Usage
Paracetamol + Thiocolchicoside is prescribed for the short-term (up to 7 days) adjunctive treatment of painful muscle contractures in acute spinal conditions in adults and adolescents from 16 years onwards. It combines the analgesic and antipyretic properties of paracetamol with the muscle relaxant effects of thiocolchicoside.
Pharmacological Classification: Analgesic, Muscle Relaxant, Antipyretic.
Mechanism of Action: Paracetamol inhibits prostaglandin synthesis, reducing pain and fever. Thiocolchicoside acts centrally, likely at the spinal cord level, to reduce muscle tone and spasm.
Alternate Names
There is no widely recognized international nonproprietary name (INN) for this combination. Regional variations exist depending on the specific brand marketed.
Brand Names: Several brand names exist for Paracetamol + Thiocolchicoside. Some examples include Nucoxia-P, Thiocolchicoside + Paracetamol, and Myoril-P.
How It Works
Pharmacodynamics: Paracetamol inhibits central and peripheral prostaglandin synthesis, impacting pain and fever pathways. Thiocolchicoside acts centrally, particularly at the spinal cord, producing GABAergic and glycinergic effects, leading to muscle relaxation. Its precise molecular mode of action is not fully elucidated but may involve modulation of GABA and glycine receptors.
Pharmacokinetics: Paracetamol is readily absorbed after oral administration, reaching peak plasma levels within 30-60 minutes. It is metabolized primarily in the liver via conjugation reactions and excreted renally. Thiocolchicoside is also readily absorbed. Its metabolic pathways and elimination routes are less clearly defined but involve hepatic metabolism and both renal and biliary excretion.
Dosage
Standard Dosage
Adults: The standard dose is one tablet of Paracetamol (typically 500mg) + Thiocolchicoside (typically 4mg) two to three times a day. The maximum daily dose of thiocolchicoside should not exceed 16 mg. The treatment duration should be limited to 7 days.
Children: Paracetamol + Thiocolchicoside is not recommended for children under 16 years of age due to safety concerns regarding thiocolchicoside.
Special Cases:
- Elderly Patients: Dosage adjustments might be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Caution should be used, with potential dose reduction of thiocolchicoside as it’s partially excreted renally.
- Patients with Hepatic Dysfunction: Paracetamol dosage should be reduced in patients with hepatic impairment. Thiocolchicoside should be used with caution.
- Patients with Comorbid Conditions: No specific dosage recommendations exist. Clinical judgment should be used to assess individual patient needs and adjust the dose accordingly.
Clinical Use Cases
The use of paracetamol + thiocolchicoside in specialized clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations is not standard practice and typically not indicated.
Dosage Adjustments
Dose adjustments are necessary for patients with renal or hepatic impairment and should be individualized based on the severity of the dysfunction.
Side Effects
Common Side Effects
Nausea, vomiting, diarrhea, drowsiness, dizziness, stomach pain, skin rash, allergic reactions.
Rare but Serious Side Effects
Severe allergic reactions (anaphylaxis), Stevens-Johnson Syndrome, liver toxicity (with paracetamol overdose), blood dyscrasias.
Long-Term Effects
Long-term use of this combination is not recommended, so chronic effects are generally not observed. However, prolonged high-dose paracetamol use carries the risk of hepatotoxicity.
Adverse Drug Reactions (ADR)
Severe allergic reactions, hepatotoxicity (paracetamol), blood dyscrasias (thiocolchicoside).
Contraindications
- Hypersensitivity to paracetamol or thiocolchicoside.
- Pregnancy and breastfeeding.
- Women of childbearing potential not using effective contraception.
- Severe hepatic impairment.
- Severe renal impairment.
Drug Interactions
- Alcohol: Increases the risk of paracetamol-induced liver damage.
- Anticoagulants (e.g., warfarin): Paracetamol may enhance the anticoagulant effect.
- Cholestyramine: May reduce the absorption of paracetamol.
- Drugs metabolized by the liver: Potential for interactions with drugs metabolized by CYP enzymes, although limited information on specific thiocolchicoside interactions is available.
Pregnancy and Breastfeeding
This drug combination is contraindicated during pregnancy and breastfeeding.
Drug Profile Summary
- Mechanism of Action: Paracetamol: Analgesic and antipyretic via inhibition of prostaglandin synthesis. Thiocolchicoside: Muscle relaxant acting centrally at the spinal cord.
- Side Effects: Nausea, vomiting, diarrhea, drowsiness, dizziness, rash, allergic reactions.
- Contraindications: Hypersensitivity, pregnancy, breastfeeding, severe hepatic or renal impairment.
- Drug Interactions: Alcohol, anticoagulants, cholestyramine, other drugs metabolized by the liver.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: One tablet (paracetamol 500mg + thiocolchicoside 4mg) two to three times daily, maximum 16mg thiocolchicoside/day for up to 7 days. Not recommended for children under 16.
- Monitoring Parameters: Monitor for liver function (especially with long-term paracetamol use), signs of allergic reactions, and any other adverse events.
Popular Combinations
It is sometimes combined with other analgesics (e.g. aceclofenac) or NSAIDs.
Precautions
- Screen for pre-existing liver or kidney disease.
- Avoid alcohol during treatment.
- Caution in the elderly and in patients with comorbid conditions.
- Discontinue if allergic reactions occur.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Paracetamol + Thiocolchicoside?
A: One tablet (usually containing 500mg paracetamol and 4mg thiocolchicoside) two or three times a day, not exceeding 16mg thiocolchicoside daily, for up to 7 days.
Q2: Can this combination be used in children?
A: No, it’s not recommended for children under 16 due to safety concerns regarding thiocolchicoside.
Q3: What are the common side effects?
A: Nausea, vomiting, diarrhea, drowsiness, dizziness, stomach pain, and skin rash.
Q4: Is it safe during pregnancy or breastfeeding?
A: No, it is contraindicated in both pregnancy and breastfeeding.
Q5: What should be done in case of an overdose?
A: Seek immediate medical attention. Paracetamol overdose can cause serious liver damage.
Q6: Can it be taken with other medications?
A: Inform your doctor about all medications you are taking as there are potential drug interactions, especially with alcohol, anticoagulants, and drugs metabolized by the liver.
Q7: What are the contraindications?
A: Hypersensitivity, pregnancy, breastfeeding, severe hepatic or renal impairment.
Q8: What is the duration of treatment?
A: Treatment should not exceed 7 days.
Q9: How does Thiocolchicoside work as a muscle relaxant?
A: It works centrally, mainly at the spinal cord level, producing GABAergic and glycinergic effects, leading to muscle relaxation.
Q10: What are the monitoring parameters for Paracetamol + Thiocolchicoside?
A: Monitor for signs of liver dysfunction, allergic reactions, or other adverse effects. Regular monitoring is important, especially with prolonged paracetamol use.
