Finished product reference

Temocillin Sodium

Injection, Powder, for Solution · Parenteral · 1 g

List code
51999
Pharmacologic class
Penicillin antibacterial (β-lactamase-stable, narrow Gram-negative spectrum)

What it is and how it works

Temocillin is a 6-α-methoxy derivative of ticarcillin that inhibits bacterial cell-wall synthesis by binding to penicillin-binding proteins. The methoxy group confers stability against many β-lactamases, including extended-spectrum β-lactamases (ESBL) and AmpC enzymes. It is active mainly against Enterobacterales and has no useful activity against Pseudomonas aeruginosa, Acinetobacter, Gram-positive organisms or anaerobes.

Indications

Infections caused by susceptible Gram-negative bacteria, including complicated urinary tract infections and pyelonephritis, lower respiratory tract infections, bacteraemia and wound infections, particularly where ESBL- or AmpC-producing Enterobacterales are suspected or confirmed.

Dosage and administration (summary)

By intravenous injection or infusion (or intramuscular injection): usually 2 g every 12 hours, increased to 2 g every 8 hours in severe infections; reduce dose in renal impairment.

Contraindications

Hypersensitivity to penicillins; history of severe immediate hypersensitivity to other β-lactam antibacterials.

Warnings and precautions

Not suitable as monotherapy when Pseudomonas, Gram-positive or anaerobic pathogens are possible. Consider the sodium load in patients on sodium restriction. As with other antibacterials, Clostridioides difficile–associated diarrhoea may occur.

Pregnancy

Penicillins are generally considered compatible with pregnancy; use when clearly indicated.

Storage and supply

Store the powder below 25 °C; use reconstituted solution promptly.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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