Cefotaxime Normon 2 g powder and solvent for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cefotaxime Normon 2 g powder and solvent for injectable solution and for infusion EFG

Read the entire leaflet carefully before you start taking 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 or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Cefotaxime Normon is and what it is used for
2. What you need to know before using Cefotaxime Normon
3. How to use Cefotaxime Normon
4. Possible adverse effects
5. How to store Cefotaxime Normon
6. Contents of the pack and other information

1. What Cefotaxima Normon is and what it is used for

This medicine belongs to a group of antibiotics called cephalosporins, used to fight bacteria.

Cefotaxime is indicated for severe, acute and chronic bacterial infections caused by pathogens 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 in stages II and III) (infection mainly caused by tick bites).

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

2. What you need to know before using Cefotaxime Normon

Do not use Cefotaxime Normon

• If you are allergic to cefotaxime, other cephalosporins, or any of the other components of this medicine (listed in section 6).
• If you have previously experienced a severe or acute hypersensitivity reaction to penicillin or other beta-lactam antibiotics. Penicillin and cephalosporins may cause cross-reactions.
• If you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

Do not take Cefotaxime Normon or inform your doctor if any of these apply to you.

The use of cefotaxime mixed with lidocaine for intramuscular injection is not indicated in children under 30 months of age. Refer to the product leaflet for instructions on the preparation of the product containing lidocaine.

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 the section "Do not use Cefotaxime Normon").
• If you have an allergic reaction (e.g., hay fever, bronchial asthma, hives) or if you have a history of allergies. In this case, you have a higher risk of more severe (and potentially 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 have renal impairment. Inform your doctor; your dose may need to 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. Your kidney function should be monitored by a doctor, as these substances may increase the risk of kidney toxicity and require caution.
• 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. Blood tests should be performed to monitor for possible blood changes (see also section 4).
• If you show signs of a new infection (e.g., fungal infection of mucous membranes with redness and a white coating). Antibiotic use may increase the number of pathogens not sensitive to the drug. Watch for signs of new infections and inform your doctor if necessary.

Take special care with Cefotaxime Normon

• 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 Cefotaxime Normon

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

Other antibiotics

Concomitant use of certain antibiotics may reduce the effect 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 harm the kidneys, such as aminoglycosides (other antibiotics) or drugs that may cause significant dehydration (diuretics like furosemide), the risk of kidney damage may increase. If used concomitantly, kidney function should be monitored (see section 2 "Warnings and precautions").

Probenecid

Concurrent administration of probenecid leads to increased serum concentrations of cefotaxime and 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, breastfeeding, and fertility

If you are pregnant, 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 have not shown teratogenic effects of cefotaxime.

Nevertheless, cefotaxime should only be used during pregnancy, especially in the first trimester, after a strict risk-benefit assessment 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 with diarrhea, fungal overgrowth, and may also lead to sensitization. Your doctor will decide whether to discontinue breastfeeding or stop treatment with cefotaxime, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using 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.

Cefotaxime Normon contains sodium

This medicine contains 101.2 mg (4.40 mmol) of sodium (the main component of table/cooking salt) per dose. This corresponds to 5.06% of the maximum daily sodium intake recommended for an adult.

3. How to use Cefotaxime Normon

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Unless otherwise determined 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 can 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 regimen:

For the treatment of gonorrhoea 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. Higher doses may be needed for less sensitive pathogenic microorganisms. 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 an antibiogram. When used in combination 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 prophylaxis of infections 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, while 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 eliminated by peritoneal dialysis.

Elderly patients

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

If you use more Cefotaxima Normon than you should

Beta-lactam antibiotics, including cefotaxime, may cause so-called encephalopathies, which are 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 impaired renal function or those suffering from 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 personnel.

If you forget to use Cefotaxima Normon

Your doctor or nurse will have instructions on when to administer the medicine, so it is unlikely that the medicine 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, as well as swelling (angioedema) and narrowing of the airways (bronchospasm). If you experience chest tightness, dizziness, nausea, or weakness, these could be signs of a hypersensitivity reaction.

• Severe persistent diarrhoea or blood in the stools due to possible life-threatening intestinal inflammation.

• Decrease in red blood cells (haemolytic anaemia), change in urine colour (to reddish-brown).

• Acute kidney failure.

• Flat red 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).

• Generalised skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Generalised, red, scaly rash with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

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 be detected by the sudden onset of signs of acute 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, pallor, 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).
• Diarrhoea.
• 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)

• Secondary infections 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 a central venous access).
• Central nervous system excitation, altered consciousness, confusion, movement disorders, muscle spasms (encephalopathy symptoms, especially with high doses, in cases of overdose or impaired renal function).
• Headache.
• Dizziness.
• Nausea, vomiting, abdominal pain.
• Kidney inflammation (interstitial nephritis).
• Intolerance reactions such as sensation of warmth or nausea with 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 symptoms of the underlying disease in treated patients.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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 Normon

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

Do not store above 25°C.

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

Reconstituted vials maintain their chemical and physical stability for 24 hours at 8 to 25°C and when stored refrigerated (2°C–8°C).

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefotaxime Normon 2 g

The active substance is cefotaxime (as cefotaxime sodium).

Each vial contains 2 g of cefotaxime (as cefotaxime sodium).

Each solvent ampoule contains water for injections.

Appearance of the product and contents of the pack

Cefotaxime Normon 2 g is presented as a white or slightly yellow powder contained in a clear glass vial, with a rubber stopper sealed with an aluminum cap, together with a glass ampoule containing 10 ml of solvent.

The vials are supplied in cartons containing 1 vial or in hospital packs of 50 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos (Madrid)
Spain

Date of the most recent review of this leaflet: June 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only.

Common information for the following presentations:

Cefotaxime Normon 250 mg powder and solvent for injectable solution EFG
Cefotaxime Normon 500 mg powder and solvent for injectable solution EFG
Cefotaxime Normon 1 g powder and solvent for injectable solution EFG
Cefotaxime Normon 2 g powder and solvent for injectable and infusion solution EFG

Intravenous injection

Cefotaxime Normon 250 mg, 500 mg, 1 g and 2 g are administered by slow intravenous injection over 3 to 5 minutes, after dilution in 2, 4 or 10 ml of solvent (water for injections).

Intravenous infusion

Reconstitute the 2 g vial with 10 ml of water for injections. Subsequently:

For rapid intravenous infusion, dilute in 40 ml of water for injections or an isotonic sodium chloride solution, and administer by intravenous infusion over approximately 20 minutes.

For slow intravenous infusion, dissolve in 100 ml of isotonic sodium chloride solution or glucose solution, and administer by intravenous infusion over a period of 50 to 60 minutes.

Intramuscular injection

Cefotaxime Normon 500 mg and 1 g:

For intramuscular injection, dissolve 500 mg of cefotaxime in 2 ml or 1 g of cefotaxime in 4 ml of water for injections. The injection should then be administered by deep gluteal route. Pain during intramuscular injection may be avoided by dissolving 1 g of cefotaxime in 4 ml or 500 mg in 2 ml of 1% lidocaine (see section 2 Do not use Cefotaxime Normon). Intravascular injection must be avoided, as intravenous administration of lidocaine may cause restlessness, tachycardia, conduction abnormalities, vomiting, and confusion. The commercial presentation Cefotaxime Normon 1 g powder and solution for intramuscular injectable solution EFG includes within the pack a lidocaine ampoule for intramuscular administration.

Unless compatibility has been demonstrated, cefotaxime solution should, in principle, be administered separately from other infusion solutions.

Cefotaxime is not compatible 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 medicinal products in the same syringe. Cefotaxime must not be mixed with aminoglycoside antibiotics in infusion sets or in the same syringe.