INTRODUCTION

AMDRON 100 TABLET contains Amiodarone which belongs to the group of medicines called Antiarrhythmics. It is used to treat uneven or fast heartbeats (like atrial flutter or atrial fibrillation), fast heartbeats which may happen suddenly and may be uneven only when other medicines either have not worked or cannot be used. It also treats Wolff-Parkinson-White Syndrome (unusually fast heartbeats). Your doctor might want you to keep out of direct sunlight while taking AMDRON 100 TABLET and for a few months after you have finished taking it.

Avoid consumption of alcohol and grapefruit juice during treatment with AMDRON 100 TABLET. AMDRON 100 TABLET is not recommended for use if you have signs of an allergic reaction including (a rash, swallowing or breathing difficulties, swelling of your lips, face, throat or tongue).

It is also not recommended to use if you have slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called sino-atrial heart block, other problems with your heartbeat without a pacemaker fitted, are going to have a heart transplantation or have thyroid problems.

Before taking AMDRON 100 TABLET, inform your doctor if you have heart failure, liver, lung problems or asthma, eyesight problems (optic neuritis), are about to have any surgery, have a pacemaker or implantable cardioverter defibrillator (ICD). Also inform your doctor if you have intolerance to certain sugars, blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever (Stevens-Johnson syndrome), layers of the skin peeling off to leave large areas of raw exposed skin over the body (Toxic Epidermal Necrolysis).

AMDRON 100 TABLET is not recommended for pregnant or breastfeeding women. It is not recommended for use in children and adolescents below 18 years of age. AMDRON 100 TABLET should be used with caution in elderly patients above 65 years of age. The most common side effects of taking AMDRON 100 TABLET are nausea, vomiting, change in taste, constipation, sleeping problems. Consult your doctor if any of the symptoms worsen.

USES OF AMDRON 100 TABLET

It is used to treat:

• sudden, fast or uneven heartbeats (atrial flutter or atrial fibrillation) when other medicines either have not worked or cannot be used
• Wolff-Parkinson-White Syndrome

HOW AMDRON 100 TABLET WORKS

AMDRON 100 TABLET works by blocking certain electrical signals and reducing the excitability of cardiac tissues which prevents the initiation and conduction of any new impulses in the heart that cause irregular heartbeats, thus making your heartbeat return to normal.

DIRECTIONS FOR USE

Take AMDRON 100 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF AMDRON 100 TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Stick to simple meals. Avoid eating oily or spicy foods. Drink more water. Consult your doctor if symptoms don't show improvement.

Constipation:

Eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. Consult your doctor if symptoms don't show improvement.

Rash:

Applying a cold compress, cool showers or damp cloth, cold water can bring immediate relief to swelling and reduce itching. Consult your doctor if symptoms don't show improvement.

Tanning:

Make sure you use high factor sun cream. Always wear a hat and clothes which cover your arms and legs. Consult your doctor if symptoms don't show improvement.

WARNING & PRECAUTIONS

PREGNANCY

AMDRON 100 TABLET is generally not recommended for use in pregnant women or women planning to have a baby. Consult your doctor before taking AMDRON 100 TABLET.

BREASTFEEDING

AMDRON 100 TABLET is generally not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking AMDRON 100 TABLET.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel like your eyesight is blurry after taking AMDRON 100 TABLET.

ALCOHOL

Avoid consumption of alcohol during treatment with AMDRON 100 TABLET, as it may increase the chances of liver problems.

LIVER

AMDRON 100 TABLET should be taken with caution in patients with liver disease. Consult your doctor before taking AMDRON 100 TABLET.

ALLERGY

Do not take AMDRON 100 TABLET if you are allergic to Amiodarone, iodine or any other ingredients of this medicine.

LUNGS

AMDRON 100 TABLET should be taken with caution in patients with asthma or other lung disease. Consult your doctor before taking AMDRON 100 TABLET.

HEART DISEASE

AMDRON 100 TABLET is not recommended for use if you have slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called sino-atrial heart block, other problems with your heartbeat without a pacemaker fitted or are going to have a heart transplantation.

AMDRON 100 TABLET should be taken with caution in patients with heart failure or if you have a pacemaker or implantable cardioverter defibrillator (ICD). Consult your doctor before taking AMDRON 100 TABLET.

INTERACTIONS

A. Drug - Drug interactions:

Before taking AMDRON 100 TABLET, inform your doctor if you are taking any of the following medicine:

• other medicines used to treat uneven heartbeats (Ex. sotalol, quinidine, procainamide, disopyramide, flecainide or bretylium)
• medicines used to treat infections (Ex. intra-venous erythromycin, co-trimoxazole, moxifloxacin, pentamidine, clarithromycin, ciprofloxacin, ofloxacin or levofloxacin)
• medicines used to treat schizophrenia (Ex. chlorpromazine, fluphenazine, thioridazine, pimozide, haloperidol, sertindole or amisulpride)
• medicines used to treat other mental illnesses (Ex. lithium, doxepin, maprotiline or amitriptyline)
• medicines used to treat malaria (Ex. quinine, mefloquine, chloroquine or halofantrine)
• medicines used to treat hay fever, rashes or other allergies (Ex. terfenadine, astemizole or mizolastine)
• medicines used to treat hepatitis C (Ex. sofosbuvir, daclatasvir, simeprevir or ledispasvir)
• medicine used to treat heart problems (such as high blood pressure, chest pain or high cholesterol) (Ex. Propranolol, diltiazem, verapamil, furosemide, simvastatin, atorvastatin or digitalis)
• medicines used to treat constipation (Ex. bisacodyl or senna)
• medicines for high cholesterol (statins) (Ex. simvastatin or atorvastatin)
• medicines used to treat fungal infection (Ex. Amphotericin IV)
• medicines used to treat inflammation (Ex. hydrocortisone, betamethasone or prednisolone)
• water tablets (diuretics like chlorthalidone) to reduce blood pressure
• medicines used during surgery (Ex. lidocaine, midazolam or high dose oxygen)
• medicines used to test some hormone problems (Ex. Tetracosactide)
• medicines used to prevent rejection of transplants (Ex. Ciclosporin, tacrolimus and sirolimus)
• medicines used to treat impotence (Ex. sildenafil, tadalafil or vardenafil)
• medicines used to treat pain (Ex. fentanyl)
• medicines used for migraines (Ex. ergotamine)
• medicines used to treat gout (Ex. Colchicine)
• medicines used to stop your blood from clotting (Ex. Warfarin, dabigatran)

B. Drug - Food interaction:

Avoid drinking grapefruit juice while taking AMDRON 100 TABLET as it may increase the risk of side effects.

Overdosage:

If you or anyone else accidentally takes too much AMDRON 100 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or nausea.

SYNOPSIS

MORE INFORMATION

• Keep AMDRON 100 TABLET out of reach of children
• Do not store above 25°C

FAQs ABOUT AMDRON 100 TABLET

What is AMDRON 100 TABLET used for?

AMDRON 100 TABLET is used to treat uneven or fast heartbeats (like atrial flutter or atrial fibrillation), fast heartbeats which may happen suddenly and may be uneven only when other medicines either have not worked or cannot be used. It also treats Wolff-Parkinson-White Syndrome (unusually fast heartbeats).

How does AMDRON 100 TABLET work?

AMDRON 100 TABLET works by blocking certain electrical signals and reducing the excitability of cardiac tissues which prevents the initiation and conduction of any new impulses in the heart that cause irregular heartbeats, thus making your heartbeat return to normal.

Can AMDRON 100 TABLET make my skin sensitive to the sun?

Yes. your skin will become much more sensitive to the sun after taking AMDRON 100 TABLET and may burn, tingle or severely blister. Do not expose yourself to direct sunlight while taking this medicine and for a few months after you have finished taking it. Use high factor sun cream without fail. Always wear a hat and clothes which cover your whole body.

What should I avoid while taking AMDRON 100 TABLET?

Avoid drinking grapefruit juice while taking AMDRON 100 TABLET as it may increase the risk of side effects. Avoid consumption of alcohol during treatment with AMDRON 100 TABLET, as it may increase the chances of liver problems.

Can AMDRON 100 TABLET cause stomach problems?

Yes, AMDRON 100 TABLET can cause nausea, vomiting, constipation or diarrhea as a common side effect. Consult your doctor if symptoms worsens or does not show any improvement.

REFERENCES

1. KD. Tripathi. Antiarrhythmic Drugs. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 533.

2. Ruben ML Colunga Biancatelli, Viviana Congedo, Leonardo Calvosa, Marco Ciacciarelli, Alessandro Polidoro and Luigi Iuliano. Adverse reactions of Amiodarone. National library of medicine, National center for biotechnology information. Pubmed Central. 2019. [Accessed on 19th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689516/

3. Hugo Van Herendael and Paul Dorian . Amiodarone for the treatment and prevention of ventricular fibrillation and ventricular tachycardiaNational library of medicine, National center for biotechnology information. Pubmed Central. 2010. [Accessed on 19th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2922307/

4. S.C. Zentiva S.A. Electronic Medicines Compendium (EMC). [Revised in March 2022] [Accessed on 19th April 2022] https://www.medicines.org.uk/emc/files/pil.2815.pdf , https://www.medicines.org.uk/emc/product/2815/smpc

USEFUL DIAGNOSTIC TESTS

• Liver Function Test (LFT)
• Thyroid Function Test (TFT)
• Complete Blood Count (CBC)
• Chest X-Ray
• Electrocardiogram (ECG)
• Eye tests
• Blood pressure test

AUTHOR DETAILS

Written By Dr. Shruthi M R, BDS
Last updated on 12 Jan 2023 | 09:57 AM(IST)