| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | Injection |
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AMPICILLIN+SULBACTAM FOR INJECTION 1.5G/10ML
Indications:
Ampicillin sodium and sulbactam sodium for injection is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration.
Dosage and Administration:
The recommended adult dosage of Ampicillin sodium and sulbactam sodium for injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of Ampicillin sodium and sulbactam sodium for injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.
Precautions & Warning:
The safety and effectiveness of Ampicillin sodium and sulbactam sodium for injection have been established for pediatric patients one year of age and older for skin and skin structure infections as approved in adults.
Use of Ampicillin sodium and sulbactam sodium for injection in pediatric patients is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetic studies, a controlled clinical trial conducted in pediatric patients and post-marketing adverse events surveillance.
Contra-indications:
The use of Ampicillin sodium and sulbactam sodium for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
Ampicillin sodium and sulbactam sodium for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Ampicillin sodium and sulbactam sodium for injection.
Drug interactions:
Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with Ampicillin sodium and sulbactam sodium for injection may result in increased and prolonged
blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with Ampicillin sodium and sulbactam sodium for injection and allopurinol administered concurrently. Ampicillin sodium and sulbactam sodium for injection and aminoglycosides should not be reconstituted together due to the in vitro inactivation of aminoglycosides by the ampicillin component of Ampicillin sodium and sulbactam sodium for injection.
Storage instructions:
Do not store above 25°C.
| Testing terms | Standards | Results |
| pH value | 8.0~10.0 | 8.90 |
| Clarity of solution | Clarified | Clarified |
| Particulate matter | Not detected | Not detected |
| Water | ≤2.0% | 0.63% |
| Uniformity of dosage units | Ampicillin:AV≤15.0 Sulbactam:AV≤15.0 |
7.37 8.62 |
| Sterility | Complies | Complies |
| Assay | ampicillin:90.0%-115.0% sulbactam:90.0%-115.0% |
106.9% 93.28% |
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