Following is information on contraindications to the use of dronedarone in general, pregnancy & amp; Breastfeeding and children. Please note that the contraindications may vary depending on the dosage form of a drug (eg tablet, syringe, ointment).
When should Dronedaron not be used?
Dronedarone must not be used with
- Hypersensitivity to the active substance
- circulatory disorders
- Patients with cardiac insufficiency or insufficient left ventricular pumping function, whether in history or current
- persistent atrial fibrillation (six months or more or unknown duration)
- Inhibition of cardiac conduction (second- or third-degree AV block or sinus node syndrome), except when using a pacemaker
- a heart rate less than 50 beats per minute
- Liver and lung complaints related to prior use of the antiarrhythmic drug amiodarone
- severe hepatic dysfunction
- severely impaired kidney function (creatinine clearance below 30 milliliters / minute).
Only under the control of a physician and following strict medical benefit-risk assessment may the active ingredient be used in
- impaired kidney function
- Lack of potassium or magnesium, because dronedarone can be ineffective. It is therefore always necessary to compensate for the shortage.
Recent research has shown that dronedarone in patients with ongoing atrial fibrillation more likely to die from a cardiovascular event, suffer a stroke or hospitalized for cardiovascular disease. Such patients should therefore be excluded from the treatment.
During treatment, the physician will carefully monitor patients’ cardiac, hepatic and pulmonary function. If new heart or lung complaints or signs of liver damage occur, patients should seek medical advice.
What should you watch out for during pregnancy and lactation?
Animal experiments have shown that dronedarone damages the body. Therefore, women of childbearing potential should use effective contraception during treatment.
It is not known if dronedarone passes into human milk in humans. In animal experiments this was the case. A decision to continue breastfeeding or to discontinue or continue or discontinue treatment should be made by the physician considering the benefits of breastfeeding for the child and the benefit of the treatment for the woman.
What should be considered in children?
Because there are no meaningful studies on the use of dronedarone in children and adolescents under the age of 18, the use of the drug in this age group is not allowed.
Warnings and Precautions
- After starting treatment, the doctor must determine kidney function so as not to make wrong decisions about other medicines.
- If upper abdominal pain, loss of appetite, nausea, jaundice, fever, tiredness, dark urine or itching occur, the doctor should be advised immediately.
- For disorders of sensation, muscle weakness, nutritional disorders and decreased tendon reflexes, a doctor must be consulted early.
Sometimes medications release allergic reactions.
If you notice any signs of allergic reaction, tell your doctor or pharmacist immediately.