Usage
Aceclofenac + Paracetamol + Tizanidine is prescribed for the relief of pain and inflammation associated with musculoskeletal conditions, such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, low back pain, muscle spasms, and spasticity. It can also be used to alleviate dental pain, menstrual cramps, and headaches. This combination medication falls under the pharmacological classifications of Nonsteroidal anti-inflammatory drug (NSAID), analgesic, and skeletal muscle relaxant.
Aceclofenac inhibits cyclooxygenase enzymes (COX-1 and COX-2), reducing prostaglandin production, which are responsible for inflammation and pain. Paracetamol is thought to inhibit COX enzymes in the central nervous system, further contributing to pain and fever reduction. Tizanidine, an α2-adrenergic agonist, acts centrally to reduce muscle tone and spasms by inhibiting the release of excitatory neurotransmitters in the spinal cord.
Alternate Names
While there are no officially recognized alternate names for this specific three-drug combination, the individual components may be known by other names (e.g., paracetamol is also known as acetaminophen). Brand names for combinations containing these three drugs include Accetiz P, Movon-MR, Alcinac MR, Ntdol MR, Anprox-MR Tablet, Kinectine MR, Valdone MR, Leemoflam-MR, Acimol-MRX, and Acelase TZ. These brand names may vary depending on the region and manufacturer.
How It Works
Pharmacodynamics: Aceclofenac, as an NSAID, primarily reduces pain and inflammation by inhibiting COX-1 and COX-2 enzymes, thus decreasing prostaglandin synthesis. Paracetamol offers additional analgesic and antipyretic effects through central COX inhibition. Tizanidine centrally mediates muscle relaxation by binding to α2-adrenergic receptors in the spinal cord, inhibiting the release of excitatory amino acids like glutamate and aspartate. This reduces neuronal excitability and muscle tone, relieving muscle spasms and spasticity.
Pharmacokinetics: Aceclofenac is well-absorbed orally, metabolized in the liver, and primarily excreted through the kidneys. Paracetamol is also rapidly absorbed and metabolized in the liver, with most being excreted in the urine as glucuronide and sulfate conjugates. Tizanidine is readily absorbed, with a peak plasma concentration reached in about one hour. It undergoes extensive hepatic metabolism, primarily by CYP1A2, and is mainly excreted renally.
Dosage
Dosage information for the combination of Aceclofenac, Paracetamol, and Tizanidine is limited, and individualized treatment is crucial. Consulting a physician is necessary for specific dosage recommendations.
Standard Dosage
Adults:
A common dosage form combines 100mg Aceclofenac, 325mg or 500mg Paracetamol, and 2mg Tizanidine. This combination is usually taken twice daily, but the exact dosage and frequency should be determined and adjusted by a physician based on the individual patient’s needs and response.
Children:
The safety and efficacy of this combination in children have not been established. Its use is generally not recommended in pediatric patients.
Special Cases:
- Elderly Patients: Close monitoring and potential dosage adjustments are advised due to age-related decline in renal and hepatic function.
- Patients with Renal Impairment: Dosage reduction may be necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Dosage adjustments are needed for impaired metabolism.
- Patients with Comorbid Conditions: Caution and individualized dosing are required in patients with comorbidities like hypertension, heart disease, or diabetes.
Clinical Use Cases and Dosage Adjustments
Dosage recommendations for clinical scenarios like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are not readily available for this combination. Dose modifications based on renal/hepatic function, metabolic disorders, or genetic polymorphisms should be made with caution and under the guidance of a healthcare professional.
Side Effects
Common Side Effects:
Nausea, vomiting, stomach pain, diarrhea/constipation, dizziness, drowsiness, loss of appetite, heartburn, indigestion, abdominal pain.
Rare but Serious Side Effects:
Allergic reactions (e.g., skin rash, itching, facial swelling, difficulty breathing), liver damage (especially with paracetamol overuse), gastrointestinal bleeding or ulceration, heart problems.
Long-Term Effects:
Potential long-term complications from prolonged NSAID use include renal dysfunction, cardiovascular issues, and gastrointestinal problems.
Adverse Drug Reactions (ADR):
Severe allergic reactions, hepatotoxicity, gastrointestinal bleeding, cardiovascular events.
Contraindications
Hypersensitivity to any of the components, active peptic ulcer, severe heart failure, severe hepatic or renal impairment, recent bypass surgery, history of gastrointestinal bleeding, pregnancy, breastfeeding.
Drug Interactions
This combination can interact with other NSAIDs, anticoagulants, antihypertensives, certain antidepressants, alcohol, and other drugs metabolized by CYP1A2 (e.g., fluvoxamine, ciprofloxacin). Consult a healthcare professional for specific interactions and potential dosage adjustments.
Pregnancy and Breastfeeding
This combination is generally contraindicated during pregnancy and breastfeeding due to potential risks to the fetus or neonate. Safer alternative analgesics should be considered.
Drug Profile Summary
- Mechanism of Action: Aceclofenac and Paracetamol: COX inhibition, reducing prostaglandin synthesis. Tizanidine: α2-adrenergic agonist, central muscle relaxation.
- Side Effects: Nausea, dizziness, drowsiness, gastrointestinal issues, liver damage (paracetamol), allergic reactions.
- Contraindications: Hypersensitivity, active peptic ulcer, severe liver/kidney/heart disease, pregnancy, breastfeeding.
- Drug Interactions: Other NSAIDs, anticoagulants, antihypertensives, CYP1A2 substrates.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adult: 100mg Aceclofenac/325mg or 500mg Paracetamol/2mg Tizanidine twice daily (adjust as needed). Pediatric: Not recommended.
- Monitoring Parameters: Liver and kidney function tests, blood pressure, signs of gastrointestinal bleeding.
Popular Combinations
Information on popular combinations specifically using this combination is limited.
Precautions
Monitor for hepatic and renal function, gastrointestinal symptoms, and allergic reactions. Caution in patients with cardiovascular disease, asthma, or bleeding disorders. Avoid alcohol. Driving impairment may occur due to drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Paracetamol + Tizanidine?
A: A common dosage is 100mg Aceclofenac, 325mg or 500mg Paracetamol, and 2mg Tizanidine twice daily. Dosage should be individualized based on patient needs and response.
Q2: Can this combination be used in children?
A: No, safety and efficacy have not been established in children.
Q3: Is it safe to take this medication during pregnancy or while breastfeeding?
A: No, it is generally contraindicated due to potential risks to the fetus/neonate.
Q4: What are the common side effects?
A: Nausea, dizziness, drowsiness, gastrointestinal issues, and loss of appetite are common.
Q5: What are the serious side effects to watch out for?
A: Allergic reactions, liver damage, gastrointestinal bleeding, and cardiovascular issues are potential serious side effects.
Q6: Can I drink alcohol while taking this medication?
A: Alcohol should be avoided as it can increase the risk of drowsiness and gastrointestinal side effects.
Q7: Can this combination interact with other medications?
A: Yes, it can interact with other NSAIDs, anticoagulants, antihypertensives, and other drugs. Consult a physician for specific interactions.
Q8: Are there any contraindications for using this medication?
A: Yes, contraindications include hypersensitivity, active peptic ulcer, severe liver/kidney/heart disease, and pregnancy/breastfeeding.
Q9: What precautions should be taken while using this medication?
A: Patients should be monitored for liver/kidney function, gastrointestinal symptoms, and allergic reactions. Caution is advised in patients with pre-existing conditions like cardiovascular disease or asthma. Avoid alcohol. Driving impairment may occur.
Q10: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember. If it is near the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
