Patient Leaflet Updated 27-Aug-2024 | Tillomed Laboratories Ltd
Amikacin 250 mg/ml Solution for Injection/Infusion
Amikacin 250mg/ml Solution for Injection/Infusion
1. What Amikacin is and what it is used for
2. What you need to know before you use Amikacin
3. How to use Amikacin
4. Possible side effects
5. How to store Amikacin
6. Contents of the pack and other information
Amikacin is an antibiotic used to treat serious infections in adults and children including, infants less than 4 weeks old.
Areas of application include infections of the respiratory tract and the lungs, the urinary and genital tract, the gastrointestinal tract, inflammation of the inner lining of the heart (endocarditis), infected burns as well as bacterial infections of the blood associated with one of the infections mentioned. Amikacin may also be used to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection.
Please talk to your doctor or pharmacist before taking Amikacin, especially
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.
Simultaneous administration of medicines which are potentially toxic to the inner ear or to the kidneys such as cephalosporins may lead to an exacerbation of renal toxicity.
Amikacin given with penicillin or cephalosporin via other routes of administration may reduce the effectiveness of the preparation. Indomethacin may increase plasma levels of amikacin in neonates.
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, consult your doctor before using this medicine
Pregnancy
The safety of the medicine in pregnant women has not been confirmed and therefore Amikacin should only be used during pregnancy when absolutely necessary.
Breast-feeding
It is not known whether amikacin passes into breast milk. Breastfeeding is not recommended during treatment. Therefore, talk to your doctor if breastfeeding or the treatment should be discontinued.
If you suffer from side effects such as dizziness, be especially careful when driving vehicles or operating machinery.
Amikacin contains sodium metabisulfite which may rarely cause severe allergic (hypersensitivity) reactions and difficulty in breathing or wheezing (bronchospasm).
Sulfite sensitivity is generally uncommon and more frequent in asthmatics than non-asthmatics.
2 ml vial
This medicine contains less than 1 mmol sodium (23mg) per 2ml vial, that is to say essentially ‘sodium-free’.
4 ml vial
This medicine contains 26.65 mg sodium (main component of cooking/table salt) in each 4ml vial. This is equivalent to 1.33% of the recommended maximum daily dietary intake of sodium for an adult.
Amikacin is given as an injection into a muscle or as an intravenous infusion over 30-60 minutes. The dose of Amikacin will be decided by your doctor depending on the severity of your infection, the sensitivity of the pathogen, your kidney function, your age and your body weight.
For children, the solution is normally given as an infusion over 30-60 minutes and for infants over 1-2 hours.
If you think you have received too much Amikacin, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms:
Common: (may affect up to 1 to in 10 people)
Uncommon: (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data):
If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and vial after ‘EXP’. The expiry date refers to the last day of that month.
The unopened vial does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Each 2ml vial contains 500mg of amikacin (as sulphate).
Each 4ml vial contains 1g of amikacin (as sulphate).
Amikacin 500mg/2ml (250mg/ml) (2ml vial) and Amikacin 1g/4ml (250mg/ml) (5ml vial) are available as a clear, colourless to light straw-coloured solution, packed in a clear Type-I glass vial with a dark grey, chlorobutyl rubber stopper and a flip off seal.
2 ml (500 mg) and 4 ml (1,000 mg): 1 and 5 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer1
This leaflet was last revised in 04/2024
220 Butterfield, Great Marlings, Luton, LU2 8DL, UK
+44 (0)1480 402 402
+44 (0)1480 402 402
+44 (0)1480 402431 / +44 (0)1480 402432
http://www.tillomed.com/
+44 (0)1480 402 400
+44 (0)1480 402 400
+44 (0)1480 402431 / +44 (0)1480 402432