TYGACIL 50 mg. 10 vials
Tygacil is an antibiotic of glycylcycline group that works by stopping the growth of bacteria that cause infections.
Your doctor prescribes e Tygacil, since you at least 18 years old and have one of the following types of serious infections:
Complicated skin and soft tissue (the tissue under the skin), with the exception of diabetic foot infections;
Complicated infection in the abdomen.
Tygacil should be used only in cases where it is known or suspected that the use of other antibiotics are not appropriate.
2. What you need to know before receiving Tygacil
Do not use Tygacil:
If you are allergic (hypersensitive) to tigecycline or any of the other ingredients of this medicine (listed in section 6). If you are allergic to tetracycline class antibiotics (eg. Minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Warnings and Precautions
Talk to your doctor or nurse before taking Tygacil:
If you have impaired or delayed wound healing;
If you suffer from diarrhea before you are given Tygacil. If you get diarrhea during or after your treatment, tell your doctor. Do not take any diarrhea medicine without first checking with your doctor;
If you have or previously had any side effects due to antibiotics belonging to the tetracycline class (eg. Skin sensitivity to sunlight, staining on developing teeth, pancreas inflammation, and alteration of certain laboratory values aimed to assess how well your blood clots);
If you are taking certain medicines (called anticoagulants), aiming to prevent excessive blood clotting (see also Other medicines and Tygacil in this leaflet);
If you are taking the contraceptive pill as you may need an additional method of contraception while receiving Tygacil (see also Other medicines and Tygacil in this leaflet);
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.
During treatment 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 (inflamed pancreas which may cause severe abdominal pain, nausea and vomiting);
In certain serious infections, your doctor may consider to use Tygacil in combination with other antibiotics;
Your doctor will closely monitor whether develop other bacterial infections. If you develop other bacterial infection, your doctor may prescribe a different antibiotic that is specific to the type of available infection;
Although 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.
Children and adolescents
Tygacil should not be used in children and adolescents (under 18 years). Tygacil should not be used in children under the age of eight years, because it can cause permanent dental defects such as staining on developing teeth.
Other medicines and Tygacil
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Tygacil may prolong certain tests that measure how well your blood is clotting. It is important to tell your doctor if you are taking medicines to prevent excessive blood clotting. If this is the case, your doctor will monitor you carefully.
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 lactation
Tygacil may cause fetal harm. If you are pregnant or planning to become pregnant, talk to your doctor before receiving Tygacil.
It is not known if Tygacil passes into breast milk in humans. Consult your doctor before breast-feeding your child.
Driving and using machines
Tygacil may cause side effects such as dizziness. This can impair your ability to drive or operate machinery.
3. How to use Tygacil
Tygacil will be administered by a doctor or nurse.
The recommended dose is 100 mg, administered 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.
The course usually lasts 5 to 14 days. Your doctor will decide how long you should be treated.
If you receive more Tygacil than
If you are concerned that you may have been given too much Tygacil, talk to your doctor or nurse.
If you miss a dose of Tygacil
If you are concerned that you may have missed a dose, talk to your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible adverse reactions listed below is defined using the following classification:
Very common (may affect more than 1 in 10 people);
Common (may affect up to 1 in 10 people);
Uncommon (may affect up to 1 in 100 people);
Rare (may affect up to 1 in 1000 people);
Very rare (may affect up to 1 in 10,000 people);
Not known (from the available data can not be estimated).
Very common side effects are:
Nausea, vomiting, diarrhea.
Common side effects are:
Abscess (collection of pus), infections;
Laboratory measurements of decreased ability to form blood clots;
Vein irritations from the injection, including pain, inflammation, swelling and clotting;
Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite);
Elevations of liver enzymes, hyperbilirubinaemia (excess of bile pigment in the blood);
Poor or delayed wound healing;
Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN);
Low blood sugar;
Sepsis (severe blood infection) / septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis);
Reaction at the site of injection (pain, redness, inflammation);
Low protein levels in the blood.
Uncommon side effects are:
Acute pancreatitis (inflamed pancreas, which can result in severe abdominal pain, nausea and vomiting);
Jaundice (yellowing of the skin), inflammation of the liver;
Low level of platelets in the blood (which may lead to an increased bleeding tendency and bruising / hematoma).
Side effects with unknown frequency are:
Anaphylactic / anaphylactoid reactions (that may range from mild to severe, generalized allergic reaction that can lead to life-threatening shock [eg. Difficulty breathing, drop in blood pressure, fast pulse]);
Skin rash, which may lead to severe blisters and peeling skin (Stevens-Johnson).
In most antibiotics including Tygacil, may appear pseudomembranous colitis. It consists of severe, persistent or bloody diarrhea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after therapy.
If you get any side effects, contact your doctor. This includes any possible effects not listed in this leaflet.
Adverse event reporting
If you get any side effects, contact your doctor. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
5. How to Store Tygacil
Keep out of the reach and sight of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of that month.
Storage after preparation
Once the powder is dissolved and diluted ready for use, it should be given to you almost immediately.
The Tygacil solution should be yellow to orange in color after dilution; otherwise the solution should be discarded.
6. Contents of the pack and other 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 as a powder for solution for infusion in a vial and looks like an orange powder or cake before it is diluted. These vials are distributed to hospitals in packs of ten. The powder should be mixed in the vial with a small amount of solution. Vial should be gently swirled until the medicine is dissolved. Then the solution should be immediately withdrawn from the vial and added to the intravenous bag of 100 ml or other suitable infusion container in the hospital.