Tigecycline side effects, dosage, interactions drugs. Common side effects of tigecycline include nausea, vomiting, and stomach pain. Sep 12, 20 tigecycline belongs to a group of drugs called glycycline antibiotics, which work by binding to bacteria and killing them. Tigecycline is the first drug in the glycylcycline class of antibiotics. Each tigecycline single dose 10 ml vial contains 50 mg tigecycline and 82. Compare headtohead ratings, side effects, warnings, dosages, interactions and. It was developed in response to the growing rate of antibiotic resistant bacteria such as staphylococcus aureus, acinetobacter baumannii, and e. 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.
Tygacil is compatible with the following drugs or diluents when used with either 0. Children younger than 8 years may be more sensitive to the side effects of tigecycline, especially tooth discoloration. Infection, bacterial infection and bacterial pneumonia. 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. 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. Jul 10, 2019 administer iv infusions over about 30 to 60 minutes. Webmd provides common contraindications for tigecycline intravenous.
Tygaciltreated patients versus comparatortreated patients. The tigecycline regimen was noninferior to the imipenemcilastatin group for nonvap, but did not meet the. Tigecycline injection may make your skin sensitive to sunlight or ultraviolet light. Alternatively, may be stored at 28c for up to 48 hours if dose of reconstituted tigecycline is immediately diluted in iv bag containing 0. The length of tigecycline therapy varied considerably range 321 days. In all phase 3 and 4 trials that included a comparator, death occurred in 4. Tygacil 50mg powder for solution for infusion summary of product.
Acinetobacter infections, especially multidrugresistant mdr acinetobacter infections, are a global health problem. Compare doxycycline vs tygacil comprehensive analysis by. Compare doxycycline vs tygacil comprehensive analysis by treato. Clostridium difficile infection cdi is a common cause of nosocomial diarrhea. Tooth discoloration has also occurred in older children and in young adults. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. 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. As tigecycline has recently entered the treatment armamentarium, its use has been limited, and the development of resistance has yet to be determined.
Tigecycline is administered only by intravenous infusion over 30 to 60. Efficacy of intravenous tigecycline in patients with acinetobacter complex infections. Seek emergency medical attention or call the poison help. Injection should be made with an infusion solution compatible with tigecycline and any.
Feb 03, 2020 tigecycline is injected into a vein through an iv. 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. Does tigecycline have a place in therapy for hospital. Tigecycline has a reduced potential for resistance, as it is not affected by the two major mechanisms of tetracycline resistance. 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. Minimum inhibitory concentrations mcgml disk diffusion zone diameter in mm. It is also active against meticillinresistant staphylococcus aureus and vancomycinresistant enterococci. 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. Increased mortality risk with use of iv tigecycline see black box warnings may cause fetal harm when administered to a pregnant woman. The ph is adjusted with hydrochloric acid, and if necessary sodium hydroxide. 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. After reconstitution, immediately withdraw the solution and add to 100 ml iv bag of ns or d5w for infusion. 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. 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. Tygacil 50mg powder for solution for infusion summary of. Adolescents aged 12 to tigecycline every 12 hours for 5 to 14 days. 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. Tigecycline is an antibiotic for a number of bacterial infections. Tigecycline is a glycylcycline antibacterial structurally related to the tetracyclines. Tygacil, inntigecycline european medicines agency europa. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Tigecycline tygacil class of antibiotic glyclycline although it is in its own class, it is similar in structure to tetracyclines. Tigecycline has a large volume of distribution 12 lkg, penetrating well into bone, lung, liver, and kidney tissues.
The marketed formulation of tigecycline tygacil includes the excipients lactose monohydrate to stabilize the drug against epimerization. Apr 15, 2019 in an openlabel, ascending multipledose study, 39 children aged 8 to 11 years with ciai or cssti were administered tigecycline 0. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk. 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. 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. A novel formulation of tigecycline has enhanced stability. 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. This medication comes in an injectable form to be given directly into the vein iv by a healthcare provider. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. 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. Tigecycline side effects, uses, dosage, overdose, pregnancy. Patients were randomized to receive tigecycline 25 or 50 mg iv q12h for 7 to 14 days.
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. 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 for the treatment of severe and severe. Tygacil tigecycline injection, powder, lyophilized, for.
Tygacil tigecycline this product information is intended only for residents of the united states. Find out what health conditions may be a health risk when taken with tigecycline intravenous. Tygacil tigecycline side effects, images, uses, dosage. Immediately withdraw 5 ml and add to a 100ml infusion bag. 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. Apr 25, 2017 subjects receiving omadacycline n41 received 100 mg iv every 12 hours for 2 doses then 100 mg iv oncedaily. Children aged 8 to tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days. Dec 03, 2018 tigecycline for injection, usp is an orange lyophilized powder or cake. 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. Tygacil tigecycline dose, indications, adverse effects. Efficacy of intravenous tigecycline in patients with. The cause of this increase has not been established. No dosage adjustment is necessary in elderly patients see section 5.
Dailymed tigecycline injection, powder, lyophilized, for. 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. Use infusion solution compatible with tigecycline and other drugs given. The primary efficacy end point was the clinically observed cure rate among clinically evaluable ce patients. Tigecycline exhibits timedependent killing and has prolonged postantibiotic effects. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Technically it is a derivative of minocycline inhibits protein synthesis of bacterial cell walls prokaryotic translation by binding to the 30s subunits of mrna. Before using tigecycline, tell your doctor or pharmacist if you are allergic to it. Tygacil tigecycline dosing, indications, interactions. Nov 09, 2018 tigecycline mixed in an iv bag with 0. Tigecycline definition of tigecycline by medical dictionary. Adverse reactions that were reported in 10% of patients in clinical trials with tigecycline include. Injection should be made with an infusion solution compatible with tigecycline and with any.
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. For information on systemic interactions resulting from concomitant use, see interactions. Tigecycline is active against grampositive and gramnegative bacteria, including tetracyclineresistant organisms, and some anaerobes. May cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy. 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. For the treatment of complicated intraabdominal infections due to susceptible isolates of citrobacter freundii, enterobacter cloacae, escherichia coli, klebsiella oxytoca, k pneumoniae.
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