Digoxin

1-10%

Dizziness (4.9%)

Mental disturbances (4.1%)

Diarrhea (3.2%)

Headache (3.2%)

Nausea (3.2%)

Vomiting (1.6%)

Maculopapular rash (1.6%)

<1%

Anorexia

Cardiac dysrhythmia

Arrhythmia in children (consider a toxicity)

Frequency Not Defined

Visual disturbance (blurred or yellow vision)

Heart block (1°/2°/3°)

Asystole

Tachycardia

Pregnancy category: C

Lactation: Drug enters breast milk; use with caution (American Academy of Pediatrics committee states, "compatible with nursing")

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

GENERIC AVAILABLE: Yes

• Digoxin may be taken with or without food.
• Digoxin primarily is eliminated by the kidneys; therefore, the dose of digoxin should be reduced in patients with kidney dysfunction.
• Digoxin blood levels are used for adjusting doses in order to avoid toxicity.
• The usual starting dose is 0.0625-0.25 mg daily depending on age and kidney function.
• The dose may be increased every two weeks to achieve the desired response.
• The usual maintenance dose is 0.125 to 0.5 mg per day.

:

• Drugs such as gentamicin, tetracycline, ranolazine (Ranexa), verapamil (Calan, Verelan, Verelan PM, Isoptin, Isoptin SR, Covera-HS), quinidine (Quinaglute, Quinide), amiodarone (Cordarone), indomethacin (Indocin, Indocin-SR), alprazolam (Xanax, Xanax XR, Niravam), spironolactone (Aldactone), and itraconazole (Sporanox) can increase digoxin levels and the risk of toxicity. The co-administration of digoxin and beta-blockers (for example propranolol [Inderal, Inderal LA]) or calcium channel blockers or CCBs (for example, verapamil), which also reduce heart rate, can cause serious heart rate slowing.
• Diuretic-induced (for example, by furosemide [Lasix]) reduction in blood potassium or magnesium levels may predispose patients to digoxin-induced abnormal heart rhythms.
• Saquinavir (Invirase) and ritonavir (Norvir) increase the amount of digoxin in the body and may cause digoxin toxicity.
• Mirabegron (Mybetriq) increases digoxin blood levels. The lowest dose of digoxin should be used if by people who are also using mirabegron.
• Omeprazole (Prilosec) and other drugs that reduce stomach acidity may increase blood levels of digoxin.

Common Side Effects of Digoxin

You should tell your doctor if any of the following side effects become severe or don't go away:

• Dizziness
• Changes in mood and mental alertness, including confusion, depression and lost interest in usual activities
• Anxiety
• Nausea, vomiting and diarrhea
• Headache
• Rash
• Growth or enlargement of breast tissue in men (gynecomastia)
• Weakness

Serious Side Effects of Digoxin

You should call your doctor immediately if you experience any of the following serious side effects:

• Changes in heart rhythm, including irregular heartbeat
• Fast or racing heartbeat
• Heart stopping or flat-lining (asystole)
• Problems with electrical functioning of the heart known as heart block
• Visual problems, including blurry vision and yellow halos
• Low platelet count

Digoxin comes in tablets and liquids for injection into muscles and veins.

Only trained medical professionals can give digoxin injections to a patient.

Tablets are available in doses of 0.125 milligram (mg) and 0.250 mg.

Sometimes, the doses may be written in micrograms (mcg): 120 mcg and 250 mcg.

Your doctor will draw blood to determine how much digoxin you should be taking each day.

This will also determine the maximum amount of digoxin you are to receive.

You should be consistent in taking digoxin the same time every day.

Digoxin Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at (800) 222-1222.

In certain situations of severe overdose, medical professionals may give you an antidote to digoxin.

Missed Dose of Digoxin

If you miss a dose of digoxin, try to take it as soon as you remember.

If it's less than 12 hours before your next scheduled dose, skip the missed dose and resume your regular dosing schedule.

Don't take two doses of the medication at the same time.

Digoxin is part of the drug class:

• Digitalis glycosides

Serious side effects have been reported with digoxin. See "Digoxin Precautions" section.

Common side effects of digoxin include:

• Dizziness
• Nausea
• Vomiting
• Vision changes (blurred or yellow)
• Upset stomach
• Loss of appetite
• Rash
• Mental changes (anxiety, depression, hallucination)
• Diarrhea
• Feet or hands swelling
• Weakness

This is not a complete list of digoxin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking digoxin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have reduced kidney function
• have electrolyte disorders
• have or have had thyroid problems
• have or had heart problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Oral Solution:

• The recommended loading dose range is 10 to 60 mcg/kg.
• The recommended maintenance dose range is 2.3 to 9.4 mcg/kg/dose (each dose taken twice daily).

Injectable:

• The recommended loading dose range is 8 to 35 mcg/kg (IV injection)
• The recommended maintenance dose range for those 10 years of age or older is 2.4 to 3.6 mcg/kg/day. The dose may also be determined according to your renal function plus your lean body weight.

Digox (digoxin tablet):

• The recommended dose range for adults is 125 to 500 mcg once daily. In these studies, the digoxin dose has been generally titrated according to the patient’s age, lean body weight, and kidney function. Therapy is generally started at a dose of 250 mcg once daily in those under age 70 with good kidney function, at a dose of 125 mcg (0.125 mg) once daily in those over age 70 or with impaired kidney function, and at a dose of 62.5 mcg (0.0625 mg) in those with considerable kidney impairment. Doses may be increased every 2 weeks according to clinical response.

• Store digoxin at room temperature.
• Protect from light.
• Keep this and all medicines out of the reach of children.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Lanoxin: 0.25 mg/mL (2 mL) [contains alcohol, usp, propylene glycol]

Lanoxin Pediatric: 0.1 mg/mL (1 mL) [contains alcohol, usp, propylene glycol]

Generic: 0.25 mg/mL (1 mL [DSC], 2 mL)

Solution, Oral:

Generic: 0.05 mg/mL (60 mL)

Tablet, Oral:

Digitek: 125 mcg [scored; contains fd&c yellow #10 aluminum lake]

Digitek: 250 mcg [scored]

Digox: 125 mcg [scored; contains fd&c yellow #10 aluminum lake]

Digox: 250 mcg [scored]

Lanoxin: 62.5 mcg [contains corn starch, fd&c yellow #6 (sunset yellow)]

Lanoxin: 125 mcg [scored; contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Lanoxin: 187.5 mcg, 250 mcg

Lanoxin: 250 mcg [scored]

Generic: 125 mcg, 250 mcg

Adults: 3 to 4 days

Half-Life Elimination

Age, renal and cardiac function dependent:

Neonates: Premature: 61 to 170 hours; Full-term: 35 to 45 hours

Infants: 18 to 25 hours

Children: 18 to 36 hours

Adults: 36 to 48 hours

Adults, anephric: 3.5 to 5 days

Parent drug: 38 hours; Metabolites: Digoxigenin: 4 hours; Monodigitoxoside: 3 to 12 hours

Protein Binding

~25%; in uremic patients, digoxin is displaced from plasma protein binding sites

Atrial dysrhythmias (rate control), HF: When changing from oral (tablets or liquid) or IM to IV therapy, dosage should be reduced by 20% to 25%. See table.

Table has been converted to the following text.

Dosage Recommendations for Digoxin1

Preterm infant:

• Total digitalizing dose2,3:

– Oral: 20-30 mcg/kg

– IV or IM5: 15-25 mcg/kg

• Daily maintenance dose2,4:

– Oral: 5-7.5 mcg/kg

– IV or IM5: 4-6 mcg/kg

Full-term infant:

• Total digitalizing dose2,3:

– Oral: 25-35 mcg/kg

– IV or IM5: 20-30 mcg/kg

• Daily maintenance dose2,4:

– Oral: 6-10 mcg/kg

– IV or IM5: 5-8 mcg/kg

1 month to 2 years:

• Total digitalizing dose2,3:

– Oral: 35-60 mcg/kg

– IV or IM5: 30-50 mcg/kg

• Daily maintenance dose2,4:

– Oral: 10-15 mcg/kg

– IV or IM5: 7.5-12 mcg/kg

2-5 years:

• Total digitalizing dose2,3:

– Oral: 30-40 mcg/kg

– IV or IM5: 25-35 mcg/kg

• Daily maintenance dose2,4:

– Oral: 7.5-10 mcg/kg

– IV or IM5: 6-9 mcg/kg

5-10 years:

• Total digitalizing dose2,3:

– Oral: 20-35 mcg/kg

– IV or IM5: 15-30 mcg/kg

• Daily maintenance dose2,4:

– Oral: 5-10 mcg/kg

– IV or IM5: 4-8 mcg/kg

>10 years:

• Total digitalizing dose2,3:

– Oral: 10-15 mcg/kg

– IV or IM5: 8-12 mcg/kg

• Daily maintenance dose2,4:

– Oral: 2.5-5 mcg/kg

– IV or IM5: 2-3 mcg/kg

1Heart failure: A lower serum digoxin concentration may be adequate to treat heart failure (compared to cardiac arrhythmias); consider doses at the lower end of the recommended range for treatment of heart failure; a digitalizing dose (loading dose) may not be necessary when treating heart failure (Ross, 2001).

2Based on lean body weight and normal renal function for age. Decrease dose in patients with decreased renal function; digitalizing dose often not recommended in infants and children.

3Do not give full total digitalizing dose (TDD) at once. Give one-half of the total digitalizing dose (TDD) in the initial dose, then give one-quarter of the TDD in each of two subsequent doses at 6- to 8-hour intervals. Obtain ECG 6 hours after each dose to assess potential toxicity.

4Divided every 12 hours in infants and children <10 years of age. Give once daily to children >10 years of age and adults.

5IM not preferred due to severe injection site pain. If IM route is necessary, administer as deep injection followed by massage of injection site.