50 mg powder for infusion, solution
tigecycline
What Tygacil is and what it is used for
Tygacil is an antibiotic in the group of glycylcyclines that works by stopping the growth of bacteria that cause infection.
Your doctor has prescribed Tygacil because you or your child over 8 years of age has one of the following serious infections.
- Complicated infections in the skin and soft tissues ( tissues under the skin), excluding foot infections in patients with diabetes.
- Complicated infection in the abdominal cavity
Tygacil is only used when your doctor considers other antibiotics unsuitable.
What you need to know before you receive Tygacil
Do not use Tygacil
- 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 antibiotics (eg, minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Warnings and precautions
Talk to your doctor or nurse before receiving Tygacil:
- If the wound does not heal normally.
- If you suffer from diarrhea before receiving Tygacil. If you get diarrhea during or after your treatment, tell your doctor right away. Do not take any diarrhea medicine without first checking with your doctor.
- If you have had any side effects in the past due to antibiotics belonging to the tetracycline class (eg skin sensitization to sunlight, discoloration of developing teeth, inflammation of the pancreas, and changes in certain laboratory values intended to measure how well your blood clots).
- If you have or have previously had, liver problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid possible side effects.
- If you have a blockage of the bile ducts (cholestasis).
- If you suffer from any type of bleeding disorder or are treated with anticoagulants, as this medicine may affect blood clotting.
During treatment with Tygacil:
- Tell your doctor immediately if you experience symptoms of an allergic reaction.
- Tell your doctor immediately if you experience severe stomach pain, nausea, and vomiting. These symptoms may be signs of inflammation of the pancreas ( acute pancreatitis ).
- For some severe infections, your doctor may consider using Tygacil together with other antibiotics.
- Your doctor will monitor you closely to make sure no other bacterial infection develops. If you suffer from another bacterial infection, the doctor may prescribe another antibiotic that is specific to that infection.
- Although antibiotics including Tygacil work against some bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you for possible infection and treat you if necessary. If you receive Tygacil, your doctor will monitor you closely to make sure no other infection develops, and treat you if necessary.
Children
Tygacil should not be used in children under 8 years of age because there is a lack of data on safety and efficacy in this age group and because it can cause permanent defects in the teeth, such as discoloration of developing teeth.
Other medicines and Tygacil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tygacil may prolong certain tests that measure how well your blood clots. You must tell your doctor if you are taking medicines to avoid excess blood clotting (so-called anticoagulants ). If so, your doctor will monitor you closely.
Tygacil can affect the effectiveness of birth control pills. Talk to your doctor about the need for additional contraception while using Tygacil.
Tygacil can increase the effect of medicines used to suppress the immune system (such as tacrolimus and ciclosporin). You must tell your doctor if you are taking these medicines so that you can be monitored closely.
Pregnancy, breastfeeding, and fertility
Tygacil may be harmful to the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving Tygacil.
It is not known whether Tygacil passes into breast milk. Consult a doctor before breastfeeding your baby.
Driving ability and use of machinery
Tygacil can cause side effects such as dizziness. This may impair the ability to drive and operate machinery.
Tygacil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml solution, i.e. it is almost “sodium-free”.
How Tygacil is given
Tygacil will be administered to you by a doctor or nurse.
The recommended dose for adults is 100 mg as an initial dose followed by 50 mg every 12 hours. This dose is given intravenously (directly into the blood) over 30 to 60 minutes.
The recommended dose for children aged 8 to <12 years is 1.2 mg/kg given every 12 hours intravenously up to a maximum dose of 50 mg every 12 hours.
The recommended dose for adolescents aged 12 to <18 years is 50 mg given every 12 hours.
Usually, the treatment lasts for 5 to 14 days. Your doctor will decide how long you will be treated.
If you receive too much Tygacil
If you are concerned that you may have received too much Tygacil, talk to your doctor or nurse immediately.
If you have forgotten a dose of Tygacil
If you are concerned that you may have missed a dose, talk to your doctor or nurse straight away.
Possible side effects
Like all medicines, Tygacil can cause side effects, although not everybody gets them.
Pseudomembranous colitis can occur during treatment with most antibiotics, including Tygacil. It presents as severe, persistent, or bloody diarrhea associated with abdominal pain or fever. This may be a sign of serious intestinal inflammation, which may occur during or after your treatment.
Very common side effects are (may affect more than 1 in 10 users):
- Nausea, vomiting, diarrhea
Common side effects are (may affect up to 1 in 10 users):
- An abscess (accumulation), infection, etc
- Laboratory measurements show that the blood has a reduced ability to clot (coagulate)
- Dizziness
- Blood vessel irritation from injection includes pain, inflammation, swelling, and coagulation
- Stomach pain, digestive problems, loss of appetite
- Increased liver enzymes, hyperbilirubinemia (excess bile pigment in the blood)
- Itching, rash
- Poor or slow wound healing
- Headache
- Increased levels of amylase, which is an enzyme found in the salivary glands and pancreas, increased levels of blood urea nitrogen (BUN)
- Pneumonia
- Low blood sugar
- Sepsis/septic shock (a serious medical condition that can lead to multiple organ failures and death due to sepsis)
- Injection site reaction (pain, redness, inflammation )
- Low levels of protein in the blood
Uncommon side effects are (may affect up to 1 in 100 users):
- Acute pancreatitis (inflammation of the pancreas, which can result in severe stomach pain, nausea, and vomiting)
- Jaundice (yellowing of the skin), inflammation of the liver
- Low levels of platelets in the blood (which can lead to an increased tendency to bleed and bruise/hematoma)
Rare side effects are (may affect up to 1 in 1,000 users):
- Low levels of fibrinogen in the blood (a protein that is important for blood clotting)
Side effects that have been reported (occurring in an unknown number of users):
- Anaphylactic/anaphylactoid hypersensitivity reaction (which can range from mild to severe, including sudden, generalized allergic reaction that can lead to life-threatening shock [eg difficulty breathing, drop in blood pressure, rapid pulse ]).
- Liver failure
- Skin rash that can lead to severe blistering of the skin and peeling of the skin ( Stevens-Johnson syndrome )
How to store Tygacil
Keep this medicine out of sight and reach of children.
Store at a maximum of 25 °C.
Use before the expiry date stated on the bottle. The expiration date is the last day of the specified month.
Storage after preparation
After the powder is dissolved and diluted, it should be administered to you immediately.
The Tygacil solution should be yellow to orange after the powder dissolves; otherwise, the solution should be discarded.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
Other ingredients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.
Appearance and package sizes of the medicine
Tygacil is supplied as a powder for infusion in a vial and looks like an orange powder or cake before dilution. These vials are distributed to hospitals in a pack of 10. The powder should be dissolved in the bottle with a small amount of solution. The vial is gently rotated until the medicine has dissolved. The solution from the vial should then be immediately added to a 100 ml infusion bag or another suitable infusion container at the hospital, for intravenous use.
| Marketing Authorisation Holder | Manufacturer |
| Pfizer Europe MA EEIGBoulevard de la Plaine 171050 BrusselsBelgium | Wyeth Lederle Srl Via Franco Gorgone ZI95100 Catania (CT)Italy |
For further information about this medicinal product, contact the representative of the marketing authorization holder:
| België/Belgique/BelgienLuxembourg/LuxembourgPfizer SA / NVTel/Tel: +32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| BulgariaPfizer Luxembourg САРЛ, Клон БулгарияTel:: +359 2 970 4333 | MagyarországPfizer Kft.Phone: +36 1 488 3700 |
| Czech RepublicPfizer s.r.oPhone: +420-283-004-111 | MaltaVivian Corporation Ltd.Phone: +35621 344610 |
| DenmarkPfizer ApSPhone: +45 44 201 100 | The NetherlandsPfizer BVPhone: +31 (0)10 406 43 01 |
| DeutschlandPfizer Pharma PFE GmbHPhone: +49 (0)800 8535555 | NorwayPfizer iPhone: +47 67 526 100 |
| EstoniaPfizer Luxembourg SARL Eesti branches.: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: +43 (0)1 521 15-0 |
| GreecePfizer ΕΛΛΑΣ Α.Ε.,Tel.: +30 210 67 85 800 | PolishPfizer Polska Sp. z o. o.Tel.: +48 22 335 61 00 |
| SpainPfizer, cellphone: +34914909900 | PortugalLaboratórios Pfizer, Lda.Phone: (+351) 21 423 55 00 |
| FrancePfizerPhone +33 (0) 1 58 07 34 40 | RomaniaPfizer Romania SRLPhone: +40 (0) 21 207 28 00 |
| HrvatskaPfizer Croatia dooPhone: +385 1 3908 777 | SlovenijaPfizer Luxembourg SARLPfizer, branch of the field pharmaceuticals activities, LjubljanaTel.: + 386 (0) 1 52 11 400 |
| IrelandPfizer Healthcare IrelandPhone: 1800 633 363 (toll free)+44 (0)1304 616161 | Slovenian RepublicPfizer Luxembourg SARL, organizačná zložkaPhone: + 421 2 3355 5500 |
| IcelandIcepharma hfSimi: +354 540 8000 | Finland/FinlandPfizer OyPhone/Tel: +358 (0)9 430 040 |
| ItalyPfizer SrlPhone: +39 06 33 18 21 | SwedenPfizer ABPhone: +46 (0)8 550 520 00 |
| CyprusPfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch), Τηλ: +357 22 817690 | United Kingdom(Northern Ireland)Pfizer Limited, Phone: +44 (0) 1304 616161 |
| in LatviaPfizer Luxembourg SARL branch in LatviaTel.: + 371 670 35 775 |