LANOXIN Solution for injection (2020)

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Covis Pharma

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1. Indications and Usage

1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. LANOXIN increases left ventricular ejection fraction and improves heart failure symptoms, ...

2. Dosage and Administration

2.1 Important Dosing and Administration Information In selecting a LANOXIN dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, ...

3. Dosage Forms and Strengths

LANOXIN Injection: Ampules of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL). LANOXIN Injection: Vials of 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per 1 mL). LANOXIN Injection Pediatric: Ampules ...

4. Contraindications

LANOXIN is contraindicated in patients with: Ventricular fibrillation [see Warnings and Precautions (5.1)] Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling ...

5. Warnings and 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 ...

6. Adverse Reactions

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 ...

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 ...

7. Drug Interactions

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 ...

8. Use in Specific Populations

8.8 Malabsorption The absorption of digoxin is reduced in some malabsorption conditions such as chronic diarrhea.

8.1. Pregnancy

Risk Summary Experience with digoxin in pregnant women over several decades, based on published retrospective clinical studies and case reports, has not led to the identification of a drug associated risk ...

8.2. Lactation

Risk Summary The digoxin dose received through breastfeeding is up to 4% of the neonatal maintenance dosage, which is unlikely to be clinically relevant. There are no data on the effects of digoxin on ...

8.4. Pediatric Use

The safety and effectiveness of LANOXIN in the control of ventricular rate in children with atrial fibrillation have not been established. The safety and effectiveness of LANOXIN in the treatment of heart ...

8.5. Geriatric Use

The majority of clinical experience gained with digoxin has been in the elderly population. This experience has not identified differences in response or adverse effects between the elderly and younger ...

8.6. Renal Impairment

The clearance of digoxin can be primarily correlated with the renal function as indicated by creatinine clearance. Table 3 and Table 5 provide the usual daily maintenance dose requirements for digoxin ...

8.7. Hepatic Impairment

Plasma digoxin concentrations in patients with acute hepatitis generally fall within the range of profiles in a group of healthy subjects.

10. Overdosage

10.1 Signs and Symptoms in Adults and Children The signs and symptoms of toxicity are generally similar to those previously described [see Adverse Reactions (6.1)] but may be more frequent and ...

11. Description

LANOXIN (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 ...

12.1. Mechanism of Action

All of digoxins actions are mediated through its effects on Na-K ATPase. This enzyme, the sodium pump, is responsible for maintaining the intracellular milieu throughout the body by moving sodium ions ...

12.2. Pharmacodynamics

The times to onset of pharmacologic effect and to peak effect of preparations of LANOXIN are shown in Table 7. Table 7. Times to Onset of Pharmacologic Effect and to Peak Effect of Preparations of LANOXIN: ...

12.3. Pharmacokinetics

Note: The following data are from studies performed in adults, unless otherwise stated. Comparisons of the systemic availability and equivalent doses for oral preparations of LANOXIN are shown in Table ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Digoxin showed no genotoxic potential in in vitro studies (Ames test and mouse lymphoma). No data are available on the carcinogenic potential of digoxin, nor have studies been conducted to assess ...

14. Clinical Studies

14.1 Chronic Heart Failure Two 12-week, double-blind, placebo-controlled studies enrolled 178 (RADIANCE trial) and 88 (PROVED trial) adult patients with NYHA Class II or III heart failure previously treated ...

16.1. How Supplied

LANOXIN (digoxin) Injection, 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL); box of 10 ampules (NDC 70515 260 10) LANOXIN (digoxin) Injection, 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL); ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] and protect from light.

17. Patient Counseling Information

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 ...