Cefotaxime Sala 2 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Cefotaxime Sala 2 g powder for injectable solution and for infusion EFG

Read the entire 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, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What you need to know before starting to use Cefotaxime Sala

3. How to use Cefotaxime Sala

1. Possible adverse effects

5. Storage of Cefotaxime Sala

Keep the medicine in its original packaging, protected from light and moisture. Store at room temperature (15°C to 25°C). Do not use after the expiry date stated on the container. Keep out of the reach and sight of children. Do not dispose of unused medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer required.

6. Contents of the pack and other information

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

Cefotaxime (an antibiotic belonging to the group of medicines known as cephalosporins) is a medicine used to fight bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after finishing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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

• respiratory tract infections,
• otorhinolaryngological 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),
• inflammation of the heart (endocarditis),
• Lyme disease (especially stages II and III) (infection caused mainly by tick bites).

In addition, for the prevention of infections following surgical procedures in patients at higher risk of infection.

2. What you need to know before using Cefotaxime Sala 2 g powder for injectable solution and infusion EFG

Do not use Cefotaxime Sala:

• if you are allergic to cefotaxime or to other cephalosporins, or to any of the components of this medicine (listed in section 6).
• if you have previously experienced a severe or acute hypersensitivity reaction to penicillin or to other beta-lactam antibiotics. Penicillin and cephalosporins may cause cross-reactions.

• if you have ever had a severe skin rash or peeling of the skin, blisters, or sores in the mouth 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 other beta-lactam antibiotics in any form (for contraindications due to known hypersensitivity reactions, see above in section "Do not use Cefotaxima Sala").
• If you have an allergic reaction (e.g., hay fever, bronchial asthma, hives) or if you have a history of such conditions. In this case, you have a higher risk of more severe (and in rare cases, fatal) hypersensitivity reactions. If you experience chest tightness, dizziness, nausea, or weakness, these may be signs of a hypersensitivity reaction (see section 4).
• If a hypersensitivity reaction occurs, treatment must be discontinued.
• If you develop severe or persistent diarrhea during treatment or for several weeks after it has ended. Inform your doctor immediately, as diarrhea in its most severe form (called pseudomembranous colitis) can be life-threatening and requires treatment. Do not take any medication that reduces intestinal motility.
• If you know you have renal impairment. Inform your doctor; if necessary, your dose may be adjusted. Your kidney function should be monitored.
• If you are receiving concomitant or subsequent treatment with aminoglycosides (other antibiotics), probenecid (for gout), or other medications that may cause kidney damage. A doctor should monitor your kidney function, as these substances may increase nephrotoxic effects and caution is required.
• If you experience movement disorders, seizures, confusion, or altered consciousness. These may be signs of what is called encephalopathy. The risk of these adverse effects increases with high doses, overdose, or in the presence of renal impairment. If such reactions occur, consult your doctor immediately.
• If your treatment lasts longer than 7 to 10 days. In this case, blood tests should be performed to monitor for possible blood abnormalities (see also section 4).
• If you show signs of a new infection (e.g., fungal infection of mucous membranes with redness and white patches). Antibiotic use may increase the number of pathogens not sensitive to the drug used. Watch for signs of new infections and inform your doctor if necessary.

Take special care with Cefotaxima Sala

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

Other medicines and Cefotaxima Sala

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

Other antibiotics

Concomitant use of certain antibiotics may reduce the effectiveness of cefotaxime. Inform your doctor if you are taking or have recently taken other antibiotics.

Diuretics and medicines potentially harmful to the kidneys

When cefotaxime is used together with medicines that may have a harmful effect on the kidneys, such as aminoglycosides (other antibiotics) or medicines that may cause significant dehydration (diuretics, such as furosemide), the nephrotoxic potential of these medicines may increase. If administered concomitantly, renal function should be monitored (see section 2 "Warnings and precautions").

Probenecid

Concomitant administration of probenecid results in increased serum concentrations of cefotaxime and thus prolongs its effect, as probenecid reduces the renal elimination of cefotaxime. Inform your doctor if you are taking probenecid, especially if you have renal impairment, so that your dose can be adjusted if necessary.

Pregnancy and breastfeeding

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

Pregnancy:

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

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

Breastfeeding:

Cefotaxime is excreted in breast milk only in small amounts. If you receive cefotaxime during breastfeeding, it may cause disturbances in intestinal flora, leading to diarrhea, fungal overgrowth, and may also cause sensitization. Your doctor will decide whether to interrupt breastfeeding or discontinue cefotaxime treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and use of machines

Based on previous experience, cefotaxime at low and medium doses has no effect on concentration or reaction ability.

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

Cefotaxima Sala contains sodium

This medicine contains 101.2 mg (4.40 mmol) of sodium per dose, equivalent to 5.1% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Cefotaxime Sala

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist. Cefotaxime will be administered to you intravenously. Remember to use your medicine as prescribed.

Your doctor will determine the appropriate dose, the duration of treatment, and the route of administration; do not stop or prolong the treatment on your own.

The dose, route of administration, and time intervals between injections depend on the dose, pathogen sensitivity, severity of the infection, and the patient's condition.

Unless otherwise directed by the physician, the recommended dose is:

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

The following table may be considered a dosage guideline:

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 the presence of syphilis.

For perioperative prophylaxis of infections, administration of 1–2 g of cefotaxime 30–60 minutes before surgery is recommended. Less sensitive pathogenic microorganisms may require a higher dose. Before starting treatment, check for the presence of syphilis.

For Lyme disease, the daily dose is 6 g of cefotaxime (for 14 to 21 days). In most cases, the daily dose is divided into 3 divided doses (2 g of cefotaxime 3 times daily), but in some cases it has been administered as 2 divided doses (3 g of cefotaxime twice daily). Dosing recommendations are not based on comparative clinical trials but on observations from individual patients.

Combination therapy

In severe, life-threatening infections, combination therapy with cefotaxime and aminoglycosides is indicated even without prior antibiogram testing. When combined with aminoglycosides, renal function must be monitored.

In infections caused by Pseudomonas aeruginosa, combination therapy with other antibiotics effective against Pseudomonas may also be indicated.

For infection prophylaxis in patients with weakened immune systems, combination therapy with other appropriate antibiotics may also be indicated.

Infants and children up to 12 years of age receive 50 to 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 equal divided doses administered at intervals of 12 (to 6) hours. In individual cases, especially in life-threatening situations, the daily dose may be increased to 200 mg of cefotaxime per kilogram of body weight.

In premature infants, it must be considered that renal function is not yet fully developed, and the dose should not exceed 50 mg of cefotaxime per kilogram of body weight per day.

In patients with severe renal impairment (creatinine clearance less than 10 ml/min), after the initial standard dose (the first dose at the beginning of treatment), the maintenance dose may be reduced to half the normal dose, maintaining the same dosing interval.

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

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

Cefotaxima Sala 2 g is administered intravenously (into a vein).

Elderly patients

In elderly patients, renal function should be carefully monitored and, if necessary, the dose should be adjusted.

Intravenous injection

For intravenous administration, dissolve 2 g of cefotaxime in at least 10 ml of water for injectable preparations and administer slowly intravenously over a period of 3 to 5 minutes.

Intravenous infusion

For intravenous infusion, reconstitute the vial contents in 10 ml of water for injectable preparations.

For rapid intravenous infusion, dissolve 2 g of cefotaxime in 40 ml of water for injectable preparations or isotonic sodium chloride solution and infuse over approximately 20 minutes.

For 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

Cefotaxima Sala 2 g must not be administered intramuscularly. Use Cefotaxima Sala 1 g instead.

Compatibility

Unless compatibility with other infusion solutions has been demonstrated, cefotaxime solution should generally be administered separately.

Cefotaxime is incompatible with:

• sodium bicarbonate solution,
• infusion solutions with a pH above 7,
• aminoglycosides.

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

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

If you use more Cefotaxima Sala than you should

Beta-lactam antibiotics, including cefotaxime, may cause so-called encephalopathies, which are accompanied by central nervous system excitation, myoclonus, seizures, confusion, impaired consciousness, and movement disorders. This risk exists when higher doses are used, in cases of overdose, and in patients with impaired renal function or who have epilepsy or meningitis.

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

If you think you have received too much cefotaxime, speak immediately with your doctor or medical staff. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Cefotaxima Sala

Your doctor or nurse will have clear instructions on when to administer the medication, so it is unlikely that the medication will not be administered according to instructions. If you think a dose has been missed, speak with your doctor or nurse.

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

4. Possible adverse effects

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

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

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

• Frequency not known (cannot be estimated from available data):

  • Severe acute hypersensitivity reactions and life-threatening allergic reactions, including swelling (angioedema) and narrowing of the airways (bronchospasm). If you experience chest tightness, or feel dizzy, sick, or weak, these could be signs of a hypersensitivity reaction.
  • Non-elevated reddish patches, or circular or target-shaped rashes on the chest, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
  • Widespread red, scaly rash, with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
  • Persistent severe diarrhea or blood in the stool due to possible life-threatening intestinal inflammation.
  • Decrease in red blood cells (hemolytic anemia), change in urine color (to reddish-brown).
  • Acute kidney failure.

Inform your doctor or nurse if you experience any of the following adverse effects with a frequency not known (cannot be estimated from available data):

• Jaundice as a sign of possible hepatitis.
• Severe decrease in white blood cells (agranulocytosis), which may present as sudden signs of infection, as well as inflammation of the oral, nasal, pharyngeal, genital, and anal areas.
• Marked decrease in all blood cells and bone marrow failure. Acute signs of infection and inflammation (see above), bleeding, bruising (due to low platelets), fatigue, paleness, or difficulty breathing (due to low red blood cells) may also occur.

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

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

• Pain at the injection site, also hardening after intramuscular administration.

Common (may affect up to 1 in 10 people)

• Joint problems (e.g., swelling).

Uncommon (may affect up to 1 in 100 people)

• Increase in eosinophils (eosinophilia).
• Decrease in platelet count (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia).
• Jarisch-Herxheimer reaction (see explanation below).
• Diarrhea.
• Loss of appetite.
• Increase in bilirubin (a bile pigment in the blood) and liver enzymes in serum (SGOT, SGPT, γ-GT, alkaline phosphatase, LDH).
• Allergic reactions such as rash, itching, hives.
• Impaired kidney function, e.g., increased serum creatinine and urea concentrations.
• Fever.

• Inflammatory reactions at the injection site and vein inflammation (phlebitis/thrombophlebitis).

Frequency not known (cannot be estimated from available data)

• New infections caused by bacteria or fungi (e.g., in the mouth or vagina).
• Decrease in certain white blood cells (neutropenia).
• Tachycardia, cardiac arrhythmia (after rapid administration via central venous access).
• Central nervous system excitation, altered consciousness, confusion, movement disorders, muscle spasms (encephalopathy symptoms, especially with high doses, overdose, or impaired kidney function).
• Headache.
• Dizziness.
• Nausea, vomiting, abdominal pain.
• Kidney inflammation (interstitial nephritis).
• Intolerance reactions such as sensation of warmth or nausea during faster 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 reported: rash, itching, fever, decreased white blood cells, increased liver enzymes, difficulty breathing, and joint pain. These symptoms partially correspond to the underlying disease symptoms in treated patients.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefotaxime Sala

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

Reconstituted solution

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

From a microbiological standpoint, it is recommended that the solution be used immediately after preparation. If not administered immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

6. Contents of the pack and other information

Composition of Cefotaxime Sala

The active substance is cefotaxime. Each vial contains: Cefotaxime 2 g (as cefotaxime sodium).

Appearance of the product and contents of the pack

The powder is white or slightly yellowish in type II glass vials with bromobutyl stoppers and aluminium caps with polypropylene overseals.

Cefotaxime Sala 2 g is available in two pack sizes:

• Pack containing one vial
• Clinical pack containing 50 vials

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Title:

Reig Jofre, S.A. Laboratory

Gran Capitán, 10 08970 Sant Joan Despí Barcelona. Spain

Manufacturer:

Reig Jofre, S.A. Jarama 111

Toledo 45007. Spain

Date of the most recent review of this leaflet: March 2025

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