What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 11184/0136.

Amikin Injection 100 mg / 2 ml (amikacin sulphate)

Package leaflet: Information for the patient

AMIKIN INJECTION

100 mg/2mL

(Amikacin Sulfate)

Please read all of this leaflet carefully before you start taking your medicine because it contains important information for you.

  • Please keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What AMIKIN is and what it is used for
2. What you need to know before you are given AMIKIN
3. How AMIKIN is given
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information

1. What AMIKIN is and what it is used for

The name of this medicine is AMIKIN. Each 2 mL vial contains 100 mg amikacin sulfate as the active ingredient.

Amikacin is an antibiotic and belongs to the group of medicines called aminoglycosides.

AMIKIN is used to treat serious infections caused by certain bacteria.

2. What you need to know before you are given AMIKIN

Do not use AMIKIN if:

  • You are allergic (hypersensitive) to any of the ingredients in AMIKIN or other antibiotics.
  • You suffer from myasthenia gravis (a disease that causes muscle weakness).

If any of the above affects you, or you are unsure if they do, tell your doctor who will be able to advise you.

You must tell your doctor if:

  • You have any kidney problems
  • You have any hearing problems or other problems with your ears.
  • You have any muscular disorders such as Parkinson's Disease

Take caution if you are elderly

Take caution if you are dehydrated (ensure you are well hydrated during treatment)

Other medicines and Amikin

Always tell your doctor or pharmacist about any other medicines you may be taking or have recently taken including those obtained without a prescription before you are given AMIKIN.

Some medicines can have an affect on the action of other medicines. It is especially important that you tell your doctor if you are taking;

  • Any diuretics e.g. frusemide (water tablet or injection)
  • Any antibiotics including, penicillin-type antibiotics or cephalosporins
  • Any muscle relaxing medication
  • Cisplatin use in the treatment of cancers
  • Amphotericin B, which is used in the treatment of fungal infections
  • Bisphosphonates (which are used to treat osteoporosis and similar diseases)
  • Platinum compounds
  • Thiamine (Vitamin B1) as 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 AMIKIN which is absorbed in new born babies

Or

  • If you have recently received an anaesthetic.

AMIKIN is not recommended to be given by injection into the stomach in young children.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or think you may be pregnant, you should speak to your doctor before you are given AMIKIN.

Driving and using machines

If you feel unwell or suffer from any of the side effects do not drive or operate machinery.

Amikin contains sodium metabisulfite and sodium

Amikin injection contains the inactive ingredient sodium metabisulfite which may rarely cause severe hypersensitivity reactions and bronchospasm (difficulty in breathing or wheezing). This medicinal product contains less than 1 mmol sodium (23mg) per vial and therefore, is essentially sodium free.

3. How AMIKIN is given

AMIKIN is given by injection into a muscle or vein, or occasionally into the abdomen. The patient's pre-treatment body weight should be obtained in order to calculate the correct dosage. The usual duration of the treatment is 7 to 10 days. The total daily dose by all routes of administration should not exceed 15-20 mg/kg/day.

Adults and children over 12 years: The usual dose is 15 mg/kg/day which is given once a day or divided into two doses which are given twice a day.

Elderly: Renal function should be assessed and dose adjusted as described under impaired renal function.

Children aged 4 weeks to 12 years: The usual dose is 15 - 20 mg/kg/day which is given once a day or divided into two doses which are given twice a day.

Neonates: The usual dose is initially 10 mg/kg followed by 7.5 mg/kg which is given twice a day.

Premature infants: The usual dose is 7.5 mg/kg twice a day.

Life-threatening infection and/or those caused by Pseudomonas: The doses may be increased to 500 mg every eight hours, but should not exceed 1.5 g/day or be administered for a period longer than 10 days.

Urinary tract infections: The usual dose is 7.5 mg/kg/day twice a day.

Impaired renal function: The daily dose should be reduced and/or the interval between doses increased to avoid build up of drug.

The doses may be increased in certain infections.

You may require hearing and kidney tests while receiving AMIKIN as well as blood tests to check the amount of amikacin received.

You should start to see an improvement in 1-2 days. If there has been no improvement after 3-5 days, go back to see your doctor.

If you are given too much or too little Amikin Injection

Amikin Injection will be given by a qualified healthcare professional (doctor or nurse) who will ensure you are given the correct dose. On rare occasions, you may be given too much Amikin Injection. If this happens, your doctor will make sure that it is removed from your blood so that you do not suffer too many side effects.

4. Possible side effects

As with all medicines, AMIKIN can cause unwanted side effects, although not everybody gets them.

If you notice any of the following, stop taking AMIKIN and contact your doctor immediately:

  • swelling of the face, lips, or tongue
  • skin rash
  • difficulty breathing

As these may be signs of an allergic reaction

The frequency of possible side effects listed below is defined using the following convention:

very common: affects more than 1 user in 10

common: affects 1 to less than 10 users in 100

uncommon: affects 1 to less than 10 users in 1,000

rare: affects 1 to less than 10 users in 10,000

very rare: affects less than 1 user in 10,000

Patients treated with AMIKIN have reported the following side effects:

Uncommon

  • feeling sick (nausea) and being sick (vomiting)
  • skin rash
  • infections with resistant bacteria or yeasts

Rare

  • abnormal white blood cells, which can be detected by blood tests
  • reduced magnesium levels in the blood
  • headache
  • tremor
  • muscle twitching
  • pins and needles
  • numbness
  • blindness or other problems with your vision
  • low blood pressure
  • ringing in the ears
  • loss of hearing
  • joint pain
  • itching and hives
  • kidney problems including a reduction in urine output and increased nitrogen in the urine
  • fever
  • dizziness
  • anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)

Other side effects where the frequencies are unknown include:

  • inability of muscles to move
  • wheezing, difficulty breathing
  • temporarily stopping breathing
  • deafness

On rare occasions, it may be necessary to inject AMIKIN directly into the eyeball which can lead to visual disturbances.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store your medicine

Do not store above 25°C.

Store in the original packaging.

Please check the expiry date of the product, shown on the packaging of AMIKIN.

Do not use after the last day of the month stated.

Do not use this medicine if it is discoloured or there are particles in the solution.

Keep all medicines out of the sight and reach of children.

The vial is to be used once only. Any unused solution in the vial should be thrown away.

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 protect the environment.

6. Contents of the pack and other information

What Amikin contains

Each 2ml vial contains amikacin sulphate (equivalent to amikacin activity 100mg) as the active ingredient.

In addition, AMIKIN contains the following inactive ingredients: sodium metabisulfite (E223), sodium citrate, sulphuric acid and water for injection.

What AMIKIN looks like and contents of the pack

Amikin Injection is a clear, colourless solution and is supplied in a cardboard carton of five 2mL glass vials with rubber stoppers.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bristol-Myers Pharmaceuticals Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex
UB8 1DH
UK
Tel.: 0800-7311736

Manufacturer

Bristol-Myers Squibb Srl.
Contrada Fontana del Ceraso
03012 Anagni (Fr)
Italy

This leaflet was last revised in: January 2018