Description

Digoxin Tablets (0.25mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Digoxin Tablets in India. Digoxin is a potent Cardiac Glycoside derived from the Foxglove plant (Digitalis lanata). It remains a critical second-line therapy for Heart Failure and a key agent for rate control in Atrial Fibrillation (AFib). Due to its “Narrow Therapeutic Index” (the difference between a safe dose and a toxic dose is very small), manufacturing requires extreme precision.

We offer Contract Manufacturing (Third Party) services for this high-risk, high-value cardiac medicine. Our WHO-GMP certified facility in Mumbai utilizes advanced Micronization and automated high-shear blending technologies to ensure absolute Content Uniformity. This guarantees that every single tablet contains exactly 0.25mg (250mcg) of the drug, preventing dangerous fluctuations in blood levels. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across the UK, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precision engineering for a narrow therapeutic window.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronized API: To ensure consistent absorption (bioavailability), we strictly use Micronized Digoxin with a defined particle size distribution. This ensures the drug dissolves at the same rate in every patient, every time.

  • Content Uniformity: Achieving a homogeneous mix for a low-dose drug (0.25mg) is challenging. We use Geometric Dilution and validated blending cycles to ensure the active ingredient is evenly distributed throughout the batch, eliminating “hot spots” (overdose risk).

  • Dissolution Testing: We perform multi-point dissolution testing to verify the release profile matches the innovator, ensuring bioequivalence.

• The Exporter: Healthy Inc

  • Specialized Packaging: We offer child-resistant packaging options, which are crucial for potent cardiac medications found in home environments.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 60 minutes.

• Assay: We confirm the potency is strictly within 90-105% of the label claim.

• Related Substances: We strictly monitor for degradation products (Digoxigenin) to ensure stability.

5. Why Use Digoxin?

Strengthens the beat, slows the rhythm.

• Mechanism: Digoxin inhibits the Sodium-Potassium Adenosine Triphosphatase (Na+/K+ ATPase) pump in the heart muscle cells. This increases the level of intracellular sodium, which in turn increases calcium levels.

  • Positive Inotropic Effect: More calcium means a stronger heartbeat (pump function).

  • Negative Chronotropic Effect: It slows down the electrical signals at the AV node, reducing the heart rate.

• Key Indications:

  • Heart Failure: Improves symptoms and reduces hospitalization in patients with reduced ejection fraction (HFrEF).

  • Atrial Fibrillation: Controls the ventricular rate (slows the heart down) in patients with irregular, rapid heartbeats.

     

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Digoxin Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Lanoxin?

  A: Lanoxin is the brand name (Aspen/GSK). We manufacture the Generic Equivalent (Digoxin), which is bioequivalent.

• Q: Do I need to check my pulse?

  A: YES. Before taking your daily dose, check your pulse. If it is below 60 beats per minute, skip the dose and call your doctor.

• Q: What are the signs of toxicity?

  A: Nausea, vomiting, “yellow-green halo” vision (seeing colored circles around lights), and confusion. Seek medical help immediately.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Loading Dose (“Digitalization”): 0.75mg to 1.5mg given in divided doses over 24 hours (Hospital only).

• Maintenance Dose: 0.125mg to 0.25mg once daily.

• Renal Impairment: Dose reduction (e.g., 0.125mg every other day) is mandatory as Digoxin is excreted by the kidneys.

• Administration: Swallow with water.

9. Side Effects and Precautions

• Arrhythmias: Paradoxically, high doses can cause heart rhythm problems (Heart Block).

• Gastrointestinal: Loss of appetite, nausea, vomiting (early signs of toxicity).

• Visual: Blurred vision, yellow/green tint to vision (Xanthopsia).

• Electrolytes: Hypokalemia (low potassium) increases the risk of toxicity. Monitor Potassium levels regularly.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.