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Antibiotics Marketed by Aerochem Neutron

SULTAVIN

Formulation Code AC-382
Commercial Status Active Product Information Available

Product Overview & Formulation Profile

Composition: Sultamicillin Tosylate Dihydrate BP eq. to Sultamicillin 375mg (eq. to Sulbactam 147mg + Ampicillin 220mg) (tablets). It is a single-ingredient product built around Sultamicillin (penicillin + beta-lactamase inhibitor prodrug).

Sultamicillin is a mutual prodrug that releases ampicillin, a penicillin antibiotic, and sulbactam, a beta-lactamase inhibitor that protects ampicillin from degradation by certain beta-lactamase-producing bacteria.

SULTAVIN-375 is a prescription medicine from Aerochem Neutron's antibiotic range, for use on the prescription of a registered medical practitioner.

Composition & Formulation Details

·       Contains Sultamicillin Tosylate Dihydrate BP eq. to Sultamicillin 375mg (eq. to Sulbactam 147mg + Ampicillin 220mg)

·       Sultamicillin — mutual prodrug that releases ampicillin, a penicillin antibiotic, and sulbactam, a beta-lactamase inhibitor that protects ampicillin from degradation by certain beta-lactamase-producing bacteria

·       Presented as tablets

Prescription-only medicine


·       Upper and lower respiratory tract infections

·       Urinary tract infections

·       Skin and soft-tissue infections

·       Infections caused by susceptible beta-lactamase-producing organisms

·       Other indications as per the approved prescribing information

Safety

·       Contraindicated in patients with known hypersensitivity to any component.

·       Contraindicated in patients with hypersensitivity to beta-lactam antibiotics (penicillins, cephalosporins or carbapenems); Clostridioides difficile-associated diarrhoea can occur. Ampicillin may cause rash in patients with infectious mononucleosis.

·       Pregnancy and lactation: use only if the prescriber judges the benefit to outweigh the risk.

Clinical Rationale: The mechanisms and labelled uses of ampicillin and sulbactam described here follow the US prescribing information (DailyMed); antibiotic choice should follow local resistance data and the WHO AWaRe antibiotic book.

References

·       DailyMed (US NLM) prescribing information – ampicillin and sulbactam: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=AMPICILLIN%20AND%20SULBACTAM

·       WHO AWaRe (Access, Watch, Reserve) antibiotic book (2022): https://www.who.int/publications/i/item/9789240062382

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