A fixed-dose combination (FDC) of a non-steroidal anti-inflammatory drug (NSAID) and a centrally-acting skeletal muscle relaxant. Aceclofenac provides potent analgesic and anti-inflammatory effects by inhibiting cyclooxygenase (COX) enzymes and prostaglandin synthesis. Tizanidine, an alpha-2 adrenergic agonist, reduces spasticity by inhibiting the release of excitatory amino acids in spinal interneurons. This combination is specifically designed for the short-term management of acute, painful musculoskeletal conditions where muscle spasm is a significant component, offering synergistic relief of pain, inflammation, and associated muscle rigidity.
Adult: One tablet (Aceclofenac 100mg + Tizanidine 2mg) twice daily, after meals. The dose should be individualized to the lowest effective dose for the shortest duration.
Note: Take with food or milk to minimize gastrointestinal upset. Swallow whole with a full glass of water. Do not crush or chew. Avoid lying down for at least 10 minutes after taking the tablet. The total duration of therapy should generally not exceed 2-3 weeks.
The combination works via two distinct but complementary pathways. Aceclofenac inhibits the enzymes cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), thereby blocking the conversion of arachidonic acid to prostaglandins (PGs) and thromboxanes. This reduces the synthesis of inflammatory mediators (PGE2, PGI2) responsible for pain, swelling, and fever. Tizanidine acts as a centrally-acting alpha-2 adrenergic receptor agonist, primarily at the level of the spinal cord. It presynaptically inhibits the release of excitatory neurotransmitters (like glutamate and aspartate) from spinal interneurons, leading to reduced facilitation of spinal motor neurons. This results in decreased muscle tone and relief of spasm.
Pregnancy: Pregnancy Category C (US FDA). Avoid, especially in the first and third trimesters. Third trimester use is contraindicated due to risk of premature closure of ductus arteriosus, oligohydramnios, and prolonged labor. Use only if potential benefit justifies potential fetal risk.
Driving: May impair alertness, reaction time, and motor coordination due to Tizanidine's sedative effect. Patients should be cautioned against driving or operating machinery, especially at initiation of therapy.
| Other NSAIDs (e.g., Ibuprofen, Naproxen, Aspirin) | Increased risk of GI toxicity (bleeding, ulcers) and renal impairment. | Major |
| Anticoagulants (Warfarin, NOACs like Rivaroxaban) | Increased risk of bleeding due to antiplatelet effect of Aceclofenac and potential pharmacokinetic interactions. | Major |
| CYP1A2 Inhibitors (Fluvoxamine, Ciprofloxacin) | Markedly increases Tizanidine plasma levels (up to 33-fold), leading to profound hypotension and sedation. CONTRAINDICATED. | Contraindicated |
| Oral Corticosteroids (Prednisolone) | Increased risk of GI ulceration and bleeding. | Major |
| Antihypertensives (ACE inhibitors, ARBs, Diuretics) | Reduced antihypertensive efficacy; increased risk of renal impairment. | Moderate |
| Selective Serotonin Reuptake Inhibitors (SSRIs e.g., Fluoxetine) | Increased risk of upper GI bleeding. | Moderate |
| Central Nervous System Depressants (Alcohol, Benzodiazepines, Opioids) | Additive sedative effects, impaired alertness and motor coordination. | Major |
| Methotrexate | Reduced renal clearance of Methotrexate, increasing its toxicity. | Major |
| Lithium | Aceclofenac may decrease renal clearance of Lithium, leading to toxicity. | Major |
Same composition (Aceclofenac (100mg) + Tizanidine (2mg)), different brands: