Sulbactam Sample Clauses

Sulbactam. Sulbactam is a penicillin derivative and is used widely as an inhibitor of β-lactamases. Although sulbactam is available as a standalone product in a small number of countries (e.g., Combactam, Germany), the vast majority of human use is in combination with β-lactams (e.g., Unasyn, ampicillin/sulbactam). Unasyn is approved by regulatory authorities in the United States, Europe, and the Asia-Pacific region. • The maximum recommended daily dose of sulbactam is 1 g q6h (maximum daily dose of 4 g). • Sulbactam is a penicillin derivative and, as such, should not be used in subjects with a history of β-lactam hypersensitivity. • Up-to-date information on sulbactam can be found in United States and European product labels (Unasyn Product Label, Ampicillin/sulbactam Summary of Product Characteristics). • The PK of ampicillin and sulbactam are linear up to at least 1000 mg. The PK profile of IV ampicillin is unaffected by co-administration of sulbactam. Similarly, the PK profile of sulbactam is not impacted by co-administration of ampicillin. • The clinical safety of sulbactam has been established by nearly 30 years of experience with Unasyn. Based on the product label, Unasyn is generally safe and well tolerated.