Usage
- This combination medication is primarily prescribed for short-term relief of pain and inflammation associated with musculoskeletal and joint disorders, such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, muscle spasms, sprains, strains, low back pain, and other painful musculoskeletal conditions.
- Pharmacological Classification: This drug is a combination of a Non-Steroidal Anti-Inflammatory Drug (NSAID) (Aceclofenac), an analgesic and antipyretic (Paracetamol), and a muscle relaxant (Thiocolchicoside).
- Mechanism of Action: Aceclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, which are mediators of pain and inflammation. Paracetamol acts centrally to relieve pain and fever. Thiocolchicoside acts on the central nervous system, reducing muscle stiffness and spasms.
Alternate Names
- There are no widely recognized alternate generic names.
- Brand Names: Several brand names exist for this combination drug. A few of these are StayHappi, Genericart, Myfla TH Max 4, MALLicide-AP, Sepiclo PT4, Miofree A, Topnac TH, Swaslife Th forte, Colchifenac, Neorelax MR. These brand names can vary regionally.
How It Works
- Pharmacodynamics: Aceclofenac exerts analgesic and anti-inflammatory effects by inhibiting COX-1 and COX-2 enzymes, thereby reducing prostaglandin synthesis. Paracetamol acts on the central nervous system to reduce pain and fever but possesses minimal anti-inflammatory activity. Thiocolchicoside acts centrally to relieve muscle spasms. The combination reduces pain, inflammation and muscle spasm.
- Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver, and excreted primarily through the kidneys. Paracetamol is also rapidly absorbed and metabolized in the liver, with excretion primarily via the kidneys. Thiocolchicoside displays good absorption when administered orally or intramuscularly.
- Mode of Action: Aceclofenac and Paracetamol act by inhibiting COX enzymes, thus decreasing prostaglandin production which is key for inflammation and pain transmission. Thiocolchicoside’s precise mechanism is unclear, but it acts on GABA and glycine receptors in the central nervous system, leading to muscle relaxation.
- Elimination Pathways: Aceclofenac is primarily eliminated via renal excretion. Paracetamol undergoes hepatic metabolism and is eliminated primarily by the kidneys. Thiocolchicoside’s elimination pathway is not completely understood.
Dosage
Standard Dosage
Adults:
- The typical adult dosage is one tablet containing Aceclofenac 100mg, Paracetamol 325mg, and Thiocolchicoside 4mg, taken two to three times daily.
- Maximum dosage: Should not exceed the recommended dose, generally not more than three tablets per day.
Children:
- Not recommended for use in children below 18 years of age due to limited safety and efficacy data.
Special Cases:
- Elderly Patients: Caution advised; start with a lower dose and monitor for adverse effects.
- Patients with Renal Impairment: Dose reduction may be necessary.
- Patients with Hepatic Dysfunction: Dose reduction is recommended.
- Patients with Comorbid Conditions: Consider interactions and adjust accordingly.
Clinical Use Cases
- Not typically used for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. This medication’s primary indication is pain and inflammation management in musculoskeletal conditions.
Dosage Adjustments
- Adjust based on individual patient factors, including renal and hepatic function and other relevant medical conditions.
Side Effects
Common Side Effects
- Nausea, vomiting, stomach pain, loss of appetite, heartburn, diarrhea, dizziness, drowsiness, headache, skin rashes, dry mouth, indigestion.
Rare but Serious Side Effects
- Allergic reactions, gastrointestinal bleeding, peptic ulcers, liver dysfunction, kidney problems, cardiovascular thrombotic events.
Long-Term Effects
- Potential for renal impairment, gastrointestinal issues, cardiovascular risks with prolonged use.
Adverse Drug Reactions (ADR)
- Angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (rare but require immediate attention).
Contraindications
- Hypersensitivity to any of the drug components.
- Active peptic ulcer, gastrointestinal bleeding.
- Severe hepatic or renal impairment.
- History of heart failure, hypertension.
- Pregnancy, especially the third trimester and breastfeeding.
Drug Interactions
- Other NSAIDs, anticoagulants (warfarin, aspirin), corticosteroids, antihypertensives, diuretics, alcohol.
- May interact with certain anticonvulsants, antitubercular drugs, antidepressants (SSRIs), and other medications.
Pregnancy and Breastfeeding
- Contraindicated during pregnancy, especially in the third trimester, and breastfeeding.
- Potential risks to the fetus include premature closure of the ductus arteriosus and other complications.
Drug Profile Summary
- Mechanism of Action: Aceclofenac: COX inhibitor, reducing prostaglandin synthesis. Paracetamol: Central analgesic and antipyretic. Thiocolchicoside: Central muscle relaxant.
- Side Effects: Nausea, vomiting, GI upset, dizziness, drowsiness, rash. Serious side effects include GI bleeding and liver/kidney problems.
- Contraindications: Hypersensitivity, active peptic ulcer, severe hepatic/renal impairment, pregnancy, breastfeeding.
- Drug Interactions: NSAIDs, anticoagulants, corticosteroids, antihypertensives.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: 1 tablet (100mg/325mg/4mg) two to three times a day. Adjust for elderly and those with renal/hepatic issues.
- Monitoring Parameters: Liver and kidney function tests, blood pressure.
Popular Combinations
- This combination itself is a commonly used formulation. Individual components may be combined with other drugs, but this specific triple combination is typical.
Precautions
- General Precautions: Evaluate for allergies, renal/hepatic function before prescribing.
- Specific Populations: Avoid in pregnancy and breastfeeding. Caution in elderly and patients with hepatic/renal impairment.
- Lifestyle Considerations: Avoid alcohol, limit driving until effects are known.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Paracetamol + Thiocolchicoside?
A: The usual adult dose is one tablet (containing 100mg Aceclofenac, 325mg Paracetamol, and 4mg Thiocolchicoside) two to three times daily. This can be adjusted based on patient-specific factors. Not recommended for children below 18.
Q2: Can this medication be used during pregnancy or while breastfeeding?
A: No, it’s contraindicated during both pregnancy, especially in the third trimester, and while breastfeeding.
Q3: What are the common side effects?
A: Nausea, vomiting, stomach pain, heartburn, diarrhea, dizziness, and drowsiness.
Q4: What are the serious side effects I should watch out for?
A: Allergic reactions, gastrointestinal bleeding, peptic ulcers, liver or kidney dysfunction.
Q5: Are there any drug interactions I should be aware of?
A: Yes, it can interact with other NSAIDs, anticoagulants (like warfarin or aspirin), corticosteroids, and antihypertensives. Alcohol should also be avoided.
Q6: Can patients with liver or kidney disease take this medication?
A: It should be used cautiously and with dose adjustments in patients with mild to moderate liver or kidney disease. It is contraindicated in severe hepatic or renal impairment.
Q7: Can this medicine be taken with aspirin?
A: Combining with aspirin or other NSAIDs is generally not recommended due to an increased risk of side effects, particularly gastrointestinal issues.
Q8: How long should this medication be taken?
A: This is a short-term medication usually prescribed for a limited period until the pain and inflammation subside. Consult a physician before prolonged use.
Q9: Can I operate machinery after taking this medication?
A: Use caution when operating machinery or driving as it can cause dizziness and drowsiness. Avoid these activities until the effects on the individual are known.
Q10: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s nearly time for your next dose. Do not double the dose to catch up.
