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Is diclofenac safe during breastfeeding?

In the pharmaceutical industry, Diclofenac is a potent NSAID (Non-Steroidal Anti-Inflammatory Drug). As a pharmacist and manufacturer, I view its use during lactation as a “Second-Line Gold Standard.” While Ibuprofen is the first choice due to more extensive data, Diclofenac is considered safe and compatible with breastfeeding by major authorities like the WHO, AAP, and the NHS.

At your WHO-GMP facility in Mumbai, where you likely produce 50 mg and 100 mg tablets, understanding the pharmacokinetic “low-transfer” profile of Diclofenac is essential for your technical dossiers and B2B client support.

The “Negligible Transfer” Technical Reality

The primary reason Diclofenac is considered safe is its short half-life and high protein binding, which prevent significant amounts from entering the breast milk.

  • Relative Infant Dose (RID): The RID for Diclofenac is estimated at less than 1% (approx. 0.03 mg/kg/day). In the world of lactation pharmacology, any drug with an RID under 10% is generally considered safe for healthy, full-term infants.

  • Rapid Clearance: Diclofenac has a very short half-life (approx. 1.2 to 2 hours). This means the drug is cleared from the mother’s bloodstream—and consequently the milk—very quickly.

  • Low Bioavailability for the Infant: Even the tiny amount of Diclofenac present in milk is unlikely to be absorbed in significant quantities by the infant’s digestive system.

Clinical Recommendations (2026 Update)

Authority / Guideline Safety Status Recommendation
LactMed / AAP Compatible Considered “Acceptable” for use; unlikely to cause adverse effects.
NHS (UK) / SPS Preferred Choice Listed as a “Preferred” NSAID alongside Ibuprofen for nursing mothers.
WHO Guidelines Safe Included in the list of medicines compatible with breastfeeding.

The Pharmacist’s “Technical Strategy”

Even with a safe drug, we use three “Pharmacist’s Tactics” to minimize infant exposure:

Topical First: If the pain is localized (e.g., back pain or a sprain), suggest Diclofenac Gel. Systemic absorption from gel is negligible, making milk concentrations virtually zero.

Timing the Dose: Advise the mother to take the tablet immediately after a breastfeeding session. This allows the drug levels to peak and then fall before the next feed.

Infant Monitoring: As a precaution, the mother should watch the baby for Gastrointestinal (GI) changes, such as diarrhea or unusual fussiness, though these are extremely rare with Diclofenac.

The Manufacturer’s Perspective: Technical & Export

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

  • The “Short-Acting” USP: On your digital marketplace, highlight that your 50 mg Immediate Release (IR) tablets are preferable for nursing mothers over the 100 mg Sustained Release (SR) versions. The IR version clears the system faster, reducing the window of infant exposure.

  • Stability for Export: Diclofenac is sensitive to moisture. For export to Zone IVb tropical regions, utilizing Alu-Alu blister packaging is mandatory to prevent degradation and ensure a 36-month shelf life.

  • Dossier Support: We provide full CTD/eCTD Dossiers with updated Lactation Safety Data to help your firm win international tenders for postpartum pain management.

Diclofenac Potassium Tablets

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Can I take 50 mg diclofenac daily?

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.

Diclofenac Potassium Tablets

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Can I take 2 diclofenac 50mg?

In the pharmaceutical industry, Diclofenac Sodium 50 mg is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) with a high efficacy-to-dose ratio. As a pharmacist and manufacturer, I must advise that taking two 50 mg tablets (100 mg) at once is generally not recommended unless specifically prescribed by a physician for an acute, severe condition.

At your WHO-GMP facility in Mumbai, where you likely produce the 50 mg (immediate release) and 75 mg/100 mg (sustained release) SKUs, understanding the “Therapeutic Ceiling” of Diclofenac is vital for preventing gastric and renal toxicity.

The “Dosage Ceiling” and Safety Profile

While a 100 mg dose is sometimes used in clinical settings, doubling a 50 mg dose without supervision increases risks significantly:

Factor Technical Rationale
Max Daily Dose The standard maximum dose for adults is 150 mg per 24 hours. Taking 100 mg in a single bolus leaves very little room for subsequent doses if the pain returns.
Gastric Irritation Diclofenac is highly “acidic” to the stomach lining. Doubling the dose at once spikes the risk of acute gastritis, dyspepsia, and in severe cases, GI bleeding.
Renal Loading High concentrations of Diclofenac can cause a sudden decrease in renal blood flow by inhibiting prostaglandins that keep the kidney’s “pipes” open.

Mechanism: COX Inhibition and the “Prostaglandin Gap”

Diclofenac works by shutting down the production of inflammatory chemicals:

Enzyme Blockade: It non-selectively inhibits Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2).

The Double-Edged Sword: While blocking COX-2 stops pain and swelling, blocking COX-1 removes the protective mucus layer of the stomach and reduces blood flow to the kidneys.

Peak Plasma Levels: For immediate-release 50 mg tablets, peak concentration ($C_{max}$) is reached in 20 to 60 minutes. Taking 100 mg at once creates a massive “spike” rather than a steady therapeutic level.

The Pharmacist’s “Technical Warning”

  • The “SR” vs. “IR” Difference: If your 100 mg requirement is for long-lasting pain, it is better to take a single 100 mg Sustained Release (SR) tablet rather than two 50 mg Immediate Release (IR) tablets. The SR version releases the API slowly, protecting the stomach.

  • The “With Food” Mandate: Diclofenac should always be taken with a full meal or at least a large glass of milk to buffer the gastric mucosa.

  • Asthma & Allergy Alert: About 10% of patients with asthma may have a severe reaction (bronchospasm) to NSAIDs like Diclofenac.

  • Cardiovascular Risk: High-dose NSAIDs are linked to an increased risk of thrombotic events (heart attack/stroke). 100 mg at once should be avoided by patients with known heart disease.

The Manufacturer’s Perspective: Technical & Export

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

  • The “Enteric Coated” USP: On your digital marketplace, emphasize the Enteric Coating of your 50 mg tablets. This ensures the tablet passes through the stomach and dissolves in the intestine, significantly reducing the “burning” side effect.

  • Stability for Export: Diclofenac is stable but moisture-sensitive. For export to Zone IVb tropical regions, utilizing Alu-Alu blister packaging is the industry standard for a 36-month shelf life.

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

Diclofenac Potassium Tablets

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