Amiodarone Hydrochloride Injection/Infusion 150mg/3ml

Amiodarone Hydrochloride Injection/Infusion 150mg/3ml
Amiodarone Hydrochloride Injection/Infusion 450mg/9ml
Amiodarone Hydrochloride Injection/Infusion 900mg/18ml

Read all of this lea?flet 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, 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 lea?et. See section 4.

What is in this lea?et:

What Amiodarone is and what it is used for
What you need to know before you are given Amiodarone
How you will be given Amiodarone
Possible side effects
How to store Amiodarone
Contents of the pack and other information
What Amiodarone is and what it is used for

Amiodarone 150mg/3ml Concentrate for Solution for Injection/Infusion (called Amiodarone in this lea?et) contains a medicine called Amiodarone hydrochloride. This belongs to a group of medicines called antiarrhythmics.

It works by controlling the uneven beating of your heart (called ?arrhythmias?). Having the injection helps your heartbeat to return to normal.
Amiodarone is normally only given in a hospital when a quick response is needed or when tablets cannot be given. Amiodarone 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 ?utter? or ?atrial ?fibrillation?. Amiodarone is used only when other medicines cannot be used
Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone is used only when other medicines cannot be used
What you need to know before you are given Amiodarone

Do not use this medicine and tell your doctor, pharmacist or nurse if you:

are allergic to iodine, Amiodarone, or any of the other ingredients of Amiodarone (listed in Section 6 below). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue have a slower than usual heartbeat (called ?sinus bradycardia?) or an illness called ?sino-atrial? heart block have any other problems with your heartbeat and do not have a pacemaker fitted have or have previously had thyroid problems. Your doctor should test your thyroid before giving you this medicine
have severe breathing problems
have serious blood circulation problems
have very low blood pressure
are taking certain other medicines which could affect your heartbeat (see ?Other medicines and Amiodarone? below) ? are pregnant or breast-feeding (see ?Pregnancy and breast-feeding? below) This product must not be given to children, premature babies or neonates. Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before using Amiodarone.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Amiodarone.

Amiodarone should be given with care if you:

have a weak heart (?cardiomyopathy?) or heart failure
have low blood pressure
are an elderly person (> 60 years)
have liver problems
require oxygen treatment
are to undergo a general anaesthetic
have any problems with your eyesight. This includes an illness called ?optic neuritis?
are taking certain other medicines ? for list of medicines see section ?Other medicines and Amiodarone? below

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Amiodarone.

Children

This medicine should not be given to neonates, infants and children up to 3 years old.

Other medicines and Amiodarone

Tell your doctor, pharmacist or nurse if you are taking or have recently taken or might take any other medicines. This is because Amiodarone can affect the way some other medicines work. Also, some medicines can affect the way

Amiodarone works.
In particular, do not take this medicine and tell your doctor, if you are taking:

Medicines which may cause heart rhythm disturbance (called torsades de pointes):
other medicines to treat irregular heartbeat (such as
Quinidine, procainamide, disopyramide, sotalol or Bretylium)
some antibiotics (such as erythromycin injection, Co-trimoxazole, pentamidine injection)
Medicines for schizophrenia (such as chlorpromazine, Thioridazine, Fluphenazine, pimozide, haloperidol, Amisulpride or Sertindole)
Medicines for other mental illnesses (such as lithium, Doxepin, maprotiline or amitriptyline)
Medicines for malaria (such as quinine, Mefloquine, Chloroquine or halofantrine)
medicines used for hay fever, rashes or other allergies called antihistamines (such as terfenadine, astemizole or mizolastine)
Gastrointestinal agents e.g. Cisapride, droperidol

Tell your doctor if you are taking any of the following medicines:

Medicines for heart problems called beta-blockers (such as propranolol)
Medicines called calcium channel blockers for chest pain (angina) or high blood pressure (such as diltiazem or verapamil)
Medicines for constipation (laxatives) such as bisacodyl or senna
Medicines for high cholesterol (statins) such as simvastatin or atorvastatin
Tetracosactrin (used in some blood tests or sometimes in the treatment of Crohn’s disease)
Drugs which may change the levels of potassium or magnesium in your blood e.g. diuretics (water tablets), steroid tablets
Monoamine oxidase inhibitors (medications used in high blood pressure)
Warfarin used for thinning the blood. Your doctor should reduce your dose of warfarin and monitor your treatment closely
Digoxin used for heart problems. Your doctor should monitor your treatment closely and may halve your dose of digoxin
Phenytoin used to treat fits
Ciclosporin and tacrolimus – used to help prevent rejection of transplants
Medicines for impotence such as sildenafil, tadalafil or vardenafil
Fentanyl used for pain relief
Ergotamine used for migraines
Midazolam used to treat anxiety or to help you relax before surgery
Lidocaine used as an anaesthetic

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Amiodarone.

Amiodarone 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.

You should limit the amount of alcohol you drink whilst being treated with this medicine.

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for a few months after you have finished taking 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 high factor sun cream
Always wear a hat and clothes which cover your arms and legs

Pregnancy and breast-feeding

Do not take this medicine if

You are pregnant, might become pregnant or think you may be pregnant
You are breast-feeding or planning to breastfeed

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

Driving and using machines

Your doctor will tell you how long to wait before driving a car or using machines after you are given this medicine.

Amiodarone Injection contains:

Iodine: Amiodarone Injection contains about 56mg of iodine in one ampoule of 3ml. Iodine is present in Amiodarone hydrochloride, the medicine your infusion contains. Iodine can cause problems to your thyroid (see ?Tests? below)
Benzyl Alcohol: Amiodarone Injection contains benzyl alcohol. It must not be given to premature or newborn babies. Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
How you will be given Amiodarone

Your doctor or nurse will normally give you Amiodarone.

This is because it needs to be given as an infusion into your vein in the hospital where the doctor can monitor your progress.

Using this medicine

? 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, nurse or pharmacist

If you are not sure why you are receiving Amiodarone or have any questions about how much Amiodarone is being given to you, speak to your doctor, pharmacist or nurse.

How much will be given to you

Your doctor will decide how much to give you depending on your illness.

Adults (including elderly)

Starting dose

The standard recommended dose is 5mg/kg bodyweight.

However, this may vary depending upon your age and how well you respond to treatment. This medicine will be diluted using a 5% glucose solution before it is given to you over a period of 20 minutes to 2 hours. It will be given slowly, usually via a drip into a vein in your arm or chest.

Depending on your response, you may be given further infusions up to 1200mg (approximately 15mg/kg body weight) in up to 500ml 5% glucose per 24 hours.

Maintenance dose

10 – 20mg per kg bodyweight in physiological glucose solution can be given every 24 hours (on average 600 to 800mg/ 24 hours up to a maximum of 1200mg/ 24 hours, equivalent to 4-5 ampoules, maximum 8 ampoules) for a few days. In some conditions, the medicine may be given as a slow injection of 150-300mg in 10-20ml 5% glucose over a minimum of 3 minutes. If Amiodarone is given in this way you will be closely monitored. As soon as an adequate response has been obtained using an intravenous treatment, you may be switched to oral treatment.

Elderly patients should be closely monitored during treatment, particularly for thyroid function.

Use in children and adolescents

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

Patients with liver and kidney problems

Although no dosage adjustment for patients with kidney or liver abnormalities has been de?ned during chronic treatment with oral amiodarone, close clinical monitoring is prudent for elderly patients.

If you have any further questions on the use of this product, ask your doctor or the other healthcare professionals.

If you use more Amiodarone than you should

Your doctor will carefully calculate how much Amiodarone you should get. Therefore it is unlikely your doctor, nurse or pharmacist will give you too much of this medicine. But, if you think that you have been given too much or too little Amiodarone, tell your doctor, nurse or pharmacist.

The following effects may happen: feeling dizzy, faint, sick, tired or confused; having an abnormally slow or fast heartbeat.

Too much Amiodarone can damage the heart and liver.

If you forget to use Amiodarone

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.

If you stop using Amiodarone

It is important for you to keep having Amiodarone until your doctor decides to stop. If you stop having this medicine the uneven heartbeats may come back. This could be dangerous.

Tests

Your doctor may do regular thyroid tests while you are taking this medicine. This is because Amiodarone contains iodine which can cause problems to 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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Amiodarone may stay in your blood for up to a month after stopping treatment.

You may still get side effects at this time.

If any of the following happen, tell your doctor immediately. These are very serious side effects and you may need urgent medical attention.

breathing difficulties
chest pain
severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), you may feel you are going to faint and there may be in?ammation of some of your blood vessels.

If you experience any of the following tell your doctor as soon as possible.

Very common (may affect more than 1 in 10 people)

blurred eyesight or seeing a coloured halo in dazzling light
burning more easily in the sun (see ?Protect your skin from sunlight? in Section 2)

Common (may affect up to 1 in 10 people)

itchy, red rash (eczema)
generally, moderate slow heart rate
a decrease in blood pressure
local injection site reactions including swelling, pain, redness, infection, and pigmentation changes (blue or grey marks on parts of your skin exposed to sunlight, especially the face)
feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat. These could be signs of an illness called ?hyperthyroidism?
feeling extremely tired, weak or run-down, weight gain, being unable to stand the cold, constipation and aching muscles. These could be signs of an illness called hypothyroidism
trembling when you move your arms or legs
muscle weakness
nightmares
problems sleeping

Uncommon (may affect up to 1 in 100 people)

feeling numb or weak, tingling or burning feelings in any part of your body
dizziness

Rare (may affect up to 1 in 1,000 people)

the excipient benzyl alcohol may cause hypersensitivity reactions

Very rare (may affect up to 1 in 10,000 people)

chest pain or palpitations, or abnormal heart rhythm
nausea
liver disorders
generalised allergic reactions such as swelling of the face, lips and/or tongue, shortness of breath,
headaches, breathing difficulties (with or without fever)
inability to breathe
hot flushes
sweating
red, scaly patches of skin, loss of hair or loosening of nails (called ?exfoliative dermatitis?)
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?
skin rash
skin redness during radio-therapy
moving unsteadily or staggering slurred or slow speech
headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea), fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with your brain
balance problems, feeling dizzy (vertigo)
headache
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).

Not known (frequency cannot be estimated from the available data)

seeing or hearing things that are not real (hallucinations)
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)).

Reporting of side effects

If you get any side effects to talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
By reporting side effects you can help provide more information on the safety of this medicine.

How to store Amiodarone

This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.

Do not use Amiodarone 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 store above 25?C. Do not refrigerate or freeze.

Storage at low temperature could cause the formation of a precipitate. Store in the original container. Do not use unless a solution is clear. Only clear solutions free of particles should be used. Reject any portion not used immediately after the opening of the ampoule. After dilution, use the solution immediately and reject any portion unused.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What Amiodarone contains

The active substance is Amiodarone hydrochloride

The other ingredients are Polysorbate 80, Benzyl alcohol, Hydrochloride acid or Sodium Hydroxide, Water for injection.

What Amiodarone looks like and contents of the pack

Amiodarone is a pale yellow solution and is available as 3ml, 9ml, and 18ml glass ampoules in cartons of 5 or 10 units.

Not all pack size may be marketed.

Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)