Audited Supplier
Ceftriaxone Sodium for Injection
Indications:
Ceftriaxone is often used (in combination, but not direct, with macrolide and/or aminoglycoside antibiotics) for the treatment of community-acquired or mild to moderate health care-associated pneumonia. It is also a choice drug for treatment of bacterial meningitis. In pediatrics, it is commonly used in febrile infants between 4 and 8 weeks of age who are admitted to the hospital to exclude sepsis.
Contra-indications:
Ceftriaxone is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium.
Adverse Effects:
Hypoprothrombinaemia and bleeding are specific side effects. Haemolysis is reported. Biliary sludging is another known though rare adverse effect which occurs primarily in neonates.
Drug Interactions:
Ceftriaxone can interact with a number of medicines. Drugs that can interact with ceftriaxone include, but are not limited to, the following: Warfarin, , Sulfinpyrazone, Calcium.
Storage instructions:
Store below 25ºC. Protect from moisture. Keep out of reach of children.
Certificate of Analysis
| Testing terms | Standards | Results |
| Shape | It is white or off-white crystalline powder; odorless | white crystalline powder; odorless |
| pH | 6.0~8.0 | 6.6 |
| Water | 8.0%~11.0% | 8.4% |
| Relative substance | Single heterogeneity ≤ 1.0% Total miscellaneous response ≤4.0% | 0.1% 0.3% |
| Loading difference | Comply with the standard | Conformity |
| Visible foreign matter | Comply with the standard | Conformity |
| Assay | 90.0%-110.0% | 99.7% |
