Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):
Tygacil should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
The duration of therapy should be guided by the severity, site of the infection, and the patient’s clinical response.
Tigecycline is only to be used to treat patients aged 8 years and older after consultation with a physician with appropriate experience in the management of infectious diseases.
Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days.
Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days.
No dosage adjustment is necessary in elderly patients (see section 5.2).
No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
In patients (including paediatrics) with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50%. Adult dose should be reduced to 25 mg every 12 hours following the 100 mg loading dose. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response (see sections 4.4 and 5.2).
No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2).
The safety and efficacy of Tygacil in children under 8 years of age have not been established. No data are available. Tygacil should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 5.1).
Tigecycline is administered only by intravenous infusion over 30 to 60 minutes (see sections 4.4 and 6.6). Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients (see section 4.4).
For instructions on reconstitution & dilution of the medicinal product before administration, see section 6.6.
No specific information is available on the treatment of overdosage. 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 haemodialysis.
Shelf life: 2 years.
Once reconstituted and diluted in the bag or other suitable infusion container (e.g. glass bottle), tigecycline should be used immediately.
Store below 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals. Tygacil is distributed in a ten vial tray pack.
The powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, dextrose 50 mg/ml (5%) solution for injection, or Lactated Ringer’s solution for injection to achieve a concentration of 10 mg/ml of tigecycline. The vial should be gently swirled until the medicinal product is dissolved. Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e.g. glass bottle).
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag or other suitable infusion container (e.g. glass bottle).
Note: The vial contains a 6% overage. Thus, 5 ml of reconstituted solution is equivalent to 50 mg of the active substance. The reconstituted solution should be yellow to orange in colour; if not, the solution should be discarded. Parenteral products should be inspected visually for particulate matter and discolouration (e.g. green or black) prior to administration.
Tigecycline should be administered intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several active substances, the line should be flushed before and after infusion of tigecycline with either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection. Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line (see section 6.2)
This medicinal product is for single use only; any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9%) solution for injection, dextrose 50 mg/ml (5%) solution for injection, and Lactated Ringer’s solution for injection.
When administered through a Y-site, compatibility of tigecycline diluted in sodium chloride 0.9% for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer’s, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
