This medication comes in an injectable form to be given directly into the vein iv by a healthcare provider. Injection should be made with an infusion solution compatible with tigecycline and with any. To evaluate mitochondrial respiratory complex iv activity upon tigecycline treatment, tex cells were treated for 48 hours with 5 m tigecycline either freshly dissolved in saline with or without additives or following a 4day incubation in the dark. Tygacil tigecycline dosage and administration pfizer. Stability and compatibility of reconstituted ertapenem with commonly. Tigecycline injection may make your skin sensitive to sunlight or ultraviolet light.
Feb 03, 2020 tygacil tigecycline for injection is supplied in a singledose 5 ml glass vial or 10 ml glass vial, each containing 50 mg tigecycline lyophilized powder for reconstitution. Common and rare side effects for tigecycline intravenous. Each monograph contains stability data, administration guidelines, and methods of preparation. Aug 15, 2006 the recommended dosage of tigecycline for the treatment of complicated intraabdominal and skinskinstructure infections in adults is 100 mg iv initially, followed by 50 mg iv every 12 h. Healthy subjects received a single 100 mg iv dose of tigecycline followed by 50 mg iv q 12 h. No specific information is available on the treatment of overdosage with tigecycline. Established name tigecycline for injection, 50 mgvial. Tygacil 50mg powder for solution for infusion summary of. In an openlabel, ascending multipledose study, 39 children aged 8 to 11 years with ciai or cssti were administered tigecycline 0. Digital books looseleaf edition database licensing. Each tigecycline single dose 10 ml vial contains 50 mg tigecycline and 82. All patients received iv tigecycline for a minimum of 3 consecutive days to a maximum of 14 consecutive days, with the option to be switched to an oral antibiotic on or after day 4. Tigecycline tygacil is an antibiotic used to treat complicated skin infections caused by susceptible strains of bacteria, for treating complicated intraabdominal infections caused by susceptible strains of bacteria, and to treat communityacquired bacterial pneumonia.
Tigecycline evades the tetae efflux pumps, 11,12 which account for most acquired resistance to tetracycline and minocycline in enterobacteriaceae and acinetobacter spp also the tetk pumps, which occur widely in staphylococci conferring resistance to tetracycline though not minocycline or doxycycline. Critical care intravenous drug administration guide. Detailed listing of the iv drug compatibility and stability updates applied to the king guide to parenteral admixtures over the last 12 years. Tygacil tigecycline this product information is intended only for residents of the united states. Nov 09, 2018 tigecycline mixed in an iv bag with 0. Tygacil tigecycline dose, indications, adverse effects. It was developed in response to the growing rate of antibiotic resistant bacteria such as staphylococcus aureus, acinetobacter baumannii, and e. Although it is structurally related to minocycline, alterations to the molecule resulted in its expanded spectrum of activity and decreased susceptibility to the development of resistance when compared with other tetracycline antibiotics. Apr 25, 2017 subjects receiving omadacycline n41 received 100 mg iv every 12 hours for 2 doses then 100 mg iv oncedaily.
Apr 15, 2019 in an openlabel, ascending multipledose study, 39 children aged 8 to 11 years with ciai or cssti were administered tigecycline 0. Intravenous compatibility chart acyclovir acyclovir. This ed material has been downloaded from a licensed data provider and is not for distribution, except. Please choose the category that best describes you. The chemical name of tigecycline is 4s,4as,5ar,12as92tertbutylaminoacetamido4,7bis dimethylamino1,4,4a,5,5a,6,11,12aoctahydro3,10,12,12atetrahydroxy1,11dioxo2naphthacenecarboxamide. Tygacil tigecycline is a tetracycline class antibacterial for intravenous infusion. Tigecycline is the first drug in the glycylcycline class of antibiotics. Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased. Detailed compatibility tables for each drug covering solution, additive, syringe, and ysite.
Patients were randomized to receive tigecycline 25 or 50 mg iv q12h for 7 to 14 days. Common side effects of tigecycline include nausea, vomiting, and stomach pain. As a tetracycline derivative antibiotic, its structural modifications has expanded its therapeutic activity to include gram. Intravenous compatibility chart free html5 flip book maker. Introduction tigecycline, the first of a new class of broadspectrum antibiotics, the glycylcyclines, was recently licensed in south africa for the parenteral treatment of adult patients. The stability of ertapenem sodium in various commonly used i.
Tigecycline inhibits protein production in bacteria by binding to the 30s ribosomal subunit and blocking entry of transfer rna molecules into the ribosome of the bacteria. Tigecycline belongs to a group of drugs called glycycline antibiotics, which work by binding to bacteria and killing them this medication comes in an injectable form to be given directly into the vein iv by a healthcare. Tigecycline for the treatment of severe and severe. Evaluation of the precipitation characteristics of ertapenem, tigecycline, colistin. The ph is adjusted with hydrochloric acid, and if necessary sodium hydroxide. Incompatibilities are based on meeting any of the following criteria. Covering the relevant world literature through 2003, this book picks up.
It is also active against meticillinresistant staphylococcus aureus and vancomycinresistant enterococci, but pseudomonas aeruginosa and many strains of proteus spp are resistant to tigecycline. Iv push allows for administration of an antibiotic in a minimal fluid volume. Omadacycline concentrations exceed tigecycline levels in. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. However, because of its extensive distribution into tissue, high blood levels are not maintained, so tigecycline is probably not a good choice for patients with bacteremia. Tigecycline is an antibiotic for a number of bacterial infections. Usual duration of therapy is 5 14 days, although actual duration should be dictated by the site and severity of infection and the patients overall clinical status. Immediately withdraw 5 ml and add to a 100ml infusion bag. The reconstituted solution may be a slightly yellow colour.
If the same iv line is used for sequential infusion of several drugs, flush line with ns, d5w, or lr before and after tigecycline administration. Tigecycline is currently approved in north america for the treatment of. Home explore intravenous compatibility chart drug information for the. Tigecycline is a glycylcycline antibiotic derived from the tetracycline group, that acts by inhibiting protein synthesis at the level of the bacterial ribosome. Tigecycline has a large volume of distribution 12 lkg, penetrating well into bone, lung, liver, and kidney tissues. Tigecycline binds to bacterial ribosomes which produce the cells proteins. Tigecycline slightly decreased the cmax of digoxin by %, but did not affect the auc or clearance of digoxin. Intravenous admixtures preparation and infusion guidelines. Tygaciltreated patients versus comparatortreated patients.
Tooth discoloration has also occurred in older children and in young adults. Tygacil tigecycline side effects, images, uses, dosage. Store in the iv bag at room temperature for up to 6 h, or refrigerated at 2. Tigecycline has a reduced potential for resistance, as it is not affected by the two major mechanisms of tetracycline resistance. If the same iv line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of tigecycline with an infusion solution compatible with tigecycline and with any other drugs administered via this common line, such as 0. Tigecycline shows higher binding affinity than tetracyclines, being active against bacterial strains with either mechanism of tetracycline resistance efflux and ribosomal protection. June 25, 20 and a paragraph iv certification regarding the above patents stating that in.
Tigecycline is supplied as a 50 mg vial for reconstitution. Does tigecycline have a place in therapy for hospital. A novel formulation of tigecycline has enhanced stability. Tigecycline for injection, usp is an orange lyophilized powder or cake.
If the same iv line is used for sequential infusion of several drugs, flush the line before and after infusion of this drug with an infusion solution compatible to all drugs. Tigecycline tygacil class of antibiotic glyclycline although it is in its own class, it is similar in structure to tetracyclines. Tigecycline is an injectable antibiotic used for the treatment of infections caused by susceptible bacteria. Compatibility with the coinfusion solutions was monitored for up to eight. Intravenous compatibility chart drug information for the. In all phase 3 and 4 trials that included a comparator, death occurred in 4. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk. A novel formulation of tigecycline has enhanced stability and.
Iv drug compatibility chart the iv drug compatibility chart is based on information from the handbook of injectable drugs, 16th edition, by lawrence a. The tigecycline regimen was noninferior to the imipenemcilastatin group for nonvap, but did not meet the. Intravenous tigecycline administered as a 100mg loading dose followed by 50 mg twice daily resulted in clinical cure in 85. Physical and chemical compatibility data supporting the drug product compatibility. Infuse over 30 to 60 minutes through dedicated line or via ysite. Dailymed tigecycline injection, powder, lyophilized, for. Potassium chloride, propofol, ropivacaine, tigecycline, ziconotide, and zidovudine. The recommended dose of tigecycline is 100 mg iv bolus followed by 50 mg iv every 12 hours to be delivered over 30 to 60 minutes.
Thus, tigecycline may have activity against tetracyclineresistant organisms 6,7. Following the administration of tigecycline 100 mg followed by 50 mg every 12 hours to 33 healthy volunteers, the tigecycline auc 012h 4 mcghml in alveolar cells was approximately 78fold higher than the auc 012h in the serum, and the auc 012h 2. Intravenous infusions of tygacil should be administered over approximately 30 to 60 minutes every 12 hours. In patients with severe hepatic impairment childpugh class c, the initial dose of tigecycline should be 100 mg iv followed by a reduced maintenance dose of 25 mg iv every 12 hours. The majority of patients n 45 were treated with the novel triple therapy combination of tigecycline, vancomycin, and metronidazole and resulted in clinical cure in 80% n. Tigecycline is similar to tetracycline antibiotics and has activity against a large number of bacteria. Intravenous admixtures preparation and infusion guidelines this reference contains standard dilutions including iv admixture drug concentration, infusion volumes, and infusion rates. Adverse reactions that were reported in 10% of patients in clinical trials with tigecycline include. However, because of its extensive distribution into tissue, high blood levels are not maintained, so tigecycline is probably not a. Tigecycline is active against grampositive and gramnegative bacteria, including tetracyclineresistant organisms, and some anaerobes.
The primary efficacy end point was the clinically observed cure rate among clinically evaluable ce patients. Minimum inhibitory concentrations mcgml disk diffusion zone diameter in mm. Technically it is a derivative of minocycline inhibits protein synthesis of bacterial cell walls prokaryotic translation by binding to the 30s subunits of mrna. Intravenous iv preparation and infusion guidelines globalrph. Administer iv infusions over about 30 to 60 minutes. Children younger than 8 years may be more sensitive to the side effects of tigecycline, especially tooth discoloration. This prevents formation of peptide chains in bacteria, thus interfering with their growth. Omeprazole is administered by intravenous infusion and intravenous injection. Appropriate use of tigecycline a j brink, d bizos, k d boffard, c feldman, d c grolman, j pretorius, g a richards, m senekal, e steyn, n welkovic 1.
It displays broadspectrum, potent activity against both grampositive and gramnegative bacteria, including many multidrugresistant pathogens. Tygacil is compatible with the following drugs or diluents when used with either 0. Tigecycline is a prescription medication used to treat serious skin and stomach infections and certain types of pneumonia lung infection. Tygacil tigecycline dosing, indications, interactions. Tigecycline 100 mg followed by 50 mg every 12 hours and digoxin 0. There is limited information regarding the compatibility of tigecycline and iv administrations.
Intravenous compatibility chart free html5 flip book. This reference contains standard dilutions including iv admixture drug concentration, infusion volumes, and infusion rates. Dec 03, 2018 tigecycline for injection, usp is an orange lyophilized powder or cake. Learn about drug imprint, side effects, uses treating, dosage, interaction, overdose, and warnings. Sep 12, 20 tigecycline belongs to a group of drugs called glycycline antibiotics, which work by binding to bacteria and killing them. Tigecycline is a similar to the tetracyclines and may chelate calcium ions and discolor teeth if administered to patients during tooth development tigecycline does not inhibit metabolism of agents via cyp pathways 1a2, 2c8, 2c9, 2c19, 2d6, and 3a4. Tigecycline is a firstinclass glycylcycline antibiotic, developed as a third generation structural analog of older tetracyclines. Trissel, fashp, 2010, american society of healthsystem pharmacists. Seek emergency medical attention or call the poison help.
Tigecycline vial side effects by likelihood and severity webmd. Tigecycline side effects, dosage, interactions drugs. May 28, 2014 complex iv cytochrome c oxidase activity assay. No dosage adjustments are required in patients with mild or moderate cirrhosis childpugh class a and b. Compatibilities compatible intravenous solutions include 0. Tigecycline is an antibiotic that is fda approved for the treatment of complicated skin and skin structure infections, complicated intraabdominal infections and communityacquired pneumonia. In order to provide you with relevant and meaningful content we need to know more about you. Jul 10, 2019 administer iv infusions over about 30 to 60 minutes. Dosing guidelines in pediatric patients have not been established.
Common adverse reactions include nausea, vomiting, diarrhea, abdominal pain, headache and increased sgpt. Tigecycline is a similar to the tetracyclines and may chelate calcium ions and discolor teeth if administered to patients during tooth development iv every 12 hours for 2 doses then 100 mg iv oncedaily. The recommended dosage regimen for tygacil is an initial dose of 100 mg, followed by 50 mg every 12 hours. Tigecycline side effects, uses, dosage, overdose, pregnancy. Selected from data included with permission and ed by first databank, inc. Several antibiotics are food and drug administrationapproved for iv push.
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