drug-medicine : amikacin

PATIENT INFORMATION LEAFLET

This leaflet contains important information about your medicine; read it carefully.

Keep this leaflet; you may want to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Amikacin 250 mg/ml Injection

The active substance is amikacin (as sulphate)
The other ingredients are sodium citrate, sodium metabisulphite and Water for Injections.

1. What Amikacin Injection is and what it is used for

Amikacin Injection is an aminoglycoside antibiotic medicine, in the form of a solution for injection (a solution which can be given as an injection).

The medicine is presented in glass containers called vials. Each millilitre (ml) of Amikacin Injection contains 250 milligrams (mg) of amikacin (as sulphate). Each 2 ml vial contains 500 mg of amikacin (as sulphate). It is available in packs containing 5 vials.

Amikacin Injection is used in the treatment of infections which should respond to this medicine.

2. Before Amikacin Injection is used

Amikacin Injection should not be used:

if you suffer from a disorder called myasthenia gravis (severe weakness of selected muscles of the body)

Amikacin Injection will not normally be used:

if you are pregnant or breastfeeding

Special care will be taken:

if you have kidney problems
if you are elderly
if you have hearing difficulties or tinnitus (ringing or buzzing in the ears)
if the amount of urine you produce decreases
if you have shown signs of hypersensitivity (severe allergy) to aminoglycosides (a particular group of antibiotics) on previous occasions
if you are having a surgical procedure
if you are taking certain other medicines, such as:
- diuretics (water tablets) such as furosemide and ethacrynic acid
- other antibiotics that can affect your kidneys or hearing, such as streptomycin, dihydrostreptomycin, gentamicin, tobramycin, kanamycin, neomycin, polymyxin B, colistin, cephaloridine or viomycin
- anaesthetics or muscle-relaxing drugs, such as ether, halothane, d-tubocurarine, succinylcholine and decamethonium
- indomethacin (an anti-inflammatory medicine)

Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.

Do not drive or use machines:

if you experience any effect which may impair your ability to drive or use machines

Important information about one of the ingredients of Amikacin Injection

This medicine contains sodium metabisulphite, which can cause an allergic type reaction (skin rash, swelling of eyelids, face or lips, or difficulty in breathing). This is rare but you may be more at risk if you suffer from allergies or asthma.

3. How Amikacin Injection is used

The dose of medicine given to you will depend upon your age, the infection you have, how well your kidneys are working, if you have poor hearing and any other medicines you may be taking.

This medicine is usually injected into a muscle but may also be injected into a vein in some patients. If it is given in a vein, it can either be given as an injection or it can be dissolved in saline or 5% dextrose in water and given as a slow injection via a drip (infusion). It will usually be given to you two or three times a day, for up to 10 days.

Amikacin can also be given into the peritoneum (abdominal cavity) during surgery, and can be used to irrigate abscess cavities, the lung cavity and the brain cavities.

During treatment you may undergo blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of unwanted effects. Your doctor may change your dose depending upon the results of these tests.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or pharmacist if you have any concerns.

4. Possible side effects

Like all medicines, Amikacin Injection can have side effects.

If any of the following happen, tell the doctor immediately:

severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

This is a very serious side effect. You may need urgent medical attention. This very serious side effect is rare.

If you experience any of the following tell your doctor as soon as possible:

ringing in your ears or loss of hearing
dizziness or vertigo (spinning sensation)
skin rash
fever
headache
abnormal tingling sensation
nausea and vomiting
decrease in the amount of urine you produce
retinal toxicity (damage to the back of the eye) may occur if amikacin is injected into the eye

Your doctor may carry out blood tests to check for changes in your kidney function.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5. Storing Amikacin Injection

Keep out of the reach and sight of children.

The vials should not be stored above 25°C.

This medicine should not be used after the expiry date printed on the vial.