Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Tygacil. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Tygacil against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Tygacil is used for
Tygacil is an antibiotic of the tetracycline class in the glycylcycline subcategory that works by stopping the growth of bacteria that cause infections.
Your doctor has prescribed Tygacil because you have one of the following types of serious infections:
•Infection of the skin, including those with resistant bacteria
•Infection in the abdomen.
Tygacil is for use in adults aged 18 and over. There is no experience with the use of Tygacil in children under 18 years of age. Tygacil, like other tetracyclines, may cause enamel loss and staining in developing teeth.
Tygacil will not work against viral infections such as colds or flu.
There is no evidence that Tygacil is addictive.
Tygacil is available only with a doctor's prescription.
Before you are given Tygacil
When you must not be given it
You should not be given Tygacil you have an allergy to:
•any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.
Do not have Tygacil after the expiry date (Exp. Date) printed on the pack has passed.
If you take this medicine after the expiry date it may not work.
Talk to your doctor if you are not sure whether you should be given Tygacil.
Before you are given it
You must tell your doctor if:
•You are allergic to tetracycline antibiotics.
You may have an increased chance of being allergic to Tygacil if you are allergic to tetracyclines.
•You are pregnant or breastfeeding.
As with many medicines, Tygacil may harm your developing or breastfeeding baby. This may include permanent staining of the child's teeth.
•You have or have had liver problems.
Depending on the condition of your liver, your doctor may need to reduce your dose to avoid potential side effects.
If you have not told your doctor or nurse about any of the above, tell them before you are given Tygacil.
Your doctor should do blood tests before you start and regularly while you are having treatment with Tygacil.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Tygacil. These include:
•Medicines to treat infections that contain ketoconazole or rifampicin
•Medicines that contain ciclosporin or tacrolimus
If you are taking warfarin, your doctor or nurse will check your blood clotting time.
•Oral contraceptives (birth control pills)
Tygacil may interfere with birth control pills.
Talk to your doctor about the need for an additional method of contraception while receiving Tygacil.
How Tygacil is given
How Tygacil will be given
Tygacil is given as an injection into a vein and administered to you by your doctor or nurse.
How much you will be given
The recommended dosage is 100 mg for the first dose, followed by 50 mg every 12 hours.
How long you will receive Tygacil
It is very important that you continue to receive Tygacil for as long as your doctor prescribes it. Your doctor will decide how many days of treatment you need. How long you receive Tygacil will depend on how severe your infection is and how quickly you respond to treatment.
If you receive more Tygacil than you should (overdose)
Tell your doctor or nurse immediately if you are concerned that you may have been given too much Tygacil.
It is unlikely that you will receive an overdose of Tygacil because a trained nurse or doctor will give it.
If you miss a dose of Tygacil
Talk to your doctor or nurse immediately if you are concerned that you may have missed a dose.
While you are receiving Tygacil
Things you must do
If you get severe diarrhoea, tell your doctor or nurse immediately. Do this even if it happens several weeks after treatment with Tygacil has been stopped.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.
Do not take any medicine for diarrhoea without first checking with your doctor.
Tell your doctor immediately if you develop severe abdominal pain, nausea and vomiting.
These may be symptoms of inflammation of the pancreas.
Tell your doctor immediately if you realise that you are pregnant while taking Tygacil.
Things to be careful of
Tell your doctor if you get thrush (a fungal infection which can affect the mouth and/or vagina) or any other infection while having, or soon after stopping, Tygacil.
Although antibiotics, including Tygacil, fight certain bacteria, other bacteria and fungi may continue to grow. Your doctor will check you for any possible infections and, if necessary, will give you treatment.
Protect your skin when you are in the sun, especially between 10 am and 3 pm. If outdoors, wear protective clothing and use a 15+ sunscreen.
Tygacil may cause your skin to be much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or severe sunburn.
Be careful driving or operating machinery until you know how Tygacil affects you.
Whilst it is unlikely that you will drive or operate machinery when having Tygacil, you need to be aware that Tygacil may cause side effects such as dizziness. This may affect your ability to drive or operate machinery.
Tell your doctor or nurse as soon as possible if you do not feel well while you are having Tygacil.
Tygacil is effective against certain serious infections for most people but it may have unwanted side effects in some.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
•Loss of appetite
•Stomach pain or heartburn
•Skin rash and itchiness
•Low sugar levels in the blood (sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat)
Tell your doctor as soon as possible if you notice any of the following:
•Increased tendency to bleed or bruise more easily than normal
•Yellowing of the skin or eyeballs also called jaundice
•Injection site reaction (pain, redness, inflammation, swelling)
•Swelling and/or clotting; and redness along a vein which is very tender when touched
•Abscesses or other infections
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
•Sepsis (rapid heart beat, rapid breathing and fever)
•Inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting)
•Stevens-Johnson Syndrome (a skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals)
•Pneumonia (fever, chills, shortness of breath, cough, phlegm and occasionally blood)
•Bleeding following injury taking longer to clot
•Sudden onset of signs of allergy such as:
•rash, itching or hives on the skin,
•swelling of the face, lips, tongue or other parts of the body,
•shortness of breath, wheezing or trouble breathing.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects (for example, abnormal blood test results including low level of protein/platelet in the blood, high levels of liver enzymes, high levels of enzyme found in the salivary glands/ pancreas and increase in blood urea nitrogen) can only be found when your doctor does tests from time to time to check your progress.
After finishing it
Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Tygacil.
•Severe abdominal cramps or stomach cramps
•Watery and severe diarrhoea, which may also be bloody
•Fever in combination with one or both of the above.
These are serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention.
Do not take any medicine for this diarrhoea without first checking with your doctor.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After receiving Tygacil
The hospital will store Tygacil under the correct conditions. Tygacil must be kept out of the reach and sight of children. Tygacil will be given to you only within the "Exp. Date" date of the product.
What it looks like
Tygacil is an orange powder supplied in glass vials. Dissolving the powder in a sterile liquid makes a solution for injection. After mixing, the solution is a yellow to orange colour.
Each Tygacil vial contains 50 mg of tigecycline as the active ingredient.
It also contains:
It does not contain any preservatives.
Tygacil is supplied in Australia by:
Pfizer Australia Pty Ltd
Toll Free Number: 1800 675 229
Australian Registration Number
AUST R 147450.
This leaflet was prepared in
® Registered Trade Mark.
© Pfizer Australia Pty Ltd