Fest Digoxin Tablets

Digoxin is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. ( 1.1 ) Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2 ) Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3 ) 1.1 Heart 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. …

• Digoxin dose is based on patient-specific factors (age, lean body weight, renal function, etc.)
• See full prescribing information
• Monitor for toxicity and therapeutic effect
• Important Dosing and Administration Information In selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels
• Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose
• Consider interruption or reduction in digoxin dose prior to electrical cardioversion [see Warnings and Precautions ]
• Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight
• Loading Dosing Regimen
• In Adults and Pediatric Patients For adults and pediatric patients if a loading dosage is to be given, administer half the total loading dose initially, then ¼ the loading dose every 6-8 hours twice, with careful assessment of clinical response and toxicity before each dose
• The recommended loading dose is displayed in Table 1
• Table 1. …

125 mcg tablets are yellow, round, scored tablets imprinted with “JSP-544”. 250 mcg tablets are white, round, scored tablets imprinted with “JSP-545”. Scored Tablets 125 and 250 mcg

• Advise patients that many drugs can interact with digoxin
• Instruct patients to inform their doctor and pharmacist if they are taking any over the counter medications, including herbal medication, or are started on a new prescription
• Advise patients to contact their doctor or a health care professional if they experience nausea, vomiting, persistent diarrhea, confusion, weakness, or visual disturbances (including blurred vision, green-yellow color disturbances, halo effect) as these could be signs that the dose of digoxin may be too high
• Advise parents or caregivers that the symptoms of having too high digoxin doses may be difficult to recognize in infants and pediatric patients. …

• Digoxin is contraindicated in patients with: Ventricular fibrillation [see Warnings and Precautions ] 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
• Ventricular fibrillation
• Known hypersensitivity to digoxin or other forms of digitalis

Digoxin has a narrow therapeutic index, increased monitoring of serum digoxin concentrations and for potential signs and symptoms of clinical toxicity is necessary when initiating, adjusting, or discontinuing drugs that may interact with digoxin. Prescribers should consult the prescribing information of any drug which is co-prescribed with digoxin for potential drug interaction information. PGP Inducers/Inhibitors: Drugs that induce or inhibit PGP have the potential to alter digoxin pharmacokinetics. ( 7.1 ) The potential for drug-drug interactions must be considered prior to and during drug therapy. See full prescribing information. …

Risk of rapid ventricular response leading to ventricular fibrillation in patients with AV accessory pathway. ( 5.1 ) Risk of advanced or complete heart block in patients with sinus node disease and AV block. ( 5.2 ) Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances, and cardiac arrhythmias. Advanced age, low body weight, impaired renal function and electrolyte abnormalities predispose to toxicity. ( 5.3 ) Risk of ventricular arrhythmias during electrical cardioversion. ( 5.4 ) Not recommended in patients with acute myocardial infarction. ( 5.5 ) Avoid digoxin in patients with myocarditis. …

The following adverse reactions are included in more detail in the Warnings and Precautions section of the label: Cardiac arrhythmias [see Warnings and Precautions (5.1 , 5.2 )] Digoxin Toxicity [see Warnings and Precautions (5.3) ] The overall incidence of adverse reactions with digoxin has been reported as 5-20%, with 15-20% 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oliva Therapeutics at 1-877-200-6088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

IN SPECIFIC POPULATIONS Pregnant patients: It is unknown whether use during pregnancy can cause fetal harm. ( 8.1 ) Pediatric patients: Newborn infants display variability in tolerance to digoxin. ( 8.4 ) Geriatric patients: Consider renal function in dosage selection, and carefully monitor for side effects. ( 8.5 ) Renal impairment: Digoxin is excreted by the kidneys. Consider renal function during dosage selection. …

10.1 Signs and Symptoms in Adults and Children The signs and symptoms of toxicity are generally similar to those described in the Adverse Reactions (6.1) but may be more frequent and can be more severe. Signs and symptoms of digoxin toxicity become more frequent with levels above 2 ng/mL. However, in deciding whether a patient’s symptoms are due to digoxin, the clinical state together with serum electrolyte levels and thyroid function are important factors [see Dosage and Administration (2) ] . …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.