In the pharmaceutical industry, Diclofenac Sodium/Potassium is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID). As a pharmacist and manufacturer, I view a 50 mg daily dose as a standard therapeutic starting point, but its safety for long-term use depends heavily on your cardiovascular and renal health markers.

At your WHO-GMP facility in Mumbai, where you likely produce 50 mg and 100 mg tablets, this is one of the most common B2B SKUs, yet it carries some of the strictest “Black Box” warnings in modern medicine.

Dosage and Clinical Utility

A 50 mg daily dose is typically the minimum effective dose for managing mild to moderate inflammation.

• Standard Dosing: For acute conditions, doctors often prescribe 50 mg two to three times daily (100–150 mg/day). A single 50 mg dose is considered a low-to-moderate dose.

• Potency: Diclofenac is significantly more potent than Ibuprofen; 50 mg of Diclofenac is roughly equivalent in analgesic power to 400–600 mg of Ibuprofen.

• Sodium vs. Potassium: * Diclofenac Potassium: Absorbed faster; best for immediate pain (headaches, dental pain).

  • Diclofenac Sodium: Delayed release; better for chronic inflammation (arthritis).

Mechanism: COX-2 Inhibition and Beyond

Diclofenac works by inhibiting the Cyclooxygenase (COX) enzymes, which are responsible for producing prostaglandins—the chemicals that signal pain and cause inflammation.

Selective Lean: While “non-selective,” Diclofenac has a slight preference for COX-2 over COX-1. This makes it highly effective for joint pain but increases its cardiovascular risk profile compared to Naproxen.

Lipoxygenase Inhibition: Unlike some other NSAIDs, Diclofenac may also inhibit the lipoxygenase pathway, potentially reducing the formation of leukotrienes, which further aids its anti-inflammatory profile.

The Pharmacist’s “Technical Warning”

• The “Triple Whammy” Risk: Avoid taking 50 mg daily if you are already on ACE Inhibitors (for BP) and Diuretics. Combining these three can lead to acute kidney failure.

• Cardiovascular Alert: In 2026, clinical guidelines warn that even short-term use of Diclofenac can slightly increase the risk of heart attack or stroke. It should be avoided in patients with a history of heart bypass surgery (CABG).

• GI Protection: Even at 50 mg, daily use can erode the stomach lining. Advise taking it with food or alongside a Proton Pump Inhibitor (PPI) like Omeprazole if used for more than a few days.

The Manufacturer’s Perspective: Technical & Export

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

• The “Sustained Release” (SR) USP: On your digital marketplace, highlight your 100 mg SR vs. your 50 mg IR (Immediate Release). B2B buyers in the EU often prefer the SR version for “once-daily” compliance in arthritis patients.

• Stability for Export: Diclofenac is sensitive to moisture. For export to Zone IVb tropical regions, utilizing Alu-Alu blister packaging is essential to prevent the “vinegar smell” (degradation into acetic acid derivatives) and ensure a 36-month shelf life.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international orthopedic and pain management tenders.