Usage
Aceclofenac + Pregabalin is prescribed for the management of neuropathic pain (nerve pain due to damage or dysfunction of the nervous system), as well as chronic musculoskeletal pain conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It can also provide short-term relief for acute pain where both anti-inflammatory and neuropathic pain relief are required.
Pharmacological Classification:
- Aceclofenac: Non-Steroidal Anti-inflammatory Drug (NSAID)
- Pregabalin: Anticonvulsant, analgesic, and GABA analogue
Mechanism of Action: Aceclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin production and thus decreasing pain and inflammation. Pregabalin binds to calcium channels on nerve cells in the brain and spinal cord, reducing the release of neurotransmitters involved in pain signaling, thereby decreasing nerve pain.
Alternate Names
There are no widely recognized alternate generic names. Brand names include Pregabrial ACP, Acenac N, Zerodol PG.
How It Works
Pharmacodynamics: Aceclofenac exerts its analgesic and anti-inflammatory effects by inhibiting COX enzymes, leading to a reduction in prostaglandin synthesis. Pregabalin binds to the alpha2-delta subunit of voltage-gated calcium channels, reducing calcium influx into nerve terminals and decreasing the release of several neurotransmitters, including glutamate, noradrenaline, and substance P. This leads to a decrease in neuronal excitability and pain signal transmission.
Pharmacokinetics:
- Aceclofenac: Well absorbed orally, metabolized in the liver primarily by CYP2C9, excreted in urine and feces.
- Pregabalin: Rapidly absorbed orally, with peak plasma concentrations reached within one hour. It is not extensively metabolized and is primarily eliminated through renal excretion.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Aceclofenac inhibits COX-1 and COX-2 enzymes. Pregabalin binds to the alpha2-delta subunit of voltage-gated calcium channels.
Elimination Pathways: Aceclofenac is primarily eliminated via hepatic metabolism followed by renal and fecal excretion. Pregabalin is primarily eliminated unchanged through renal excretion.
Dosage
Standard Dosage
Adults: The typical starting dose is one tablet containing 200 mg of aceclofenac and 150 mg of pregabalin once or twice daily, after meals. The dosage may be adjusted based on the patient’s response and tolerance.
Children: The safety and efficacy of this combination have not been established in children under 12 years of age. Limited data suggests that for children aged 1 month and older, pregabalin dosing can be initiated based on weight and titrated according to clinical response and tolerability, but caution and close monitoring are necessary.
Special Cases:
- Elderly Patients: The lowest effective dose should be used for the shortest possible duration due to the increased risk of adverse effects.
- Patients with Renal Impairment: Dose adjustments are necessary for moderate to severe renal impairment. In severe cases, the combination may be contraindicated.
- Patients with Hepatic Dysfunction: Dose adjustments are required for moderate to severe hepatic impairment. Contraindicated in severe hepatic impairment.
- Patients with Comorbid Conditions: Use with caution in patients with cardiovascular disease, diabetes, gastrointestinal disorders, or substance abuse.
Clinical Use Cases
Dosage in specific clinical settings (intubation, surgical procedures, mechanical ventilation, ICU, emergency situations) should be individualized based on the patient’s condition, pain level, and other clinical factors. No standard guidelines exist for these situations with this specific combination.
Dosage Adjustments
Dose modifications are based on patient response, renal function, hepatic function, and other patient-specific factors.
Side Effects
Common Side Effects: Nausea, vomiting, diarrhea, stomach pain, dizziness, drowsiness, blurred vision, dry mouth, peripheral edema, weight gain, muscle pain, fatigue, headache, uncoordinated body movements.
Rare but Serious Side Effects: Allergic reactions (anaphylaxis, angioedema), gastrointestinal bleeding, cardiovascular events (heart failure, myocardial infarction), Stevens-Johnson syndrome, meningitis, difficulty breathing.
Long-Term Effects: Potential long-term effects include gastrointestinal issues, cardiovascular complications, and renal impairment.
Contraindications
- Hypersensitivity to aceclofenac or pregabalin.
- History of asthma or allergic reactions after taking aspirin or other NSAIDs.
- Active gastric/duodenal ulcers or bleeding.
- Severe hepatic impairment.
- Severe renal impairment.
- Severe heart failure.
Drug Interactions
Aceclofenac + Pregabalin may interact with NSAIDs (e.g., ibuprofen), anticoagulants (e.g., warfarin), antihypertensives, diuretics (e.g., furosemide), oral hypoglycemic agents, and certain other medications. It may also interact with alcohol, increasing dizziness and drowsiness. Consult a comprehensive drug interaction database for a full list of potential interactions.
Pregnancy and Breastfeeding
The safety of Aceclofenac + Pregabalin during pregnancy and breastfeeding has not been fully established. It should be used only if the potential benefits outweigh the potential risks. Aceclofenac is not recommended during pregnancy, especially during the third trimester. Limited data suggests that pregabalin amounts in breast milk are low, but caution is advised when nursing a newborn or preterm infant. It is essential to consult with a healthcare professional before using this combination during pregnancy or while breastfeeding.
Drug Profile Summary
- Mechanism of Action: Aceclofenac inhibits COX enzymes, reducing inflammation and pain. Pregabalin modulates neurotransmitter release in the central nervous system, reducing nerve pain.
- Side Effects: Common: Nausea, dizziness, drowsiness. Serious: Allergic reactions, gastrointestinal bleeding, cardiovascular events.
- Contraindications: Hypersensitivity, active ulcers, severe hepatic/renal impairment, severe heart failure.
- Drug Interactions: NSAIDs, anticoagulants, antihypertensives, alcohol.
- Pregnancy & Breastfeeding: Use with caution only if benefits outweigh risks.
- Dosage: Adults: One tablet (200mg aceclofenac + 150mg pregabalin) once or twice daily after meals. Adjust based on individual response and tolerance.
- Monitoring Parameters: Renal function, hepatic function, cardiovascular status, gastrointestinal symptoms.
Popular Combinations
While Aceclofenac + Pregabalin is itself a combination, it may be used in conjunction with other medications for managing specific conditions, such as additional analgesics or medications for underlying diseases. Any combined use requires careful consideration of potential drug interactions and side effects.
Precautions
- General Precautions: Pre-screening for allergies, renal/hepatic dysfunction, cardiovascular disease is crucial.
- Specific Populations: Monitor closely in pregnant/breastfeeding women, children, and the elderly.
- Lifestyle Considerations: Avoid alcohol. Driving restrictions may be necessary due to dizziness and drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Pregabalin?
A: The typical starting dose for adults is one tablet (200 mg aceclofenac + 150 mg pregabalin) once or twice daily, after meals. Adjust based on individual response and tolerability. Pediatric dosing requires careful consideration based on weight and necessitates close monitoring.
Q2: What are the common side effects?
A: Common side effects include nausea, dizziness, drowsiness, dry mouth, peripheral edema, and gastrointestinal discomfort.
Q3: Is Aceclofenac + Pregabalin safe during pregnancy?
A: No, it’s generally not recommended during pregnancy, particularly the third trimester, unless the potential benefits clearly outweigh the risks. Consult a healthcare professional before use.
Q4: Can I consume alcohol while taking this medication?
A: Alcohol consumption should be avoided as it can exacerbate side effects like dizziness and drowsiness.
Q5: What conditions does Aceclofenac + Pregabalin treat?
A: It treats neuropathic pain, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and other conditions involving both inflammatory and neuropathic pain components.
Q6: Are there any serious side effects I should be aware of?
A: Yes, rare but serious side effects can include allergic reactions, gastrointestinal bleeding, and cardiovascular events. Seek immediate medical attention if these occur.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is close to your next scheduled dose. Do not double the dose.
Q8: How does Aceclofenac + Pregabalin work at the cellular level?
A: Aceclofenac inhibits COX enzymes, reducing prostaglandin production. Pregabalin binds to voltage-gated calcium channels, decreasing neurotransmitter release.
Q9: Who should not take Aceclofenac + Pregabalin?
A: Individuals with hypersensitivity to either drug, active ulcers, severe liver or kidney impairment, severe heart failure, or a history of aspirin/NSAID-induced asthma should not take this medication.
