A fixed-dose combination (FDC) of Ketorolac Tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID), and Dexamethasone, a potent synthetic glucocorticoid. This combination provides synergistic anti-inflammatory, analgesic, and anti-edema effects, primarily used for short-term management of moderate to severe acute pain and inflammation, particularly in post-operative, musculoskeletal, and ophthalmic conditions. The combination aims to reduce the total dose of each component, potentially minimizing individual side effects while enhancing therapeutic efficacy.
Adult: Dosage must be individualized. Typical: 1 tablet (Ketorolac 10 mg + Dexamethasone 0.5 mg) orally every 8 to 12 hours. For IM use: As directed by physician, typically once or twice daily. MAXIMUM DURATION: 5 DAYS for Ketorolac component.
Note: Take with food or a full glass of milk to minimize GI upset. Do not crush or chew sustained-release formulations. For IM injection, administer deep into a large muscle mass. Do not use for more than 5 days. Do not switch from parenteral to oral therapy (leads to excessive total dose).
The combination exerts a multi-modal action. Ketorolac is a non-selective, reversible inhibitor of cyclooxygenase (COX-1 and COX-2) enzymes, thereby inhibiting the synthesis of prostaglandins (PGs), thromboxanes, and prostacyclins from arachidonic acid. This reduces pain, fever, and inflammation at the site. Dexamethasone acts as a potent glucocorticoid receptor agonist. The drug-receptor complex translocates to the nucleus, modulating gene transcription. It induces the synthesis of anti-inflammatory proteins (like lipocortin) and inhibits the production of pro-inflammatory mediators (cytokines, chemokines, adhesion molecules, COX-2). The synergy results in enhanced suppression of inflammation and pain with a potential steroid-sparing effect.
Pregnancy: CATEGORY C (D in third trimester for NSAIDs). Ketorolac may cause premature closure of ductus arteriosus in third trimester. Dexamethasone crosses placenta. Use only if potential benefit justifies potential fetal risk. Avoid in first trimester and after 30 weeks gestation.
Driving: May cause dizziness, vertigo, or visual disturbances. Patients should not drive or operate machinery if affected.
| Anticoagulants (Warfarin, NOACs) | Increased risk of bleeding due to antiplatelet effect of Ketorolac and potential GI ulceration. | Major |
| Anti-platelets (Aspirin, Clopidogrel) | Additive risk of GI bleeding. Ketorolac may antagonize antiplatelet effect of aspirin. | Major |
| Other NSAIDs or Corticosteroids | Increased risk of GI toxicity and renal impairment. | Major |
| ACE Inhibitors (Enalapril), ARBs (Losartan), Diuretics | Reduced antihypertensive efficacy; increased risk of renal impairment. | Moderate |
| Methotrexate | Decreased renal clearance of Methotrexate, leading to increased toxicity. | Major |
| Lithium | Decreased renal clearance of Lithium, leading to toxicity. | Major |
| Antidiabetics (Insulin, Metformin) | Dexamethasone causes hyperglycemia; may require dose adjustment. | Moderate |
| Cyclosporine, Tacrolimus | Increased risk of nephrotoxicity and seizures. | Major |
| Enzyme Inducers (Phenytoin, Rifampicin) | Increased metabolism of Dexamethasone, reducing its efficacy. | Moderate |
| Ketoconazole, Itraconazole | Inhibit CYP3A4, increasing Dexamethasone levels and toxicity. | Moderate |
| Probenecid | Markedly increases Ketorolac plasma levels; contraindicated. | Major |
Same composition (Ketorolac (NA) + Dexamethasone (NA)), different brands: