Cefotaxime 1g Solution for Injection in Vial x10

Generic

Pharmaceutical Product

Systemic antibiotic (parenteral solution for injection/infusion)

UK Licensed Prescription Only Medicine (POM) with MHRA marketing authorisations under various generic product licences for cefotaxime 1g powder for solution for injection/infusion.
Formulated and manufactured in accordance with Good Manufacturing Practice (GMP) standards for sterile parenteral products.
Listed in standard national prescribing references (e.g. BNF) as a parenteral third Generation cephalosporin antibiotic for systemic use.

UK Licensed Prescription Only Medicine (POM) with MHRA marketing authorisations under various generic product licences for cefotaxime 1g powder for solution for injection/infusion.
Formulated and manufactured in accordance with Good Manufacturing Practice (GMP) standards for sterile parenteral products.
Listed in standard national prescribing references (e.g. BNF) as a parenteral third Generation cephalosporin antibiotic for systemic use.

Systemic antibiotic (parenteral solution for injection/infusion)

Description

Cefotaxime 1g Solution for Injection in Vial x10 is a prescription-only (POM) parenteral formulation of cefotaxime, a third-generation cephalosporin (β-lactam) antibiotic for systemic use. Each glass vial contains cefotaxime (typically as cefotaxime sodium) equivalent to 1 g of cefotaxime, supplied as a powder intended to be reconstituted with a suitable diluent to produce a solution for intravenous (IV) injection, IV infusion or intramuscular (IM) injection, according to the product’s Summary of Product Characteristics (SmPC). Cefotaxime acts by inhibiting bacterial cell wall synthesis and is used in hospital and specialist settings for the treatment of serious infections caused by susceptible organisms.

Bnefits

Broad-spectrum third-generation cephalosporin antibiotic with activity against many Gram-negative and some Gram-positive organisms.
Parenteral route (IV/IM) allows treatment of moderate to severe infections and situations where oral therapy is not appropriate.
Well-established clinical use in hospital settings with an extensively characterised efficacy and safety profile.
Suitable for a range of serious infections when caused by cefotaxime-susceptible organisms, in line with local antimicrobial guidelines.
Standardised 1 g vial strength facilitates dosing calculations and preparation in adult and paediatric patients by healthcare professionals.

Indications

Treatment of severe bacterial infections due to cefotaxime-susceptible organisms, where parenteral therapy is indicated.
Lower respiratory tract infections, including pneumonia, when caused by susceptible bacteria and requiring IV/IM therapy.
Infections of the urinary tract, skin and soft tissue, intra-abdominal, gynaecological, bone and joint infections, when appropriate and in line with the product SmPC.
Bacterial meningitis and other serious systemic infections caused by susceptible organisms, as determined by a specialist.
Peri-operative prophylaxis in certain surgical procedures where the use of a parenteral cephalosporin is considered appropriate according to local guidelines.
Use should always follow the licensed indications and local/national antimicrobial stewardship policies.

Composition

Active ingredient: cefotaxime (typically as cefotaxime sodium) equivalent to 1 g cefotaxime per vial.
Excipients: standard injectable excipients (e.g. sodium carbonate or similar buffering agents) as listed in the specific manufacturer’s SmPC.
No antimicrobial preservative is usually included; the product is intended for single use after reconstitution.

Formulation

Pharmaceutical form: powder for solution for injection/infusion in glass vials.
Strength: 1 g cefotaxime per vial after reconstitution.
Route of administration: intravenous injection, intravenous infusion or intramuscular injection, as specified in the SmPC.
Legal category (UK): POM – Prescription Only Medicine.

Packaging

Hospital pack containing 10 single-use vials, each with 1 g cefotaxime (as powder for solution).
Vials are typically type I glass with rubber stopper and aluminium or flip-off cap, packed in a cardboard carton.
Outer carton is labelled with the generic name (Cefotaxime 1g), route of administration (for injection/infusion), pack size (10 vials), legal category (POM), batch number and expiry date.
A Summary of Product Characteristics and/or patient information leaflet is supplied in accordance with regulatory requirements; use is restricted to healthcare professionals.

Usage

For use only by, or under the direct supervision of, suitably qualified healthcare professionals experienced in parenteral antibiotic therapy.
Reconstitute each vial with an appropriate diluent (e.g. sterile water for injection or compatible infusion fluid) using aseptic technique and in accordance with the product SmPC and local hospital policies.
Inspect the reconstituted solution visually for particulate matter or discoloration; use only clear solutions and discard any unused portion in line with local procedures.
Administer via intravenous injection, intravenous infusion or intramuscular injection as specified in the SmPC, following the prescribed dose, dosing interval and duration determined by the treating clinician.
Adjust dosing regimen in patients with impaired renal function according to the product information and local guidelines.
Do not mix cefotaxime in the same syringe or infusion line with other medicinal products that are known to be incompatible.
Monitor the patient for clinical response and for potential adverse effects, including signs of hypersensitivity, renal function changes and gastrointestinal symptoms.
Dispose of vials, needles, syringes and any unused solution as clinical waste in accordance with local regulations and infection prevention policies.

Contraindications

Known hypersensitivity to cefotaxime, other cephalosporins or any of the excipients in the formulation.
History of severe immediate-type hypersensitivity (e.g. anaphylaxis) to penicillins or other β-lactam antibiotics, where cross-reactivity risk is considered clinically unacceptable.
Use in situations where a cephalosporin is contraindicated according to local antimicrobial guidelines or specific patient factors.

Adverse Effects

Gastrointestinal effects such as diarrhoea, nausea, vomiting and abdominal discomfort.
Antibiotic-associated colitis, including Clostridioides difficile-associated diarrhoea, which may be severe and requires prompt medical evaluation.
Hypersensitivity reactions including rash, pruritus, urticaria, drug fever and, rarely, severe reactions such as angioedema, anaphylaxis or Stevens–Johnson syndrome.
Hematological changes such as eosinophilia, leucopenia, neutropenia, thrombocytopenia and, rarely, haemolytic anaemia.
Transient increases in liver enzymes and bilirubin, and rare cases of hepatitis or cholestatic jaundice.
Renal effects, including transient increases in serum creatinine or urea and rare interstitial nephritis, particularly when combined with other nephrotoxic drugs.
Local reactions at the injection site (e.g. pain, induration, phlebitis or inflammation), more common after IM injection or rapid IV administration.
Overgrowth of non-susceptible organisms, including fungi, with prolonged use (superinfection).

Storage Conditions

Store below 25°C or as specified in the individual product’s SmPC.
Keep vials in the outer carton to protect from light.
Do not use after the expiry date printed on the packaging.
Reconstituted solutions should be used within the time frame and under the storage conditions stated in the SmPC; any unused solution must be discarded in accordance with local requirements.
Keep out of the sight and reach of children.

Duration

The duration of therapy must be determined by the prescribing clinician based on the type and severity of infection, patient response, microbiological findings and local guidelines. Courses for serious infections often extend over several days to weeks and may be modified in line with clinical progress and specialist advice.

Onset

Bactericidal activity begins once adequate serum and tissue concentrations are achieved following IV/IM administration; clinical improvement in susceptible infections is typically observed within a few days, though treatment should be continued for the full course as determined by the clinician.