Amiodarone 30mg/ml Injection
- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor, pharmacist or nurse
- If you get any of the side effects talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.
1. What Amiodarone Injection is, and what it is used for
2. What you need to know before you are given Amiodarone Injection
3. How Amiodarone Injection is given
4. Possible side effects
5. How to store Amiodarone Injection
6. Contents of the pack and other information
Amiodarone Injection contains the active substance amiodarone hydrochloride. It belongs to a group of medicines called anti-arrhythmics.
It works by controlling the uneven beating of your heart (called arrhythmias). Having the injection helps your heartbeat to return to normal.
Amiodarone Injection is normally only given in a hospital when a quick response is needed or when tablets cannot be given. Amiodarone Injection can be used to:
- Treat uneven heartbeats where other medicines either have not worked or cannot be used
- Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast
- Treat other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial fibrillation.
- You are allergic to amiodarone hydrochloride, iodine or to any of the other ingredients of this medicine (listed in section 6)
- You have heart problems such as heart block, which can cause a slow heart rate (such as sino-atrial heart block, sinus bradycardia, high grade AV block, bifascicular or trifascicular block or sinus node disease) and you do not have a pacemaker
- You have heart failure or weakness of the heart muscle (cardiomyopathy)
- You have or have had thyroid problems. Your doctor will test your thyroid before giving you this medicine
- You have severe breathing problems
- You have very low blood pressure
- You are taking other medicines that can make your heartbeat very quickly (these are listed in below under the section ‘Taking other medicines’)
- You are pregnant, think you may be pregnant or are breastfeeding (unless treatment is considered absolutely essential by your doctor)
Do not use this medicine if any of the above applies to you and talk to your doctor or nurse.
Amiodarone Injection must not be given to premature babies or neonates.
Talk to your doctor or nurse before you are given Amiodarone Injection if:
- You have mild to moderate low blood pressure
- You have been drinking a lot of alcohol
- You are receiving high dose oxygen therapy
- You are due to have an operation involving general anaesthesia
- You are elderly
The following drugs must not be taken with Amiodarone Injection as together they can cause a very severe fast heartbeat that can be fatal:
- Medicines to treat irregular heart rhythms (anti-arrhythmics), such as quinidine, procainamide, disopyramide and sotalol
- Antibiotic injections, such as erythromycin, co-trimoxazole and pentamidine
- Medicines to treat mental illness (anti-psychotics), such as chlorpromazine, thioridazine, haloperidol and pimozide
- Medicines to treat depression, such as lithium and tricyclic antidepressants, including doxepin, maprotiline and amitriptyline
- Certain medicines to treat allergic reactions (antihistamines), such as terfenadine, astemizole
- Medicines used to treat or prevent malaria, such as quinine, mefloquine, chloroquine and halofantrine
If any of the above applies to you, do not use this medicine and talk to your doctor or nurse.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicine, including medicines obtained without a prescription.
- Oral anticoagulants e.g. warfarin (used to thin the blood), phenytoin (used to treat epilepsy) and digoxin (used to treat certain heart conditions). Your doctor may reduce your dose of these medicines and your blood will need to be monitored before and after treatment
- Stimulant laxatives such as bisacodyl and senna, medicines called diuretics or water tablets, steroids and the antifungal medicine amphotericin. These can cause low levels of potassium in the blood, which can increase the risk of getting a fast heart rate (tachycardia).
- Rifampicin (an antibiotic) and St. John’s Wort (a herbal medicine) can cause lower levels of Amiodarone Injection in the body if they are taken at the same time
- Medicines that can either be affected by or effect the level of amiodarone in the body if taken at the same time:
- Cyclosporin, tacrolimus (immunosuppressants)
- Flecainide, used to treat irregular heart rhythms
- Simvastatin and atorvastatin (drugs to reduce blood cholesterol), as there is a risk of developing muscle pains and kidney failure (rhabdomyolysis) if doses of more than 20 mg of simvastatin are taken
- Lidocaine (a local anaesthetic)
- Sildenafil (used for erectile dysfunction)
- Fentanyl (used for pain relief)
- Midazolam (a sedative)
- Ergotamine (for migraine)
- Beta-blockers, such as metoptolol, sotalol and bretylium
- Calcium channel blockers diltiazem and verapamil, used to treat high blood pressure
- Indinavir (an anti-viral drug)
- Cimetidine (an anti-ulcer drug)
- Clarithromycin (an antibiotic)
- Ketoconazole and itraconazole (antifungal drugs)
- Dextromethorphan (cough medicine).
Do not drink grapefruit juice while using this medicine because it can increase amiodarone levels in your blood.
Keep out of direct sunlight while using this medicine and for a few months after you have finished using it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:
- make sure you use a high factor sun cream
- always wear a hat and clothes which cover your arms and legs
- Your doctor will prescribe amiodarone injection only in exceptional circumstances, if the benefit of treatment outweighs the risks during your pregnancy
- You should not be given amiodarone if you are breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using any medicine.
Some of the side effects in section 4 together with how you feel after your treatment may make it unsafe for you to drive or operate machinery. If you feel unwell, you must speak to your doctor or nurse before driving or operating machinery.
This medicine contains:
- Iodine: Amiodarone Injection contains approximately 112mg of iodine in a 10ml pre-filled syringe. Iodine is present in amiodarone hydrochloride, the medicine your infusion contains. Iodine can cause problems with your thyroid
(see ‘Tests’ below)
- Benzyl Alcohol: Amiodarone Injection contains 20mg/ml benzyl alcohol as preservative.
It may cause toxic and allergic reactions in infants and children up to 3 years old
Your doctor or nurse will normally give you Amiodarone Injection. This is because it needs to be given as an infusion into your vein in the hospital where the doctor can monitor your progress.
- This medicine will be diluted before it is given to you
- Your doctor will change you over to Amiodarone tablets as soon as possible
- If you feel the effect of your medicine is too weak or too strong, tell your doctor or nurse
If you are not sure why you are receiving Amiodarone Injection or have any questions about how much Amiodarone Injection is being given to you, speak to your doctor.
Your doctor will decide how much to give you depending on your illness..
- The recommended dose is 5 mg for every kilogram of your bodyweight. This is given by intravenous infusion over a period of 20 minutes to 2 hours
- You may be given another infusion of approximately 15 mg for every kilogram of your bodyweight every 24 hours depending on your illness
- In an emergency, your doctor may decide to give you a dose of 150 mg to 300 mg as a slow injection over 3 minutes
Children and adolescents:
- There is only limited information on the use in children. The child’s doctor will carefully calculate the amount of Amiodarone Injection depending on the child’s body weight.
This medicine is not for use in premature babies or neonates.
- The doctor may give you a lower dose of Amiodarone Injection and monitor your heart rate and thyroid function more closely.
Your doctor will carefully calculate how much Amiodarone Injection you should get, therefore it is unlikely your doctor or nurse will give you too much of it. If you think that you have been given too much or too little Amiodarone Injection, tell your doctor or nurse.
If you are given too much Amiodarone Injection the following effects may happen: feeling dizzy, faint, sick, tired or confused.
You may have an abnormally slow or fast heartbeat. Too much amiodarone can damage the heart and liver.
Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse.
It is important for you to keep having Amiodarone Injections until your doctor decides to stop them. If you stop having this medicine the uneven heartbeats may come back. This could be dangerous.
- Your doctor will take regular tests to check how your liver is working. Amiodarone Injection can affect how your liver works. If this happens, your doctor will decide whether you should keep having this medicine
- Your doctor will do regular thyroid tests while you are taking this medicine. This is because Amiodarone Injection contains iodine which can cause problems with your thyroid
- Your doctor may also do other regular tests such as blood tests, chest X-rays, ECG (electrical test of your heartbeat) and eye tests both before and while you are having Amiodarone Injection If you have any further questions on the use of this product, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Amiodarone Injection may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.
- Severe allergic reactions causing:
- Swelling of hands, feet, lips, mouth, tongue or throat
- Difficulty in breathing
- Itchy skin rash (hives)
- Stomach pains
- Excessive thyroid activity (hyperthyroidism) causing:
- Weight loss
- Increased heart rate
- Irregular heart rate
- Heart failure
- Rhabdomylosis (this can occur when some medicines used to reduce blood cholesterol, called statins, are taken with Amiodarone), which can cause:
- muscle pain, tenderness, weakness or cramps
- breakdown of muscle tissue causing kidney damage, which may lead to swelling of the hands or feet, shortness of breath, darker urine than normal and abnormal blood test results
Common (may affect up to 1 in 10 people):
Itchy, red rash (eczema)
Very rare (affects less than 1 in 10,000 people):
Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH)
Not known (frequency cannot be estimated from the available data):
Sudden inflammation of the pancreas (pancreatitis (acute)); confusion (delirium); life-threatening skin reactions characterised by rash, blisters, peeling skin and pain (toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, Drug reaction with eosinophilia and systematic symptoms (DRESS)
- Slow or irregular heartbeat
- Abnormal heart rhythm leading to heart attack
- Heart block that can lead to slow heart rate
- Low blood pressure which can make you feel dizzy or faint
- Reduced heartbeat, which may lead to shock
- Inflammation of blood vessels (vasculitis) seen as weight loss, fever and aches
- Reduced numbers of platelets in the blood causing bleeding and bruising
- Loss of red blood cells causing tiredness
- Hypersensitivity pneumonitis, alveolar/interstitial pneumonia or fibrosis, pleuritis, bronchiolitis obliterans organising pneumonia, pulmonary haemorrhage, respiratory distress syndrome (severe fluid build-up in the lungs) causing:
- Chest pains
- Difficulty breathing.
- Wheezing and breathing difficulties in patients with asthma
- Cirrhosis causing bruising and bleeding
- Hepatitis and jaundice causing a yellow colour to the whites of your eyes and your skin
- Increased liver enzymes which can show up in tests
- An enlarged liver causing jaundice
- Decreased thyroid activity and hypothyroidism causing weight gain, tiredness, aches and pains and a slow heart beat
- Thyrotoxicosis causing weight loss, a rapid heart rate, shaking, sweating and an enlarged thyroid gland at the front of the neck
- Nerve disease (neuropathy) causing burning, numbness and pins and needles
- Muscle disease (myopathy) causing tiredness, weakness and muscle pain
- A lack of co-ordination
- Sensitivity to sunlight (photosensitivity) causing skin discolouration, rash, tingling, burning, redness when exposed to sun and blistering of the skin, when severe. Avoid exposing your skin to the sun or to sun-lamps after receiving this injection, cover the skin and use high factor sun cream.
- Pain and irritation at the site of the injection
- Hot flushes, sweating and feeling sick if Amiodarone Injection is given too quickly
- Increased pressure in the skull (raised intracranial hypertension)
- Being sick
- A metallic taste in the mouth.
- Pain, redness and swelling of the testicles
- Hair loss
- Moderate kidney problems with increased creatinine show in tests.
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. By reporting side effects you can help provide more information on the safety of this medicine.
- Your doctor or pharmacist is responsible for storing Amiodarone Injection in a safe place where children cannot see or reach it. They are also responsible for disposing of any unused Amiodarone Injection correctly
- You should not be given Amiodarone Injection after the expiry date (EXP) which is stated on the outer packaging. The expiry date refers to the last day of that month. Your doctor or nurse will check that the date has not passed before giving this medicine to you
- This medicine will be stored below 25°C in the original container. Only clear solutions free of particles should be used
- For single use only. Discard any unused product.
- Each 10ml pre-filled syringe contains 300mg of the active substance, amiodarone hydrochloride
- The other ingredients are benzyl alcohol, polysorbate 80 and water for injections
- Amiodarone Injection is a clear, pale yellow solution and is available as a single 10ml pre-filled syringe.
Aurum Pharmaceuticals Limited
Harold Hill Romford
Mylan Pharmaceuticals Sp.z.o.o.
ul. Daniszewska 10
MA number: PL 12064/0047
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist or contact Medical Information at the above address.
This leaflet was last revised in October 2018.