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Tigecycline
Overview
What is Tigecycline?
Tigecycline for injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4,4a,5a,12a)-9-[2-(-butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide.
The following represents the chemical structure of tigecycline:
CHNO
M.W. 585.65
Figure 1: Structure of Tigecycline
Tigecycline for injection, USP is an orange lyophilized powder or cake. Each tigecycline single dose 10 mL vial contains 50 mg tigecycline and 82.6 mg of arginine as lyophilized powder for reconstitution for intravenous infusion. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives.
What does Tigecycline look like?
What are the available doses of Tigecycline?
For Injection: 50 mg, lyophilized powder for reconstitution in a single dose 10 mL vial. ()
What should I talk to my health care provider before I take Tigecycline?
Pediatrics: Use in patients under 18 years of age is not recommended. Pediatric trials were not conducted because of the higher risk of mortality seen in adult trials. ()
How should I use Tigecycline?
Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of(vancomycin-susceptible isolates), (methicillin-susceptible and -resistant isolates), grp. (includes and ), and
The recommended dosage regimen for tigecycline for injection is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions of tigecycline for injection should be administered over approximately 30 to 60 minutes every 12 hours. The recommended duration of treatment with tigecycline for injection for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days.The recommended duration of treatment with tigecycline for injection for community-acquired bacterial pneumonia is 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient’s clinical and bacteriological progress.
What interacts with Tigecycline?
Sorry No Records found
What are the warnings of Tigecycline?
Sorry No Records found
What are the precautions of Tigecycline?
Sorry No Records found
What are the side effects of Tigecycline?
Sorry No records found
What should I look out for while using Tigecycline?
Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline. Reactions have included anaphylactic reactions .
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable
What might happen if I take too much Tigecycline?
No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. Tigecycline is not removed in significant quantities by hemodialysis.
How should I store and handle Tigecycline?
Store between 2-8°C (36°-46°F).Tigecycline for injection, USP is supplied in a single dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution. The 10 mL vials are supplied in packages of ten (NDC # 63323-960-10).Prior to reconstitution, Tigecycline for injection, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].The reconstituted solution of Tigecycline for injection, USP may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). The container closure is not made with natural rubber latex.Tigecycline for injection, USP is supplied in a single dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution. The 10 mL vials are supplied in packages of ten (NDC # 63323-960-10).Prior to reconstitution, Tigecycline for injection, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].The reconstituted solution of Tigecycline for injection, USP may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). The container closure is not made with natural rubber latex.Tigecycline for injection, USP is supplied in a single dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution. The 10 mL vials are supplied in packages of ten (NDC # 63323-960-10).Prior to reconstitution, Tigecycline for injection, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].The reconstituted solution of Tigecycline for injection, USP may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). The container closure is not made with natural rubber latex.Tigecycline for injection, USP is supplied in a single dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution. The 10 mL vials are supplied in packages of ten (NDC # 63323-960-10).Prior to reconstitution, Tigecycline for injection, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].The reconstituted solution of Tigecycline for injection, USP may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). The container closure is not made with natural rubber latex.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Tigecycline is a tetracycline class antibacterial
Non-Clinical Toxicology
Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline. Reactions have included anaphylactic reactions .An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator-treated patients. In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3,788) of patients receiving tigecycline and 3.0% (110/3,646) of patients receiving comparator drugs. In a pooled analysis of these trials, based on a random effects model by trial weight, the adjusted risk difference of all-cause mortality was 0.6% (95% CI 0.1, 1.2) between tigecycline and comparator-treated patients. An analysis of mortality in all trials conducted for approved indications (cSSSI, cIAI, and CABP), including post-market trials showed an adjusted mortality rate of 2.5% (66/2,640) for tigecycline and 1.8% (48/2,628) for comparator, respectively. The adjusted risk difference for mortality stratified by trial weight was 0.6% (95% CI 0.0, 1.2). The cause of this mortality difference has not been established.Generally, deaths were the result of worsening infection, complications of infection or underlying co-morbidities. Tigecycline should be reserved for use in situations when alternative treatments are not suitable
The following serious adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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