Patient leaflet - Amikacin 125 mg/ml solution for injection/infusion
1. What Amikacin is and what it is used for
Amikacin 125 mg/ml solution for injection/infusion and Amikacin 250 mg/ml contain the active substance amikacin as amikacin sulfate.
Amikacin is an antibiotic used to treat serious infections in adults and children including, infants less than 4 weeks old.
It can be used to treat infections of the respiratory tract and the lungs, the urinary and genital tract, the gastrointestinal (stomach and intestines) 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.
2. What you need to know before you are given Amikacin
Amikacin must not be given
if you are allergic to amikacin or
any of the other ingredients of this medicine (listed in section 6),
if you are allergic to other
aminoglycoside antibiotics,
if you have bronchial asthma with a
known allergy to sulfites.
Warnings and precautions
Talk to your doctor, pharmacist or nurse if:
you have previous kidney problems
(renal dysfunction), neuromuscular disease (Myasthenia gravis or Parkinson’s disease) or hearing problems (inner ear damage),
you have just been treated with
another aminoglycoside antibiotic,
you have any breathing difficulties
(asthma),
- you are allergic to sulfites,
you or your family members have
a mitochondrial mutation disease (a genetic condition) or loss of hearing due to antibiotic medicines, you are advised to inform your doctor or pharmacist before you take an aminoglycoside; certain mitochondrial mutations may increase your risk of hearing loss with this product. Your doctor may recommend genetic testing before administration of Amikacin.
In patients with kidney problems or those receiving either high doses or long-term therapy, the risk of aminoglycoside induced hearing impairment and kidney damage is increased. If you experience ringing in ears or any difficulty in balancing during body movements, inform your doctor immediately as these may be symptoms of nerve damage.
If you experience any numbness, tingling of skin or muscle twitches or spasms, contact your doctor as these may be symptoms of nerve damage.
Your kidney function may be evaluated before beginning treatment and monitored during treatment with Amikacin as per the doctor’s discretion. However, if you experience decreased urination, inform your doctor.
Patients need to drink a lot of water during treatment with amikacin, especially when used for longer than 5-7 days.
During therapy, your doctor may measure the level of amikacin in your blood and, if necessary, test your blood, liver, kidney, hearing and balance functions.
Special care should be taken in the treatment of premature babies and newborn infants.
Other medicines and Amikacin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking at the same time medicines which are potentially toxic to the nervous system or the kidneys, such as cisplatin, cephalosporins, polymyxins, amphotericin B, cyclosporin, tacrolimus, bacitracin, cephaloridine, paramomycin, viomycin, colistin, vancomycin, ethacrynic acid, furosemide, other aminoglycosides, cephalosporins or cytostatics, may lead to an increase of toxicity.
Other toxicity risks include an advanced age and dehydration.
It is especially important that you tell your doctor if you have recently received an anaesthetic or are taking any of the following medicines:
diuretics (water tablet or injection)
such as furosemide,
- other antibiotics called beta-lactamases such as penicillins or cephalosporins,
- inhalation narcotics (such as ether, halothane),
- muscle relaxants (such as d-tubocurarine, succinyl choline, decamethonium, atracurium, rocuronium, vecuronium) and volatile anaesthetics (increased risk of paralysis and respiratory paralysis [neuromuscular blockade]),
- cisplatin blood transfusions,
- amphotericin B used in the treatment of fungal infections,
- bisphosphonates (used to treat osteoporosis and similar diseases), may lead to low blood calcium levels,
- platinum compounds (increased risk of kidney toxicity and possible hearing damage),
- thiamine (Vitamin B1). If taken with amikacin it may lose its effectiveness,
- any other medicines which are bad for your kidneys or hearing,
- indomethacin (an anti-inflammatory).
This can increase the amount of amikacin which is absorbed in new born babies.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Amikacin should only be given during pregnancy if it is deemed absolutely necessary.
Tell your doctor if you are breast-feeding.
It is unknown whether or not amikacin passes through into breast milk. Therefore, if treatment with amikacin is deemed necessary, breast milk must be pumped out and discarded.
Driving and using machines
If you feel unwell or suffer from any of the side effects do not drive or operate machinery.
Amikacin contains sodium metabisulfite and sodium
Amikacin contains sodium metabisulfite which may rarely cause severe hypersensitivity reactions (severe allergy) and bronchospasm (difficulty breathing).
This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially ‘sodium free’.
3. How Amikacin is given
Amikacin is given by injection/infusion into either a muscle or vein two to three times daily.
The dose of Amikacin will be adjusted by your doctor depending on the severity of your infection, the sensitivity of the pathogen, your kidney function, your age and your body weight. The treatment duration is generally 7 to 10 days.
The following information is
intended for medical or healthcare professionals only:
How to prepare and administer Amikacin 125 mg/ml and Amikacin 250 mg/ml solution for injection/ infusion
IM use or IV use after dilution.
Amikacin solution for injection/infusion is intended for single use. Residual quantities are to be discarded. Only clear solution free from particles and discoloration should be used.
Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route.
In paediatric patients the amount of diluents used will depend on the amount of amikacin tolerated by the patient. The solution should normally be infused over a 30 to 60-minute period. Infants should receive a 1 to 2-hour infusion.
The solution is administered to adults over a 30 to 60-minute period.
Aseptic techniques must be followed during preparation of the infusion. The infusion must be conducted according to standard medical practice.
How to store Amikacin 125 mg/ml and Amikacin 250 mg/ml solution for injection/infusion
- 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 label after “EXP”. The expiry date refers to the last day of that month.
- Store the unopened ampoule below 25oC.
- Chemical and physical in-use stability has been demonstrated for 24 hours at 23-27°C under artificial light and 2-8°C with 0.9% Sodium Chloride Injection and Lactated Ringer’s Injection, at a concentration of Amikacin of 2.5 mg/ml and 5.0 mg/ml.
- Chemical and physical in-use stability has been demonstrated for 6 hours at 23-27°C under artificial light and for 24 hours at 2-8°C with 5% Dextrose Injection, 5% Dextrose and 0.2% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection and Lactated Ringer’s Injection with 5% Dextrose, at a concentration of Amikacin of 2.5 mg/ml.
- Chemical and physical in-use stability has been demonstrated for 12 hours at 23-27°C under artificial light and for 24 hours at 2-8°C with 5% Dextrose Injection, 5% Dextrose and 0.2% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection and Lactated Ringer’s Injection with 5% Dextrose, at a concentration of Amikacin of 5 mg/ml.
If you take more Amikacin than you should
If you are given more of this medicine than you should, it might possibly affect your kidney (renal), hearing and have a neuro-toxic effect (neuromuscular blockade).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
- ringing in the ears (tinnitus)
hearing impairment, inner ear
damage
- problems with kidney function
decreased urinary excretion
(oliguria)
Uncommon: may affect up to 1 in 100 people
infections with resistant bacteria or
yeasts
feeling sick (nausea) and being
sick (vomiting)
- skin rash
Rare: may affect up to 1 in 1,000 people
reduced red blood cell count
(erthrocytopenia)
an increase in white blood cell
subset
a deficiency in certain white blood
cells (leukopenia)
- severe platelet loss (thrombolysis)
reduced magnesium levels in the
blood
- headache
- tremor
- sensory disturbances
- balance disorders
- muscle twitching (myokymia)
blindness or other problems with
your vision
changes in the area of the retina of
your eye(s) (retinopathy)
- low blood pressure
inflammation of vein walls
(phlebitis)
- loss of hearing
- joint pain
- itching, hives, joint pain (arthralgia)
- fever, changes in liver function
- increased heart rate
inflammation of the heart muscle
(myocarditis)
Not known: frequency cannot be estimated from the available data
allergic reaction (sometimes
severe)
signs of muscular weakness
caused by nerve damage or disease (paresis)
- deafness (cochlear damage)
- numbness or numb feeling
paralysis of the respiratory
(breathing) system
temporary stopping of breathing
(apnea)
breathing difficulties due to
narrowing of the respiratory (breathing) tract (bronchospasm)
- sudden kidney failure
increase in serum creatinine
(metabolic product used to measure renal function),
excretion of albumin protein in
urine (albuminuria),
increased concentration of nitrogen
containing protein products in the blood (azotemia),
red and / or white blood cells in the
urine,
- pain at the injection site
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website:
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.
5. How to store Amikacin
Keep this medicine out of the sight and reach of children.
Store below 25oC.
Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Amikacin contains
The active substance is amikacin sulphate.
Each ml of solution for injection/ infusion contains 125 mg amikacin (as sulphate).
Each ml of solution for injection/ infusion contains 250 mg amikacin (as sulphate).
Each 2 ml ampoule contains 250 mg amikacin.
Each 2 ml ampoule contains 500 mg amikacin.
Each 4 ml ampoule contains 1000 mg amikacin.
- The other ingredients are sodium citrate dihydrate, sodium metabisulfite, sulfuric acid (2N), water for injections.
What Amikacin looks like and contents of the pack
Amikacin solution is a clear, colourless to pale yellow solution in clear glass ampoules containing 2 ml or 4 ml of solution for injection/ infusion. Pack sizes: 1 and 10 ampoules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DEMO PHARMA UK LIMITED 2nd Floor Connect 38, 1 Dover Place, Ashford, Kent, TN23 1FB,
England
Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece
This leaflet was last revised in 09/2024
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC or than the times stated above for the chemical and physical in-use stability, whichever is the shorter unless opening/dilution has taken place in controlled and validated aseptic conditions.