Usage
- Aceclofenac + Thiocolchicoside is prescribed for the relief of pain and inflammation associated with musculoskeletal conditions, particularly muscle spasms. These conditions include degenerative vertebral disorders, vertebral static problems, dorsal pain, low back pain, torticollis (neck muscle contractions), sprains, strains, and muscle injuries. It may also be used in the management of pain and stiffness associated with rheumatoid arthritis and osteoarthritis, and post-operatively.
- Pharmacological Classification: Analgesic (pain reliever), Non-Steroidal Anti-Inflammatory Drug (NSAID), Muscle Relaxant.
- Mechanism of Action: Aceclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin production, thereby decreasing pain and inflammation. Thiocolchicoside acts on the central nervous system, inhibiting receptors in the brain and spinal cord to relieve muscle stiffness and spasms.
Alternate Names
- No widely recognized alternate generic names exist.
- Brand Names: Several brands market this combination, including Noblinac-T, Zerodol-TH, Sonic-T, and others. Brand names may vary regionally.
How It Works
- Pharmacodynamics: Aceclofenac exerts its analgesic and anti-inflammatory effects by inhibiting COX-1 and COX-2 enzymes, leading to reduced prostaglandin synthesis. Thiocolchicoside’s muscle relaxant properties are mediated through its action on the gamma-aminobutyric acid (GABA)ergic system and glycine receptors in the spinal cord, leading to a reduction in muscle tone and spasm.
- Pharmacokinetics: Aceclofenac is well-absorbed orally, reaching peak plasma concentrations within 1-3 hours. It is metabolized in the liver and primarily excreted renally. Thiocolchicoside is also well-absorbed orally, with peak plasma levels reached in approximately 1 hour. It undergoes hepatic metabolism and is primarily eliminated through the kidneys.
- Mode of Action: Aceclofenac targets COX enzymes, blocking the conversion of arachidonic acid to prostaglandins, which are mediators of pain and inflammation. Thiocolchicoside is believed to act centrally, specifically targeting GABA and glycine receptors in the spinal cord to reduce muscle excitability.
- Elimination Pathways: Both Aceclofenac and Thiocolchicoside are predominantly excreted by the kidneys, with a smaller portion eliminated through the biliary route. Metabolism by CYP enzymes occurs for both drugs.
Dosage
Standard Dosage
Adults:
- The typical adult dose is one tablet of Aceclofenac 100mg + Thiocolchicoside 4mg twice daily. The duration of treatment generally should not exceed 7 days.
Children:
- This combination is generally not recommended for children under 18 years of age, as safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Start with a lower dose and monitor closely for adverse events due to potential age-related decline in renal and hepatic function.
- Patients with Renal Impairment: Caution is advised. Dose reduction may be necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Use with caution and consider dose reduction, especially in severe hepatic impairment.
- Patients with Comorbid Conditions: Careful monitoring is necessary in patients with cardiovascular disease, diabetes, or other conditions.
Clinical Use Cases
- The combination of Aceclofenac and Thiocolchicoside is not typically indicated for use in clinical settings such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Other medications are typically preferred in these contexts.
Dosage Adjustments:
- Dosage adjustments should be based on patient-specific factors like renal or hepatic function, comorbid conditions, and concomitant medications.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea, stomach pain, heartburn, loss of appetite, dizziness, drowsiness.
Rare but Serious Side Effects:
- Gastrointestinal bleeding or perforation, allergic reactions, Stevens-Johnson Syndrome, toxic epidermal necrolysis, liver damage, kidney damage.
Long-Term Effects:
- Prolonged use can increase the risk of gastrointestinal complications, cardiovascular events, and renal impairment.
Adverse Drug Reactions (ADR):
- Anaphylaxis, angioedema, severe skin reactions, hepatotoxicity, nephrotoxicity.
Contraindications
- Hypersensitivity to aceclofenac, thiocolchicoside, or any component of the formulation.
- Active or history of recurrent peptic ulcer/gastrointestinal bleeding.
- Severe hepatic impairment or renal failure.
- Pregnancy (especially third trimester).
- Breastfeeding.
- Patients with bleeding disorders.
- Patients with severe heart failure, ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
Drug Interactions
- Anticoagulants (e.g., warfarin): Increased risk of bleeding.
- Diuretics: Increased risk of renal impairment.
- Methotrexate: Increased risk of methotrexate toxicity.
- Lithium: Increased risk of lithium toxicity.
- ACE inhibitors: Reduced effectiveness of ACE inhibitors.
- Other NSAIDs: Increased risk of gastrointestinal side effects.
- Alcohol: Increased risk of gastrointestinal side effects.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not recommended during pregnancy, particularly in the third trimester.
- Fetal Risks: Potential for premature closure of the ductus arteriosus, fetal renal dysfunction.
- Breastfeeding: The drug is excreted in breast milk and should be avoided during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Aceclofenac: COX inhibitor; Thiocolchicoside: Centrally acting muscle relaxant.
- Side Effects: Nausea, vomiting, diarrhea, stomach pain, dizziness, drowsiness, GI bleeding (rare).
- Contraindications: Hypersensitivity, peptic ulcer, severe liver/kidney disease, pregnancy, breastfeeding.
- Drug Interactions: Anticoagulants, diuretics, methotrexate, lithium, ACE inhibitors, alcohol.
- Pregnancy & Breastfeeding: Avoid.
- Dosage: 100mg/4mg twice daily, max 7 days.
- Monitoring Parameters: Liver function tests, renal function tests, signs of GI bleeding.
Popular Combinations
- Aceclofenac + Thiocolchicoside + Paracetamol: This combination is sometimes used for enhanced pain relief.
Precautions
- General Precautions: Use cautiously in patients with a history of peptic ulcer disease, gastrointestinal bleeding, renal or hepatic impairment, asthma, or cardiovascular disease.
- Specific Populations: Use with caution in the elderly and avoid in pregnancy and breastfeeding.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Thiocolchicoside?
A: The standard adult dose is one tablet of Aceclofenac 100mg + Thiocolchicoside 4mg twice daily, not to exceed 7 days.
Q2: Can I take this medication if I am pregnant or breastfeeding?
A: No, this combination should be avoided during pregnancy, especially the third trimester, and during breastfeeding.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, stomach pain, heartburn, and dizziness.
Q4: How does this medication work?
A: Aceclofenac reduces pain and inflammation by inhibiting COX enzymes, while Thiocolchicoside relaxes muscles by acting on the central nervous system.
Q5: Are there any serious side effects I should be aware of?
A: Though rare, serious side effects include gastrointestinal bleeding, allergic reactions, and liver or kidney damage. Seek immediate medical attention if these occur.
Q6: Can I drink alcohol while taking this medication?
A: Alcohol should be avoided, as it can increase the risk of gastrointestinal side effects.
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 the time for your next dose. Do not double the dose to catch up.
Q8: Can I drive while taking this medication?
A: Use caution, as the medication may cause dizziness or drowsiness. Avoid driving or operating machinery if you experience these side effects.
Q9: What are the contraindications for this medication?
A: Contraindications include hypersensitivity, active peptic ulcer disease, severe liver/kidney disease, pregnancy, breastfeeding, bleeding disorders, severe heart failure, ischemic heart disease, and cerebrovascular disease.
