This product may contain inactive ingredients, which can cause allergic reactions or other problems. Tooth discoloration has also occurred in older children and in young adults. It is also active against meticillinresistant staphylococcus aureus and vancomycinresistant enterococci. Feb 03, 2020 tigecycline is injected into a vein through an iv. Infection, bacterial infection and bacterial pneumonia. Clostridium difficile infection cdi is a common cause of nosocomial diarrhea. It is also active against meticillinresistant staphylococcus aureus and vancomycinresistant enterococci, but pseudomonas aeruginosa and many strains of proteus spp are resistant to tigecycline. It was developed in response to the growing rate of antibiotic resistant bacteria such as staphylococcus aureus, acinetobacter baumannii, and e. Jul 10, 2019 administer iv infusions over about 30 to 60 minutes. Acinetobacter infections, especially multidrugresistant mdr acinetobacter infections, are a global health problem. Children aged 8 to tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days. Injection should be made with an infusion solution compatible with tigecycline and any. Apr 15, 2019 in an openlabel, ascending multipledose study, 39 children aged 8 to 11 years with ciai or cssti were administered tigecycline 0.
Increased mortality risk with use of iv tigecycline see black box warnings may cause fetal harm when administered to a pregnant woman. No dosage adjustment is necessary in elderly patients see section 5. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, iv tubing, and other items used. Omadacycline concentrations exceed tigecycline levels in. Sep 12, 20 tigecycline belongs to a group of drugs called glycycline antibiotics, which work by binding to bacteria and killing them. Alternatively, may be stored at 28c for up to 48 hours if dose of reconstituted tigecycline is immediately diluted in iv bag containing 0. Tigecycline definition of tigecycline by medical dictionary. Tygacil 50mg powder for solution for infusion summary of product. Tigecycline is administered only by intravenous infusion over 30 to 60.
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. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk. 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. The marketed formulation of tigecycline tygacil includes the excipients lactose monohydrate to stabilize the drug against epimerization. Patients were randomized to receive tigecycline 25 or 50 mg iv q12h for 7 to 14 days. The primary efficacy end point was the clinically observed cure rate among clinically evaluable ce patients. May cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy. For clinical use, tigecycline is currently formulated as a lyophilized powder or cake, which is reconstituted 10 mgml and diluted 1 mgml for intravenous administration 4.
Tygacil, inntigecycline european medicines agency europa. The length of tigecycline therapy varied considerably range 321 days. Webmd provides common contraindications for tigecycline intravenous. Minimum inhibitory concentrations mcgml disk diffusion zone diameter in mm. Tigecycline has a large volume of distribution 12 lkg, penetrating well into bone, lung, liver, and kidney tissues. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk difference of allcause mortality was 0. Efficacy of intravenous tigecycline in patients with. Common side effects of tigecycline include nausea, vomiting, and stomach pain. Compare headtohead ratings, side effects, warnings, dosages, interactions and. In all phase 3 and 4 trials that included a comparator, death occurred in 4. Aug 15, 2006 tigecycline provides high intracellular concentrations in other tissues such as lung and bowel that exceed serum concentrations by 2 to 8fold. Tigecycline has a reduced potential for resistance, as it is not affected by the two major mechanisms of tetracycline resistance. The cause of this increase has not been established. Once reconstituted, tygacil may be stored at room temperature for up to 24 hours up to 6 hours in the vial and the remaining time in the iv bag.
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. 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. Tigecycline tygacil class of antibiotic glyclycline although it is in its own class, it is similar in structure to tetracyclines. 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. Before using tigecycline, tell your doctor or pharmacist if you are allergic to it. Thus, tigecycline may have activity against tetracyclineresistant organisms 6,7. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Children younger than 8 years may be more sensitive to the side effects of tigecycline, especially tooth discoloration. Tygaciltreated patients versus comparatortreated patients. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Find out what health conditions may be a health risk when taken with tigecycline intravenous. Tigecycline is active against grampositive and gramnegative bacteria, including tetracyclineresistant organisms, and some anaerobes. Technically it is a derivative of minocycline inhibits protein synthesis of bacterial cell walls prokaryotic translation by binding to the 30s subunits of mrna. In all of the included cases, tigecycline was administered intravenously as a 100mg loading dose, followed by 50 mg twice daily for the subsequent duration of treatment.
Eligible patients can register for valuable savings offers for nearly 40 brand name medications. 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. For the treatment of complicated intraabdominal infections due to susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, k pneumoniae. Tygacil tigecycline this product information is intended only for residents of the united states. Tigecycline injection may make your skin sensitive to sunlight or ultraviolet light.
Tygacil is compatible with the following drugs or diluents when used with either 0. Adverse reactions that were reported in 10% of patients in clinical trials with tigecycline include. Theres more to see the rest of this entry is available only to subscribers. The ph is adjusted with hydrochloric acid, and if necessary sodium hydroxide. 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 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. Adolescents aged 12 to tigecycline every 12 hours for 5 to 14 days. Tygacil tigecycline injection, powder, lyophilized, for. 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. Seek emergency medical attention or call the poison help.
A novel formulation of tigecycline has enhanced stability. For information on systemic interactions resulting from concomitant use, see interactions. Tigecycline is administered only by intravenous infusion over 30 to 60 minutes see. Metronidazole and vancomycin are the primary treatment options for cdi, but increasing rates of antimicrobial resistance and severe, refractory disease have prompted the need for alternative agents. Tygacil tigecycline side effects, images, uses, dosage. Each tigecycline single dose 10 ml vial contains 50 mg tigecycline and 82. Tigecycline side effects, dosage, interactions drugs. Tigecycline exhibits timedependent killing and has prolonged postantibiotic effects. Efficacy of intravenous tigecycline in patients with acinetobacter complex infections. Tigecycline is an antibiotic for a number of bacterial infections. 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 is a glycylcycline antibacterial structurally related to the tetracyclines. 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.
Apr 25, 2017 subjects receiving omadacycline n41 received 100 mg iv every 12 hours for 2 doses then 100 mg iv oncedaily. After reconstitution, immediately withdraw the solution and add to 100 ml iv bag of ns or d5w for infusion. Tigecycline is the first drug in the glycylcycline class of antibiotics. Injection should be made with an infusion solution compatible with tigecycline and with any.
Dailymed tigecycline injection, powder, lyophilized, for. When administered through a ysite, compatibility of tigecycline diluted in. Immediately withdraw 5 ml and add to a 100ml infusion bag. Use infusion solution compatible with tigecycline and other drugs given. Does tigecycline have a place in therapy for hospital. Tigecycline concentrations found in bone have been. Subjects receiving omadacycline n41 received 100 mg iv every 12 hours for 2 doses then 100 mg iv oncedaily. Tigecycline for the treatment of severe and severe. Compare doxycycline vs tygacil comprehensive analysis by.
Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Alternatively, tygacil may be stored refrigerated at 2 to 8c 36 to 46f for up to 45 hours following immediate transfer of the reconstituted solution into the iv bag. 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. Tygacil 50mg powder for solution for infusion summary of. As tigecycline has recently entered the treatment armamentarium, its use has been limited, and the development of resistance has yet to be determined. This medication comes in an injectable form to be given directly into the vein iv by a healthcare provider. Tygacil tigecycline dosing, indications, interactions. Compare doxycycline vs tygacil comprehensive analysis by treato. The tigecycline regimen was noninferior to the imipenemcilastatin group for nonvap, but did not meet the. Dec 03, 2018 tigecycline for injection, usp is an orange lyophilized powder or cake.
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