Digoxin Tablets

Description

Digoxin Tablets (62.5mcg / 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. manufactures Digoxin Tablets in India. Digoxin is a cardiac glycoside used in selected cardiovascular conditions, including certain patients with heart failure and ventricular rate control in atrial fibrillation. Digoxin has a narrow therapeutic index, so small changes in dose, kidney function, interacting medicines or electrolyte status can materially affect toxicity risk. Manufacturing, prescribing and monitoring therefore require particular precision.

2. Product Specifications

3. Manufacturing Technology

• Low-Dose Content Uniformity: Validated dispensing and blending processes are critical because Digoxin is present at very low dose and has a narrow therapeutic index.
• API / Particle Control: Raw-material attributes that can influence product performance are controlled according to the approved material and finished-product specifications; micronization should only be claimed where it is actually part of the registered manufacturing process.
• Dissolution: Finished tablets are tested using the applicable pharmacopoeial/registered dissolution method and acceptance criteria.
• Packaging: Product-specific blister or bottle configurations can be supplied according to destination-market registration and stability requirements.

4. Quality Assurance

• Assay & Content Uniformity: Potency and individual dosage-unit uniformity are verified against approved pharmacopoeial/registered limits.
• Dissolution: Release testing follows the applicable product specification rather than a universal percentage/time target.
• Related Substances: Relevant Digoxin impurities and degradation products are monitored using validated analytical methods.
• Stability: Shelf life and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Digoxin inhibits the sodium-potassium ATPase pump, indirectly increasing intracellular calcium in cardiac myocytes and increasing cardiac contractility. It also increases vagal activity and slows conduction through the atrioventricular (AV) node.

• Heart Failure: May improve symptoms and reduce heart-failure hospitalization in selected patients, but its role depends on the patient's clinical status and contemporary guideline-directed therapy.
• Atrial Fibrillation: May be used for ventricular rate control in selected patients, particularly when other clinical factors make it appropriate.
• Narrow Therapeutic Index: Kidney function, age, body size, electrolyte status, interacting medicines and serum Digoxin concentration when clinically indicated can affect safe dosing.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Packaging: Finished packs can be configured according to approved destination-market labeling.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Digoxin Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Digoxin tablet formulations in India.

Q: Is Digoxin sold under brand names?
A: Yes. Digoxin is available under multiple brands. A manufacturer's product should only be described as bioequivalent or therapeutically interchangeable with a specific reference product when supported by the required regulatory evidence.

Q: Should a patient check their pulse?
A: Some patients may be instructed by their clinician to monitor heart rate, but a universal rule to skip every dose below a single heart-rate threshold is not appropriate for all patients. Follow the individual prescriber's instructions and seek advice for unusually slow pulse, dizziness, fainting or other concerning symptoms.

Q: What can Digoxin toxicity look like?
A: Possible features include loss of appetite, nausea, vomiting, confusion, weakness, visual disturbances and new or worsening rhythm abnormalities. Suspected toxicity requires prompt medical assessment.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Dosing: Loading and maintenance dosing are not universal. They depend on indication, age, lean body weight, kidney function, interacting medicines and whether rapid therapeutic effect is clinically required.
• Renal Function: Digoxin is substantially cleared by the kidneys; impaired renal function generally requires dose/interval adjustment and closer monitoring.
• Monitoring: Clinical response, heart rate/rhythm, renal function and electrolytes should be assessed as appropriate. Serum Digoxin concentrations can be useful in selected circumstances when sampled and interpreted correctly.
• Administration: Take exactly as prescribed. Do not double a dose after a missed dose unless specifically instructed.

9. Side Effects and Precautions

• Cardiac: Excess Digoxin can cause or worsen many types of arrhythmia, including bradyarrhythmias and AV block.
• Gastrointestinal / Neurologic: Loss of appetite, nausea, vomiting, weakness, dizziness and confusion can occur and may be toxicity signals.
• Visual: Blurred or altered color vision can occur with toxicity, although visual symptoms are not required for diagnosis.
• Electrolytes: Low potassium or magnesium and high calcium can increase susceptibility to Digoxin toxicity in relevant settings.
• Interactions: Numerous medicines can change Digoxin exposure or additive effects on heart rate; medication review is important when therapy is started, stopped or changed.
• Kidney Disease / Older Adults: Reduced clearance can increase toxicity risk and may require lower exposure and closer follow-up.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive light and moisture and keep the container/package securely closed.
• Keep out of reach of children.