| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | for Injection |
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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.
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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