Cardiac Glycoside
Digoxin
The FDA lists this product in 25 strengths and forms.
Indications
1. INDICATIONS & USAGE
1.1Heart Failure in Adults
Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms, as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
1.2Atrial Fibrillation in Adults
Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
Contraindications
4. CONTRAINDICATIONS Digoxin is contraindicated in patients with: Ventricular fibrillation [see WARNINGS & PRECAUTIONS (5.1)] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
Warnings and precautions
5. WARNINGS & PRECAUTIONS
5.1 Ventricular Fibrillation in Patients With Accessory AV Pathway (Wolff-Parkinson-White Syndrome) Patients with Wolff-Parkinson-White syndrome who develop atrial fibrillation are at high risk of ventricular fibrillation. Treatment of these patients with digoxin leads to greater slowing of conduction in the atrioventricular node than in accessory pathways, and the risks of rapid ventricular response leading to ventricular fibrillation are thereby increased.
5.2Sinus Bradycardia and Sino-atrial Block
Digoxin may cause severe sinus bradycardia or sino-atrial block particularly in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. Consider insertion of a pacemaker before treatment with digoxin.
At a glance
- Brand name
- Digoxin
- Pharmacologic class
- Cardiac Glycoside
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Hikma
- Status
- Prescription
- FDA approval
- 24 Oct 1975
- Application
- ANDA083391-001



