INTRODUCTION

DIGON 0.25MG contains Digoxin which belongs to the group of medicines called Cardiac glycosides. It is used in the treatment of arrhythmias (irregular heartbeat, which causes the heart to skip a beat or beat at the wrong speed) and heart failure. Heart failure is a chronic condition where the heart doesn’t pump sufficient blood to other parts of the body, which is generally characterized by symptoms such as shortness of breath, fatigue, weakness, rapid or irregular heartbeat and swelling in the legs, ankles or feet.

DIGON 0.25MG is not recommended for use in patients with serious heart problems (such as stokes-Adams attacks (condition where you suddenly feel faint and can pass out due to changes in heart rate) or irregular heartbeat due to cardiac glycoside intoxication).

Before taking DIGON 0.25MG, inform your doctor if you have beri-beri disease (which occurs due to vitamin B1 deficiency), severe lung disease, reduced renal function or liver failure. Along treatment with DIGON 0.25MG, your doctor might advise you to take regular blood test to determine the amount of digoxin in your blood and to check the status of the kidney function, especially in patients with kidney disorders.

DIGON 0.25MG should be used with caution in pregnant and breastfeeding women. Also, it should be used with caution in children and adolescents (below 18 years of age) and in elderly patients (aged 65 years and above).

The most common side effects of taking DIGON 0.25MG are nausea, vomiting, diarrhea, abnormal heartbeat and dizziness. Consult your doctor if any of the side effect gets worse.

USES OF DIGON 0.25MG

Treats,

• arrhythmia
• heart failure

HOW DIGON 0.25MG WORKS

DIGON 0.25MG works by increasing the force of contraction of the heart by reversibly inhibiting an enzyme (responsible for controlling the movement of ions into the heart), which leads to correction of irregular heartbeats and strengthening of contraction force, thus helps to treat irregular heartbeat and heart failure.

DIRECTIONS FOR USE

Take DIGON 0.25MG as directed by your physician. It can be taken with or without meals. Swallow the medicine as whole with a sip 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 health condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF DIGON 0.25MG

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting :

Take DIGON 0.25MG with meals. Stick to simple meals while taking this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.

Diarrhea:

Drink lot of fluids, such as water to keep yourself hydrated. Avoid eating high-fat or spicy foods. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.

Dizziness:

Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol and drugs. Consult your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

INTERACTIONS

Before taking DIGON 0.25MG, inform your doctor if you are taking any of the following medicines:

• angiotensin receptor blockers (Ex. telmisartan, irbesartan), angiotensin-converting-enzyme inhibitors (Ex. captopril, enalapril) and nifedipine, verapamil, felodipine, carvedilol, prazosin and diuretics (Ex. chlorothiazide, chlorthalidone) and beta-blockers Ex. atenolol, metoprolol, esmolol (used to treat high blood pressure)

• lithium, nefazodone, st. john’s wort, bupropion (used to treat depression)
• indomethacin and corticosteroids such as dexamethasone, hydrocortisone (used to provide relief from inflammation)
• carbenoxolone (used to treat digestive tract ulcers)
• other medicines used to prevent and treat arrhythmias (Ex. amiodarone, flecainide, propafenone, quinidine, dronedarone)
• canagliflozin, acarbose (used to treat type 2 diabetes mellitus)
• neomycin, penicillamine, rifampicin, erythromycin, clarithromycin, tetracycline, gentamicin, trimethoprim (antibiotics used to treat bacterial infections)
• telaprevir or daclatasvir, simeprevir, velpatasvir (used with or without other medicines to treat hepatitis C)
• flibanserin (used to treat low sexual desire in women who have not gone through menopause)
• sennosides (used to treat constipation)
• isavuconazole, itraconazole (used to treat fungal infections)
• ivacaftor (used to treat cystic fibrosis)
• spironolactone (medicine used to treat heart failure)
• alprazolam (used to treat anxiety)
• indomethacin (used to treat inflammation)
• quinine (used to prevent malaria infection)
• propantheline (used to prevent muscle spasms)
• mirabegron (used to treat overactive bladder)
• atorvastatin, colestyramine (used to lower blood cholesterol)
• cyclosporine (used to prevent organ rejection after transplantation)
• epoprostenol (used to treat pulmonary arterial hypertension)
• tolvaptan, conivaptan (used to treat low blood sodium levels)
• ritonavir (used to treat HIV infection)
• ranolazine, tiapamil (used to treat chest pain)
• lapatinib (used to treat breast cancer)
• ticagrelor (used to prevent heart attack or stroke)
• vandetanib (used to treat certain cancers of the thyroid gland)
• venetoclax (used to treat patients with chronic lymphocytic leukemia)
• vemurafenib (used to treat adult patients with a type of cancer called melanoma)
• proton pump inhibitors (PPIs) (used to relieve symptoms of acid reflux) Ex. lansoprazole, omeprazole
• medicines used to treat pain and inflammation such as non-steroidal anti-inflammatory drugs (Ex. ibuprofen, naproxen), and COX-2 inhibitors (Ex. celecoxib, rofecoxib)
• antacids (used to treat gastric acidity) Ex. aluminum hydroxide and magnesium carbonate.
• bulk-forming laxatives (used to treat constipation) Ex. psyllium, polycarbophil
• kaolin-pectin (used to treat diarrhoea)
• cytostatic drugs such as epirubicin, bleomycin (used as chemotherapy for cancer treatment)
• metoclopramide (used to treat nausea and vomiting)
• sulfasalazine (used to treat inflammatory diseases of the intestine)
• adrenaline (used to treat severe allergic reactions)
• salbutamol (used to treat asthma)
• phenytoin (used to treat epilepsy)
• supplemental enteral nutrition (used to augment nutrition)
• intravenous calcium (used to treat calcium deficiency)
• sympathomimetics (used to treat heart attack and low blood pressure) Ex. amphetamine, benzylpiperazine

B. Drug - Food interactions:

Avoid having foods high in fiber (dietary fiber) while taking DIGON 0.25MG as it may reduce the absorption of this medicine in the body

Over dosage:

If you or anyone else accidentally take too much of DIGON 0.25MG, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of DIGON 0.25MG are heart rhythm disturbances, gastrointestinal symptoms (such as loss of appetite, nausea and vomiting) dizziness, fatigue, various neurological disturbances including visual disturbances and non-heart related symptoms (such as weakness and general feeling of being unwell).

SYNOPSIS

MORE INFORMATION

• Keep DIGON 0.25MG out of reach of children
• Store DIGON 0.25MG at room temperature

FAQs ABOUT DIGON 0.25MG

What are the common side effects of DIGON 0.25MG?

The most common side effects of taking DIGON 0.25MG are allergic reactions (signs include skin rash or urticaria), abnormal heartbeat, nausea, vomiting, diarrhea and dizziness. Consult your doctor if any of the side effect gets worse during treatment with DIGON 0.25MG.

Can DIGON 0.25MG be used in pregnant women?

DIGON 0.25MG should be taken with caution during pregnancy only if clearly advised by the doctor. Consult your doctor before taking DIGON 0.25MG if you are pregnant or planning to get pregnant.

Does DIGON 0.25MG cause diarrhea?

DIGON 0.25MG may cause diarrhea in some individuals. To manage this effect, drink lot of fluids, such as water to keep yourself hydrated. Avoid eating high-fat or spicy foods. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.

How does DIGON 0.25MG work?

DIGON 0.25MG works by increasing the force of contraction of the heart by reversibly inhibiting an enzyme (responsible for controlling the movement of ions into the heart), which leads to correction of irregular heartbeats and strengthening of contraction force, thus helps to treat irregular heartbeat and heart failure.

Is DIGON 0.25MG safe to use in patients with kidney impairment?

DIGON 0.25MG should be used with caution in patients with reduced renal function or impairment. Your doctor may adjust the dose based on kidney function to prevent any unusual effects. Consult your doctor before taking DIGON 0.25MG.

REFERENCES

1. K.D. Tripathi. Cardiac Glycosides and Drugs for Heart Failure. Essentials of medical pharmacology. Seventh edition. 2013. Page 515.

2. Rim Charfi, Mouna Ben Sassi, Emna Gaies, Nadia Jebabli, Riadh Daghfous, Sameh Trabelsi. Digoxin therapeutic drug monitoring: age influence and adverse events. NIH National Library of medicine. National Center for Biotechnology Information. PubMed.gov. [Revised in January 2020] [Accessed on 11th May 2022] https://pubmed.ncbi.nlm.nih.gov/32395775/

3. University Medical Center Groningen. Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands (DECISION). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2022] [Accessed on 11th May 2022] https://clinicaltrials.gov/ct2/show/NCT03783429

4. Aspen Bad Oldesloe GmbH. Electronic Medicines Compendium (EMC). [Revised in April 2022] [Accessed on 11th May 2022] https://www.medicines.org.uk/emc/files/pil.5465.pdf

USEFUL DIAGNOSTIC TESTS

• Echocardiogram (ECG)
• Kidney function test