Tigecycline 50 mg Infusion

TIGECYCLINE PFIZER is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections.

TIGECYCLINE PFIZER is used in:

• Infection of the skin excluding diabetic foot infections
• Infection in the abdomen

You should not be given TIGECYCLINE PFIZER:

• if you are hypersensitive (allergic) to tigecycline or any of the other ingredients of TIGECYCLINE PFIZER (listed in section 6)
• if you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline
• if you are pregnant, think you might be pregnant, or are breastfeeding
• if you have pneumonia that developed during your stay in hospital

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• if you develop symptoms of an allergic reaction
• if you develop severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis
• if you are suffering from diarrhoea before you are given TIGECYCLINE PFIZER. 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 (e.g., skin sensitisation 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 using TIGECYCLINE PFIZER in combination with other antibiotics
• if you suffer from a bleeding disorder or are on treatment with anticoagulant medicines, as TIGECYCLINE PFIZER can interfere with blood coagulation (see Other medicines and TIGECYCLINE PFIZER)
• if you are taking the contraceptive pill, as you may need an additional method of contraception while receiving TIGECYCLINE PFIZER (see Other medicines and TIGECYCLINE PFIZER)
• 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 TIGECYCLINE PFIZER 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
• TIGECYCLINE PFIZER is not recommended for use in children or adolescents (under 18 years of age)

Other medicines and TIGECYCLINE PFIZER

Always tell your health care provider if you are taking any other medicine (This includes all complimentary or traditional medicines.)

TIGECYCLINE PFIZER 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 is the case, your doctor will monitor you closely.

TIGECYCLINE PFIZER may interfere with the contraceptive pill (birth control pill). Talk to your doctor about the need for an additional method of contraception while receiving TIGECYCLINE PFIZER.

Other medicines may interfere with TIGECYCLINE PFIZER. Examples of these are ketoconazole (used to treat fungal infections), ciclosporin (an immunosuppressant used during transplant surgery), tacrolimus (an immunosuppressant used following organ transplant) and rifampicin (used to treat tuberculosis). Please consult your doctor if you are taking any of these medicines.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before being given TIGECYCLINE PFIZER.

TIGECYCLINE PFIZER may cause foetal harm. It is not known if TIGECYCLINE PFIZER passes into breast milk in humans. Because many medicines are excreted in human milk, ask your doctor for advice before breastfeeding your baby.

Driving and using machines

TIGECYCLINE PFIZER may cause side effects such as dizziness. This may impair your ability to drive or operate machinery. It is not always possible to predict to what extent TIGECYCLINE PFIZER may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which TIGECYCLINE PFIZER affects them.

TIGECYCLINE PFIZER contains sodium. TIGECYCLINE PFIZER contains less than 1 mmol sodium (23 mg) per 5 mL of suspension, that is to say essentially ‘sodium-free’.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself TIGECYCLINE PFIZER. It will be given to you by a person who is qualified to do so.

The recommended dose is 100 mg given initially, followed by 50 mg every 12 hours. This 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 have the impression that the effect of TIGECYCLINE PFIZER is too strong or too weak, tell your doctor of pharmacist.

If you receive more TIGECYCLINE PFIZER than you should Since a health care provider will administer TIGECYCLINE PFIZER he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use TIGECYCLINE PFIZER Since a health care provider will administer TIGECYCLINE PFIZER, it is unlikely that the dose will be missed.

TIGECYCLINE PFIZER can have side effects. Not all side effects reported for TIGECYCLINE PFIZER are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TIGECYCLINE PFIZER, please consult your health care provider for advice.

Tell your doctor if you notice any of the following:

Frequent side effects

• nausea
• vomiting
• diarrhoea
• abscess (collection of pus)
• infections
• laboratory measurements of decreased ability to form blood clots
• low platelet levels in the blood (which may lead to an increased bleeding tendency and bruising)
• dizziness
• vein irritations from the injection, including pain, inflammation, swelling and clotting
• pneumonia
• abdominal pain
• dyspepsia (stomach-ache and indigestion)
• anorexia (loss of appetite)
• increases in liver enzymes
• hyperbilirubinaemia (excess of bile pigment in the blood)
• low protein levels in the blood
• low blood sugar
• pruritus (itching)
• rash
• headache
• impaired healing
• increase in amylase, which is an enzyme found in the salivary glands and pancreas
• increased blood urea

Less frequent side effects

• 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)
• acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
• jaundice
• inflammation of the liver
• 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])
• liver failure
• severe skin reactions, including Stevens-Johnson Syndrome (a skin rash, which may lead to severe blistering and peeling of the skin)
• low fibrinogen levels in the blood (a protein involved in blood clotting)

Pseudomembranous colitis may occur with most antibiotics including TIGECYCLINE PFIZER. 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 you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of TIGECYCLINE PFIZER.

• Store all medicines out of reach of children.
• TIGECYCLINE PFIZER will be stored in the hospital in the appropriate conditions [stored at or below 25 °C prior to being made into a solution and at room temperature (not to exceed 25 °C) for up to 24 hours or at 2 °C to 8 °C for up to 48 hours once transferred to the infusion bag].
• If the storage conditions exceed 25 °C after reconstitution, TIGECYCLINE PFIZER should be used immediately.
• Do not use TIGECYCLINE PFIZER 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.