Tygacil 50 mg powder for solution for infusion
tigecycline
Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Tygacil is and what it is used for
2. Before you receive Tygacil
3. How Tygacil is given
4. Possible side effects
5. How to store Tygacil
6. Further information
What Tygacil Is And What It Is Used For
Tygacil is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.
Your doctor prescribed Tygacil because you have one of the following types of serious infections:
- Complicated infection of the skin and soft tissues
Tygacil is not indicated for the treatment of diabetic foot infections. - Complicated infection in the abdomen
Before You Receive Tygacil
Do not use Tygacil
- If you are allergic (hypersensitive) to tigecycline, the active substance of Tygacil. If you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Take special care with Tygacil
- 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.
- Tell your doctor if you are suffering from diarrhoea before you are given Tygacil. 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.
- Tell your doctor if you have or previously had any side effects due to antibiotics belonging to the tetracycline class (e.g., 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).
- In certain serious infections, your doctor may consider to use Tygacil in combination with other antibiotics.
- Tell your doctor if you are taking certain medicines (named anticoagulants) aimed at avoiding an excess of blood clotting (see also Using other medicines in this leaflet).
- Tell your doctor if you are taking the contraceptive pill as you may need an additional method of contraception while receiving Tygacil (see also Using other medicines in this leaflet).
- Tell your doctor 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.
- While antibiotics including Tygacil fight certain bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you for any potential infections and treat you if necessary.
- Tygacil is not to be used in children or adolescents (under 18 years of age) In children less than 8 years, tigecycline may induce permanent dental defects such as staining on the developing teeth.
Using other medicines
Always tell your doctor if you are taking or have recently taken any other medicines, including medicines you buy without a prescription.
Tygacil 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. If this were the case, your doctor will monitor you closely.
Tygacil may interfere with the contraceptive pill (birth control pill). Talk to your doctor about the need for an additional method of contraception while receiving Tygacil.
Pregnancy and breast-feeding
Tygacil may cause foetal harm. If you are pregnant, or are planning to become pregnant, talk to your doctor before receiving Tygacil.
It is not known if Tygacil passes into breast milk in humans. Ask your doctor for advice before breastfeeding your baby.
Driving and using machines
Tygacil may cause side effects such as dizziness. This may impair your ability to drive or operate machinery.
How Tygacil Is Given
Tygacil will be given to you by a doctor or a nurse.
The recommended dose 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.
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 Tygacil than you should
If you are concerned that you may have been given too much Tygacil, talk to your doctor or nurse immediately.
If you miss a dose of Tygacil
If you are concerned that you may have missed a dose, talk to your doctor or nurse immediately.
Possible Side Effects
Like all medicines, Tygacil may have side effects, although not everybody gets them.
The most common side effects reported in at least 1 in 10 patients receiving Tygacil are:
- Nausea, vomiting, diarrhoea.
Common side effects reported in at least 1 in 100 patients but in less than 1 in 10 patients receiving Tygacil are:
- 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
- Headache
- Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
Uncommon side effects reported in at least 1 in 1,000 patients but less than 1 in 100 patients receiving Tygacil are:
- 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)
- Low protein levels in the blood
- Acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
- Jaundice, inflammation of the liver
- Injection site reaction (pain, redness, inflammation).
Other side effects reported (frequency not known) in patients receiving Tygacil are:
- Anaphylaxis/anaphylactoid reactions (that may range from mild to severe, including a sudden, generalised allergic reaction that may lead to a life-threatening shock [e.g. difficulty in breathing, drop of blood pressure, fast pulse]).
- Low platelet levels in the blood (which may lead to an increased bleeding tendency and bruising/haematoma)
- Liver Failure
Pseudomembranous colitis may occur with most antibiotics including Tygacil. 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Tygacil
Keep out of the reach and sight of children.
Tygacil should be stored at or below 25°C.
Do not use Tygacil after the expiry date which is stated on the vial.
Storage after preparation
Once the powder has been made into a solution and diluted ready for use, it should be given to you almost immediately.
Further Information
What Tygacil contains
The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
The other ingredients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.
What Tygacil looks like and contents of the pack
Tygacil is supplied in a vial and looks like an orange powder or cake before it is diluted. These vials are distributed to the hospital in a ten tray pack. The powder should be mixed in the vial with a small amount of solution. The vial should be gently swirled until the medicine is dissolved. Thereafter, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag or other suitable infusion container in the hospital.
The Tygacil solution should be yellow to orange in colour after dissolving; if it is not, the solution should be discarded.
Marketing Authorisation Holder:
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in 07/2010.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Doc ID 61293(clean copy of doc id 61292)
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