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Cordarone 150 mg/3 mL solution for injection – amiodarone for serious heart rhythm disorders
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- Stock: Zabrana online prodaje
- Brand: SANOFI
- Model: BR-60516206203
Cordarone contains amiodarone hydrochloride, a medicine from the group of antiarrhythmics – medicines used to treat heart rhythm disorders. The solution for injection is used to treat certain serious heart rhythm disorders when oral treatment is not appropriate, and in cardiopulmonary resuscitation for cardiac arrest due to ventricular fibrillation that does not respond to electric shock.
This text describes Cordarone 150 mg/3 mL solution for injection (6 ampoules), which in Serbia may only be used in an inpatient healthcare facility, with continuous monitoring of blood pressure and ECG.
Important warning
- Prescription status: may only be used in an inpatient healthcare facility (hospital medicine).
- It is given only in specialised hospital settings (except in life-threatening emergencies) with continuous blood pressure and ECG monitoring.
- It must not be used in pregnancy or during breast-feeding; because of benzyl alcohol it must not be given to premature babies, newborns or children up to 3 years.
- The medicine contains iodine and can affect the thyroid gland; the skin becomes sensitive to sunlight during treatment and for several months afterwards.
- This page is for information only and is not an offer to buy the medicine online.
What is Cordarone used for and how is it given?
Key facts about the medicine
| Name of the medicine | Cordarone®, 150 mg/3 mL, solution for injection |
|---|---|
| Active substance | amiodarone hydrochloride |
| Strength | 150 mg amiodarone hydrochloride in a 3 mL ampoule |
| Pharmaceutical form | solution for injection – clear, pale yellow solution free of visible particles |
| Therapeutic group | antiarrhythmics, class III (ATC C01BD01) |
| Pack | 6 colourless glass ampoules of 3 mL |
| Marketing authorisation holder / manufacturer | SANOFI-AVENTIS D.O.O. BEOGRAD; manufacturers: Sanofi Winthrop Industrie, Ambarès-et-Lagrave and Delpharm Dijon, Quetigny, France |
| ALIMS authorisation number | 515-01-02724-21-001 of 26.05.2022 |
| Prescription status (Serbia) | SZ – may only be used in an inpatient healthcare facility |
What is Cordarone injection used for?
- serious heart rhythm disorders when oral treatment is not appropriate, in particular: atrial arrhythmias with rapid ventricular rate, tachycardia in Wolff-Parkinson-White syndrome and documented symptomatic and disabling ventricular arrhythmias
- cardiopulmonary resuscitation for cardiac arrest due to ventricular fibrillation resistant to external electric shocks
The indications are given according to the part of the leaflet intended for healthcare professionals. The doctor decides on use.
How is it given and dosed?
The medicine is given by healthcare staff in hospital, intravenously, with continuous monitoring of blood pressure and ECG. It is diluted only with isotonic (5%) glucose solution and given via a central vein (except during resuscitation, when a large peripheral vein may be used).
| Situation | Usual dosing according to the leaflet |
|---|---|
| Serious rhythm disorders – initial treatment | on average 5 mg/kg body weight by infusion over 20 minutes to 2 hours; may be repeated 2–3 times in 24 hours |
| Serious rhythm disorders – maintenance | 10–20 mg/kg daily (on average 600–800 mg, up to 1.2 g in 24 hours) for several days; switching to oral amiodarone (3 tablets daily, if needed 4–5) starts from the first day of infusion |
| Resuscitation in shock-resistant ventricular fibrillation | 300 mg (or 5 mg/kg) diluted in 20 mL of 5% glucose, injected rapidly; in persistent fibrillation the doctor may give an additional 150 mg (or 2.5 mg/kg) |
The doctor determines the dose for each patient individually.
Special patient groups
- Children: safety and efficacy have not been established; in premature babies, newborns and children up to 3 years the medicine is contraindicated because of benzyl alcohol.
- Over 65 years: higher risk of very slow pulse – the doctor monitors the heart closely.
- Liver or kidney disease: tell your doctor – the medicine contains benzyl alcohol, which may accumulate in these conditions (metabolic acidosis).
- Patients on the heart transplant waiting list: the doctor may change treatment because of the risk of primary graft dysfunction.
Contraindications – when the medicine must not be used
- allergy to iodine, amiodarone or any of the excipients
- slow pulse (sinus bradycardia) or sino-atrial block; other pulse disorders without a pacemaker
- serious breathing problems, circulatory collapse, very low blood pressure
- heart failure or cardiomyopathy
- thyroid disorders (now or in the past)
- concomitant use of certain medicines affecting heart rhythm (see Interactions)
- pregnancy and breast-feeding; premature babies, newborns and children up to 3 years (benzyl alcohol)
Warnings and precautions
- Tell your doctor if you have liver, heart or blood pressure problems, lung problems (including asthma), thyroid or eye problems (optic neuropathy, optic neuritis), if you take amiodarone tablets or are about to have surgery.
- Sofosbuvir (a hepatitis C medicine) with amiodarone can cause life-threatening slowing of the heart – the doctor considers alternative treatment or additional monitoring.
- Sun protection: during treatment and for several months afterwards the skin may become oversensitive to sunlight – use a high-factor sunscreen and wear a hat and clothing that covers arms and legs.
- The medicine contains 60 mg benzyl alcohol per ampoule and iodine.
- Because of slow elimination the medicine may remain in the body for up to a month after stopping treatment, so side effects may also occur then.
Interactions with other medicines, food and drink
- Must not be used during treatment: other antiarrhythmics (sotalol, quinidine, procainamide, disopyramide, bretylium), some anti-infectives (intravenous erythromycin, co-trimoxazole, moxifloxacin, pentamidine), some antipsychotics (e.g. chlorpromazine, haloperidol, amisulpride, sertindole), lithium and some antidepressants (doxepin, maprotiline, amitriptyline), antimalarials (quinine, mefloquine, chloroquine, halofantrine), the antihistamines terfenadine, astemizole and mizolastine, hepatitis C medicines (sofosbuvir, daclatasvir, simeprevir, ledipasvir).
- Tell the doctor about: medicines that prolong the QT interval (e.g. clarithromycin, ciprofloxacin, levofloxacin), beta-blockers, diltiazem and verapamil, laxatives (bisacodyl, senna), statins (simvastatin, atorvastatin).
- Higher risk of side effects with: intravenous amphotericin B, corticosteroids, diuretics, general anaesthetics and high-dose oxygen, tetracosactide, amiodarone tablets.
- Cordarone may increase the effect of: ciclosporin, sirolimus and tacrolimus, sildenafil/tadalafil/vardenafil, fentanyl, ergotamine, midazolam, colchicine, flecainide, lidocaine, warfarin, digitalis and dabigatran.
- Also tell the doctor about herbal and over-the-counter medicines.
Pregnancy and breast-feeding
Cordarone must not be used during pregnancy. It must not be used during breast-feeding either, because amiodarone passes into breast milk in significant amounts. If you are pregnant or breast-feeding, also seek advice because of the benzyl alcohol content.
Driving and using machines
Not relevant, because the solution for injection is given only in specialised hospital settings.
Possible side effects
- Common: slow heartbeat, drop in blood pressure (dizziness, light-headedness, fainting), injection-site reactions (pain, redness, swelling, irritation, necrosis, inflammation, hardening, pigmentation changes), itching and red rash (eczema), decreased sex drive.
- Very rare: anaphylactic shock, very slow pulse and other rhythm disorders (sometimes with cardiac arrest), liver damage (jaundice), lung inflammation (difficulty breathing, cough, fever), brain disorders (headache, usually worse in the morning or after coughing or exertion, nausea, seizures, fainting, vision problems, confusion), bronchospasm in severe respiratory failure, raised liver enzymes, nausea, headache, sweating, hot flushes, SIADH.
- Frequency not known: confusion (delirium), severe skin reactions (TEN, Stevens-Johnson syndrome, DRESS), pancreatitis, neutropenia and agranulocytosis, optic nerve inflammation and loss of vision, hyperthyroidism, hives, back pain, hallucinations, primary graft dysfunction after heart transplantation.
- Photosensitivity (skin oversensitive to sunlight).
Report suspected side effects to your doctor, pharmacist or ALIMS.
Overdose, missed dose and stopping treatment
- Overdose: the medicine is given in hospital under strict supervision, so overdose is unlikely.
- Missed dose: the medicine is given by medical staff, so a missed dose is unlikely.
- Stopping treatment: the doctor decides on stopping and switching to oral treatment.
When to seek medical help immediately?
- swelling of the lips, face, throat or tongue, difficulty breathing, drop in blood pressure, loss of consciousness (anaphylactic shock)
- fainting, dizziness, unusual tiredness and shortness of breath (very slow pulse) or a feeling of irregular heartbeat
- yellowing of the skin or eyes, loss of appetite, stomach pain, high temperature (liver damage)
- difficulty breathing, chest tightness, persistent cough, wheezing, fever (lung inflammation)
- loss or blurring of vision in one eye; severe rash with blisters and peeling skin
Pharmacist's advice
Cordarone injection is given in hospital, but after discharge treatment usually continues with amiodarone tablets – so it is important to know that the medicine stays in the body for a long time. Protect your skin from the sun with high-factor sunscreen, a hat and clothing during treatment and for several months afterwards.
At home, check your pulse and blood pressure from time to time and report dizziness, marked tiredness, persistent cough or vision changes to your doctor. Before taking any new medicine, including senna laxatives, antibiotics and herbal products, ask your pharmacist.
Availability and price
Cordarone solution for injection is a hospital medicine – it may only be used in an inpatient healthcare facility and is not dispensed by pharmacies on prescription or online. This page is for information only.
For information about your treatment, contact your treating doctor.
Related information
If you continue treatment with amiodarone tablets, also look for information on the medicine Amiodaron (amiodarone 200 mg tablets) and always follow the leaflet supplied with your medicine.
Composition, pack and manufacturer
- Active substance: amiodarone hydrochloride 150 mg in a 3 mL ampoule.
- Excipients: benzyl alcohol (60 mg per ampoule), polysorbate 80, water for injections.
- Pack: carton with 6 colourless glass ampoules of 3 mL, in a plastic tray.
- Marketing authorisation holder: SANOFI-AVENTIS D.O.O. BEOGRAD, Španskih boraca 3/VI, Belgrade – Novi Beograd. Manufacturers: Sanofi Winthrop Industrie, 1 rue de la Vierge, Ambarès-et-Lagrave, France; Delpharm Dijon, 6 boulevard de l’Europe, Quetigny, France.
Storage
- Store below 25 °C, in the original package.
- After opening the ampoule, use the solution immediately; solutions with fewer than 2 ampoules in 500 mL of 5% glucose are not stable.
- Keep out of the sight and reach of children; shelf life 2 years.
Frequently asked questions
Can Cordarone injection be obtained at a pharmacy?
No. The solution for injection is a hospital medicine and may only be used in an inpatient healthcare facility, with monitoring of blood pressure and ECG.
Why should I protect myself from the sun after amiodarone treatment?
Amiodarone makes the skin oversensitive to sunlight during treatment and for several months afterwards. The leaflet advises a high-factor sunscreen, a hat and clothing that covers arms and legs.
How long does the medicine stay in the body?
Because of slow elimination, amiodarone may remain in the body for up to a month after stopping treatment, so side effects can also occur during that period.
Why must young children not receive the medicine?
The solution contains benzyl alcohol, which in premature babies, newborns and children up to 3 years can cause serious reactions, including breathing problems.
Sources
- ALIMS – Summary of Product Characteristics, Cordarone® 150 mg/3 mL solution for injection (Serbian)
- ALIMS – Patient leaflet, Cordarone® 150 mg/3 mL solution for injection (May 2022, Serbian)
Sources checked on: 24 October 2026.
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