Usage
- Medical Conditions: This combination medication is primarily prescribed for the management of moderate to severe pain associated with conditions such as osteoarthritis, rheumatoid arthritis, musculoskeletal disorders, and postoperative pain. It may also be used for other painful conditions as deemed appropriate by a physician.
- Pharmacological Classification: Analgesic (pain reliever), Nonsteroidal anti-inflammatory drug (NSAID), Opioid analgesic.
- Mechanism of Action: Aceclofenac, an NSAID, inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, which are mediators of pain and inflammation. Paracetamol has analgesic and antipyretic effects through central mechanisms, possibly by inhibiting COX-3 in the brain and spinal cord. Tramadol, an opioid analgesic, acts on mu-opioid receptors and inhibits serotonin and norepinephrine reuptake, modifying pain perception in the central nervous system.
Alternate Names
- No widely recognized alternate names for the combination exist.
- Brand Names: Numerous brand names exist depending upon the country and manufacturer. Some examples are listed in the “Other brands with the same generic” section.
How It Works
- Pharmacodynamics: Aceclofenac and paracetamol work synergistically to reduce pain and inflammation peripherally, while tramadol acts centrally to modify pain perception.
- Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver, and excreted primarily through the kidneys. Paracetamol is rapidly absorbed, also metabolized in the liver, and excreted in the urine. Tramadol undergoes hepatic metabolism, and its metabolites are eliminated renally.
- Mode of Action: Aceclofenac and paracetamol inhibit COX enzymes, while tramadol binds to mu-opioid receptors, inhibits serotonin and norepinephrine reuptake in the CNS.
- Elimination Pathways: Aceclofenac and paracetamol are primarily excreted via renal pathways following hepatic metabolism. Tramadol and its metabolites are also renally excreted following hepatic biotransformation.
Dosage
Standard Dosage
Adults:
- One tablet containing Aceclofenac (100mg), Paracetamol (325mg), and Tramadol (37.5mg) or equivalent, taken twice daily, every 12 hours. Or one tablet containing Aceclofenac (100mg), Paracetamol (325mg), and Tramadol (50mg) or equivalent, taken twice daily, every 12 hours. The maximum daily dose should not exceed 8 tablets of the 37.5mg dose or 4 tablets of the 75mg dose. The dosage interval should not be less than six hours.
Children:
- Not recommended for children under 12 years of age. Safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Caution is advised; dose adjustments may be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Dose adjustments may be required. Consult drug prescribing information for dosage recommendations based on creatine clearance levels.
- Patients with Hepatic Dysfunction: Use with caution; dose adjustments may be necessary. Consult drug prescribing information for dosage recommendations based on liver function tests.
- Patients with Comorbid Conditions: Caution is advised for patients with cardiovascular disease, respiratory depression, or epilepsy.
Clinical Use Cases
The standard dosage guidelines generally apply to these settings; dosage individualization may be necessary.
- Intubation: Standard dosage or as per anesthesiologist’s discretion.
- Surgical Procedures: Standard dosage for postoperative pain management.
- Mechanical Ventilation: No specific dosage adjustments indicated; consider patient-specific factors.
- Intensive Care Unit (ICU) Use: Dosage may be adjusted based on individual needs and pain assessment.
- Emergency Situations: Consider alternative analgesics in acute emergencies requiring rapid pain control. Tramadol may not be the best approach, and other opioids and/or analgesics should be considered.
Dosage Adjustments:
Adjustments may be required based on renal or hepatic function, other medical conditions, and concomitant medications. Close monitoring is necessary.
Side Effects
Common Side Effects:
Nausea, vomiting, dizziness, drowsiness, headache, constipation, dry mouth, sweating, indigestion, anxiety, and changes in mood or sleep patterns.
Rare but Serious Side Effects:
Allergic reactions (skin rash, itching, swelling), respiratory depression, seizures, serotonin syndrome (fever, confusion, muscle rigidity), Stevens-Johnson syndrome, toxic epidermal necrolysis. Liver toxicity with higher doses of paracetamol, particularly with concurrent alcohol use.
Long-Term Effects:
Potential for opioid tolerance, dependence, and withdrawal symptoms with prolonged tramadol use. Potential for NSAID-induced gastrointestinal complications and renal dysfunction with long-term aceclofenac use. Potential for liver toxicity with chronic use of excessive paracetamol.
Adverse Drug Reactions (ADR):
Any severe side effect listed above requires immediate medical attention.
Contraindications
- Hypersensitivity to any component of the medication.
- Severe hepatic or renal impairment.
- Severe respiratory depression.
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
- Suspected or confirmed paralytic ileus.
- Acute intoxication with alcohol, hypnotic drugs, centrally acting analgesics, opioids, or psychotropic drugs.
- Patients currently receiving MAOIs or who have taken them within the past two weeks.
- Convulsive disorders.
- Pregnancy, especially the third trimester.
- Breastfeeding, particularly during early lactation.
- Children under 12 years old.
Drug Interactions
- Other NSAIDs, corticosteroids, anticoagulants (warfarin), SSRIs, tricyclic antidepressants, MAOIs, opioids, benzodiazepines, alcohol, and other CNS depressants. Concomitant use can exacerbate side effects like drowsiness, dizziness, respiratory depression, gastrointestinal bleeding, and serotonin syndrome.
- CYP450 interactions: Tramadol is metabolized by CYP2D6; coadministration with inhibitors or inducers of this enzyme can alter tramadol levels.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not recommended, especially in the third trimester, due to the potential for neonatal withdrawal symptoms and other complications. Caution advised throughout pregnancy.
- Breastfeeding: Tramadol and paracetamol are excreted in breast milk. Not generally recommended, especially during early lactation.
- Consult with a physician regarding potential risks and benefits if use is considered essential.
Drug Profile Summary
- Mechanism of Action: Aceclofenac and paracetamol reduce prostaglandin synthesis, Tramadol activates mu opioid receptors, and inhibits serotonin and norepinephrine uptake.
- Side Effects: Nausea, vomiting, dizziness, drowsiness, constipation; rarely, respiratory depression, seizures, serotonin syndrome, liver damage.
- Contraindications: Hypersensitivity, severe hepatic/renal impairment, respiratory depression, epilepsy, MAOI use, pregnancy (3rd trimester).
- Drug Interactions: NSAIDs, anticoagulants, SSRIs, opioids, CNS depressants.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: Adults: One tablet (Aceclofenac 100mg + Paracetamol 325mg + Tramadol 37.5/50mg) twice daily.
- Monitoring Parameters: Liver and renal function tests, respiratory rate, mental status, pain assessment.
Popular Combinations
Aceclofenac + Paracetamol + Tramadol is itself a combination product. Further combinations are generally not recommended and should only be utilized under close medical supervision.
Precautions
- Evaluate renal and hepatic function, history of gastrointestinal bleeding, and opioid dependence before initiating therapy.
- Closely monitor patients for adverse reactions, especially during initial treatment.
- Avoid concurrent use with alcohol and other CNS depressants.
- Exercise caution in elderly patients.
- Not recommended for pregnant or breastfeeding women.
- Advise patients not to drive or operate machinery while experiencing drowsiness or dizziness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Paracetamol + Tramadol?
A: Adults: One tablet (Aceclofenac 100mg + Paracetamol 325mg + Tramadol 37.5/50mg) twice daily. Not recommended for children under 12.
Q2: What are the common side effects?
A: Nausea, dizziness, drowsiness, constipation, headache.
Q3: Is it safe during pregnancy?
A: Not recommended, especially in the third trimester.
Q4: Can I take it with alcohol?
A: No, avoid alcohol while taking this medication.
Q5: What are the serious side effects I should be aware of?
A: Allergic reactions, respiratory depression, seizures, serotonin syndrome.
Q6: 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 next scheduled dose. Do not double the dose.
Q7: What are the contraindications?
A: Hypersensitivity, severe hepatic/renal impairment, respiratory depression, current MAOI use, epilepsy.
Q8: Can it be used for long-term pain management?
A: Long-term use should be carefully evaluated due to the potential for tolerance, dependence, and other adverse effects. Close monitoring is essential.
Q9: What if the pain persists despite taking the medication?
A: Contact your physician, as alternative pain management strategies may be necessary. Do not exceed the recommended dosage without medical advice.
Q10: Can I crush or chew the tablet?
A: No. Swallow the tablet whole with a glass of water, with or without food. Crushing or chewing can alter the drug release profile.
