Diclofenac Potassium Tablets

Description

Diclofenac Potassium Tablets

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

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Diclofenac Potassium Tablets in India. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used for selected painful and inflammatory conditions. Immediate-release Diclofenac Potassium formulations are commonly intended for acute treatment settings. Product selection, dose and duration should follow the registered indication and individual gastrointestinal, cardiovascular, renal and other risk factors.

2. Product Specifications

3. Manufacturing Technology

• Formulation Control: The potassium salt, strength, excipients and coating system are controlled according to the registered master formula.
• Blend Uniformity: Validated granulation or blending processes support consistent active distribution.
• Tablet Performance: Disintegration and dissolution are controlled against product-specific specifications appropriate to the dosage form.
• Combination Product: Diclofenac Potassium + Paracetamol requires separate validated formulation and quality specifications from the single-ingredient tablet.

4. Quality Assurance

• Assay & Uniformity: Active ingredient potency and dosage-unit uniformity are verified against approved limits.
• Dissolution: Drug release follows the applicable pharmacopoeial or registered finished-product specification rather than a universal time target.
• Related Substances: Relevant impurities and degradation products are monitored using validated analytical methods.
• Stability: Shelf life and storage conditions are supported by product-specific stability data.

5. Pharmacology and Clinical Use

Diclofenac inhibits cyclooxygenase-mediated prostaglandin synthesis, producing analgesic and anti-inflammatory effects.

• Acute Musculoskeletal Pain: May be used for selected sprains, strains or other painful inflammatory conditions.
• Dental Pain: May be prescribed for short-term dental or post-procedural pain.
• Dysmenorrhea: NSAIDs may relieve menstrual pain in appropriate patients.
• Migraine / Other Acute Pain: Some Diclofenac formulations have approved acute-pain indications; suitability depends on the exact product and local labeling.
• Potassium vs Sodium: Certain immediate-release potassium formulations may have faster absorption than some sodium formulations, but clinical performance also depends on dosage form. Sodium should not simply be characterized as the universally preferred form for chronic pain.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Private Label: Contract manufacturing can be supported subject to formulation approval and destination-market requirements.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

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

Q: What is the difference between Diclofenac Potassium and Sodium?
A: They are different salt forms of Diclofenac. Some immediate-release potassium formulations are absorbed more rapidly than certain sodium formulations, but the exact dosage form and registered label determine how each product should be used.

Q: Are sugar-coated tablets available?
A: A 50mg BP sugar-coated formulation is included in the supplied product range; availability for a particular market depends on registration.

Q: Does the combination contain Paracetamol?
A: The separately specified combination contains Diclofenac Potassium BP 50mg + Paracetamol BP 650mg. Patients should account for Paracetamol from all other medicines to avoid accidental overdose.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Dose and frequency depend on the exact formulation, indication, age and patient risk factors. Follow the registered prescribing information or clinician's directions.
• Duration: Use the lowest effective NSAID dose for the shortest duration appropriate to the indication.
• Combination Tablets: When Paracetamol is present, total daily Paracetamol/Acetaminophen intake from all products must be considered.
• Administration: Follow the specific label's food and administration instructions rather than assuming taking before meals is appropriate for every patient.

9. Side Effects and Precautions

• Gastrointestinal: Dyspepsia, nausea and abdominal pain may occur. Serious ulceration, bleeding or perforation can occur, sometimes without warning.
• Cardiovascular: Diclofenac and other NSAIDs can increase the risk of serious cardiovascular thrombotic events. Use requires particular caution in patients with cardiovascular disease or risk factors.
• Renal: Kidney function can worsen, particularly in dehydration, kidney disease, heart failure or with interacting medicines.
• Hepatic: Diclofenac can affect liver function. Combination products containing Paracetamol also carry serious dose-related liver toxicity risk if recommended limits are exceeded.
• Hypersensitivity / Asthma: Avoid use in patients with relevant Diclofenac/NSAID hypersensitivity and follow label contraindications for aspirin/NSAID-associated asthma reactions.
• Pregnancy: NSAID use has important gestational-age-specific fetal and maternal risks; use should follow current prescribing information and clinician guidance.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive light and moisture.
• Keep in original packaging and out of reach of children.