Digoxin

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 2.1 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.
• Parenteral administration of digoxin should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orallly.
• Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred.
• If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage.
• For
• adults, no more than 500 mcg of Digoxin Injection should be injected into a single site.
• For pediatric patients, see the full prescribing information for pediatric digoxin injection (not available from Hikma Pharmaceuticals) for specific recommendations.
• Administer the dose over a period of 5 minutes or longer and
• avoid bolus administration to prevent systemic and coronary vasoconstriction.
• Mixing of Digoxin Injection with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.
• Digoxin Injection can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection.
• The use of less than a 4 fold-volume of diluent could lead to precipitation of the digoxin.
• Immediate use of the diluted product is recommended.
• If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to
• avoid over administration of digoxin.
• Consider interruption or reduction in digoxin dose prior to electriclal cardioversion [see Warnings and Precautions (5.4)].
• Loading Dosing Regimen in Adults and Pediatric Patients Over 10 Years Old
• Maintenance Dosing in
• Adults and Pediatric Patients Over 10 Years Old The maintenance dose is based on lead body weight, renal function, age, and concomitant products [ see Clinical Pharmacology (12.3)].
• The recommended starting maintenance dose in
• adults and pediatric patients over 10 years old with normal renal function is given in Table 2.
• Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.
• Table 3 provides the recommended (once daily) maintenance dose for
• adults and pediatric patients over 10 years old according to lean body weight and renal function.
• The doses are based on studies in adult patients with heart failure.
• Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):
• Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100 (% Daily Loss = 14 + Creatinine clearance/5) Reduce the dose of digoxin in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema a For
• adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m² body surface area.
• If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr.
• For women, this result should be multiplied by 0.85.
• For pediatric patients, the modified Schwartz equation may be used.
• The formula is based on height in cm and Scr in mg/dL where k is a constant.
• Ccr is corrected to 1.73 m² body surface area.
• During the first year of life, the value of k is 0.33 for pre-term babies and 0.45 for term infants.
• The k is 0.55 for pediatric patients and adolescent girls and 0.7 for adolescent boys.
• GFR (mL/min/1.73m²) = (k x Height)/Scr b If no loading dose administered c The doses listed assume average body composition.
• 2.4 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels Monitor for signs and symptoms of digoxin toxicity and clinical response.
• Adjust dose based on toxicity, efficacy, and blood levels.
• Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.
• Interpret the serum digoxin concentration in the overall clinical context, and
• do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the digoxin dose.
• Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [ see Drug Interactions (7.4)].
• If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting digoxin and correct post-treatment values by the reported baseline level.
• Obtain serum digoxin concentrations just before the next scheduled digoxin dose or at least 6 hours after the last dose.
• The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing).
• However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.
• 2.5 Switching from Intravenous Digoxin to Oral Digoxin When switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 4).
• Table 4.
• Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous Digoxin 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.
• (2) Intravenous administration is preferable to intramuscular.
• Avoid bolus administration.
• (2) Image1.jpg Image2.jpg Image3.jpg Image4.jpg

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Side effects

• 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)]
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
• In general, the adverse reactions of digoxin are dose-dependent and occur at doses higher than those needed to achieve a therapeutic effect.
• Hence, adverse reactions are less common when digoxin is used within the recommended dose range, is maintained within the therapeutic serum concentration range, and when there is careful attention to concurrent medications and conditions.
• In the DIG trial (a trial investigating the effect of digoxin on mortality and morbidity in patients with heart failure), the incidence of hospitalization for suspected digoxin toxicity was 2% in patients taking digoxin compared to 0.9% in patients taking placebo [see Clinical Studies (14.1)].
• 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.
• Gastrointestinal:
• In addition to nausea and vomiting, the use of digoxin has been associated with abdominal pain, intestinal ischemia, and hemorrhagic necrosis of the intestines.
• CNS:
• Digoxin can cause headache, weakness, dizziness, apathy, confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).
• Other:
• Gynecomastia has been occasionally observed following the prolonged use of digoxin.
• Thrombocytopenia and maculopapular rash and other skin reactions have been rarely observed.
• 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 Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

• FORMS AND STRENGTHS Digoxin Injection:
• Ampuls of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL). Digoxin Injection:
• Ampuls containing 500 mcg (0.5 mg) in 2 mL. (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Digoxin Injection, USP is available as:
• 500 mcg/2 mL (250 mcg/mL) ampuls packaged in 25s (NDC 0641-1410-35)
• Store at 20˚to 25˚C (68˚to 77˚F), excursions permitted to 15˚to 30˚C (59˚to 86˚F) [see USP Controlled Room Temperature].
• Protect from light.
• Product repackaged by:
• Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0641-1410-35 Ampuls packaged in 25s NDC 0404-9850-02 1 ampul in a bag (Ampul bears NDC 0641-1410-31) 500 mcg/2mL (250 mcg/mL)

Quoted from the official label, section “How Supplied”.

What is in it

• Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium.
• These drugs are found in a number of plants.
• Digoxin is extracted from the leaves of Digitalis lanata .
• The term “digitalis” is used to designate the whole group of glycosides.
• The glycosides are composed of two portions:
• a sugar and a cardenolide (hence “glycosides”).
• Digoxin has the chemical name:
• 3β-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D- ribo -hexopy­ranosyl-(1→4)-2,6-dideoxy-β-D- ribo -hexopyranosyl)oxy]-12β,14-dihydroxy-5β-card-20(22)-enolide, and the following structural formula:
• Digoxin exists as odorless white crystals that melt with decomposition above 230°C.
• The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.
• Digoxin Injection is a sterile solution for slow intravenous or deep intramuscular injection.
• Each mL contains digoxin 250 mcg (0.25 mg), alcohol 0.1 mL, propylene glycol 0.4 mL, dibasic sodium phosphate, anhydrous 3 mg and citric acid, anhydrous 0.8 mg in Water for Injection. pH 6.7-7.3; citric acid and/or sodium phosphate added, if necessary, for pH adjustment.
• Dilution is not required.
• Formual1.jpg

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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