In the pharmaceutical industry, Ketorol 10 mg (Ketorolac Tromethamine) is a high-potency, non-steroidal anti-inflammatory drug (NSAID) used for short-term management of acute, severe pain. As a pharmacist and manufacturer, I view it as a “Non-Opioid Analgesic Bridge”—it is one of the few NSAIDs with an analgesic efficacy comparable to low-dose morphine, but it lacks the addictive potential of narcotics.
At your WHO-GMP facility in Mumbai, where technical precision and safety are paramount, positioning this molecule correctly is essential. It is vital to emphasize that this is not a routine painkiller for minor aches, but a specialized drug for intense, post-procedural pain.
Therapeutic Profile: Primary Indications
Ketorol 10 mg is indicated exclusively for the short-term treatment of moderate to severe acute pain that requires analgesia at the opioid level.
| Indication | Technical Rationale |
| Post-Surgical Pain | Frequently used following dental, orthopedic, or gynecological surgeries. |
| Acute Renal Colic | Highly effective in relaxing the ureter and reducing the intense inflammation caused by kidney stones. |
| Opioid Sparing | Used in combination with opioids to reduce the total narcotic dose needed, thereby minimizing respiratory depression and constipation. |
| Limitation of Use | Strictly limited to 5 days. Prolonged use exponentially increases the risk of renal failure and GI bleeding. |
Mechanism: Potent Prostaglandin Inhibition
Ketorolac works by shutting down the chemical “pain messengers” at the source:
COX Inhibition: It is a non-selective inhibitor of the enzymes Cyclooxygenase-1 (COX-1) and COX-2.
Prostaglandin Blockade: By inhibiting these enzymes, it prevents the synthesis of prostaglandins, which are the primary mediators of peripheral pain, fever, and inflammation.
Analgesic Superiority: Its high affinity for COX enzymes allows it to provide intense pain relief without the sedative effects associated with opioids.
The Pharmacist’s “Technical Warning”
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The “5-Day Rule”: As a pharmacist, I must stress that Ketorolac is contraindicated for chronic pain. Use beyond 5 days is a “hard stop” in clinical practice due to severe gastric and renal toxicity.
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Renal Guard: It is contraindicated in patients with advanced renal impairment or those at risk for renal failure due to volume depletion.
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GI Hemorrhage: Ketorolac has one of the highest risks of gastrointestinal bleeding among NSAIDs. It must be used with extreme caution in the elderly and those with a history of ulcers.
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Bleeding Risk: It inhibits platelet aggregation. It should not be used as a prophylactic analgesic before major surgery or in patients with high bleeding risks.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Analgesic Alternative” USP: On your digital marketplace, position Ketorol 10 mg as the premier alternative to narcotics for surgical centers. In 2026, with the global focus on reducing opioid dependency, Ketorolac is a high-demand SKU for international hospital tenders.
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Stability for Export: Ketorolac Tromethamine is sensitive to light. Utilizing Amber-colored blisters or Opaque Alu-Alu packaging is mandatory for ensuring a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full WHO-standard CTD/eCTD Dossiers to support your firm’s registration in international hospital procurement systems and ministry of health (MOH) registries.