A fixed-dose combination (FDC) of a centrally-acting skeletal muscle relaxant (Cyclobenzaprine) and a non-steroidal anti-inflammatory drug (NSAID) of the phenylacetic acid group (Aceclofenac). It is primarily indicated for the short-term management of acute, painful musculoskeletal conditions associated with muscle spasm. The combination provides a dual mechanism: Cyclobenzaprine acts centrally to reduce tonic somatic motor activity, while Aceclofenac acts peripherally to reduce inflammation and pain. This FDC is widely used in India for conditions like low back pain, cervical spondylosis, and post-traumatic muscle spasm, offering symptomatic relief. However, its use is typically restricted to short-term therapy (2-3 weeks) due to the risk of adverse effects and lack of evidence for long-term efficacy of Cyclobenzaprine.
Adult: One tablet (Cyclobenzaprine 15mg + Aceclofenac 200mg) orally, twice daily after meals. The total daily dose of Cyclobenzaprine should not exceed 30mg. Duration of therapy should not exceed 2-3 weeks.
Note: Take with food or milk to minimize gastrointestinal upset. Swallow the tablet whole with a full glass of water. Do not crush or chew. Avoid lying down for at least 10 minutes after taking the dose. Do not take more than the prescribed dose or for longer than prescribed.
The combination exerts a synergistic effect. Cyclobenzaprine acts primarily at the brainstem (reticular formation and spinal cord) to reduce tonic somatic motor activity, likely by inhibiting gamma and alpha motor neurons. It does not directly relax skeletal muscles. Aceclofenac acts peripherally by inhibiting the enzyme cyclooxygenase (COX), preferentially COX-2, thereby reducing the synthesis of prostaglandins (PGs), which are key mediators of inflammation, pain, and fever.
Pregnancy: Category C (US FDA). Avoid, especially in the first and third trimesters. In the third trimester, it is contraindicated (risk of premature closure of ductus arteriosus, oligohydramnios, and prolonged labor). Use only if potential benefit justifies potential fetal risk.
Driving: May impair mental and/or physical abilities required for driving or operating machinery. Drowsiness and dizziness are common. Patients should be cautioned not to drive or use machinery until they know how the medication affects them.
| Monoamine Oxidase Inhibitors (MAOIs) - Phenelzine, Tranylcypromine | Risk of hyperpyretic crisis, severe seizures, serotonin syndrome, and death. | Contraindicated |
| Other CNS Depressants - Alcohol, Benzodiazepines, Opioids | Additive CNS depression, increased risk of sedation, dizziness, and impaired psychomotor performance. | Major |
| Other NSAIDs (including Aspirin, COX-2 inhibitors) or Corticosteroids | Increased risk of gastrointestinal ulceration and bleeding. | Major |
| Anticoagulants (Warfarin) and Antiplatelets (Clopidogrel) | Increased risk of bleeding due to antiplatelet effect of Aceclofenac and potential displacement from protein binding. | Major |
| Selective Serotonin Reuptake Inhibitors (SSRIs) - Fluoxetine, Sertraline | Increased risk of serotonin syndrome with Cyclobenzaprine. | Moderate |
| Antihypertensives (ACE Inhibitors, ARBs, Diuretics like Furosemide) | Aceclofenac may reduce the antihypertensive and natriuretic effect, leading to worsened hypertension or renal impairment. | Moderate |
| Lithium | Aceclofenac may decrease renal clearance of Lithium, leading to increased Lithium levels and toxicity. | Moderate |
| Methotrexate | Aceclofenac may decrease renal excretion of Methotrexate, increasing its toxicity. | Moderate |
| Cyclosporine, Tacrolimus | Increased risk of nephrotoxicity. | Moderate |
| Anticholinergics (e.g., Atropine, Trihexyphenidyl) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, blurred vision). | Moderate |
| CYP3A4 Inhibitors (e.g., Ketoconazole, Clarithromycin) | May increase Cyclobenzaprine levels, increasing risk of adverse effects. | Moderate |
| CYP2C9 Inhibitors (e.g., Fluconazole, Amiodarone) | May increase Aceclofenac levels. | Moderate |
Same composition (Cyclobenzaprine (15mg) + Aceclofenac (200mg)), different brands: