Europe — EMA
Gloryfen
Gloryfen cefotaxime sodium injectable solution is a prescription third‑generation cephalosporin for serious bacterial infections in the EU.
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What is Cefotaxime Sodium?
Gloryfen is a prescription injectable solution containing the third‑generation cephalosporin cefotaxime sodium. It is supplied as a sterile powder for reconstitution, intended for intramuscular or intravenous administration. Marketed in the European Union, Gloryfen belongs to the antibiotic class and is used to treat a range of bacterial infections. The product requires a healthcare professional for preparation and dosing, according to prescribing guidelines.
What is Cefotaxime Sodium used for?
Gloryfen is indicated for the treatment of several serious bacterial infections where cefotaxime is appropriate. It is commonly employed in hospital settings for patients with confirmed or suspected susceptible organisms.
- Gram‑negative infections such as those caused by Escherichia coli, Klebsiella spp., and Haemophilus influenzae - Respiratory tract infections including pneumonia and bronchitis - Urinary tract infections, especially complicated cases - Skin and soft‑tissue infections like cellulitis and wound infections - Central nervous system infections such as bacterial meningitis - Intra‑abdominal infections when broad‑spectrum coverage is required
What are the side effects of Cefotaxime Sodium?
Side effects of Gloryfen vary in frequency and severity. Patients should be monitored for any adverse reactions during therapy.
Common: - Diarrhea or loose stools - Nausea or vomiting - Injection site pain or erythema - Transient elevation of liver enzymes - Rash or mild skin itching - Headache
Serious: - Severe allergic reactions (anaphylaxis, Stevens‑Johnson syndrome) - Clostridioides difficile‑associated colitis - Hematologic abnormalities (e.g., neutropenia, thrombocytopenia) - Renal impairment or acute kidney injury - Hepatotoxicity with jaundice - Seizures in patients with pre‑existing CNS disorders
What precautions apply to Cefotaxime Sodium?
Gloryfen should be used with caution in specific patient populations and clinical situations. The following precautions are recommended:
- Assess renal and hepatic function before initiating therapy and adjust dosing if necessary - Use carefully in patients with a history of hypersensitivity to cephalosporins or penicillins - Monitor for signs of superinfection, especially with prolonged treatment - Consider pregnancy and lactation status; cefotaxime is classified as pregnancy category B - Avoid use in neonates and premature infants unless clearly indicated - Review concomitant medications that may affect coagulation or renal clearance
What does Cefotaxime Sodium interact with?
Gloryfen may interact with other drugs, altering efficacy or increasing toxicity. Clinicians should evaluate potential interactions before prescribing.
Avoid: - Concurrent use with nephrotoxic agents such as aminoglycosides without dose adjustment - Combination with anticoagulants (e.g., warfarin) that may increase bleeding risk - Use with probenecid, which can reduce renal excretion of cefotaxime
Use with caution: - Loop diuretics that may affect electrolyte balance - Anticonvulsants that lower seizure threshold - Oral contraceptives, as antibiotics can reduce their effectiveness - Immunosuppressants, where infection risk is already elevated
Frequently asked questions
What type of medication is Gloryfen?+
For which infections is Gloryfen commonly prescribed?+
How is Gloryfen administered?+
Is Gloryfen safe to use during pregnancy?+
What are the most common side effects of Gloryfen?+
What serious adverse reactions can occur with Gloryfen?+
Should kidney function be checked before using Gloryfen?+
Can Gloryfen be given together with other antibiotics?+
What drug interactions should be avoided with Gloryfen?+
How should Gloryfen be stored before reconstitution?+
Is there a need for dose adjustment in patients with liver disease?+
What monitoring is recommended during treatment with Gloryfen?+
Product details
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