Amiodaron hameln

Amiodarone is used to treat irregular heart rhythms (arrhythmia), helping to control the heart's rhythm if it doesn't beat normally.

Form
injektio-/infuusiokonsentraatti, liuosta varten
Strength
50 mg/ml
Active Ingredient
Amiodarone hydrochloride
Manufacturer
Hameln Pharma GmbH

How to Use

Dosage

The usual dose is 5 mg per kilogram of body weight, unless your doctor tells you otherwise.

Method

Amiodarone is given by a healthcare professional directly into a vein as an injection or infusion.

Important

The maximum daily dose is 15–25 mg per kilogram of body weight over 24 hours, depending on the severity of your condition.

Possible Side Effects

COMMON
  • Blurred vision or seeing colored halos around bright lights.
  • Slightly slower heart rate.
  • Flaking and itchy rash (eczema).
  • Dizziness, lightheadedness, or fainting due to low blood pressure.
  • At the injection or infusion site, you might experience: pain, skin redness or discoloration, local soft tissue damage, fluid leakage, subcutaneous swelling, inflammation or inflamed blood vessels, abnormally hard tissue, or infection.
  • Tremors that occur when moving your arms or legs.
  • Decreased sex drive.
RARE
  • Allergic reaction with symptoms like rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.
  • Your heart rate becomes very slow or your heart stops.
  • Dizziness, unusual tiredness, and shortness of breath, especially in people over 65 or those with heart rate problems.
  • Your heart rate becomes more irregular or unstable, which can lead to a heart attack; seek immediate hospital care.
  • Yellow skin or eyes (jaundice), tiredness, feeling unwell, loss of appetite, stomach pain, or high fever; these can be signs of serious liver problems.
  • Difficulty breathing or chest tightness, persistent cough, wheezing, weight loss, and fever; these can be due to lung inflammation.
  • Life-threatening irregular heartbeat (Torsade de pointes).
  • Swelling of the skin and mucous membranes (angioedema).
  • Blister formation or skin peeling around the lips, eyes, mouth, nose, and genitals, with flu-like symptoms and fever (Stevens-Johnson syndrome).
  • Severe blistering rash where skin layers peel off, leaving large raw areas on the body. General malaise, fever, chills, and muscle aches (toxic epidermal necrolysis).
  • Skin inflammation characterized by fluid-filled blisters (bullous dermatitis).
  • Flu-like symptoms and facial rash, followed by a prolonged rash, high fever, elevated liver enzymes, increased specific white blood cells (eosinophilia), and enlarged lymph nodes (DRESS).
  • Headache (often worse in the morning or after coughing/exertion), feeling unwell (nausea), seizures, fainting, vision problems, or confusion (signs of brain problems).
  • Pancreatitis, causing severe stomach and back pain.
  • Visual, auditory, or sensory hallucinations.
  • Increased susceptibility to infections (decreased white blood cells, neutropenia).
  • Severe decrease in white blood cells, increasing the likelihood of infections (agranulocytosis).
  • Loss of vision in one eye or blurred vision and difficulty distinguishing colors. Pain or soreness in the eyes (optic neuropathy or neuritis).
  • Extreme restlessness or agitation, weight loss, increased sweating, and inability to tolerate heat (hyperthyroidism).
  • Overgrowth of tissue within the larger bones of the body (bone marrow granulomas).
  • Numbness or weakness, tingling, or burning sensation in any part of the body.
  • The excipient benzyl alcohol can cause hypersensitivity reactions.
  • Changes in liver enzyme levels at the beginning of treatment, seen in blood tests.
  • Feeling unwell (nausea).
  • Headache.
  • Sweating.
  • Hot flashes.
  • Feeling unwell, confusion or weakness, sickness (nausea), loss of appetite, irritability (SIADH).
  • Heart conduction disorders.
  • Hives (itchy, bumpy rash).
  • Back pain.
  • Decreased sexual desire.
  • Hypothyroidism (underactive thyroid) – extreme tiredness, weakness or exhaustion, weight gain, constipation, and muscle pain. Difficulty tolerating low temperatures.
  • Confusion (delirium).

Important Warnings

  • Do not use if you are allergic to amiodarone, iodine, or any other ingredient in this medicine.
  • Do not use if you have a very slow heart rate or a heart condition causing irregular rhythms (like sick sinus syndrome).
  • Do not use if you have other heart problems and no pacemaker (e.g., AV block).
  • Do not use if your thyroid gland is not working properly; your doctor will check it before treatment.
  • Do not use if you are taking certain other medicines that affect heart rhythm.
Show 3 more warnings
  • Do not use if you are pregnant or breastfeeding (use is only allowed in life-threatening situations).
  • Do not use if the person receiving the medicine is a premature or full-term newborn baby.
  • If you are awaiting a heart transplant, using amiodarone before transplant may increase the risk of a life-threatening complication where the new heart fails.

Use in Elderly Patients

Category D

Avoid use in older adults. Start the treatment only in specialized care. Risk of QT prolongation. Elimination is very slow. Significant adverse effects include hypo- or hyperthyroidism, pulmonary changes, hepatic impairment and torsades de pointes ventricular tachycardia. Consider the numerous potential interactions. Avoid grapefruit. Remember blood tests to monitor safety. (updated 19.5.2025)