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About DRONEDARONE

DRONEDARONE belongs to a group of medications known as 'anti-arrhythmic' primarily used to treat arrhythmia (irregular heartbeat) in patients with paroxysmal (sudden attack) or persistent atrial fibrillation (irregular heartbeat due to poor blood flow). Besides this, DRONEDARONE is also used to treat 'cardioversion' which is a medical procedure that changes the abnormal heartbeat to a normal rhythm. Arrhythmia is a problem associated with the rate of rhythm at which the heartbeats.

DRONEDARONE contains 'Dronedarone' a Class III anti-arrhythmic drug that restores normal heart rhythm and reduces heart rate in atrial fibrillation. DRONEDARONE blocks abnormal electrical signals in the heart. Also, it prevents ventricular fibrillation (a rapid contraction of heart muscle) and ventricular tachycardia (lower chambers of the heart ventricles that beat quickly than normal).

Take DRONEDARONE as prescribed by your doctor. Your dose and duration of DRONEDARONE will be advised by your doctor, depending upon your medical condition. In some cases, you may experience slow heartbeat, diarrhoea, nausea and vomiting. Most of these side effects of DRONEDARONE do not require medical attention and gradually resolve over time. However, if the side effects are persistent, reach out to your doctor.  

Please inform your doctor if you are using any prescription, non-prescription drugs, including vitamins and herbal products. Let your doctor know if you have any allergic reactions to DRONEDARONE or any other medicines, before starting DRONEDARONE. Inform your doctor if you have heart, kidney or liver problems and electrolyte imbalance. It is advised to consult a doctor if you are a pregnant or breastfeeding mother. DRONEDARONE is not recommended for use during pregnancy. Do not stop taking DRONEDARONE without consulting your doctor since it may worsen your condition and increase the risk of future heart problems. 

Uses of DRONEDARONE

Arrhythmia (irregular heartbeat).

Medicinal Benefits

DRONEDARONE contains Dronedarone, a class III anti-arrhythmic drug. It treats arrhythmia (irregular heartbeat) in patients with paroxysmal (sudden attack) or persistent atrial fibrillation (irregular heartbeat due to poor blood flow). It blocks abnormal electrical signals in the heart and works by restoring normal heart rhythm. It also prevents ventricular fibrillation (a rapid contraction of heart muscle) and ventricular tachycardia (lower chambers of the heart (ventricles) beat quickly than normal). DRONEDARONE is used in cardioversion, a medical procedure that changes the abnormal heartbeat to a normal rhythm.

Directions for Use

Tablet: Take it with or without food at regular intervals, as prescribed by the doctor. Do not crush, chew or break it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of DRONEDARONE

  • Slow heartbeat
  • Diarrhoea
  • Increased liver enzymes
  • Nausea
  • Vomiting 
  • Abdominal pain
  • Fatigue

In-Depth Precautions and Warning

Drug Warnings

Brief your medical history to the doctor if you have any heart problems liver, kidney diseases and electrolyte imbalance (low potassium and magnesium) before starting DRONEDARONE. DRONEDARONE may affect QT prolongation (heart muscle takes longer than usual to recharge between beats) that can cause serious fast/irregular heartbeat. Hence it is advised to inform your doctor if you have heart-related problems like heart failure, slow heartbeat and a family history of heart diseases. DRONEDARONE is contraindicated during pregnancy since it has harmful effects on the foetus. Consult your doctor before using DRONEDARONE if you are a breastfeeding mother. Do not drive or operate machinery if you experience any side effects that affect your ability to concentrate and drive. Avoid consumption of alcohol with DRONEDARONE as it may decrease the efficacy of DRONEDARONE. DRONEDARONE is not recommended in patients younger than 18 years of age.

Drug Interactions

Drug-Drug Interaction: DRONEDARONE may interact with antibiotics (ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, telithromycin), HIV drugs (lopinavir, ritonavir, rifampin), fits medicines (carbamazepine, phenobarbital, phenytoin), antidepressants (nefazodone, flibanserin), multiple sclerosis treating drugs (fingolimod), blood thinners (dabigatran) and heart-related drugs (digoxin).

Drug-Food Interaction: Avoid grapefruit and its products to prevent the occurrence of side effects of DRONEDARONE.

Drug-Disease Interaction: People with heart problems, liver and kidney diseases, and electrolyte imbalance (low levels of potassium and magnesium) should consult the doctor before taking DRONEDARONE. DRONEDARONE is contraindicated in patients with class IV heart failure requiring hospitalization or referral to a specialized heart failure clinic. 

Drug-Drug Interactions Checker List:

  • KETOCONAZOLE
  • ITRACONAZOLE
  • VORICONAZOLE
  • CLARITHROMYCIN
  • ERYTHROMYCIN
  • TELITHROMYCIN
  • LOPINAVIR
  • RITONAVIR
  • RIFAMPIN
  • CARBAMAZEPINE
  • PHENOBARBITAL
  • PHENYTOIN
  • NEFAZODONE
  • FLIBANSERIN
  • FINGOLIMOD
  • DABIGATRAN
  • DIGOXIN
  • Safety Advice

    • Safety Warning

      Alcohol

      caution

      It is advised to limit alcohol intake when you are being treated with DRONEDARONE.

    • Safety Warning

      Pregnancy

      unsafe

      DRONEDARONE is a pregnancy category X drug, so it is not recommended and unsafe in pregnancy. It can affect and harm the developing baby. Please seek medical advice for more information.

    • Safety Warning

      Breast Feeding

      caution

      It is not known if DRONEDARONE is excreted into the breast milk. Due to possible effects on the breastfed infant, DRONEDARONE is not recommended for use if you are a nursing mother. Please consult your doctor for more information before taking DRONEDARONE.

    • Safety Warning

      Driving

      caution

      DRONEDARONE is possibly safe and does not affect your ability to drive. However, if you experience any symptoms that may affect your mental focus and ability to drive, do not drive or operate machinery until you feel better.

    • Safety Warning

      Liver

      caution

      Let your doctor know if you have any history of liver diseases before taking DRONEDARONE. Your doctor will weigh the benefits and any potential risks before prescribing DRONEDARONE.

    • Safety Warning

      Kidney

      caution

      Let your doctor know if you have any history of kidney diseases before taking DRONEDARONE. Your doctor will weigh the benefits and any potential risks before prescribing DRONEDARONE.

    • Safety Warning

      Children

      unsafe

      Safety and effectiveness of DRONEDARONE have not been established in patients below 18 years of age.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Keep your weight under control with BMI 19.5-24.9.
    • Opt for a diet rich in whole grains, fruits, veggies, and low-fat dairy products.
    • Limit sodium chloride intake (table salt) in your daily diet to 2300 mg per day or less than 1500 mg is ideal for most adults.
    • If you are taking alcohol, then only one serving for women and two servings for men is advisable.
    • Quitting smoking is the best strategy to lower the risk of heart disease.
    • Avoid chronic stress as it can raise your blood pressure. Try to enjoy and spent time with your loved ones to cope with stress and practice mindfulness techniques.
    • Try to include heart-healthy omega 3 fatty acid containing food drinks in your daily diet. You can also use low-fat cooking oil like olive oil, soybean oil, canola oil and coconut oil to lower your elevated blood pressure.

    Special Advise

    • Keep a check on your daily blood pressure, and if you notice any fluctuations, please consult a doctor.
    • Regular monitoring of heart function with ECG or EKG is necessary.
    • Liver and kidney function tests are recommended to rule out any chances of kidney or liver impairment.
    • Regular examinations of your electrolytes like potassium and magnesium are recommended. Prolonged use may decrease the level of potassium and magnesium level in the body. 

    Patients Concern

    Disease/Condition Glossary

    Arrhythmia: It is a problem associated with the rate of rhythm at which the heart beats. Generally, in this condition, the heart beats too fast, too slow or with an irregular rate. It can lead to severe heart damage. A cardiac arrhythmia occurs when there are abnormal electrical signals in the heart. When the heart beats too fast, it is known as tachycardia, and if it is too slow, it is called bradycardia. Treatment of arrhythmia includes drugs, medical procedures, implantable devices and sometimes surgery.

    FAQs

    How does DRONEDARONE work?

    DRONEDARONE contains Dronedarone that works as an antiarrhythmic by blocking abnormal electrical signals in the heart. Thus DRONEDARONE helps to treat the uneven heartbeats and helps in normalising the heart rhythm.

    Can I stop using DRONEDARONE when my symptoms are relieved?

    Do not stop using DRONEDARONE even if you feel better. It should be strictly used as advised by your doctor to avoid the recurrence of symptoms like irregular heartbeat and worsening of the disease.

    In which conditions, should I stay cautious while using DRONEDARONE?

    DRONEDARONE should be used with caution in cases of any allergic reactions, heart problems like heart failure, slow heartbeat, QT prolongation (heart muscle takes longer than usual to recharge between beats) in the ECG (electrocardiogram), liver, kidney diseases and electrolyte imbalance (low levels of potassium and magnesium).

    How should DRONEDARONE be stored?

    Store DRONEDARONE away from direct sunlight and at a temperature not exceeding 30°C. Keep this medicine out of sight and reach of children.

    What happens if I miss a dose of DRONEDARONE?

    If you missed a dose, take DRONEDARONE as soon as possible. However, if it is time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double the dose.

    Available Medicines for

    DRONEDARONE