Amiodarone Hydrochloride 20 mg / ml solution for infusion – patient leaflet, side effects, dosage

1. What Amiodarone Hydrochloride 20 mg/ml is and what it is used for

Amiodarone Hydrochloride 20 mg/ml is used to treat irregular heartbeat called “arrhythmias” in adults. Amiodarone works by controlling your heart if it is not beating normally. Amiodarone Hydrochloride 20 mg/ml is given when a quick response is needed or if you are unable to take tablets. Your doctor will give you this medicine and you will be monitored under hospital or specialist supervision.

2. What you need to know before you are given Amiodarone Hydrochloride 20 mg/ml

You should not be given Amiodarone Hydrochloride 20 mg/ml if:

• you are allergic to amiodarone, iodine or any of the other ingredients of this medicine (listed in see section 6);
• you have a slower than usual heartbeat (called sinus bradycardia) or are suffering from an illness which causes irregular heartbeats (e.g. sino-atrial block, sick sinus syndrome);
• you have any other problems with your heart and do not have a pacemaker, for example if you have AV block (a type of heart conduction disorder);
• you need a life-saving procedure to help pump blood around the body and to the brain (cardiopulmonary resuscitation) when your heart stops working (cardiac arrest) due to life-threatening changes in the rhythm of your heart that do not respond to controlled electric shock (defibrillation), as Amiodarone Hydrochloride 20 mg/ml should not be given directly as an injection into the vein;
• you have severe breathing problems;
• you have severe blood circulation problems;
• you have very low blood pressure;
• your thyroid gland is not working properly. Your doctor should test your thyroid before giving you this medicine;
• you are taking certain other medicines which could affect your heartbeat (see also “Other medicines and Amiodarone Hydrochloride 20 mg/ml”);
• you are pregnant or breast-feeding (use of Amiodarone Hydrochloride 20 mg/ml is only allowed in life-threatening circumstances).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given this medicine if:

• you are on a heart transplant waiting list, your doctor may change your treatment. This is because taking amiodarone before heart transplantation has shown an increased risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working properly within the first 24 hours after surgery.
• you currently take a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heart beat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring.

You should also tell your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:

• slow or irregular heartbeat or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• light-headedness;
• palpitations;
• near-fainting or fainting.

Tell your doctor, pharmacist or nurse immediately if any of the following reactions occurs:

• any problems with your eyesight. This includes an illness called ‘optic neuropathy’ or ‘neuritis’;
• blistering or bleeding of the skin, including around lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be a condition called ‘Stevens-Johnson syndrome’;
• a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel general unwell, have a fever, chills and aching muscles (‘Toxic Epidermal Necrolysis’);
• pain, burning, tingling, numbness, especially in the feet, legs, hands and arms and/or muscle weakness which may be symptoms of nerve damage (peripheral neuropathy and/or myopathy);
• yellowing of the skin or eyes (jaundice), feeling tired or sick, loss of appetite, stomach pain, high temperature, which may be a sign of changes to your liver;
• difficulties breathing such as shortness of breath or a cough, accompanied by fatigue, weight loss or fever, this may be signs of a rare side effect called amiodarone induced pneumonitis;
• your heart is beating irregularly or very slowly, this may be signs of a rare side effect called amiodarone-induced arrhythmia/bradycardia.

Your doctor will perform tests to check the function of your thyroid gland before, during and following treatment with this medicine, particularly in patients who previously experienced thyroid disorders or who also take or have taken amiodarone orally. This is because Amiodarone Hydrochloride 20 mg/ml can cause changes to the thyroid function. Symptoms of too high thyroid activity include weight loss, trembling, nervousness, increased sweating and heart problems. By contrast, symptoms of too low thyroid activity include weight gain, sensitivity to cold, fatigue, and unexpectedly slow heartbeat. Amiodarone may cause changes to your liver after it is administered to you, therefore your doctor will carefully monitor the functioning of your liver whilst you are receiving treatment with Amiodarone Hydrochloride 20 mg/ml.

Your doctor will carefully and regularly monitor your ECG and blood pressure, liver and thyroid function if you have:

• a weak heart or heart failure;
• low blood pressure;
• liver problems;
• any problems with your lungs including asthma;
• any problems with your thyroid gland.

You will receive your medicine via a central line, also known as a Central Venous Catheter or CVC. This is a long, soft, thin, hollow tube that is placed into a large vein (blood vessel) and allows you to receive your treatment with Amiodarone Hydrochloride 20 mg/ml over a period of time.

Your doctor and/ or nurse will carefully monitor your central line and the surrounding area both during and after treatment. Should you experience any pain, redness, swelling or blistering around the area where the central line enters your skin, you should tell your doctor or nurse immediately.

Consult your doctor if any of the above mentioned warnings apply to you, or have applied to you in the past.

Protect your skin from sunlight

Keep out of direct sunlight and avoid the use of solariums/ sunbeds, whilst receiving treatment with Amiodarone Hydrochloride 20 mg/ml and for a few months after you have finished receiving it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister.

If this cannot be avoided, you should take the following precautions:

• Make sure you use high factor sun cream
• Always wear a hat and clothes which cover your arms and legs

Other medicines and Amiodarone Hydrochloride 20 mg/ml

Tell your doctor or nurse if you are taking, or have recently taken or might take any other medicines. This is especially important with the following medicines as they may interact with amiodarone.

These medicines should not be used together with amiodarone:

• Certain antiarrhythmic medicines for an irregular heartbeat (e.g. quinidine, procainamide, disopyramide, sotalol and bretylium);
• Certain medicines for mental illnesses (e.g. chlorpromazine, fluphenazine, haloperidol, amisulpride, sertindole, sultopride, sulpiride, pimozide) and some types of medicines called phenothiazines (e.g. thioridazine);
• Certain medicines used for digestive problems (e.g. cisapride);
• Certain medicines for infections (e.g. erythromycin given by injection, co-trimoxazole, moxifloxacin);
• Injections of pentamidine (used in certain types of pneumonia);
• Certain antidepressants (e.g. amitriptyline, clomipramine, dosulepin, doxepin, imipramine, lofepramine, nortriptyline, trimipramine, maprotiline and lithium) including MAO inhibitors (e.g. moclobemide);
• Certain antiallergic medicines used for hay fever and rashes called antihistamines (e.g. terfenadine, astemizole, mizolastine);
• Certain medicines for malaria (e.g. quinine, mefloquine, chloroquine, halofantrine).

Combined use with medicines that cause QT interval prolongation (a disturbance of the heartbeat detected in the ECG) requires careful monitoring as it may increase the chance of life-threatening arrhythmias (torsade de pointes). Your doctor will make a decision whether this combination is suitable for you based on the assessment of possible risks and benefits.

Combined use with antibiotic medicines called fluoroquinolones is not recommended as it may change the way your heart beats.

Drugs that may lower heart rate

It is not recommended to use the following medicines at the same time as Amiodarone:

• Medicines for heart problems and high blood pressure called beta-blockers (e.g. propranolol);
• Medicines for chest pain (angina) or high blood pressure called calcium channel blockers (e.g. diltiazem or verapamil);
• Sofosbuvir, used for the treatment of hepatitis C;
• Certain types of laxatives.

Drugs that may cause low levels of potassium in your blood

You should use caution when using the following medicines at the same time as amiodarone. These medicines can cause low blood levels of potassium which can increase the risk of life-threatening irregular heartbeats:

• Laxatives - used for constipation (e.g. bisacodyl, senna);
• Corticosteroids - used for inflammation (e.g. prednisolone);
• Tetracosactide - used to test some hormone problems;
• Diuretics (water tablets) e.g. furosemide;
• Amphotericin, when given directly into a vein - used for fungal infections.

Amiodarone may increase the effects of the following medicines:

• Medicines used for thinning the blood (e.g. warfarin). Your doctor should adjust your dose and monitor your treatment closely;
• Phenytoin - used to treat fits;
• Digoxin - used for heart problems. Your doctor should monitor your treatment closely and may adjust your dose of digoxin;
• Flecainide - used for uneven heart beats. Your doctor should monitor your treatment closely and may adjust your dose of flecainide;
• Medicines for high cholesterol called statins (e.g. simvastatin, atorvastatin, lovastatin);
• Ciclosporin, tacrolimus and sirolimus - used to help prevent rejection of transplants;
• Fentanyl - used for pain relief;
• Lidocaine - a local anaesthetic;
• Sildenafil - used to treat erection problems and pulmonary arterial hypertension;
• Midazolam and triazolam - used to help you relax e.g. before a medical procedure;
• Ergotamine - used for migraines;
• Dabigatran – used to prevent the formation of blood clots;
• Colchicine - used to treat gout attacks and to prevent flare-ups of gout.

Surgery

If you are to have any surgery or if you have to undergo anaesthesia, you must tell the doctors treating you that you are using amiodarone.

Amiodarone Hydrochloride 20 mg/ml with food and drink

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking amiodarone can increase your chance of getting side effects.

Pregnancy and breast-feeding

Your doctor will prescribe Amiodarone Hydrochloride 20 mg/ml only if he considers the benefit of treatment outweighs the risks during your pregnancy. Amiodarone Hydrochloride 20 mg/ml can be used during pregnancy in life-threatening circumstances only.

You should not be given Amiodarone Hydrochloride 20 mg/ml if you are breast-feeding. If you are given amiodarone during breast-feeding, breast-feeding should be stopped. 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 taking this medicine.

Driving and using machines

Amiodarone may affect your ability to drive or use machines. Do not drive or use machines if you are affected. In such a case ask your doctor for advice.

Amiodarone Hydrochloride 20 mg/ml contains polysorbate 80

This medicine contains 40 mg of polysorbate 80 in each ml, which is equivalent to 2 g in a 50 ml vial. Rarely, polysorbates can cause severe allergic reactions. If you have breathing difficulty or swelling or you feel faint, get medical help at once.

Polysorbate can have an effect on your circulation and heart (e.g. low blood pressure, heart beat changes) and of liver function.

3. How Amiodarone Hydrochloride 20 mg/ml is given

Amiodarone Hydrochloride 20 mg/ml will be given to you in hospital by a doctor or nurse.

Amiodarone Hydrochloride 20 mg/ml should not be diluted before use; it is a ready to use solution in a 50 ml vial. Amiodarone Hydrochloride 20 mg/ml will be administered by intravenous infusion (into a vein) and via a central venous catheter. A syringe driver pump will be used to adjust the dose according to the response with the aim to establish a normal heart rhythm. During maintenance infusion, the product should be protected from light.

Amiodarone Hydrochloride 20 mg/ml solution for infusion

amiodarone hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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Please refer to the Summary of Product Characteristics for full prescribing and other information.

Therapeutic indications

Amiodarone hydrochloride is indicated for the treatment of serious cardiac arrhythmias in adults, in cases where other therapies are not effective or contraindicated:

• atrial arrhythmias, including paroxysmal atrial fibrillation or flutter
• AV nodal arrhythmias and AV reentrant tachycardia, e.g. as a manifestation of Wolff-Parkinson-White syndrome

• life-threatening ventricular arrhythmias, including persistent or non-persistent ventricular tachycardia or episodes of ventricular fibrillation.

  Amiodarone Hydrochloride 20 mg/ml solution for infusion

  Amiodarone Hydrochloride 20 mg/ml can be used where a rapid response is required or where oral administration is not possible.

  Amiodarone hydrochloride may be used prior to DC cardioversion.

  Administration

  For intravenous infusion only.

  Amiodarone Hydrochloride 20 mg/ml must not be administered as a direct IV (bolus) injection. pH 2.8-3.6

  Osmolality 270-310 mOsmol/kg

  Amiodarone Hydrochloride 20 mg/ml should not be diluted before use: it is supplied ready to use. The name of this medicine is Amiodarone Hydrochloride 20 mg/ml solution for infusion but it will be referred to as Amiodarone Hydrochloride 20 mg/ml throughout the remainder of this leaflet. Your doctor will change you over to amiodarone tablets as soon as possible.

Adults

The recommended dose of Amiodarone Hydrochloride 20 mg/ml will depend on your medical condition. Unless otherwise prescribed by your doctor, the usual dose is 5 mg per kg of body weight over a period of 20 minutes to 2 hours. The administration may be repeated 2-3 times per day. Your doctor will determine the correct dose for you. After the initial dose your doctor will assess your response and adjust the dose accordingly. You may be given another dose of 10 to 20 mg for every kilogram of weight every 24 hours depending on your illness.

Most of the side effects which occur during treatment occur if you are given too much Amiodarone Hydrochloride 20 mg/ml. You should therefore be given the lowest possible dose of Amiodarone Hydrochloride 20 mg/ml. This will keep side effects to a minimum. See also “If you are given more Amiodarone Hydrochloride 20 mg/ml than you should”.

Children and adolescents

There are only limited data on the efficacy and safety in neonates, children and adolescents. Your doctor will decide on an appropriate dose.

Elderly

As with all patients it is important that the minimum effective dose is used. Your doctor will carefully calculate how much Amiodarone Hydrochloride 20 mg/ml you should get and monitor your heart rate and thyroid function more closely.

If you are given more Amiodarone Hydrochloride 20 mg/ml than you should

As this medicine will be given to you whilst you are in hospital or under the care of your doctor it is unlikely that you will be given too much.

If, however, you have received higher doses than those recommended you will be carefully monitored by your doctor and will receive supportive therapy if necessary. You may experience the following effects: feeling sick, being sick, constipation or sweating. You may have an abnormally slow or fast heartbeat.

If you have any further question on the use of this medicine, ask your doctor or other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Evaluation of side effects is based on the following frequency information:

The following side effects have been reported:

Very Common:

• Blurred eyesight or seeing a coloured halo in dazzling light;
• Nausea, vomiting, taste disturbances at the beginning of treatment;
• Increased levels of liver enzymes seen in blood tests;
• Skin sensitivity to sunlight.

Common:

• Excessive thyroid activity (hyperthyroidism) causing restlessness, agitation, shaking, sweating, weight loss, weakness, an increased or irregular heart rate and you may feel sensitive to or unable to cope with high temperatures;
• Reduced thyroid activity (hypothyroidism) causing feelings of extremely tiredness, weakness or ‘run-down’, experience weight gain, constipation and aching muscles and you may feel sensitivity to or unable to cope with low temperatures;
• Trembling when you move your arms or legs;
• Sleep problems, nightmares;
• Slow heart rate;
• Drop in blood pressure and a rapid heart rate, experienced straight after starting the infusion;
• Inflammation of the lung tissue caused by hypersensitivity to this medicine (hypersensitivity pneumonitis). This can lead to irreversible lung scarring (fibrosis), inflammation of the structures within the lungs (alveolar/interstitial pneumonitis), inflammation of the membranes that surround the lungs and line the chest cavity (pleuritis) and obstruction of the lung's smallest airways (bronchiolitis obliterans). These conditions can cause breathing difficulties;
• Acute liver function disorders with yellowing of the skin and eyes (jaundice), increases in liver enzymes which can sometimes be fatal;
• Itchy, red rash (eczema);
• Muscle weakness;

• At the site where you are given the infusion you may experience:

  • Pain;
  • Skin redness or a change in skin colour;
  • Localised soft-tissue damage;
  • Fluid leakage;
  • Swelling caused by fluid within the skin;
  • Inflammation or inflamed blood vessels;
  • Abnormally hard tissue;
  • Infection.
• Decrease in sex drive

Uncommon:

• Feeling numb or weak, tingling or burning feelings in any part of your body;
• Disturbances to the electrical signals within the heart (conduction disturbances);
• Newly occurring heart rhythm disorder or worsening of existing heart rhythm disorders;
• Abdominal pain and bloating, constipation, lack or loss of appetite;
• Feeling tired (fatigue).

Rare:

• Inflammation of blood vessels (vasculitis);
• The excipient polysorbate 80 may cause severe allergic reactions such as breathing difficulty, swelling, feeling faint.

Very rare:

• Reduced numbers of red blood cells (aplastic or haemolytic anaemia);

• A severe allergic reaction (anaphylactic shock). Symptoms of anaphylactic shock include:

  • A sharp fall in blood pressure;
  • Paleness;
  • Restlessness;
  • Weak and rapid heartbeat;
  • Clammy skin;
  • Reduced consciousness;
• Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ‘syndrome of inappropriate antidiuretic hormone secretion’ (SIADH);
• Swelling of the testicles;
• Increase in pressure inside the skull, accompanied by headache, feeling sick and vomiting;
• Damage to the part of the brain responsible for controlling balance and limb coordination;
• Headache;
• Loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy or neuritis’;
• Very slow heart beat;
• Hot flushes;
• Serious difficulties breathing (acute respiratory distress syndrome, bronchospasm);
• Long-term liver function abnormalities including liver scarring (cirrhosis);
• Redness of the skin under radiation therapy, skin inflammation with reddish, painful, tender lumps, widespread skin rash, redness and peeling of large areas of the skin;
• Hair loss;

• Sweating.

  Not known:

  • Granulomas inside the body which are seen by X-ray;
  • Angioedema: symptoms include swollen face, tongue or throat, difficult swallowing, breathing difficulties, sudden onset rash or hives;
  • Confusion (delirium);
  • Seeing, hearing or feeling things that are not there (hallucinations);
  • Sexual dysfunction;
  • Heart rhythm problems (Torsade de pointes, ventricular fibrillation/ flutter);
  • Sudden inflammation of the pancreas (pancreatitis (acute));
  • Hives (urticarial);
  • 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));
  • Back pain;
  • Elevated creatinine levels in blood;
  • Life-threatening complication after heart transplantation (primary graft dysfunction) in which the transplanted heart stops working properly (see section 2, Warnings and precautions).
  • You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia).
  • Severe reduction in the number of white blood cells which makes infections more likely (agranulocytosis). 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, 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 Amiodarone Hydrochloride 20 mg/ml

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. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep the vial in the outer carton in order to protect from light.

Do not use this medicine if the solution is not clear or if it contains a precipitate or if the container is damaged. For single use only. This medicine should be used immediately after first opening.

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 Amiodarone Hydrochloride 20 mg/ml contains

• The active substance is amiodarone hydrochloride. Each ml of solution contains 20 mg of amiodarone hydrochloride, equivalent to 18.9 mg amiodarone. Each 50 ml vial contains 1000 mg amiodarone hydrochloride, equivalent to 946.54 mg amiodarone.
• The other ingredients are glucose monohydrate, hydrochloric acid (for pH adjustment), polysorbate 80 (E433) and water for injections.

What Amiodarone Hydrochloride 20 mg/ml looks like and contents of the pack

Amiodarone is a clear, slightly green-yellow free from visible particles, ready to use solution for infusion. This medicinal product is supplied in a clear glass vial of 50 ml.

Pack sizes of 1, 5 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

hameln pharma ltd

Nexus, Gloucester Business Park

Gloucester, GL3 4AG

United Kingdom

Manufacturers

Solupharm Pharmazeutische Erzeugnisse GmbH Industriestraße 3

34212 Melsungen

Germany

hameln rds s.r.o.

Horná 36

900 01 Modra

Slovak Republic

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in December 2024.

40014/23/25

Inadvertent dilution of Amiodarone Hydrochloride 20 mg/ml could lead to under-dosing of the patients and decreased therapeutic response.

Amiodarone Hydrochloride 20 mg/ml must be administered via a central line, especially if repeated or continuous infusions are required.

Amiodarone Hydrochloride 20 mg/ml should be used with a suitable syringe driver /syringe pump capable of accurately and consistently delivering the specified volume at a strictly controlled rate of infusion. During maintenance infusion, the product should be protected from light.

Incompatibilities

Amiodarone Hydrochloride 20 mg/ml should not be mixed with other medicines and is incompatible with sodium chloride 0.9% infusion fluids.

In situations where it may be urgently required to administer concomitant medicinal products through a central line, careful consideration should be given to the compatibility of the medicinal products administered and the type of vascular access device used.

In the presence of amiodarone the use of administration equipment containing softening agents such as DEHP (di-2-ethylhexyl phthalate) may cause DEHP to leach into the solution.

In order to minimise patient exposure to DEHP, amiodarone solutions for infusion should be administered through sets that do not contain DEHP, such as polyolefin (PE, PP) or glass sets. No other agents may be added to amiodarone infusions.

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