| Dossier: | Ctd |
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| Transport Package: | Free |
| Specification: | 50mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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| Generic Name | Tigecycline for Injection 50mg |
| Strength | 50mg |
| Packing | 10 vials/box |
| Origin | China |
This product is orange freeze-dried lump or powder.
This product is indicated for the treatment of infections caused by sensitive strains of specific bacteria in patients over 18 years of age in the following situations:
Complex skin and soft tissue infections - Escherichia coli, Enterococcus faecalis (vancomycin-sensitive strains only), Staphylococcus aureus (methicillin-sensitive and resistant strains only), Streptococcus agalactis, Streptococcus angina family (including Streptococcus angina, Streptococcus intermedius and S. constellatus), Streptococcus pyogenes and Bacteroides fragilis.
Complex intrabitoneal infections - Citrobacter Fraudiensis, Enterobacter cloacae, Escherichia coli, Klebsiella acidogenes, Klebsiella pneumoniae, Enterococcus faecalis (limited to vancomycin-sensitive strains), Staphylococcus aureus (limited to methicillin-sensitive strains), Streptococcus angina family (including Streptococcus angina, Streptococcus intermedius and S. constellatus), Bacteroides fragilis, Bacteroides polymorphus, Bacteroides monoformis, Bacteroides commens, Clostridium perfringens and peptostreptococcus minutus.
In order to isolate and identify the pathogen and determine its sensitivity to tigecycline, appropriate specimens should be taken for bacteriological testing. Until the results of these trials are known, this product may be used as an empirical monotherapy.
To reduce the appearance of resistant bacteria and maintain the effectiveness of this product and other antimicrobial agents, this product should only be used to treat infections caused by confirmed or highly suspected bacteria. Antimicrobial therapy should be selected or adjusted based on culture and susceptibility test results once known. In the absence of such data, empiric agents may be selected based on local epidemiology and sensitivity patterns.
Usage and dosage:
The recommended dosing regimen for tigecycline is 100 mg for the first dose and then 50 mg every 12 hours. The intravenous (IV) infusion of tigecycline should be administered every 12 hours for about 30 to 60 minutes.
The recommended course of treatment for complex skin and soft tissue infections or intraperitoneal infections is 5 to 14 days. The course of treatment should be determined according to the severity and location of the infection and the patient's clinical and bacteriological progress.
The dosage does not need to be adjusted according to age, gender or race. (See [Pharmacokinetics] - Special Populations and [Precautions] - Applications in elderly patients)
Medication for patients with renal injury
Patients with renal impairment or undergoing hemodialysis do not need to adjust the dose of tigecycline. (See [Pharmacokinetics] - Special Populations - Patients with renal impairment).
Medication for patients with liver function injury
Patients with mild to moderate liver impairment (Child Pugh grades A and B) do not need to adjust the dose. Based on the pharmacokinetic profile of patients with severe liver function impairment (Child Pugh Class C), the dose of tigecycline should be adjusted to 100mg and then maintained at 25mg every 12 hours. Patients with severe liver function impairment should be treated with caution and monitor treatment response. (See [Pharmacokinetics] - Special Population - Patients with Liver Function Impairment and [Precautions] - Medication for Patients with Liver function Impairment)
Medicine for children
The efficacy and safety of this product in pediatric patients younger than 18 years of age are unclear. (See [Precautions] - Warnings] Therefore, this product is not recommended for use in patients younger than 18 years of age.
Matters needing attention:
Warnings
All-cause mortality
Phase III and IV clinical studies found an increase in all-cause mortality in the tigecycline group compared with the control group. In all 13 Phase III and IV studies with control groups, the mortality rate was 4.0% (150/3788) in patients receiving tigecycline and 3.0% (110/3646) in controls. In a pooled analysis of these studies, the adjusted difference in risk of all-cause mortality between tigecycline and the control drug was 0.6% (95% CI 0.1, 1.2), based on a random-effects model stratified by study weight. The cause of this increase is unknown. This increase in all-cause mortality should be considered in the selection of therapeutic agents (see Precautions and adverse Effects).
Anaphylaxis/anaphylaxis
Almost all antimicrobials (including tigecycline) have been reported to have anaphylaxis/anaphyloid reactions and can be life-threatening. Tigecycline is structurally similar to tetracycline antibiotics; therefore, tigecycline should be used with caution in patients allergic to tetracycline antibiotics.
Liver effect
Increases in total bilirubin concentration, prothrombin time, and transaminases were observed in patients treated with tigecycline. Cases of severe liver dysfunction and liver failure have been reported. Some of these patients were taking multiple medications at the same time. Patients receiving tigecycline for abnormal liver function tests should be monitored to prevent further deterioration of liver function and to evaluate the risks and benefits of tigecycline therapy. These adverse events may occur after discontinuation of the drug.
Treatment of ventilator-associated pneumonia presents an unbalanced death rate and low cure rate
A study of patients with hospital-acquired pneumonia failed to demonstrate the effectiveness of tigecycline. In the study, patients were randomly assigned to either tigecycline (100mg for the first dose, then 50mg every 12 hours) or a control group. In addition, patients are allowed to receive specific complementary therapies. The subgroup of patients with ventilator-associated pneumonia treated with tigacycline had a lower cure rate (47.9% vs. 70.1% of the clinically evaluable population) and a higher mortality rate (25/131 [19.1%] vs. 15/122 [12.3%]) compared with the control group. In particular, the mortality rate of patients with ventilator-associated pneumonia and baseline bacteremia after treatment with tigecycline was higher than that of the control group (9/18 (50.0%) and 1/13 (7.7%), respectively).
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