In the pharmaceutical industry, Digoxin 0.25 mg is a cardiac glycoside derived from the digitalis (foxglove) plant. As a pharmacist and manufacturer, I view this as a “Narrow Therapeutic Index” (NTI) drug, meaning the difference between a therapeutic dose and a toxic dose is very small.

At your WHO-GMP facility in Mumbai, you likely handle this in the standard 0.25 mg (250 mcg) and 0.125 mg (125 mcg) strengths.

Primary Clinical Uses

• Atrial Fibrillation (AFib): It is used to control the ventricular rate in patients with chronic AFib by slowing down the electrical conduction in the heart.

• Heart Failure: Digoxin is used to manage symptoms of mild-to-moderate heart failure, particularly when the heart’s pumping ability (ejection fraction) is reduced.

Mechanism: The Sodium-Potassium Exchange

Digoxin increases the strength of heart contractions while slowing the heart rate.

Inhibition of Na+/K+-ATPase: Digoxin binds to and inhibits the sodium-potassium pump in the cardiac cell membrane.

Increased Intracellular Calcium: This inhibition leads to an increase in intracellular sodium, which in turn slows down the sodium-calcium exchanger. This results in higher levels of calcium inside the heart muscle cells.

Positive Inotropy: The extra calcium allows the heart muscle to contract more forcefully, improving cardiac output.

Vagal Effect (Negative Chronotropy): It also increases vagal tone, which slows the electrical impulses at the AV node, thereby slowing the heart rate.

Safety & The “Digitalis Toxicity” Warning

As a pharmacist, providing these technical warnings on your digital platforms is critical for professional authority:

• Therapeutic Monitoring: Patients must have regular blood tests to ensure Digoxin levels remain within the narrow window of 0.5 to 2.0 ng/mL.

• Hypokalemia Risk: Low potassium levels (hypokalemia) significantly increase the risk of Digoxin toxicity because potassium competes with Digoxin for the binding site on the Na+/K+ pump.

• Signs of Toxicity: Patients must be educated to watch for “yellow-green halos” in their vision, nausea, confusion, or a dangerously slow pulse.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• Micro-Dosing Accuracy: Because 0.25 mg is a very small amount of active ingredient, your Content Uniformity must be impeccable. On your marketplace, highlight your high-precision blending and compression technology to reassure B2B buyers.

• Bioavailability & Dissolution: Digoxin has variable oral absorption (60–80%). Highlighting that your generic has a consistent Dissolution Profile equivalent to the innovator (Lanoxin) is a major USP.

• Stability & Packaging: Digoxin is sensitive to light. At our facility, we utilize Alu-Alu blister packaging or Amber glass/high-density polyethylene (HDPE) bottles to ensure a 36-month shelf life, especially for export to Zone IVb tropical regions.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in regulated markets worldwide.