Etodolac + Paracetamol

This drug combination has been banned by the Central Government of India, effective August 12, 2024, due to a lack of therapeutic justification and potential health risks. Therefore, the following information is for historical reference only and should not be used for prescribing or administering this medication.

Usage (Historical)

• This fixed-dose combination was previously indicated for pain and inflammation associated with chronic conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
• Pharmacological classification: Non-steroidal anti-inflammatory drug (NSAID) + Analgesic/Antipyretic.
• Mechanism of action: Etodolac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin production, thereby decreasing inflammation and pain. Paracetamol’s analgesic and antipyretic effects are thought to involve inhibition of prostaglandin synthesis in the central nervous system, although the exact mechanism remains unclear.

Alternate Names (Historical)

• While no specific alternate names exist for the combination, the individual components have their own variations. Internationally, paracetamol may be referred to as acetaminophen.
• Brand Names: This combination was marketed under various brand names, with “Etowise-P” being one example. However, these brands are no longer available due to the ban.

How It Works (Historical)

• Pharmacodynamics: Etodolac reduces inflammation, pain, and fever. Paracetamol primarily reduces pain and fever.
• Pharmacokinetics: Etodolac is well-absorbed orally, metabolized in the liver, and primarily excreted by the kidneys. Paracetamol is also readily absorbed orally, metabolized in the liver, and eliminated in the urine.
• Mode of action: Etodolac acts peripherally by inhibiting COX enzymes, thus blocking prostaglandin production. Paracetamol’s central action likely involves similar inhibition, although the details are not fully understood.
• Receptor binding, enzyme inhibition, or neurotransmitter modulation: Etodolac primarily inhibits COX enzymes. The exact mechanism of paracetamol is not fully elucidated but is thought to involve central COX inhibition.
• Elimination pathways: Both drugs are primarily metabolized in the liver and excreted by the kidneys.

Dosage (Historical)

The following dosage information is provided solely for historical context. This combination is no longer recommended or available for use.

Standard Dosage

Adults:

• Specific dosage regimens varied depending on the formulation and brand. One example was Etodolac 400mg + Paracetamol 325mg taken once daily.
• Dosage adjustments were sometimes necessary depending on the severity of symptoms and individual patient response.

Children:

• This combination was generally not recommended for children under 12.
• For older children (6-16 years), limited dosing guidelines existed, often based on weight. For example, one guideline offered the following based on extended-release tablets: 20-30 kg: 400 mg once daily; 31-45 kg: 600 mg once daily; 46-60 kg: 800 mg once daily; >60 kg: 1000 mg once daily.

Special Cases:

• Elderly Patients: Dose reduction may have been considered due to increased risk of adverse effects.
• Patients with Renal Impairment: Use was not recommended in severe renal impairment. Careful monitoring was advised if used.
• Patients with Hepatic Dysfunction: Dosage adjustment may have been required for severe liver disease.
• Patients with Comorbid Conditions: Caution was advised for patients with heart failure, high blood pressure, and gastrointestinal issues.

Clinical Use Cases & Dosage Adjustments (Historical)

This medication was not indicated for use in acute settings like intubation, surgical procedures, mechanical ventilation, ICU care, or emergencies. Dose modifications were based on factors like renal/hepatic function and other medical conditions.

Side Effects (Historical)

Common Side Effects:

• Nausea, vomiting, stomach pain, indigestion, diarrhea, constipation, gas, dizziness, headache, fatigue, rash, tinnitus.

Rare but Serious Side Effects:

• Allergic reactions, heart attack, stroke, liver damage, kidney damage, gastrointestinal bleeding, skin reactions.

Long-Term Effects:

• Potential for liver and kidney damage with chronic use.

Adverse Drug Reactions:

• Severe allergic reactions, gastrointestinal bleeding, Stevens-Johnson syndrome.

Contraindications (Historical)

• Hypersensitivity to etodolac or paracetamol.
• Active peptic ulcer or gastrointestinal bleeding.
• Severe heart failure.
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
• Third trimester of pregnancy.
• Severe renal impairment.

Drug Interactions (Historical)

• Alcohol
• Other NSAIDs
• Anticoagulants (e.g., warfarin)
• Antihypertensives (e.g., ACE inhibitors)
• Lithium
• Methotrexate
• Corticosteroids

Pregnancy and Breastfeeding (Historical)

• Pregnancy: This combination was contraindicated during the third trimester and not recommended during the first and second trimesters.
• Breastfeeding: Use should be avoided during breastfeeding due to potential risks to the infant.

Drug Profile Summary (Historical)

This information is for historical reference only. The drug is banned in India.

Popular Combinations, Precautions, FAQs (Historical)

Since this combination is no longer used, any discussion of popular combinations, precautions, or FAQs is irrelevant in current clinical practice. Consult updated resources for current information on pain management strategies.