Finished product reference

Penicillin V Benzathine

Powder, for Suspension · Oral · 400000 IU/5mL · 100 mL

List code
963
Pharmacologic class
Antibacterial; oral phenoxymethylpenicillin (beta-lactam)

What it is and how it works

Benzathine phenoxymethylpenicillin is a sparingly soluble, taste-masked salt of penicillin V used in oral suspensions; it releases phenoxymethylpenicillin, which is acid-stable and inhibits bacterial cell-wall synthesis by binding penicillin-binding proteins.

Indications

Mild to moderate infections caused by penicillin-susceptible organisms, especially streptococcal tonsillitis and pharyngitis, skin and soft-tissue infections and otitis media; prophylaxis of rheumatic fever recurrence and pneumococcal infection in asplenia or sickle-cell disease.

Dosage and administration (summary)

Oral suspension after reconstitution, dose expressed as phenoxymethylpenicillin; adults usually 250–500 mg (about 400,000–800,000 units) every 6 hours, or twice daily for prophylaxis; children dosed by age or weight.

Contraindications

Hypersensitivity to penicillins.

Warnings and precautions

Anaphylaxis may occur, and cross-sensitivity with cephalosporins is possible. Not suitable for severe infections because absorption is variable. Prolonged use may lead to superinfection, including Clostridioides difficile-associated diarrhoea.

Pregnancy

Considered safe for use in pregnancy.

Storage and supply

Store dry powder below 25 °C; after reconstitution, store in a refrigerator at 2–8 °C and use within the period stated on the label (usually 7–14 days).

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

Other presentations of the same active ingredient

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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