Amoxicillin Sodium/Sulbactam Sodium for Injection
- Main ingredients：
- Strength：
- Package：
【Trade Name】
Xidilin
【Description】
White or almost white powder or crystalline powder, very hygroscopic.
【Indications】
This product is a compound product, composite of amoxicillin sodium and sulbactam sodium, applicable to the infections caused by enzyme- production Staphylococcus, pneumobacillus, other streptococcus, hemophilus influenzae, gonococcus , Escherichia Coli, Proteus, Morgan coli, citrobacter, enterobacterium, Salmonella:
1．Upper respiratory tract infection: Sinusitis, tonsillitis, otitis media, laryngitis, pharyngitis, and so on.
2．Lower respiratory tract infections: acute bronchitis, acute exacerbation of chronic bronchitis, bronchiectasis with infection, pneumonia, empyema, lung abscess.
3．Urinary tract infections: acute pyelonephritis, acute exacerbation of chronic pyelonephritis, acute lower urinary tract infection, pelvic infection (such as gynecological infections and postpartum infection).
4．Skin and soft tissue infections: Boils, abscesses, cellulitis, wound infections.
5. Venereal disease: Gonorrhea;
6. Oral abscess: drugs used in operation;
7．Other infections: infectious diarrhea, abdominal infection, sepsis, bacterial endocarditis.
【Usage and Dosage】
Adjust the dosage based on the doctor’s judgment criteria and patients’ individual demand.
Recommend dosage as below:
Adults: intramuscular injection or intravenous drip after dilution. Each time with 1.5-3g, add 150-200ml of 0.9% sodium chloride injection or 5% glucose solution for intravenous drip, within one hour, 2-3times a day. For medium or heavy infection patients, 4.5-6.0g per day, for serious infection patients, 9.0g per day or 150mg/kg per day, divided in 2-3times. Treatment course for 7-14days, it can be extended properly for heavy infection patients.
Children: deep intramuscular infection, direct intravenous injection or drip, 60-70mg/kg daily (40-50mg/kg daily for amoxicillin, 20-25mg/kg daily for sulbactam), divided in 2-3times.
When deep IM or IV, recommend diluting with at least 3.5ml of sterile water for injection. The solution should be used within 60min of preparation. Once beyond the time limit, discard the solution.
This product can be diluted with the following solvents, see below table:
|
Solvent |
Max concentration * |
Duration |
|
|
25℃ |
4℃ |
||
|
Sterile water for injection |
45 |
8 hours |
48 hours |
|
0.9% sodium chloride solution |
45 |
8 hours |
48 hours |
|
Ringer’s lactate solution |
45 |
8 hours |
48 hours |
|
5% glucose solution |
30 |
2 hours |
4 hours |
|
1/6M sodium lactate solution |
45 |
8 hours |
8 hours |
|
5% dextrose saline solution |
3 |
4 hours |
-- |
* amoxicillin + sulbactam compound preparation, mg/ml
For patients with renal insufficiency, the dose should be reduced properly, see below table:
|
Creatinine clearance rate, ml/min/1.73m2 |
Half life, hour |
Recommended dose |
|
≥30 |
1 |
1.5-3.0 g, daily, within 6-8 hours |
|
15-29 |
5 |
1.5-3.0 g, daily, within 12 hours |
|
5-14 |
9 |
1.5-3.0 g, daily, within 24 hours |
【Strength】
0.75 g (C16H19N3O5S 0.5 g and C8H11NO5S 0.25 g); 1.5 g (C16H19N3O5S 1.0 g and C8H11NO5S 0.5 g); 3.0 g (C16H19N3O5S 2.0 g and C8H11NO5S 1.0 g).
【Storage】
Sealed containers, stored in a cool, dark and dry place.
【Package】
Packed into tubing vials for antibiotics.
【Shelf life】
24 months
