisch-Herxheimer reaction:

When starting treatment for spirochetal infections (e.g., Lyme disease), you may experience fever, chills, headache, and joint pain. After several weeks of treatment for Lyme disease, one or more of the following symptoms have been described: rash, itching, fever, decreased white blood cells, increased liver enzymes, difficulty breathing, and joint pain. These symptoms correspond partially to the underlying disease symptoms of patients being treated.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Reconstituted Solution

The physical and chemical stability of the reconstituted solution (2g/10ml of injection water) has been demonstrated for 8 hours at 25°C and 24 hours at 2-8°C.

From a microbiological standpoint, it is recommended to use the solutions immediately after preparation. If they are not administered immediately, the time and conditions under which they can be stored will be the responsibility of the user and should normally not exceed 24 hours at 2-8°C, unless the reconstitution was performed under controlled and validated aseptic conditions.

Cefotaxime Sodium Composition

Theactiveingredientiscefotaxime. Each vial contains: Cefotaxime 2 g (as cefotaxime sodium).

Product appearance and packaging contents

The powder is white or slightly yellowish in type II glass vials with a bromobutyl stopper and an aluminum cap with a polipropylene coating.

Cefotaxime sodium 2 g is presented in two formats:

• Package with a single vial
• Clinical package with 50 vials

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing Authorization Holder:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10 08970 Sant Joan Despí Barcelona. Spain

Manufacturer:

Laboratorio Reig Jofre, S.A. Jarama 111

Toledo 45007. Spain

Last review date of this leaflet: March 2025

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es