Digox

Digoxin is a prescription medication used to treat mild to moderate heart failure and abnormal heart rhythms (atrial fibrillation). Digoxin belongs to a group of drugs called cardiac glycosides, which help control heart rate and strengthens the heart’s pump.

This medication comes in tablet and solution forms and is taken once or twice a day, with or without food. This medication also comes in injection form and is injected by a healthcare professional when needed.

Common side effects of digoxin include headache, nausea, and vomiting. Digoxin can also cause blurred vision or dizziness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Digoxin is used to treat congestive heart failure, usually in combination with a diuretic (water pill) and an angiotensin-converting enzyme (ACE) inhibitor. It is also used to treat a heart rhythm problem called atrial fibrillation.

Digoxin belongs to the class of medicines called digitalis glycosides. It is used to improve the strength and efficiency of the heart, or to control the rate and rhythm of the heartbeat. This leads to better blood circulation and reduced swelling of the hands and ankles in patients with heart problems.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain digoxin. It may not be specific to Digox. Please read with care.

To keep your heart working properly, take this medicine exactly as directed even though you may feel well. Do not take more of it than your doctor ordered and do not miss any doses. Take the medicine at the same time each day. This medicine works best when there is a constant amount in the blood.

When you are taking this medicine, it is very important that you get the exact amount of medicine that you need. The dose of digoxin will be different for different patients. Your doctor will determine the proper dose of digoxin for you. Follow your doctor's orders or the directions on the label.

Measure the oral solution correctly using the marked measuring dropper that comes with the package or an oral syringe. Do not use teaspoons and tablespoons that are used for serving and eating food. They do not measure exact amounts.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For heart failure or atrial fibrillation:
  • For oral dosage form (solution):
    • Adults, teenagers, and children 10 years of age and older—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 10 to 15 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 3 to 4.5 mcg per kg of body weight per day.
    • Children 5 to 10 years of age—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 20 to 35 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 5.6 to 11.3 mcg per kg of body weight per day.
    • Children 2 to 5 years of age—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 30 to 45 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 9.4 to 13.1 mcg per kg of body weight per day.
    • Infants 1 month to 24 months of age—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 35 to 60 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 11.3 to 18.8 mcg per kg of body weight per day.
    • Full-term babies—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 25 to 35 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 7.5 to 11.3 mcg per kg of body weight per day.
    • Premature babies—Dose is based on age, body weight, and medical condition and must be determined by your doctor. At first, the dose is usually 20 to 30 micrograms (mcg) per kilogram (kg) of body weight. Your doctor may adjust your dose as needed. However, the maintenance dose is usually 4.7 to 7.8 mcg per kg of body weight per day.
  • For oral dosage form (tablets):
    • Adults—Your doctor will give your first few doses intravenously (rapid digitalization) and then, you'll be switched to oral tablets for maintenance therapy. A maintenance dose of 0.125 to 0.5 milligram (mg) once a day will be given depending on your body weight and medical condition.
    • Teenagers and children older than 10 years of age—Dose is based on body weight and must be determined by your doctor.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

If you miss a dose of this medicine, and you remember it within 12 hours, take it as soon as you remember. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. If you have any questions about this or if you miss doses for 2 or more days in a row, check with your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Applies to digoxin: oral capsule liquid filled, oral elixir, oral solution, oral tablet

Other dosage forms:

• injectable, solution

Along with its needed effects, digoxin (the active ingredient contained in Digox) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking digoxin:

• Dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• slow heartbeat

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• bloody vomit
• pinpoint red spots on the skin
• rash with flat lesions or small raised lesions on the skin
• severe stomach pain
• unusual bleeding or bruising

• Chest pain or discomfort
• nausea
• shortness of breath
• sweating
• swelling of the feet and lower legs
• troubled breathing
• unusual tiredness or weakness

Some side effects of digoxin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Agitation or combativeness
• anxiety
• confusion
• depression
• diarrhea
• expressed fear of impending death
• hallucinations
• rash
• vomiting

• Blurred or loss of vision
• disturbed color perception
• double vision
• halos around lights
• headache
• lack of feeling or emotion
• loss of appetite
• night blindness
• overbright appearance of lights
• swelling of the breasts or breast soreness in both females and males
• tunnel vision
• weakness
• weight loss

Applies to digoxin: compounding powder, injectable solution, oral capsule, oral elixir, oral tablet

General

Overall incidence of adverse reactions with this drug has been reported to be 5% to 20%, with 15% to 20% of adverse events considered serious. Cardiac toxicity accounts for about one-half, gastrointestinal disturbances for about one-fourth, and CNS and other toxicity for about one-fourth of these adverse events.[Ref]

Cardiovascular

Common (1% to 10%): Arrhythmia, conduction disturbances, bigeminy, trigeminy, PR prolongation, sinus bradycardia
Postmarketing reports: Supraventricular tachyarrhythmia, atrial tachycardia, nodal tachycardia, ventricular arrhythmia, ventricular premature contraction, ST segment depression, atrioventricular block, ventricular fibrillation[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, diarrhea, lower stomach pain
Frequency not reported: Intestinal ischemia, intestinal hemorrhagic necrosis[Ref]

Nervous system

Common (1% to 10%): Central nervous system (CNS) disturbances, dizziness, drowsiness, headache[Ref]

Other

Common (1% to 10%): Central nervous system (CNS) disturbances, dizziness, drowsiness, headache[Ref]

Dermatologic

Common (1% to 10%): Skin rashes of urticarial or scarlatiniform character
Frequency not reported: Maculopapular rash[Ref]

Metabolic

Common (1% to 10%): Anorexia or loss of appetite[Ref]

Ocular

Common (1% to 10%): Blurred vision or visual disturbances[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression
Frequency not reported: Apathy, confusion, anxiety, delirium, hallucination
Postmarketing reports: Psychosis[Ref]

Hematologic

Frequency not reported: Thrombocytopenia[Ref]

Some side effects of Digox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.