Tigecycline Adco 50 mg Solution

Tigecycline Adco is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections. Your doctor has prescribed Tigecycline Adco because you have one of the following types of serious infections:

• Complicated infection of the skin and soft tissues (the tissue below the skin), excluding diabetic foot infections
• Complicated infection in the abdomen

Tigecycline Adco should not be administered to you:

• If you are hypersensitive (allergic) to tigecycline or to any other ingredients of Tigecycline Adco (listed in section 6).
• If you are pregnant or breastfeeding.

Warnings and precautions

Taking special care with Tigecycline Adco: Tell your doctor or healthcare provider before being given the injection:

• If you experience impaired healing of surgical wounds, your doctor may consider using Tigecycline Adco in combination with other antibiotics in certain serious infections
• If you develop another bacterial infection, your doctor may prescribe a different antibiotic specific for the type of infection present. Your doctor will monitor you closely for the development of any other bacterial infections
• If you develop symptoms of an allergic reaction, tell you doctor immediately
• 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
• If you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to Tigecycline Adco
• If you develop severe abdominal pain, nausea, and vomiting, tell you doctor immediately. These may be symptoms of acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
• 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 and alteration of certain laboratory values aimed at measuring how well your blood clots)
• If you have underlying diseases such as diabetes, peripheral vascular disease and HIV
• If you have blockage of the bile ducts (cholestasis)
• If you are suffering from diarrhoea before you are given Tigecycline Adco. 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
• Although antibiotics including Tigecycline Adco fight certain bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you closely for any potential infections and treat you if necessary.

Children

Tigecycline Adco should not be used in children.

Other medicines and Tigecycline Adco

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

Tigecycline Adco 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 (named anticoagulants). If this were the case, your doctor will monitor you closely.

Tigecycline Adco 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 Adco.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before receiving Tigecycline Adco. Tigecycline Adco may cause foetal harm. It is not known if Tigecycline Adco passes into breast milk in humans. You should not receive Tigecycline Adco if you are pregnant or breastfeeding your baby.

Driving and using machines

Tigecycline Adco may cause side effects such as dizziness. This may impair your ability to drive a vehicle or operate machinery. It is not always possible to predict to what extent Tigecycline Adco may interfere with your daily activities. You should ensure that you do not engage in driving a vehicle or using machines until you are aware of the measure to which Tigecycline Adco affects you.

Your doctor will tell you how long your treatment with Tigecycline Adco will last. If you have the impression that the effect of Tigecycline Adco is too strong or too weak, tell your doctor or pharmacist. You will not be expected to give yourself Tigecycline Adco. It will be given to you by a person who is qualified to do so. The recommended dose in adults 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.

Tigecycline Adco should not be given to children under 18 years of age. A course of treatment usually lasts for 5 to 14 days. Your doctor will decide how long you should be treated.

If you use more Tigecycline Adco than you should

Since a healthcare provider will administer Tigecycline Adco, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use Tigecycline Adco

Since a healthcare provider will administer Tigecycline Adco, it is unlikely that the dose will be missed.

Tigecycline Adco can have side effects. Not all side effects reported for Tigecycline Adco are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Tigecycline Adco, please consult your healthcare provider for advice. If any of the following happens, stop receiving Tigecycline Adco and tell your doctor immediately and go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to Tigecycline Adco. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

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)
• pneumonia (lung infection)

Less frequent side effects:

• acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
• jaundice (yellow colouration of the skin), inflammation of the liver

These are serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• abscess (collection of pus), infections
• decreased ability to form blood clots
• low blood sugar
• low protein levels in the blood
• dizziness
• vein irritations from the injection, including pain, inflammation, swelling and clotting
• stomach pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite)
• increases in liver enzymes, hyperbilirubinaemia (excess of bile pigment in the blood)
• poor or slow wound healing
• headache
• injection site reaction (pain, redness, inflammation)
• increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).

Less frequent side effects:

• low platelet levels in the blood (which may lead to an increased bleeding tendency and bruising/haematoma)
• inflammation of the wall of a vein with associated thrombosis
• pain, inflammation or swelling at the injection site

Side effects with unknown frequency:

• low fibrinogen levels in the blood (a protein involved in blood clotting)
• liver failure
• skin rash, which may lead to severe blistering and peeling of the skin (Stevens - Johnson syndrome)

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, pharmacist or nurse. 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 Adco.

Store all medicines out of reach of children. Store at or below 25 °C. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Storage after preparation

Once reconstituted Tigecycline Adco may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time in the I.V. bag). Alternatively, Tigecycline Adco mixed with 0,9 % Sodium Chloride Injection, USP or 5 % Dextrose Injection, USP, may be stored refrigerated at 2 °C – 8 °C for up to 48 hours following immediate transfer of the reconstituted solution into the I.V. bag. The Tigecycline Adco solution should be yellow to orange in colour after dissolving; if it is not, the solution should be discarded.