GMP Certified / Tigecycline for Injection 50mg

• Quality Standard: USP, Bp
• Usage Mode: Injection
• Factory Certified: GMP
• Transport Package: Carton
• Specification: 50mg
• Trademark: Sinolead
• Model NO.: injection
• Origin: China
• Production Capacity: 100000ctns Per Month

Product Description

Generic Name	Tigecycline for Injection
Strength	50 mg
Packing	10 vials /box
Origin	China

 

 

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 Packaging design by our team
 Registration service by our team
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Product name:
Tigecycline for Injection 50mg

Character:
This product is orange freeze-dried lump or powder.

Indications:
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.

Drug interaction:
In drug interaction studies, healthy subjects were given both this product (first dose 100 mg, then 50 mg every 12 hours) and digoxin (first dose 0.5 mg followed by 0.25 mg orally every 24 hours). Tigecycline slightly reduced digoxin Cmax by 13%, but had no effect on digoxin AUC or clearance. Slight changes in Cmax did not affect the steady-state pharmacodynamics of digoxin as measured by ECG interval changes. In addition, digoxin did not affect the pharmacokinetic properties of tigecycline. Therefore, there is no need to adjust the dosage of this product when combined with digoxin.
In healthy subjects, simultaneous administration of this product (first 100 mg, then 50 mg every 12 hours) and warfarin (25 mg single dose) resulted in a 40% and 23% reduction in R-warfarin and S-warfarin clearance, a 38% and 43% increase in Cmax, and a 68% and 29% increase in AUC, respectively. Tigacycline did not significantly change the effect of warfarin on INR. In addition, warfarin did not affect the pharmacokinetic properties of tigecycline. However, when tegecycline is used with warfarin, prothrombin time or other appropriate anticoagulation tests should be monitored. (See [Drug Interactions])
In vitro studies of human liver microsomes suggest that tigecycline does not inhibit metabolic processes mediated by the following six cytochrome P450 (CYP) subtypes: 1A2, 2C8, 2C9, 2C19, 2D6, and 3A4. Therefore, tigecycline is not expected to alter the metabolic process of drugs that are metabolized by the above-mentioned metabolic enzymes. In addition, because the metabolism of tigecycline is not widespread, agents that inhibit or induce the activity of these CYP450 subtypes are not expected to affect the clearance of Tigecycline.
Simultaneous use of antibacterial drugs with oral contraceptives can lead to reduced effectiveness of oral contraceptives.

Pharmacology and toxicology:
Pharmacological action:
Tigecycline is A glycylcycline antibacterial drug that inhibits bacterial protein synthesis by binding to ribosome 30S subunits and preventing aminoacylated tRNA molecules from entering ribosome A site. This prevents the peptide chain from lengthening due to the incorporation of amino acid residues. Tigacycline contains a glycine amino group, which replaces the 9 position of minocycline. This substituted form is not found in any natural or semi-synthetic tetracycline compounds, giving tigacycline its unique microbial properties. Tigacycline is not affected by the two major tetracycline resistance mechanisms (ribosome protection and efflux mechanism). Accordingly, in vitro and in vivo studies confirmed the broad-spectrum antibacterial activity of tigecycline. No cross-resistance between tigecycline and other antibiotics has been found. Tigecycline is not affected by resistance mechanisms such as β-lactamases (including ultra-broad spectrum β-lactamases), target modifications, macrolide efflux pumps, or enzyme target changes such as rotases/topoisomerases. In vitro studies have not confirmed the antagonism between tigacycline and other commonly used antibiotics. Overall, tigecycline is a bacteriostatic.
Toxicological studies:
Toxicity of repeated administration:
Erythrocyte, reticular cell, leukocyte, and thrombocytopenia associated with myelosuppression were observed in rats and dogs exposed to 8 and 10 times the daily dose of tigecycline as measured by AUC, respectively, during the 2-week study. After 2 weeks of administration, these changes were reversible.
No evidence of photosensitivity was observed after administration of tigacycline in rats.
Genotoxicity:
In a set of tests, including Chinese hamster ovary (CHO) cell chromosome aberration detection in vitro, CHO cell (HGRPT locus) in vitro positive mutation detection, mouse lymphoma cell positive mutation detection in vitro, and mouse micronucleus detection, no mutagenicity of tigecycline was found.
Reproductive toxicity:
According to AUC calculations, tigecycline exposure doses up to 5 times the daily human dose did not affect mating or fertility in rats, and there was no drug-related effect on ovarian or estrous cycles in female rats.
Carcinogenicity:
No lifetime animal studies have been conducted to evaluate the carcinogenicity of tigecycline.
Others:
In preclinical studies, high intravenous administration of tigecycline was associated with histamine response.

Storage:
Before preparation, this product should be stored at 20~25ºC, with an allowable deviation of 15~30ºC. This product can be stored at room temperature for up to 24 hours after redissolution (up to 6 hours if stored in infusion bottle or IV bag at room temperature after redissolution). Accordingly, the product should be mixed with 0.9% sodium chloride injection (USP) or 5% glucose injection (USP) immediately after redissolution and stored at 2~8ºC for 48 hours. This product should be transferred and diluted by intravenous infusion immediately after redissolution for intravenous infusion.