Patient leaflet - Tigecycline 50 mg powder for solution for infusion
1. What Tigecycline is and what it is used for
Tigecycline is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.
Your doctor has prescribed this medicine because you or your child at least 8 years old has one of the following types of serious infections:
Complicated infection of the skin and
soft tissues (the tissue below the skin), excluding diabetic foot infections
- Complicated infection in the abdomen
Tigecycline is only used when your doctor thinks other antibiotics are not suitable.
2. What you need to know before you are given Tigecycline
Tigecycline must not be given
if you are allergic to tigecycline or any
of the other ingredients of this medicine (listed in section 6).
If you are allergic to tetracycline class
antibiotics (such as minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Warnings and precautions
Talk to your doctor or nurse before you are given Tigecycline
- if you have poor or slow wound healing.
if you are suffering from diarrhoea before
you are given this medicine. If you develop diarrhoea during or after your treatment, tell your doctor at once. Do not take any diarrhoea medicine without first checking with your doctor.
if you have or previously had any side
effects due to antibiotics belonging to the tetracycline class (such as skin sensitization to sun light, staining on developing teeth, pancreas inflammation, and alteration of certain laboratory values aimed at measuring how well your blood clots).
if you have, or previously had liver
problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects.
if you have blockage of the bile ducts
(cholestasis).
if you suffer from a bleeding disorder or are
in treatment with anticoagulant medicines, as Tigecycline can interfere with blood coagulation.
During treatment with Tigecycline:
tell your doctor immediately if you develop
symptoms of an allergic reaction.
tell your doctor immediately if you develop
severe abdominal pain, nausea, and vomiting.
These may be symptoms of acute
pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting).
in certain serious infections, your doctor
may consider to use Tigecycline in combination with other antibiotics.
your doctor will monitor you closely for
the development of any other bacterial infections. If you develop another bacterial
infection, your doctor may prescribe a different antibiotic specific for the type of infection present.
- although antibiotics including Tigecycline fight certain bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you closely for any potential infections and treat you if necessary.
Children
This medicine is not to be used in children less than 8 years of age due to the lack of data on safety and efficacy in this age group and because it may cause permanent dental defects such as staining on the developing teeth.
Other medicines and Tigecycline
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Tigecycline may prolong certain tests that measure how well your blood is clotting. It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting (named anticoagulants). If this were the case, your doctor will monitor you closely.
This medicine may interfere with the contraceptive pill (birth control pill). Talk to your doctor about the need for an additional method of contraception while receiving this medicine.
Tigecycline may increase the effect of medicines used to suppress the immune system (such as tacrolimus or cyclosporine). It is important that you tell your doctor if you are taking these medicines so you can be closely monitored.
Pregnancy and breast-feeding
Tigecycline may cause foetal harm. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving Tigecycline.
It is not known if Tigecycline passes into breast milk in humans. Ask your doctor for advice before breast-feeding your baby.
Driving and using machines
Tigecycline may cause side effects such as dizziness. This may impair your ability to drive or operate machinery.
Tigecycline contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How Tigecycline is given
This medicine will be given to you by a doctor or a nurse.
The recommended dose in adults is 100 mg given initially, followed by 50 mg every 12 hours. This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes.
Use in children and adolescents
The recommended dose in children aged
8 to <12 years is 1.2 mg/kg given every 12 hours intravenously to a maximum dose of 50 mg every 12 hours.
- The recommended dose in adolescents aged 12 to <18 years is 50 mg given every 12 hours.
A course of treatment usually lasts for 5 to 14 days. Your doctor will decide how long you should be treated.
If you receive more Tigecycline than you should
If you are concerned that you may have been given too much Tigecycline, talk to your doctor or nurse immediately.
If you miss a dose of Tigecycline
If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
The following information is intended for healthcare professionals only:
Instructions for use and handling (see also
- 3. How Tigecycline is given in this leaflet)
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 active substance 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 for infusion 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 free of visible evidence of contamination; 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.
The ready-to-use solution for infusion 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pseudomembranous colitis (swelling or inflammation of the large intestine) may occur with most antibiotics including tigecycline. This consists of severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after your treatment.
Very common: (may affect more than 1 in 10 people)
nausea (feeling sick), vomiting (being sick),
diarrhoea.
Common: (may affect up to 1 in 10 people)
- abscess (collection of pus), infections
laboratory measurements of decreased
ability to form blood clots
- dizziness
vein irritations from the injection, including
pain, inflammation, swelling and clotting
abdominal pain, dyspepsia (stomach ache
and indigestion), anorexia (loss of appetite)
increases in liver enzymes,
hyperbilirubinaemia (excess of bile pigment in the blood)
- pruritus (itching), rash
- poor or slow wound healing
- headache
increase in amylase, which is an enzyme
found in the salivary glands and pancreas, increased blood urea nitrogen (BUN)
- pneumonia
- low blood sugar
sepsis (severe infection in the body and
blood stream)/septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis)
injection site reaction (pain, redness,
inflammation)
- low protein levels in the blood
Uncommon: (may affect up to 1 in 100 people)
acute pancreatitis (inflamed pancreas
which may result in severe abdominal pain, nausea, and vomiting)
jaundice (yellow coloration of the skin),
inflammation of the liver
low platelet levels in the blood (which may
lead to an increased bleeding tendency and bruising/haematoma)
Rare: (may affect up to 1 in 1,000 people)
low fibrinogen levels in the blood (a protein
involved in blood clotting)
Not known: (frequency cannot be estimated from the available data)
anaphylaxis/anaphylactoid reactions
which are serious, potentially fatal allergic reaction. They may range from mild to severe, including a sudden, generalised allergic reaction that may lead to a life-threatening shock (such as difficulty in breathing, drop of blood pressure, fast pulse)
- liver failure
skin rash, which may lead to severe
blistering and peeling of the skin (Stevens-Johnson Syndrome)
Tigecycline belongs to the tetracycline class of antibiotics and may have similar adverse effects. Such effects may include: fixed eruption (may look like round or oval patches of redness and swelling of the skin, blistering (hives), itching.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tigecycline
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and the outer carton after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Storage after preparation
After reconstitution:
Once the powder has been made into a solution it should be used immediately.
After dilution:
Chemical and physical in-use stability after reconstitution and immediate dilution in the bag or other suitable infusion container (e.g. glass bottle) has been demonstrated for:
6 hours at 23 - 27°C both under artificial light and protected from light when diluted with 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 at a concentration of Tigecycline 0.476 mg/mL & 0.909 mg/mL.
- 48 hours at 2 - 8°C protected from light and for 1 additional hour at 23 - 27°C exposed to light when diluted with 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 at a concentration of Tigecycline 0.476 mg/mL & 0.909 mg/mL.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
The Tigecycline solution should be clear yellow to orange in colour after dissolving; if it is not, the solution should be discarded.
Do not throw away any medicines via wastewater or <household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Tigecycline contains
- The active substance is tigecycline. Each vial contains 50 mg of tigecycline. After reconstitution 1 ml solution contains 10 mg of tigecycline.
- The other ingredients are lactose monohydrate, hydrochloric acid concentrated (for pH adjustment) and sodium hydroxide (for pH adjustment).
What Tigecycline looks like and contents of the pack
Tigecycline is supplied as a powder for solution for infusion in 6 mL Type I clear glass vials with grey Type I bromobutyl rubber stopper, aluminium seal and a yellow polypropylene plastic flip off closure and looks like an orange powder before it is diluted.
This medicine is supplied in packs of 1 and 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DEMO PHARMA UK LIMITED
2nd Floor Connect 38, 1 Dover Place, Ashford, Kent, TN23 1FB,
England
Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY 21st Km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece
This leaflet was last revised in 07/2026.
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 9 mg/mL (0.9 %) solution for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, Lactated Ringer’s, lidocaine hydrochloride, metoclopramide, norepinephrine, piperacillin/ tazobactam , potassium chloride, propofol, theophylline, and tobramycin.
Tigecycline must not be mixed with other medicinal products for which compatibility data are not available.
For single use only, any unused solution should be discarded.